issue-1996-10-02•Federal Register final rules — 1996-10-02
Federal Register final rules — 1996-10-02
issue-1996-10-02Federal Register final rules — 1996-10-02Regulation
Published Federal Register documents, not public-inspection drafts. The GPO XML/text rendition is a research aid; the linked complete official PDF retains the printed layout and all graphics. Graphics are retained in that PDF and are not independently reproduced in this text rendition. Publication does not establish that every provision remains legally in force.
FR Doc. 96-25233 Clean Air Act Final Interim Approval of Operating Permits Program; Delegation of Section 112 Standards; State of Vermont
[Federal Register Volume 61, Number 192 (Wednesday, October 2, 1996)]
[Rules and Regulations]
[Pages 51368-51370]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-25233]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 70
[AD-FRL-5612-6]
Clean Air Act Final Interim Approval of Operating Permits
Program; Delegation of Section 112 Standards; State of Vermont
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final interim approval.
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SUMMARY: The EPA is promulgating interim approval of the Operating
Permits Program submitted by the State of Vermont for the purpose of
complying with Federal requirements for an approvable State program to
issue operating permits to all major stationary sources, and to certain
other sources.
EFFECTIVE DATE: November 1, 1996.
ADDRESSES: Copies of the State's submittal and other supporting
information used in developing the final interim approval are available
for inspection during normal business hours at the following location:
Office of Ecosystem Protection, U.S. Environmental Protection Agency,
Region I, One Congress Street, 11th floor, Boston, MA.
FOR FURTHER INFORMATION CONTACT: Ida Gagnon, (617) 565-3500.
SUPPLEMENTARY INFORMATION:
I. Background
Title V of the 1990 Clean Air Act Amendments (sections 501-507 of
the Clean Air Act (``the Act'')), and implementing regulations at 40
Code of Federal Regulations (CFR) Part 70 require that States develop
and submit operating permits programs to EPA by November 15, 1993, and
that EPA act to approve or disapprove each program within 1 year after
receiving the submittal. The EPA's program review occurs pursuant to
section 502 of the Act and the Part 70 regulations, which together
outline criteria for approval or disapproval. Where a program
substantially, but not fully, meets the requirements of Part 70, EPA
may grant the program interim approval for a period of up to 2 years.
If EPA has not fully approved a program by 2 years after the November
15, 1993 date, or by the end of an interim program, it must establish
and implement a Federal program.
On May 24, 1996, EPA proposed interim approval of the operating
permits program for the State of Vermont. See 61 FR 26145. The EPA
received comments from the State of Vermont on the proposal. In this
document EPA is taking final action to promulgate interim approval of
the operating permits program for the State of Vermont.
II. Response to Comments
The comments received on the May 24, 1996 proposed rulemaking in
the Federal Register proposing interim approval of the Vermont Program
and EPA's response to those comments are as follows:
Comment: Vermont believes that EPA should grant Vermont ``full
approval until, at a minimum, all relevant litigation pertaining to
Part 70 is finalized and a static set of requirements to judge the
approvability of Vermont's program is in place.'' Specifically, Vermont
comments that ``EPA's interpretation of Section 502(b)(10) is currently
the subject of litigation and is likely to change.'' In addition,
Vermont asserts that its emissions trading requirements are more
stringent than the requirements of the Act and therefore, are not
preempted by federal law.
Response: Vermont's rule currently provides the State with the
authority to prohibit emissions trades under an emissions cap and does
not require that emissions be quantifiable as a precondition to
allowing such trades when a permit does contain an emissions cap. In
addition, Vermont's rule does not provide for ``Section 502(b)(10)
changes.''
To address the emissions trading issue, EPA is requiring Vermont to
adopt regulatory language requiring the State to include, upon request
by a source, emission trading provisions in a title V permit for the
purpose of complying with an emissions cap established in the permit,
provided that the emissions involved in such trades are quantifiable.
Vermont retains the option to include language in its regulation that
would require all such trades to be consistent with State requirements
as well as applicable requirements, and therefore EPA is not attempting
to supersede more stringent State law. EPA is also requiring Vermont to
adopt regulatory provisions to implement ``Section 502(b)(10) changes''
as defined in Part 70 so that both aspects of Part 70's operational
flexibility requirement are met.
EPA understands Vermont's concerns about the pending litigation,
but EPA is obligated to evaluate the State's program based on the Part
70 rules promulgated on July 21, 1992. Specifically, Part 70 currently
requires both ``Section 502(b)(10) changes'' and emissions trading
under emission caps established in a title V permit as mechanisms to
implement operational flexibility. In an August 29, 1994 (FR 44572)
rulemaking
[[Page 51369]]
proposal, EPA proposed to eliminate Section 502(b)(10) changes as a
mechanism for implementing operational flexibility. When the proposed
changes to Part 70 are finalized, EPA and the State will revisit this
matter and address it consistent with the program transition provisions
of the revised Part 70 regulations.
Comment: Vermont does not agree that it must include language in
its regulations requiring it to reopen and reissue operating permits
``for cause'' as defined by Part 70. Vermont feels that by mandating
such actions in its regulations, it imposes a regulatory burden on
itself that could be interpreted to limit its ability to reopen a
permit for reasons not specifically enumerated in its regulation.
Response: It is not EPA's intent to limit Vermont's ability to
reopen a permit for any reason the State believes is appropriate. EPA's
interim approval condition is intended to ensure that Vermont's
regulation requires permit reopening under the conditions required by
40 CFR 70.7(f)(1). Vermont is free to add to the list of conditions in
40 CFR 70.7(f)(1) requiring reopening, or to provide the Commissioner
with the discretion to reopen permits for reasons in addition to those
specified in 40 CFR 70.7(f)(1).
Comment: Vermont objects to EPA's position that Vermont's
regulations must list the terms and conditions that must appear in
every permit. Vermont believes the intent of the Act is for Vermont to
demonstrate that it has legal authority to include the necessary terms
and conditions, ``not to unnecessarily clutter its regulations with a
detailed list of all permit terms and conditions.'' Furthermore,
Vermont objects to promulgating regulations which it claims impose
requirements upon itself rather than the regulated community.
Response: Forty CFR 70.6 requires that a permitting authority
commit in the program regulations to incorporate critical permit
elements including prompt reporting of deviations, recordkeeping of
different operating scenarios, and separating permit terms which are
enforceable only by the State from those that are enforceable by both
the State and EPA. The State must also indicate the origin and
authority of all permit terms and conditions as well as identify any
difference in form as compared to the applicable requirement. It is
this regulatory commitment that makes the permitting authority
accountable not only to EPA but also to citizens and the regulated
community.
III. Final Action
The EPA is promulgating interim approval of the operating permits
program submitted by the State of Vermont on April 28, 1995. The State
must make the changes specified in the proposed rulemaking, under
II.B., Proposed Action, in order to be granted full approval.
The scope of the State of Vermont's Part 70 program approved in
this document applies to all Part 70 sources (as defined in the
approved program) within the State of Vermont, except any sources of
air pollution over which an Indian Tribe has jurisdiction. See, e.g.,
59 FR 55813, 55815-18 (Nov. 9, 1994). The term ``Indian Tribe'' is
defined under the Act as ``any Indian tribe, band, nation, or other
organized group or community, including any Alaska Native village,
which is Federally recognized as eligible for the special programs and
services provided by the United States to Indians because of their
status as Indians.'' See section 302(r) of the CAA; see also 59 FR
43956, 43962 (Aug. 25, 1994); 58 FR 54364 (Oct. 21, 1993).
This interim approval extends until November 2, 1998. During this
interim approval period, the State of Vermont is protected from
sanctions, and EPA is not obligated to promulgate, administer and
enforce a Federal operating permits program in the State of Vermont.
Permits issued under a program with interim approval have full standing
with respect to Part 70, and the 1-year time period for submittal of
permit applications by subject sources begins upon the effective date
of this interim approval, as does the 3-year time period for processing
the initial permit applications.
If the State of Vermont fails to submit a complete corrective
program for full approval by May 4, 1998, EPA will start an 18-month
clock for mandatory sanctions. If the State of Vermont then fails to
submit a corrective program that EPA finds complete before the
expiration of that 18-month period, EPA will be required to apply one
of the sanctions in section 179(b) of the Act, which will remain in
effect until EPA determines that the State of Vermont has corrected the
deficiency by submitting a complete corrective program. If, six months
after application of the first sanction, the State of Vermont still has
not submitted a corrective program that EPA has found complete, a
second sanction will be required.
If EPA disapproves the State of Vermont's complete corrective
program, EPA will be required to apply one of the section 179(b)
sanctions on the date 18 months after the effective date of the
disapproval, unless prior to that date the State of Vermont has
submitted a revised program and EPA has determined that it corrected
the deficiencies that prompted the disapproval. If, six months after
EPA applies the first sanction, the State of Vermont has not submitted
a revised program that EPA has determined corrects the deficiencies, a
second sanction is required.
In addition, discretionary sanctions may be applied where warranted
any time after the expiration of an interim approval period if the
State of Vermont has not timely submitted a complete corrective program
or EPA has disapproved its submitted corrective program. Moreover, if
EPA has not granted full approval to the State of Vermont program by
the expiration of this interim approval, since the expiration would
occur after November 15, 1995, EPA would be required to promulgate,
administer and enforce a Federal permits program for the State of
Vermont upon interim approval expiration.
Requirements for approval, specified in 40 CFR 70.4(b), encompass
section 112(l)(5) requirements for approval of a program for delegation
of section 112 standards as promulgated by EPA as they apply to Part 70
sources. Section 112(l)(5) requires that the State's program contain
adequate authorities, adequate resources for implementation, and an
expeditious compliance schedule, which are also requirements under Part
70. Vermont submitted a supplemental letter dated March 6, 1996
addressing the 112(l)(5) requirements for area/minor sources.
Therefore, the EPA is also promulgating approval under section
112(l)(5) and 40 CFR 63.91 of the State's program for receiving
delegation of section 112 standards that are unchanged from Federal
standards as promulgated. This program for delegations applies to
sources covered by the Part 70 program as well as area/minor sources.
See 61 FR 26145 for a fuller discussion of Section 112(l)(5)
delegations.
IV. Administrative Requirements
A. Docket
Copies of the State's submittal and other information relied upon
for the final interim approval, including comments received by the
State of Vermont and reviewed by EPA on the proposal, are contained in
the docket maintained at the EPA Regional Office. The docket is an
organized and complete file of all the information
[[Page 51370]]
submitted to, or otherwise considered by, EPA in the development of
this final interim approval. The docket is available for public
inspection at the location listed under the ADDRESSES section of this
document.
B. Petitions for Judicial Review
Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by December 2, 1996. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this rule for the purposes of judicial
review nor does it extend the time within which a petition for judicial
review may be filed, and shall not postpone the effectiveness of such
rule or action. This action may not be challenged later in proceedings
to enforce its requirements. (See section 307(b)(2).)
C. Executive Order 12866
The Office of Management and Budget has exempted this action from
Executive Order 12866 review.
D. Regulatory Flexibility Act
The EPA's actions under section 502 of the Act do not create any
new requirements, but simply address operating permits programs
submitted to satisfy the requirements of 40 CFR Part 70. Because this
action does not impose any new requirements, it does not have a
significant impact on a substantial number of small entities.
E. Unfunded Mandates
Under Sections 202 of the Unfunded Mandates Reform Act of 1995
(``Unfunded Mandates Act''), signed into law on March 22, 1995, EPA
must prepare a budgetary impact statement to accompany any proposed or
final rule that includes a Federal mandate that may result in estimated
costs to State, local, or tribal governments in the aggregate; or to
the private sector, of $100 million or more. Under Section 205, EPA
must select the most cost-effective and least burdensome alternative
that achieves the objectives of the rule and is consistent with
statutory requirements. Section 203 requires EPA to establish a plan
for informing and advising any small governments that may be
significantly or uniquely impacted by the rule.
EPA has determined that the approval action promulgated does not
include a Federal mandate that may result in estimated costs of $100
million or more to either State, local, or tribal governments in the
aggregate, or to the private sector. This Federal action approves pre-
existing requirements under State or local law, and imposes no new
Federal requirements. Accordingly, no additional costs to State, local,
or tribal governments, or to the private sector, result from this
action.
F. Submission to Congress and the General Accounting Office
Under 5 U.S.C. 801(a)(1)(A) as added by the Small Business
Regulatory Enforcement Fairness Act of 1996, EPA submitted a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives and the Comptroller General of the
General Accounting Office prior to publication of the rule in today's
Federal Register. This rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 70
Environmental protection, Administrative practice and procedure,
Air pollution control, Environmental Protection, Intergovernmental
relations, Operating permits, Reporting and recordkeeping requirements.
Dated: September 8, 1996.
John P. DeVillars,
Regional Administrator, Region I.
Part 70, title 40 of the Code of Federal Regulations is amended as
follows:
PART 70--[AMENDED]
1. The authority citation for Part 70 continues to read as follows:
Authority: 42 U.S.C. 7401, et seq.
2. Appendix A to Part 70 is amended by adding the entry for Vermont
in alphabetical order to read as follows:
Appendix A to Part 70--Approval Status of State and Local Operating
Permits Programs
* * * * *
Vermont
(a) Department of Environmental Conservation: submitted on April
28, 1995; interim approval effective on November 1, 1996; interim
approval expires November 2, 1998.
(b) (Reserved)
* * * * *
[FR Doc. 96-25233 Filed 10-1-96; 8:45 am]
BILLING CODE 6560-50-P
Complete official Federal Register PDF
FR Doc. 96-25232 Control of Air Pollution From New and In-Use Motor Vehicles and New and In-Use Motor Vehicle Engines: Certification and Test Procedures
[Federal Register Volume 61, Number 192 (Wednesday, October 2, 1996)]
[Rules and Regulations]
[Pages 51365-51366]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-25232]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 9 and 86
[FRL-5618-2]
Control of Air Pollution From New and In-Use Motor Vehicles and
New and In-Use Motor Vehicle Engines: Certification and Test Procedures
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule; technical amendments.
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SUMMARY: This document contains technical amendments to regulations
controlling air pollution from new and in-use motor vehicles and motor
vehicle engines. This final rule removes regulations that are obsolete.
EFFECTIVE DATE: October 2, 1996.
FOR FURTHER INFORMATION CONTACT: Dick Nash, Office of Mobile Sources,
Vehicle Programs and Compliance Division, 2565 Plymouth Road, Ann
Arbor, MI 48105, 313-668-4412.
SUPPLEMENTARY INFORMATION:
Background
The Agency has reviewed the regulations currently contained in
Title 40, Part 86 of the Code of Federal Regulations (CFR) and has
determined that a number of sections have become obsolete or redundant.
By this action the agency is removing them from the CFR.
By issuing these technical amendments directly as a final rule, EPA
is foregoing the issuance of a Notice of Proposed Rulemaking (NPRM) and
the opportunity for public comment. Such a curtailed procedure is
permitted by 5 U.S.C. 553(b) and Sec. 307(d) of the Clean Air Act when
issuance of a proposal and public comments would be impracticable,
unnecessary, or contrary to the public interest. The Agency is
publishing this action without prior proposal because these are non-
controversial changes that delete sections of the regulations that are
obsolete because they do not regulate future conduct concerning
existing motor vehicles or any motor vehicles which may be certified in
the future. The Agency finds that this constitutes good cause under 5
U.S.C. 553(b) for a determination that the issuance of an NPRM is
unnecessary.
Today's action does not create any new regulatory requirements. For
this reason, EPA finds that good cause exists to provide for an
immediate effective date.
The Agency has determined that this action does not meet any of the
criteria for classification as a significant rule under Executive Order
12866. Therefore, no Regulatory Impact Analysis is required.
This action does not include any new information collection
requirements. The Paperwork Reduction Act is not applicable to this
action as these changes to the regulations at 40 part CFR part 86 will
not impose any information collection requirements on affected parties.
The Environmental Protection Agency has determined that it is not
necessary to prepare a regulatory flexibility analysis in connection
with this final rule. The Agency has determined that the action adopted
today will not have a significant impact on small entities;
[[Page 51366]]
this action is limited to deleting obsolete regulatory provisions.
Description of Changes
The following paragraphs describe the individual revisions that are
being adopted in this rule.
1. Part 9 is amended by removing references to any sections which
are being removed from part 86.
2. Part 86 is being amended by removing certain sections which are
obsolete because they do not regulate future conduct but only apply to
prior conduct, affecting prior model year motor vehicles and engines.
However, any conduct or actions involving such vehicles or engines
occurring prior to the deletion of these provisions will be controlled
by the provisions in effect when the action or conduct occurred.
3. Section 86.113 is being amended by deleting paragraphs
(g)(1)(iii), (g)(1)(iv), and (g)(1)(v). This action eliminates the
calculation that adjusts the payment of a nonconformance penalty to the
federal government based on payment of a nonconformance penalty to the
state of California. California does not collect nonconformance
penalties. This action makes clear that the penalty will be paid in
full to the Federal Government. Additionally, paragraph(g)(1)(ii) is
being amended to eliminate references to the subparagraphs deleted.
Submission to Congress and the General Accounting Office
Under 5 U.S.C. 801(a)(1)(A) as added by the Small Business
Regulatory Enforcement Fairness Act of 1996, EPA submitted a report
containing this rule and other required information to the U.S. Senate,
House of Representatives and the Comptroller General of the General
Accounting Office prior to publication of the rule in today's Federal
Register. This is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects
40 CFR Part 9
Reporting and recordkeeping requirements.
40 CFR Part 86
Environmental protection, Administrative practice and procedure,
Motor vehicle pollution.
Dated: September 23, 1996.
Mary Nichols,
Assistant Administrator for Air and Radiation.
For the reasons set forth in the preamble, title 40, chapter I,
parts 9 and 86 of the Code of Federal Regulations are amended as set
forth below:
PART 9--[AMENDED]
1. The authority citation for part 9 continues to read as follows:
Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003,
2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1321, 1326, 1330, 1344,
1345(d) and (e), 1361; E.O. 11735 38 FR 21243, 3 CFR 1971-1975 Comp.
p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g-1, 300g-2, 300g-3,
300g-4, 300g-5, 300g-6, 300j-1, 300j-2, 300j-3, 300j-4, 300j-9, 1857
et seq., 6901-6992k, 7401-7671q, 7542, 9601-9657, 11023, 11048.
Sec. 9.1 [Amended]
2. Section 9.1 is amended by removing from the table entries for
86.1003-88, 86.1005-88, 86.1008-88.
PART 86--[AMENDED]
3. The authority citation for part 86 continues to read as follows:
Authority: Secs. 202, 203, 204, 205, 206, 207, 208, 209, 213,
215, 216, and 301(a) of the Clean Air Act as amended (42 U.S.C.
7521, 7522, 7523, 7524, 7525, 7541, 7542, 7543, 7547, 7549, 7550,
and 7601(a)).
Secs. 86.610-84, 86.1003-88, 86.1005-88, 86.1008-88, 86.1010-84
[Removed]
4. Part 86 is amended by removing Secs. 86.610-84, 86.1003-88,
86.1005-88, 86.1008-88, 86.1010-84.
5. Section 86.1113-87 is amended by revising paragraph (g)(1)(ii)
and by removing paragraphs (g)(1)(iii), (g)(1)(iv) and (g)(1)(v) to
read as follows:
Sec. 86.1113-87 Calculation and payment of penalty.
* * * * *
(g) * * *
(1) * * *
(ii) The penalty shall be payable to U.S. Environmental Protection
Agency, NCP Fund, P.O. Box 360277M, Pittsburgh, PA 15251.
* * * * *
[FR Doc. 96-25232 Filed 10-1-96; 8:45 am]
BILLING CODE 6560-50-P
Complete official Federal Register PDF
FR Doc. 96-25231 Clean Air Act Interim Approval of Operating Permits Program; Delegation of Section 112 Standards; State of New Hampshire
[Federal Register Volume 61, Number 192 (Wednesday, October 2, 1996)]
[Rules and Regulations]
[Pages 51370-51372]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-25231]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 70
[AD-FRL-5619-4]
Clean Air Act Interim Approval of Operating Permits Program;
Delegation of Section 112 Standards; State of New Hampshire
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final interim approval.
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SUMMARY: The EPA is promulgating interim approval of the Operating
Permits Program submitted by the State of New Hampshire for the purpose
of complying with Federal requirements for an approvable State program
to issue operating permits to all major stationary sources, and to
certain other sources.
EFFECTIVE DATE: November 1, 1996.
ADDRESSES: Copies of the State's submittal and other supporting
information used in developing the final interim approval are available
for inspection during normal business hours at the following location:
U.S. Environmental Protection Agency, Region 1, One Congress Street,
11th floor, Boston, MA 02203.
FOR FURTHER INFORMATION CONTACT: Ida E. Gagnon, Air Permits Program,
CAP, U.S. Environmental Protection Agency, Region 1, JFK Federal
Building, Boston, MA 02203-2211, (617) 565-3500.
SUPPLEMENTARY INFORMATION:
I. Background and Purpose
A. Introduction
Title V of the 1990 Clean Air Act Amendments (sections 501-507 of
the Clean Air Act (``the Act'')), and implementing regulations at 40
Code of Federal Regulations (CFR) Part 70 require that States develop
and submit operating permits programs to EPA by November 15, 1993, and
that EPA act to approve or disapprove each program within 1 year after
receiving the submittal. The EPA's program review occurs pursuant to
section 502 of the Act and the Part 70 regulations, which together
outline criteria for approval or disapproval. Where a program
substantially, but not fully, meets the requirements of Part 70, EPA
may grant the program interim approval for a period of up to 2 years.
If EPA has not fully approved a program by 2 years after the November
15, 1993 date, or by the end of an interim program, it must establish
and implement a Federal program.
On August 14, 1996, EPA proposed interim approval of the operating
permits program for the State of New Hampshire. See 61 FR 42222. The
[[Page 51371]]
August 14, 1996 document also proposed approval of New Hampshire's
mechanism for implementing section 112(g) and for delegation of section
112 standards as promulgated. EPA did not receive any comments on the
proposal. In this document EPA is taking final action to promulgate
interim approval of the operating permits program, and approving the
section 112(g) and section 112(l) mechanisms noted above for the State
of New Hampshire.
II. Final Action and Implications
A. Final Action
The EPA is promulgating interim approval of the operating permits
program submitted to EPA for the State of New Hampshire on October 26,
1995. Among other things, New Hampshire has demonstrated that the
program will be adequate to meet the minimum elements of a State
operating permits program as specified in 40 CFR Part 70. The State
must make the changes specified in the proposed rulemaking, under
II.B., Proposed Action, in order to be granted full approval.
This interim approval extends for a period of up to 2 years. During
the interim approval period, the State is protected from sanctions for
failure to have a program, and EPA is not obligated to promulgate a
Federal permits program in the State. Permits issued under a program
with interim approval have full standing with respect to Part 70, and
the 1-year time period under the Act for submittal of permit
applications by subject sources begins upon interim approval, as does
the 3-year time period for processing the initial permit applications.
The scope of the New Hampshire Part 70 program applies to all Part
70 sources (as defined in the approved program) within the State of New
Hampshire, except any sources of air pollution over which an Indian
Tribe has jurisdiction. See, e.g., 59 FR 55813, 55815-18 (Nov. 9,
1994). The term ``Indian Tribe'' is defined under the Act as ``any
Indian tribe, band, nation, or other organized group or community,
including any Alaska Native village, which is Federally recognized as
eligible for the special programs and services provided by the United
States to Indians because of their status as Indians.'' See section
302(r) of the CAA; see also 59 FR 43956, 43962 (Aug. 25, 1994); 58 FR
54364 (Oct. 21, 1993).
EPA is approving New Hampshire's authority to implement and enforce
section 112 standards at Part 70 sources. Requirements for operating
permit program approval, specified in 40 CFR 70.4(b), encompass section
112(l)(5) requirements for approval of a program for delegation of
section 112 standards as promulgated by EPA as they apply to Part 70
sources. Section 112(l)(5) requires that the State's program contain
adequate authorities, adequate resources for implementation, and an
expeditious compliance schedule, which are also requirements under Part
70. Therefore, the EPA has also granted approval under section
112(l)(5) and 40 CFR 63.91 of the State's program for receiving
delegation of section 112 standards that are unchanged from Federal
standards as promulgated. This program for delegations only applies to
sources covered by the Part 70 program.
III. Administrative Requirements
A. Docket
Copies of the State's submittal and other information relied upon
for the final interim approval, are contained in a docket maintained at
the EPA Regional Office. The docket is an organized and complete file
of all the information submitted to, or otherwise considered by, EPA in
the development of this final interim approval. The docket is available
for public inspection at the location listed under the ADDRESSES
section of this document.
B. Submission to Congress and the General Accounting Office
Under 5 U.S.C. 801(a)(1)(A) as added by the Small Business
Regulatory Enforcement Fairness Act of 1996, EPA submitted a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives and the Comptroller General of the
General Accounting Office prior to publication of the rule in today's
Federal Register. This rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
C. Petitions for Judicial Review
Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by December 2, 1996. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this rule for the purposes of judicial
review nor does it extend the time within which a petition for judicial
review may be filed, and shall not postpone the effectiveness of such
rule or action. This action may not be challenged later in proceedings
to enforce its requirements. (See section 307(b)(2))
D. Executive Order 12866
The Office of Management and Budget has exempted this action from
Executive Order 12866 review.
E. Regulatory Flexibility Act
The EPA's actions under section 502 of the Act do not create any
new requirements, but simply address operating permits programs
submitted to satisfy the requirements of 40 CFR Part 70. Because this
action does not impose any new requirements, it does not have a
significant impact on a substantial number of small entities.
F. Unfunded Mandates
Under Section 202 of the Unfunded Mandates Reform Act of 1995
(``Unfunded Mandates Act''), signed into law on March 22, 1995, EPA
must prepare a budgetary impact statement to accompany any proposed or
final rule that includes a Federal mandate that may result in estimated
costs to State, local, or tribal governments in the aggregate; or to
the private sector, of $100 million or more. Under Section 205, EPA
must select the most cost-effective and least burdensome alternative
that achieves the objectives of the rule and is consistent with
statutory requirements. Section 203 requires EPA to establish a plan
for informing and advising any small governments that may be
significantly or uniquely impacted by the rule.
EPA has determined that the action promulgated today does not
include a Federal mandate that may result in estimated costs of $100
million or more to either State, local, or tribal governments in the
aggregate, or to the private sector. This Federal action approves
preexisting requirements under State or local law, and imposes no new
Federal requirements. Accordingly, no additional costs to State, local,
or tribal governments, or to the private sector, result from this
action.
List of Subjects in 40 CFR Part 70
Environmental protection, Administrative practice and procedure,
Air pollution control, Intergovernmental relations, Operating permits,
Reporting and recordkeeping requirements.
Dated: September 23, 1996.
John P. DeVillars,
Regional Administrator, Region I.
Part 70, title 40 of the Code of Federal Regulations is amended as
follows:
PART 70--[AMENDED]
1. The authority citation for Part 70 continues to read as follows:
[[Page 51372]]
Authority: 42 U.S.C. 7401, et seq.
2. Appendix A to Part 70 is amended by adding the entry for New
Hampshire in alphabetical order to read as follows:
Appendix A to Part 70--Approval Status of State and Local Operating
Permits Programs
* * * * *
New Hampshire
(a) Department of Environmental Services: submitted on October 26,
1995; interim approval effective on November 1, 1996.
(b) (Reserved)
* * * * *
[FR Doc. 96-25231 Filed 10-1-96; 8:45 am]
BILLING CODE 6560-50-P
Complete official Federal Register PDF
FR Doc. 96-25211 Amendment of Class D Airspace; Jacksonville, Craig Municipal Airport, FL
[Federal Register Volume 61, Number 192 (Wednesday, October 2, 1996)]
[Rules and Regulations]
[Pages 51360-51361]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-25211]
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
14 CFR Part 71
[Airspace Docket No. 96-ASO-21]
Amendment of Class D Airspace; Jacksonville, Craig Municipal
Airport, FL
AGENCY: Federal Aviation Administration (FAA), DOT.
ACTION: Final rule; request for comments.
-----------------------------------------------------------------------
SUMMARY: This amendment modifies the Jacksonville, Craig Municipal
Airport, FL, Class D airspace area from continuous to part time. Since
August 31, 1996, when the operation of the airport control tower was
transferred from the FAA to a contractor, the control tower no longer
operates 24 hours a day. When the tower is not in operation, the
airspace below 700 feet AGL becomes Class G, uncontrolled airspace.
DATES: Effective Date. 0901 UTC, December 5, 1996.
Comment Date: Comments must be received on or before November 5,
1996.
ADDRESSES: Send comments on the proposal in triplicate to: Federal
Aviation Administration, Docket No. 96-ASO-21, Manager, Operations
Branch, ASO-530, P.O. Box 20636, Atlanta, Georgia 30320.
The official docket may be examined in the Office of the Assistant
Chief Counsel for Southern Region, Room 550, 1701 Columbia Avenue,
College Park, Georgia 30337, telephone (404) 305-5586.
FOR FURTHER INFORMATION CONTACT: Benny L. McGlamery, Operations Branch,
Air Traffic Division, Federal Aviation Administration, P.O. Box 20636,
Atlanta, Georgia 30320; telephone (404) 305-5570.
SUPPLEMENTARY INFORMATION:
Request for Comments on the Rule
Although this action is a final rule, which involves modifying the
Class D airspace at the Jacksonville, Craig Municipal Airport, FL, from
continuous to part time, comments are invited on the rule. This rule
will become effective on the date specified in the DATES section.
However, after the review of
[[Page 51361]]
any comments and, if the FAA finds that further changes are
appropriate, it will initiate rulemaking proceedings to extend the
effective date or to amend the regulation.
Comments that provide the factual basis supporting the views and
suggestions presented are particularly helpful in evaluating the
effects of the rule and in determining whether additional rulemaking is
needed. Comments are specifically invited on the overall regulatory,
aeronautical, economic, environmental, and energy-related aspects of
the rule that might suggest the need to modify the rule.
The Rule
This amendment to Part 71 of the Federal Aviation Regulations (14
CFR part 71) modifies the Class D airspace at the Jacksonville, Craig
Municipal Airport, FL, from continuous to part time.
This action lessens the impact on users of this airspace. Class D
airspace designations are published in Paragraph 5000 of FAA Order
7400.9D dated September 4, 1996, and effective September 16, 1996. The
Class D airspace designation listed in this document will be published
subsequently in the Order.
Under the circumstances presented, the FAA concludes that there is
an immediate need to modify the Class D airspace at the Jacksonville,
Craig Municipal Airport, FL, from continuous to part time, to ensure
that users of this airspace will be able to comply with appropriate
federal regulations governing non-controlled airspace. Therefore, I
find that notice and public procedure under 5 U.S.C. 553(b) are
impracticable and contrary to the public interest.
The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore, (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this rule will not have a significant economic impact on
a substantial number of small entities under the criteria of the
Regulatory Flexibility Act.
List of Subjects in 14 CFR Part 71
Airspace, Incorporation by reference, Navigation (air).
Adoption of the Amendment
In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR Part 71 as follows:
PART 71--[AMENDED]
1. The authority citation for 14 CFR Part 71 continues to read as
follows:
Authority: 49 U.S.C. 106(g); 40103, 40113, 40120; EO 10854, 24
FR 9565, 3 CFR, 1959-1963 Comp., p. 389; 14 CFR 11.69.
Sec. 71.1 [Amended]
2. The incorporation by reference in 14 CFR 71.1 of Federal
Aviation Administration Order 7400.9D, Airspace Designations and
Reporting Points, dated September 4, 1996, and effective September 16,
1996, is amended as follows:
Paragraph 5000 Class D airspace.
* * * * *
ASO FL D Jacksonville Craig Municipal Airport, FL [Revised]
Jacksonville, Craig Municipal Airport, FL
(Lat. 30 deg.20'11'' N, Long. 81 deg.30'52'' W)
Mayport NAS, FL
(Lat. 30 deg.23'31'' N, Long. 81 deg.25'25'' W)
That airspace extending upward from the surface to and including
2,500 feet MSL within a 4.2-mile radius of Craig Municipal Airport;
excluding the portion northeast of a line connecting the 2 points of
intersection with a 4.2-mile radius circle centered on Mayport NAS,
FL. This Class D airspace area is effective during the specific days
and times established in advance by a Notice to Airmen. The
effective days and times will thereafter be continuously published
in the Airport/Facility Directory.
* * * * *
Issued in College Park, Georgia, on September 24, 1996.
Benny L. McGlamery,
Acting Manager, Air Traffic Division, Southern Region.
[FR Doc. 96-25211 Filed 10-1-96; 8:45 am]
BILLING CODE 4910-13-M
Complete official Federal Register PDF
FR Doc. 96-25207 Fisheries of the Exclusive Economic Zone Off Alaska; Amendment 38; Pacific Ocean Perch
[Federal Register Volume 61, Number 192 (Wednesday, October 2, 1996)]
[Rules and Regulations]
[Pages 51374-51375]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-25207]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric Administration
50 CFR Part 679
[I.D. 062596B]
RIN 0648-AH68
Fisheries of the Exclusive Economic Zone Off Alaska; Amendment
38; Pacific Ocean Perch
AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA), Commerce.
ACTION: Approval of a fishery management plan amendment.
-----------------------------------------------------------------------
SUMMARY: NMFS announces approval of Amendment 38 to the Fishery
Management Plan for Groundfish of the Gulf of Alaska (FMP). Amendment
38 provides the flexibility for the North Pacific Fishery Management
Council (Council) to recommend a total allowable catch (TAC) amount for
Pacific ocean perch (POP) below the level currently established in the
FMP. This action is necessary to improve the conservation and
management of POP and is intended to further the goals and objectives
of the FMP.
EFFECTIVE DATE: September 25, 1996.
ADDRESSES: Copies of Amendment 38, the environmental assessment, and
the economic analysis prepared for the amendment are available from the
Council, 605 West 4th Avenue, Suite 306, Anchorage, AK 99501-2252;
telephone 907-271-2809.
FOR FURTHER INFORMATION CONTACT: Kaja Brix, 907-586-7228.
SUPPLEMENTARY INFORMATION: Decline of the POP stock since the early
period of the foreign fishery (mid-1960's) prompted the Council to
recommend a rebuilding plan for POP. The Pacific Ocean Perch Rebuilding
Plan (Rebuilding Plan) was established in Amendment 32 to the FMP.
Details of the justification for the Rebuilding Plan can be found in
the Notice of Availability for Amendment 32 (59 FR 295, January 4,
1994). The Rebuilding Plan provides a specific rebuilding strategy for
POP stocks, based on available biological and economic information. The
Rebuilding Plan establishes a formula to determine annually the POP
TAC, which is then apportioned among Gulf of Alaska (GOA) regulatory
areas based on biomass distribution. However, the amendment does not
provide for any flexibility to reduce the TAC below the amount
specified by the formula.
Under the current Rebuilding Plan, the potential exists for the
calculated TAC to be greater than the acceptable biological catch
level, which would be inconsistent with the current management practice
for other groundfish stocks. The Council also has expressed concern
that it does not have the flexibility to lower the POP TAC under the
Rebuilding Plan to accommodate other resource conservation concerns.
Therefore, at its December 1995 meeting, the Council adopted Amendment
38 to the FMP for review by NMFS under section 304(b) of the Magnuson
Fishery Conservation and Management Act (Magnuson Act). Amendment 38
does not prescribe a TAC lower than that specified by the formula;
however, it allows the Council the flexibility to recommend a TAC below
the level of the specified formula in one or more GOA regulatory areas
or districts.
The FMP amendment gives the Council the alternative of recommending
a lower POP TAC in the annual specifications process only for the
purpose of addressing biological or resource conservation concerns that
are not addressed under the Rebuilding Plan or Stock Assessment and
Fishery Evaluation reports. If socioeconomic concerns exist with
respect to the management of the POP fishery, particularly in the
Eastern GOA, the Council would need to consider a separate amendment to
address these issues.
[[Page 51375]]
A Notice of Availability of Amendment 38, which described the
proposed action and solicited comments from the public until August 30,
1996, was published in the Federal Register on July 5, 1996 (61 FR
35174). No written comments were received during the 60-day comment
period. After review under the Magnuson Act, NMFS determined that
Amendment 38 is consistent with the Magnuson Act and other applicable
laws and approved Amendment 38 on September 25, 1996. Additional
information on this action is contained in the Notice of Availability.
No regulatory changes are necessary to implement this FMP
amendment. Any recommendation that the Council may make for the POP TAC
as a result of this amendment will take place during the annual
groundfish TAC specification process under regulations at
Sec. 679.20(a)(2).
Authority: 16 U.S.C. 1801 et seq.
Dated: September 26, 1996.
Gary C. Matlock,
Director, Office of Sustainable Fisheries, National Marine Fisheries
Service.
[FR Doc. 96-25207 Filed 10-1-96; 8:45 am]
BILLING CODE 3510-22-F
Complete official Federal Register PDF
FR Doc. 96-25201 Cranberries Grown in the States of Massachusetts, Rhode Island, Connecticut, New Jersey, Wisconsin, Michigan, Minnesota, Oregon, Washington, and Long Island in the State of New York; Assessment Rate
[Federal Register Volume 61, Number 192 (Wednesday, October 2, 1996)]
[Rules and Regulations]
[Pages 51353-51354]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-25201]
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DEPARTMENT OF AGRICULTURE
7 CFR Part 929
[Docket No. FV96-929-3 FIR]
Cranberries Grown in the States of Massachusetts, Rhode Island,
Connecticut, New Jersey, Wisconsin, Michigan, Minnesota, Oregon,
Washington, and Long Island in the State of New York; Assessment Rate
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Department of Agriculture (Department) is adopting as a
final rule, without change, the provisions of an interim final rule
establishing an assessment rate for the Cranberry Marketing Committee
(Committee) under Marketing Order No. 929 for the 1996-97 and
subsequent fiscal periods. The Committee is responsible for local
administration of the marketing order which regulates the handling of
cranberries grown in the States of Massachusetts, Rhode Island,
Connecticut, New Jersey, Wisconsin, Michigan, Minnesota, Oregon,
Washington, and Long Island in the State of New York. Authorization to
assess cranberry handlers enables the Committee to incur expenses that
are reasonable and necessary to administer the program.
EFFECTIVE DATE: September 1, 1996.
FOR FURTHER INFORMATION CONTACT: Kathleen M. Finn, Marketing
Specialist, Marketing Order Administration Branch, Fruit and Vegetable
Division, AMS, USDA, P.O. Box 96456, room 2523-S, Washington, DC 20090-
6456, telephone (202) 720-1509, FAX# (202) 720-5698, or Tershirra
Yeager, Program Assistant, Marketing Order Administration Branch, Fruit
and Vegetable Division, AMS, USDA, P.O. Box 96456, room 2523-S,
Washington, DC 20090-6456, telephone (202) 720-5127, FAX# (202) 720-
5698. Small businesses may request information on compliance with this
regulation by contacting: Jay Guerber, Marketing Order Administration
Branch, Fruit and Vegetable Division, AMS, USDA, P.O. Box 96456, Room
2523-S, Washington, D.C. 20090-6456; telephone: (202) 720-2491, FAX#
(202) 720-5698.
SUPPLEMENTARY INFORMATION: This rule is issued under Marketing Order
No. 929 (7 CFR part 929), as amended, regulating the handling of
cranberries grown in the States of Massachusetts, Rhode Island,
Connecticut, New Jersey, Wisconsin, Michigan, Minnesota, Oregon,
Washington, and Long Island in the State of New York, hereinafter
referred to as the ``order.'' The marketing order is effective under
the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C.
601-674), hereinafter referred to as the ``Act.''
The Department of Agriculture (Department) is issuing this rule in
conformance with Executive Order 12866.
This rule has been reviewed under Executive Order 12988, Civil
Justice Reform. Under the marketing order now in effect, cranberry
handlers are subject to assessments. Funds to administer the order are
derived from such assessments. It is intended that the assessment rate
as issued herein will be applicable to all assessable cranberries
beginning September 1, 1996, and continuing until amended, suspended,
or terminated. This rule will not preempt any State or local laws,
regulations, or policies, unless they present an irreconcilable
conflict with this rule.
The Act provides that administrative proceedings must be exhausted
before parties may file suit in court. Under section 608c(15)(A) of the
Act, any handler subject to an order may file with the Secretary a
petition stating that the order, any provision of the order, or any
obligation imposed in connection with the order is not in accordance
with law and request a modification of the order or to be exempted
therefrom. Such handler is afforded the opportunity for a hearing on
the petition. After the hearing the Secretary would rule on the
petition. The Act provides that the district court of the United States
in any district in which the handler is an inhabitant, or has his or
her principal place of business, has jurisdiction to review the
Secretary's ruling on the petition, provided an action is filed not
later than 20 days after the date of the entry of the ruling.
Pursuant to requirements set forth in the Regulatory Flexibility
Act (RFA), the Agricultural Marketing Service (AMS) has considered the
economic impact of this rule on small entities.
The purpose of the RFA is to fit regulatory actions to the scale of
business subject to such actions in order that small businesses will
not be unduly or disproportionately burdened. Marketing orders issued
pursuant to the Act, and the rules issued thereunder, are unique in
that they are brought about through group action of essentially small
entities acting on their own behalf. Thus, both statutes have small
entity orientation and compatibility.
There are approximately 1,050 producers of cranberries in the
production area and approximately 30 handlers subject to regulation
under the marketing order. Small agricultural producers have been
defined by the Small Business Administration (13 CFR 121.601) as those
having annual receipts less than $500,000, and small agricultural
service firms are defined as those whose annual receipts are less than
$5,000,000. The majority of cranberry producers and handlers may be
classified as small entities. Interested persons are invited to submit
information on the regulatory and informational impacts of this action
on small businesses.
The cranberry marketing order provides authority for the Committee,
with the approval of the Department, to formulate an annual budget of
expenses and collect assessments from handlers to administer the
program. The members of the Committee are producers and handlers of
cranberries. They are familiar with the Committee's needs and with the
costs for goods and services in their local area and are thus in a
position to formulate an appropriate budget and assessment rate. The
assessment rate is formulated and discussed in a public meeting. Thus,
all directly affected persons have an opportunity to participate and
provide input.
The Committee met on March 4, 1996, and recommended by a 7 to 1
vote an assessment rate of $0.04 per barrel of cranberries. A mail vote
was conducted by the Committee regarding the budget, requiring
responses by June 20, 1996. Seven out of eight responses were received
in favor of the proposed budget. The 1996-97 recommended
[[Page 51354]]
expenditures are $192,980. In comparison, last year's budgeted
expenditures were $201,336. The assessment rate of $0.04 is $0.01
higher than last year's established rate. Major expenditures
recommended by the Committee for the 1996-97 year include $63,764 for
administrative expenses, and $66,732 for compensation.
The assessment rate recommended by the Committee was derived by
dividing anticipated expenses by expected shipments of cranberries.
Cranberry shipments for the year are estimated at 4,737,000 barrels
which should provide $189,480 in assessment income. Income derived from
handler assessments, along with interest income, will be adequate to
cover budgeted expenses. Funds in the reserve will be kept within the
maximum permitted by the order.
An interim final rule regarding this action was published in the
August 12, 1996, issue of the Federal Register (61 FR 41729). That rule
provided a 30-day comment period. No comments were received.
While this rule will impose some additional costs on handlers, the
costs are in the form of uniform assessments on all handlers. Some of
the additional costs may be passed on to producers. However, these
costs will be offset by the benefits derived by the operation of the
marketing order. Therefore, the AMS has determined that this rule will
not have a significant economic impact on a substantial number of small
entities.
The assessment rate established in this rule will continue in
effect indefinitely unless modified, suspended, or terminated by the
Secretary upon recommendation and information submitted by the
Committee or other available information.
Although this assessment rate is effective for an indefinite
period, the Committee will continue to meet prior to or during each
fiscal period to recommend a budget of expenses and consider
recommendations for modification of the assessment rate. The dates and
times of Committee meetings are available from the Committee or the
Department. Committee meetings are open to the public and interested
persons may express their views at these meetings. The Department will
evaluate Committee recommendations and other available information to
determine whether modification of the assessment rate is needed.
Further rulemaking will be undertaken as necessary. The Committee's
1996-97 budget and those for subsequent fiscal periods will be reviewed
and, as appropriate, approved by the Department.
After consideration of all relevant material presented, including
the information and recommendation submitted by the Committee and other
available information, it is hereby found that this rule, as
hereinafter set forth, will tend to effectuate the declared policy of
the Act.
Pursuant to 5 U.S.C. 553, it is also found and determined that good
cause exists for not postponing the effective date of this action until
30 days after publication in the Federal Register because: (1) The
Committee needs to have sufficient funds to pay its expenses which are
incurred on a continuous basis; (2) the 1996-97 fiscal period began on
September 1, 1996, and the marketing order requires that the rate of
assessment for each fiscal period apply to all assessable cranberries
handled during such fiscal period; (3) handlers are aware of this
action which was unanimously recommended by the Committee at a public
meeting and is similar to other assessment rate actions issued in past
years; and (4) an interim final rule was published on this action,
providing a 30-day comment period, and no comments were received.
List of Subjects in 7 CFR Part 929
Cranberries, Marketing agreements, Reporting and recordkeeping
requirements.
For the reasons set forth in the preamble, 7 CFR part 929 is
amended as follows:
PART 929--CRANBERRY MARKETING COMMITTEE
Accordingly, the interim final rule amending 7 CFR part 929 which
was published at 61 FR 41729 on August 12, 1996, is adopted as a final
rule without change.
Dated: September 26, 1996.
Sharon Bomer Lauritsen,
Acting Director, Fruit and Vegetable Division.
[FR Doc. 96-25201 Filed 10-1-96; 8:45 am]
BILLING CODE 3410-02-P
Complete official Federal Register PDF
FR Doc. 96-25174 General Services Administration Acquisition Regulation; Authorizing Deviations From the FAR and GSAR
[Federal Register Volume 61, Number 192 (Wednesday, October 2, 1996)]
[Rules and Regulations]
[Pages 51373-51374]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-25174]
=======================================================================
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GENERAL SERVICES ADMINISTRATION
48 CFR Part 501
[APD 2800.12A, CHGE 73]
RIN 3090-AG09
General Services Administration Acquisition Regulation;
Authorizing Deviations From the FAR and GSAR
AGENCY: Office of Acquisition Policy, GSA.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The General Services Administration Acquisition Regulation
(GSAR) is amended to revise Subpart 501.4 to modify the policy on GSA
contracting activities deviating from the Federal Acquisition
Regulation (FAR) and GSAR and to lower the approval levels for both
individual and class deviations from the regulations.
EFFECTIVE DATE: October 2, 1996.
FOR FURTHER INFORMATION CONTACT: Al Matera, GSA Acquisition Policy
Division, (202) 501-1224.
SUPPLEMENTARY INFORMATION: .
A. Executive Order 12866
This rule is not a significant rule as defined in Executive Order
12866.
B. Regulatory Flexibility Act
The Regulatory Flexibility Act does not apply to this rule because
it does not have an impact beyond the internal operations of GSA and is
not required to be published for public comment.
C. Paperwork Reduction Act
The Paperwork Reduction Act does not apply because the changes to
the GSAR do not impose recordkeeping or information collection
requirements, or otherwise collect information from offerors,
contractors or members of the public that require approval of the
Office of Management and Budget under 44 U.S.C. 3501, et seq.
D. Small Business Regulatory Enforcement Fairness Act of 1996
This rule is not a major rule under 5 U.S.C. 804. This rule was
submitted to Congress and GAO under 5 U.S.C. 804.
List of Subjects in 48 CFR Part 501
Government procurement.
Accordingly, 48 CFR 501 is amended as follows:
PART 501--GENERAL SERVICES ADMINISTRATION ACQUISITION REGULATION
SYSTEM
1. The authority citation for 48 CFR 501 continues to read as
follows:
[[Page 51374]]
Authority: 40 U.S.C. 486(c).
2. Subpart 501.4 is revised to read as follows:
Subpart 501.4--Deviations From the FAR and GSAR
501.402 Policy.
(a) Uniformity is an objective of the GSA Acquisition Regulatory
System. However, the desire for consistency of action by GSA
contracting activities must not restrict or discourage development and
testing of new procedures and techniques. Similarly, the desire for
consistency must not prevent GSA contracting activities from adopting
alternate procedures determined to be in the Government's interest
based on unique programmatic or managerial considerations.
(b) A contracting activity may deviate from a regulatory provision
which implements a statutory requirement only to the extent that the
deviation does not violate the underlying statute.
(c) Deviations must not be used to defeat the FAR and GSAR approval
requirements.
501.403 Individual deviations.
Individual deviations from the GSAR or the FAR must be approved by
the Contracting Director. A copy must be submitted to GSA's Senior
Procurement Executive (MV).
501.404 Class deviations.
(a) Class deviations from the FAR or the GSAR must be approved by
the head of the contracting activity (HCA). A copy must be submitted to
GSA's Senior Procurement Executive (MV).
(b) Requests for class deviations must be supported by statements
that disclose the need for and the nature of the deviation.
(c) Class deviations from the GSAR will expire in 12 months if not
extended. They may be rescinded earlier by the Senior Procurement
Executive or the HCA without prejudice to any action previously taken.
Dated: September 26, 1996.
Ida M. Ustad,
Deputy Associate Administrator for Acquisition Policy.
[FR Doc. 96-25174 Filed 10-1-96; 8:45 am]
BILLING CODE 6820-61-M
Complete official Federal Register PDF
FR Doc. 96-25151 Customs Service Field OrganizationCorpus Christi, Freeport and Port Lavaca-Point Comfort, Texas as Ports of Entry
[Federal Register Volume 61, Number 192 (Wednesday, October 2, 1996)]
[Rules and Regulations]
[Pages 51363-51364]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-25151]
=======================================================================
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DEPARTMENT OF THE TREASURY
Customs Service
19 CFR Part 101
[T.D. 96-68]
Customs Service Field Organization--Corpus Christi, Freeport and
Port Lavaca-Point Comfort, Texas as Ports of Entry
AGENCY: U.S. Customs Service, Department of the Treasury.
ACTION: Final rule; technical correction.
-----------------------------------------------------------------------
SUMMARY: This document corrects an error in the Customs Regulations
regarding the listing of ports of entry in the State of Texas as the
listing does not reflect the proper status of Corpus Christi, Freeport
and Port Lavaca-Point Comfort as separate ports of entry. This
technical correction has no operational impact, since all three of
these locations have consistently operated as separate ports of entry,
notwithstanding the technical error in the Customs Regulations.
EFFECTIVE DATE: October 2, 1996.
FOR FURTHER INFORMATION CONTACT:
Harry Denning, Office of Field Operations, Resource Management
Division, (202) 927-0196.
SUPPLEMENTARY INFORMATION:
Background
It has come to the attention of the Customs Service that the
listing of the ports of entry in the State of Texas in Sec. 101.3,
Customs Regulations (19 CFR 101.3) does not reflect the proper status
of Corpus Christi, Freeport and Port Lavaca-Point Comfort as separate
ports of entry.
When Customs amended its regulations in T.D. 95-77, published in
the Federal Register (60 FR 50008) on September 27, 1995, to reflect
Customs new organizational structure, the listing of Customs ports of
entry in Sec. 101.3 was redrafted, for ease of reference, to list the
ports of entry by State. Previously, the listing of ports was organized
by districts and regions. Districts and regions were eliminated in
Customs new organizational structure set forth in T.D. 95-77.
Despite the fact that the port description of the Houston-Galveston
consolidated port in T.D. 95-77 merely reiterated a previously
published description of the port (with minor editorial changes), the
new method of listing the ports of entry in Sec. 101.3 set forth in
T.D. 95-77 first brought to the attention of certain readers of the
Customs Regulations that Corpus Christi, Freeport and Port Lavaca-Point
Comfort, Texas, were not listed as separate ports of entry, but were
included within the consolidated port of entry of Houston-Galveston.
Corpus Christi, Freeport and Port Lavaca-Point Comfort have
consistently operated as separate ports, with separate port codes.
Research reveals that the incorrect description of the Houston-
Galveston port stems from an earlier punctuation error--periods were
inadvertently converted to commas--in the regulations by T.D. 83-209,
published in the Federal Register (48 FR 45538) on October 6, 1983.
This typographical error has been carried forward in each volume of the
regulations since that date. T.D. 83-209, the purpose of which was to
reflect a 1983 reorganization of Customs field organization, was
intended to have no effect on services provided by Customs. However,
because of the punctuation errors, Corpus Christi, Freeport and Port
Lavaca-Point Comfort appeared as part of the description of the
Houston-Galveston port of entry rather than as separate port of entry
listings under the Houston-Galveston district.
Further research reveals that this listing was in error because
when the districts and ports of Galveston and Houston were consolidated
in 1981 pursuant to T.D. 81-160, the port limits of the consolidated
port of entry of Houston and Galveston were set forth to encompass
Galveston, including Port Bolivar and Texas City, Texas, and the area
within the present Houston, Texas limits including territory described
in T.D. 54409. Corpus Christi, Freeport and Port Lavaca-Point Comfort
were listed as separate ports of entry in the Houston-Galveston
consolidated district in T.D. 81-160. It is noted that the port limits
of the consolidated port of Houston-Galveston were later amended by
T.D. 82-15, but that change also did not affect Corpus Christi,
Freeport or Port Lavaca-Point Comfort.
In accordance with the above discussion, in this document, Customs
is correcting the listing of the ports of entry in the State of Texas
in Sec. 101.3 of the Customs Regulations to accurately reflect that
Corpus Christi, Freeport and Port Lavaca-Point Comfort, which have
consistently operated as separate ports of entry with separate port
codes, are indeed separate ports of entry, outside the Houston-
Galveston consolidated port of entry.
Regulatory Flexibility Act, Executive Order 12866, Inapplicability of
Public Notice and Comment Requirements, and Delayed Effective Date
Requirements
Inasmuch as this document relates to agency management, merely
corrects a typographical error and has no operational impact, it is not
subject to the notice and public procedure requirements or the delayed
effective date requirements of 5 U.S.C. 553. Because the document
relates to agency management and organization and is not subject to
notice and public comment, the document is not subject to the
regulatory analysis or other requirements of 5 U.S.C. 603 or 604.
Agency organization matters such as this are exempt from Executive
Order 12866.
List of Subjects in Part 101
Customs duties and inspection, Harbors, Organization and functions
(Government agencies), Seals and insignia, Vessels.
Amendments to the Regulations
For the reasons set forth in the preamble, part 101 of the Customs
Regulations (19 CFR part 101) is amended as set forth below:
PART 101--GENERAL PROVISIONS
1. The general authority citation for part 101 and the relevant
specific authority citation continue to read as follows:
Authority: 5 U.S.C. 301; 19 U.S.C. 2, 66, 1202 (General Note 20,
Harmonized Tariff Schedule of the United States), 1623, 1624.
Sections 101.3 and 101.4 also issued under 19 U.S.C. 1 and 58b;
* * * * *
2. In the table under Sec. 101.3(b)(1), the listings for the State
of Texas are amended by revising the entry for Houston--Galveston and
adding in appropriate alphabetical order entries
[[Page 51364]]
for Corpus Christi, Freeport, and Port Lavaca-Point Comfort to read as
follows:
Sec. 101.3 Customs service ports and ports of entry.
* * * * *
(b) List of Ports of Entry and Service Ports. * * *
(1) Customs ports of entry. * * *
------------------------------------------------------------------------
Ports of entry Limits of port
------------------------------------------------------------------------
* * * * *
Texas
* * * * *
Corpus Christi............................ E.O. 8288, Nov. 22, 1939 (4
FR 4691), and territory
described in T.D. 78-130.
* * * * *
Freeport.................................. E.O. 7632, June 15, 1937 (2
FR 1245).
* * * * *
+ Houston-Galveston....................... Consolidated port includes
territory lying within
corporate limits of both
Houston and Galveston, and
remaining territory in
Harris and Galveston
Counties, T.D.s 81-160 and
82-15.
* * * * *
Port Lavaca-Point Comfort................. T.D. 56115.
* * * * *
------------------------------------------------------------------------
+ Indicates Drawback unit/office.
George J. Weise,
Commissioner of Customs.
Approved: September 4, 1996.
John P. Simpson,
Deputy Assistant Secretary of the Treasury.
[FR Doc. 96-25151 Filed 10-1-96; 8:45 am]
BILLING CODE 4820-02-M
Complete official Federal Register PDF
FR Doc. 96-25128 Amendment to Class E Airspace, Seward, NE
[Federal Register Volume 61, Number 192 (Wednesday, October 2, 1996)]
[Rules and Regulations]
[Pages 51362-51363]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-25128]
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
14 CFR Part 71
[Docket No. 96-ACE-10]
Amendment to Class E Airspace, Seward, NE
AGENCY: Federal Aviation Administration, DOT.
ACTION: Direct final rule; confirmation of effective date.
-----------------------------------------------------------------------
SUMMARY: This rule amends the Class E airspace area at Seward Airport,
Seward, Nebraska. The effect of this rule is to provide additional
controlled airspace for aircraft executing the new Standard Instrument
Approach Procedure (SIAP) at Seward Airport and departing aircraft to
transition into controlled airspace.
EFFECTIVE DATE: 0901 UTC October 25, 1996.
FOR FURTHER INFORMATION CONTACT: Kathy Randolph, Air Traffic Division,
Operations Branch, ACE-530C, Federal Aviation Administration, 601 East
12th Street, Kansas City, Missouri 64106: telephone (816) 426-3408.
SUPPLEMENTARY INFORMATION: The FAA published this direct final rule
with a request for comments in the Federal Register on August 6, 1996
(61 FR 40718). The FAA uses the direct final
[[Page 51363]]
rulemaking procedure for a non-controversial rule where the FAA
believes that there will be no adverse public comment. This direct
final rule advised the public that no adverse comments were
anticipated, and that unless a written adverse comment, or a written
notice of intent to submit such an adverse comment, were received
within the comment period, the regulation would become effective on
October 25, 1996. No adverse comments were received, and thus this
notice confirms that this final rule will become effective on that
date.
Issued in Kansas City, MO, on September 16, 1996.
Herman J. Lyons, Jr.,
Manager, Air Traffic Division, Central Region.
[FR Doc. 96-25128 Filed 10-1-96; 8:45 am]
BILLING CODE 4910-13-M
Complete official Federal Register PDF
FR Doc. 96-25127 Establishment of Class E Airspace; Mosby, MO
[Federal Register Volume 61, Number 192 (Wednesday, October 2, 1996)]
[Rules and Regulations]
[Pages 51361-51362]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-25127]
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
14 CFR Part 71
[Airspace Docket No. 96-ACE-9]
Establishment of Class E Airspace; Mosby, MO
AGENCY: Federal Aviation Administration [FAA], DOT.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This action establishes a Class E airspace area at the new
Clay County Regional Airport, Mosby, MO, with a projected opening in
late 1996. The FAA has developed Standard Instrument Approach
Procedures (SIAP) to accommodate a planned Global Positioning System
(GPS) and a Non-directional Radio Beacon (NDB) at the new Clay County
Regional Airport. This action will provide for controlled airspace
necessary for aircraft executing the SIAPs at the new airport.
EFFECTIVE DATE: 0901 UTC, October 10, 1996.
[[Page 51362]]
FOR FURTHER INFORMATION CONTACT:
Kathy Randolph, Air Traffic Operations Branch, ACE-530C, Federal
Aviation Administration, 601 E. 12th St., Kansas City, MO, 64106;
telephone (816) 426-3408.
SUPPLEMENTARY INFORMATION:
History
On August 2, 1996, the FAA proposed to amend Part 71 of the Federal
Aviation Regulations (14 CFR Part 71) by establishing Class E airspace
at the new Clay County Regional Airport, Mosby, MO (61 FR 40365). The
proposed action would provide controlled airspace to accommodate the
new SIAP to Clay County Regional Airport.
Interested parties were invited to participate in this rulemaking
proceeding by submitting written comments on the proposal to the FAA.
No comments objecting to the proposal were received. Class E airspace
areas extending from 700 feet or more above the surface of the earth
are published in paragraphs 6005 of FAA Order 7400.9D, dated September
4, 1996, and effective September 16, 1996, which is incorporated by
reference in 14 CFR 71.1. The Class E airspace designation listed in
this documented will be published subsequently in the order.
The Rule
This amendment to Part 71 of the Federal Aviation Regulations (14
CFR Part 71) establishes the Class E airspace area at Mosby, MO, by
providing additional controlled airspace for aircraft executing the new
SIAP to the airport.
The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this regulation (1) is not a ``significant regulatory
action'' under Executive Order 12866; (2) is not a ``significant rule''
under DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a Regulatory Evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule will not have a significant economic impact on
a substantial number of small entities under the criteria of the
Regulatory Flexibility Act.
List of Subjects in 14 CFR Part 71
Aviation, Incorporation by reference, Navigation (air).
Adoption of the Amendment
In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR Part 71 as follows:
PART 71--[AMENDED]
1. The authority citation for Part 71 continues to read as follows:
Authority: 49 U.S.C. 106(g); 40103, 40113 40120; E.O. 10854, 24
FR 9565, 3 CFR, 1959-1963 Comp., p. 389; 14 CFR 11.69.
Sec. 71.1 [Amended]
2. The incorporation by reference in 14 CFR 71.1 of Federal
Aviation Administration Order 7400.9D, Airspace Designations and
Reporting Points, dated September 4, 1996, and effective September 16,
1996, is amended as follows:
Paragraph 6005 Class E airspace areas extending from 700 feet or
more above the surface of the earth.
* * * * *
ACE MO E5 Mosby, MO [New]
Clay County Regional Airport
(Lat. 39 deg.19'50''N., long. 94 deg.18'36''W.)
Mosby NDB
(Lat. 39 deg.20'46''N., long 94 deg.18'27''W.)
That airspace extending upward from 700 feet above the surface
within a 6.4-mile radius of Clay County Regional Airport and within
2.5 miles each side of the 007 deg. bearing from the Mosby NDB
extending from the 6.4-mile radius of 7.9 miles north of the
airport.
* * * * *
Issued in Kansas City, MO, on September 12, 1996.
Jack L. Skelton,
Acting, Manager, Air Traffic Division, Central Region.
[FR Doc. 96-25127 Filed 10-1-96; 8:45 am]
BILLING CODE 4910-13-M
Complete official Federal Register PDF
FR Doc. 96-25126 Amendment to Class E Airspace, Russell, KS
[Federal Register Volume 61, Number 192 (Wednesday, October 2, 1996)]
[Rules and Regulations]
[Page 51361]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-25126]
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
14 CFR Part 71
[Docket No. 96-ACE-7]
Amendment to Class E Airspace, Russell, KS
AGENCY: Federal Aviation Administration, DOT.
ACTION: Direct final rule; confirmation of effective date.
-----------------------------------------------------------------------
SUMMARY: This rule amends the Class E airspace area at Russell
Municipal Airport, Russell, KS. The effect of this rule is to provide
additional controlled airspace for aircraft executing the new Standard
Instrument Approach Procedure (SIAP) at Russell Municipal Airport and
departing aircraft to transition into controlled airspace.
EFFECTIVE DATES: 0901 UTC October 10, 1996.
FOR FURTHER INFORMATION CONTACT: Kathy Randolph, Air Traffic Division,
Operations Branch, ACE-530C, Federal Aviation Administration, 601 East
12th Street, Kansas City, Missouri 64106; telephone (816) 426-3408.
SUPPLEMENTARY INFORMATION: The FAA published this direct final rule
with a request for comments in the Federal Register on July 17, 1996
(61 FR 37205). The FAA uses the direct final rulemaking procedure for a
non-controversial rule where the FAA believes that there will be no
adverse public comment. This direct final rule advised the public that
no adverse comments were anticipated, and that unless a written adverse
comment, or a written notice of intent to submit such an adverse
comment, were received within the comment period, the regulation would
become effective on October 10, 1996. No adverse comments were
received, and thus, this notice confirms that this final rule will
become effective on that date.
Issued in Kansas City, MO, on August 21, 1996.
Donovan D. Schardt,
Acting Manager, Air Traffic Division, Central Region.
[FR Doc. 96-25126 Filed 10-01-96; 8:45 am]
BILLING CODE 4910-13-M
Complete official Federal Register PDF
FR Doc. 96-25125 Amendment to Class E Airspace, McCook, NE
[Federal Register Volume 61, Number 192 (Wednesday, October 2, 1996)]
[Rules and Regulations]
[Page 51362]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-25125]
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
14 CFR Part 71
[Docket No. 96-ACE-8]
Amendment to Class E Airspace, McCook, NE
AGENCY: Federal Aviation Administration, DOT.
ACTION: Direct final rule; confirmation of effective date.
-----------------------------------------------------------------------
SUMMARY: This rule amends the Class E airspace area at McCook Municipal
Airport, McCook, NE. The effect of this rule is to provide additional
controlled airspace for aircraft executing the new Standard Instrument
Approach Procedure (SIAP) at McCook Municipal Airport and departing
aircraft to transition into controlled airspace.
EFFECTIVE DATES: 0901 UTC October 10, 1996.
FOR FURTHER INFORMATION CONTACT: Kathy Randolph, Air Traffic Division,
Operations Branch, ACE-530C, Federal Aviation Administration, 601 East
12th Street, Kansas City, Missouri 64106; telephone (816) 426-3408.
SUPPLEMENTARY INFORMATION: The FAA published this direct final rule
with a request for comments in the Federal Register on July 17, 1996
(61 FR 37204). The FAA uses the direct final rulemaking procedure for a
non-controversial rule where the FAA believes that there will be no
adverse public comment. This direct final rule advised the public that
no adverse comments were anticipated, and that unless a written adverse
comment, or a written notice of intent to submit such an adverse
comment, were received within the comment period, the regulation would
become effective on October 10, 1996. No adverse comments were
received, and thus, this notice confirms that this final rule will
become effective on that date.
Issued in Kansas City, MO, on August 21, 1996.
Donovan D. Schardt,
Acting Manager, Air Traffic Division, Central Region.
[FR Doc. 96-25125 Filed 10-1-96; 8:45 am]
BILLING CODE 4910-13-M
Complete official Federal Register PDF
FR Doc. 96-25122 Indirect Food Additives: Polymers
[Federal Register Volume 61, Number 192 (Wednesday, October 2, 1996)]
[Rules and Regulations]
[Pages 51364-51365]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-25122]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 177
[Docket No. 91F-0289]
Indirect Food Additives: Polymers
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the food
additive regulations to provide for the safe use of methyl
methacrylate/butyl acrylate-grafted polypropylene copolymer containing
methyl methacrylate/butyl acrylate-grafted polypropylene, methyl
methacrylate/butyl acrylate copolymer, methyl methacrylate homopolymer,
and polypropylene, resulting from the reaction of a mixture of methyl
methacrylate and butyl acrylate with polypropylene, as a component of
food-contact materials. This action is in response to a food additive
petition filed by Rohm and Haas Co.
DATES: Effective October 2, 1996; written objections and requests for a
hearing by November 1, 1996. The Director of the Office of the Federal
Register approves the incorporation by reference in accordance with 5
U.S.C. 552(a) and 1 CFR part 51 of a certain publication listed in 21
CFR 177.1520(b), effective October 2, 1996.
ADDRESSES: Submit written objections to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Hortense S. Macon, Center for Food
Safety and Applied Nutrition (HFS-216), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-418-3086.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of August 23, 1991 (56 FR 41850), FDA announced that a food
additive petition (FAP 1B4272) had been filed by Rohm and Haas Co., c/o
1150 17th St. NW., Washington, DC 20036 (currently c/o Keller and
Heckman, 1001 G St. NW., suite 500 West, Washington, DC 20001). The
petition proposed to amend the food additive regulations in
Sec. 177.1520 Olefin polymers (21 CFR 177.1520) to provide for the safe
use of methyl methacrylate/butyl acrylate-grafted polypropylene as a
component of propylene homopolymer and copolymer food-contact
materials.
FDA has evaluated data in the petition and other relevant material.
The agency concludes that the proposed use of the food additive is safe
and that Sec. 177.1520 should be amended as set forth below. The agency
further concludes that methyl methacrylate/butyl acrylate-grafted
polypropylene copolymer containing methyl methacrylate/butyl acrylate-
grafted polypropylene, methyl methacrylate/butyl acrylate copolymer,
methyl methacrylate homopolymer, and polypropylene, resulting from the
reaction of a mixture of methyl methacrylate and butyl acrylate with
polypropylene, is a more accurate and descriptive name for the food
additive than the name given in the petition. Therefore, FDA is using
this name to identify the additive in the final rule.
In accordance with Sec. 171.1(h) (21 CFR 171.1(h)), the petition
and the documents that FDA considered and relied upon in reaching its
decision to approve the petition are available for inspection at the
Center for Food Safety and Applied Nutrition by appointment with the
information contact person listed above. As provided in 21 CFR
171.1(h), the agency will delete from the documents any materials that
are not available for public disclosure before making the documents
available for inspection.
The agency has carefully considered the potential environmental
effects of this action. FDA has concluded that the action will not have
a significant impact on the human environment, and that an
environmental impact statement is not required. The agency's finding of
no significant impact and the evidence supporting that finding,
contained in an environmental assessment, may be seen in the Dockets
Management Branch (address above) between 9 a.m. and 4 p.m., Monday
through Friday.
Any person who will be adversely affected by this regulation may at
any time on or before November 1, 1996, file with the Dockets
Management Branch (address above) written objections thereto. Each
objection shall be separately numbered and each numbered objection
shall specify with particularity the provisions of the regulation to
which objection is made and the grounds for the objection. Each
numbered objection on which a hearing is requested shall specifically
so state. Failure to request a hearing for any particular objection
shall constitute a waiver of the right to a hearing on that objection.
Each numbered objection for which a hearing is requested shall include
a detailed description and analysis of the specific factual information
intended to be presented in support of the objection in the event that
a hearing is held. Failure to include such a description and analysis
for any particular objection shall constitute a waiver of the right to
a hearing on the objection. Three copies of all documents shall be
submitted and shall be identified with the docket number found in
brackets in the heading of this regulation. Any objections received in
response to the regulation may be seen in the Dockets Management Branch
between 9 a.m. and 4 p.m., Monday through Friday.
List of Subjects in 21 CFR Part 177
Food additives, Food packaging, Incorporation by reference.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner
[[Page 51365]]
of Food and Drugs and redelegated to the Director, Center for Food
Safety and Applied Nutrition, 21 CFR part 177 is amended as follows:
PART 177--INDIRECT FOOD ADDITIVES: POLYMERS
1. The authority citation for 21 CFR part 177 continues to read as
follows:
Authority: Secs. 201, 402, 409, 721 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 321, 342, 348, 379e).
2. Section 177.1520 is amended in the table in paragraph (b) by
alphabetically adding a new entry under the headings ``Substance'' and
``Limitations'' to read as follow:
Sec. 177.1520 Olefin polymers.
* * * * *
(b) * * *
------------------------------------------------------------------------
Substance Limitations
------------------------------------------------------------------------
* * * *
* * *
Methyl methacrylate/butyl acrylate- For use only at levels not to
grafted polypropylene copolymer exceed 6 percent by weight of
containing methyl methacrylate/butyl olefin polymers complying with
acrylate-grafted polypropylene (CAS paragraph (c) of this section,
Reg. No. 121510-09-6), methyl items 1.1, 3.1a, 3.2a, and 3.2b,
methacrylate/butyl acrylate where the copolymers complying
copolymer (CAS Reg. No. 25852-37-3), with items 3.1a, 3.2a, and 3.2b
methyl methacrylate homopolymer (CAS contain not less than 85 weight-
Reg. No. 9011-14-7), and percent of polymer units derived
polypropylene (CAS Reg. No. 9003-07- from propylene.
0), resulting from the reaction of a
mixture of methyl methacrylate and
butyl acrylate with polypropylene.
The finished product contains no
more than 55 percent by weight of
polymer units derived from methyl
methacrylate and butyl acrylate as
determined by a method entitled,
``Determination of the Total Acrylic
in PP-MMA/BA Polymers,'' which is
incorporated by reference in
accordance with 5 U.S.C. 552(a) and
1 CFR part 51. Copies are available
from the Office of Premarket
Approval, Center for Food Safety and
Applied Nutrition (HFS-200), Food
and Drug Administration, 200 C St.
SW., Washington, DC 20204, or may be
examined at the Center for Food
Safety and Applied Nutrition's
Library, 200 C. St. SW., rm. 3321,
Washington, DC, or at the Office of
the Federal Register, 800 North
Capitol St. NW., suite 700,
Washington, DC.
* * * *
* * *
------------------------------------------------------------------------
* * * * *
Dated: September 23, 1996.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 96-25122 Filed 10-1-96; 8:45 am]
BILLING CODE 4160-01-F
Complete official Federal Register PDF
FR Doc. 96-25103 Irish Potatoes Grown in Certain Designated Counties in Idaho, and Malheur County, Oregon; Assessment Rate
[Federal Register Volume 61, Number 192 (Wednesday, October 2, 1996)]
[Rules and Regulations]
[Pages 51354-51356]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-25103]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
7 CFR Part 945
[Docket No. FV96-945-1 FIR]
Irish Potatoes Grown in Certain Designated Counties in Idaho, and
Malheur County, Oregon; Assessment Rate
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Department of Agriculture (Department) is adopting as a
final rule, without change, the provisions of an interim final rule
that established an assessment rate for the Idaho-Eastern Oregon Potato
Committee (Committee) under Marketing Order No. 945 for the 1996-97 and
subsequent fiscal periods. The Committee is responsible for local
administration of the marketing order which regulates the handling of
potatoes grown in designated counties in Idaho, and Malheur County,
Oregon. Authorization to assess potato handlers enables the Committee
to incur expenses that are reasonable and necessary to administer the
program.
EFFECTIVE DATE: August 1, 1996.
FOR FURTHER INFORMATION CONTACT: Martha Sue Clark, Program Assistant,
Marketing Order Administration Branch, Fruit and Vegetable Division,
AMS, USDA, P.O. Box 96456, room 2525-S, Washington, DC 20090-6456,
telephone 202-720-9918; FAX 202-720-5698, or Dennis L. West, Marketing
Specialist, Northwest Marketing Field Office, Fruit and Vegetable
Division, AMS, USDA, Green-Wyatt Federal Building, room 369, 1220
Southwest Third Avenue, Portland, OR 97204, telephone 503-326-2724; FAX
503-326-7440. Small businesses may request information on compliance
with this regulation by contacting: Jay Guerber, Marketing Order
Administration Branch, Fruit and Vegetable Division, AMS, USDA, P.O.
Box 96456, room 2525-S, Washington, DC 20090-6456, telephone 202-720-
2491; FAX 202-720-5698.
SUPPLEMENTARY INFORMATION: This rule is issued under Marketing
Agreement No. 98 and Order No. 945, both as amended (7 CFR part 945),
regulating the handling of Irish potatoes grown in designated counties
in Idaho, and Malheur County, Oregon, hereinafter referred to as the
``order.'' The order is effective under the Agricultural Marketing
Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter
referred to as the ``Act.''
The Department is issuing this rule in conformance with Executive
Order 12866.
This rule has been reviewed under Executive Order 12988, Civil
Justice Reform. Under the marketing order now in effect, Idaho-Eastern
Oregon potato handlers are subject to assessments. Funds to administer
the order are derived from such assessments. It is intended that the
assessment rate as issued herein will be applicable to all assessable
potatoes beginning August 1, 1996, and continuing until amended,
suspended, or terminated. This rule will not preempt any State or local
laws, regulations, or policies, unless they
[[Page 51355]]
present an irreconcilable conflict with this rule.
The Act provides that administrative proceedings must be exhausted
before parties may file suit in court. Under section 608c(15)(A) of the
Act, any handler subject to an order may file with the Secretary a
petition stating that the order, any provision of the order, or any
obligation imposed in connection with the order is not in accordance
with law and request a modification of the order or to be exempted
therefrom. Such handler is afforded the opportunity for a hearing on
the petition. After the hearing the Secretary would rule on the
petition. The Act provides that the district court of the United States
in any district in which the handler is an inhabitant, or has his or
her principal place of business, has jurisdiction to review the
Secretary's ruling on the petition, provided an action is filed not
later than 20 days after the date of the entry of the ruling.
Pursuant to requirements set forth in the Regulatory Flexibility
Act (RFA), the Agricultural Marketing Service (AMS) has considered the
economic impact of this rule on small entities.
The purpose of the RFA is to fit regulatory actions to the scale of
business subject to such actions in order that small businesses will
not be unduly or disproportionately burdened. Marketing orders issued
pursuant to the Act, and the rules issued thereunder, are unique in
that they are brought about through group action of essentially small
entities acting on their own behalf. Thus, both statutes have small
entity orientation and compatibility.
There are approximately 2,100 producers of Idaho-Eastern Oregon
potatoes in the production area and approximately 61 handlers subject
to regulation under the marketing order. Small agricultural producers
have been defined by the Small Business Administration (13 CFR 121.601)
as those having annual receipts of less than $500,000, and small
agricultural service firms are defined as those whose annual receipts
are less than $5,000,000. The majority of Idaho-Eastern Oregon potato
producers and handlers may be classified as small entities.
The Idaho-Eastern Oregon potato marketing order provides authority
for the Committee, with the approval of the Department, to formulate an
annual budget of expenses and collect assessments from handlers to
administer the program. The members of the Committee are producers and
handlers of Idaho-Eastern Oregon potatoes. They are familiar with the
Committee's needs and with the costs of goods and services in their
local area and are thus in a position to formulate an appropriate
budget and assessment rate. The assessment rate is formulated and
discussed in a public meeting. Thus, all directly affected persons have
an opportunity to participate and provide input.
The Committee met on June 4, 1996, and unanimously recommended
1996-97 expenditures of $122,046 and an assessment rate of $0.0026 per
hundredweight of potatoes. In comparison, last year's budgeted
expenditures were $111,732. The assessment rate of $0.0026 is the same
as last year's established rate. Major expenditures recommended by the
Committee for the 1996-97 year include $63,896 for salaries, $7,000 for
the manager's travel, $5,500 for Federal payroll taxes, and $15,000 for
reserve/auto purchase. Budgeted expenses for these items in 1995-96
were $63,232, $6,000, $5,300, and $9,000, respectively.
The assessment rate recommended by the Committee was derived by
dividing anticipated expenses by expected shipments of Idaho-Eastern
Oregon potatoes. Potato shipments for the year are estimated at
34,000,000 hundredweight, which should provide $88,400 in assessment
income. Income derived from handler assessments, along with funds from
interest income and the Committee's authorized reserve, will be
adequate to cover budgeted expenses. Funds in the reserve will be kept
within the maximum permitted by the order.
An interim final rule regarding this action was published in the
July 29, 1996, issue of the Federal Register (61 FR 39270). That
interim final rule added Sec. 945.249 to establish an assessment rate
for the Committee. That rule provided that interested persons could
file comments through August 28, 1996. No comments were received.
While this rule will impose some additional costs on handlers, the
costs are in the form of uniform assessments on all handlers. Some of
the additional costs may be passed on to producers. However, these
costs will be offset by the benefits derived by the operation of the
marketing order. Therefore, the AMS has determined that this rule will
not have a significant economic impact on a substantial number of small
entities.
The assessment rate established in this rule will continue in
effect indefinitely unless modified, suspended, or terminated by the
Secretary upon recommendation and information submitted by the
Committee or other available information.
Although this assessment rate is effective for an indefinite
period, the Committee will continue to meet prior to or during each
fiscal period to recommend a budget of expenses and consider
recommendations for modification of the assessment rate. The dates and
times of Committee meetings are available from the Committee or the
Department. Committee meetings are open to the public and interested
persons may express their views at these meetings. The Department will
evaluate Committee recommendations and other available information to
determine whether modification of the assessment rate is needed.
Further rulemaking will be undertaken as necessary. The Committee's
1996-97 budget and those for subsequent fiscal periods will be reviewed
and, as appropriate, approved by the Department.
After consideration of all relevant material presented, including
the information and recommendation submitted by the Committee and other
available information, it is hereby found that this rule, as
hereinafter set forth, will tend to effectuate the declared policy of
the Act.
Pursuant to 5 U.S.C. 553, it is also found and determined that good
cause exists for not postponing the effective date of this rule until
30 days after publication in the Federal Register because: (1) The
Committee needs to have sufficient funds to pay its expenses which are
incurred on a continuous basis; (2) the 1996-97 fiscal period began on
August 1, 1996, and the marketing order requires that the rate of
assessment for each fiscal period apply to all assessable potatoes
handled during such fiscal period; (3) handlers are aware of this
action which was unanimously recommended by the Committee at a public
meeting and is similar to other assessment rate actions issued in past
years; and (4) an interim final rule was published on this action and
provided for a 30-day comment period, and no comments were received.
List of Subjects in 7 CFR Part 945
Marketing agreements, Potatoes, Reporting and recordkeeping
requirements.
For the reasons set forth in the preamble, 7 CFR part 945 is
amended as follows:
Note: This section will appear in the Code of Federal
Regulations.
PART 945--IRISH POTATOES GROWN IN CERTAIN DESIGNATED COUNTIES IN
IDAHO AND MALHEUR COUNTY, OREGON
Accordingly, the interim final rule amending 7 CFR part 945 which
was published at 61 FR 39270 on July 29,
[[Page 51356]]
1996, is adopted as a final rule without change.
Dated: September 25, 1996.
Sharon Bomer Lauritsen,
Acting Director, Fruit and Vegetable Division.
[FR Doc. 96-25103 Filed 10-1-96; 8:45 am]
BILLING CODE 3410-02-P
Complete official Federal Register PDF
FR Doc. 96-25102 Dried Prunes Produced in California; Assessment Rate
[Federal Register Volume 61, Number 192 (Wednesday, October 2, 1996)]
[Rules and Regulations]
[Pages 51356-51357]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-25102]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
7 CFR Part 993
[Docket No. FV96-993-1 FIR]
Dried Prunes Produced in California; Assessment Rate
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Department of Agriculture (Department) is adopting as a
final rule, without change, the provisions of an interim final rule
establishing an assessment rate for the Prune Marketing Committee
(Committee) under Marketing Order No. 993 for the 1996-97 and
subsequent crop years. The Committee is responsible for local
administration of the marketing order which regulates the handling of
dried prunes produced in California. Authorization to assess prune
handlers enables the Committee to incur expenses that are reasonable
and necessary to administer the program.
EFFECTIVE DATE: August 1, 1996.
FOR FURTHER INFORMATION CONTACT: Mary Kate Nelson, Marketing Assistant,
Marketing Order Administration Branch, California Marketing Field
Office, Fruit and Vegetable Division, AMS, USDA, suite 102B, 2202
Monterey Street, Fresno, California 93721, telephone 209-487-5901; FAX
209-487-5906, or Martha Sue Clark, Program Assistant, Marketing Order
Administration Branch, Fruit and Vegetable Division, AMS, USDA, P.O.
Box 96456, room 2525-S, Washington, DC 20090-6456, telephone 202-720-
9918; FAX 202-720-5698. Small businesses may request information on
compliance with this regulation by contacting: Jay Guerber, Marketing
Order Administration Branch, Fruit and Vegetable Division, AMS, USDA,
P.O. Box 96456, room 2525-S, Washington, DC 20090-6456, telephone 202-
720-2491; FAX 202-720-5698.
SUPPLEMENTARY INFORMATION: This rule is issued under Marketing
Agreement and Order No. 993, both as amended (7 CFR part 993),
regulating the handling of dried prunes produced in California,
hereinafter referred to as the ``order.'' The order is effective under
the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C.
601-674), hereinafter referred to as the ``Act.''
The Department is issuing this rule in conformance with Executive
Order 12866.
This rule has been reviewed under Executive Order 12988, Civil
Justice Reform. Under the marketing order now in effect, California
prune handlers are subject to assessments. Funds to administer the
order are derived from such assessments. It is intended that the
assessment rate as issued herein will be applicable to all assessable
prunes beginning August 1, 1996, and continuing until amended,
suspended, or terminated. This rule will not preempt any State or local
laws, regulations, or policies, unless they present an irreconcilable
conflict with this rule.
The Act provides that administrative proceedings must be exhausted
before parties may file suit in court. Under section 608c(15)(A) of the
Act, any handler subject to an order may file with the Secretary a
petition stating that the order, any provision of the order, or any
obligation imposed in connection with the order is not in accordance
with law and request a modification of the order or to be exempted
therefrom. Such handler is afforded the opportunity for a hearing on
the petition. After the hearing the Secretary would rule on the
petition. The Act provides that the district court of the United States
in any district in which the handler is an inhabitant, or has his or
her principal place of business, has jurisdiction to review the
Secretary's ruling on the petition, provided an action is filed not
later than 20 days after the date of the entry of the ruling.
Pursuant to requirements set forth in the Regulatory Flexibility
Act (RFA), the Agricultural Marketing Service (AMS) has considered the
economic impact of this rule on small entities.
The purpose of the RFA is to fit regulatory actions to the scale of
business subject to such actions in order that small businesses will
not be unduly or disproportionately burdened. Marketing orders issued
pursuant to the Act, and the rules issued thereunder, are unique in
that they are brought about through group action of essentially small
entities acting on their own behalf. Thus, both statutes have small
entity orientation and compatibility.
There are approximately 1,400 producers of dried prunes in the
production area and approximately 21 handlers subject to regulation
under the marketing order. Small agricultural producers have been
defined by the Small Business Administration (13 CFR 121.601) as those
having annual receipts of less than $500,000, and small agricultural
service firms are defined as those whose annual receipts are less than
$5,000,000. The majority of California dried prune producers and
handlers may be classified as small entities.
The California prune marketing order provides authority for the
Committee, with the approval of the Department, to formulate an annual
budget of expenses and collect assessments from handlers to administer
the program. The members of the Committee are producers and handlers of
California dried prunes. They are familiar with the Committee's needs
and with the costs of goods and services in their local area and are
thus in a position to formulate an appropriate budget and assessment
rate. The assessment rate is formulated and discussed in a public
meeting. Thus, all directly affected persons have an opportunity to
participate and provide input.
The Committee met on June 27, 1996, and unanimously recommended
1996-97 expenditures of $283,500 and an assessment rate of $1.50 per
salable ton of dried prunes. In comparison, last year's budgeted
expenditures were $275,280. The assessment rate of $1.50 per salable
ton is $0.05 lower than last year's established rate. Major
expenditures recommended by the Committee for the 1996-97 crop year
include $142,120 for salaries and wages, $30,000 for research and
development, $22,000 for office rent, $20,000 for travel, $11,000 for
an acreage survey, $8,430 for the reserve for contingency, and $6,500
each for office supplies and data processing. Budgeted expenses for
these items in 1995-96 were $131,320, $30,000, $22,000, $20,000,
$10,500, $19,310, $5,000, and $3,500, respectively.
The assessment rate recommended by the Committee was derived by
dividing anticipated expenses by expected shipments of California dried
prunes. Dried prune shipments for the year are estimated at 189,000
salable tons which should provide $283,500 in assessment income. Income
derived from handler assessments will be adequate to cover budgeted
expenses. Any funds not expended by the Committee during a crop year
may be used, pursuant to Sec. 993.81(c), for a period of five months
subsequent to that crop year. At the end of such period, the excess
funds are returned or credited to handlers.
An interim final rule regarding this action was published in the
July 31, 1996, issue of the Federal Register (61 FR 39842). That
interim final rule added Sec. 993.347 to establish an assessment rate
for the Committee. That rule provided
[[Page 51357]]
that interested persons could file comments through August 30, 1996. No
comments were received.
This action will reduce the assessment obligation imposed on
handlers. While this rule will impose some additional costs on
handlers, the costs are in the form of uniform assessments on all
handlers. Some of the additional costs may be passed on to producers.
However, these costs will be offset by the benefits derived from the
operation of the marketing order. Therefore, the AMS has determined
that this rule will not have a significant economic impact on a
substantial number of small entities.
The assessment rate established in this rule will continue in
effect indefinitely unless modified, suspended, or terminated by the
Secretary upon recommendation and information submitted by the
Committee or other available information.
Although this assessment rate is effective for an indefinite
period, the Committee will continue to meet prior to or during each
crop year to recommend a budget of expenses and consider
recommendations for modification of the assessment rate. The dates and
times of Committee meetings are available from the Committee or the
Department. Committee meetings are open to the public and interested
persons may express their views at these meetings. The Department will
evaluate Committee recommendations and other available information to
determine whether modification of the assessment rate is needed.
Further rulemaking will be undertaken as necessary. The Committee's
1996-97 budget and those for subsequent crop years will be reviewed
and, as appropriate, approved by the Department.
After consideration of all relevant material presented, including
the information and recommendation submitted by the Committee and other
available information, it is hereby found that this rule, as
hereinafter set forth, will tend to effectuate the declared policy of
the Act.
Pursuant to 5 U.S.C. 553, it is also found and determined that good
cause exists for not postponing the effective date of this rule until
30 days after publication in the Federal Register because: (1) The
Committee needs to have sufficient funds to pay its expenses which are
incurred on a continuous basis; (2) the 1996-97 crop year began August
1, 1996, and the marketing order requires that the rate of assessment
for each crop year apply to all assessable dried prunes handled during
such crop year; (3) handlers are aware of this action which was
unanimously recommended by the Committee at a public meeting and is
similar to other assessment rate actions issued in past years; and (4)
an interim final rule was published on this action which provided a 30-
day comment period, and no comments were received.
List of Subjects in 7 CFR Part 993
Marketing agreements, Plums, Prunes, Reporting and recordkeeping
requirements.
Note: This section will appear in the Code of Federal
Regulations.
For the reasons set forth in the preamble, 7 CFR part 993 is
amended as follows:
PART 993--DRIED PRUNES PRODUCED IN CALIFORNIA
Accordingly, the interim final rule amending 7 CFR part 993 which
was published at 61 FR 39842 on July 31, 1996, is adopted as a final
rule without change.
Dated: September 25, 1996.
Sharon Bomer Lauritsen,
Acting Director, Fruit and Vegetable Division.
[FR Doc. 96-25102 Filed 10-01-96; 8:45 am]
BILLING CODE 3410-02-P
Complete official Federal Register PDF
FR Doc. 96-25054 Office of the Assistant Secretary for Community Planning and Development; Streamlining the Emergency Shelter Grants Program
[Federal Register Volume 61, Number 192 (Wednesday, October 2, 1996)]
[Rules and Regulations]
[Pages 51546-51553]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-25054]
[[Page 51545]]
_______________________________________________________________________
Part IV
Department of Housing and Urban Development
_______________________________________________________________________
24 CFR Part 576
Streamlining the Emergency Shelter Grants Program; Final Rule
Federal Register / Vol. 61, No. 192 / Wednesday, October 2, 1996 /
Rules and Regulations
[[Page 51546]]
DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT
24 CFR Part 576
[Docket No. FR-4088-F-01]
RIN 2506-AB84
Office of the Assistant Secretary for Community Planning and
Development; Streamlining the Emergency Shelter Grants Program
AGENCY: Office of the Assistant Secretary for Community Planning and
Development, HUD.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This final rule amends HUD's regulations for the Emergency
Shelter Grants (ESG) Program. In an effort to comply with the
President's regulatory reform initiatives, this rule will streamline
the regulations by eliminating provisions that are redundant of
statutes or are otherwise unnecessary. This final rule will make the
ESG regulations clearer and more concise. In addition, this rule will
reflect provisions implementing legislation that has amended the
program since the last general rule amending the ESG regulations. The
legislation has, among other changes to the program: Extended program
entitlements to Indian tribes; established new limits on expenditures
for specified purposes, including administrative costs, services, and
prevention activities; reduced the amount required to be matched by
grantees and recipients, especially those non-State recipients that are
least capable of meeting matching funds requirements; and mandated
habitability standards and required the implementation of procedures to
ensure confidentiality of records relating to family violence services.
EFFECTIVE DATE: November 1, 1996.
FOR FURTHER INFORMATION CONTACT: Mark Johnston, Director, Program
Coordination and Analysis Division, Office of Community Planning and
Development, Room 7262, telephone (202) 708-1226. For questions on
program requirements for Indian tribes, contact: Bruce Knott, Director,
Housing and Community Development Division, Office of Native American
Programs, Room B-133, telephone (202) 755-0068. (These telephone
numbers are not toll-free.) For hearing- and speech-impaired persons,
these numbers may be accessed via TTY (text telephone) by calling the
Federal Information Relay Service at 1-800-877-8339.
The address for both of these persons is: Department of Housing and
Urban Development, 451 Seventh Street, SW., Washington, DC 20410.
SUPPLEMENTARY INFORMATION:
Background
On March 4, 1995, President Clinton issued a memorandum to all
Federal departments and agencies regarding regulatory reinvention. In
response to this memorandum, the Department of Housing and Urban
Development conducted a page-by-page review of its regulations to
determine which can be eliminated, consolidated, or otherwise improved.
HUD has determined that the regulations for the ESG Program can be
improved and streamlined by eliminating unnecessary provisions.
Several provisions in the regulations repeat statutory language. It
is unnecessary to maintain statutory requirements in the Code of
Federal Regulations (CFR), because those requirements are otherwise
fully accessible and binding. Furthermore, if regulations contain
statutory language, HUD must amend the regulations whenever Congress
amends the statute. Therefore, this final rule removes repetitious
statutory language and replaces it with a citation to the specific
statutory section for easy reference.
Several other provisions in the regulations apply to more than one
program, and therefore HUD repeated these provisions in different
parts. This repetition is unnecessary, and updating these scattered
provisions is cumbersome and often creates confusion. Therefore, this
final rule consolidates duplicative and related provisions, maintaining
appropriate cross-references for the reader's convenience. For example,
requirements for environmental review have been moved into the section
on ``Other federal requirements'' (Sec. 576.57) and have been
streamlined by reference to a new rule on these requirements that was
published on April 30, 1996 (61 FR 19120). This April 30 rule also
permits streamlining of references to flood hazards and coastal
barriers in Sec. 576.57.
Similarly, provisions that are not regulatory requirements--for
example, provisions containing nonbinding guidance or explanations--
have been removed. Although this information can be helpful to program
participants, HUD will more appropriately provide this information
through handbook guidance or other materials, rather than maintain it
in the CFR.
Justification for Final Rulemaking
HUD generally publishes a rule for public comment before issuing a
rule for effect, in accordance with its own regulations on rulemaking
in 24 CFR part 10. However, part 10 provides for exceptions to the
general rule if the agency finds good cause to omit advance notice and
public participation. The good cause requirement is satisfied when
prior public procedure is ``impracticable, unnecessary, or contrary to
the public interest'' (24 CFR 10.1). HUD finds that good cause exists
to publish portions of this rule for effect without first soliciting
public comment. This rule merely removes unnecessary regulatory
provisions and does not establish or affect substantive policy.
Therefore, prior public comment is unnecessary.
Some portions of this rule have been subject to notice-and-comment
rulemaking in the past. A proposed rule that was published in 58 FR
17766 (April 5, 1993) included statutory provisions applicable to
Indian tribe allocations, and was based on the first Notice of Funding
Availability (NOFA) that the Department used to distribute Emergency
shelter grant (ESG) amounts to Indian tribes. Normally, the Department
would not allow a final rule to be based on a proposed rule for which
so much time has lapsed. Because this very limited portion of the
program has been operating in accordance with the statutory
requirements and expressly based upon the methodology included in the
proposed rule, and because this is the first general rule that the
Department has published on this program subsequent to the proposed
rule (upon which the Department received no comments), an exception is
being made to the standard rulemaking policy. The Department
emphasizes, however, that any provisions in the proposed rule that are
made final in this rule are based strictly upon the statutory
provisions and are allowed primarily because inclusion in this rule
provides better notice to affected parties.
Similarly, this rule also makes final a very limited interim rule
on the reallocation of unused ESG amounts that was published on
November 19, 1992 (57 FR 54505) and has remained in effect since that
time. The Department received three comments on the interim rule, one
of which praised the rule and two which suggested changes. Based on its
experience in operating under the provision contained in the interim
rule, the Department does not believe that the administrative mechanism
chosen to distribute the unused funds is unfair, as suggested by one of
the commenters. The regulations already ensure a preference for using
grant amounts in the jurisdiction to which they were allocated. A
change suggested by
[[Page 51547]]
another commenter, regarding advance notification by the Department
before an action to recover unspent grant amounts, does not require a
regulation for implementation. Therefore, in issuing this final
streamlining rule, the Department is not changing the provision on
reallocation of unused grant amounts.
The ESG Program
The more general regulations applicable to the ESG Program (24 CFR
part 576) were amended most recently by a final rule published on
November 7, 1989 (54 FR 46799). Today's streamlining rule incorporates
provisions in two subsequent statutes that contain numerous amendments
to subtitle B of title IV of the Stewart B. McKinney Homeless
Assistance Act (42 U.S.C. 11371-11377) (the McKinney Act), the
authorizing legislation for the ESG program: (1) section 832 (104 Stat.
4359) of the National Affordable Housing Act (Pub. L. 101-625, approved
November 28, 1990) (NAHA); and (2) section 1402 (106 Stat. 4012) of the
Housing and Community Development Act of 1992 (Pub. L. 102-550,
approved October 28, 1992) (1992 Act).
Changes in NAHA
Section 832(b) of NAHA permits recipients to use up to 5% of an
annual ESG Program grant for administrative purposes. Section 832(c)
increased from 20% to 30% the percentage of a grant that may be used to
provide essential services. Section 832(d) withdraws homelessness
prevention activities from categorization as ``essential services'',
and imposes a separate limit of 30% of the aggregate amount of
assistance to a State (including each territory), local government, or
Indian tribe that may be used for efforts to prevent homelessness.
Section 832(e) reduced by $100,000 the amount that States are
required to provide as a match to assistance received under the ESG
program. The $100,000 reduction is required to be implemented by each
State in a manner that will benefit those participating local
governments, Indian tribes, agencies, and nonprofit organizations that
are least able to contribute to the State's matching funds. The
Department is revising Sec. 576.51 (as redesignated) to reflect the
determination under which the Department has been operating that a
territory is not required to provide matching funds. This revision,
which is authorized as a matter of the Department's discretion by 48
U.S.C. 1469a(d), ensures that the funds allocated to the territories
can be provided whether or not they are able to meet the matching
requirements otherwise applicable under this program.
Section 832(e) of NAHA requires each recipient to certify that it
will develop and implement procedures to ensure the confidentiality of
records pertaining to any individual provided family violence
prevention or treatment services with ESG Program assistance. In
addition, the address or location of any ESG-assisted housing used as a
family violence shelter may not be made public without the written
authorization of persons responsible for the operation of the shelter.
Section 832(f) expressly extends eligibility for assistance under
the ESG Program to Indian tribes. This extension is reflected in
numerous sections of this rule. Additional requirements that will be
applicable to Indian tribes interested in competing for ESG set-aside
funds will be included in periodic NOFAs published in the Federal
Register, as provided in Sec. 576.31 of this final rule.
Section 832(g) mandates the Secretary to prescribe standards for
emergency shelters that ensure appropriate privacy, safety, and health-
related living conditions. Section 576.55 of this rule continues to
require that buildings used for emergency shelters comply with local
government safety and sanitation standards.
Changes in Housing and Community Development Act of 1992
Section 1402(b) of the 1992 Act requires a certification regarding
the involvement of homeless individuals and families in providing work
or services pertaining to facilities or activities assisted under the
ESG program. Section 1402(c) requires each unit of local government,
Indian tribe, and nonprofit recipient that receives ESG funds to
provide for the participation of homeless individuals on its board of
directors or other policymaking entity. Section 1402(d) provides that
grantees and recipients may terminate assistance provided to an
individual or family who violates program requirements only in
accordance with a formal process. Section 1402(e) expressly authorizes
as an eligible activity the use of not more than 10 percent of any ESG
grant for costs of staff.
Policy Emphasis
The Department seeks to emphasize that emergency shelters are
intended to be part of a process for ending homelessness. Thus,
emergency shelter grant funds are also appropriately targeted on
efforts to avoid homelessness for families and individuals at imminent
risk of becoming homeless. This policy is reflected in language added
to Sec. 576.1, ``Applicability and purpose''.
While the Department is not expanding its definition of
``homeless'', it is restating in this preamble its understanding of the
scope of that definition. The Department does not believe that the
limited resources of the ESG program were intended by Congress to be
used to serve persons who are poorly housed; the primary purpose of the
program is to help persons who lack shelter. Therefore, in this program
the Department is concerned with persons who are, or may soon become,
homeless, rather than persons who are living in overcrowded or
substandard housing. Other programs administered by the Department,
such as the Section 8 housing assistance payments programs, public and
Indian housing, and the HOME Program, target persons living in
overcrowded or substandard housing.
The Department would correct several omissions from the current
regulations by adding paragraphs (h) and (i) to Sec. 576.57 (as
redesignated). Paragraph (h) refers to statutory lobbying and
disclosure requirements. Paragraph (i) clarifies that the Davis-Bacon
Act (40 U.S.C. 276a-276a-5), which establishes minimum wage
requirements, does not apply to this Program. Although the Davis-Bacon
Act was never incorporated into the McKinney Act and therefore is not
applicable to the ESG program, a specific statement to this effect was
not included in the program regulations. Similar references may be
found in other McKinney Act programs administered by HUD.
Findings and Certifications
Paperwork Reduction Act Statement.
The information collection requirements contained in Secs. 576.21,
576.31, 576.57, 576.43, 576.59, and 576.61 in this rule have been
approved by the Office of Management and Budget (OMB) in accordance
with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520), and
assigned OMB control numbers 2506-0117 and 2506-0089. An agency may not
conduct or sponsor, and a person is not required to respond to, a
collection of information unless the collection displays a valid
control number.
Regulatory Flexibility Act
In accordance with the Regulatory Flexibility Act (5 U.S.C.
605(b)), the Secretary has reviewed this rule before publication and by
approving it certifies that this rule will not have a significant
economic impact on a substantial
[[Page 51548]]
number of small entities. The rule is largely in the nature of
technical amendments to existing regulations for the purpose of
recognizing specific statutory requirements under which the program
already is operating. The remainder of the rule merely streamlines
regulations by removing unnecessary provisions. The rule will have no
adverse or disproportionate economic impact on small businesses.
Environmental Review
This rulemaking does not have an environmental impact. This
rulemaking simply amends existing regulations by streamlining and
updating provisions and does not alter the environmental effect of the
regulations being amended. A Finding of No Significant Impact with
respect to the environment was made in accordance with HUD regulations
in 24 CFR part 50 that implement section 102(2)(C) of the National
Environmental Policy Act of 1969 (42 U.S.C. 4332) at the time of
development of the ESG program regulations. That Finding remains
applicable to this rule, and is available for public inspection between
7:30 a.m. and 5:30 p.m. weekdays in the Office of the Rules Docket
Clerk at the above address.
Executive Order 12612, Federalism
The General Counsel, as the Designated Official under section 6(a)
of Executive Order 12612, Federalism, has determined that the policies
contained in this rule will not have federalism implications, because
the regulatory changes either: (1) Would not have substantial direct
effects on States, including units of local government and other
political subdivisions established by the States; on the relationship
between the Federal Government and the States; or on the distribution
of power and responsibilities among the various levels of government;
or (2) would merely implement statutory changes to the Emergency
Shelter Grants Program. A more comprehensive review under Executive
Order 12612 of any of these changes is not required because the
implementation of the statutes leaves little discretion with the
Department to lessen these impacts.
Executive Order 12606, The Family
The General Counsel, as the Designated Official under Executive
Order 12606, The Family, has determined that this rule does not have
potential for significant impact on family formation, maintenance, and
general well-being, and, thus, is not subject to review under the
Order. No significant change in existing HUD policies or programs would
result from promulgation of this rule.
Unfunded Mandates Reform Act
The Secretary has reviewed this rule before publication and by
approving it certifies, in accordance with the Unfunded Mandates Reform
Act of 1995 (2 U.S.C. 1532), that this rule does not impose a Federal
mandate that will result in the expenditure by State, local, and tribal
governments, in the aggregate, or by the private sector, of $100
million or more in any one year. This rule is limited to simplifying
and streamlining the Emergency Shelter Program regulations.
The Catalog of Federal Domestic Assistance program number is
14.231.
List of Subjects in 24 CFR Part 576
Community facilities, Emergency shelter grants, Grant programs--
housing and community development, Grant programs--social programs,
Homeless, Reporting and recordkeeping requirements.
For the reasons stated in the preamble, part 576 of title 24 of the
Code of Federal Regulations is amended as follows:
PART 576--EMERGENCY SHELTER GRANTS PROGRAM: STEWART B. McKINNEY
HOMELESS ASSISTANCE ACT
1. The authority citation for part 576 continues to read as
follows:
Authority: 42 U.S.C. 3535(d) and 11376.
Subpart A--General
2. Section 576.1 is revised to read as follows:
Sec. 576.1 Applicability and purpose.
This part implements the Emergency Shelter Grants program contained
in subtitle B of title IV of the Stewart B. McKinney Homeless
Assistance Act (42 U.S.C. 11371-11378). The program authorizes the
Secretary to make grants to States, units of general local government,
territories, and Indian tribes (and to private nonprofit organizations
providing assistance to homeless individuals in the case of grants made
with reallocated amounts) for the rehabilitation or conversion of
buildings for use as emergency shelter for the homeless, for the
payment of certain operating expenses and essential services in
connection with emergency shelters for the homeless, and for homeless
prevention activities. The program is designed to be the first step in
a continuum of assistance to enable homeless individuals and families
to move toward independent living as well as to prevent homelessness.
3. Section 576.3 is amended as follows:
a. By revising the first sentence in the definition of
``Consolidated plan.'';
b. By revising the definitions of ``Conversion'', ``Homeless'',
``Major rehabilitation'', ``Metropolitan city'', ``Private nonprofit
organization'', ``Rehabilitation'', ``Renovation'', and ``Urban
county'';
c. By removing the definition for ``Emergency shelter grant amounts
or grant amounts'';
d. By redesignating paragraphs (a) through (h) of the definition of
``Essential services'' as paragraphs (1) through (8), respectively; and
e. By redesignating paragraphs (a) through (f) of the definition of
``Homeless prevention'' as paragraphs (1) through (6), respectively;
and
f. By adding definitions in alphabetical order of ``Administrative
costs'', ``Indian tribe'', and ``Responsible entity''; to read as
follows:
Sec. 576.3 Definitions.
* * * * *
Administrative costs means as the term is defined in 583.135(b) of
this part, except that the exclusion relates to the costs of carrying
out eligible activities under Sec. 576.21(a).
Consolidated plan means the plan prepared in accordance with part
91 of this title. * * *
Conversion means a change in the use of a building to an emergency
shelter for the homeless under this part, where the cost of conversion
and any rehabilitation costs exceed 75 percent of the value of the
building after conversion.
* * * * *
Formula city or county means a metropolitan city or urban county
that is eligible to receive an allocation of grant amounts under
Sec. 576.5.
* * * * *
Homeless means as the term is defined in 42 U.S.C. 11302.
* * * * *
Indian tribe means as the term is defined in 42 U.S.C. 5302(a).
Major rehabilitation means rehabilitation that involves costs in
excess of 75 percent of the value of the building before
rehabilitation.
Metropolitan city means a city that was classified as a
metropolitan city under 42 U.S.C. 5302(a) for the fiscal year
immediately preceding the fiscal year for which emergency shelter grant
amounts are made available.
* * * * *
[[Page 51549]]
Private nonprofit organization means as the term is defined in 42
U.S.C. 11371.
Rehabilitation means the labor, materials, tools, and other costs
of improving buildings, other than minor or routine repairs. The term
includes where the use of a building is changed to an emergency shelter
and the cost of this change and any rehabilitation costs does not
exceed 75 percent of the value of the building before the change in
use.
Renovation means rehabilitation that involves costs of 75 percent
or less of the value of the building before rehabilitation.
Responsible entity means as the term is defined in Sec. 58.2 of
this title, as applied though Sec. 58.1(b)(3) of this title and
Sec. 576.57(e).
* * * * *
Urban county means a county that was classified as an urban county
under 42 U.S.C. 5302(a) for the fiscal year immediately preceding the
fiscal year for which emergency shelter grant amounts are made
available.
* * * * *
4. A new Sec. 576.5 is added in subpart A, to read as follows:
Sec. 576.5 Allocation of grant amounts.
(a) Territories. HUD will set aside for allocation to the
territories an amount equal to 0.2 percent of the total amount of each
appropriation under this part in any fiscal year. HUD will allocate
this set-aside amount to each territory based upon its proportionate
share of the total population of all territories.
(b) States, metropolitan cities, urban counties, and Indian tribes.
HUD will allocate the amounts that remain after the set-aside to
territories under paragraph (a) of this section, to States,
metropolitan cities, urban counties, and Indian tribes, as provided in
42 U.S.C. 11373. HUD will subsequently distribute the amount set aside
for Indian tribes under this paragraph as provided in Sec. 576.31.
(c) Notification of allocation amount. HUD will notify in writing
each State, metropolitan city, urban county, and territory that is
eligible to receive an allocation under this section of the amount of
its allocation.
Subpart B--Eligible Activities
5. Section 576.21 is revised to read as follows:
Sec. 576.21 Eligible activities.
(a) Eligible activities. Emergency shelter grant amounts may be
used for one or more of the following activities relating to emergency
shelter for the homeless:
(1) Renovation, major rehabilitation, or conversion of buildings
for use as emergency shelters for the homeless;
(2) Provision of essential services to the homeless, subject to the
limitations in paragraph (b) of this section;
(3) Payment for shelter maintenance, operation, rent, repairs,
security, fuel, equipment, insurance, utilities, food, and furnishings.
Not more than 10 percent of the grant amount may be used for costs of
staff;
(4) Developing and implementing homeless prevention activities,
subject to the limitations in 42 U.S.C. 11374(a)(4) and paragraph (c)
of this section. Grant funds may be used under this paragraph to assist
families that have received eviction notices or notices of termination
of utility services only if the conditions stated in 42 U.S.C.
11374(a)(4) are met; and
(5) Administrative costs, in accordance with 42 U.S.C. 11378.
(b) Limitations on provision of essential services. (1) Grant
amounts provided by HUD to units of general local government,
territories, or Indian tribes, and grant amounts provided by a State to
State recipients, may be used to provide an essential service under
paragraph (a)(2) of this section only if the service is a new service,
or is a quantifiable increase in the level of a service above that
which the unit of general local government (or, in the case of a
nonprofit organization, the unit of general local government in which
the proposed activities are to be located), territory, or Indian tribe,
as applicable, provided with local funds during the 12 calendar months
immediately before the grantee or State recipient received initial
grant amounts.
(2) Limits on the use of assistance for essential services
established in 42 U.S.C. 11374(a)(2) are applicable even when the unit
of local government, territory, or Indian tribe provides some or all of
its grant funds to a nonprofit recipient. This limitation may be waived
in accordance with 42 U.S.C. 11374.
(c) Limitation on homeless prevention activities. Limits on the use
of assistance for homeless prevention activities established in 42
U.S.C. 11374(a)(4) are applicable even when the unit of local
government, territory, or Indian tribe provides some or all of its
grant funds to a nonprofit recipient.
Secs. 576.22 and 576.23 [Redesignated as Secs. 576.23 and 576.25]
6. Sections 576.22 and 576.23 are redesignated as Secs. 576.23 and
576.25, respectively, and are revised to read as follows:
Sec. 576.23 Limitations--Primarily religious organizations.
(a) Provision of assistance. (1) Assistance may be provided under
this part to a grantee or recipient that is a primarily religious
organization if the primarily religious organization agrees to provide
all eligible activities under this program in a manner that is free
from religious influences and in accordance with the following
principles:
(i) It will not discriminate against any employee or applicant for
employment on the basis of religion and will not limit employment or
give preference in employment to persons on the basis of religion;
(ii) It will not discriminate against any person applying for
shelter or any of the eligible activities under this part on the basis
of religion and will not limit such housing or other eligible
activities or give preference to persons on the basis of religion; and
(iii) It will provide no religious instruction or counseling,
conduct no religious services or worship (not including voluntary
nondenominational prayer before meetings), engage in no religious
proselytizing, and exert no other religious influence in the provision
of shelter and other eligible activities under this part.
(2) HUD may provide reallocated amounts to a recipient that is a
primarily religious organization if the assistance will not be used by
the organization to acquire a structure (in the case of homeless
prevention activities under Sec. 576.21(a)(4)), or to rehabilitate a
structure owned by the organization, except as described in paragraph
(b) of this section.
(b) Rehabilitation or conversion of emergency shelters. Grants may
be used to rehabilitate or convert to an emergency shelter a structure
that is owned by a primarily religious organization, only if:
(1) The structure (or portion thereof) that is to be renovated,
rehabilitated, or converted with HUD assistance has been leased to an
existing or newly established wholly secular organization;
(2) The HUD assistance is provided to the secular organization (and
not the religious organization) to make the improvements;
(3) The leased structure will be used exclusively for secular
purposes available to all persons;
(4) The lease payments paid to the primarily religious organization
do not exceed the fair market rent for the structure before the
renovation, rehabilitation, or conversion;
(5) The portion of the cost of any improvements that benefit any
unleased
[[Page 51550]]
portion of the structure will be allocated to, and paid for by, the
religious organization; and
(6) The primarily religious organization agrees that if the
recipient does not retain the use of the leased premises for wholly
secular purposes for the useful life of the improvements, the primarily
religious organization will pay to the original grantee (from which the
amounts used to renovate, rehabilitate, or convert the building were
derived) an amount equal to the residual value of the improvements. A
private nonprofit organization must remit to HUD this amount if the
organization is the lessee as well as the grantee. The original grantee
is expected to use this amount to alleviate homelessness in its
jurisdiction, but there is no requirement that funds received after the
close of the grant period be used in accordance with the requirements
of this part.
(c) Assistance to a wholly secular private nonprofit organization.
(1) A primarily religious organization may establish a wholly secular
private nonprofit organization to serve as a recipient. The secular
organization may be eligible to receive all forms of assistance
available under this part, subject to the following:
(i) The secular organization must agree to provide shelter and
services eligible under this part in a manner that is free from
religious influences and in accordance with the principles set forth in
paragraph (a)(1) of this section.
(ii) The secular organization may enter into a contract with the
religious organization to provide essential services or undertake
homeless prevention activities. The religious organization must agree
in the contract to carry out its contractual responsibilities in a
manner free from religious influences and in accordance with the
principles set forth in paragraph (a)(1) of this section.
(iii) The rehabilitation, conversion, or renovation of emergency
shelters are subject to the requirements of paragraph (b) of this
section.
(2) HUD will not require the religious organization to establish
the secular organization before the selection of its application. In
such a case, the religious organization may apply on behalf of the
secular organization. The application will be reviewed on the basis of
the religious organization's financial responsibility and capacity, and
its commitment to provide appropriate resources to the secular
organization after formation. After formation, a secular organization
that is not in existence at the time of the application will be
required to demonstrate that it meets the definition of private
nonprofit organization contained in Sec. 576.3. The obligation of funds
will be conditioned upon compliance with these requirements.
Sec. 576.25 Who may carry out eligible activities.
(a) Generally. As provided in 42 U.S.C. 11373 eligible activities
may be carried out by all State recipients and grantees, except States.
(b) States. All of a State's formula allocation, except for
administrative costs, must be made available to the following entities:
(1) Units of general local government in the State, which may
include formula cities and counties even if such cities and counties
receive grant amounts directly from HUD; or
(2) Private nonprofit organizations, in accordance with 42 U.S.C.
11373(c).
(c) Nonprofit recipients. Units of general local government,
territories, and Indian tribes may distribute all or part of their
grant amounts to nonprofit recipients to be used for emergency shelter
grant activities.
Subparts C and D--[Removed]
7. Subparts C and D are removed.
Subparts E through H [Redesignated as Subparts C through F]
8. Subparts E through H are redesignated as subparts C through F
Subpart C--Award and Use of Grant Amounts
Sec. 576.51 [Redesignated as Sec. 576.31]
9. Section 576.51 is redesignated as Sec. 576.31 and is revised to
read as follows:
Sec. 576.31 Application requirements.
(a) Indian tribes. After funds are set aside for allocation to
Indian tribes under Sec. 576.5, HUD will publish a Notice of Funding
Availability (NOFA) in the Federal Register. The NOFA will specify the
requirements and procedures applicable to the allocation and
competitive awarding of these set-aside funds to eligible Indian tribe
applicants.
(b) States, territories, and formula cities and counties. To
receive emergency shelter grant amounts, a State, territory, or formula
city or county must:
(1) Submit documentation required under this part, part 5 of this
title, or any other applicable provisions of Federal law; and
(2) Submit and obtain HUD approval of a consolidated plan that
includes activities to be funded under this part. This consolidated
plan serves as the jurisdiction's application for funding under this
part.
Sec. 576.52 [Removed]
10. Section 576.52, ``Environmental review'', is removed.
Sec. 576.53 [Redesignated as Sec. 576.33 and amended]
11. Section 576.53, ``Review and approval of applications'', is
redesignated as Sec. 576.33 and is amended by removing the reference
``576.89'' and adding in its place the reference ``576.69''.
Sec. 576.55 [Redesignated as Sec. 576.35 and amended]
12. Section 576.55 is redesignated as Sec. 576.35 and is amended by
revising (a)(1), (b), and (c), to read as follows:
Sec. 576.35 Deadlines for using grant amounts.
(a)(1) States. Each State must make available to its State
recipients all emergency shelter grant amounts that it was allocated
under Sec. 576.5 within 65 days of the date of the grant award by HUD.
Funds set aside by a State for homeless prevention activities under
Sec. 576.21(a)(4) must be made available to State recipients within 180
days of the grant award by HUD.
* * * * *
(b) Formula cities and counties, territories and Indian tribes--
Expenditure of grant funds. Each formula city or county, territory, and
Indian tribe must spend all of the grant amounts it was allocated or
awarded under Secs. 576.5 or 576.31 within 24 months of the date of the
grant award by HUD.
(c) Failure to meet deadlines. (1) Any emergency shelter grant
amounts that are not made available or obligated within the applicable
time periods specified in paragraphs (a)(1) or (b) of this section will
be reallocated under Sec. 576.45.
(2) The State must recapture any grant amounts that a State
recipient does not obligate and spend within the time periods specified
in paragraph (a)(2) of this section. The State, at its option, must
make these amounts and other amounts returned to the State (except
amounts referred to in Sec. 576.22(b)(6) available as soon as
practicable to other units of general local government for use within
the time period specified in paragraph (a)(2) of this section or to HUD
for reallocation under Sec. 576.45.
[[Page 51551]]
Subpart D--Reallocations
Sec. 576.61 [Redesignated as Sec. 576.41 and amended]
13. Section 576.61 is redesignated as Sec. 576.41 and is amended
by:
a. Revising the section heading;
b. Revising paragraphs (b), (d)(1), (d)(2), (e), (f), and (g); and
c. Revising the heading of paragraph (c) to read as follows:
Sec. 576.41 Reallocation; lack of approved consolidated plan--formula
cities and counties.
* * * * *
(b) Grantee. HUD will make available to the State in which the city
or county is located the amounts that a city or county referred to in
paragraph (a) of this section would have received.
(c) Notification of availability. * * *
(d) * * *
(1) Execute a grant agreement with HUD for the fiscal year for
which the amounts to be reallocated were initially made available.
(2) If necessary, submit an amendment to its application for that
fiscal year for the reallocation amounts it wishes to receive. The
amendment must be submitted to the responsible HUD field office no
later than 30 days after notification is given to the State under
paragraph (c) of this section.
(e) Amendment review and approval. (1) Section 576.33 governs the
review and approval of application amendments under this section. HUD
will endeavor to make grant awards within 30 days of the application
amendment deadline, or as soon thereafter as practicable.
(2) Program activities represented by proposed amendments are
subject to environmental review under Sec. 576.57 in the same manner as
original proposals.
(f) Deadlines for using reallocated grant amounts. Section 576.35
governs the use of amounts reallocated under this section.
(g) Amounts that cannot be reallocated. Any grant amounts that
cannot be reallocated to a State under this section will be reallocated
as provided by Sec. 576.43. Amounts that are reallocated under this
section, but that are returned or unused, will be reallocated under
Sec. 576.45.
Sec. 576.63 [Redesignated as Sec. 576.43 and amended]
14. Section 576.63 is redesignated as Sec. 576.43 and is amended:
a. By revising the section heading;
b. By revising paragraphs (a) and (b);
c. By revising the first sentence of paragraph (c);
d. By revising the introductory text of paragraph (d);
e. By revising paragraph (d)(2);
f. By removing the parenthetical ``(except paragraph (e))'' in the
introductory text of paragraph (e); and
g. By revising paragraphs (f), (g), and (h), to read as follows:
Sec. 576.43 Reallocation of grant amounts; lack of approved
Consolidated Plan--States, territories, and Indian tribes.
(a) Applicability. This section applies when:
(1) A State, territory, or Indian tribe fails to obtain approval of
its consolidated plan within 90 days of the date upon which amounts
under this part first become available for allocation in any fiscal
year; or
(2) Grant amounts cannot be reallocated to a State under
Sec. 576.41.
(b) Grantees. (1) HUD will reallocate the amounts that a State or
Indian tribe referred to in paragraph (a)(1) of this section would have
received:
(i) In accordance with 42 U.S.C. 11373(d)(3); and
(ii) If grant amounts remain, then to territories that demonstrate
extraordinary need or large numbers of homeless individuals.
(2) HUD will make available the amounts that a territory under
paragraph (a)(1) of this section would have received to other
territories that demonstrate extraordinary need or large numbers of
homeless individuals.
(c) Notification of funding availability. HUD will make
reallocations to States and Indian tribes under this section by direct
notification or Federal Register notice that will set forth the terms
and conditions under which amounts under this section are to be
reallocated and grant awards made. In the case of reallocations to
territories, the responsible HUD field office will promptly notify each
territory of any reallocation amounts under this section and will
indicate the terms and conditions under which reallocation amounts are
to be made available and grant awards made.
(d) Eligibility for reallocation amounts. In order to receive
reallocation amounts under this section, the formula city or county,
State, territory, or Indian tribe must:
(1) * * *
(2) Execute a grant agreement with HUD for the fiscal year for
which the amounts to be reallocated were initially made available.
* * * * *
(f) Grant amounts. HUD may make a grant award for less than the
amount applied for or for fewer than all of the activities identified
in the application amendment.
(g) Deadlines for using reallocated amounts. Section 576.35 governs
the use of amounts reallocated under this section.
(h) Amounts not reallocated. Any grant amounts that are not
reallocated under this section, or that are reallocated, but are
unused, will be reallocated under Sec. 576.45(d). Any amounts that are
reallocated, but are returned, will be reallocated under
Sec. 576.45(c).
Sec. 576.67 [Redesignated as Sec. 576.45 and amended]
15. Section 576.67 is redesignated as Sec. 576.45, and is amended
as follows:
a. In paragraph (c)(1), by italicizing the first sentence and by
removing the reference ``Sec. 576.43'' and adding in its place the
reference ``Sec. 576.5'';
b. By redesignating paragraphs (c) (2) and (3) as paragraphs (c)
(3) and (4), respectively;
c. By adding a new paragraph (c)(2);
d. By revising paragraphs (c)(3) and (c)(4), as redesignated;
e. In paragraph (c)(9), by removing the reference to
``Sec. 576.52'' and adding in its place a reference to ``576.57'';
f. In paragraph (d), by removing the reference to ``subpart D'' and
adding in its place a reference to ``Sec. 576.5'';
g. By revising the heading of paragraph (f); and
h. By revising paragraph (f)(2) to read as follows:
Sec. 576.45 Reallocation of grant amounts; returned or unused amounts.
* * * * *
(c) * * *
(1) States and formula cities and counties. * * *
(2) Indian tribes. Returned grant amounts that were allocated to an
Indian tribe will be made available to other Indian tribes.
(3) Territories. Returned grant amounts that were allocated to a
territory will be made available, first, to other territories and, if
grant amounts remain, then to States.
(4) Further reallocation: States, formula cities and counties,
territories, and Indian tribes. HUD will reallocate under paragraph (e)
of this section any grant amounts that remain after applying the
preceding provisions of paragraph (c) of this section or that are
returned to HUD after reallocation under those provisions.
* * * * *
(f) Definitions--returned or unused grant amounts. * * *
(2) For purposes of this section, emergency shelter grant amounts
are considered ``unused'' (i.e., Federal deobligation):
(i) When they become available for reallocation by HUD after a
grantee has
[[Page 51552]]
executed a grant agreement with HUD for those amounts; or
(ii) The amounts remain after reallocation under Sec. 576.43 or
paragraph (c) of this section.
Subpart E--Program Requirements
Sec. 576.71 [Redesignated as Sec. 576.51 and revised]
16. Section 576.71 is redesignated as Sec. 576.51 and is revised to
read as follows:
Sec. 576.51 Matching funds.
(a) General. Each grantee, other than a territory, must match the
funding provided by HUD under this part as set forth in 42 U.S.C.
11375. The first $100,000 of any assistance provided to a recipient
that is a State is not required to be matched, but the benefit of the
unmatched amount must be shared as provided in 42 U.S.C. 11375(c)(4).
Matching funds must be provided after the date of the grant award to
the grantee. Funds used to match a previous ESG grant may not be used
to match a subsequent grant award under this part. A grantee may comply
with this requirement by providing the matching funds itself, or
through matching funds or voluntary efforts provided by any State
recipient or nonprofit recipient (as appropriate).
(b) Calculating the matching amount. In calculating the amount of
matching funds, in accordance with 42 U.S.C. 11375(a)(3), the time
contributed by volunteers shall be determined at the rate of $5 per
hour. For purposes of this paragraph, the grantee will determine the
value of any donated material or building, or of any lease, using a
method reasonably calculated to establish a fair market value.
Sec. 576.73 [Redesignated as Sec. 576.53 and amended]
17. Section 576.73 is redesignated as Sec. 576.53, and is amended
by revising paragraph (a) and the introductory text of paragraph (b),
to read as follows:
Sec. 576.53 Use as an emergency shelter.
(a)(1) Restrictions and definition. Period of use restrictions
applicable to assistance provided under this part are governed by 42
U.S.C. 11375(a). Use of grant amounts for developing and implementing
homeless prevention activities does not trigger period of use
requirements.
(2) For purposes of the requirements under this section, the term
same general population means either the same types of homeless persons
originally served with ESG assistance (i.e., battered spouses, runaway
children, families, or mentally ill individuals), or persons in the
same geographic area.
(b) Calculating the applicable period. The 3- and 10-year periods
applicable under paragraph (a) of this section begin to run:
* * * * *
Sec. 576.75 [Redesignated as Sec. 576.55]
18. Section 576.75 is redesignated as Sec. 576.55 and is revised to
read as follows:
Sec. 576.55 Building standards.
(a) Any building for which emergency shelter grant amounts are used
for conversion, major rehabilitation, rehabilitation, or renovation
must meet local government safety and sanitation standards.
(b) For projects of 15 or more units, when rehabilitation costs
are:
(1) 75 percent or more of the replacement cost of the building,
that project must meet the requirements of Sec. 8.23(a) of this title;
or
(2) Less that 75 percent of the replacement cost of the building,
that project must meet the requirements of Sec. 8.23(b) of this title.
Sec. 576.77 [Redesignated as Sec. 576.56]
19. Section 576.77 is redesignated as Sec. 576.56, and is revised
to read as follows:
Sec. 576.56 Homeless assistance and participation.
(a) Assistance. (1) Grantees and recipients must assure that
homeless individuals and families are given assistance in obtaining:
(i) Appropriate supportive services, including permanent housing,
medical health treatment, mental health treatment, counseling,
supervision, and other services essential for achieving independent
living; and
(ii) Other Federal, State, local, and private assistance available
for such individuals.
(2) Requirements to ensure confidentiality of records pertaining to
the provision of family violence prevention or treatment services with
assistance under this part are set forth in 42 U.S.C. 11375(c)(5).
(3) Grantees and recipients may, in accordance with 42 U.S.C.
11375(e), terminate assistance provided under this part to an
individual or family who violates program requirements.
(b) Participation. (1) Each unit of local government, Indian tribe,
and nonprofit recipient that receives funds under this part must
provide for the participation of homeless individuals on its
policymaking entity in accordance with 42 U.S.C. 11375(d).
(2) Each State, territory, Indian tribe, unit of local government,
and nonprofit recipient that receives funds under this part must
involve homeless individuals and families in providing work or services
pertaining to facilities or activities assisted under this part, in
accordance with 42 U.S.C. 11375(c)(7).
Sec. 576.79 [Redesignated as Sec. 576.57 and amended]
20. Section 576.79 is redesignated as Sec. 576.57, and is amended
as follows:
a. By revising paragraphs (e) and (f);
b. By redesignating paragraph (h) as paragraph (j); and
c. By adding new paragraphs (h) and (i) to read as follows:
Sec. 576.57 Other Federal requirements.
* * * * *
(e) Environmental review responsibilities.--(1) Generally.
Responsible entities must assess the environmental effects of each
application under part 58 of this title. An applicant must include in
its application an assurance that the applicant will assume all the
environmental review responsibility that would otherwise be performed
by HUD as the responsible Federal official under the National
Environmental Policy Act of 1969 (NEPA) and related authorities listed
in part 58 of this title. The grant award is subject to completion of
the environmental responsibilities set out in part 58 of this title
within a reasonable time period after notification of the award. This
provision does not preclude the applicant from enclosing its
environmental certification and Request for Release of Funds with its
application.
(2) Awards to States. In the case of emergency shelter grants to
States that are distributed to:
(i) Units of general local government, the unit of general local
government shall be the responsible entity, and the State will assume
HUD's functions with regard to the release of funds; or
(ii) Nonprofit organizations, the State shall be the responsible
entity, and HUD will perform functions regarding release of funds under
part 58 of this title.
(3) Release of funds. HUD will not release funds for an eligible
activity if the grantee, recipient, or any other party commits
emergency shelter grant funds before the grantee submits, and HUD
approves, any required Request for Release of Funds.
(f) Audit. The financial management systems used by a State,
formula city or county, governmental entity, or an Indian tribe that is
a grantee under this program must provide for audits in
[[Page 51553]]
accordance with part 44 of this title. A private nonprofit organization
is subject to the audit requirements of OMB Circular A-133, as set
forth in part 45 of this title. (OMB Circulars are available from the
Executive Office of the President, Publication Service, 725 17th
Street, NW., Suite G-2200, Washington, DC 20503, Telephone, 202-395-
7332.)
* * * * *
(h) Lobbying and disclosure requirements. The disclosure
requirements and prohibitions of 42 U.S.C. 3537a and 3545 and 31 U.S.C.
1352 (the Byrd Amendment), and the implementing regulations at parts 4
and 87 of this title.
(i) Davis-Bacon Act. The provisions of the Davis-Bacon Act (40
U.S.C. 276a-276a-5) do not apply to this program.
Sec. 576.80 [Redesignated as Sec. 576.59]
21. Section 576.80, ``Relocation and acquisition'', is redesignated
as Sec. 576.59.
Subpart F--Grant Administration
Sec. 576.81 [Redesignated as Sec. 576.61 and amended]
22. Section 576.81 is redesignated as Sec. 576.61, and is amended
by revising the second sentence and adding paragraphs (a) and (b), to
read as follows:
Sec. 576.61 Responsibility for grant administration.
* * * The State, territory, Indian tribe, or unit of local
government is responsible for ensuring that its recipients carry out
the recipients' emergency shelter grant programs in compliance with all
applicable requirements in the case of:
(a) A State making grant amounts available to State recipients; or
(b) A territory, Indian tribe, or unit of general local government
distributing grant amounts to nonprofit recipients.
Sec. 576.83 [Redesignated as Sec. 576.63 and amended]
23. Section 576.83, ``Method of payment'', is redesignated as
Sec. 576.63, and is amended by removing the last sentence.
Sec. 576.87 [Redesignated as Sec. 576.65]
24. Section 576.87 is redesignated as Sec. 576.65 and is revised to
read as follows:
Sec. 576.65 Recordkeeping.
(a) Each grantee must ensure that records are maintained for a 4-
year period to document compliance with the provisions of this part.
(b) Requirements to ensure confidentiality of records pertaining to
the provision of family violence prevention or treatment services with
assistance under this part are set forth in 42 U.S.C. 11375(c)(5).
Sec. 576.89 [Redesignated as Sec. 576.67 and amended]
25. Section 576.89, ``Sanctions'', is redesignated as Sec. 576.67,
and is amended as follows:
a. By removing a reference in paragraph (b) to
``Sec. 576.55(a)(2)'' and adding in its place a reference to
``Sec. 576.35(a)(2)''; and
b. By removing references in paragraphs (b) and (c) to
``Sec. 576.67(d)'' and adding in their places references to
``Sec. 576.45(d)''.
Dated: September 20, 1996.
Andrew Cuomo,
Assistant Secretary for Community Planning and Development.
[FR Doc. 96-25054 Filed 10-1-96; 8:45 am]
BILLING CODE 4210-29-P
Complete official Federal Register PDF
FR Doc. 96-24996 National Oil and Hazardous Substances Pollution Contingency Plan; National Priorities List
[Federal Register Volume 61, Number 192 (Wednesday, October 2, 1996)]
[Rules and Regulations]
[Page 51373]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-24996]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 300
[FRL-5619-1]
National Oil and Hazardous Substances Pollution Contingency Plan;
National Priorities List
AGENCY: Environmental Protection Agency.
ACTION: Notice of deletion of the AMP site in Glen Rock, in York
County, Pennsylvania, from the National Priorities List.
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SUMMARY: The Environmental Protection Agency (``EPA'') announces the
deletion of the AMP Site (``Site''), located in Glen Rock, York County,
Pennsylvania, from the National Priorities List (``NPL''). The NPL, a
list of sites EPA evaluates for priority cleanup of hazardous wastes,
is found in Appendix B of the National Oil and Hazardous Substances
Pollution Contingency Plan (``NCP''), 40 CFR part 300, Appendix B. EPA
promulgated the NCP pursuant to section 105 of the Comprehensive
Environmental Response, Compensation, and Liability Act of 1980
(``CERCLA'').
EPA announces this deletion under the terms of a policy published
in the Federal Register on March 20, 1995. In this policy EPA announced
that, consistent with NCP criteria for deletion of sites from the NPL,
the Agency would delete sites if corrective action was proceeding
pursuant to the Resource Conservation and Recovery Act (``RCRA''). EPA
has determined that this deferral to RCRA authorities is appropriate.
EPA has received the following concurrence from Commonwealth of
Pennsylvania Department of Environmental Protection: ``The Commonwealth
of Pennsylvania concurs in the decision to delete the site from the
NPL, but reserves all of its rights, abilities and authorities to
address contamination at the site and to pursue responsible parties
regarding this contamination.''
EFFECTIVE DATE: October 2, 1996.
FOR FURTHER INFORMATION CONTACT: Frank Vavra, Remedial Project Manager,
Superfund Branch--3HW22, 841 Chestnut Street, Philadelphia,
Pennsylvania 19107, (215) 566-3221.
SUPPLEMENTARY INFORMATION: A Notice of Intent to Delete this Site was
published on July 26, 1996 in the Federal Register (56 FR 39104). The
closing date for comments on the Notice of Intent to Delete was August
26, 1996. EPA did not receive any comments on the proposed deletion.
EPA identifies sites that appear to present a significant risk to
public health or the environment and maintains the NPL as the list of
those sites. Sites on the NPL may be the subject of remedial actions
financed by the Hazardous Substances Superfund Response Trust Fund
(Fund). Pursuant to 40 CFR 300.425(e)(3), any site deleted from the NPL
remains eligible for Fund-financed remedial actions in the unlikely
event that conditions at the site warrant such action in the future.
Deletion of a site from the NPL does not affect responsible party
liability or impede agency efforts to recover costs associated with
response efforts.
List of Subjects in 40 CFR Part 300
Environmental protection, Air pollution control, Chemicals,
Hazardous substances, Hazardous waste, Intergovernmental relations,
Penalties, Reporting and recordkeeping requirements, Superfund, Water
pollution control, Water supply.
For the reasons set out in the preamble, 40 CFR part 300 is amended
as follows:
PART 300--[AMENDED]
1. The authority citation for part 300 continues to read as
follows:
Authority: 33 U.S.C. 1321(c)(2); 42 U.S.C. 9601-9657; E.O.
12777, 56 FR 54757, 3 CFR, 1991 Comp., p. 351; E.O. 12580, 52 FR
2923, 3 CFR, 1987 Comp., p. 193.
Appendix B--[Amended]
2. Table 1 of Appendix B to part 300 is amended by removing the
site AMP Inc., Glen Rock, Pennsylvania.
Dated: September 17, 1996.
Alvin R. Morris,
Acting Regional Administrator, U.S. EPA Region 3.
[FR Doc. 96-24996 Filed 10-01-96; 8:45 am]
BILLING CODE 6560-50-P
Complete official Federal Register PDF
FR Doc. 96-24994 Fenpropathrin; Pesticide Tolerance, Correction
[Federal Register Volume 61, Number 192 (Wednesday, October 2, 1996)]
[Rules and Regulations]
[Pages 51372-51373]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-24994]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 4F4327/R2253A; FRL-5393-8]
RIN 2070-AB78
Fenpropathrin; Pesticide Tolerance, Correction
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final Rule, correction.
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SUMMARY: EPA is correcting its rule published on July 31, 1996, which
established tolerances for residues of the insecticide/miticide
fenpropathrin, a synthetic pyrethroid, in or on the raw agricultural
commodities (RACs) peanuts and peanut hay, and increases tolerances in
meat, meat byproduct and fat of cattle, goats, hogs, horses and sheep
and poultry; eggs; and milkfat.
EFFECTIVE DATE: This regulation becomes effective October 2, 1996.
FOR FURTHER INFORMATION CONTACT: By mail: George T. LaRocca, Product
Manager (PM) 13, Registration Division (7505C), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location and telephone number: Second Floor, Crystal
Mall #2, 1921 Jefferson Davis Highway, Arlington, VA 22202. (703) 305-
6100, e-mail: [email protected].
SUPPLEMENTARY INFORMATION: EPA issued a rule in the Federal Register of
July 31, 1996 (FRL-5385-1) which amended 40 CFR 180.466 by establishing
tolerances for residues of the insecticide fenpropathrin (alpha-cyano-
3-phenoxybenzyl 2,2,3,3-tetramethylcyclopropanecarboxylate) in or on
the raw agricultural commodities (RACs) peanuts, vines and peanuts, hay
(dried) at 20 parts per million (ppm); milkfat at 2.0 ppm (reflecting
0.08 ppm in whole milk); fat (cattle, goats, hogs, horses, and sheep)
at 1.0 ppm; peanut hulls at 0.3 ppm; meat and meat byproducts (mbyp)
(cattle, goats, horses, and sheep) at 0.1 ppm; poultry meat, fat, mbyp
and eggs at 0.05 ppm; and peanut nut meat at 0.01 ppm.
In this rule EPA inadvertently left out of the preamble certain
information relevant to the conditional registration for fenpropathrin
and did not include the expiration date for these new tolerances, which
were established as time-limited tolerances that would expire on
November 15, 1997.
In addition, EPA inadvertently omitted from the table the new
tolerance levels for sheep, fat, sheep, mbyp and sheep, meat. These
oversight are corrected below.
Accordingly, FR Doc. 96-19330, published in the Federal Register of
July 31, 1996 at page 39887, is corrected as follows:
1. On page 39888, at the bottom of the first column, insert the
following two paragraphs.
``The Agency issued a conditional registration for fenpropathrin
for use on cotton with an expiration date of November 15, 1993 (see the
Federal Register of April 14, 1993 (58 FR 19357)). The conditional
registration was subsequently amended and extended to November 15, 1996
(see the Federal Register dated February 22, 1995 (60 FR 9783)). The
registrations were amended and extended to allow time for submission
and evaluation of additional environmental effects data. In order to
evaluate the effects of the pyrethroids on fish and aquatic organisms
and its fate in the environment, additional data were required to be
collected and submitted during the period of conditional registration.
Such requirements included a sediment bioavailability and toxicity
study and a small-plot runoff study that must be submitted to the
Agency by July 1, 1996. Due to the conditional status of the
registration, tolerances have been established for fenpropathrin on a
temporary basis, (until November 15, 1997) on cottonseed, meat, fat and
meat-byproducts of hogs, horses, cattle, goats, sheep, poultry, eggs
and milk to cover residues expected to be present from use during the
period of conditional registration. To be consistent with the
conditional registration status of fenpropathrin on cotton the Agency
is establishing these tolerances with an expiration date of November
15, 1997.
Residues remaining in or on the above commodities after expiration
of these tolerances will not be considered actionable if the pesticide
is legally applied during the term of and in accordance with provisions
of the conditional registration.''
2. On page 39889, the table to Sec. 180.466 is corrected by
revising the entry for cattle, fat and by adding entries alphabetically
for sheep, fat, sheep, mbyp and sheep, meat, to read as follows:
----------------------------------------------------------------------------------------------------------------
Commodity Parts per million Expiration date
----------------------------------------------------------------------------------------------------------------
Cattle, fat........................................ 1.0 Nov. 15, 1997
* * * * * * *
Sheep, fat......................................... 1.0 Do.
Sheep, mbyp........................................ 0.1 Do.
Sheep, meat........................................ 0.1 Do.
* * * * * * *
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[[Page 51373]]
List of Subjects in 40 CFR Part 180
Environmental Protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: September 23, 1996.
Daniel M. Barolo,
Director, Office of Pesticide Programs.
[FR Doc. 96-24994 Filed 10-01-96; 8:45 am]
BILLING CODE 6560-50-F
Complete official Federal Register PDF
FR Doc. 96-24968 Waiver of Informed Consent Requirements in Certain Emergency Research
[Federal Register Volume 61, Number 192 (Wednesday, October 2, 1996)]
[Rules and Regulations]
[Pages 51531-51533]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-24968]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
45 CFR Part 46
Waiver of Informed Consent Requirements in Certain Emergency
Research
AGENCY: National Institutes of Health, HHS.
ACTION: Waiver.
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SUMMARY: The Department of Health and Human Services (HHS) is
announcing the waiver of the applicability of the title 45 CFR part 46
(protection of human subjects) requirement for obtaining and
documenting informed consent, for a strictly limited class of research
involving activities which may be carried out in human subjects who are
in need of emergency therapy and for whom, because of the subjects'
medical condition and the unavailability of legally authorized
representatives of the subjects, no legally effective informed consent
can be obtained. However, because of special regulatory limitations
relating to research involving prisoners (subpart C of 45 CFR part 46)
and research involving fetuses, pregnant women, and human in vitro
fertilization (subpart B of 45 CFR part 46), this waiver is
inapplicable to these categories of research.
EFFECTIVE DATE: November 1, 1996.
FOR FURTHER INFORMATION CONTACT:
F. William Dommel, Jr., J.D. Senior Policy Advisor, Office for
Protection from Research Risks, 6100 Executive Boulevard, Suite 3B01J,
National Institutes of Health, MSC 7507, Rockville, MD 20892-7507.
Telephone (301) 496-7005, ext. 203 (not a toll-free number).
SUPPLEMENTARY INFORMATION:
Waiver
Pursuant to Section 46.101(i) of title 45 of the Code of Federal
Regulations, the Secretary of Health and Human Services (HHS) has
waived the general requirements for informed consent at 45 CFR 46.116
(a) and (b), and at 46.408, to be referred to as the ``Emergency
Research Consent Waiver,'' for a class of research consisting of
activities \1\, each of which have met the following strictly limited
conditions detailed under either (a) or (b) below:
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\1\ Because of special regulatory limitations relating to
research involving prisoners (subpart C of 45 CFR part 46), and
research involving fetuses, pregnant women, and human in vitro
fertilization (subpart B of 45 CFR part 46), this waiver is
inapplicable to these categories of research.
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[[Page 51532]]
(a) The Institutional Review Board (IRB) responsible for the
review, approval, and continuing review of the research activity has
approved both the activity and a waiver of informed consent and found
and documented:
(1) that the research activity is subject to regulations codified
by the Food and Drug Administration (FDA) at Title 21 CFR part 50 and
will be carried out under an FDA investigational new drug application
(IND) or an FDA investigational device exemption (IDE), the application
for which has clearly identified the protocols that would include
subjects who are unable to consent, and
(2) that the requirements for exception from informed consent for
emergency research detailed in title 21 CFR section 50.24 have been met
relative to those protocols, or
(b) The IRB responsible for the review, approval, and continuing
review of the research has approved both the research and a waiver of
informed consent and has found and documented that the research is not
subject to regulations codified by the FDA at title 21 CFR part 50 and
found and documented and reported to the Office for Protection from
Research Risks, Department of Health and Human Services, that the
following conditions have been met relative to the research:
(1) The human subjects are in a life-threatening situation,
available treatments are unproven or unsatisfactory, and the collection
of valid scientific evidence, which may include evidence obtained
through randomized placebo-controlled investigations, is necessary to
determine the safety and effectiveness of particular interventions.
(2) Obtaining informed consent is not feasible because:
(i) The subjects will not be able to give their informed consent as
a result of their medical condition;
(ii) The intervention involved in the research must be administered
before consent from the subjects' legally authorized representatives is
feasible; and
(iii) There is no reasonable way to identify prospectively the
individuals likely to become eligible for participation in the
research.
(3) Participation in the research holds out the prospect of direct
benefit to the subjects because:
(i) Subjects are facing a life-threatening situation that
necessitates intervention;
(ii) Appropriate animal and other preclinical studies have been
conducted, and the information derived from those studies and related
evidence support the potential for the intervention to provide a direct
benefit to the individual subjects; and
(iii) The risks associated with the research are reasonable in
relation to what is known about the medical condition of the potential
class of subjects, the risks and benefits of standard therapy, if any,
and what is known about the risks and benefits of the proposed
intervention or activity.
(4) The research could not practicably be carried out without the
waiver.
(5) The proposed research protocol defines the length of the
potential therapeutic window based on scientific evidence, and the
investigator has committed to attempting to contact a legally
authorized representative for each subject within that window of time
and, if feasible, to asking the legally authorized representative
contacted for consent within that window rather than proceeding without
consent. The investigator will summarize efforts made to contact
representatives and make this information available to the IRB at the
time of continuing review.
(6) The IRB has reviewed and approved informed consent procedures
and an informed consent document in accord with Sections 46.116 and
46.117 of title 45 of the Code of Federal Regulations. These procedures
and the informed consent document are to be used with subjects or their
legally authorized representatives in situations where use of such
procedures and documents is feasible. The IRB has reviewed and approved
procedures and information to be used when providing an opportunity for
a family member to object to a subject's participation in the research
consistent with paragraph (b)(7)(v) of this waiver.
(7) Additional protections of the rights and welfare of the
subjects will be provided, including, at least:
(i) Consultation (including, where appropriate, consultation
carried out by the IRB) with representatives of the communities in
which the research will be conducted and from which the subjects will
be drawn;
(ii) Public disclosure to the communities in which the research
will be conducted and from which the subjects will be drawn, prior to
initiation of the research, of plans for the research and its risks and
expected benefits;
(iii) Public disclosure of sufficient information following
completion of the research to apprise the community and researchers of
the study, including the demographic characteristics of the research
population, and its results;
(iv) Establishment of an independent data monitoring committee to
exercise oversight of the research; and
(v) If obtaining informed consent is not feasible and a legally
authorized representative is not reasonably available, the investigator
has committed, if feasible, to attempting to contact within the
therapeutic window the subject's family member who is not a legally
authorized representative, and asking whether he or she objects to the
subject's participation in the research. The investigator will
summarize efforts made to contact family members and make this
information available to the IRB at the time of continuing review.
In addition, the IRB is responsible for ensuring that procedures
are in place to inform, at the earliest feasible opportunity, each
subject, or if the subject remains incapacitated, a legally authorized
representative of the subject, or if such a representative is not
reasonably available, a family member, of the subject's inclusion in
the research, the details of the research and other information
contained in the informed consent document. The IRB shall also ensure
that there is a procedure to inform the subject, or if the subject
remains incapacitated, a legally authorized representative of the
subject, or if such a representative is not reasonably available, a
family member, that he or she may discontinue the subject's
participation at any time without penalty or loss of benefits to which
the subject is otherwise entitled. If a legally authorized
representative or family member is told about the research and the
subject's condition improves, the subject is also to be informed as
soon as feasible. If a subject is entered into research with waived
consent and the subject dies before a legally authorized representative
or family member can be contacted, information about the research is to
be provided to the subject's legally authorized representative or
family member, if feasible.
For the purposes of this waiver ``family member'' means any one of
the following legally competent persons: spouses; parents; children
(including adopted children); brothers, sisters, and spouses of
brothers and sisters; and any individual related by blood or affinity
whose close association with the subject is the equivalent of a family
relationship.
Background
It had come to the attention of HHS that there are proposals to
conduct certain research, including National Institutes of Health (NIH)
funded research, which could not go forward in
[[Page 51533]]
the context of the current HHS regulations for the protection of human
subjects (45 CFR part 46), unless certain informed consent requirements
of those regulations were waived in accord with the waiver provisions
provided at 45 CFR 46.101(i). HHS carefully reviewed the need for the
exercise of the Section 46.101(i) waiver authority in these
circumstances, and the requirements for informed consent were waived by
the Secretary in the instance of only one specific multi-site study of
head injuries which is currently underway (60 FR 38353).
The Secretary is now waiving the informed consent requirements for
the class of research activities and no longer restricting the waiver
to a single research project. This waiver provides clear instruction as
to when research in emergency circumstances may proceed without
obtaining an individual subject's informed consent. Elsewhere in this
edition of the Federal Register, the FDA is publishing a final rule
which amends FDA regulations to authorize a nearly identical waiver of
informed consent in research which is regulated by FDA. The joint
publication of these actions permit harmonization of the HHS and FDA
regulations regarding research in emergency circumstances. The HHS
waiver, just as the FDA regulatory change, provides a narrow exception
to the requirement for obtaining and documenting informed consent from
each human subject or his or her legally authorized representative
prior to initiation of research if the waiver of informed consent is
approved by an IRB. The waiver authorization applies to a limited class
of research activities involving human subjects who are in need of
emergency medical intervention but who cannot give informed consent
because of their life-threatening medical condition, and who do not
have available a legally authorized person to represent them. The
Secretary, HHS is authorizing this waiver in response to growing
concerns that current regulations, absent this waiver, are making high
quality research in emergency circumstances difficult or impossible to
carry out at a time when the need for such research is increasingly
recognized.
HHS notes testimonies to this effect delivered to (i) the
Subcommittee on Regulation, Business Opportunities, and Technology,
Committee on Small Business, U.S. House of Representatives (Washington
DC, May 23, 1994); (ii) the Coalition Conference of Acute Resuscitation
Researchers (Washington DC, October 25, 1994); (iii) the meeting of
Applied Research Ethics National Association (Boston MA, October 30,
1994); (iv) the meeting of Public Responsibility in Medicine & Research
(Boston MA, November 1, 1994); and (v) the Food and Drug
Administration/National Institutes of Health Public Forum on Informed
Consent in Clinical Research Conducted in Emergency Circumstances
(Rockville MD, January 9-10, 1995).
Periodic Review
A periodic review of the implementation by IRBs of this Section
101(i) waiver will be conducted by the Office for Protection from
Research Risks, National Institutes of Health, to determine the
adequacy of the waiver in meeting its intended need or if adjustments
to the waiver might be necessary and appropriate.
Dated: July 17, 1996.
Donna E. Shalala,
Secretary.
[FR Doc. 96-24968 Filed 9-26-96; 8:59 am]
BILLING CODE 4150-04-M
Complete official Federal Register PDF
FR Doc. 96-24967 Protection of Human Subjects; Informed Consent
[Federal Register Volume 61, Number 192 (Wednesday, October 2, 1996)]
[Rules and Regulations]
[Pages 51498-51531]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-24967]
[[Page 51497]]
_______________________________________________________________________
Part II
Department of Health and Human Services
_______________________________________________________________________
Food and Drug Administration
Office of the Secretary
_______________________________________________________________________
21 CFR Part 50, et al.
45 CFR Part 46
Protection of Human Subjects; Informed Consent and Waiver of Informed
Consent Requirements in Certain Emergency Research; Final Rules
Federal Register / Vol. 61, No. 192 / Wednesday, October 2, 1996 /
Rules and Regulations
[[Page 51498]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 50, 56, 312, 314, 601, 812, and 814
[Docket No. 95N-0158]
RIN 0910-AA60
Protection of Human Subjects; Informed Consent
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending its current
informed consent regulations to permit harmonization of the Department
of Health and Human Services' (DHHS) policies on emergency research and
to reduce confusion on when such research can proceed without obtaining
an individual subject's informed consent. This regulation provides a
narrow exception to the requirement for obtaining and documenting
informed consent from each human subject, or his or her legally
authorized representative, prior to initiation of an experimental
intervention. The exception would apply to a limited class of research
activities involving human subjects who are in need of emergency
medical intervention but who cannot give informed consent because of
their life-threatening medical condition, and who do not have a legally
authorized person to represent them. FDA is taking this action in
response to growing concerns that current rules are making high quality
acute care research activities difficult or impossible to carry out at
a time when the need for such research is increasingly recognized.
EFFECTIVE DATE: These regulations are effective November 1, 1996.
FOR FURTHER INFORMATION CONTACT: Glen D. Drew, Office of Health Affairs
(HFY-20), Food and Drug Administration, Rockville, MD 20852, 301-443-
1382.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of September 21, 1995 (60 FR 49086), the
Secretary of Health and Human Services and the Commissioner of Food and
Drugs proposed to amend FDA's current informed consent regulations to
permit emergency care research. FDA proposed this action in response to
growing concerns that current rules are making high quality acute care
research activities difficult or impossible to carry out at a time when
the need for such research is increasingly recognized. By permitting
certain adequate and well-controlled clinical trials to occur that
involve human subjects who are confronted by a life-threatening
situation and who also are unable to give informed consent because of
their medical condition, the agency expects the clinical trials to
allow individuals in these situations access to potentially life-saving
therapies and to result in advancement in knowledge and improvement of
therapies used in emergency medical situations that currently have poor
clinical outcome.
FDA allowed 45 days for comment on the proposal of September 21,
1995. Written comments received in response to the proposal are on file
in the Dockets Management Branch. Comments were received from clinical
investigators, institutional review boards, patient advocacy groups,
trade associations, professional societies, drug and medical device
companies, and private citizens. The substantive comments received and
FDA's responses are discussed below.
Approximately 90 comments were received on the proposed rule. The
vast majority of these comments supported the proposal, although many
of these comments contained suggestions or requests for clarification.
A number of the comments that supported the proposal came from
organizations and associations representing large numbers of members.
These included the Brain Injury Association, the National Stroke
Association, the American Academy of Orthopaedic Surgeons, the
Coalition of Acute Resuscitation and Critical Care Researchers, Applied
Research Ethics National Association, Pharmaceutical Research and
Manufacturers of America, Health Industry Manufacturers Association
(HIMA), the American Academy of Pediatrics, the American Heart
Association Emergency Cardiac Care Committee, the American College of
Emergency Physicians, the American Medical Association, the American
College of Cardiology, the Society of Critical Care Medicine, the
National Association of EMS Physicians, the American College of
Obstetricians and Gynecology, and the American College of Physicians.
A number of the comments in favor of the proposal cited how it will
facilitate research in this patient population, provide the necessary
safeguards to ensure responsible and ethical research with protection
of the human subjects, and ultimately speed the wide availability of
products proven efficacious to individuals in life-threatening
situations. For example, the American College of Physicians and the
Project on Informed Consent of the University of Pennsylvania Center
for Bioethics commented that they ``applaud these proposed regulations
as a much needed step in the advancement of vital emergency research
with careful attention to the rights and welfare of human research
subjects.'' The American Heart Association commented that ``We are
particularly pleased with the balance that appears to have been struck
between the need for conducting high quality clinical research in an
effort to develop better treatments for critically ill patients and the
protection of human subjects.'' The American Medical Association
commented that ``The proposed rules are far superior to their
inadequate antecedents in balancing the need for emergency research
with respect for the paramount concern for patient safety, welfare and
comfort.'' The Brain Injury Association commented that ``* * * this
rule is a major step towards increasing the available therapies and
medical care available for those individuals who are critically ill or
injured.'' The Coalition of Acute Resuscitation and Critical Care
Researchers commented that ``* * * this proposed rule is a significant
step forward towards advancing the medical care of critically ill or
injured patients for whom current therapies are unsatisfactory or
unproven.'' The National Stoke Association commented that ``* * * once
in practice it will help to appropriately expedite study enrollments
thus allowing for earlier study completion, analysis, and ultimately
will speed the availability of those drugs proven efficacious to the
one-half million people who suffer stroke each year.''
These comments are addressed in more detail in sections II and III
of this document.
Generally, the 16 comments opposed to the proposed rule were from
individuals who were not convinced by the agency's description of the
legal and ethical basis for the rule, and these comments concluded that
informed consent should not be waived under any circumstances. Some of
these comments suggested that the agency was proceeding hastily and
under undue pressure from the research community. In section II of this
document, we address the general comments first, followed by the more
specific comments.
II. General Comments
A. Need for the Rule
1. One comment questioned the need for the rule and whether there
were hard data documenting the number of
[[Page 51499]]
subjects eligible for these types of research activities who are lost
to enrollment due to an inability to obtain informed consent from the
subject or the subject's authorized representative. Another comment
questioned the need for this rule based on the DHHS waiver granted in
July 1995 for a hypothermia study, arguing that: (1) The waiver was not
needed to complete a reasonable preliminary sample, (2) the criteria
for participation were needlessly inclusive, (3) the investigator used
questionable tactics to achieve waiver, (4) the provisions for
oversight were inadequate, and (5) the provisions for monitoring were
inadequate. This comment went on to discuss ``the overarching
considerations'' for the rule, arguing that it is not in the subject's
interest to prevent death in order to linger in a vegetative state;
that the high percentage of families agreeing to continuing
participation in the research after the fact demonstrates how ill-
informed they are about the possibility of negative outcomes, e.g.,
prolonged vegetative state, dissipation of financial resources, court
challenges to terminate life support; that subjects will be misenrolled
in ``an abundance'' of life-threatening situations; that the rule does
not address or provide for followup or special circumstances for
terminating life support for ``saved'' individuals in these studies;
and that it is not clear who will bear the cost and burden to sustain
an individual who has been ``saved'' from a life-threatening medical
condition by being on a research study.
The preamble to the proposed rule extensively discussed why this
rule is needed and why this limited class of research has been unable
to proceed under existing requirements. The purpose of this rule is to
permit the study of potential improvements in the treatment of life-
threatening conditions where current treatment is unproven or
unsatisfactory, in order to improve interventions and patient outcomes.
It is not the goal of this rule to leave study subjects in vegetative
states or to have any of the other negative outcomes outlined in the
comments. The risks to patients of having these negative outcomes exist
now with interventions that are unproven or unsatisfactory. If
interventions are improved, patient outcomes will be improved. The
possibility of worsened outcome or adverse reactions will be assessed
before the clinical investigation begins by the IRB and during the
investigation by the data monitoring committee that is required under
the regulation. The regulations require the institutional review board
(IRB) to ensure that risks to subjects are minimized and to determine
that risks to subjects are reasonable in relation to anticipated
benefits to subjects (see Sec. 56.111(a)(1) and (a)(2) (21 CFR
56.111(a)(1) and (a)(2)), respectively). The rule does not address the
issue of terminating life support because this is dictated by State law
and is implemented through such standard procedures as ``do not
resuscitate'' orders.
B. Ethical Objections to the Rule
2. Several objections to the proposed rule noted that the major
protection from research risks remains informed consent and that
without this procedure, potential abuse of research subjects will
always remain unacceptably high; that it is unethical for patients who
cannot consent to receive nonstandard care; that overriding individual
autonomy and not obtaining informed consent is unacceptable; that
therapeutic intent is not sufficient to obviate consent when there are
no data or when there is uncertainty or disagreement. Some of these
comments mentioned the recent report of the President's Advisory
Committee on Human Radiation Experiments, in which radiation
experiments without the subjects' consent are condemned as a wrongful
use of persons as means to the ends of others; others mentioned
examples from Nazi Germany, Stalin's U.S.S.R. and other totalitarian
regimes. Some of these comments noted that it is particularly
objectionable that there is no way to avoid involvement as a subject in
this research if, as an individual, one objects to the research.
The agency acknowledges that the waiver of informed consent is a
serious matter. That is why it has developed a regulation that requires
additional protections when informed consent is waived. The purpose of
this rule is to ensure such protections.
The National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research states in The Belmont Report that:
Respect for persons incorporates at least two basic ethical
convictions: first, that individuals should be treated as autonomous
agents, and second, that persons with diminished autonomy are
entitled to protection. The principle of respect for persons thus
divides into two separate moral requirements: the requirement to
acknowledge autonomy and the requirement to protect those with
diminished autonomy.
This rule, Sec. 50.24 (21 CFR 50.24) in part 50 (21 CFR part 50), can
be invoked for emergency research in which it is not feasible to obtain
informed consent from prospective subjects. As such, these subjects
have diminished autonomy and are entitled to protection. The Belmont
Report states that:
The extent of protection afforded [to individuals with
diminished autonomy] should depend upon the risk of harm and the
likelihood of benefit. The judgment that any individual lacks
autonomy should be periodically reevaluated and will vary in
different situations.
The Belmont Report, thus, states that: (1) Subjects with diminished
autonomy are entitled to protection; (2) the extent of protection
should depend upon the risk of harm and the likelihood of benefit; and
(3) the judgment that any individual lacks autonomy should be
periodically reevaluated. This regulation incorporates each of these
principles.
The regulation recognizes that subjects with diminished autonomy
are entitled to protection. These additional protections include the
requirements in the regulation for consultation with representatives of
the communities from which the subjects will be drawn; public
disclosure of the clinical investigation and its risks and expected
benefits prior to initiation of the investigation; public disclosure of
sufficient information following completion of the investigation to
apprise the community and researchers of the results of the
investigation; the establishment of a data monitoring committee to
exercise oversight of the investigation; and, if consent is not
feasible and a legally authorized representative is not available,
providing an opportunity for a family member to object to a subject's
participation in the investigation, if feasible within the therapeutic
window.
The regulation recognizes that the extent of protection should
depend upon the risk of harm and the likelihood of benefit to the
subjects. The regulation requires the IRB to find and document that
appropriate animal and other preclinical studies have been conducted;
that the information derived from those studies and related evidence
support the potential of providing a direct benefit to the individual
subjects; and that the risks associated with the investigation are
reasonable in the light of what is known about the prospective
subjects' medical condition, the risks and benefits of standard
therapy, if any, and what is known about the risks and benefits of the
proposed intervention or activity.
The regulation recognizes that the judgment that any individual
lacks autonomy should be periodically reevaluated. This is reflected in
two requirements: (1) The IRB must review and approve informed consent
[[Page 51500]]
procedures and an informed consent document for use with subjects or
their legal representatives in situations where use of such procedures
and documents is feasible; and (2) at the earliest feasible
opportunity, each subject (or a legally authorized representative or
family member) will be informed of the subject's inclusion in the
research, the details of the research, and that the subject (or
representative or family member) may discontinue the subject's
participation at any time without penalty or loss of benefits to which
the subject is otherwise entitled.
In response to the comments that expressed concern about the
ability of an individual to avoid involvement as a subject in this
research, the agency thinks that the opportunity for individuals to
express objections to the research may be optimized in a number of
ways. Comments suggested making available medical bracelets that record
refusal to participate in the research, and publicizing the existence
of the bracelets; and excluding from participation those individuals
with advance directives rejecting such research (most feasible for
hospitalized patients). The agency encourages IRB's, investigators, and
sponsors to work together to maximize the ability of individuals to
prevent their inclusion in research to which they would object. The
agency does not believe that this rule creates a situation that differs
significantly from other emergency situations warranting intervention
in that individuals in life-threatening situations are often unable to
direct decisions concerning their health care and are, therefore,
unable to consent or object to a particular treatment. Yet they are
routinely treated by State-licensed medical practitioners. This
inability to exercise autonomy is not unique to the subjects who will
be eligible for this research--it is common to the majority of
individuals who may be in these life-threatening situations.
FDA thinks that the protections contained in this rule including
IRB review, the requirements for obtaining informed consent when it is
feasible, and for community consultation and disclosure will prevent
unethical research from occurring.
FDA expects these procedures involving waiver of informed consent
to be used infrequently. As noted, the research carried out under such
a waiver must present the potential of direct benefit to the individual
subjects. It should be initiated only after appropriate animal and
other preclinical studies have been conducted, and it is clear that the
information derived from those studies and related evidence support the
potential of direct benefit to the individual subjects.
3. One comment stated that the proposal violates the American
Hospital Association's ``Patient's Bill of Rights'' to fully informed
consent.
The agency has reviewed the AHA's Patient's Bill of Rights and
concludes that there is no conflict between this rule and that
document. In particular, the agency notes that the Patient's Bill of
Rights recognizes that an exception occurs ``in emergencies when the
patient lacks decision-making capacity and the need for treatment is
urgent.''
4. Another comment questioned the agency's discussion of respect
for persons in the preamble to the proposal and the agency's supposed
conclusion that if individuals capable of exercising their autonomy
refuse to enroll in research, this justifies diminished protection to
those individuals who lack the capacity for autonomous choice. This
comment defined the informed consent doctrine as: (1) Promoting
individual autonomy; (2) respecting human dignity; (3) encouraging
professional self-scrutiny; (4) promoting rational decisionmaking; (5)
avoiding deceit and coercion; and (6) educating the public. It then
concluded, that by exempting emergency research from informed consent,
the agency was concluding that these values have no relevance to
decisions made in the context of emergency research.
This comment misrepresents the agency's discussion of the principle
of respect for persons. In the preamble to the proposed rule, the
agency described:
[H]ow the principle of respect for persons incorporates two
general rules of ethical behavior: (1) Competent individuals must be
treated as autonomous agents * * *; and (2) persons whose autonomy
is absent or diminished may participate in research only if
additional protections are provided for them.
(60 FR 49086 at 49093, September 21, 1995)
This rule, in fact, incorporates the values described in the comment to
the extent that they are relevant to decisions made in the context of
emergency research.
5. A number of comments misinterpreted the agency's description of
the principle of justice in the preamble to the proposed rule, and were
offended by the idea that it is acceptable for a researcher to waive
consent because if consent were requested, it would be refused. One
comment suggested that the agency clarify that it meant that it is
often easier to locate legal representatives from white populations
than from minority populations, and for that reason if consent were
required from a legally authorized representative, the requirement
could prevent equitable numbers of minority patients from having the
opportunity to participate in emergency research. The Indian Health
Service recommended that the agency supplement its discussion of
justice by adding the following:
Waiving informed consent will increase justice only in
communities or sub-communities with a low percentage of people who
would refuse to participate if asked. Many minority or economically
disadvantaged communities distrust research more, and have higher
percentages of refusers, than white middle class communities; in
such communities, the ethical principle of justice would favor
maximizing self-determination (i.e., informed consent) over
achieving high rates of participation. Justice would also require
the public disclosure to and consultation with those communities as
required in the Proposed Rule; if those communities do not agree to
be sites, consideration should be given to doing the research
elsewhere.
The Indian Health Service, in supporting the intent of the rule,
articulated two aspects of the problem: (1) Finding legally qualified
surrogates for individuals who lack telephones, for example, which is a
socioeconomic barrier; and (2) a surrogate's unwillingness to enroll a
relative in the research, based on distrust of research and
researchers. If certain communities have a higher prevalence of
refusers than others, the ethical harm of inadvertently enrolling
people in research against their will would fall on those communities
with a higher prevalence of refusers. Thus, the Indian Health Service
(IHS) concluded that while it may be appropriate to waive informed
consent based on socioeconomic barriers, it is not appropriate to waive
informed consent in communities in which there are lower rates of
obtaining surrogate consent due to the unwillingness of surrogates,
i.e., high refusal rates. Another comment noted that if the community
in which an emergency research study is carried out has a large
minority and lower income population, then the likelihood of the
community agreeing prospectively to participate in the study would be
small or nonexistent; ethically this would violate the principle of
justice in that such communities would be unlikely to share the burdens
and benefits of participation in such research.
The agency's comments concerning justice, in the preamble to the
proposed rule, concerned the ability of health care delivery personnel
to locate legally authorized representatives. The agency agrees with
the IHS articulation of the
[[Page 51501]]
two aspects of the problem. The agency would not consider writing a
rule that would permit the waiver of informed consent in a situation
where if consent were requested, it would be refused. Such an action
would violate ethical principles.
The agency has implicitly addressed the problem of a surrogate's
unwillingness to enroll a relative in research through the rule's
requirement for community involvement, including consultation with and
disclosure to the community, and by providing that consent from the
subject or the subject's legally authorized representative be obtained
or an opportunity for a family member to object be provided when it is
feasible.
If an IRB decides that its community should not participate in
research, the agency does not believe that decision would violate the
principle of justice. Justice, in this context, requires only that the
community have the opportunity to participate in the research if asked.
C. Harmonization
6. A number of comments applauded the intent of FDA and DHHS to
harmonize regulations in this area. Concern was expressed, however,
that because FDA and DHHS did not propose regulations simultaneously,
the two regulations may not ultimately be identical, thus thwarting a
major objective of this endeavor. One comment expressed concern that
the DHHS waiver might follow the specific project waiver for
hypothermia research that was published in July 1995, that, according
to the comment, was not sufficiently protective of subject rights.
Another comment suggested that for studies that do not involve drugs or
devices, DHHS develop an analogous mechanism to FDA's requirement that
studies be submitted for agency review. Another comment suggested that
the two sets of regulations not be in total harmony in this regard,
because a greater degree of protection of subjects is necessary for
studies of drugs and devices that are not yet FDA-approved, than for
those involving drugs or devices that have received approval. One
comment encouraged FDA and the Office for Protection from Research
Risks (OPRR) to work together to ensure that current Multiple Project
Assurances remain valid and not require renegotiation as a result of
this rule.
DHHS has committed to consistency between the FDA final rule and
the Secretarial waiver of the DHHS regulations in all critical
respects. Elsewhere in this issue of the Federal Register is the
Secretarial waiver of the DHHS regulations for the protection of
research subjects for emergency research. The agency notes that FDA's
rule requires investigational new drug applications (IND's) and
investigational device exemptions (IDE's) for all clinical
investigations involving drugs and devices seeking an exception to the
requirement for informed consent, including both those that have
received marketing approval and those that have not.
7. Other comments asked for clarification as to whether the
requirement contained in Sec. 50.24(d) would apply to studies that
attempt to elucidate a pathophysiologic explanation (e.g., blood
drawing studies); studies that use interventions of different
techniques (e.g., two different methods of bystander CPR); research
designed to explore basic pathophysiological mechanisms in emergency
situations; studies to compare the timing of standard fluid
administration for shock and surgical techniques; etc. If FDA's
regulation did not apply, these comments asked if the DHHS
``harmonized'' regulation would apply to these studies and require
prior DHHS review or whether some other agency would be responsible for
prior review of the proposed research.
These regulations are applicable only to clinical investigations
involving products that are regulated by FDA. The DHHS regulations
apply to research supported or conducted by the Department or conducted
in an institution that has agreed to review all research, regardless of
its funding source, in accord with the DHHS regulations. The
``harmonized'' regulations have compatible criteria; their basic
requirements are in agreement. FDA includes terms specific to the type
of research covered by FDA regulations (e.g., it uses the term clinical
investigation instead of research). Both the DHHS and FDA recognize
that there may be research that is neither regulated by FDA nor
supported or conducted by DHHS; for that research, it is possible that
neither regulation will apply.
D. Comment Period and Effective Date
Several comments opposed to the regulation objected to the 45-day
comment period and the agency's proposal that the final rule will be
effective upon publication.
8. One comment suggested that the effective date of the regulations
should be 30 days after publication of the final rule. This comment
noted that this research has been halted since mid-1993, that all
parties will need time to develop adequate policies and procedures to
comply with the new rule, and that distribution of the policy to those
affected will take up to 30 days.
The agency agrees with this comment and has made the effective date
of the final rule 30 days after its publication in the Federal
Register. The agency notes that the Secretarial waiver of the DHHS
regulations, published elsewhere in this Federal Register, is also
effective 30 days after its publication. IND's and IDE's that intend to
invoke this rule may be submitted to the agency on or after its
publication date and should include a description of how the clinical
investigation proposes to meet the conditions of this regulation. These
investigations cannot begin until the rule is effective, the agency has
reviewed the investigation against the requirements contained in this
final rule, a letter has issued to the sponsor advising the sponsor
that the investigation may proceed, the investigation has been reviewed
and approved by an IRB, and the community consultation and disclosure
required by this rule have occurred.
9. Comments objecting to the 45-day comment period suggested that
there was inadequate time to discuss the proposed changes in the
regulation at length with a broader audience, that the IRB community is
ill-informed about the proposed rule change and therefore the comment
period should be extended, the issue revisited, and the rule
reconsidered. One of these comments stated that the process leading to
development of the rule was flawed and that it appears that the comment
period is irrelevant, that no significant review of the basic issues
will occur, and, thus, the rule is a fait accompli.
As described in detail in the preamble to the proposed rule, the
issues associated with this rule were debated at length at conferences,
during FDA and NIH cosponsored Public Forum on Informed Consent in
Clinical Research Conducted in Emergency Circumstances, at a
congressional hearing, and in various articles. The agency received no
formal request for a general extension of the comment period; instead,
it received numerous thoughtful comments and has modified the proposed
rule as a result of those comments. 21 CFR 10.40(b)(2) states that a
proposed rule ``* * * will provide 60 days for comment, although the
Commissioner may shorten or lengthen this time period for good cause.
In no event is the time for comment to be less than 10 days.'' In the
proposed rule, the agency explained why the Commissioner determined
that there was good cause to shorten the comment period from 60 to 45
days.
[[Page 51502]]
In order to encourage comments on this rule, the agency conducted a
number of out-reach efforts to publicize publication of the proposal.
The agency provided information on the proposed rule to national media
and trade press contacts. The agency mailed copies of the proposal to
all registrants at the January 1995 Public Forum on Informed Consent in
Clinical Research Conducted in Emergency Circumstances and to over
1,000 IRB's and over 250 health professional organizations and consumer
groups. FDA also distributed copies at workshops and at national
meetings of IRB organizations. The agency invited consumer, health
professional, and industry organizations to briefing meetings where the
proposal was described and questions could be answered. The agency
encouraged the submission of comments to the administrative record
maintained by the Dockets Management Branch whenever possible.
E. Preemptive Effect
10. In the preamble to the proposed rule, FDA requested comment on
the need to preempt local and State regulations. The agency received a
number of comments both for and against the need for preemption.
Comments received that were opposed to preemption included the
following: There is no legitimate (constitutional) over-riding Federal
concern that requires the Federal Government to preempt local and State
requirements; it is inappropriate to remove the ability of citizens to
enact State and/or local laws that would require additional protections
for research subjects, or to restrict the conduct of this type of
research if citizens find it objectionable based on community
standards; it is not logical to prohibit local action when the
regulation itself emphasizes community involvement and deference to
community standards.
The IHS objected to Federal preemption because it would: (1)
Counter the long-standing Federal policy not to place restrictions on
tribal sovereignty; (2) be an unnecessary limitation, because retaining
tribal sovereignty would have no measurable adverse effect on the
nation or on emergency research as a whole; (3) give American Indian
and Alaska Native (AI/AN) people and governments one more reason to
distrust the Federal Government, because they would see the rule as
putting AI/AN people at risk for the good of non-AI/AN people and
communities; and give AI/AN people and governments one more reason to
distrust research, because they would see the rule as overriding a
patient's or family's desire not to participate in research--a desire
more common in AI/AN communities than in white middle class
communities.
Other comments noted that the proposal did not recognize tribal
sovereignty and that it undermines the tribal government's authority to
implement stricter requirements for biomedical research conducted on
persons residing in tribal jurisdictional boundaries. Comments noted
that the tribal review process is in place to protect tribal members
from unnecessary or undesirable research.
Another comment opposed to preemption noted that the rule would
preempt State and local laws for the minimum protections acceptable for
emergency research involving waiver of informed consent; however,
without preemption, it permits greater protections to be imposed at the
State or local levels. One comment suggested that in lieu of
preemption, FDA and IRB's should track how States, local, or tribal
governments retain or amend their laws in response to public discussion
by researchers with those governments and assess the various reactions
after 3 years.
Other comments supported the need for preemption in order to ensure
national uniformity; to prevent or limit liability of universities,
hospitals, IRB members, clinical investigators, and sponsors for
failure to provide informed consent under State law or in the event of
a poor subject outcome; and to enhance the ability to conduct valuable
research with critically ill subjects. These comments stated that the
subject protections included in the proposed regulation are substantial
enough to justify Federal preemption of State and local law, and that
current State laws (e.g., in the State of Florida) would preclude
research that otherwise could be authorized by IRB's under these rules.
Several comments supported the need for preemption, noting the
difficulty caused by differing State laws that define who may serve as
a legal representative or that are ambiguous on this issue. Another
comment noted that without Federal preemption, Federal uniformity in
the application of waiver of informed consent in a specific setting
will not occur. This comment argued that Federal preemption would: (1)
Forestall wasteful State court litigation to explore whether the scope
of the privilege of emergency action without consent is consistent with
the proposed Federal rule, and any related potential liability; and (2)
implement congressional intent to create nationally uniform criteria
for informed consent and research involving human subjects.
The Coalition of Acute Resuscitation and Critical Care Researchers
surveyed a number of State representatives regarding State regulations
for informed consent for research and identification of surrogates. The
results of that survey (with 19 States represented) indicate that there
are very few States that have specific legal requirements pertaining to
waiver of consent for research.
The agency has carefully considered each of these arguments in
support of, and opposed to, preemption of State law. The agency has
concluded that it would be inappropriate to preempt State law at this
time. Preemption of State law would prevent the application of State or
local law that requires additional protections to research subjects
and, as such, would be inconsistent with the existing Federal policy
for the Protection of Human Subjects and the DHHS regulations (45 CFR
46); in addition, it would be inconsistent with the notion of community
norms, upon which this regulation is based.
F. Followup/Reassessment
11. One comment recommended that the implementation of this rule be
assessed in 3 years and that any pending questions be addressed during
the assessment. Another comment asked the agency to announce its intent
to survey and analyze the experience with the rule following 3 years of
implementation. The comment recommended that the rule encourage IRB's
and researchers to track implementation information including: The
number of times the researcher was able to contact legally authorized
representatives within the allowed therapeutic window time period;
problems with the documentation and procedures used for the consent
process with those representatives; the percentage of subjects or
legally authorized representatives who wanted to discontinue the
intervention or to remove their data from the research database in the
posthoc debriefing; problems with documents and procedures used to give
the community the preresearch public information and the post-research
information; and problems with the documents and procedures for
consulting with community representatives. This comment suggested that
this information be described both as seen by the IRB and by the
experienced researcher.
The agency agrees that it will be important to assess
implementation of this rule and, thus, the agency intends to evaluate
implementation of this rule
[[Page 51503]]
on an ongoing basis. The agency believes that a sponsor's IND or IDE
and new drug application (NDA), product license application (PLA), or
premarket approval application (PMA) should contain sufficient
information under the agency's existing reporting and recordkeeping
requirements for the agency to assess how well this rule is working
without requiring additional information collection and recordkeeping
by researchers and IRB's of their experiences under the rule. The
agency, however, encourages IRB's, researchers, and sponsors to share
their experiences under this rule, for example, in publications and at
conferences, so that the research community and public can benefit from
their experiences. The agency notes that for research that is regulated
by FDA, although subjects, legally authorized representatives, or
family members may elect to withdraw from continued participation in
the clinical investigation, they may not remove previously collected
data from the research database because it is critical that FDA obtain
and be able to consider all data on a product's use in order to be able
to determine its safety and efficacy.
G. Scope/Applicability
1. Special Populations
12. One comment questioned the applicability of this rule to
specific special patient populations. This comment recommended that FDA
rule state that it does not apply to research involving prisoners or
fetuses; and urged that the decision about its applicability to
emergency research targeting pregnant women be made after the DHHS
regulations have been revised and the 3 year period in which experience
of implementing the rule will be obtained and analyzed. This comment
recommended that pregnant women should not be excluded from emergency
research. This comment also recommended that the rule state that it
does not apply to children now; rules for pediatric emergency research
should be developed by the end of the 3 year period of experience and
assessment; and noted that the process of Secretarial waiver is
available if an exception for a specific pediatric emergency protocol
must be made before then.
Taking a contrary view, the American Academy of Pediatrics stated
that:
* * * it is important that children be included in research
protocols, including those on emergency treatments, so that the
safety and efficacy of various treatment methods can be determined
in a scientific manner. We believe that this proposed regulation
will help to further that objective while protecting children as
much as possible by requiring that a consent document be available
in cases where surrogate permission can be obtained in a timely
manner.
The agency believes that it would be inappropriate to exclude any
special subject population from this regulation. Moreover, for research
regulated by FDA, a Secretarial waiver of the informed consent
requirement may not be an option. Thus, the agency is not limiting the
applicability of this regulation to exclude any special subject
population. The agency notes that it is the general responsibility of
the IRB, where some or all of the subjects are likely to be vulnerable
to coercion or undue influence, to ensure that appropriate additional
safeguards have been included in the clinical investigation to protect
the rights and welfare of these subjects. (See 21 CFR 56.111(b).) The
subject population covered in this rule is, in a sense, a particularly
vulnerable population, by having no capacity to decide about medical
treatments. The additional safeguards in the rule are included for this
reason.
2. Existing Regulations
13. One comment asked the agency and DHHS, respectively, to
explicitly state, when this rule is finalized, that FDA will retain
Sec. 50.23(a) (21 CFR 50.23(a)) and the DHHS will retain 45 CFR
46.116(d).
Both FDA and DHHS will retain these sections in the Code of Federal
Regulations. These sections will continue to be useful in situations
not otherwise covered by this regulation.
14. Another comment suggested that the regulations address
compensation or medical treatment available in the event of
unanticipated injuries or death.
The agency agrees that it is important for all subjects in a
clinical investigation to be provided with the basic information
required by Sec. 50.25, including Sec. 50.25(a)(6) that requires that
information be provided to each subject about whether any compensation
and any medical treatments are available if injury occurs and, if so,
what they consist of, or where further information may be obtained. As
a result, the agency has modified Sec. 50.24(a)(6), previously numbered
Sec. 50.24(a)(5), to make it clear that the IRB-approved informed
consent document must be consistent with Sec. 50.25. The agency has
also modified Sec. 50.24(b) to make it clear that when prospective
informed consent cannot be obtained, the subject, or the subject's
legally authorized representative or family member is to be informed,
at the earliest feasible opportunity, of the subject's inclusion in the
clinical investigation, the details of the investigation, and other
information contained in the informed consent document.
15. A third comment requested the agency to retain two protections
previously established by the agency that are not contained in the
proposed rule: (1) That the intervention be in the health interest of
the subjects; and (2) that an attempt to obtain informed consent be
made and documented for enrolled research subjects by a physician
unaffiliated with the research activity.
The agency thinks that the concerns expressed by the first
protection are addressed in Sec. 50.24(a)(3), which requires that
participation in the research hold out the prospect of direct benefit
to the subjects. The second protection is similar to that contained in
Sec. 50.23(a), which requires, in effect, a second opinion from a
physician who is not otherwise participating in the clinical
investigation that the conditions for waiving informed consent are met.
This protection is performed for the class of subjects in this research
by the requirement in Sec. 50.24(a)(2) that a determination be made
that obtaining informed consent is not feasible and that this
determination receive the concurrence of a licensed physician who is
either an IRB member or a consultant to the IRB, and who is not
otherwise participating in the clinical investigation (Sec. 50.24(a)).
The agency notes that Sec. 50.24(b) requires that at the earliest
feasible opportunity, each subject is to be informed of the subject's
inclusion in the clinical investigation, the details of the
investigation and other information contained in the informed consent
document. The agency also notes that under new Sec. 50.24(a)(5), the
researcher is required to describe the efforts made to obtain informed
consent and make this information available to the IRB at the time of
continuing review.
3. Foreign Data
16. One comment noted that the rule was silent as to its potential
impact on the acceptability of data generated in emergency research
studies that are not subject to the proposed rule--i.e., studies
conducted outside the United States and outside the scope of the IND
and IDE regulations. This comment asked FDA to make it clear that such
studies will continue to be considered acceptable in terms of providing
evidence of safety and effectiveness and could be treated as pivotal
trials, even though they may not meet some of the proposed requirements
for the conduct
[[Page 51504]]
of emergency research. This comment stated that if this clarification
is not consistent with the agency's intent, then the proposal
effectively establishes a new, inappropriate standard concerning the
adequacy of clinical studies for purposes of providing evidence of
safety and effectiveness that would require specific notice-and-comment
rulemaking.
Sections 312.120 and 814.15 (21 CFR 312.120 and 814.15) describe
the criteria for acceptance by FDA of foreign clinical investigations
not conducted under an IND and IDE, respectively. In general, FDA
accepts such clinical investigations provided they are well designed,
well conducted, performed by qualified investigators, and conducted in
accordance with ethical principles acceptable to the world community.
FDA will accept such emergency research investigations provided that
they meet the requirements of Sec. 312.120 and Sec. 814.15. This rule
does not change the requirements of Sec. 312.120 and Sec. 814.15.
17. One comment noted that the International Conference on
Harmonisation Draft Guideline on Good Clinical Practice (GCP) (60 FR
42948, August 17, 1995) states that ``the rights, safety, and well-
being of the trial subjects are the most important considerations and
should prevail over [the] interests of science and society.'' This
comment suggested that the main argument for the proposed rule is for
the benefit that the new drugs and devices will bring to science and
society, rather then recognizing, as the GCP does, the value of the
individual and subject rights.
The agency disagrees that this rule is inconsistent with the ICH
Draft Guideline and has emphasized in the preamble to this regulation
that the basic rationale for this rule is that it holds out the
prospect of direct benefit to the subjects. The agency is committed to
protecting the rights of research subjects. In addition, FDA recognizes
that this rule may also serve society by making available more drugs
and devices for use in emergency, life-threatening situations. The
agency notes that the draft GCP cited specifically acknowledges the
need for waivers of informed consent in some circumstances.
4. Independent IRB's
18. One comment expressed concern about FDA's continued acceptance
of reviews by ``independent'' IRB's. This comment questioned the
ability of a nonlocal, independent IRB to have local insight and
knowledge necessary for comprehensive review and continuing oversight,
and suggested that unless there is monitoring of independent IRB's by
OPRR, they should not be allowed to approve research under this rule.
The agency received other comments asserting that independent IRB's are
well-qualified to maintain the requisite oversight and responsibilities
of emergency research trials and that independent IRB's can maintain
ethical standards equivalent to dependent IRB's.
As previously discussed in the preamble to the proposed rule, the
agency thinks that independent IRB's can properly review this type of
research. The agency thinks that duly constituted IRB's can ensure that
the rights and welfare of research subjects are protected by fulfilling
the requirements of part 56 (21 CFR part 56) and Sec. 50.24, including
Sec. 50.24(a)(7) requiring public disclosure as well as consultation
with the communities from which the subjects will be drawn. FDA
anticipates that this type of research will usually be performed in an
institution with an IRB. In that case, the IRB for the institution has
the responsibility and authority to review all studies performed in the
institution. This review responsibility may not be delegated to another
IRB unless the institution and the IRB for the institution agree to the
delegation and the agreement is documented in writing.
5. Conflicts with Statutes, the Constitution, and Other Standards
19. One comment stated that the rule conflicts with State common
law--that is, a physician who performs research without obtaining
consent for that research will be liable under common law for
malpractice and battery, and is likely to lose his or her license. This
comment stated that by adopting the proposed rule, FDA is overstepping
its authority by attempting to regulate the practice of medicine and by
attempting to override State law, and that FDA lacks the authority to
permit anyone in the medical profession to practice without obtaining
consent.
FDA disagrees with the comment. This rule does not attempt to
regulate the practice of medicine. Rather, as discussed more fully in
the preamble to the proposed rule, FDA is regulating investigational
products under the statutory authority contained in the Federal Food,
Drug, and Cosmetic Act (the act). FDA also disagrees with the comment
that FDA is overriding State law. As stated elsewhere in this preamble,
FDA is not changing the existing Federal policy that recognizes the
continuing validity of applicable State or local laws and regulations
on human subject protections. With regard to physician liability for
performing research under this regulation, FDA disagrees with the
comment's blanket conclusion that physicians participating in such
research are committing malpractice and battery. FDA notes that this
rule does not override existing State and local laws and regulations
that may apply to such research. Institutions wishing to participate in
such research may wish to consult their attorneys regarding any State
and local restrictions that preclude such research. As with other
research, physician liability for activities engaged in during
emergency research will vary from State to State because of different
laws on human subject protections. FDA notes that an existing
regulation Sec. 50.23 permits waiver of informed consent in certain
limited emergency situations. FDA is unaware of any research conducted
in accordance with that regulation that has resulted in physician
liability for malpractice or battery.
20. One comment stated that the proposal violates Federal law under
the Patient Self-Determination Act of 1990.
FDA disagrees with the comment. The Patient Self-Determination Act
of 1990 defines an advance directive as ``a written instruction, such
as a living will or durable power of attorney for health care,
recognized under State law (whether statutory or as recognized by the
courts of the State) and relating to the provision of such care when
the individual is incapacitated.'' (42 U.S.C. 1395cc(f)(3).) That act
imposes obligations on certain facilities (hospitals, skilled nursing
homes, home health agencies, and hospice programs) participating in the
Medicare program regarding advance directives. (42 U.S.C. 1395cc.) The
Patient Self-Determination Act requires these facilities to give
information to patients about their rights under State law to accept or
refuse treatment and to make advance directives. These facilities also
are required to document in the patient's medical records whether the
patient has executed an advance directive and to ensure compliance with
State laws on advance directives. The comment did not explain how he
believed the rule violates the Patient Self-Determination Act; nothing
in this rule prevents facilities from continuing to act in compliance
with the requirements contained in that act.
21. Another comment questioned the validity of the claim in the
proposal that ``the proposed rule gives double weight to the statutory
'necessitates' criterion'' because ``(1) intervention is needed because
of the medical condition, and (2) the collection of valid data is
needed
[[Page 51505]]
because of the absence of proven satisfactory available treatment for
the condition.'' This comment stated that the context of the
``necessitates'' clause makes it clear that what is necessary is the
use of a device to preserve the life of the subject--that the
relationship of necessity is between the intervention and the subject's
condition. This comment stated that it is a perversion of the statutory
language to claim that it uses ``necessitates'' to refer to the
relationship between the collection of data and proven treatment. The
comment noted further that randomly assigning subjects to a treatment
that some researchers consider unsatisfactory and to a treatment
researchers think may be an improvement is not necessitated by the
subject's life-threatening condition and, further, a placebo can never
be necessitated to preserve a subject's life.
The agency agrees that the ``necessitates'' clause focuses on the
relationship between the treatment and the subject's condition. The
idea that an intervention using an investigational product is
``necessary'' may, at first, appear to be contradictory. It does not
mean the product is safe and effective and that it must be given to
everyone. Read this way the exception would apply to products that are
not investigational and it would be irrelevant. The device amendments
to the act are referring to an investigational intervention that is not
known to be beneficial, and ``necessitate'' means that because
available therapy is inadequate, potentially beneficial intervention is
needed. Thus, there is no obligation to give everyone the
investigational intervention despite the patient's need for some better
treatment; it is possible to give only some subjects the intervention,
leaving others to the care they would get were there no study. In the
absence of an obligation to give every patient the investigational
intervention, it is possible to consider other factors, such as the
need to evaluate the intervention and learn from the exposure, which
potentially may benefit the subject in the study, the community, and
future patients with the disease. The critical and potentially
difficult concept is that the intervention is given because the
patient/subject needs it, yet enough is not known about the
intervention to support giving it to everyone as therapy.
It is clear, despite the uncertainty, that the investigational
intervention is intended to be beneficial and that there is conceptual,
preclinical, and possibly clinical (e.g., other settings, preliminary
results) evidence that the hoped for benefits outweigh the potential
risks, all of which leads the investigator (and the pertinent IRB) to
hope for, even anticipate, benefit. Such anticipation is compatible
with the state of clinical equipoise needed to allow a clinical
investigation. Indeed, true neutrality is rarely present at the start
of an investigation; in the absence of expectation that an intervention
may represent an improvement, or a belief that a standard therapy might
not work, there is little incentive to proceed. The experienced
clinical investigator, however, also knows that expectations are not
the same as knowledge and that disappointments are too common to
ignore. Therefore, despite optimistic expectations, one can be in the
state of equipoise needed to allow a clinical investigation to be
conducted.
In the current rule, addressing the special case of nonconsenting
subjects, the agency is asking for more than the usual assurances that
the investigational intervention is promising, and that accumulating
results have not taken us all the way past equipoise (through the data
monitoring committee's considerations). This extra assurance is
necessary because it must be possible to state honestly that the
intervention is for the patient's benefit, at least at the level of
being promising, and is not a project only for pure science, future
generations, or the community, although it will, of course, benefit
those too.
Therefore, if there are available only unproven or unsatisfactory
therapies and appropriate animal and other preclinical studies support
the potential of benefit to subjects from a new intervention, the
agency thinks it can be said that the subject's condition
``necessitates'' alternative treatment. In the case under
consideration, where the new intervention is not known to be of value,
although it is promising and has been evaluated in animals and in less
emergent settings, it is reasonable to randomize to a standard therapy
not yet shown inferior to the new intervention. The subject receiving
standard therapy is no worse off than if there had been no clinical
investigation.
22. Another comment considered the rule contrary to the Nuremberg
Code and to the U.S. Constitution; it stated that the agency's reliance
on Doe v. Sullivan is inappropriate. Another comment suggested that the
decisions of the U.S. Supreme Court in Cruzan v. Director Mo.
Department of Health, and Griswald v. State of Connecticut present
constitutional barriers to the proposal to eliminate the requirement of
informed consent in biomedical research involving emergency conditions.
This comment also analyzed an attorney's observations at the Public
Forum with respect to State law and criticized the proposal for not
addressing these. Another comment stated that the rule denies persons
with disabilities equal protection under the law and their rights to
due process in that it treats competent and incompetent patient-
subjects in a distinct, unequal manner.
FDA disagrees with these comments and with the assertions that the
cases cited present constitutional barriers to the issuance of this
rule. FDA strongly endorses the concept of informed consent. Obtaining
informed consent is not always possible, however, as Congress has
recognized in enacting amendments to the Act. Congress explicitly has
authorized exceptions from the requirement for informed consent in
research in limited situations. (See preamble to the proposed rule for
a more detailed discussion of authority in the act for permitted
exceptions from informed consent (60 FR 49086)).
Unlike situations involving a failure to inform a competent person
of the risks and consequences associated with participating in research
(see In Re Cincinnati Radiation Litigation, 874 F. Supp. 796, 800-01
(S.D.Ohio 1995)), this rule seeks to maximize an individual's access to
potentially beneficial drugs and devices at a time when, due to an
emergency which causes incompetency, informed consent cannot be
obtained. The issuance of this rule does not result in the automatic
entry of an individual in a clinical investigation without informed
consent. Rather, it contains important protections that must be met
before such a clinical investigation may proceed. Decisions on whether
an investigation may proceed will be made on a case-by-case basis by
individual IRB's and need the concurrence of a licensed physician.
Contrary to the comment's suggestion, the Supreme Court's decision
in Cruzan v. Director Mo. Department of Health does not create a hurdle
to the issuance of this rule. In Cruzan v. Director Mo. Department of
Health, 497 US 261 (1990), the Supreme Court, in reviewing a Missouri
statute which required clear and convincing evidence of an incompetent
person's wishes as to whether or not life-sustaining treatment should
be employed, balanced a State's interest in the preservation of life
with an individual's wish to terminate life support rather than remain
in a vegetative state. Unlike Cruzan, this rule focuses on the
preservation of life when an individual's wishes are unknown. As in
other emergency situations, where an individual is incompetent, if it
is feasible to obtain informed consent from the individual's legally
authorized
[[Page 51506]]
representative, then such consent should be obtained. FDA notes that it
is possible that an individual may have previously issued advance
directives on life-sustaining treatment. FDA believes that, where
feasible, attempts should be made consistent with State law to identify
the existence of such directives prior to enrolling an individual into
a clinical investigation without informed consent. FDA recognizes,
however, that in many life-threatening instances it may not be feasible
to learn of the existence of any existing directives prior to taking
potentially life-saving intervention and that in many instances, an
individual may not have issued such advance directives. In such cases,
FDA believes that interventions consistent with this rule are
constitutionally permissible.
H. Clarifications
23. HIMA noted that it was one of the organizations that endorsed
the October 25, 1994, consensus document on Informed Consent in
Emergency Research from the Coalition Conference of Acute Resuscitation
and Critical Care Researchers.
The agency acknowledges that HIMA endorsed the consensus document
on Informed Consent in Emergency Research from the Coalition Conference
of Acute Resuscitation and Critical Care Researchers.
24. HIMA also suggested that FDA recognize the diversity of opinion
on ``deferred consent'' and its history of successful use from
approximately 1980 until mid-1993, rather than simply disregard this
concept as ``post-hoc ratification'' unworthy of ``genuine'' informed
consent.
FDA disagrees and thinks that its earlier rejection of ``deferred''
consent was appropriate. As described in the preamble to the proposed
rule, posthoc ratification is not genuine consent because the subject
or representative has no opportunity to prevent the administration of
the test article, and cannot, therefore, meaningfully be said to have
consented to its use.
III. Specific Comments on the Proposed Regulation
A discussion of the specific comments received in response to this
proposal follows:
A. Definitions
25. Four comments requested clarification of the proposed
definition of family members in Sec. 50.3. Two comments questioned what
one should do if there is disagreement among family members. One asked
whether a family member could provide informed consent for emergency
research if State law does not explicitly provide for consent from
family members. Another questioned whether family members, even those
who do not possess power of attorney for health care rights, can
provide informed consent for emergency research under this rule.
One individual suggested that it may be unwise to provide a new
definition for such a familiar expression as ``family member'' and
suggested that the phrase ``any individual related by blood or affinity
whose close association with the subject is the equivalent of a family
relationship'' be used in its place. Another comment commended the
agency for including in its definition those individuals whose
relationship resemble family relationships.
One comment suggested that the hierarchy of the decision-making
authority of family members should be clearly stated. This comment
questioned whether one family member could overrule the decision of
another and questioned whether all family members must agree.
The agency thinks that it is appropriate to retain the phrase
``family member'' and its definition. The agency has specifically
included family members under this rule because the opportunity for an
available family member to object to a potential subject's
participation in such a clinical investigation provides an additional
and an important protection to these individuals. Otherwise, if consent
from a subject or the subject's legally authorized representative were
not feasible, the eligible individual could be enrolled into the
investigation. Thus, by permitting a family member (even one who is not
a legally authorized representative) to object to an individual's
inclusion in the investigation, a further protection is provided to
that individual. This rule has been modified to make clear that a
family member must be provided an opportunity to object to the
potential subject's participation, if feasible within the therapeutic
window when obtaining informed consent from the subject is not feasible
and a legally authorized representative is not available. The agency
recognizes that this may not constitute legally effective informed
consent if the family member is not a legally authorized representative
under State law. FDA is not establishing a hierarchy of family members
although an IRB may consider the need for creating a hierarchy in
reviewing individual investigations. Under this rule only one family
member would need to be consulted and agree or object to the patient's
participation in the research. If family members were to disagree, the
researcher and family members would need to work out the disagreement.
26. One individual, who was opposed to the entire rule, suggested
that by not providing a definition of ``emergency,'' FDA's quest for
harmony and uniformity would be defeated by the various definitions
provided by State law. He suggested that without such a definition, too
much discretion is delegated to medical researchers and IRB's; that the
agency will have little basis to monitor the activities carried out by
these researchers; and that the exception will be used to exempt all
emergency research from consent, even when it is feasible to
prospectively identify and secure the consent of hospitalized
individuals. Finally, he noted that the Health Care Financing
Administration has issued regulations under the Emergency Medical
Treatment and Active Labor Act which define the term ``emergency
medical condition;'' this act's regulations link an emergency medical
condition to the manifestation of ``acute symptoms of sufficient
severity * * * such that the absence of immediate medical attention
could reasonably be expected to result in: (a) Placing the health of
the individual * * * in serious jeopardy; (b) serious impairment to
bodily functions; [or] (c) serious dysfunction of any bodily organ or
part.'' He suggested that health care professionals will be confused by
the different use of the term ``emergency'' in this regulation and
under the Emergency Medical Treatment and Active Labor Act.
The agency disagrees with these comments. Sufficient guidance is
given in the regulation in Sec. 50.24, particularly in
Sec. 50.24(a)(2)(iii), to ensure that there is a clear understanding of
what constitutes a life-threatening situation that could invoke this
rule and to ensure that it is not used routinely in all emergency
research. In addition, each clinical investigation will be reviewed by
FDA and the IRB to help ensure that this exception from informed
consent is not used for research for which it was not intended.
Further, emergency room personnel should not be confused because they
should know when they are participating in FDA regulated research. The
agency notes that the purpose of the Emergency Medical Treatment and
Active Labor Act is different from this rule. This informed consent
exception is intended to allow certain FDA-regulated research to
proceed without informed consent provided specific conditions are met.
Entities that deal with both regulations
[[Page 51507]]
will be able to understand whether one or the other regulation applies.
B. Exception Criteria
1. Section 50.24(a)
27. One comment suggested that additional conditions be added to
Sec. 50.24(a) to reinforce the statement in the preamble to the
proposed rule that appropriate evidence is available to document
clinical equipoise and to ensure that efforts are made to obtain
consent from a legally authorized representative whenever possible. The
two proposed additional sections would read: ``[a]ppropriate animal and
preclinical trial studies have been completed, and the information
derived from those and related studies support the likelihood of
providing a direct benefit to the individual subjects'' and ``[t]he IRB
finds that the researcher defined the length of the therapeutic window
based on scientific evidence, will try to contact the legally
authorized representative within that window of time, and will ask each
representative contacted for consent within that window rather than
waive consent. The researcher will track the number of representatives
contacted and provide that information to the IRB.''
The agency agrees that these are important concepts that should be
contained explicitly in the regulation. It has incorporated these
comments in the regulation, with slight modification to the language
proposed in the comment. The agency has added a new paragraph to
Sec. 50.24(a)(3) to read as follows: ``(ii) Appropriate animal and
other preclinical studies have been conducted, and the information
derived from those studies and related evidence support the potential
for the intervention to provide a direct benefit to the individual
subjects.'' The agency also has added a new paragraph Sec. 50.24(a)(5)
and a new paragraph Sec. 50.24(a)(7)(v). The new paragraph
Sec. 50.24(a)(5) reads as follows: ``(5) The proposed investigational
plan defines the length of the potential therapeutic window based on
scientific evidence, and the investigator has committed to attempting
to contact a legally authorized representative for each subject within
that window of time and, if feasible, to asking the legally authorized
representative contacted for consent within that window rather than
proceeding without informed consent. The investigator will summarize
efforts made to contact legally authorized representatives and make
this information available to the IRB at the time of continuing
review.'' The new paragraph Sec. 50.24(a)(7)(v) reads as follows: ``(v)
If obtaining informed consent is not feasible and a legally authorized
representative is not reasonably available, the investigator has
committed, if feasible, to attempting to contact within the therapeutic
window the subject's family member who is not a legally authorized
representative, and asking whether he or she objects to the subject's
participation in the clinical investigation. The investigator will
summarize efforts made to contact family members and make this
information available to the IRB at the time of continuing review.''
The agency notes that if the window of time is narrow, it will be
difficult or impossible to identify a legally authorized representative
or family member, especially for potential subjects whose identities
are unknown at the time of presentation.
28. One comment suggested that, in order to prevent abuses, the
agency provide all IRB's with standardized forms that strictly define
the circumstances and process for an IRB to invoke the waiver of
informed consent.
The agency does not think that standardized forms would be useful
or practical. The regulation provides sufficient information and allows
flexibility for each IRB to develop procedures and methods (and forms,
if necessary) to fulfill its requirements.
29. Several wording changes were suggested to clarify
Sec. 50.24(a). Two comments suggested that Sec. 50.24(a) be revised to
add ``prior to initiation of research'' after the words ``without
requiring that informed consent be obtained'' in order to stress that
consent is being waived for the necessary immediate intervention.
The agency thinks this change is unnecessary. This is clear from
Sec. 50.24(a)(2) and new Sec. 50.24(a)(5).
30. One comment suggested the addition ``of all research subjects''
following the phrase ``without requiring that informed consent'' and
modifying the parenthetical phrase in the next sentence to read:
``(with the concurrence of a licensed physician voting member of the
IRB or the concurrence of a licensed physician who serves as a
consultant).''
The agency has incorporated this language, with minor changes, to
emphasize the need for concurrence by a licensed physician who is
either an IRB member or consultant and who is not otherwise
participating in the clinical investigation. The agency recognizes that
in some instances it will be possible to obtain informed consent from
some individuals or their legal representatives, or contact a family
member when this exception is invoked for a clinical investigation. The
agency has not included the term ``voting'' because it does not believe
that it is necessary to explicitly require that this licensed physician
who concurs be a voting member of the IRB because concurrence by this
licensed physician is required by the regulation. Since 1981, FDA has
stated its expectations that an IRB that reviews investigational new
drug studies will include at least one physician. (See 46 FR 8942 at
8966, January 27, 1981.) This expectation is not changed by this rule.
31. Other comments were received on the ``concurring li
FR Doc. 96-24967 Protection of Human Subjects; Informed Consent
censed
physician member or consultant.'' Three comments felt that this
physician member or consultant would add nothing to the process because
of pressure to endorse the study; one comment suggested that the
interests of subjects would be better served if this physician or
consultant were independent of the IRB; two comments suggested that the
physician be independent of the investigator (i.e., have no ties to or
be in the same department or supervised by, the investigator).
The requirement for a concurring licensed physician is contained in
the Medical Device Amendments of 1976 and, thus, it must be retained.
The agency agrees with the need for this individual to be independent
from the clinical investigation but disagrees with the suggestion that
the physician be independent of the IRB. Thus, the agency has amended
the language in Sec. 50.24(a) to make clear that the licensed physician
must be one who is not otherwise participating in the clinical
investigation. This language parallels the language contained in
Sec. 50.23(a).
32. One of these comments suggested that an independent ombudsman
who is aware of the acute risks of the specific research, the long term
risks of the research for the individual, family, and society, based on
the condition of the potential subject be appointed to oversee the
study.
The agency does not agree. There is no need for a special
requirement for an ombudsman for these clinical investigations. Current
Sec. 50.25(a)(7) requires the consent form to contain an ``explanation
of whom to contact for answers to pertinent questions about the
research and research subjects' rights, and whom to contact in the
event of a research-related injury to the subject.'' It may be the IRB
or some other designated individual who performs these ombudsman-type
functions for these investigations.
[[Page 51508]]
2. Section 50.24(a)(1)
33. A few comments expressed concern about the phrase contained in
Sec. 50.24(a)(1) that ``available treatments are unproven or
unsatisfactory.'' One comment suggested that ``unproven'' be changed to
``ineffective.''
The agency disagrees with this suggestion because one may have
insufficient data to know whether a treatment is ineffective. One may,
however, know from the limited data available that it is ``unproven.''
34. Another comment suggested that the phrase ``available
treatments are unproven or unsatisfactory'' be changed to read ``the
efficacy of available treatments has not been demonstrated, or is
regarded as unsatisfactory.''
The agency does not believe this change is necessary or desirable.
Available treatments need to be assessed in terms of both safety and
effectiveness. The agency believes that the change proposed in the
comment focuses solely on effectiveness.
35. Another comment expressed concern that nonscientific members of
IRB's will have a particularly difficult time making determinations
about whether available treatments are unproven or unsatisfactory.
The agency disagrees. Current Sec. 56.107(a) requires the IRB
membership to possess the professional competence necessary to review
specific research activities. Further, current Sec. 56.107(f) permits
an IRB to invite ``* * * individuals with competence in special areas
to assist in the review of complex issues which require expertise
beyond or in addition to that available on the IRB.'' Thus, the IRB
should have sufficient information from its own professional expertise,
or from consultants, to make determinations about whether available
treatments are unproven or unsatisfactory.
36. One comment suggested that guidance on the criteria for
determining that current therapy is unsatisfactory should be provided
or that the rule should explicitly recognize that IRB's have the
discretion to make independent decisions on this point. One comment
suggested that a study be allowed to proceed if there is an alternative
therapy, provided that equipoise exists between the investigational
product and current therapy.
It is clear from the existing wording in Sec. 50.24(a) that it is
the IRB's responsibility to make decisions as to whether the criteria
in the rule are met. The agency notes that it will also be reviewing
these clinical investigations and will evaluate whether these
investigations meet the criteria in this regulation. There is nothing
in this rule that would prohibit an investigation from proceeding if
there is an alternative therapy where the alternative therapy is
unproven or unsatisfactory. The agency expects that in most clinical
investigations under this rule, the experimental intervention will be
added to standard therapy. That is, subjects in the investigation would
receive standard therapy, with a portion of the subjects receiving the
investigational product in addition. In some clinical investigations,
some subjects may receive standard therapy, while others may receive
the investigational product instead of standard therapy because, for
example, use of the investigational product precludes use of the
standard treatment. In these latter investigations, the IRB may need to
look more closely at why standard therapy is unproven or
unsatisfactory, and may want to review additional preclinical data or
results in less ill human subjects that the intervention is promising,
because the standard care will not be provided to a portion of the
subject population.
37. Other comments suggested that without clear definitions for
``unsatisfactory'' and other terms used in the proposal's preamble to
describe clinical equipoise, i.e., `unknown,'' ``believe,'' and
``reasonable minority,'' that abuse of the consent exception is likely.
The agency disagrees with these comments. The agency has explained
this provision in more detail in the preamble to the proposed rule and
believes that such definitions are unnecessary. The agency also notes
that the conduct of this research will be carefully monitored and will
be subjected to public scrutiny through the requirements for community
consultation and community disclosure. In the preamble to the proposed
rule, the agency stated that ``[w]hen the relative benefits and risks
of the proposed intervention, as compared to standard therapy, are
unknown, or thought to be equivalent or better, there is clinical
equipoise between the historic intervention and the proposed test
intervention. Clinical equipoise would exist * * * whenever at least a
reasonable minority of medical professionals believe the experimental
treatment would be as good as, or better than, the standard
treatment.'' (60 FR 49086 at 49093, September 21, 1995.) The agency
thinks that this description provides sufficient guidance to IRB's and
that it is appropriate to allow IRB's to determine when clinical
equipoise exists.
38. A number of comments suggested that the scope of the research
covered by the proposed rule and contained in Sec. 50.24(a)(1) be
extended to conditions beyond those that are immediately life-
threatening so that conditions that result in permanent disabilities,
such as a long-term or permanent coma, or conditions that would result
in other serious irreversible injury are included under the rule. One
example given was a near-drowning patient resuscitated in the
prehospital setting who arrives at the Emergency Department comatose;
the acute injury may no longer be immediately life-threatening, but the
chances that the patient will regain consciousness again are highly
unlikely. One comment noted that FDA has in the past interpreted
``life-threatening'' to include threats of serious disability and, if
this is intended in the proposed rule, it would be helpful to add this
interpretation to the supplementary information. Another comment
suggested that both stroke and head injury do not necessarily
immediately result in death and that potentially effective treatments
are being developed for these conditions which may leave the patient
with profound deficits. This comment proposed that such emergencies be
covered under the final rule. Two comments suggested that ``life-
threatening'' be defined and limited to include only those situations
believed to be immediately life-threatening. Another comment suggested
that ``emergency privilege'' is limited and should extend to care
needed to stabilize or prevent further deterioration of the patient's
condition as well as care necessary to prevent death or serious bodily
injury or harm. Therefore, the care justified must be balanced with the
emergent nature of the patient's condition, the patient's potentially
transient incompetence to make decisions and give consent, and the time
needed to make a reasonable effort to contact and involve the patient's
family.
The agency notes that the Medical Device Amendments limit this
exception to life-threatening situations; the agency and the IRB will
need to judge each clinical investigation to ensure that it meets the
criteria of the statute and regulations. Specifically, the IRB must
conclude that the intervention to treat a life-threatening condition
must be administered before consent can be obtained.
The criteria contained in the rule do not require the condition to
be immediately life-threatening or to immediately result in death.
Rather, the subjects must be in a life-threatening situation requiring
intervention before
[[Page 51509]]
consent from a legally authorized representative is feasible. Life-
threatening includes diseases or conditions where the likelihood of
death is high unless the course of the disease or condition is
interrupted. (See Sec. 312.81.) People with the conditions cited in the
examples provided in the comments--e.g., long-term or permanent coma,
stroke and head injury--may survive for long periods but the likelihood
of survival is not known during the therapeutic window of treatment.
People with these conditions are clearly at increased risk of death due
to infection, pulmonary embolism, progression of disease, etc. The rule
would apply in such situations if the intervention must be given before
consent is feasible in order to be successful. The informed consent
waiver provision is not intended to apply to persons who are not in an
emergent situation, e.g., individuals who have been in a coma for a
long period of time and for whom the research intervention should await
the availability of a legally authorized representative of the subject.
39. The agency received a number of comments on the reference to
placebo-controlled trials in Sec. 50.24(a)(1). One comment stated that
it was vitally important to retain the reference. Other comments
requested that the reference be removed. Reasons given for its removal
included concern that placebo-controlled studies will not meet the
requirement of clinical equipoise unless the placebo control is the
standard of care for the situation or there is absolutely no standard
therapy; that this conflicts with agency statements that the use of a
placebo is not necessary when the end-point is clear and reasonably
predictable; it is inappropriate for the agency to specify one study-
design among many; and that unless the potential subject or legally
authorized representative can consent, a placebo should not be an
alternative.
Some of the comments appear to presume that in a placebo-controlled
trial, the placebo group would be untreated. In virtually all cases,
when a placebo is used, standard care, if any, would be given to all
subjects, with subjects randomized to receive, in addition, the test
treatment or a placebo. An exception to this would be the situation in
which the test is to determine whether standard treatment is in fact
useful. In that case, there must be a group that does not receive it.
The agency believes that it is important to recognize in the regulation
that placebo-controlled trials may be conducted under this emergency
research provision; thus, it is retaining the wording in this section.
Different kinds of controls are described in FDA's regulations. For
example, FDA regulations for drugs (Sec. 314.126) describe five kinds
of study designs that can be used in carrying out the well-controlled
investigations needed under law to provide the ``substantial evidence
of effectiveness'' needed to market a drug. They are: Placebo
concurrent control, dose-response concurrent control, no-treatment
concurrent control, active treatment concurrent control, and historical
control. In any given year, drug approvals will be based on clinical
investigations using each of these designs. The study design used must,
however, be adequate to the task of providing evidence that the drug or
device will have the effect claimed.
40. Two comments suggested changing the wording of Sec. 50.24(a)(1)
from ``what particular intervention is most beneficial'' to ``the
safety and efficacy of a particular intervention'' in order to provide
greater flexibility. Another comment suggested that ``most beneficial''
be followed by the clarifying phrase ``to patients in the life-
threatening situation.''
The agency agrees that it would be more precise to indicate that
the clinical investigation is necessary to determine whether a
particular intervention is safe and effective and it has modified the
wording in the regulation accordingly.
3. Section 50.24(a)(2)
41. A number of comments on Sec. 50.24(a)(2)(ii) recommended that
``or family members'' be added to ``legally authorized
representatives'' at each occurrence in the proposal and in its
conforming amendments in order to ensure that the exception is used
only in those cases where it is not feasible to contact the legally
authorized representative or a family member.
The agency generally agrees with these comments for the reasons
previously stated and has modified the regulations accordingly.
42. Two comments requested that a definition of the term ``legally
authorized representative'' be provided. One comment suggested that the
language be clarified to read ``* * * consent from the subjects'
legally authorized representatives is feasible.''
``Legally authorized representative'' is currently defined in
Sec. 50.3(m) to mean ``an individual or judicial or other body
authorized under applicable law to consent on behalf of a prospective
subject to the subject's participation in the procedure(s) involved in
the research.'' This definition is being retained in the regulation.
The agency has added the clarifying language that it is ``the
subject's'' legally authorized representative.
43. One comment questioned whether one should seek oral consent/
assent from a family member or other individual in those instances in
which there may only be a few moments to convey the nature of the
intervention, precluding full informed consent. If such assent is not
given, the comment requested clarification on options available to the
researcher.
If it is feasible to obtain informed consent for some potential
subjects, informed consent is required for those individuals. If there
is insufficient time to obtain informed consent for some potential
subjects, but there is sufficient time to convey some basic risk and
benefit information about the clinical investigation, then that
information should be provided to the subject, the subject's legally
authorized representative, or the subject's family member. If the
subject, legally authorized representative, or family member objects to
the individual's inclusion in the investigation based upon the
information provided, then that individual should be excluded from
participation in the clinical investigation. If only partial
information was conveyed, then the information described in
Sec. 50.24(b) is to be provided at the earliest feasible opportunity.
44. Another comment suggested that there be a requirement that the
determination that a subject cannot provide informed consent and
efforts made to obtain informed consent from the subject's legally
authorized representative be documented and notarized by an individual
not directly involved in the research. This comment suggested that
without such a requirement, investigators are likely to make little
effort to obtain consent from subjects prior to enrollment. This
concern was echoed by another comment, which suggested that the
investigators' documentation of efforts to obtain informed consent
would encourage researchers to expend greater efforts to obtain
informed consent for these activities. Another comment suggested that
this documentation be made by an individual not affiliated with the
study team.
The agency expects the IRB to determine, based on the specific
details of the individual clinical investigation (including the window
of opportunity for treatment), the procedures the investigator must
follow to attempt to obtain informed consent before enrolling a subject
in an investigation without such consent. The agency has added a new
paragraph Sec. 50.24(a)(5) that requires the investigator to attempt to
[[Page 51510]]
contact a legally authorized representative for each subject within the
therapeutic window and, if feasible, ask for consent within that window
rather than proceeding without consent. The agency also has added a new
paragraph Sec. 50.24(a)(7)(v) that requires the investigator to attempt
to contact a family member within the therapeutic window and ask
whether the family member objects to the subject's participation in the
clinical investigation, if informed consent is not feasible and a
legally authorized representative is not available. IRB's may create a
hierarchy of family members or impose other conditions to increase the
protections provided to research subjects. These paragraphs further
require the investigator to summarize efforts made to contact
representatives and family members and to make this information
available to the IRB at the time of continuing review. The agency
believes that these procedures will ensure that appropriate efforts are
made by the investigator to obtain consent from subjects prior to
enrollment. The agency expects these procedures to be documented in the
protocol and/or by the IRB, and the efforts made by investigators to be
documented in the material presented to the IRB for its continuing
review. The agency believes that this documentation provides the
necessary protections suggested by these comments.
45. One comment suggested that Sec. 50.24(a)(2)(iii) be modified to
read ``There is no reasonable way to identify prospectively the
individuals likely to become eligible for participation in the research
study,'' omitting the remainder of the sentence.
The agency agrees that the last phrase in the proposal that read
``because the emergence of the condition to be studied cannot be
predicted reliably in particular individuals'' is not needed and it has
therefore deleted this phrase from the final rule as suggested.
46. Although two comments stressed the importance of retaining the
word ``reasonable'' in order to allow IRB's to exercise the judgment
necessary to make satisfactory decisions about application of the
exception in particular contexts, another comment suggested that the
term ``reasonable'' may provide more flexibility than is desirable.
The agency thinks that IRB's must be allowed to make responsible
judgments when they review clinical investigations, and that it is
important to retain the term ``reasonable'' in order to permit the IRB
to judge the particular circumstances surrounding each investigation
under review.
47. One comment asked how to document the case where prospective
individuals have been notified and prior consent for participation has
been sought in an institution with several co-investigators or where
more than one institution in the area may be participating in the
research. The comment asked further whether only those subjects with
the condition who gave prior consent could be enrolled and whether
those who did not render a decision would be excluded from
participation in the study.
Generally, the agency recommends that when prospective consent is
being sought in an institution, the documentation that a potential
subject consented or refused to consent be placed prominently in the
subject's medical file. Consent will typically be documented through a
signature on the consent form. It is the responsibility of the clinical
investigator to determine how to identify prospective subjects who have
agreed or refused to participate in a clinical investigation if they
should become eligible in order to help ensure that their decisions are
followed. When an IRB determines that it is not appropriate to waive
the requirement of informed consent because there is a reasonable way
to identify prospectively the individuals likely to become eligible for
the clinical investigation, then only those subjects with the condition
who gave prior consent may be enrolled in the investigation. Those
individuals who either did not make a decision or who refused would be
excluded from participation in the investigation.
48. Another comment noted that if a subset of the general
population can be identified as potential subjects, anticipatory
informed consent must be obtained, even if the subset is a very small
percentage of a large patient population. For example, where a small
percentage of patients undergoing a standard procedure may suffer a
complication that would render them unconscious and make them potential
subjects, informed consent should be obtained for that clinical
investigation. The comment went on to note that if that procedure
carries some known risk for a complication, the potential subjects
would need to be informed of that risk in any event, and obtaining
anticipatory consent for the investigation should therefore not be
burdensome.
The agency generally agrees with the concept that obtaining
anticipatory consent from a target population where the complication
rate is modest often would be feasible. As the complication rate grows
small and the population hard to identify, this strategy becomes
problematic. Each clinical investigation must be judged individually by
FDA and the IRB.
49. Another comment suggested that the Coalition Conference
Consensus Statement wrongly discounted the value of securing and the
ability to secure prospective consent from identifiable individuals at
high risk for study enrollment, particularly those in hospitals, and
that neither the consensus statement nor the proposed rule mentioned
the role of advance medical directives in guiding enrollment decisions.
This comment, supported by others, suggested that a good faith effort
should be mandated to locate advance directives and that the regulation
should include a new paragraph, as follows: ``Any individual likely to
be eligible for a research protocol under this section may not be
enrolled in the research if the investigators know, or reasonably
should know, that the individual did not want to receive medical
interventions of the type under study.'' Another comment suggested
that, although advance directives have been addressed in clinical
practice, their application to the conduct of clinical research has not
received much scrutiny. This comment described the difficult task for
potential subjects to imagine the kind of research they would want
should they suffer a catastrophic illness; it went on to recommend that
either FDA clarify how it intends clinical investigators to adopt the
practice of advance consent, or this statement should be deleted. It
further suggested that FDA consider requiring the use of consent
auditors whose role would be to determine whether the subject truly
understands the consent process.
The agency does not believe that these comments require a change in
this regulation. The agency recognizes that it may be possible in some
situations to secure prospective consent from identifiable individuals
at high risk for study enrollment, particularly if they are inpatients.
It is for that reason that the agency has included
Sec. 50.24(a)(2)(iii), which requires the IRB to determine that there
is no reasonable way to identify prospectively the individuals likely
to become eligible for the clinical investigation. Both the American
Hospital Association's Patient Bill of Rights and section 4206 of the
Omnibus Budget Reconciliation Act of 1990 recognize a patient's right
to participate in and direct health care decisions affecting the
patient. The agency agrees, particularly for clinical investigations
involving inpatients, that
[[Page 51511]]
appropriate efforts be made to review the patient's medical file to
determine whether there exists an advance medical directive or other
indication of the patient's desires (e.g., do not resuscitate order).
However, the agency also recognizes that, for at least some of the
research that will be eligible for this exemption, there will be
insufficient time to search for or locate such directives. The IRB
should be knowledgeable about an institution's procedures regarding the
use of advance medical directives and assess whether the proposed
clinical investigation is consistent with those procedures.
As discussed previously, if an IRB determines that it is not
appropriate to waive the requirement of informed consent because there
is a reasonable way to identify prospectively the individuals likely to
become eligible for the clinical investigation, then only those
subjects with the condition who gave prior consent may be enrolled in
the investigation. Those individuals who either did not make a decision
or who refused would be excluded from participation in the
investigation. For research where individuals can give informed consent
prospectively, the individual's consent or refusal should be documented
in such a way to ensure that the individual's determinations are
followed. As in other research that is reviewed by an IRB, it is up to
the IRB to determine whether there is a need for a consent auditor.
50. Another comment recommended that the question of whether prior
consent of subjects must be obtained should be resolved by considering
the following questions: (1) From which populations will subjects be
drawn; (2) what is the probability that any particular member of the
at-risk population will become a potential subject; (3) where is the
population from which subjects will be drawn; (4) how much effort is
needed to inform the population of the study; and (5) what is the most
effective communications media or mechanism to reach the population.
Based on these questions, this comment recommended that a new section
be added that would state: ``When individuals likely to become eligible
for the research are members of identifiable and accessible populations
of the community at large, reasonable effort to target communications
to those sub-populations should be made.''
This comment suggests what may be a reasonable thought process for
an IRB to follow. However, it combines two different concepts:
communication with the community and prior consent of individual
subjects. As the agency has previously stated, if one can obtain prior
consent of subjects, that should be done. Examples of situations where
it may be feasible to obtain prior informed consent include: use of a
surgical procedure with a known severe consequence; administration of a
drug product with a known serious adverse reaction; identification of a
population with a particular disease or condition who are at an
extremely high risk for a serious event. In each of these instances, it
may be feasible to identify in advance the specific patient population
susceptible to the condition being studied and obtain consent. The
agency believes that it would be inappropriate to add the suggested
section to the regulation because it confuses efforts to inform the
community with efforts to obtain prior consent of the individual.
51. Another comment recommended that the agency require preliminary
studies of new products in patients admitted to intensive or critical
care units who are able to consent or who have a legal representative
who can consent on their behalf. This comment suggested that this would
strengthen an inadequacy in the existing regulations that permits
studies (with subjects unable to provide informed consent) to begin,
without any knowledge regarding the clinical performance of the drug/
device.
Given the nature of the product and the medical condition, this
suggestion may not be feasible for many of these clinical
investigations. The agency, in its review of these investigations, will
review the adequacy of the information about the proposed intervention
to help ensure that there is sufficient knowledge, including clinical
performance in other settings when possible, of the drug or device to
justify its use in such investigations. In addition, the regulation has
been modified to specify that evidence from appropriate animal and
other preclinical studies support the potential for the intervention to
provide a direct benefit to the individual subjects.
4. Section 50.24(a)(3)
52. A number of comments suggested deleting the phrase ``is in the
interests of the subjects'' in Sec. 50.24(a)(3) in part because this
phrase requires that a judgment be made about subjects whose interests
may be largely, if not totally, unknown to the IRB and to the
investigators. Some comments argued that there would be no possible
benefit to the subject, but only to society at large if the
experimental intervention were shown to be effective; the goal of the
research is not to benefit subjects in the research, but rather to
benefit science in the pursuit of knowledge. Others suggested that
Sec. 50.24(a)(3) be modified to read: ``The opportunity to participate
in the research holds out the prospect of direct benefit to the
subjects because * * *.'' Other comments objected to the word
``opportunity'' as being disingenuous and paternalistic and suggested
that this section be modified to read: ``Participation in the research
* * *.''
The agency agrees that Sec. 50.24(a)(3) should be modified in
response to some of these comments. The first comment points out that
one cannot really know about all the interests of a person in these
situations. The modification would make clear that the clinical
investigation holds out the prospect of direct benefit to the subjects.
The agency does not agree with the second comment that there would be
no possible benefit to the subject, but only to society at large. To
justify the use of this exception the IRB must believe that
participation in the study holds out the prospect of direct benefit to
the subjects. It is also true, but not the basis for the exception,
that the interests of society will be served by the waiver because the
research will produce valuable knowledge, applicable to future
patients, that would otherwise never be obtained; an IRB should not
approve a clinical investigation that is poorly designed and, thus,
unable to answer the scientific question posed. In response to the
third suggestion, the agency is clarifying any mis-impression that it
would be the ``opportunity'' rather than the actual ``participation''
in the research that is beneficial. The agency intended that
participation in the research should hold out the prospect of direct
benefit to the subject and has revised the rule accordingly.
53. Another comment noted that if the null hypothesis is plausible,
that is, if the effect of the investigational intervention is no
different from that of the standard treatment, the subject has little
to gain by being in a randomized trial rather than being treated by
whichever arm of the study is standard. This comment recommended that
historical controls be used when investigators or potential subjects
are not ``indifferent'' to the treatment alternatives.
If the use of a historical control is appropriate for the clinical
situation being studied, that control may be used, but the difficulties
of this design are well-known and it cannot reliably assess small, but
potentially meaningful benefits and is frequently associated with false
positive results. The comment related to the null hypothesis is not
unique to emergency research. Rather, it reflects a fundamental ethical
dilemma
[[Page 51512]]
in all clinical trials. This dilemma, however, has not been considered
by most bioethicists as an impassable obstacle for the conduct of
controlled trials. This is because continuing an intervention, even one
thought to have promise, without determining that it does provide
benefit, is not a responsible alternative. The investigational
intervention in these clinical investigations must be promising, but
one does not know that it is in fact safe and effective. Further, in
these investigations, the standard treatment being compared to the
investigational product or to which the investigational product is
added will be of unproven benefit or unsatisfactory.
54. One comment suggested that an additional condition be added to
50.24(a)(3) which would require that the weight of scientific evidence
be sufficient to support the likelihood that the individual subjects
will receive a direct benefit. Another comment suggested that the rule
require a progression of research from less severe medical cases to
more severe and only permit the inclusion of patients unable to consent
if there is an ombudsman independent from the research activity.
As previously described, FDA has added a new Sec. 50.24(a)(3)(ii)
which requires that ``Appropriate animal and other preclinical studies
have been conducted, and the information derived from those studies and
related evidence support the potential for the intervention to provide
a direct benefit to the individual subjects.'' There is nothing in this
rule that would preclude research from being conducted in subjects with
less severe medical conditions (not in a life-threatening situation)
before being conducted in subjects with more severe medical conditions
provided that informed consent is obtained from the research subjects
with the less severe conditions. When this exception is invoked for a
particular clinical investigation, however, the FDA, sponsor, clinical
investigator, and IRB will be responsible for ensuring that the subject
population is appropriate; that is, that the subjects are in a life-
threatening situation.
55. One comment recommended that Sec. 50.24(a)(3)(i) be reworded to
clarify that ``subjects are facing a life-threatening situation that
necessitates intervention.''
The agency agrees with the comment and has modified this section
accordingly.
56. One comment suggested that proposed Sec. 50.24(a)(3)(ii) be
reworded to clarify that the rule is addressing the ``prospective
subjects' condition'' and that ``current therapy'' equates to
``standard therapy.'' This comment suggested that proposed
Sec. 50.24(a)(3)(ii) be rewritten to state ``risks associated with the
intervention are reasonable in the light of what is known of the
prospective subjects' medical condition, the risks and benefits of
standard therapy * * *.''
The agency has renumbered proposed Sec. 50.24(a)(3)(ii) to be
Sec. 50.24(a)(3)(iii) in the final rule. The agency agrees with the
comment and has modified this section accordingly. The risk and benefit
assessment that is required by Sec. 50.24(a)(3)(iii) will be conducted
for future subjects meeting the entry criteria for the clinical
investigation; therefore, it is appropriate to refer to these subjects
as the ``potential class of subjects.'' The agency intended that the
risks and benefits of ``standard'' therapy be considered; it recognizes
that ``current'' therapy may be too broad.
57. Several comments requested a definition of ``reasonable.'' One
comment noted that the rule requires a complex judgment about risks and
benefits and yet lacks specificity as to how this judgment is to be
made. This comment noted that in most research, an IRB can rely on the
risks and benefits being explained to the subject and the subject
judging whether they are reasonable. In the case of the research
covered by this regulation, that recourse is not available.
It is not possible to be specific about how to make the judgment
about risks and benefits because, as the comment notes, the judgment to
be made is complex, with different information and considerations
determined by the particular clinical investigation. The agency thinks
that sufficient clarity is contained in Sec. 50.24(a)(3)(iii) to allow
an IRB to understand that it must consider: (1) What is known about the
medical condition, (2) what is known about standard therapy, and (3)
what is known about the proposed intervention or activity. The risks of
the investigation must be considered reasonable in relationship to all
of this information. The agency does not think that this requirement
needs further explanation.
58. Two comments suggested that proposed Sec. 50.24(a)(3)(ii) be
modified to incorporate the Coalition of Acute Resuscitation and
Critical Care Researcher's concept of ``appropriate incremental risk''
stating that this would better protect the rights of subjects. One of
these comments suggested that the 1981 FDA regulatory requirement that
``there is available no alternative method of approved or generally
recognized therapy that provides an equal or greater likelihood of
saving the life of the subject'' is the standard that should be used in
this regulation.
The agency disagrees with both suggestions. The protections
provided by the rule are substantial and sufficient without these
changes. The standard for risks, described in the regulation, are that
they be ``reasonable'' in relationship to what is known of the medical
condition of the potential class of subjects, the risks and benefits of
standard therapy, if any; and what is known about the risks and
benefits of the proposed intervention. The term ``appropriate
incremental risk'' does not have a clearly different meaning, although
it may imply greater precision than usually exists. In order to invoke
this exception, the available treatments must be unproven or be
regarded as unsatisfactory.
5. Section 50.24(a)(4)
59. Several comments suggested deleting or clarifying
Sec. 50.24(a)(4) concerning the ``practicability'' of conducting the
research without the waiver. One comment requested clarification as to
whether ``practicability'' only referred to whether there is sufficient
time to obtain consent from a subject's legally authorized
representative; and recommended that if this is the sole basis for
determining practicability, it should be added to the regulation.
Another comment noted that ``practicability'' should not refer to
convenience, cost, or speed. One other individual commented that
although certain institutions may be unable to perform specific acute
injury research because of logistical considerations, it is likely that
most research projects could be designed such that performance under
existing rules for nonconsenting subjects would be possible in other
locations. This comment cited a multicenter trial where only one
institution requested a waiver.
One comment suggested that Sec. 50.24(a)(2)(ii) is sufficient for
determining whether a study can be done; this comment stated that the
primary reason that it would not be practical to carry out the research
without the waiver would be because it is not feasible to contact the
legally authorized representative or family member before the
intervention must be administered.
Another comment objected to Sec. 50.24(a)(4) and argued that the
rule should state that if there are any potential subjects otherwise
eligible for a trial for whom consent from a legally authorized
representative cannot be obtained, the provisions of Sec. 50.24(a) may
be utilized to include them, even if the trial could be carried out
without
[[Page 51513]]
their participation, so long as all of the requirements for that
section are met. This comment noted that if this section meant only
that consent should be obtained wherever it can be, even when most
subjects in a study do not have an available legally authorized
representative, it would be unexceptionable, but the section goes
beyond that to proscribe participation in a trial by patients without
consent when the majority of eligible patients do have such consent
available because in that case the study can be carried out
``practicably'' without those patients. This comment noted that it is
the value of participation to the subject that permits an exception to
the informed consent requirement; that implicit in the proposal is the
view that most patients would choose a chance to receive promising
rather than standard therapy that is known to have an often
unsatisfactory outcome. Thus, to exclude patients unable to consent
from this research is unethical, even if the study could be conducted
with subjects for whom surrogate consent is possible.
The agency has carefully considered these comments, particularly
the latter comment that in effect contended that the ``practicably''
requirement is inconsistent with the ethical basis for the rule because
it implies that the exception to consent is available to serve the
community's needs rather than the individual's. The agency included
this requirement not because it thought the research was not in
individual patients' interests, but because research without informed
consent represents a more difficult and complex situation than research
with consent, in that it is a kind of research with greater than usual
ethical issues that should be taken only when necessary. This is
because the agency believes it is generally preferable to obtain case-
by-case consent even from a representative of the individual. Just as
consent by the subject is preferable to consent by their
representative, consent by the subject's representative is preferable
to the procedure in this regulation. This does not mean that these
procedures are inadequate or unethical; rather, it recognizes within
the realm of ethically proper actions a hierarchy of values and that we
should seek the highest level of those values feasible in this
situation.
Similar considerations have arisen in the past. The National
Commission for the Protection of Research Subjects of Biomedical and
Behavioral Research argued that (wherever possible) clinical trials
intended to benefit young children should first involve adult subjects,
later older children as subjects, and finally trials in younger
children (who cannot consent or assent). This is not because the trials
in younger subjects are considered inappropriate or ethically doubtful.
The agency understands the Commission to be saying that the principle
of respect for persons of diminished autonomy applies in such a way
that the less autonomy a subject possesses, the less suitable that
subject is for research, even if the research shows promise. The
Commission did not say to never involve persons with minimal or no
capacity to exercise autonomy, but to do so only as a last resort.
It is critical to recognize that an investigation of a promising
(but unproven) intervention is not carried out universally, i.e.,
studies are conducted in particular places. Similarly, although a
parent of a young child could argue that his or her child should not
have to wait for the trial in adults and older children to be completed
before having an opportunity to participate in research, the Commission
was not persuaded by that argument (although, in some cases, early
trials in young children might be carried out). The Commission did not
recognize the right of a needy person to gain access to a research
protocol. In choosing among sites for a clinical investigation, for
example, it is usual to select those in which the skills of
investigators and availability of subjects appear to predict an ability
to carry out the investigation successfully. Similarly, it is
reasonable to consider, in deciding where or in whom to conduct an
investigation, the ability of subjects to consent (or have consent
given for them). Widely accepted ethical principles indicate that a
decision to participate or not to participate in an investigation
should, if at all possible, be made by a competent subject who should
(as stated in the Nuremberg Code) be free of all force, fraud, fear, or
coercion. An exception from the requirement for informed consent should
be rare and narrow, confined to cases where consenting subjects are not
reasonably available. In addition, participation in the research must
hold out the prospect of direct benefit to the subjects and the
investigation must be one that is capable of providing useful
scientific/medical information.
If serving the interests of the subjects were considered sufficient
alone, that would imply that potential subjects have a right to
participate in the trial, an inappropriate consideration for an
investigational use and unrealistic, because studies cannot in fact be
carried out at all potential sites and in all patients.
The agency thus agrees with the comment that it is necessary for
there to be value to the subject from participating in the research;
but, given the general principle of obtaining informed consent where
possible, does not think that such potential benefit is sufficient
justification to include nonconsenting patients when it is reasonably
possible to conduct the clinical investigation in subjects who can
consent.
Therefore, if scientifically sound research can be practicably
carried out using only consenting subjects (directly, or in most cases
for the research contemplated in the rule, with legally authorized
representatives), then the agency thinks it should be carried out
without involving nonconsenting subjects. By practicable, the agency
means, for example, (1) That recruitment of consenting subjects does
not bias the science and the science is no less rigorous as a result of
restricting it to consenting subjects; or (2) that the research is not
unduly delayed by restricting it to consenting subjects.
6. Section 50.24(a)(5)(i)-(a)(5)(iii)--Community Consultation and
Public Disclosure
The greatest number of comments were received on
Sec. 50.24(a)(5)(i) through (a)(5)(iii), which have been renumbered
Sec. 50.24(a)(7)(i) through (a)(7)(iii) in this final rule in order to
have a more logical presentation of information. To assist readers,
these sections will be referred to as Sec. 50.24(a)(7)(i) through (iii)
in the discussion that follows. While most comments supported the
requirement for community consultation and public disclosure, many
requested clarification, offered suggestions, or concluded that
fulfilling these requirements would be impossible. Other comments
questioned whose responsibility it would be to disclose--the clinical
investigator, sponsor, or IRB. These comments are discussed in more
detail below.
60. A number of comments suggested alternatives to the requirement
for Sec. 50.24(a)(7)(i) for consultation with representatives of the
communities from which the subjects will be drawn. These included
limiting this provision to only those diseases for which a patient
advocacy organization exists; relying on the existing IRB mechanism
that already requires inclusion of an individual not otherwise
affiliated with the institution; requiring that IRB's have a community
member or an ad hoc community consultant who is intimately involved
with the projected research population; permitting an IRB to determine
that balanced community consultation is not feasible and documenting
and reporting
[[Page 51514]]
this determination to the sponsor and to FDA; increasing public
participation in the IRB process by specifying acceptable kinds of
individuals (e.g., clergy, local commissioners, police, paramedics) who
should be added to the IRB (limited to two); having the IRB membership
include individuals from the community groups from which subjects would
come and ensuring that the preferences of those members were followed;
establishing a standing community advisory board that would reflect the
diverse values and beliefs of the community. This board could serve
several IRB's within the same community. Another comment stressed that
the IRB must take into account the diverse religious and community
beliefs and attitudes about treatment of the dying and of research.
None of the suggested alternatives to Sec. 50.24(a)(7)(i) would by
themselves provide the protections of broad community consultation of
this section. While an IRB may appropriately decide to supplement its
members with consultants from the community, broader consultation with
the community is needed for this type of research. The agency expects
the IRB to provide an opportunity for the community from which research
subjects may be drawn to understand the proposed clinical investigation
and its risks and benefits and to discuss the investigation. The IRB
should consider this community discussion in reviewing the
investigation. Based on this community consultation, the IRB may
decide, among other things, that it is appropriate to attempt to
exclude certain groups from participation in the investigation; or that
wider community consultation and discussion is needed. As described in
the preamble to the proposed rule (60 FR 49086, September 21, 1995),
IRB's should consider, for example, having a public meeting in the
community to discuss the protocol; establishing a separate panel of
members of the community from which the subjects will be drawn;
including consultants to the IRB from the community from which the
subjects will be drawn; enhancing the membership of the IRB by adding
members who are not affiliated with the institution and are
representative of the community; or developing other mechanisms to
ensure community involvement and input into the IRB's decisionmaking
process. It is likely that multiple methods may be needed in order to
provide the supplemental information that the IRB will need from the
community to review this research.
61. Another comment noted that tribal approval and not just
consultation should be required and suggested that for American Indian/
Alaska Native tribal governments, the regulation require approval by
the tribal government for all research done within its jurisdiction.
This comment suggested that the regulation permit a recognized
government of the political community to disapprove research.
This regulation does not restrict or have an impact on any existing
authority of tribal governments to review and approve or disapprove
research that would otherwise be conducted on persons residing in
tribal jurisdictional boundaries. If existing tribal authorities
require tribal government approval of such research before it proceeds,
then the tribal governments continue to have that authority. Thus, the
agency thinks that adopting this suggestion is unnecessary.
62. Comments opposed to the community consultation required in
Sec. 50.24(a)(7)(i) suggested that the current requirement for a
community representative on the IRB (56.107(a)) was adequate; that this
would be burdensome for noncommercially sponsored studies; that it was
an insurmountable goal and that there is no guarantee that an IRB could
reach all impacted individuals. Other comments suggested that only a
central agency such as FDA or the Public Health Service should decide
because the clinical investigator will bias the outreach meetings to a
disinterested community that would be unable to make knowledgeable
decisions, and the community will be biased because the research would
bring funding support to the community, and because it is difficult to
define the community, especially for those institutions that receive
patients from a large region or State. A number of comments suggested
that community consultation could lead to IRB liability on the basis of
failure to solicit adequate community participation in the decision
process. Other comments noted that disclosure to the community does not
substitute for consent and that unless one included information about
the subject's right to refuse and how to exercise that right, community
consultation would be inadequate.
As discussed previously, the agency does not think that the current
IRB membership requirements adequately substitute for the community
consultation called for in this rule. The agency thinks that community
consultation provides a very important protection for research subjects
and, therefore, every effort should be made by the IRB to involve, and
consult with, the community from which research subjects may be drawn.
63. Other comments stated that without clear definition of terms,
the vagueness of the requirement would lead to inadequate consultation
and disclosure. Another comment noted that if minority or lower income
populations were unlikely to agree to the research and they represented
a large proportion of the potential research population, then the
conduct of the research would violate the principle of justice because
these populations would not share in its benefits or burdens.
The agency thinks that IRB's will ensure, through their review and
oversight activities, adequate consultation and disclosure. It is
impossible, without conscription, to ensure that each subpopulation
shares both the benefits or burdens of all research. Achieving the
principle of justice is a goal that must be balanced by other
principles. In the case of a population that is unwilling to agree to
participation in a research activity, honoring this population's
unwillingness is, in effect, permitting the community to express its
views.
64. A number of comments requested clarification of this
requirement. These comments asked how the consultation should take
place (newspaper, institutional newsletter, advertisement, local radio
stations, meeting); who in the community needs to be informed and who
may be legitimate representatives of the community; what the IRB does
with the community response (e.g., can a community veto research, what
if a small or a large number oppose the research, what is the sponsor
or IRB's responsibility to respond to questions or requested changes in
the research); how is an IRB to assess the effectiveness of the
consultation (e.g., if there is a poor turnout at an adequately
publicized meeting, is the IRB obliged to do more)? Another comment
requested clarification of what the public representatives and
representatives of the population at risk would be asked to do. One
comment urged the agency to refrain from providing precise definitions
for the various terms in Sec. 50.24(a)(7)(i) through (a)(7)(iii) in
order to permit IRB's adequate flexibility in making judgments.
Community consultation is likely to be multifaceted and to use a
number of the mechanisms suggested by the comments. As described
earlier, the IRB needs to provide an opportunity for broad community
discussion. If, for example, there is poor turn-out at a meeting to
discuss the research, an IRB may consider targeting specific
[[Page 51515]]
community representatives for inclusion in an additional meeting, or it
may decide that the research was not found by the community to be
objectionable. The IRB is responsible for listening and considering the
community's support, concerns, etc., and then ultimately deciding
whether the investigation should be modified, approved, or disapproved.
The community is expected to provide input to the IRB on its support
for or concerns about the research activity.
65. A number of comments requested clarification on who is
responsible for the community consultation and disclosure requirements
contained in Sec. 50.24(a)(7)(i) through (a)(7)(iii). Most comments
suggested that the IRB should be responsible for reviewing and
approving the content and method of consultation and disclosure; the
sponsor should be responsible for developing the plan for consultation
with the community and for disclosure and provide this information to
the IRB to review for adequacy.
Although a sponsor may provide to an IRB model information for use
in consultation with the community and for disclosure, just as it may
now provide a model consent form for a clinical investigation, it is
the responsibility of the IRB to ensure the adequacy of the community
consultation and disclosure requirements contained in
Sec. 50.24(a)(7)(i) and (a)(7)(ii).
66. Another comment recommended that the sponsor and clinical
investigator should pay for the costs associated with the disclosure
requirements.
The agency does not dictate the entity responsible for the costs
related to research. However, the agency anticipates that the sponsor
would normally incur the costs associated with disclosure to and
consultation with the community.
67. Several comments on Sec. 50.24(a)(7)(ii) suggested that for
multicenter trials, disclosure be required once for each metropolitan
area and that the disclosure be made by the sponsor or a designated
institution in a notice that would list all institutions,
investigators, and IRB contacts.
The agency would not object to such centralized disclosure if all
of the responsible IRB's agreed that this is appropriate and
acceptable.
68. Another comment suggested that instead of requiring disclosure
prior to the commencement of the study, disclosure occur at periodic
time intervals (e.g., every 2 years) and include a public notice of
general issues, specific projects, results of the research, and permit
public input.
It is the responsibility of the IRB to consider how to maintain the
flow of information to the community. In addition to requiring
disclosure to the community prior to the initiation of the clinical
investigation, the IRB may determine that it is appropriate to require
further disclosure at periodic intervals of time.
69. Another comment requested that the regulation specifically ban
``general disinformation campaigns'' by sponsors performing the
research.
The agency thinks that such a ban is unnecessary and that IRB
involvement in the disclosure process helps to eliminate the
possibility that biased or misleading information will be disseminated.
The information disseminated will be reviewed by the IRB to ensure its
adequacy and balance.
70. A number of comments were opposed to the requirements for
disclosure contained in Sec. 50.24(a)(7)(ii). The comments suggested
that they would take an exhaustive amount of time; could prevent
valuable research because the investigator and institution could be
targets of a poorly informed community; the investigator may not be the
best individual to discuss the study; they could cause persons to not
seek care; they would be burdensome for noncommercially sponsored
studies; for parties with an interest in the research, a requirement
for disclosure could lead to either a dishonest or incomplete
disclosure of information; the regulation requires disclosure of less
information than that which would be given to a research subject; that
it is essential to include information about financial and economic
incentives for the research; and that it is essential to permit public
participation in the disclosure sessions.
As discussed previously, it is the IRB's responsibility to
determine the information to be disclosed. As described in the preamble
to the proposed rule, the IRB should consider how best to publicly
disclose, prior to the commencement of the clinical investigation,
sufficient information to describe the investigation's risks and
benefits, e.g., relevant information from the investigator's brochure,
the informed consent document, and investigational protocol. Initial
disclosure of information will occur during the community consultation
process. Disclosure of this information to the community will inform
individuals within the community about the clinical investigation and
permit them to raise concerns and objections.
71. Another comment suggested that the release of confidential
information required by this section could serve as a disincentive for
sponsors to conduct the research and that it would create a precedent
that could affect companies not otherwise affected by the regulation.
The agency disagrees with this comment. While it is true that much
information relating to clinical investigations is normally treated as
confidential by sponsors, the agency believes that when a sponsor
chooses to invoke the exception from informed consent contained in this
rule that it is essential that reasonable disclosure occur to the
community. The agency believes that the benefit to a sponsor of
invoking the rule will outweigh concerns that a sponsor will have about
disclosing information about the investigation. Because this disclosure
is made only when the exception from informed consent is invoked, it
will not create any precedent for companies not invoking the exception.
The agency notes that sponsors release research information to
investigators and IRB's (for example, through the protocol and
investigators brochure) and to potential subjects in the research
through the informed consent process and informed consent form; this
rule states that the same information should be released to the
community so it can be informed as it considers the research.
FDA believes that American Indian and Alaska Native Tribal
governments and communities currently require both presentation of the
research protocol and reporting results to the community before they
permit any research to occur on their reservation. Recent Phase 2 and
Phase 3 trials of several vaccines (e.g., Haemophilus B, Hepatitis A,
and rotavirus vaccines) have been done on reservations under those
rules by the pharmaceutical companies sponsoring the research. Under
this rule, no company is required to release additional information to
a community if it does not want to have a waiver of consent for its
emergency research.
72. One of these comments stated that information is a property
right and to require that it be surrendered without compensation may
violate the Fifth Amendment of the Constitution.
The agency disagrees with this comment. The Fifth Amendment
requires that no private property be taken for a public purpose without
just compensation. (U.S. Constitution, Amendment V.) One factor used to
determine whether there has been a taking is whether the action
interferes with the reasonable investment backed expectations of the
owner of the alleged
[[Page 51516]]
property right. (Kaiser Aetna v. United States, 444 U.S. 164, 175
(1979).) Where a voluntary submitter of information is aware of the
conditions under which the information must be disclosed, the submitter
gains an economic advantage related to the submission (such as
registration), and the disclosure is rationally related to a legitimate
government interest, there is no taking. (Ruckelshaus v. Monsanto Co.,
467 U.S. 986, 1007-8 (1984).) Under this rule, the disclosure is
directly related to protecting the individual members of a community
that may be involved in the clinical investigation without informed
consent by providing the community with advance notice of the nature of
the investigation and the possibility that they may be involved in the
clinical investigation without their informed consent. Furthermore, the
regulation provides a mechanism under which the sponsor may perform the
clinical investigations and sets the conditions under which the
disclosure will occur. Therefore, the regulation serves as advance
notice that prevents a sponsor from having any reasonable investment-
backed expectation concerning the information and, thus, there is no
unconstitutional taking.
73. A number of comments raised questions about
Sec. 50.24(a)(7)(ii) including: what criteria would be used to
determine that disclosure was adequate; when is the disclosed
information to be provided to FDA; what is meant by ``sufficient'' and
``relevant''; whether it is sufficient prior to the study to simply
post a notice on the bulletin board; who determines the adequacy of the
disclosure; whether this places an obligation to ``disclose'' or to
``disseminate'' information to the community; what this disclosure is
supposed to accomplish. Clarification was requested as to the method
and scope of disclosure.
It is the responsibility of the IRB to determine the
``sufficiency'' of the information to be disclosed. The agency advises
that this information could include, but may not necessarily be limited
to, the information that is found in the informed consent document, the
investigator's brochure, and the research protocol. The obligation to
disclose information includes an obligation to disseminate information
to the community. The purposes of disclosure are to provide community
confidence in the role of the IRB and in its decisionmaking capability,
to permit the community to express its concerns and possible objections
to the research, and to inform the community so that it is aware that
the research is to be conducted involving individuals from the
community.
74. Another comment suggested that FDA and DHHS should provide
IRB's with copies of disclosure forms.
The agency disagrees. It is the IRB's responsibility to determine
the method for disclosure and information to be disclosed. A ``form''
would stifle IRB creativity and flexibility.
75. Comments on Sec. 50.24(a)(7)(iii) suggested that the regulation
specifically include the requirement that the underlying data be
disclosed following the end of the study; another suggested that
product approval decisions should be based on compliance with this
requirement as well as the timeliness of disclosure.
The agency does not think that these comments require a change in
the regulation. The agency thinks that it is necessary to provide
comprehensive summary data from the completed trial to the research
community in order to permit other researchers to assess the results of
the clinical investigation. The agency thinks that there must be a
scientific need to conduct clinical investigations involving subjects
who are unable to consent; if previous investigations have already
provided the scientific answer, this should be shared broadly with the
research community. Sufficient information may be contained in a
scientific publication of the results of the completed investigation;
in other instances, it may need to be supplemented by additional
information. The agency has modified Sec. 50.24(a)(7)(iii) to clarify
that the information to be disclosed is to include the demographic
characteristics (age, gender, and race) of the research population.
In response to the suggestion that product approval decisions
should be based on compliance with this requirement, the agency notes
that it has a variety of compliance procedures that it may use to
enforce this disclosure requirement.
76. Comments opposed to this disclosure requirement suggested that
it would jeopardize the ability to publish the results of the research
in peer review journals; it would foster unscientific conclusions
without peer review; an investigator cannot control the peer review
process to ensure publication; it could negatively influence future
trial recruitment and force a sponsor to disclose proprietary
information. Several comments suggested that in multicenter studies,
one institution may get a negative result, while another may get a
positive result; thus, disclosure could be misleading. Comments
suggested that updating the disclosure could be burdensome and that the
disclosure itself could be considered dissemination of off-label use
information and advertising. Another comment questioned the need for
such disclosure because the community would have no opportunity to
modify the research; another commented that the disclosure would be so
delayed and the community to which the disclosure would occur has such
insufficient knowledge to understand the disclosure, that the
disclosure would be meaningless.
Some comments requested that the agency define what and how
disclosure is to be accomplished; what is ``sufficient'' and what would
constitute the ``scientific community.'' One comment questioned whether
the information that would be disclosed to the community and
researchers would differ.
The comments opposed to this disclosure requirement illustrate a
need for the agency to clarify what is intended by this section. For a
multicenter investigation, the agency anticipates that the sponsor and/
or lead investigators will be responsible for analyzing the results of
the overall investigation, including the demographic characteristics of
the research population, and that these results will be published (or
reported in the lay press) within a reasonable period of time following
completion of the investigation. Publication in a scientific journal or
reports of the results by lay press, that would be supplemented upon
request by comprehensive summary data, will enable the research
community, e.g., researchers not connected to the clinical
investigation, to learn of the research's results. Following
publication, the IRB will be responsible for determining appropriate
mechanisms for providing this information, possibly supplemented by a
lay description, to the community from which research subjects were
drawn. The usual rules of marketing and promotion apply to the
disclosure of this information. The agency notes that it is common for
the results of research to be reported in the lay press and published
in peer reviewed journals.
77. One comment noted that the comment in the preamble that there
would be a need for fewer subjects if disclosure took place did not
recognize the possible need for replication of the research--a sound
scientific principle.
In the preamble to the proposed rule, the agency stated that:
``[b]y broadly sharing the results of the research with the scientific
community, there may be less need to replicate the research; therefore,
fewer subjects may be needed
[[Page 51517]]
to obtain the same level of scientific knowledge and to advance
emergency medicine.'' The agency recognizes that there is frequently a
need to replicate research in order to verify its findings. The agency
thinks, however, that broadly sharing both positive and negative
results of research with the scientific community may reduce or
eliminate unnecessary duplication of research that has been conducted
and verified by others.
7. Section 50.24(a)(5)(iv)--Data Monitoring Committees
A number of comments on proposed Sec. 50.24(a)(5)(iv), which has
been renumbered Sec. 50.24(a)(7)(iv) in this final rule, supported the
requirement for the establishment of an independent data monitoring
committee. These comments also requested clarification of the
requirement and offered various suggestions. A discussion of these
comments and the agency's response follows.
78. Editorial changes were suggested to this section to clarify the
function of the data monitoring committee.
The regulation has been changed to clarify that the purpose of the
data monitoring committee is to exercise oversight of the clinical
investigation. In addition, on the agency's own initiative, the agency
has changed ``data and safety monitoring board'' to ``independent data
monitoring committee'' to conform to wording used in the international
community.
79. Clarification was requested on the function, nature, authority,
and responsibility of the committee. One comment requested citations to
reference materials on data monitoring committees; another suggested
that the regulation reference FDA's ``Guideline for the Monitoring of
Clinical Investigations'' (53 FR 4723). One comment questioned whether
the committee was simply advisory or whether it would have authority to
halt a study. Other comments requested advice on the appropriate
composition of the committee and another requested that FDA define its
minimum size and expertise.
A number of comments requested clarification as to who is
responsible for establishing and operating the data monitoring
committee. One comment suggested that if it is the responsibility of
the sponsor to establish the committee, then the term ``independent''
needs to be defined. Several comments noted that if the responsibility
for establishing the committee changes, depending upon whether the
study is multicenter with a commercial sponsor or a single center,
noncommercially sponsored study, the circumstances for this shift in
responsibility must be clearly described. Another comment asked for
clarification as to who is responsible for establishing ``the
preestablished stopping rules'' and how these rules are defined.
Several comments suggested that it should be the responsibility of the
principal investigator and/or the sponsor of the research to convene
the committee. Another comment suggested that if it is the
responsibility of the sponsor to convene the committee for multicenter
studies, it should be explicitly stated in the regulations.
A number of suggestions were given for how the committee should be
composed and its functions. The agency also received suggestions for
alternatives to the establishment of such a committee. Several comments
suggested that the IRB be responsible for approving the composition of
the committee based on the complexity, size, and risks associated with
the study. Others suggested that the committee should be composed of
specific types of individuals, including scientists, community members,
IRB representatives without a conflict of interest, data management
representatives, biostatisticians, and noninvestigator clinicians.
Others suggested that a link be created between the committee and the
IRB and that specific reporting requirements between the two entities
be established so that the IRB c
FR Doc. 96-24967 Protection of Human Subjects; Informed Consent
an have the necessary information to
terminate or modify the study.
The agency recognizes that there is no clear consensus within the
scientific community regarding the optimal model for data monitoring
committees. It is not the intention of the agency to settle the debates
that are ongoing in the scientific community at this time. Rather, the
agency recognizes that there is diversity in this area; the role,
functions, and responsibilities of data monitoring committees are
evolving, and it may be the case that there is no single model that is
optimal in all circumstances. The data monitoring committee is
established by the sponsor of the research, as an advisory body to the
sponsor. An independent committee is constituted of individuals not
otherwise connected with the particular clinical investigation. A
variety of expertise is required for an effective data monitoring
committee. Typically included are clinicians specializing in the
relevant medical field(s), biostatisticians, and bioethicists. The data
monitoring committee receives study data on an ongoing basis on a
schedule generally defined in the investigational protocol; based on
its review of the data it may recommend to the sponsor that the
clinical investigation be modified or stopped. In effect, it is
responsible for making sure that continuing the investigation in its
current format remains appropriate, on both safety and scientific
grounds. A number of reasonable models for establishment and function
of these committees are described and discussed in S. Ellenberg, N.
Geller, R. Simon, S. Yusuf (editors), Practical issues in data
monitoring of clinical trials (Proceeding of an International Workshop)
Statistics in Medicine, vol. 12; 1993. If a sponsor accepts a data
monitoring committee's recommendation to stop the investigation or to
institute a major modification of the trial, the sponsor is required to
notify FDA and all participating investigators and IRB's in a written
IND or IDE safety report within 10 working days after the sponsor's
initial receipt of the information. (See Secs. 312.32, 312.56(d), and
812.150(b)(1)).
Protocols frequently contain statistical guidelines for permitting
trials to stop prior to completing the protocol-specified accrual and
followup, on the basis of definitive efficacy or safety differences
between the treatments being compared.
80. Comments opposed to this requirement mainly cited concern that
for single project/single institutional studies without a commercial
sponsor, the cost and resources required for establishing such a body
would be prohibitive and, therefore, important research would not be
done. Another comment suggested that for noncommercially funded
studies, the agency permit the investigator/sponsor to request a waiver
of the requirement to FDA. If such a waiver were granted, timely data
summaries could be submitted to FDA for review.
The agency disagrees with these comments. Trials of life-
threatening conditions may discover favorable or adverse effects on
survival during the trial. Requiring a data monitoring committee will
help ensure that if it becomes clear that the benefits of the
investigational intervention are established, or that risks are greater
than anticipated, or that the benefits do not justify the risks of the
research, the investigation can be modified to minimize those risks or
the clinical investigation can be halted. The data monitoring committee
is established by the sponsor of the research, as an advisory body to
the sponsor. It is the appropriate role of the sponsor, not FDA, to
receive and evaluate a data monitoring committee's
[[Page 51518]]
recommendation. The agency thinks that a data monitoring committee is a
very necessary protection for the human subjects participating in this
research. The agency thinks that the cost of operating such committees
does not need to be prohibitive and that the cost is justified by the
protections provided by having such a committee.
81. Others commented that the requirement for a data monitoring
committee is unnecessary given that these studies already will have
oversight by FDA and the IRB, both of which are independent of the
research, as well as by the sponsor and the clinical investigator.
The agency disagrees. The FDA, IRB, and research sponsor, unlike
the data monitoring committee, do not receive outcome data from the
clinical investigation on an ongoing basis. Thus, oversight by these
entities does not substitute for the requirement for a data monitoring
committee.
82. Another comment pointed out that there was no need for such a
committee for nondrug and nondevice studies if these involved no more
than minimal risk.
This regulation is applicable only to clinical investigations
involving products regulated by FDA.
83. One other comment suggested that this requirement would be
unduly burdensome unless the sponsor paid for the cost of establishing
and operating the committee (including paying for the salaries of
members on the committee).
As discussed previously, FDA does not prescribe what entity pays
for particular aspects of clinical research and review. However, if, as
previously described, the data monitoring committee is established by
the sponsor of the research as an advisory body to the sponsor, the
agency believes that it is likely that the sponsor will pay the cost of
establishing and operating the committee.
84. Another comment suggested that the make-up of the data
monitoring committee should not be left to the sponsor or clinical
investigator to decide and that ``independent'' should be defined as
``separate'' from the research team and sponsor. Another comment noted
that financial interest is only one aspect of what constitutes a
conflict of interest and that the preamble to the final rule should
clarify both terms when describing what constitutes an ``independent''
committee.
The agency believes that the 1993 Statistics in Medicine
publication of the proceedings of an international workshop (previously
referenced) will assist sponsors in establishing appropriate data
monitoring committees. As previously discussed, a variety of expertise
is required for an effective data monitoring committee; the agency
believes that it would be inappropriate for it to dictate the specific
make-up of each such committee. In the preamble to the proposed rule,
the agency defined ``independent'' to mean that the committee would be
composed solely of individuals who have no financial interest in the
outcome of the clinical investigation, and who have not been involved
in the design or conduct of the investigation. The agency does not
think that further clarification of ``independent'' is needed, but
other factors can certainly be taken into consideration in individual
cases.
85. One comment stated that the data monitoring committee should be
charged with monitoring the makeup of the study population to ensure
that it does not disproportionately consist of disadvantaged groups.
There is nothing to prevent a data monitoring committee from
performing this type of monitoring. It is the responsibility of the
sponsor to determine the scope of the data monitoring committee's
responsibilities.
86. Some comments suggested alternatives to requiring the creation
of a data monitoring committee, including requiring more frequent
continuing review by the IRB or permitting a sponsor's monitor to
perform the function. For noncommercially funded studies, it was
suggested that the agency permit the IRB, with scientific and
statistical consultants if needed, to perform the function.
An IRB, as well as a sponsor's monitor, may not have access to
study data on an ongoing basis and may not have the variety of
expertise required for an effective data monitoring committee. If an
IRB, a subcommittee of the IRB, or some other preexisting institutional
committee were to serve as a data monitoring committee, it would need
to be constituted as a data monitoring committee when it functions in
that capacity. The agency thinks that the duties and scope of
activities of an IRB and a data monitoring committee are quite
different and that it is important for separate entities to be
established. The agency would not object, however, to an already
established committee, such as an IRB, serving as a data monitoring
committee as long as that committee was constituted to perform the
duties of a data monitoring committee and operated as such separately
and distinctly from its IRB activities.
87. As described previously, the agency has added a new section,
Sec. 50.24(a)(7)(v), to provide an additional protection to research
subjects. This new section clarifies that if obtaining informed consent
is not feasible and if a legally authorized representative is not
available, the investigator will attempt to contact a family member of
the subject to determine whether the family member objects to the
subject's participation in the clinical investigation.
8. Section 50.24(a)(6)
88. Several comments were received on Sec. 50.24(a)(6). One comment
questioned whether the statement ``obtaining such consent may be
feasible for some subjects'' referred to a circumstance in which
obtaining consent may become feasible.
This comment did not take into account Sec. 50.24(b). Section
50.24(b) concerns providing information to the subject, representative,
or family member at the earliest feasible opportunity. Section
50.24(a)(6) is included to cover those instances where it may be
feasible to obtain informed consent from the individual subject or
subject's representative or contact a family member prior to entry into
the clinical investigation.
89. Two comments suggested specific wording changes to acknowledge
the IRB's responsibility to review informed consent procedures. One
suggested that this section be reworded to state:
The IRB has reviewed and approved informed consent procedures
and an informed consent document for subjects or their legal
representatives in situations where use of such procedures and
documents is feasible.
The agency has incorporated wording similar to that suggested into
the regulation. It is appropriate to recognize the informed consent
process, and not just the document, as requiring IRB review and
approval. In addition, in order to help ensure that the family member
has sufficient information to make a decision about a subject's
participation in a trial, the agency has added a sentence to the end of
Sec. 50.24(a)(6) that states ``[t]he IRB has reviewed and approved
procedures and information to be used when providing an opportunity for
a family member to object to a subject's participation in the clinical
investigation consistent with paragraph (a)(7)(v) of this section.''
The agency anticipates that these procedures and information will
likely parallel those approved by the IRB for use in obtaining informed
consent from subjects or their legally authorized representatives.
[[Page 51519]]
90. A second comment suggested that this section be replaced with
the following:
The IRB has reviewed and approved: (i) the informed consent
document and procedures to ask for informed consent by subjects or
legally authorized representatives when obtaining such consent may
be feasible for some subjects, (ii) the information provided and
process to ask for a decision by subject or legally authorized
representative to continue or discontinue participation after the
research has begun, (iii) the information provided and procedures
for consultation with representatives of the community, (iv) the
information provided and procedures for public disclosure before the
research, and (v) the information provided and procedures for public
disclosure of the results of the research. All documents and
procedures should also be submitted to the FDA for review.
This modification would require both the IRB and FDA to review and
approve all documents or procedures that give information to the
public, subjects, or representatives. The comment suggesting this
modification notes that this is currently required for all nonemergency
IND and IDE research.
The language suggested in this comment appears to duplicate
requirements already contained in the regulation, that is: the
requirement for review of informed consent documents is already
contained in Sec. 50.24(a)(6); the requirement for review of
information concerning the subject's ability to discontinue
participation in the research is contained in Sec. 50.24(b); and the
requirements for review of information used during consultation with or
disclosure to the community are contained in Sec. 50.24(a)(7)(i) to
(a)(7)(iii). FDA has confidence in the IRB review process and does not
think that it is necessary for all of these documents and procedures to
be submitted to FDA for its review. The agency notes that conforming
amendments to this regulation require that a copy of the information
publicly disclosed under Sec. 50.24(a)(7)(ii) and (a)(7)(iii) be
submitted to the IND or IDE file and to Dockets Management Branch. The
agency further notes that the statement that FDA currently requires all
of these documents and procedures to be submitted for its review for
all nonemergency IND and IDE research is incorrect. Rather, it is the
IRB that traditionally reviews information that is to be provided to
the research subject; the requirements for consultation with and
disclosure to the community have not been previously required.
9. Section 50.24(b)
91. A number of comments were received on Sec. 50.24(b) that
suggested clarifying or tightening the requirement for informing
subjects or their legal representatives. One comment recommended that
the agency change the wording from ``at the earliest possible
opportunity'' to the ``earliest feasible opportunity.'' Another comment
suggested that the timeframe for notification was too open-ended and
that there should be a specific time limit.
The agency agrees with the wording change and has incorporated it
into the regulations. The term ``feasible'' incorporates the idea of
``practicability'' and recognizes that in some instances it may not be
feasible to provide information to the subject (e.g., if the individual
does not survive or is mentally incompetent), and to the subject's
legal representative or family member (if the identity of the subject
is never determined). The agency also thinks that the phrase ``at the
earliest feasible opportunity'' establishes a reasonable time limit.
92. Another comment suggested deleting the initial phrase ``when
possible and,'' noting that if the subject does not survive and no
representative is found, then there will be no ``opportunity'' for a
debriefing--thus, the initial phrase is not needed.
The agency agrees with this comment and for the reasons addressed
in the previous response, has deleted this initial phrase from the
regulation.
93. One comment suggested that the regulation require that if a
representative is told and the subject's condition improves, the
subject must also be informed as soon as possible. Two comments stated
that if the subject dies, the subject's legal representative or family
member must be provided with this information.
The agency agrees with these comments and has modified
Sec. 50.24(b) to state:
If a legally authorized representative or family member is told
about the clinical investigation and the subject's condition
improves, the subject is also to be informed as soon as feasible. If
a subject is entered into a clinical investigation with waived
consent and the subject dies before a legally authorized
representative or family member can be contacted, information about
the clinical investigation is to be provided to the subject's
legally authorized representative or family member, if feasible.
94. A few comments suggested that Sec. 50.24(b) be revised to
require documentation that the subject, authorized representative, or
family member, were informed of the research. Another comment suggested
that the agency require a signed consent document for continued
participation in the research.
The agency thinks that it may not always be possible to develop a
meaningful informed consent document for continued participation in the
research, because the relevant information may vary significantly
depending upon when it becomes feasible to provide the information to
the subject or legally authorized representative. The agency is,
therefore, not requiring that such a form be developed. The agency
notes, however, that Sec. 50.24(a)(6) places the responsibility on the
IRB to review and approve ``informed consent procedures and an informed
consent document'' for use with subjects or their legal
representatives, and procedures and information to be used in
consultations with family members, in situations where use of such
procedure is feasible. Thus, a consent form will have been reviewed and
approved for use in the clinical investigation. The agency has modified
the wording in Sec. 50.24(b) to specify that the ``information
contained in the informed consent document'' is to be provided to the
subject, legal representative, or family member. This will help to
ensure that adequate information is provided to the subject, legal
representative, or family member upon which a judgment can be made as
to whether to continue or discontinue the subject's participation in
the investigation.
It is up to the IRB to determine whether it is possible or
desirable, given the nature of the clinical investigation, to have an
actual document that could be signed for continued participation in the
investigation. The agency notes that such a document, that would be
signed after entry into an investigation, would not constitute consent
for what had already occurred; it could, however, serve to document
that the subject consented to continued participation in the
investigation. The agency notes that Secs. 312.60 and 812.140 require
the clinical investigator to document data pertinent to each individual
in the investigation. This documentation should include information
that the subject, legally authorized representative, or family member
was informed of the subject's inclusion in the clinical investigation,
the details of the investigation, and other information contained in
the informed consent document.
95. One comment on the subject's ability to discontinue
participation in the research suggested that Sec. 50.24(b) be reworded
to state:
[[Page 51520]]
The subject or legally authorized representative should be
presented with three options: continue fully, continue the
intervention (if it is still taking place) but do not include the
subject's data in the research database or results, or discontinue
both the intervention and the use of the subject's data. The
researcher will track the percentage of subjects or representatives
choosing each option.
FDA regulations (see, for example, Sec. 312.62 and
Sec. 812.140(a)(3)) require investigators to prepare and maintain
adequate case histories recording all observations and other data
pertinent to the investigation on each individual treated with the drug
or exposed to the device. The agency needs all such data in order to be
able to determine the safety and effectiveness of the drug or device.
The fact of having been in an investigation cannot be taken back. Also,
if a subject were able to control the use (inclusion and exclusion) of
his or her data, and particularly if the clinical investigation were
not blinded, the bias potential would be immense. Thus, the agency
rejects this comment because it could prevent FDA from learning of an
important effect of the product and significantly bias the results of
the investigation.
96. One comment noted that in cases where withdrawal from a study
would be life-threatening, FDA might consider additional guidance on
counseling of subjects who have regained competence regarding their
remaining in the study. Another comment noted that in some cases, a
subject cannot be withdrawn from the study, particularly in the case of
an implanted device, without some degree of medical harm--that is, the
possibility of additional risk for the subject due to its removal. In
this case there is a ``penalty'' for withdrawal from the research.
In all clinical investigations, when appropriate, it is the
responsibility of an investigator to advise the subject of the
consequences of a subject's decision to withdraw from the investigation
and explain procedures for orderly termination of participation by the
subject. (See Sec. 50.25(b)(4)). If withdrawal from an investigation
would or could be life-threatening, this consequence would need to be
conveyed to the subject. The agency acknowledges that for certain
interventions, such as implantation of an investigational device, there
may be a serious consequence following a subject's decision to
discontinue participation in the research. Similarly, for an
investigational drug that cannot be halted immediately without medical
consequences, the subject will need to be advised of the consequences
of a decision to withdraw and procedures for withdrawal that would
minimize risks to the subject.
10. Section 50.24(d)
A number of comments expressed concern about Sec. 50.24(d)
requiring a separate IND or IDE for studies conducted under Sec. 50.24
if an IND or IDE already exists. Others expressed concern about
requiring an IND or an IDE for products that have received FDA approval
for other uses.
97. One comment suggested a modification to the wording of
Sec. 50.24(d) to state that: ``[s]uch IND or IDE should only include
enough detail to satisfy the administrative oversight responsibilities
of appropriate FDA officials.''
The agency disagrees with this suggestion. The information that is
required to be in an IND or IDE is the information that is needed by
the agency to conduct an adequate review of the application. As
described in more detail below, if an IND or IDE exists, the separate
application does not need to duplicate, and the sponsor does not need
to resubmit, information that is contained in the existing IND or IDE;
the separate application will need to reference the existing IND or
IDE, contain a protocol for the clinical investigation that includes a
description of how the investigation proposes to meet the conditions of
this regulation, and contain only the study-specific information
required by Secs. 312.23, 812.20, and 812.25, as appropriate.
98. A number of comments suggested alternative approaches to the
requirement contained in Sec. 50.24(d) for products that have received
marketing approval or for which there already exists an IND or IDE,
noting that for these studies this requirement would be unduly
burdensome, would create the need for unnecessary paperwork, and could
effectively prohibit much needed research. One comment suggested that
the agency limit the scope of this requirement or consider an
alternative for single-center studies under which an IRB can waive
consent if the investigator has informed the appropriate branch of FDA
of the proposed study at least 30 days before submission to the IRB to
allow FDA time to submit its views on the study for consideration by
the IRB. This comment argued that such a requirement would provide
sufficient opportunity for FDA involvement, while at the same time
permit a focused FDA review, consuming fewer resources than would the
review of an IND or IDE for each study. Other comments suggested that
the agency has ample authority under existing IND and IDE regulations
to require strict adherence to the 30-day review period and that the
agency should simply require that emergency research protocols be
clearly identified as such, submitted to the agency under an existing
IND or IDE, and be unable to commence until 30 days after submission.
These comments argued that this would meet the objective of the
regulation without adding additional administrative burdens to the
sponsor or investigator.
These comments may not appreciate why the agency is requiring the
submission of an IND or IDE for each clinical investigation and the
information that must be contained in such an IND or IDE. The
submission of a separate IND or IDE will ensure that FDA reviews the
application before the study may proceed. FDA review of the application
will enable the agency to assess whether the available treatments for
the condition are unproven or unsatisfactory, whether the intervention
is reasonable, whether the study design will provide the information
sought, and whether other conditions of the regulations are met. The
amount of information needed in the application will differ depending
upon the particular intervention. If an IND or IDE exists, the separate
application does not need to duplicate, and the sponsor does not need
to resubmit, information that is contained in the existing IND or IDE;
the separate application will need to reference the existing IND or
IDE, contain a protocol for the clinical investigation that includes a
description of how the investigation proposes to meet the conditions of
this regulation, and contain only the study-specific information
required by Secs. 312.23, 812.20, and 812.25, as appropriate.
If the investigation involves a product that has received marketing
approval and the use is within the product's approved labeling, and
without dosage or schedule change if for a drug product, the protocol
may simply need to be accompanied by the product's approved labeling
and a description of how the investigation proposes to meet the
conditions of this regulation; no toxicology or manufacturing controls
or chemistry information may need to be submitted. By submitting this
information to the agency for review, the dual review by both FDA and
an IRB will provide additional protections to the subjects of this
research. The agency does not think that this requirement is unduly
burdensome, creates unnecessary paperwork, or would prohibit needed
research.
If the clinical investigation involves a product that has received
marketing
[[Page 51521]]
approval, but involves a route of administration or dosage level or use
in a subject population or other factor that significantly increases
the risks (or decreases the acceptability of the risks) associated with
the use of the product, or if the investigation involves an
investigational product for which an IND or IDE does not exist, then
the IND or IDE would need to include information to support the altered
conditions of use, including toxicology, chemistry, and clinical
information, as appropriate.
99. Another comment suggested that the agency should: (1) Include a
mandatory internal ``ethics consult'' of the protocol and informed
consent (this would necessitate requiring the submission of proposed
informed consent documents with the IND/IDE application); (2) ensure
that data on these submissions are captured in a readily retrievable
form for future analysis and reporting so that information on the types
and numbers of such submissions will be available; (3) be able to
provide names and contact information for IRB's reviewing these
protocols to ensure communication among these IRB's; and (4) respond
actively in writing to any submission under these regulations either
placing the study on ``clinical hold'' or indicating that the agency's
review has been completed. This would ensure that the agency has
completed its review before the study is permitted to proceed.
The agency's response to each of these suggestions follows: (1) The
agency believes that it would be inappropriate to mandate an internal
agency ``ethics'' consultation on each protocol proposing to invoke
this exception from informed consent. It is within the province of the
IRB to determine the ethical acceptability of a proposed clinical
investigation. The agency does intend, however, to periodically review
actions on these protocols to help ensure that the rule is implemented
consistently and appropriately throughout the agency. The agency notes
that under the IDE regulations the agency requires the submission of
the proposed informed consent documents with the IDE application. (2)
FDA thinks that it can best monitor the implementation of this rule by
requiring the submission of a separate IND or IDE for these clinical
investigations. By requiring the submission of a separate IND or IDE
for these investigations, FDA expects to be able to provide information
on their type and number. (3) The agency believes that it would be more
appropriate for the sponsor of the research to facilitate communication
among reviewing IRB's, instead of FDA performing this function. (4) FDA
agrees that it should provide a written response to the sponsor
following the agency's review of these protocols. FDA currently sends
written responses following review of IDE's and treatment IND's and
believes that sending letters here will serve as an additional
protection for subjects. The response will serve to document that FDA
has reviewed the clinical investigation and agreed that it may proceed,
and the letters will result in the ability of sponsors to begin these
investigations as expeditiously as possible. The agency has added
language to Secs. 312.20(c) and 812.20(a)(4)(i) to clarify that a
clinical investigation involving an exception from informed consent
under Sec. 50.24 is not permitted to proceed without the prior written
authorization from FDA. FDA will provide such notification 30 days
after FDA receives the application, or earlier.
100. Section 50.24(d) raised a number of questions and caused
confusion concerning its applicability to: Studies designed to compare
the efficacy of two already marketed agents; the study of systems,
processes, and procedures that are not designed to assess the efficacy
of a test agent, but rather to determine the best process or technique
for its use; a study comparing the effect of a standard of care with
the use of no agent at all; and FDA exercising jurisdiction over
studies that do not involve evaluating the safety or efficacy of a
product subject to FDA regulation. One comment recommended that the
regulations be expanded to apply to not only new devices or drugs, but
also to new uses for existing devices and drugs, as well as to new
therapeutic techniques and that researchers be permitted to seek FDA
approval for research on drugs or devices already in use through
alternate forms and/or procedures developed by FDA for this purpose.
This comment incorrectly interpreted the wording in Sec. 50.24(d)
to apply only to unapproved new devices or unapproved new drugs. As
discussed earlier, Sec. 50.24(d) also applies to clinical
investigations involving already marketed products that are regulated
by FDA. This regulation does not apply to research that is outside of
FDA's regulatory jurisdiction--that is, studies involving no product
subject to FDA regulation.
101. A number of examples were provided of studies that purportedly
would have been prevented if an IND or IDE had been required: (1) High
versus low dose epinephrine; (2) interposed abdominal counterpulsation
CPR; (3) saline infusion during trauma; (4) effect of high pressure
ventilation during CPR; (5) studies on sodium bicarbonate during CPR;
(6) studies on MAST trousers during CPR; and (7) comparison of various
intravenous crystalloid solutions in shock-trauma. The application of
this requirement to these types of studies was described, by at least
one comment, as the ``fatal flaw'' in the regulation. Other comments
suggested that the broad scope of this requirement would be wasteful of
sponsor resources in terms of filing the IND and IND annual reports,
wasteful of FDA resources in terms of reviewing such studies, cause
unnecessary paperwork, and would suppress necessary studies.
As discussed previously, the agency believes that it is necessary
to require an IND or IDE for these types of clinical investigations and
it does not believe that this requirement is unduly burdensome or that
it will prevent needed research. The information required in a
sponsor's annual report would not increase because of the requirement
for a separate IND or IDE. The sponsor would simply need to prepare a
separate cover letter and excerpt the information from the other IND's
or IDE's annual report, and file it in the separate IND or IDE.
102. Several comments suggested that the IND/IDE regulations could
be revised to allow for a 30-day review period for those studies that
qualify for this exemption; that sponsors would voluntarily agree to
wait 30 days for agency review of such studies; or that the agency
could place ``on hold'' for 30 days such studies in order to allow for
agency review.
FDA thinks that the most efficient way for the agency to ensure
that these clinical investigations are reviewed by the agency before
they commence is to require the submission of a separate IND or IDE for
that investigation. FDA is concerned that to allow these investigations
to be submitted as amendments to existing IND's or IDE's could be
confusing to sponsors and might lead to these investigations beginning
before FDA review. This is because the agency's current regulations do
not require a 30-day wait for amendments; they can begin immediately
following submission to the agency and receipt of IRB approval. The
agency thinks that this is a simple and nonburdensome mechanism that
achieves an important protection for subjects in this research in which
subjects may be enrolled without informed consent.
11. Section 50.24(e)
103. Most of the comments on Sec. 50.24(e) objected to FDA
modifying
[[Page 51522]]
the traditional reporting/information flow from IRB to clinical
investigator to sponsor and the reverse. These comments requested that
the agency retain this flow of communication in the rule.
The agency disagrees with these comments. Although FDA recognizes
that the sponsor's interaction with the IRB should primarily occur
through the investigator who conducts the clinical investigation, FDA
has never prohibited direct communication between the sponsor and the
IRB when doing so would result in a more efficient flow of information.
For clinical investigations involving medical devices, FDA requires
direct communication between the sponsors and the IRB's in a number of
instances. (See, for example, multiple paragraphs in Sec. 812.150(b).)
The agency thinks that it is appropriate for the IRB to communicate
directly with the sponsor and for the sponsor to communicate directly
with the IRB when this improves efficiency and/or safety, as it does in
this regulation. The agency has amended this section and its related
conforming amendments to specify that the IRB shall document its
findings and provide them promptly in writing to the investigator and
the sponsor of the clinical investigation when an IRB determines that
it cannot approve the investigation because the investigation does not
meet the criteria in the exception or because of other relevant ethical
concerns. The agency thinks that this is the most efficient mechanism
to ensure that both the investigator and sponsor are advised of the
IRB's findings in a timely manner.
104. In a related comment, clarification was requested for studies
in which there is no commercial sponsor and whether it is then the
responsibility of the institution or the individual investigator to
carry out the requirements specified in this section (as well as in the
conforming amendments of Secs. 56.109(g), 312.30, and 312.54).
Whether or not there is a commercial sponsor, each clinical
investigation has a sponsor and it remains the sponsor's responsibility
to carry out the requirements assigned to the sponsor in this section.
(I.e., if the investigation is investigator-sponsored, the investigator
is the sponsor of the research and, therefore, the investigator assumes
all the responsibilities of the ``sponsor.'')
105. Another comment suggested that when an investigator is
proposing a previously IRB-rejected protocol, the investigator is
ethically obligated to disclose the rationale of the earlier rejecting
IRB.
The agency agrees with this comment, but it believes that no change
is needed in the regulations. The requirements in Sec. 50.24(e) will
compel a sponsor to disclose to IRB's that have reviewed or are asked
to review a clinical investigation the findings of an IRB that could
not approve the investigation because the investigation does not meet
the criteria in this exception provided under paragraph (a) of
Sec. 50.24 or because of other relevant ethical concerns.
106. Another comment suggested that in order to avoid delay or
failure to convey information about previously disapproved protocols,
the IRB should submit information directly to FDA.
The agency disagrees with this comment. The conforming amendments
(Sec. 312.54(b) and Sec. 812.47(b)) require a sponsor to monitor these
studies to identify when an IRB determines that it cannot approve the
research because it does not meet the criteria in Sec. 50.24(a) or
because of other relevant ethical concerns, and to promptly provide
this information in writing to FDA. The sponsor is, therefore,
obligated to submit this information promptly to the agency.
107. Another comment suggested that sharing IRB research rejection
information compromises the autonomy of the IRB and that it will make
impartial decision making more difficult.
The agency disagrees and believes that human subject protections
will be enhanced by sharing of this information.
108. A number of comments and questions addressed the phrase
``substantially equivalent clinical trials.'' Several comments noted
that a given sponsor may not be aware of a substantially equivalent
clinical trial proposed by another sponsor; thus, FDA and/or OPRR
should be responsible for ensuring that communication about such trials
takes place. One suggestion was for FDA to establish an on-line
registry at FDA of studies that have applied for waiver of consent;
this registry could be searched by IRB's and investigators to determine
which other IRB's have reviewed the same or substantially equivalent
trials.
The agency intended this requirement to refer to clinical trials
with the same sponsor. The regulation has been modified to clarify this
issue.
109. One comment suggested that the extent of this reporting (of
``disapproval'' information) should be defined in the preamble, with
the minimum content of such a report contained in the regulation.
Existing Sec. 56.109(d), redesignated as Sec. 56.109(e) requires an
IRB to ``notify investigators and the institution in writing of its
decision to approve or disapprove the proposed research activity, or of
modifications required to secure IRB approval of the research
activity.'' It states that ``[i]f the IRB decides to disapprove a
research activity, it shall include in its written notification a
statement of the reasons for its decision.* * *'' The new sentences to
Sec. 56.109(e) requires the IRB to notify the investigator and sponsor
in writing when an IRB determines that it cannot approve the research
because it does not meet the requirements of Sec. 50.24(a) or because
of other ethical concerns. FDA has revised the wording of
Sec. 56.109(e) to make it explicit that this written notification must
include a statement of the reasons for the IRB's determination. The
correspondence from the IRB should contain sufficient information for a
receiving IRB to understand the concerns of the initial IRB.
110. One comment noted that if it is the agency's concern that a
sponsor may minimally modify the rejected proposal (i.e., a
substantially equivalent trial) and submit it to another IRB, that
should be clarified and prohibited. Another questioned whether
``equivalent'' referred to medical conditions, treatments compared,
subject populations, or something else. Another comment questioned
whether ``substantially equivalent'' only applies to other trials with
the same drug/device; if the sponsor subsequently requests an exemption
for a similar trial with another drug in the same class must the
sponsor disclose the IRB findings about the first drug.
By ``substantially equivalent'' the agency means other clinical
investigations that propose to invoke this exception from informed
consent and that involve basically the same medical conditions and
investigational treatments. As noted previously, the agency intends
this requirement to refer to clinical investigations conducted by the
same sponsor.
111. Another comment questioned who is expected to make the
determination that a study is ``substantially equivalent.'' This
comment described a potential situation whereby an IRB rejected a
protocol as written and the sponsor then modified the protocol
according to the IRB's recommendations. This comment, as well as
others, questioned whether, in a multicenter study, the other centers
that approved and initiated the initial protocol would have to review
this trial again.
It is the sponsor's responsibility to determine that a study is
``substantially
[[Page 51523]]
equivalent.'' If, in the scenario described, a protocol invoking this
exception is modified by the sponsor in order to respond to IRB
concerns that it does not meet the criteria in Sec. 50.24(a) of the
exception or because of other relevant ethical concerns, and it is a
multicenter study, then the IRB's written findings are to be disclosed
to other centers that either are, or may be, participating in the
study. If there is a change in a protocol in a multicenter trial, there
is re-review of the protocol by all the IRB's of the institutions
participating in the multicenter trial. If the change is minor, it may
be eligible for expedited review under Sec. 56.110, which permits the
IRB to use an expedited review procedure to review minor changes in
previously approved research during the period for which approval is
authorized. If the change is significant, it would need to be reviewed
by the full committee. It is the sponsor's responsibility to determine
if it has a substantially similar protocol necessitating information
dissemination.
112. One comment noted that the current wording of Sec. 50.24(e)
appeared to require disclosure of IRB disapprovals only to future IRB's
and investigators. This comment suggested that the regulation should
specify that investigators already participating and IRB's that have
already approved the study be notified of an IRB disapproval.
The agency agrees with this comment and has modified Sec. 50.24(e)
accordingly. The agency thinks that this information is relevant to
IRB's that have reviewed and approved the study and that will be
responsible for conducting continuing review of the research as well as
to IRB's that will be asked to review the study. Although this
information may not change an IRB's final determination on the
approvability of a particular protocol, it will allow access to, and
the ability to consider, information that negatively influenced another
IRB.
113. Several comments questioned the timing of IRB review and
submission of the IND. One comment suggested that IRB review precede
the submission of the IND to prevent agency review of studies that
would eventually be found to be unacceptable to the reviewing IRB's.
This comment suggested that the regulations be modified to indicate
that if an IRB refuses to approve the study, the sponsor could request
a pre-IND meeting with FDA to discuss the reasons for the disapproval.
Another comment suggested the opposite, noting that many IRB's will not
consider a protocol under an IND or IDE until after FDA approval
because FDA review includes aspects that are not within the scope of
IRB review. Thus, FDA should agree to review and approve IND's and
IDE's that contain a firm and binding sponsor commitment to local IRB
review. This comment noted that implementation of the Sec. 50.24(a)
provisions will be policed by OPRR and, thus, both FDA and the public
can be ensured that the sponsor's advance commitment will be met. This
comment suggested the following language:
Sec. 312.40(b)(3) For a separate IND submitted under
Sec. 312.20(c), if a sponsor provides a commitment to local IRB
establishment and approval of procedures for compliance with
Sec. 50.24(a).
Sec. 812.30(a)(3) For a separate IDE submitted under
Sec. 812.20(a)(4), if a sponsor provides a commitment to local IRB
establishment and approval of procedures for compliance with
Sec. 50.24(a).
Sec. 50.24(c) [Add the following sentences] The IRB must
document the additional protections provided under subsection (a)(5)
in writing to the sponsor of the research. The sponsor of the
research must share this information with FDA.
The agency does not agree that it should mandate the timing of IRB
and FDA review. As evidenced by the comments, sponsors currently differ
in whether they request FDA or IRB review first. FDA does not believe
it should reduce the sponsor's flexibility to determine the sequence of
IRB and FDA review. The agency notes that FDA may find a clinical
investigation unacceptable or require modifications in an investigation
which, if it had been reviewed by an IRB, would require re-review by
the IRB.
The comment concerning an IRB refusal to approve a study and the
need for a pre-IND meeting does not explain the reason such a meeting
should occur. As described in 312.47(a): ``[m]eetings between a sponsor
and the agency are frequently useful in resolving questions and issues
raised during the course of a clinical investigation. FDA encourages
such meetings to the extent that they aid in the evaluation of the drug
and in the solution of scientific problems concerning the drug, to the
extent that FDA's resources permit.'' Thus, while there is nothing to
prevent a sponsor from requesting a meeting with FDA, it is not clear
that a sponsor would want to meet with the agency to discuss why an IRB
did not approve its investigation.
In response to the comment that FDA should agree to review and
approve IND's and IDE's that contain a firm and binding sponsor
commitment to obtain local IRB review, FDA agrees. FDA will accept a
sponsor's commitment in an IND or IDE application to obtain IRB review
in this situation as it does in others. The agency understands that IRB
review may follow submission and review of the investigation by FDA.
Thus, where an IRB has not yet reviewed and approved the protocol that
the agency has reviewed and allowed to proceed, an IRB's review and
approval, as well as community consultation and disclosure, are then
required prior to subjects entering the investigation.
The agency notes that OPRR does not enforce the provisions in
Sec. 50.24(a) for clinical investigations that are regulated by FDA.
Instead, FDA oversees the quality and integrity of the research that is
conducted under the agency's jurisdiction through its Bioresearch
Monitoring Program. FDA's Bioresearch Monitoring Program includes
inspections of clinical investigators, sponsors, and IRB's to evaluate
whether each entity's obligations are met.
Finally, the agency does not believe there is a need to adopt the
additional language suggested regarding IRB review because the language
is redundant with existing regulations, i.e., the regulations already
require sponsors to obtain the investigator's commitment to obtain IRB
review (see, for example, 312.53(c)(1)(vii)); IRB's are required to
``find and document'' each item under (a), including (a)(6)) (see
Sec. 50.24(a)); and IRB's are required to provide information that has
been publicly disclosed under Sec. 50.24(a)(7)(ii) and (a)(7)(iii) to
the sponsor and the sponsor is required to provide this information to
FDA (see, for example, Sec. 56.109(g), Sec. 312.54(a), Sec. 601.51(d),
and Sec. 812.38(b)(2)). In addition, as previously described, FDA
expects the protocol for the investigation to include a description of
how the investigation proposes to meet the conditions of this
regulation.
114. A number of comments questioned the value of Sec. 50.24(e) and
suggested that it be deleted. The reasons given in these comments
included: its impracticality, its irrelevance to local decision making,
the inappropriate line of communication (previously discussed), and the
precedent that it establishes for requiring public disclosure of IRB
decision-making (potentially leading to extra liability from disclosure
for the IRB). Comments also questioned whether the requirement would
apply to unsponsored research (discussed above), noted that if FDA
needs this information it can request it from the IRB, and asserted
that it is inappropriate for the IRB to apparently review a study and
give feedback to FDA when IRB's depend on FDA to conduct an adequate
preliminary review of such studies. Comments also noted the paperwork
[[Page 51524]]
burden on IRB's (which may need to write a very different type of
document than the one that it would typically write in rejecting a
study), and that this requirement could undermine the authority of the
IRB if it were obliged to report each rejection to FDA. One other
comment questioned the value of this requirement noting that one IRB's
decision to reject a study would have no impact on the substantive,
factual medical and other information available to all IRB's. This
comment noted that the relevance of this evaluation for an IRB that has
already approved a study would be even more untenable and burdensome
and could potentially be disruptive to the sponsor and ongoing studies.
Another comment noted that this requirement is ambiguous and questioned
whether the sponsor would need to provide the report exactly as
provided by the IRB or whether the sponsor could summarize the IRB's
findings. This comment also questioned how FDA would use this
information.
The agency disagrees with these comments. The agency does not think
that this will create an additional recordkeeping burden on IRB's
because these findings are already required to be documented by the IRB
under Sec. 56.109(e) and Sec. 56.115(a)(2). As noted earlier, the
agency has modified this section to require the IRB to provide these
findings to the clinical investigator and to the sponsor of the
research. The agency has a great deal of respect for the IRB system and
for decision-making that occurs by IRB's. Given the nature of this
research, the agency thinks that it is important for entities with
responsibility for allowing these investigations to proceed to consider
IRB concerns related to these investigations. The agency will expect
the sponsor to forward the report exactly as it was provided by the
IRB; however, the sponsor may choose to provide additional relevant
information to the agency along with the IRB's findings. Similarly, if
an IRB chooses to prepare more extensive documentation of its findings
than that which is required by Sec. 56.109(e), Sec. 56.115(a)(2), and
Sec. 56.115(a)(4), there is nothing in this regulation that would
prevent the IRB from so doing.
115. One comment noted that an IRB may reject a study based on the
ethical criticism of a single member. This comment argued that if an
IRB raised a relevant ethical issue, the sponsor, which is the entity
with the greatest legal liability, should evaluate the issue and if the
concern is found to be valid, it should be up to the sponsor to decide
to communicate the issue to other IRB's. This comment suggested that
abridging the sponsor's responsibility will lead to less independent
thinking by IRB's, slower progress in expanding clinical trials, and a
``mass'' of less than well-considered ethical comments being presented
to FDA for its consideration.
The agency intends to monitor and evaluate the implementation of
this regulation on an ongoing basis. While the agency doubts that such
effects will be caused by this requirement, the agency will evaluate
the impact of this requirement on IRB's and the conduct of clinical
investigations. The agency notes that if an IRB ``rejected'' an
investigation on the basis of an argument put forth by a single IRB
member, it would appear likely that member's arguments were persuasive
to the whole IRB.
116. The agency received a number of comments that suggested
editorial or technical changes to clarify the language contained in the
regulations.
The agency has incorporated editorial and technical changes where
the agency thinks that they add clarification to the language in the
regulation. In certain cases, the agency disagreed that the editorial
or technical changes would clarify the language in the regulation.
C. Conforming Amendments
A variety of comments were received on the conforming amendments.
Some of these have been previously discussed. Others, that relate
solely to the conforming amendments, are discussed below.
117. One comment objected to Sec. 56.109(c)(1) which allows an IRB
to waive the requirement that the subject sign a written consent form
if it finds that the research presents no more than minimal risk of
harm to subjects and involves no procedures for which written consent
is normally required outside the research context. This comment noted
that one cannot ensure that informed consent is obtained, if a written
consent form is not signed.
The language contained in Sec. 56.109(c)(1) has been in effect
since 1981 and applies to research that involves no more than minimal
risk of harm to subjects and involves no procedures for which written
consent is normally required outside the research context. This section
does not apply to research conducted under the provisions of this rule.
118. One comment suggested that Sec. 56.109(c)(2) be modified to
include the suggestion that the IRB should seek additional input, as
necessary, from sponsors or other experts to aid them in their decision
making.
The IRB currently is free to consult with anyone that it wants; no
change in the regulation is needed.
119. One comment on Sec. 56.109(d) suggested that the discretion
suggested by the use of the term ``may'' was inappropriate and that
this term should be changed to ``must'' in order to require the
investigator to provide subjects with a written statement. Another
comment questioned whether the proposed Sec. 56.109(d) replaced the
current (d) or extended it.
Proposed Sec. 56.109(d) was taken from the existing IRB regulation;
it was the last sentence in Sec. 56.109(c). Section 56.109(d) became
proposed Sec. 56.109(e) with an additional sentence added at the end.
In writing this conforming amendment, the agency intended new
Sec. 56.109(d) to apply only to Sec. 56.109(c)(1)--that is, to studies
that involve no more than minimal risk and involve no procedures for
which written consent is normally required outside the research
context. The agency has modified Sec. 56.109(d) to make this clear; on
its own initiative, the agency has also corrected a typographical error
in this paragraph. The agency notes that Sec. 50.24(b) describes the
requirements for emergency research.
120. One comment suggested that Sec. 56.109(e) does not match the
intent of Sec. 50.24(e), in that not only the notice of disapproval,
but also the reason and/or concern needs to be provided. This comment
suggested that Sec. 56.109(e) be modified to include the following
sentence: ``The written notification shall include a statement of the
reasons for the disapproval.''
The agency agrees with this comment and had intended that the
reasoning behind the IRB's determination be provided. The agency notes
that it is not only IRB disapprovals, but also an IRB's determination
that it cannot approve an investigation, that triggers this
requirement.
121. Another comment suggested that elsewhere in the regulations,
there is allowance given for discussion between an investigator whose
study has been disapproved and the reviewing IRB. This comment
suggested that similar wording, or clarification, should allow for
sponsor and IRB negotiation.
The agency disagrees with this comment. The purpose of this
requirement is to enhance, not limit, communication of information
between IRB's, investigators, sponsors, and FDA. Sec. 56.109(d),
renumbered as Sec. 56.109(e), continues to state that ``[i]f the IRB
decides to disapprove a research activity, it shall include in its
written notification a statement of the reasons for its decision and
give the investigator an opportunity to respond in person or in
writing.'' There is nothing in this regulation that prevents this
[[Page 51525]]
opportunity for discussion from occurring. It is up to the IRB,
however, to determine when a final determination has been made on a
study.
122. One comment questioned whether Sec. 56.109(e) should be
paragraph (f) (a new paragraph), referring only to documentation of
refusals to approve.
Old 56.109(d) which concerns decisions to approve, disapprove, or
modify research, was renumbered in the proposal as new section
56.109(e). Thus, this paragraph does address documentation of
disapprovals.
123. One comment recommended that the responsibility for
determining when disclosure has occurred be assigned to the IRB's and
that IRB's should be required to notify the sponsor so that the sponsor
could notify FDA. This comment would affect Secs. 56.109(g),
314.430(d), 812.38(b)(2) and 812.47(a).
The responsibility for determining when information has been
publicly disclosed is a dual responsibility of the IRB and sponsor.
Section 56.109(g) requires the IRB to provide a copy of information
that has been publicly disclosed to the sponsor of the research; the
sponsor is responsible for notifying FDA. Sections 312.54(a) and
812.47(a) require the sponsor to monitor the progress of all research
invoking Sec. 50.24 to determine when the public disclosures occur and
to promptly submit copies of the information that has been publicly
disclosed to the IND or IDE file and also to the Dockets Management
Branch.
124. One comment recommended that proposed section 56.111(c) be
deleted, noting that this section is a documentation statement, rather
than an approval criterion. This comment notes that proposed
Sec. 50.24(a) contains similar language requiring such documentation
and, therefore, no benefit is evident in the proposed modification to
Sec. 56.111.
The agency agrees that there is no need for proposed section
56.111(c). Under Sec. 50.24(a), the IRB is responsible for finding and
documenting that each of the safeguards are met; this is also covered
broadly by Sec. 56.111(a)(4).
125. Several comments suggested that Sec. 312.54(a) be modified to
state that the ``sponsor shall document'' rather than ``determine''
when public disclosure has occurred. These comments suggested that
``determine'' could be misconstrued to mean that the sponsor shall
``decide'' what constitutes adequate public disclosure, and that it is
the responsibility of the IRB to make that determination.
The agency agrees that it is the responsibility of the IRB to
determine what constitutes adequate disclosure to the community;
however, it is the responsibility of the sponsor to provide copies of
the information disclosed to the agency. The language in Sec. 312.54(a)
has been modified to clarify that when the sponsor receives from the
IRB information concerning the public disclosures required by
Sec. 50.24(a)(7)(ii) and (a)(7)(iii), the sponsor is required to submit
the information that was disclosed to FDA.
126. One comment recommended that the reference to Sec. 50.23 be
removed from Sec. 312.60 but provided no explanation.
FDA rejects this comment and believes that the reference to
Sec. 50.23 in Sec. 312.60 is needed to identify the various provisions
in the regulations permitting an exception to informed consent. Because
Sec. 50.23 provides different criteria for permitting an exception to
the informed consent requirement, the agency is retaining reference to
this section in Sec. 312.60.
127. One comment questioned the meaning of the modification to
Sec. 314.430 and whether it means that Freedom of Information (FOI)
requests for this information will not be processed, or that requests
for information publicly disclosed under Sec. 50.24(a)(7)(ii) and (iii)
must be submitted to the Dockets Management Branch.
Requests for copies of this public disclosure information are to be
submitted as Freedom of Information Act requests. FDA has amended Sec.
312.130(d), 314.430(d)(2), 601.51(d)(2), 812.38(b)(4), and 814.9 to
clarify that persons wishing to request the publicly disclosed
information in the IND or IDE that was required to be filed with the
Dockets Management Branch shall submit a request under the Freedom of
Information Act. Alternatively, persons wishing to view this
information may visit FDA's Dockets Management Branch (HFA-305), Food
and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD
20857. A special docket, Docket Number 95S-0158, has been established
for this purpose. To facilitate retrieval of information that may
pertain to a single clinical investigation, FDA is specifying that
information submitted to the docket must be identified by the IND or
IDE number.
128. This comment also suggested that Sec. 312.130 be modified by
the addition of
312.130(d) For investigational new drug applications involving
an exception from informed consent under Sec. 50.24 of this chapter,
sponsors are required to submit copies of information that has been
publicly disclosed under Sec. 50.24(a)(5)(ii) and (a)(5)(iii)
[renumbered Sec. 50.24(a)(7)(ii) and (a)(7)(iii)] to the IND file
and to Dockets Management Branch. Copies of this information will be
available to the public from the Dockets Management Branch.
The agency agrees with this comment that it would be clearer if
Sec. 312.130(d) were modified. Consistent with the discussion above,
the agency has amended Sec. 312.130 to add a new paragraph (d) which
contains similar language to that suggested in the comment.
129. On the agency's own initiative, FDA is amending the clinical
hold regulation at Sec. 312.42 to explicitly include a failure to
comply with the requirements in Sec. 50.24 as a reason for clinical
hold. The agency believes this revision will remove any confusion that
may exist regarding the authority to stop, where warranted, an
investigation invoking this rule. The agency does not believe a change
is needed to the device regulation at Sec. 812.30 on disapproving or
withdrawing approval of an IDE because that regulation currently
expressly authorizes FDA to take such action for failure to comply with
``any other applicable regulation or statute, or any condition of
approval imposed by an IRB or FDA.''
D. Preemptive Effect
In developing these rules, FDA considered whether there were
existing State or local legal requirements governing informed consent
that might limit or preclude participation in research in circumstances
that otherwise could be authorized by IRB's acting in accord with these
proposed rules. FDA recognizes that nationally uniform informed consent
requirements governing this type of research could serve to lessen the
current confusion created in the research community by differing
Federal regulations. FDA also recognizes that the existing Federal
Policy for the Protection of Human Subjects, which governs much of this
type of research, currently provides that it does not affect any State
or local laws or regulations that may otherwise be applicable and that
provide additional protections for human subjects. Accordingly, FDA
specifically invited comment on whether there are existing State or
local legal requirements that might limit or preclude participation in
research in circumstances that otherwise could be authorized by IRB's
acting in accord with these proposed rules and whether any such
requirements should be preempted by Federal requirements. As discussed
previously, FDA received limited information on existing State or local
legal requirements that might limit or preclude participation in
research covered by this rule. The agency also
[[Page 51526]]
received a number of comments in favor of the status quo. The
information submitted on existing State or local legal requirements was
insufficient for the agency to justify changing the existing Federal
policy for the protection of human subjects, which governs much of this
type of research, and which currently provides that it does not affect
any State or local laws or regulations which may otherwise be
applicable and which provide additional protections for human subjects.
Thus, the agency does not intend to preempt existing State or local
requirements that provide additional protections for human subjects.
IV. Effective Date
These regulations are effective November 1, 1996. IND's and IDE's
that intend to invoke this rule may be submitted to the agency on or
after the publication date of this rule and must include a description
of how the clinical investigation proposes to meet the conditions of
this regulation. These investigations cannot begin until the rule is
effective, the agency has reviewed the investigation against the
requirements contained in this final rule, a letter has issued to the
sponsor advising the sponsor that the investigation may proceed, the
investigation has been reviewed and approved by an IRB, and the
community consultation and disclosure required by this rule have
occurred.
V. Environmental Impact
The agency has determined under 21 CFR 25.24(a)(8) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
VI. Executive Orders
A. Executive Order 12606: The Family
Executive Order 12606 directs Federal agencies to determine whether
policies and regulations may have a significant impact on family
formation, maintenance, and general well-being. FDA has analyzed this
rule in accordance with Executive Order 12606, and has determined that
it has no potential negative impact on family formation, maintenance,
and general well-being.
FDA has determined that this rule will not affect the stability of
the family, and particularly, the marital commitment. It will not have
any significant impact on family earnings. The rule would not erode the
parental authority and rights in the education, nurture, and
supervision of children.
B. Executive Order 12612: Federalism
Executive Order 12612 requires Federal agencies to carefully
examine regulatory actions to determine if they would have a
significant effect on Federalism. Using the criteria and principles set
forth in the order, FDA has considered the rule's impact on the States,
on their relationship with the Federal Government, and on the
distribution of power and responsibilities among the various levels of
government. FDA concludes that this rule is consistent with the
principles set forth in Executive Order 12612.
Executive Order 12612 states that agencies formulating and
implementing policies are to be guided by certain Federalism
principles. Section 2 of Executive Order 12612 enumerates fundamental
federalism principles. Section 3 states that, in addition to these
fundamental principles, executive departments and agencies shall
adhere, to the extent permitted by law, to certain listed criteria when
formulating and implementing policies that have federalism
implications. Section 4 lists special requirements for preemption.
Section 4 of Executive Order 12612 states that an executive
department or agency foreseeing the possibility of a conflict between
State law and federally protected interests within its area of
regulatory responsibility is to consult with States in an effort to
avoid such conflict. Section 4 of the Executive Order also states that
an executive department or agency proposing to act through rulemaking
to preempt State law is to provide all affected States notice and
opportunity for appropriate participation in the proceedings. As
required by the Executive Order, States have had, through this rule's
notice of proposed rulemaking, an opportunity to raise the possibility
of conflicts and to participate in the proceedings (section 4(d) and
(e)). Consistent with Executive Order 12612, FDA requested information
and comments from interested parties, including but not limited to
State and local authorities, on these issues of federalism. FDA is not
preempting State law through this rulemaking.
VII. Analysis of Impacts
FDA has examined the impacts of the final rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612).
Executive Order 12866 directs agencies to assess all costs and benefits
of available regulatory alternatives and, when regulation is necessary,
to select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this rule is consistent with the regulatory philosophy and principles
identified in the Executive Order. The agency has determined that this
rule is a ``significant regulatory action'' as defined in section
3(f)(4) of the Executive Order because it raises novel policy issues.
If a rule has a significant economic impact on a substantial number
of small entities, the Regulatory Flexibility Act requires agencies to
analyze regulatory options that would minimize any significant impact
of a rule on small entities. This rule is a deregulatory action insofar
as it will permit research to proceed that could not proceed under
existing regulations, and because relatively few research projects will
need to meet the requirements of this rule. Therefore, under the
Regulatory Flexibility Act 5 U.C.C. 605(b), the Commissioner certifies
that the rule will not have a significant economic impact on a
substantial number of small entities. Therefore, under the Regulatory
Flexibility Act, no further analysis is required.
VIII. Paperwork Reduction Act of 1995
This rule contains information collection requirements that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (Pub. L. 104-13, May 22, 1995), and
that are already approved under Protection of Human Subjects--
Recordkeeping Requirements for Institutional Review Boards, part 56 (21
CFR part 56) under OMB Control No. 0910-0130; Investigational New Drug
Application under OMB Control No. 0910-0014; and Investigational
Devices Exemption Reports and Records, part 812 (21 CFR 812) under OMB
Control No. 0910-0078. Modifications to these approved information
collection requirements are underway or will be made at the time that
each information collection is renewed. The agency believes that this
is appropriate because this rule has only a minor impact on these
existing information collection packages.
One comment was received on the agency's estimate of paperwork
burden. That comment noted that the estimate of 20 sponsored
investigational drug and 10 sponsored device studies that will require
waiver of consent may be correct for multicenter studies sponsored by
manufacturers. However, based on results from an informal survey of
[[Page 51527]]
Emergency Medicine Research Directors conducted in May 1994 and again
in December 1994, there may be a substantial number of single
investigator/single institution studies that will also involve waiver
of consent. The comment, thus, concluded that the agency had
underestimated the total number of studies that will be advanced for
consideration of a waiver of consent.
This comment is correct; the agency did not consider single-
investigator/single-institution studies. In response to this comment,
the agency has estimated that there will be approximately 25 single-
institution studies requiring an IDE and 50 single-institution studies
requiring an IND annually. This paperwork section has been revised
accordingly.
For Protection of Human Subjects--Recordkeeping Requirements for
IRB's under OMB Control No. 0910-0130, FDA has calculated the existing
recordkeeping burden on IRB's required by Sec. 56.115 based on the
estimated number of IRB's and the estimated annual number of hours each
IRB spends in recordkeeping activities. FDA does not believe that this
rule will increase the number of IRB's. However, the agency estimates
that the number of hours for recordkeeping related to studies that
propose to invoke this exception from informed consent will increase
for an estimated 275 IRB's by 5 annual hours per record-keeper. This
will change the estimated recordkeeper burden from 65 to 70 hours
annually for these estimated 275 IRB's.
The newly redesignated and revised Sec. 56.109(e) proposes to
require that an IRB notify in writing the sponsor of the research when
an IRB determines that it cannot approve the research because it does
not meet the criteria in the exception provided under Sec. 50.24(a) of
this chapter or because of other relevant ethical concerns. In accord
with the Paperwork Reduction Act of 1995, the agency discloses that
this rule requires this third party notification.
For Investigational New Drug Application under OMB Control No.
0910-0014, the agency estimates that sponsors will submit an average of
20 studies a year, with an average of 20 clinical investigators each,
that propose to invoke this exception from informed consent and that
sponsor-investigators will submit an average of 50 studies a year.
Currently, the agency estimates the reporting requirements contained in
part 312 (21 CFR 312) to ave
FR Doc. 96-24967 Protection of Human Subjects; Informed Consent
rage 123.34 hours per respondent annually.
Reporting requirements are contained in the following sections of part
312: 312.7, 312.10, 312.23, 312.30, 312.31, 312.32, 312.33, 312.35,
312.36, 312.38, 312.41, 312.44(c)(d), 312.45, 312.47, 312.53, 312.55,
312.56, 312.58, 312.64, 312.66, 312.70, 312.83, 312.85, 312.110,
312.120(b), 312.120(c)(3), 312.140, and 312.145. FDA estimates that
respondents will increase by 450 annually, resulting in an increase of
55,503 hours over that currently estimated. The reporting burden for
respondents will, as a result, increase from an estimated 3,926,308
hours annually to 3,971,811 hours annually.
New Sec. 312.54(b) proposes to require the sponsor to provide
information when an IRB determines that it cannot approve the research
because it does not meet the criteria in the exception in Sec. 50.24(a)
or because of other relevant ethical concerns. This information is to
be provided promptly in writing to FDA, investigators who are asked to
participate in the clinical investigation or a substantially equivalent
investigation, and other IRB's that are asked to review the
investigation or a substantially equivalent investigation. In accord
with the Paperwork Reduction Act of 1995, the agency discloses that
this rule requires this third party notification.
For recordkeeping, under Sec. 312.52, 312.57, 312.59, 312.62(a),
312.62(b), 312.62(c), 312.160(a) and (c), the agency estimated that an
average of 165.13 hours were spent per respondent. For the estimated
additional 450 recordkeeping respondents invoking this rule, this would
result in approximately 74,309 hours annually. The recordkeeping burden
for respondents will, as a result, increase from an estimated 2,244,090
hours annually to 2,318,399 hours annually.
For Investigational Devices Exemption Reports and Records under OMB
Control No. 0910-0078, the agency estimates that 35 studies proposing
to invoke this exception will be submitted to the agency annually. The
number of studies upon which the current paperwork reporting burden is
estimated (Sec. 812.20, 812.25, 812.27, 812.35, and 812.150) may,
therefore, increase from 244 original submissions to 279 original
submissions, increasing the number of hours by 2,800 for respondents
(estimated at 80 hours per submission), from a total of 19,520 to
22,320 hours annually.
New Sec. 812.47(b) proposes to require the sponsor to provide
information when an IRB determines that it cannot approve the research
because it does not meet the criteria in the exception in Sec. 50.24(a)
of this chapter or because of other relevant ethical concerns. This
information is to be provided promptly in writing to FDA, investigators
who are asked to participate in the clinical investigation or a
substantially equivalent investigation, and other IRB's that are asked
to review the investigation or a substantially equivalent
investigation. In accord with the Paperwork Reduction Act of 1995, the
agency discloses that this rule requires this third party notification.
The number of recordkeepers, under Secs. 812.43 and 812.140, is
currently estimated at 700; this number is not expected to change. The
estimated number of annual hours for recordkeeping requirements is
expected to increase by 350 hours. The agency had estimated that
original submissions require 10 hours annually of recordkeeping per
submission; recordkeeping related to studies invoking this rule are
expected to increase the submissions from 244 to a total of 279.
As required by section 3507(d) of the Paperwork Reduction Act of
1995, FDA has submitted a copy of this rule to OMB for its review of
these previously approved information collection requirements. The
agency solicited comments on the information collection requirements in
order to: (1) Evaluate whether the collection of information is
necessary for the proper performance of the functions of the agency,
including whether the information will have practical utility; (2)
evaluate the accuracy of the agency's estimate of the burden of the
collection of information, including the validity of the methodology
and assumptions used; (3) enhance the quality, utility, and clarity of
the information to be collected; and (4) minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses.
List of Subjects
21 CFR Part 50
Human research subjects, Prisoners, Reporting and recordkeeping
requirements, Safety.
21 CFR Part 56
Human research subjects, Reporting and recordkeeping requirements,
Safety.
21 CFR Part 312
Drugs, Exports, Imports, Investigations, Labeling, Medical
research, Reporting and recordkeeping requirements, Safety.
[[Page 51528]]
21 CFR Part 314
Administrative practice and procedure, Confidential business
information, Drugs, Reporting and recordkeeping requirements.
21 CFR Part 601
Administrative practice and procedure, Biologics, Confidential
business information.
21 CFR Part 812
Health records, Medical devices, Medical research, Reporting and
recordkeeping requirements.
21 CFR Part 814
Administrative practice and procedure, Confidential business
information, Medical devices, Medical research, Reporting and
recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
50, 56, 312, 314, 601, 812, and 814 are amended as follows:
PART 50--PROTECTION OF HUMAN SUBJECTS
1. The authority citation for 21 CFR part 50 continues to read as
follows:
Authority: Secs. 201, 406, 408, 409, 502, 503, 505, 506, 507,
510, 513-516, 518-520, 701, 721, 801 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321, 346, 346a, 348, 352, 353, 355, 356,
357, 360, 360c-360f, 360h-360j, 371, 379e, 381); secs. 215, 301,
351, 354-360F of the Public Health Service Act (42 U.S.C. 216, 241,
262, 263b-263n).
2. Section 50.3 is amended by adding a new paragraph (n) to read as
follows:
Sec. 50.3 Definitions.
* * * * *
(n) Family member means any one of the following legally competent
persons: Spouse; parents; children (including adopted children);
brothers, sisters, and spouses of brothers and sisters; and any
individual related by blood or affinity whose close association with
the subject is the equivalent of a family relationship.
3. Section 50.24 is added to subpart B to read as follows:
Sec. 50.24 Exception from informed consent requirements for emergency
research.
(a) The IRB responsible for the review, approval, and continuing
review of the clinical investigation described in this section may
approve that investigation without requiring that informed consent of
all research subjects be obtained if the IRB (with the concurrence of a
licensed physician who is a member of or consultant to the IRB and who
is not otherwise participating in the clinical investigation) finds and
documents each of the following:
(1) The human subjects are in a life-threatening situation,
available treatments are unproven or unsatisfactory, and the collection
of valid scientific evidence, which may include evidence obtained
through randomized placebo-controlled investigations, is necessary to
determine the safety and effectiveness of particular interventions.
(2) Obtaining informed consent is not feasible because:
(i) The subjects will not be able to give their informed consent as
a result of their medical condition;
(ii) The intervention under investigation must be administered
before consent from the subjects' legally authorized representatives is
feasible; and
(iii) There is no reasonable way to identify prospectively the
individuals likely to become eligible for participation in the clinical
investigation.
(3) Participation in the research holds out the prospect of direct
benefit to the subjects because:
(i) Subjects are facing a life-threatening situation that
necessitates intervention;
(ii) Appropriate animal and other preclinical studies have been
conducted, and the information derived from those studies and related
evidence support the potential for the intervention to provide a direct
benefit to the individual subjects; and
(iii) Risks associated with the investigation are reasonable in
relation to what is known about the medical condition of the potential
class of subjects, the risks and benefits of standard therapy, if any,
and what is known about the risks and benefits of the proposed
intervention or activity.
(4) The clinical investigation could not practicably be carried out
without the waiver.
(5) The proposed investigational plan defines the length of the
potential therapeutic window based on scientific evidence, and the
investigator has committed to attempting to contact a legally
authorized representative for each subject within that window of time
and, if feasible, to asking the legally authorized representative
contacted for consent within that window rather than proceeding without
consent. The investigator will summarize efforts made to contact
legally authorized representatives and make this information available
to the IRB at the time of continuing review.
(6) The IRB has reviewed and approved informed consent procedures
and an informed consent document consistent with Sec. 50.25. These
procedures and the informed consent document are to be used with
subjects or their legally authorized representatives in situations
where use of such procedures and documents is feasible. The IRB has
reviewed and approved procedures and information to be used when
providing an opportunity for a family member to object to a subject's
participation in the clinical investigation consistent with paragraph
(a)(7)(v) of this section.
(7) Additional protections of the rights and welfare of the
subjects will be provided, including, at least:
(i) Consultation (including, where appropriate, consultation
carried out by the IRB) with representatives of the communities in
which the clinical investigation will be conducted and from which the
subjects will be drawn;
(ii) Public disclosure to the communities in which the clinical
investigation will be conducted and from which the subjects will be
drawn, prior to initiation of the clinical investigation, of plans for
the investigation and its risks and expected benefits;
(iii) Public disclosure of sufficient information following
completion of the clinical investigation to apprise the community and
researchers of the study, including the demographic characteristics of
the research population, and its results;
(iv) Establishment of an independent data monitoring committee to
exercise oversight of the clinical investigation; and
(v) If obtaining informed consent is not feasible and a legally
authorized representative is not reasonably available, the investigator
has committed, if feasible, to attempting to contact within the
therapeutic window the subject's family member who is not a legally
authorized representative, and asking whether he or she objects to the
subject's participation in the clinical investigation. The investigator
will summarize efforts made to contact family members and make this
information available to the IRB at the time of continuing review.
(b) The IRB is responsible for ensuring that procedures are in
place to inform, at the earliest feasible opportunity, each subject, or
if the subject remains incapacitated, a legally authorized
representative of the subject, or if such a representative is not
reasonably available, a family member, of the subject's inclusion in
the clinical investigation, the details of the
[[Page 51529]]
investigation and other information contained in the informed consent
document. The IRB shall also ensure that there is a procedure to inform
the subject, or if the subject remains incapacitated, a legally
authorized representative of the subject, or if such a representative
is not reasonably available, a family member, that he or she may
discontinue the subject's participation at any time without penalty or
loss of benefits to which the subject is otherwise entitled. If a
legally authorized representative or family member is told about the
clinical investigation and the subject's condition improves, the
subject is also to be informed as soon as feasible. If a subject is
entered into a clinical investigation with waived consent and the
subject dies before a legally authorized representative or family
member can be contacted, information about the clinical investigation
is to be provided to the subject's legally authorized representative or
family member, if feasible.
(c) The IRB determinations required by paragraph (a) of this
section and the documentation required by paragraph (e) of this section
are to be retained by the IRB for at least 3 years after completion of
the clinical investigation, and the records shall be accessible for
inspection and copying by FDA in accordance with Sec. 56.115(b) of this
chapter.
(d) Protocols involving an exception to the informed consent
requirement under this section must be performed under a separate
investigational new drug application (IND) or investigational device
exemption (IDE) that clearly identifies such protocols as protocols
that may include subjects who are unable to consent. The submission of
those protocols in a separate IND/IDE is required even if an IND for
the same drug product or an IDE for the same device already exists.
Applications for investigations under this section may not be submitted
as amendments under Secs. 312.30 or 812.35 of this chapter.
(e) If an IRB determines that it cannot approve a clinical
investigation because the investigation does not meet the criteria in
the exception provided under paragraph (a) of this section or because
of other relevant ethical concerns, the IRB must document its findings
and provide these findings promptly in writing to the clinical
investigator and to the sponsor of the clinical investigation. The
sponsor of the clinical investigation must promptly disclose this
information to FDA and to the sponsor's clinical investigators who are
participating or are asked to participate in this or a substantially
equivalent clinical investigation of the sponsor, and to other IRB's
that have been, or are, asked to review this or a substantially
equivalent investigation by that sponsor.
PART 56--INSTITUTIONAL REVIEW BOARDS
4. The authority citation for 21 CFR part 56 continues to read as
follows:
Authority: Secs. 201, 406, 408, 409, 501, 502, 503, 505, 506,
507, 510, 513-516, 518-520, 701, 721, 801 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 321, 346, 346a, 348, 351, 352, 353, 355,
356, 357, 360, 360c-360f, 360h-360j, 371, 379e, 381); secs. 215,
301, 351, 354-360F of the Public Health Service Act (42 U.S.C 216,
241, 262, 263b-263n).
5. Section 56.109 is amended by revising paragraph (c), by
redesignating paragraphs (d) and (e) as paragraphs (e) and (f), by
adding two new sentences to the end of newly redesignated paragraph
(e), and by adding new paragraphs (d) and (g) to read as follows:
Sec. 56.109 IRB review of research.
* * * * *
(c) An IRB shall require documentation of informed consent in
accordance with Sec. 50.27 of this chapter, except as follows:
(1) The IRB may, for some or all subjects, waive the requirement
that the subject, or the subject's legally authorized representative,
sign a written consent form if it finds that the research presents no
more than minimal risk of harm to subjects and involves no procedures
for which written consent is normally required outside the research
context; or
(2) The IRB may, for some or all subjects, find that the
requirements in Sec. 50.24 of this chapter for an exception from
informed consent for emergency research are met.
(d) In cases where the documentation requirement is waived under
paragraph (c)(1) of this section, the IRB may require the investigator
to provide subjects with a written statement regarding the research.
(e)* * * For investigations involving an exception to informed
consent under Sec. 50.24 of this chapter, an IRB shall promptly notify
in writing the investigator and the sponsor of the research when an IRB
determines that it cannot approve the research because it does not meet
the criteria in the exception provided under Sec. 50.24(a) of this
chapter or because of other relevant ethical concerns. The written
notification shall include a statement of the reasons for the IRB's
determination.
* * * * *
(g) An IRB shall provide in writing to the sponsor of research
involving an exception to informed consent under Sec. 50.24 of this
chapter a copy of information that has been publicly disclosed under
Sec. 50.24(a)(7)(ii) and (a)(7)(iii) of this chapter. The IRB shall
provide this information to the sponsor promptly so that the sponsor is
aware that such disclosure has occurred. Upon receipt, the sponsor
shall provide copies of the information disclosed to FDA.
PART 312--INVESTIGATIONAL NEW DRUG APPLICATION
6. The authority citation for 21 CFR part 312 continues to read as
follows:
Authority: Secs. 201, 301, 501, 502, 503, 505, 506, 507, 701 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C 321, 331, 351,
352, 353, 355, 356, 357, 371); sec 351 of the Public Health Service
Act (42 U.S.C. 262).
7. Section 312.2 is amended by adding paragraph (b)(6) to read as
follows:
Sec. 312.2 Applicability.
* * * * *
(b) * * *
(6) A clinical investigation involving an exception from informed
consent under Sec. 50.24 of this chapter is not exempt from the
requirements of this part.
* * * * *
8. Section 312.20 is amended by adding new paragraph (c) to read as
follows:
Sec. 312.20 Requirement for an IND.
* * * * *
(c) A sponsor shall submit a separate IND for any clinical
investigation involving an exception from informed consent under
Sec. 50.24 of this chapter. Such a clinical investigation is not
permitted to proceed without the prior written authorization from FDA.
FDA shall provide such written authorization 30 days after FDA receives
the IND or earlier.
9. Section 312.23 is amended by adding new paragraph (f) to read as
follows:
Sec. 312.23 IND content and format.
* * * * *
(f) Identification of exception from informed consent. If the
investigation involves an exception from informed consent under
Sec. 50.24 of this chapter, the sponsor shall prominently identify on
the cover sheet that the investigation is subject to the requirements
in Sec. 50.24 of this chapter.
10. Section 312.30 is amended by adding a new sentence to the end
of the introductory text to read as follows:
[[Page 51530]]
Sec. 312.30 Protocol amendments.
* * * Whenever a sponsor intends to conduct a clinical
investigation with an exception from informed consent for emergency
research as set forth in Sec. 50.24 of this chapter, the sponsor shall
submit a separate IND for such investigation.
* * * * *
11. Section 312.42 is amended by adding new paragraph (b)(5) to
read as follows:
Sec. 312.42 Clinical holds and requests for modification.
* * * * *
(b) * * *
(5) Clinical hold of any investigation involving an exception from
informed consent under Sec. 50.24 of this chapter. FDA may place a
proposed or ongoing investigation involving an exception from informed
consent under Sec. 50.24 of this chapter on clinical hold if it is
determined that:
(i) Any of the conditions in paragraphs (b)(1) or (b)(2) of this
section apply; or
(ii) The pertinent criteria in Sec. 50.24 of this chapter for such
an investigation to begin or continue are not submitted or not
satisfied.
* * * * *
12. New section 312.54 is added to subpart D to read as follows:
Sec. 312.54 Emergency research under Sec. 50.24 of this chapter.
(a) The sponsor shall monitor the progress of all investigations
involving an exception from informed consent under Sec. 50.24 of this
chapter. When the sponsor receives from the IRB information concerning
the public disclosures required by Sec. 50.24(a)(7)(ii) and (a)(7)(iii)
of this chapter, the sponsor promptly shall submit to the IND file and
to Docket Number 95S-0158 in the Dockets Management Branch (HFA-305),
Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville,
MD 20857, copies of the information that was disclosed, identified by
the IND number.
(b) The sponsor also shall monitor such investigations to identify
when an IRB determines that it cannot approve the research because it
does not meet the criteria in the exception in Sec. 50.24(a) of this
chapter or because of other relevant ethical concerns. The sponsor
promptly shall provide this information in writing to FDA,
investigators who are asked to participate in this or a substantially
equivalent clinical investigation, and other IRB's that are asked to
review this or a substantially equivalent investigation.
13. Section 312.60 is amended by revising the second and third
sentences in the text as follows:
Sec. 312.60 General responsibilities of investigators.
* * * An investigator shall, in accordance with the provisions of
part 50 of this chapter, obtain the informed consent of each human
subject to whom the drug is administered, except as provided in
Secs. 50.23 or 50.24 of this chapter. Additional specific
responsibilities of clinical investigators are set forth in this part
and in parts 50 and 56 of this chapter.
14. Section 312.130 is amended by adding a new paragraph (d) to
read as follows:
Sec. 312.130 Availability for public disclosure of data and
information in an IND.
* * * * *
(d) The availability of information required to be publicly
disclosed for investigations involving an exception from informed
consent under Sec. 50.24 of this chapter will be handled as follows:
Persons wishing to request the publicly disclosable information in the
IND that was required to be filed in Docket Number 95S-0158 in the
Dockets Management Branch (HFA-305), Food and Drug Administration,
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, shall submit a
request under the Freedom of Information Act.
PART 314--APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG OR AN
ANTIBIOTIC DRUG
15. The authority citation for 21 CFR part 314 continues to read as
follows:
Authority: Secs. 201, 301, 501, 502, 503, 505, 506, 507, 701,
704, 721 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321,
331, 351, 352, 353, 355, 356, 357, 371, 374, 379e).
16. Section 314.430 is amended by redesignating paragraph (d) as
paragraph (d)(1) and by adding new paragraph (d)(2) to read as follows:
Sec. 314.430 Availability for public disclosure of data and
information in an application or abbreviated application.
* * * * *
(d)(1) * * *
(2) Notwithstanding paragraph (d)(1) of this section, FDA will make
available to the public upon request the information in the
investigational new drug application that was required to be filed in
Docket Number 95S-0158 in the Dockets Management Branch (HFA-305), Food
and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD
20857, for investigations involving an exception from informed consent
under Sec. 50.24 of this chapter. Persons wishing to request this
information shall submit a request under the Freedom of Information
Act.
* * * * *
PART 601--LICENSING
17. The authority citation for 21 CFR part 601 continues to read as
follows:
Authority: Secs. 201, 501, 502, 503, 505, 510, 513-516, 518-520,
701, 704, 721, 801 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321, 351, 352, 353, 355, 360, 360c-360f, 360h-360j, 371, 374,
379e, 381); secs. 215, 301, 351, 352 of the Public Health Service
Act (42 U.S.C. 216, 241, 262, 263); secs. 2-12 of the Fair Packaging
and Labeling Act (15 U.S.C. 1451-1461).
18. Section 601.51 is amended by redesignating paragraph (d) as
paragraph (d)(1) and by adding new paragraph (d)(2) to read as follows:
Sec. 601.51 Confidentiality of data and information in applications
for establishment and product licenses.
* * * * *
(d)(1) * * *
(2) Notwithstanding paragraph (d)(1) of this section, FDA will make
available to the public upon request the information in the IND that
was required to be filed in Docket Number 95S-0158 in the Dockets
Management Branch (HFA-305), Food and Drug Administration, 12420
Parklawn Dr., rm. 1-23, Rockville, MD 20857, for investigations
involving an exception from informed consent under Sec. 50.24 of this
chapter. Persons wishing to request this information shall submit a
request under the Freedom of Information Act.
* * * * *
PART 812--INVESTIGATIONAL DEVICE EXEMPTIONS
19. The authority citation for 21 CFR part 812 continues to read as
follows:
Authority: Secs. 301, 501, 502, 503, 505, 506, 507, 510, 513-
516, 518-520, 701, 702, 704, 721, 801 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331, 351, 352, 353, 355, 356, 357, 360,
360c-360f, 360h-360j, 371, 372, 374, 379e, 381); secs. 215, 301,
351, 354-360F of the Public Health Service Act (42 U.S.C 216, 241,
262, 263b-263n).
20. Section 812.20 is amended by revising paragraph (a)(1) and
adding new paragraph (a)(4) to read as follows:
Sec. 812.20 Application.
(a) Submission. (1) A sponsor shall submit an application to FDA if
the sponsor intends to use a significant risk device in an
investigation, intends to conduct an investigation that involves an
exception from informed consent under Sec. 50.24 of this chapter, or if
FDA
[[Page 51531]]
notifies the sponsor that an application is required for an
investigation.
* * * * *
(4)(i) A sponsor shall submit a separate IDE for any clinical
investigation involving an exception from informed consent under
Sec. 50.24 of this chapter. Such a clinical investigation is not
permitted to proceed without the prior written authorization of FDA.
FDA shall provide such written authorization 30 days after FDA receives
the IDE or earlier.
(ii) If the investigation involves an exception from informed
consent under Sec. 50.24 of this chapter, the sponsor shall prominently
identify on the cover sheet that the investigation is subject to the
requirements in Sec. 50.24 of this chapter.
* * * * *
20. Section 812.35 is amended by adding a new sentence to the end
of paragraph (a) to read as follows:
Sec. 812.35 Supplemental applications.
(a) * * * Whenever a sponsor intends to conduct a clinical
investigation with an exception from informed consent for emergency
research as set forth in Sec. 50.24 of this chapter, the sponsor shall
submit a separate IDE for such investigation.
* * * * *
21. Section 812.38 is amended by adding a new paragraph (b)(4) to
read as follows:
Sec. 812.38 Confidentiality of data and information.
* * * * *
(b) * * *
(4) Notwithstanding paragraph (b)(2) of this section, FDA will make
available to the public, upon request, the information in the IDE that
was required to be filed in Docket Number 95S-0158 in the Dockets
Management Branch (HFA-305), Food and Drug Administration, 12420
Parklawn Dr., rm. 1-23, Rockville, MD 20857, for investigations
involving an exception from informed consent under Sec. 50.24 of this
chapter. Persons wishing to request this information shall submit a
request under the Freedom of Information Act.
* * * * *
22. New section 812.47 is added to subpart C to read as follows:
Sec. 812.47 Emergency research under Sec. 50.24 of this chapter.
(a) The sponsor shall monitor the progress of all investigations
involving an exception from informed consent under Sec. 50.24 of this
chapter. When the sponsor receives from the IRB information concerning
the public disclosures under Sec. 50.24(a)(7)(ii) and (a)(7)(iii) of
this chapter, the sponsor shall promptly submit to the IDE file and to
Docket Number 95S-0158 in the Dockets Management Branch (HFA-305), Food
and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD
20857, copies of the information that was disclosed, identified by the
IDE number.
(b) The sponsor also shall monitor such investigations to determine
when an IRB determines that it cannot approve the research because it
does not meet the criteria in the exception in Sec. 50.24(a) of this
chapter or because of other relevant ethical concerns. The sponsor
promptly shall provide this information in writing to FDA investigators
who are asked to participate in this or a substantially equivalent
clinical investigation and other IRB's that are asked to review this or
a substantially equivalent investigation.
PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES
23. The authority citation for 21 CFR part 814 is revised to read
as follows:
Authority: Secs. 501, 502, 503, 510, 513-520, 701, 702, 703,
704, 705, 708, 721, 801 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 351, 352, 353, 360, 360c-360j, 371, 372, 373, 374, 375,
379, 379e, 381).
24. Section 814.9 is amended by redesignating paragraph (d) as
paragraph (d)(1) and by adding new paragraph (d)(2) to read as follows
Sec. 814.9 Confidentiality of data and information in a premarket
application (PMA) file.
* * * * *
(d)(1) * * *
(2) Notwithstanding paragraph (d)(1) of this section, FDA will make
available to the public upon request the information in the IDE that
was required to be filed in Docket Number 95S-0158 in the Dockets
Management Branch (HFA-305), Food and Drug Administration, 12420
Parklawn Dr., rm. 1-23, Rockville, MD 20857, for investigations
involving an exception from informed consent under Sec. 50.24 of this
chapter. Persons wishing to request this information shall submit a
request under the Freedom of Information Act.
* * * * *
Dated: July 17, 1996.
David A. Kessler,
Commissioner of Food and Drugs.
Donna E. Shalala,
Secretary of Health and Human Services.
[FR Doc. 96-24967 Filed 9-26-96; 8:59 am]
BILLING CODE 4160-01-F
Complete official Federal Register PDF
FR Doc. 96-24885 Airworthiness Directives; JanAero Devices B-Series Combustion Heaters, Models B1500, B2030, B3040, and B4050 (formerly owned by Janitrol, C&D, FL Aerospace, and Midland-Ross Corporation)
[Federal Register Volume 61, Number 192 (Wednesday, October 2, 1996)]
[Rules and Regulations]
[Pages 51357-51360]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-24885]
=======================================================================
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DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 39
[Docket No. 95-CE-83-AD; Amendment 39-9773; AD 96-20-07]
RIN 2120-AA64
Airworthiness Directives; JanAero Devices B-Series Combustion
Heaters, Models B1500, B2030, B3040, and B4050 (formerly owned by
Janitrol, C&D, FL Aerospace, and Midland-Ross Corporation)
AGENCY: Federal Aviation Administration, DOT.
ACTION: Final rule
-----------------------------------------------------------------------
SUMMARY: This amendment supersedes Airworthiness Directive (AD) 82-07-
03, which currently requires repetitively testing (pressure decay) the
combustion tube of JanAero Devices B-Series combustion heaters, Models
B1500, B2030, B3040, and B4050, that are installed on aircraft, and
overhauling any heater that does not pass one of these pressure decay
tests. This action retains the pressure decay test and possible heater
overhaul requirements of AD 82-07-03; and requires repetitive
operational testing of the combustion air pressure switch, and
replacing any combustion pressure switch that does not pass one of
these tests. Two occurrences of failure of the affected heaters
prompted this action. In one case, an explosion resulted and the
baggage compartment door was blown off the airplane. In the other case,
a fire occurred in the baggage compartment while the airplane was in
flight. The actions specified by this AD are intended to prevent an
airplane fire or explosion caused by failure of the heater combustion
tube assembly or combustion air pressure switch.
DATES: Effective November 14, 1996.
The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of November 14, 1996.
ADDRESSES: Service information that applies to this AD may be obtained
from JanAero Devices, Airport Complex, P.O. Box 273, Fort Deposit,
Alabama 36032; telephone (334) 227-8306; facsimile (334) 227-8596. This
information may also be examined at the Federal Aviation Administration
(FAA), Central Region, Office of the Assistant Chief Counsel,
Attention: Rules Docket 95-CE-83-AD, Room 1558, 601 E. 12th Street,
Kansas City, Missouri 64106; or at the Office of the Federal Register,
800 North Capitol Street, NW., suite 700, Washington, DC.
FOR FURTHER INFORMATION CONTACT: Ms. Linda Haynes, Aerospace Engineer,
FAA, Atlanta Aircraft Certification Office, Campus Building, 1701
Columbia Avenue, suite 2-160, College Park, Georgia 30337-2748;
telephone (404) 305-7377; facsimile (404) 305-7348.
SUPPLEMENTARY INFORMATION:
Events Leading to This AD
A proposal to amend part 39 of the Federal Aviation Regulations (14
CFR part 39) to include an AD that would apply to JanAero Devices B-
Series combustion heaters, Models B1500, B2030, B3040, and B4050, that
are installed on aircraft was published in the Federal Register on
March 15, 1996 (61 FR 10703). The action proposed to supersede AD 82-
07-03 with a new AD that would (1) retain the requirements of
repetitively testing (pressure decay) the combustion tubes of the
heaters, and overhauling any heater that does not pass one of these
pressure decay tests; (2) require repetitive operational testing of the
combustion air pressure switch, and replacing any combustion pressure
switch that does not pass one of these tests; and (3) provide the
option of installing a combustion air pressure
[[Page 51358]]
switch of improved design as terminating action for the repetitive
operational tests. Accomplishment of the proposed actions as specified
in the notice of proposed rulemaking (NPRM) are as follows:
--The pressure decay tests, combustion air pressure switch operational
tests, and possible heater overhaul in accordance with the Overhaul and
Maintenance Manual; and
--The improved design combustion air pressure switch installation in
accordance with JanAero Devices Service Bulletin (SB) # A-102, dated
September 1994.
The proposal was the result of two occurrences of heater failure.
In one case, an explosion resulted and the baggage compartment door was
blown off the airplane. In the other case, a fire occurred in the
baggage compartment while the airplane was in flight.
Interested persons have been afforded an opportunity to participate
in the making of this amendment. Due consideration has been given to
the comments received.
Comment Issue No. 1: New Ceramic Coated Combustion Tubes Should Require
Pressure Decay Tests
Four commenters state that the new ceramic coated combustion tubes,
when installed, should still require repetitive pressure decay tests.
These commenters feel that more failures occur in the areas of the
cross-over passages, exhaust or outermost layer, end cap, and the third
layer; the cross-over passage, exhaust layer, and end cap failing
because of cracks or metal fatigue separation, and the third layer
because of cracks caused by heat warping. These commenters further
state that the JanAero ceramic coated tube does not reduce failures in
these areas in that an improved fourth layer and inner cone does not
increase the longevity of a combustion tube.
The FAA does not concur that repetitive pressure decay tests should
be required on the new ceramic coated combustion tubes. The FAA
approved the ceramic combustion tube based on the coating being able to
withstand high temperatures and because testing results of the heater
assembly exceed FAA Technical Standard Order (TSO) requirements. The
FAA believes that, with proper maintenance as specified within the
Janitrol Maintenance and Overhaul Manual, the ceramic coated combustion
tube will operate safely without a repetitive inspection requirement.
No changes to the AD have been made as a result of these comments.
Comment Issue No. 2: New Part Number (P/N) 94E42 Series Combustion Air
Pressure Switch Should Require Repetitive Checks
Four commenters state the ``improved'' JanAero Devices P/N 94E42
switch utilizes the exact same principle as the old switch; that is,
the spring pressure regulates the air pressure required to close the
micro switch. These commenters express the following:
This spring pressure can be adjusted during periodic
maintenance. When power is supplied to the heater, both switches are
closed (spring is in compression). In both of the switch operations,
if the switch fail opens, the heater will not operate. However, if
the switch fails in the closed position, it would go undetected
until the switch is properly inspected. If the defective switch then
remained in service until the combustion air source failed, fuel and
spark in the combustion tube (with no combustion air) could result
in an explosion. Periodic adjustments to the switch is a necessity
because of reduced spring constant. As the spring is compressed over
time, less force is needed to close the circuit.
One of these four commenters went on to express the following:
The new air switch (P/N 94E42) is slightly more tamper-proof,
but the internal construction is similar to the original and subject
to the same failures; that is a microswitch against a diaphragm with
an adjustment screw. The new switch can be field adjusted just like
the old switch, with design the only major difference. The new
switch cannot be adjusted to the point where it closes with no air
pressure on the diaphragm. In time, the spring inside these pressure
switches will sag under load, which will cause a decrease in the
switch setting and result in the switch contacting at an earlier
point than when new.
The FAA does not concur. The new air switch, P/N 94E42, is forward
spring biased; that is, any extreme or over adjustments will cause the
device to fail in a normal open position, thereby preventing any fuel
introduction or ignition with an improperly adjusted switch. The
adjusting screw housing is potted after factory adjustment to prevent
accidental movement during field readjustment. The intent of this AD is
to prevent failure of the switch. The FAA believes that, with proper
maintenance as called for in the Janitrol Maintenance and Overhaul
Manual, the combustion air pressure switch will not fail and will
operate safely. No changes to the AD have been made as a result of
these comments.
Comment Issue No. 3: Change The AD Applicability to Include All
Combustion Heaters
One commenter suggests the AD cover all combustion heaters because
of aging and lack of maintenance or periodic checks. Another commenter
states that, since all combustion heaters are subject to the same
operation and conditions, all have the same failure capacity and
subsequent failure results.
The FAA does not concur. AD actions provide corrective action for
products where an unsafe condition has been identified, either through
documented service problems or scientific testing, knowledge, etc. AD's
are not used to mandate routine maintenance, in this case as outlined
in the Janitrol Maintenance and Overhaul Manual. The FAA has no data
for which to issue an AD against all combustion heaters; only for those
that are affected by this action. The FAA will consider future
rulemaking action against other combustion heaters if data indicates
that an unsafe condition exists as a result of conditions other than
aircraft owners/operators not accomplishing routine maintenance
actions. No changes have been made to the AD as a result of these
comments.
Comment Issue No. 4: Change the Applicability of the AD
One commenter suggests that the FAA clarify the AD by changing the
Applicability section of the AD to read as follows:
Applicability: B-Series Combustion Heaters, Models B1500, B2030,
B3040, and B4050, marked as meeting the standards of TSO-320 and are
installed on, but not limited to, the following aircraft (all serial
numbers), certificated in any category:
Note: Superseding new B-Series combustion heaters, Models 2500,
B3500, and B4500 incorporate a ceramic coated combustion tube and
new combustion air pressure switch, P/N 94E42, are exempt from the
AD (see JanAero Devices Service Letter # A-101 for superseding
data).
The FAA partially concurs. The only difference that the FAA has
found between the wording currently in the proposal and what the
commenter has suggested is the addition of the note to clarify that
certain combustion heater models incorporate the P/N 94E42 combustion
tube and air pressure switch and are exempt from the AD. The FAA will
add a similar note to the AD for clarification purposes.
Comment Issue No. 5: Assure the Correct Service Bulletin Is Called Out
in the AD
One commenter states that in the preamble to the NPRM, reference to
[[Page 51359]]
JanAero Devices SB # A-102 was incorrectly referenced as JanAero SB NZ
A-102. The commenter requests that all subsequent references to the
service bulletin accurately reflect the title.
The FAA concurs that all reference to the service bulletin should
reflect the correct title, and will assure that reference is correct in
the final rule. In addition, JanAero Devices has superseded JanAero SB
#A- 102 with JanAero SB # A-103, dated September 1995. All reference to
JanAero Devices SB # A-102 will be changed to JanAero Devices SB # A-
103.
Comment Issue No. 6: Change the Wording of the AD for Clarification
One commenter requests that the FAA clarify the AD by combining and
rewording paragraphs (a)(1) and (a)(2) of the AD to read as follows:
If any heater does not pass any of the repetitive combustion
tube pressure decay tests required by this AD, prior to further
flight, overhaul the heater and replace the combustion tube with a
serviceable tube or replace the heater assembly and revert to the
initial 500 hours accumulated time-in-service (TIS) to begin
repetitive testing per this AD.
Note: Replacement with a new or rebuilt superseding Heater Model
(B2500, B3500, or B4500) that incorporates a ceramic coated
combustion tube exempts the heater from this AD.
The FAA does not concur. The only difference that the FAA has found
between the wording currently in the proposal and what the commenter
has suggested is the addition of the note to clarify that certain
combustion heater models incorporate the P/N 94E42 combustion tube and
air pressure switch and are exempt from the AD. However, this note has
already been added after the Applicability section of the AD so the
only thing this note would add is duplication. No changes have been
made to the AD as a result of this comment.
The FAA's Determination
After careful review of all available information related to the
subject presented above, the FAA has determined that air safety and the
public interest require the adoption of the rule as proposed except for
the addition of the clarification note, the change in service
information, and minor editorial corrections. The FAA has determined
that the addition, change, and minor corrections will not change the
meaning of the AD and will not add any additional burden upon the
public than was already proposed.
Compliance Times of This Action
The compliance times of this AD are presented in both hours time-
in-service and calendar time (with the prevalent one being whichever
occurs first). The reason for the dual compliance time is that the
affected combustion heaters are susceptible to corrosion (occurs
regardless of whether the airplane is in flight or on the ground) as
well as being affected by thermodynamic and pressure cycles accumulated
through regular airplane usage.
Cost Impact
The FAA estimates that 25,700 airplanes in the U.S. registry will
be affected by this AD, that it will take approximately 1 workhour per
aircraft to accomplish the required initial inspection, and that the
average labor rate is approximately $60 an hour. Based on these
figures, the total cost impact of the AD on U.S. operators is estimated
to be $1,542,000 or $60 per aircraft. This figure does not take into
account the number of repetitive inspections each aircraft owner/
operator will incur over the life of the aircraft, or the number of
aircraft that have an improved design combustion air pressure switch
installed. The FAA has no way of determining the number of repetitive
inspection each owner/operator would incur over the life of the
airplane. The FAA is not aware of any affected airplane owner/operator
that has incorporated the new design parts as of the issuance of this
AD.
AD 82-03-07 currently requires the pressure decay tests on aircraft
with the affected heaters installed. This action maintains these
inspections; so the only cost impact of the required action is that of
the combustion air pressure switch operational tests.
Regulatory Impact
The regulations adopted herein will not have substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government. Therefore, in
accordance with Executive Order 12612, it is determined that this final
rule does not have sufficient federalism implications to warrant the
preparation of a Federalism Assessment.
For the reasons discussed above, I certify that this action (1) is
not a ``significant regulatory action'' under Executive Order 12866;
(2) is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979); and (3) will not have a
significant economic impact, positive or negative, on a substantial
number of small entities under the criteria of the Regulatory
Flexibility Act. A copy of the final evaluation prepared for this
action is contained in the Rules Docket. A copy of it may be obtained
by contacting the Rules Docket at the location provided under the
caption ADDRESSES.
List of Subjects in 14 CFR Part 39
Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.
Adoption of the Amendment
Accordingly, pursuant to the authority delegated to me by the
Administrator, the Federal Aviation Administration amends part 39 of
the Federal Aviation Regulations (14 CFR part 39) as follows:
PART 39--AIRWORTHINESS DIRECTIVES
1. The authority citation for part 39 continues to read as follows:
Authority: 49 U.S.C. 106(g), 40113, 44701.
Sec. 39.13 [Amended]
2. Section 39.13 is amended by removing Airworthiness Directive
(AD) 82-07-03, Amendment 39-4354, and by adding a new AD to read as
follows:
96-20-07 Janaero Devices (formerly Janitrol, C&D, FL Aerospace, and
Midland-Ross Corporation): Amendment 39-9773; Docket No. 95-CE-83-
AD; Supersedes AD 82-07-03, Amendment 39-4354.
Applicability: B-Series combustion heaters, Models B1500, B2030,
B3040, and B4050, marked as meeting the standards of TSO-C20, that
do not incorporate a ceramic combustion tube and a part number (P/N)
94E42 combustion air pressure switch, and are installed on, but not
limited to, the following aircraft (all serial numbers),
certificated in any category:
------------------------------------------------------------------------
Manufacturer Models and series model airplanes
------------------------------------------------------------------------
Beech.................... Models 95-B55 Series, 58, 58TC, 58P, 60, A60,
and 76.
Canadair................. Models CL-215, CL-215T, and CLT-415.
Cessna................... Models 208, 303, 310F, 310G, 310H, 310I,
310J, 310K, 310L, 310M, 310N, 310O, 310P,
320C, 320D, 320E, 320F, 337 series, 340,
340A, 414, 414A, 421, 421A, 421B, and 421C.
------------------------------------------------------------------------
[[Page 51360]]
Note 1: B-Series combustion heaters, Models 2500, B3500, and
B4500, incorporate a ceramic-coated combustion tube and new
combustion air pressure switch, P/N 94E42. This AD does not apply to
this configuration.
Note 2: This AD applies to each aircraft identified in the
preceding applicability provision, regardless of whether it has been
modified, altered, or repaired in the area subject to the
requirements of this AD. For airplanes that have been modified,
altered, or repaired so that the performance of the requirements of
this AD is affected, the owner/operator must request approval for an
alternative method of compliance in accordance with paragraph (d) of
this AD. The request should include an assessment of the effect of
the modification, alteration, or repair on the unsafe condition
addressed by this AD; and, if the unsafe condition has not been
eliminated, the request should include specific proposed actions to
address it.
Compliance: Required as follows, as applicable:
--For aircraft with 450 or more heater hours time-in-service (TIS)
(see Note 3 for information on how to determine heater hours TIS)
accumulated on an installed heater since the last overhaul or new
installation, within the next 50 heater hours TIS or 12 calendar
months after the effective date of this AD, whichever occurs first,
unless already accomplished, and thereafter at intervals not to
exceed 100 heater hours TIS or 24 calendar months, whichever occurs
first;
--For aircraft with less than 450 heater hours TIS accumulated on an
installed heater since the last overhaul or new installation, upon
accumulating 500 heater hours TIS on the new or overhauled heater or
within the next 12 calendar months after the effective date of this
AD, whichever occurs first, unless already accomplished, and
thereafter at intervals not to exceed 100 heater hours TIS or 24
calendar months, whichever occurs first; and
--Upon installing one of the affected heaters, and thereafter at
intervals not to exceed 100 heater hours TIS or 24 calendar months,
whichever occurs first.
Note 3: A heater hour meter may be used to determine heater
hours TIS. Also, aircraft hours TIS may be divided in half to come
up with heater hours TIS.
To prevent an airplane fire or explosion caused by failure of
the heater combustion tube assembly or combustion air pressure
switch, accomplish the following:
(a) Test (pressure decay test) the combustion tube of the heater
and conduct an operational test of the combustion air pressure
switch in accordance with Section III, paragraph 3.3.1 through
3.3.13 (pressure decay test) and Section IV, paragraph 4.9c
(operational switch test), of the Janitrol Maintenance and Overhaul
Manual, part number (P/N) 24E25-1, dated October 1981.
(1) If any heater does not pass any of the repetitive combustion
tube pressure decay tests required by this AD, prior to further
flight, overhaul the heater and replace the combustion tube with a
serviceable tube or replace the heater assembly. If the new or
rebuilt heater assembly incorporates a ceramic combustion tube, then
the repetitive pressure decay tests are no longer required.
(2) If any heater does not pass any of the repetitive combustion
air pressure switch operational tests required by this AD, prior to
further flight, replace the switch with one of the same design or
with a P/N 94E42 switch in accordance with JanAero Devices Service
Bulletin # A-103, dated September 1995. Replacing the combustion air
pressure switch with a P/N 94E42 switch eliminates the repetitive
operational testing requirement of this AD.
(b) As an alternative method of compliance to the requirements
of this AD, the heater may be disabled by accomplishing the
following:
(1) Cap the fuel supply line;
(2) Disconnect the electrical power and ensure that the
connections are properly secured to reduce the possibility of
electrical spark or structural damage;
(3) Inspect and test to ensure that the cabin heater system is
disabled;
(4) Ensure that no other aircraft system is affected by this
action;
(5) Ensure there are no fuel leaks; and
(6) Fabricate a placard with the words: ``System Inoperative''.
Install this placard at the heater control valve within the pilot's
clear view.
(c) Special flight permits may be issued in accordance with
sections 21.197 and 21.199 of the Federal Aviation Regulations (14
CFR 21.197 and 21.199) to operate the airplane to a location where
the requirements of this AD can be accomplished.
(d) An alternative method of compliance or adjustment of the
compliance time that provides an equivalent level of safety may be
approved by the Manager, Atlanta Aircraft Certification Office
(ACO), Campus Building, 1701 Columbia Avenue, suite 2-160, College
Park, Georgia 30337-2748. The request shall be forwarded through an
appropriate FAA Maintenance Inspector, who may add comments and then
send it to the Manager, Atlanta ACO. Alternative methods of
compliance for the combustion tube repetitive inspections required
by this AD that are approved in accordance with AD 82-07-03
(superseded by this action) are approved as alternative methods of
compliance with the applicable portion of paragraph (a) of this AD.
Note 4: Information concerning the existence of approved
alternative methods of compliance with this AD, if any, may be
obtained from the Atlanta ACO.
(e) The possible switch replacement required by this AD shall be
done in accordance with JanAero Devices Service Bulletin # A-103,
dated September 1995. This incorporation by reference was approved
by the Director of the Federal Register in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. Copies may be obtained from JanAero
Devices, Airport Complex, P.O. Box 273, Fort Deposit, Alabama 36032.
Copies may be inspected at the FAA, Central Region, Office of the
Assistant Chief Counsel, Room 1558, 601 E. 12th Street, Kansas City,
Missouri, or at the Office of the Federal Register, 800 North
Capitol Street, NW., suite 700, Washington, DC.
(f) This amendment (39-9773) supersedes AD 82-07-03, Amendment
39-4354.
(g) This amendment (39-9773) becomes effective on November 14,
1996.
Issued in Kansas City, Missouri, on September 20, 1996.
Michael Gallagher,
Manager, Small Airplane Directorate, Aircraft Certification Service.
[FR Doc. 96-24885 Filed 10-1-96; 8:45 am]
BILLING CODE 4910-13-U
Complete official Federal Register PDF
FR Doc. 96-24664 Removal of Selected Regulations
[Federal Register Volume 61, Number 192 (Wednesday, October 2, 1996)]
[Rules and Regulations]
[Pages 51349-51353]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-24664]
========================================================================
Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.
========================================================================
Federal Register / Vol. 61, No. 192 / Wednesday, October 2, 1996 /
Rules and Regulations
[[Page 51349]]
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Parts 90, 91, 92, 93, 94, 95, 96, 97, and 98
[Docket Number S&TD-96-004]
Removal of Selected Regulations
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This rule amends laboratory support functions and
responsibilities administered by the Agricultural Marketing Services
covering testing services for agricultural food commodities. These
sections which were originally enacted to administer specific programs
have been found to be obsolete or duplicative. Also, amendments in this
rule would clarify and remove sections from the Code of Federal
Regulations (CFR) thus reducing recurrent printing costs as well as
streamline the operation of Agricultural Marketing Service's (AMS)
commodity programs.
EFFECTIVE DATE: October 3, 1996.
FOR FURTHER INFORMATION CONTACT: James V. Falk, 202-690-4089.
SUPPLEMENTARY INFORMATION: This regulatory action is being taken as
part of the Administration's National Performance Review Program and
Regulatory Reinvention Initiative to eliminate unnecessary regulations
and improve the public understanding of those that remain in force.
The Department of Agriculture (Department) is issuing this rule in
conformance with Executive Order 12866.
This rule has been reviewed under Executive Order 12988, Civil
Justice Reform. It is not intended to have preemptive effect. This rule
will not preempt any State or local laws, regulation, or policies,
unless they present an irreconcilable conflict with this rule. There
are no administrative procedures which must be exhausted prior to any
judicial challenge to this rule or the application of its provisions.
Regulatory Impact Analysis
Pursuant to requirements set forth in the Regulatory Flexibility
Act (RFA) (5 U.S.C. 601 et seq.), the Administrator of the Agricultural
Marketing Service (AMS) has considered the economic impact of this rule
on small entities.
The purpose of the RFA is to fit regulatory actions to the scale of
business subject to such actions in order that small businesses will
not be unduly or disproportionally burdened. The Administrator of AMS
determined that this action will not have a significant economic impact
on a substantial number of small entities because the changes remove
unnecessary, obsolete and duplicative material from the text of the
regulations. This action also updates and corrects information
contained in certain sections of the regulations.
Paperwork Reduction Act
In accordance with the provisions of the Paperwork Reduction Act of
1980 (44 U.S.C. Chapter 35), the information collection requirements
contained in the provisions to be updated have been previously approved
by the Office of Management and Budget.
No additional recordkeeping requirements are imposed as a result of
this rule.
Background
The Secretary of Agriculture is authorized under various statutes
to develop and establish efficient marketing methods and practices
concerning agricultural commodities. This has usually been accomplished
by promulgating and codifying regulations in the CFR.
Rapid changes in consumer preferences, together with associated
changes in commodity characteristics, and analytical services have
created a need to amend and modify the regulations. In addition,
industry and the marketplace have been in some instances burdened with
outdated and unnecessary regulatory language.
The President issued a directive in March 1995 to Federal agencies
concerning their responsibilities under the Regulatory Reinvention
Initiative, which is part of the National Performance Review. The
initiative has provided an impetus to develop new approaches to meet
more effectively the needs of U.S. food and fiber industries,
government agencies, and consumers, and still reduce the regulatory
burden. To meet this initiative, regulatory text in the CFR such as
voluntary grading or testing standards or other related provisions have
been removed from the CFR. Name changes which better clarify and
identify existing programs are also being implemented and placed in the
CFR. Additionally, any regulations which are deemed outdated or
obsolete will be removed. Updates and corrections are also made in
certain sections of the regulations. This rule eliminates regulatory
text which encompasses approximately 4 pages of the CFR.
The regulations at 7 CFR section 90.1 paragraphs (i) (j) and (m)
describe laboratory support functions and responsibilities of the
Science and Technology Division (S&TD) of AMS. These paragraphs will be
eliminated to conform with parallel 7 CFR parts 99, 100 and 101 removed
in AMS's rule in the Federal Register (60 FR 62974) on December 7,
1995. The regulations at part 99, Statistical Science Program; part
100, National Laboratory Accreditation Program concerning laboratory
services, statistical science support; and part 101, Pesticide Data
Program were removed because they are either reserved or contain only
informational non-regulatory text.
The listing of the SD Aflatoxin Laboratory at Camilla, Georgia is
removed at 7 CFR section 91.5 paragraph (a)(2)(vi) and 7 CFR part 93.
The Camilla Laboratory has been closed due to the consolidation of
laboratory operations.
The regulations at 7 CFR part 93, subpart B (Secs. 93.10-93.14),
Processed Fruits and Vegetables, Processed Products Thereof, and
Certain Other Processed Food Products; and 7 CFR part 95, Processed
Dairy Products, are being revised and removed respectively. These
provisions describe tests or determinations for grade or quality
attributes of processed food products that are handled by the Dairy
Division or Fruit and Vegetable Division and their designates. The
Midwestern Laboratory of the Science and Technology Division (S&TD) is
[[Page 51350]]
sometimes chosen to provide such testing services. However, these AMS
Commodity Divisions often perform the tests and determinations on
processed products themselves. The duplication of testing services
provided by separate AMS divisions could be confusing to the public.
The necessary information can best be disseminated through AMS
directives or guidelines.
The name ``Science Division'' is being replaced with the name
``Science and Technology Division'' in 7 CFR parts 90, 91, 92, 93, 94,
96, 97, and 98. On October 1, 1995 the Information Resources Management
Division (IRMD) merged with the Science Division to form the Science
and Technology Division (S&TD). This merger of two AMS Divisions is a
result of the momentum to reinvent Government by eliminating or
restructuring agencies and programs of the Department. By careful
sorting out of the responsibilities of the different divisions within
AMS, the Science and Technology Division came into being. S&TD
represents an excellent union of Agency Divisions, since advanced
communications and information technology improves not only Agency
commodity program support but also various laboratory programs needs.
In addition, the public benefits from the increased assistance given to
locate and access all kinds of technical information.
Pursuant to the provisions in 5 U.S.C. 553 (b)(B), it is found and
determined upon good cause that it is impracticable, unnecessary, and
contrary to the public interest to give preliminary notice or to engage
in farther public procedures prior to putting this rule into effect.
Accordingly, good cause exists for not postponing for 30 days the
effective date of this action in the Federal Register for the following
reasons: (1) The sections being removed are either duplicative,
obsolete, or do not need to be in the CFR, and removal will not alter
any aspect of an existing program; (2) the amendments consist of
updates and corrections of information contained in the regulations;
and (3) no useful purpose would be served by a delay of the effective
date.
List of Subjects
7 CFR Part 90
Agricultural commodities, Laboratories, Reporting and recordkeeping
requirements.
7 CFR Part 91
Administrative practice and procedure, Agricultural commodities,
Laboratories, Reporting and recordkeeping requirements.
7 CFR Part 92
Agricultural commodities, Laboratories, Pesticides and pests,
Tobacco.
7 CFR Part 93
Agricultural commodities, Citrus fruits, Fruit juices, Fruits,
Laboratories, Nuts, Vegetables.
7 CFR Part 94
Agricultural commodities, Egg and egg products, Laboratories,
Poultry and poultry products.
7 CFR Part 95
Agricultural commodities, Dairy products, Laboratories.
7 CFR Part 96
Administrative practice and procedure, Agricultural commodities,
Laboratories, Reporting and recordkeeping requirements.
7 CFR Part 97
Administrative practice and procedure, Labeling, Laboratories,
Plants, Reporting and recordkeeping requirements, Seeds.
7 CFR Part 98
Agricultural commodities, Laboratories, Meat and meat products.
For the reasons set forth in the preamble, and under the authority
of 7 U.S.C. 1621-1627, 7 CFR chapter I is amended as follows:
PART 90--[AMENDED]
1. The authority citation for part 90 is revised to read as
follows:
Authority: 7 U.S.C. 1622, 1624.
2. Part 90 is amended by removing the words ``Science Division'',
``Science Division's'', and ``(SD)'' and adding in their place the
words ``Science and Technology Division'', ``Science and Technology
Division's'', and ``S&TD'' respectively, everywhere they appear.
Sec. 90.1 [Amended]
3. In Sec. 90.1, paragraphs (i), (j), and (m) are removed and
paragraphs (k), (l), (n), and (o) are redesignated as paragraphs (i),
(j), (k), and (l) respectively.
PART 91--[AMENDED]
1. The authority citation for part 91 continues to read as follows:
Authority: 7 U.S.C. 1622, 1624.
2. Part 91 is amended by removing the words ``Science Division''
and ``SD'' and adding in their place the words ``Science and Technology
Division'' and ``S&TD'' respectively, everywhere they appear.
3. In Sec. 91.5, paragraph (a)(2) is revised to read as follows:
Sec. 91.5 Where services are offered.
* * * * *
(a) * * *
(2) Science and Technology Division aflatoxin laboratories. The
specialty laboratories performing aflatoxin testing on peanuts, peanut
products, tree nuts and other commodities are located as follows:
(i) USDA, AMS, S&TD, 1557 Reeves Street, Mail: P.O. Box 1368, Dothan,
AL 36302.
(ii) USDA, AMS, S&TD, c/o Golden Peanut Company, 200 West Washington
Street, Mail: P.O. Box 488, Ashburn, GA 31714.
(iii) USDA, AMS, S&TD, 1211 Schley Avenue, Albany, GA 31707.
(iv) USDA, AMS, S&TD, c/o Golden Peanut Company, 301 West Pearl Street,
Mail: P.O. Box 279, Aulander, NC 27805.
(v) USDA, AMS, S&TD, 610 North Main Street, Blakely, GA 31723.
(vi) USDA, AMS, S&TD, 107 South Fourth Street, Madill, OK 73446.
(vii) USDA, AMS, S&TD, c/o Steven Industries, Cargill, Inc., 715 North
Main Street, Mail: P.O. Box 272, Dawson, GA 31742.
(viii) USDA, AMS, S&TD, 308 Culloden Street, Mail: P.O. Box 1130,
Suffolk, VA 23434.
* * * * *
4. In Sec. 91.23, paragraphs (e) and (f) are revised to read as
follows:
Sec. 91.23 Analytical methods.
* * * * *
(e) Official Methods and Recommended Practices of the American Oil
Chemists' Society (AOCS), American Oil Chemists' Society, 1608
Broadmoor Drive, P.O. Box 3489, Champaign, IL 61826-3489.
(f) Official Methods of Analysis of AOAC INTERNATIONAL, Suite 500,
481 North Frederick Avenue, Gaithersburg, MD 20877-2417.
* * * * *
PART 92--[AMENDED]
1. The authority citation for part 92 is revised to read as
follows:
Authority: 7 U.S.C. 511m, 511r.
2. Part 92 is amended by removing the words ``Science Division''
and ``Science Division's'' and adding in their place the words
``Science and Technology Division'' and ``Science and Technology's''
respectively, everywhere they appear.
1. Part 93 is revised to read as follows:
[[Page 51351]]
PART 93--PROCESSED FRUITS AND VEGETABLES
Subpart A--Citrus Juices and Certain Citrus Products
Sec.
93.1 General.
93.2 Definitions.
93.3 Analyses available and location of laboratory.
93.4 Analytical methods.
93.5 Fees for citrus product analyses set by cooperative agreement.
Subpart B--Peanuts, Tree Nuts, Corn and Other Oilseeds
93.10 General.
93.11 Definitions.
93.12 Analyses available and locations of laboratories.
93.13 Analytical methods.
93.14 Fees for aflatoxin testing.
93.15 Fees for analytical testing of oilseeds.
Authority: 7 U.S.C. 1622, 1624.
Subpart A--Citrus Juices and Certain Citrus Products
Sec. 93.1 General.
Domestic and imported citrus products are tested to determine
whether quality and grade standards are satisfied as set forth in the
Florida Citrus Code.
Sec. 93.2 Definitions.
Words used in the regulations in this subpart in the singular form
will import the plural, and vice versa, as the case may demand. As used
throughout the regulations in this subpart, unless the context requires
otherwise, the following terms will be construed to mean:
Acid. The grams of total acidity, calculated as anhydrous citric
acid, per 100 grams of juice or citrus product. Total acidity is
determined by titration with standard sodium hydroxide solution, using
phenolphthalein as indicator.
Brix or degrees Brix. The percent by weight total soluble solids of
the juice or citrus product when tested with a Brix hydrometer
calibrated at 20 deg. C (68 deg. F) and to which any applicable
temperature correction has been made. The Brix or degrees Brix may be
determined by any other method which gives equivalent results.
Brix value. The refractometric sucrose value of the juice or citrus
product determined in accordance with the ``International Scale of
Refractive Indices of Sucrose Solutions'' and to which the applicable
correction for acid is added. The Brix value is determined in
accordance with the refractometric method outlined in the Official
Methods of Analysis of AOAC INTERNATIONAL, Suite 500, 481 North
Frederick Avenue, Gaithersburg, MD 20877-2417.
Brix value/acid ratio. The ratio of the Brix value of the juice or
citrus product, in degrees Brix, to the grams of anhydrous citric acid
per 100 grams of juice or citrus product.
Brix/acid ratio. The ratio of the degrees Brix of the juice to the
grams of anhydrous citric acid per 100 grams of the juice.
Citrus. All plants, edible parts and commodity products thereof,
including pulp and juice of any orange, lemon, lime, grapefruit,
mandarin, tangerine, kumquat or other tree or shrub in the genera
Citrus, Fortunella, or Poncirus of the plant family Rutaceae.
Recoverable oil. The percent of oil by volume, determined by the
Bromate titration method as described in the current edition of the
AOAC INTERNATIONAL.
Sec. 93.3 Analyses available and location of laboratory.
(a) Laboratory analyses of citrus juice and other citrus products
are being performed at the following Science and Technology Division
location: Science and Technology Division Citrus Laboratory, 98 Third
Street, SW, Winter Haven, FL 33880.
(b) Laboratory analyses of citrus fruit and products in Florida are
available in order to determine if such commodities satisfy the quality
and grade standards set forth in the Florida Citrus Code (Florida
Statutes Pursuant to Chapter 601). Such analyses include tests for acid
as anhydrous citric acid, Brix, Brix-acid ratio, recoverable oil, and
artificial coloring matter additive, as turmeric. The Florida Division
of Fruit and Vegetable Inspection may also request analyses for arsenic
metal, pulp wash (ultraviolet and fluorescence), standard plate count,
yeast with mold count, and nutritive sweetening ingredients as sugars.
(c) Additional laboratory tests are available upon request at the
Science and Technology Division Citrus Laboratory at Winter Haven,
Florida. Such analyses include tests for vitamins, naringin, sodium
benzoate, Salmonella, protein, salt, pesticide residues, sodium metal,
ash, potassium metal, and coliforms for citrus products.
Sec. 93.4 Analytical methods.
(a) The majority of analytical methods for citrus products are
found in the Official Methods of Analysis of AOAC INTERNATIONAL.
(b) Other analytical methods for citrus products may be used as
approved by the Director, Science and Technology Division.
Sec. 93.5 Fees for citrus product analyses set by cooperative
agreement.
The fees for the analyses of fresh citrus juices and other citrus
products shall be set by mutual agreement between the applicant, the
State of Florida, and the Director, Science and Technology Division. A
Memorandum of Understanding (MOU) or cooperative agreement exists
presently with the AMS Science and Technology Division and the State of
Florida, regarding the set hourly rate and the costs to perform
individual tests on Florida citrus products, for the State.
Subpart B--Peanuts, Tree Nuts, Corn and Other Oilseeds
Sec. 93.10 General.
Chemical analyses are performed to detect the presence of aflatoxin
in lots of shelled peanuts and peanut products, as well as in other
nuts and agricultural products. In addition, proximate chemical
analyses for quality determination are performed on oilseeds.
Sec. 93.11 Definitions.
Words used in the regulations in this subpart in the singular form
will import the plural, and vice versa, as the case may demand. As used
throughout the regulations in this subpart, unless the context requires
otherwise, the following terms will be construed to mean:
Aflatoxin. A toxic metabolite produced by the molds Aspergillus
flavus and Aspergillus parasiticus. The aflatoxin compounds fluoresce
when viewed under UV light as follows: aflatoxin B1 and
derivatives with a blue fluorescence, aflatoxin B2 with a blue-
violet fluorescence, aflatoxin G1 with a green fluorescence,
aflatoxin G2 with a green-blue fluorescence, aflatoxin M1
with a blue-violet fluorescence, and aflatoxin M2 with a violet
fluorescence. These closely related molecular structures are referred
to as aflatoxin B1, B2, G1, G2, M1, M2,
GM1, B2a, G2a, R0, B3, 1- OCH3B2,
and 1CH3G2.
Peanut Administrative Committee (PAC). The committee established
under the U.S. Department of Agriculture Marketing Agreement for
Peanuts, 7 CFR part 998, which administers the terms and provisions of
this Agreement, including the aflatoxin control program for
domestically produced raw peanuts, for peanut shellers.
Peanut Marketing Agreement. The agreement concerning the
regulations and instructions set forth since July 12, 1965, by the
Peanut Administrative Committee for the marketing of peanuts entered
into by handlers of domestically
[[Page 51352]]
produced peanuts under the authority of the Agricultural Marketing
Agreement Act of 1937, as amended (7 U.S.C. 601 et seq.).
Peanuts. The seeds of the legume Arachis hypogaea, and includes
both inshell and shelled nuts.
Seed. Any vegetable or other agricultural plant ovule having an
embryo that is capable of germinating to produce a plant.
Sec. 93.12 Analyses available and locations of laboratories.
(a) Aflatoxin testing services. The aflatoxin analyses for peanuts,
other nuts, corn, and other oilseed products are performed at the
following 8 locations for Science and Technology Division (S&TD)
Aflatoxin Laboratories:
(1) USDA, AMS, S&TD, 1557 Reeves Street, Mail: P.O. Box 1368, Dothan,
AL 36302.
(2) USDA, AMS, S&TD, 1211 Schley Avenue, Albany, GA 31707.
(3) USDA, AMS, S&TD, 610 North Main Street, Blakely, GA 31723.
(4) USDA, AMS, S&TD, 107 South Fourth Street, Madill, OK 73446.
(5) USDA, AMS, S&TD, 308 Culloden Street, Mail: P.O. Box 1130, Suffolk,
VA 23434.
(6) USDA, AMS, S&TD, c/o Golden Peanut Company, 200 West Washington
Street, Mail: P.O. Box 488, Ashburn, GA 31714.
(7) USDA, AMS, S&TD, c/o Golden Peanut Company, 301 West Pearl Street,
Mail: P.O. Box 279, Aulander, NC 27805.
(8) USDA, AMS, S&TD, c/o Stevens Industries, Cargill, Inc., 715 North
Main Street, Mail: P.O. Box 272, Dawson, GA 31742.
(b) Peanuts, peanut products, and oilseed testing services. (1) The
Science and Technology Division Aflatoxin Laboratories at Dothan,
Alabama and Albany and Blakely, Georgia will perform other analyses for
peanuts, peanut products, and a variety of oilseeds. The analyses for
oilseeds include testing for free fatty acids, ammonia, nitrogen or
protein, moisture and volatile matter, foreign matter, and oil (fat)
content.
(2) All of the analyses described in paragraph (b)(1) of this
section performed on a single seed sample are billed at the rate of one
hour per sample. Any single seed analysis performed on a single sample
is billed at the rate of one-half hour per sample. The standard hourly
rate shall be as specified in 7 CFR 91.37(b).
(c) Vegetable oil testing services. The analyses for vegetable oils
are performed at the Science and Technology Division Midwestern
Laboratory, 3570 North Avondale Ave., Chicago, IL 60618. The analyses
for vegetable oils will include the flash point test, smoke point test,
acid value, peroxide value, phosphorus in oil, and specific gravity.
The fee charged for any single laboratory analysis for vegetable oils
shall be obtained from the schedules of charges in 7 CFR 91.37(a).
Sec. 93.13 Analytical methods.
Official analyses for peanuts, nuts, corn, oilseeds, and related
vegetable oils are found in the following manuals:
(a) Analyst's Instruction for Aflatoxin (August 1994), S&TD
Instruction No. 1, USDA, Agricultural Marketing Service, Science and
Technology Division, South Agriculture Building, 14th & Independence
Avenue, SW, P.O. Box 96456, Washington, DC 20090-6456.
(b) Official Methods and Recommended Practices of the American Oil
Chemists' Society (AOCS), American Oil Chemists' Society, 1608
Broadmoor Drive, P.O. Box 3489, Champaign, IL 61826-3489.
(c) Official Methods of Analysis of AOAC INTERNATIONAL, Suite 500,
481 North Frederick Avenue, Gaithersburg, MD 20877-2417.
(d) Standard Analytical Methods of the Member Companies of Corn
Industries Research Foundation, Corn Refiners Association (CRA), Suite
1120, 1100 Connecticut Avenue, NW, Washington, DC 20036.
Sec. 93.14 Fees for aflatoxin testing.
(a) The fee charged for any single laboratory analysis for
aflatoxins shall be obtained from the schedules of charges in 7 CFR
91.37(a).
(b) The charge for the aflatoxin testing of raw peanuts under the
Peanut Marketing Agreement for subsamples 1-AB, 2-AB, 3-AB, and 1-CD is
a set cost per pair of analyses and shall be set by cooperative
agreement between the Peanut Administrative Committee and AMS Science
and Technology Division.
(c) The charge for any requested laboratory analysis for aflatoxins
not listed shall be based on the standard hourly rate specified in 7
CFR 91.37(b).
Sec. 93.15 Fees for analytical testing of oilseeds.
(a) The fee charged for any single laboratory analysis for oilseeds
shall be obtained from the schedules of charges in 7 CFR 91.37(a).
(b) The charge for any requested laboratory analysis for oilseeds
not listed shall be based on the standard hourly rate specified in 7
CFR 91.37(b).
PART 94--[AMENDED]
1. The authority citation for part 94 continues to read as follows:
Authority: Secs. 2-28 of the Egg Products Inspection Act (84
Stat. 1620-1635; 21 U.S.C. 1031-1056), Agricultural Marketing Act of
1946, Secs. 202-208 as amended (60 Stat. 1087-1091; 7 U.S.C. 1621-
1627).
2. Part 94 is amended by removing the words ``Science Division''
and ``Science Division's'' and adding in their place the words
``Science and Technology Division'' and ``Science and Technology
Division's'' respectively, everywhere they appear.
3. In Sec. 94.4, paragraph (c) is revised to read as follows:
Sec. 94.4 Analytical methods.
* * * * *
(c) Official Methods of Analysis of AOAC INTERNATIONAL, Suite 500,
481 North Frederick Avenue, Gaithersburg, MD 20877-2417.
* * * * *
4. Sec. 94.303 is revised to read as follows:
Sec. 94.303 Analytical methods.
The analytical methods used by the USDA laboratories to perform
analyses for processed poultry products are found in the latest edition
of the Official Methods of Analysis of AOAC INTERNATIONAL, Suite 500,
481 North Frederick Avenue, Gaithersburg, MD 20877-2417.
PART 95--[REMOVED AND RESERVED]
1. Part 95 is removed and reserved.
PART 96--[AMENDED]
1. The authority citation for part 96 is revised to read as
follows:
Authority: 7 U.S.C. 1622, 1624.
2. In part 96, the words ``Science Division'' are revised to read
``Science and Technology Division'' everywhere they appear.
PART 97--[AMENDED]
1. The authority citation for part 97 continues to read as follows:
Authority: Secs. 6, 22, 23, 26, 31, 43, 56, 57, 91(c), Plant
Variety Protection Act, as amended; 7 U.S.C. 2321, 2326, 2352, 2353,
2356, 2371, 2402b, 2403, 2426, 2427, 2501(c); Sec. 14, Plant Variety
Protection Act amendments of 1994; 7 U.S.C. 2401 note; 29 FR 16210,
as amended, 37 FR 6327, 6505.
2. In part 97, the words ``Science Division'' are revised to read
``Science and Technology Division'' everywhere they appear.
[[Page 51353]]
PART 98--[AMENDED]
1. The authority citation for part 98 is revised to read as
follows:
Authority: 7 U.S.C. 1622, 1624.
2. In part 98, the words ``Science Division'' and ``SD'' are
revised to read ``Science and Technology Division'' and ``S&TD''
respectively, everywhere they appear.
3. In Sec. 98.4, paragraph (a)(1) is revised to read as follows:
Sec. 98.4 Analytical methods.
(a) * * *
(1) Official Methods of Analysis of AOAC INTERNATIONAL, Suite 500,
481 North Frederick Avenue, Gaithersburg, MD 20877-2417.
* * * * *
Dated: September 20, 1996.
Jon E. McNeal,
Acting Director, Science and Technology Division.
[FR Doc. 96-24664 Filed 10-1-96; 8:45 am]
BILLING CODE 3410-02-P
Complete official Federal Register PDF
FR Doc. 96-24528 Approval and Promulgation of Implementation Plans; State of Kansas
[Federal Register Volume 61, Number 192 (Wednesday, October 2, 1996)]
[Rules and Regulations]
[Pages 51366-51368]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-24528]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 52
[KS 008-1008(a); FRL-5556-8]
Approval and Promulgation of Implementation Plans; State of
Kansas
AGENCY: Environmental Protection Agency (EPA).
ACTION: Direct final rule.
-----------------------------------------------------------------------
SUMMARY: By this action the EPA gives full approval to the State
Implementation Plan (SIP) submitted by the state of Kansas for the
purpose of fulfilling the requirements set forth in the EPA's General
Conformity rule. The SIP was submitted by the state to satisfy the
Federal requirements in 40 CFR 51.852 and 93.151. Additionally, the EPA
is approving in the SIP revisions to the state's open burning rules.
SIP approval of revised state rules ensures that the SIP is current and
permits Federal enforceability of the state rules.
DATES: This action is effective December 2, 1996 unless by November 1,
1996 adverse or critical comments are received.
ADDRESSES: Copies of the documents relevant to this action are
available for public inspection during normal business hours at the:
Environmental Protection Agency, Air Planning and Development Branch,
726 Minnesota Avenue, Kansas City, Kansas 66101; and the EPA Air &
Radiation Docket and Information Center, 401 M Street, SW., Washington,
DC 20460.
FOR FURTHER INFORMATION CONTACT: Wayne Kaiser at (913) 551-7603.
SUPPLEMENTARY INFORMATION:
General Conformity
Section 176(c) of the Clean Air Act (CAA), as amended (the Act),
requires the EPA to promulgate criteria and procedures for
demonstrating and ensuring conformity of Federal actions to an
applicable implementation plan developed pursuant to section 110 and
Part D of the Act. Conformity to a SIP is defined in the Act as meaning
conformity to an SIP's purpose of eliminating or reducing the severity
and number of violations of the National Ambient Air Quality Standards,
and achieving expeditious attainment of such standards. The Federal
agency responsible for the action is required to determine if its
actions conform to the applicable SIP. On November 30, 1993, the EPA
promulgated the final rule (hereafter referred to as the General
Conformity rule), which establishes the criteria and procedures
governing the determination of conformity for all Federal actions,
except Federal highway and transit actions.
The General Conformity rule also establishes the criteria for the
EPA approval of SIPs. See 40 CFR 51.851 and 93.151. These criteria
provide that the state provisions must be at least as stringent as the
requirements specified in the EPA's General Conformity rule, and that
they can be more stringent only if they apply equally to Federal and
nonfederal entities (section 51.851(b)).
On June 23, 1992, the EPA promulgated the Kansas City ozone
redesignation and maintenance plan for Wyandotte and Johnson counties
in Kansas, and three adjoining counties in Missouri. Section 51.851 and
section
[[Page 51367]]
93.151 of the General Conformity rule require that states submit a SIP
revision containing the criteria and procedures for assessing the
conformity of Federal actions to the applicable SIP, within 12 months
after November 30, 1993. As the rule applies to all nonattainment areas
and maintenance areas, a SIP revision which addresses the requirements
of the General Conformity rule became due on November 30, 1994.
On June 6, 1996, the state of Kansas submitted a SIP revision
meeting the requirements of sections 51.851 and 93.151 of the General
Conformity rule. The submission adopts by reference 40 CFR 93, subpart
B, except 40 CFR 93.151. The omitted section contains the criteria for
the EPA approval of General Conformity SIP revisions, and also states
the effect of the EPA approval of a SIP revision. It is not a necessary
component of the state's substantive rules governing general conformity
determinations.
The Kansas rule also does not adopt paragraph 40 CFR 93.160(f),
which states that written commitments to mitigation measures must be
obtained prior to a positive conformity determination and that such
commitments must be fulfilled. However, these requirements are
contained in paragraph 93.160(b), which the state did adopt, so its
omission is not significant.
This SIP revision was adopted by the Secretary of the Kansas
Department of Health and Environment on February 21, 1996, and became
effective on March 15, 1996.
Because the Kansas rule adopts the substantive requirements of the
EPA's rule by reference, it meets the criteria in sections 51.851 and
93.151 for approval of General Conformity SIP revisions.
Open Burning Rules
The state revised its open burning regulations by revoking old
rules and adopting similar renumbered, revised rules. One significant
change was separating out the requirements for agricultural open
burning as a separate rule in K.A.R. 28-19-648. Substantative change to
the agricultural open burning rule includes more stringent conditions
under which open burning can be approved by local authorities, and
authorizing local authorities to adopt additional restrictions or
requirements deemed appropriate. The state retains the authority to
enforce the rule. The revisions provide added health and environmental
protection.
EPA ACTION: By this action the EPA grants full approval of Kansas' June
6, 1996, submittal. This SIP revision meets all of the requirements set
forth in 40 CFR 51.851 and 93.151, and Part 51.
The EPA is publishing this action without prior proposal because
the Agency views this as a noncontroversial amendment and anticipates
no adverse comments. However, in a separate document in the Federal
Register publication, the EPA is proposing to approve the SIP revision
should adverse or critical comments be filed.
If the EPA receives such comments, this action will be withdrawn
before the effective date by publishing a subsequent notice that will
withdraw the final action. All public comments received will then be
addressed in a subsequent final rule, based on this action serving as a
proposed rule. The EPA will not institute a second comment period on
this action. Any parties interested in commenting on this action should
do so at this time.
Nothing in this action should be construed as permitting or
allowing or establishing a precedent for any future request for
revision to any SIP. Each request for revision to the SIP shall be
considered separately in light of specific technical, economic, and
environmental factors, and in relation to relevant statutory and
regulatory requirements.
Under the Regulatory Flexibility Act, 5 U.S.C. 600 et seq., the EPA
must prepare a regulatory flexibility analysis assessing the impact of
any proposed or final rule on small entities (5 U.S.C. 603 and 604).
Alternatively, the EPA may certify that the rule will not have a
significant impact on a substantial number of small entities. Small
entities include small businesses, small not-for-profit enterprises,
and government entities with jurisdiction over populations of less than
50,000.
SIP approvals under section 110 and subchapter I, Part D of the CAA
do not create any new requirements, but simply approve requirements
that the state is already imposing. Therefore, because the Federal SIP
approval does not impose any new requirements, the EPA certifies that
it does not have a significant impact on any small entities affected.
Moreover, due to the nature of the Federal-state relationship under the
CAA, preparation of a regulatory flexibility analysis would constitute
Federal inquiry into the economic reasonableness of state action. The
CAA forbids the EPA to base its actions concerning SIPs on such grounds
(Union Electric Co. v. U.S. E.P.A., 427 U.S. 246, 256-66 (S.Ct. 1976);
42 U.S.C. 7410(a)(2)).
This action has been classified as a Table 3 action for signature
by the Regional Administrator under the procedures published in the
Federal Register on January 19, 1989 (54 FR 2214-2225), as revised by a
July 10, 1995, memorandum from Mary Nichols, Assistant Administrator
for Air and Radiation. The Office of Management and Budget has exempted
this regulatory action from E.O. 12866 review.
Unfunded Mandates
Under sections 202, 203, and 205 of the Unfunded Mandates Reform
Act of 1995 (``Unfunded Mandates Act''), signed into law on March 22,
1995, the EPA must undertake various actions in association with
proposed or final rules that include a Federal mandate that may result
in estimated costs of $100 million or more to the private sector, or to
state, local, or tribal governments in the aggregate.
Through submission of this SIP, the state has elected to adopt the
program provided for under section 110 of the CAA. These rules may bind
state and local governments to perform certain actions and also require
the private sector to perform certain duties. To the extent that the
rules being finalized for approval by this action will impose new
requirements, sources are already subject to these regulations under
state law. Accordingly, no additional costs to state or local
governments, or to the private sector, result from this final action.
The EPA has also determined that this final action does not include a
mandate that may result in estimated costs of $100 million or more to
state or local governments in the aggregate or to the private sector.
The EPA has determined that these rules result in no additional costs
to tribal government.
Under section 801(a)(1)(A) of the Administrative Procedure Act
(APA) as amended by the Small Business Regulatory Enforcement Fairness
Act of 1996, the EPA submitted a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the General Accounting
Office prior to publication of the rule in today's Federal Register.
This rule is not a ``major rule'' as defined by section 804(2) of the
APA as amended.
Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by December 2, 1996. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this rule for the purposes of judicial review, nor does
it extend the time within which a petition for judicial review may be
filed, and shall not postpone the effectiveness of
[[Page 51368]]
such rule or action. This action may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)
List of Subjects in 40 CFR Part 52
Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Lead, Ozone, Particulate
matter, Reporting and recordkeeping requirements.
Dated: August 2, 1996.
William Rice,
Acting Regional Administrator.
Part 52, chapter I, title 40 of the Code of Federal Regulations is
amended as follows:
PART 52--[AMENDED]
1. The authority citation for part 52 continues to read as follows:
Authority: 42 U.S.C. 7401-7671q.
Subpart CC--Kansas
2. Section 52.870 is amended by adding paragraph (c)(32) to read as
follows:
Sec. 52.870 Identification of plan.
* * * * *
(c) * * *
(32) A Plan revision was submitted by the Kansas Department of
Health and Environment (KDHE) on June 6, 1996, which incorporates by
reference the EPA's regulations relating to determining conformity of
general Federal actions to State or Federal Implementation Plans, and
which revokes old and adopts new open burning regulations.
(i) Incorporation by reference.
(A) Regulation K.A.R. 28-19-800, adopted by the Secretary of the
KDHE on February 21, 1996, effective March 15, 1996.
(B) Regulations K.A.R. 28-19-645 to K.A.R. 28-19-648, adopted by
the Secretary of KDHE on February 6, 1996, effective March 1, 1996.
(C) Regulations K.A.R. 28-19-45 to K.A.R. 28-19-47, revoked by the
Secretary of KDHE on February 6, 1996, effective March 1, 1996.
[FR Doc. 96-24528 Filed 10-1-96; 8:45 am]
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