issue-1996-03-04•Federal Register final rules — 1996-03-04
Federal Register final rules — 1996-03-04
issue-1996-03-04Federal Register final rules — 1996-03-04Regulation
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. 96-4973 Exchange Visitor Program
[Federal Register Volume 61, Number 43 (Monday, March 4, 1996)]
[Rules and Regulations]
[Pages 8215-8216]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-4973]
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UNITED STATES INFORMATION AGENCY
22 CFR Part 514
Exchange Visitor Program
AGENCY: United States Information Agency.
ACTION: Statement of policy and notice to sponsors.
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SUMMARY: Public Law 104-72 directs the Agency to continue its oversight
of au pair activities in the United States until September 30, 1997.
This announcement sets forth the Agency's intended implementation of
this law.
EFFECTIVE DATE: This policy statement is effective March 4, 1996.
FOR FURTHER INFORMATION CONTACT:
Stanley S. Colvin, Assistant General Counsel, United States Information
Agency, 301 4th Street SW., Washington, DC 20547; telephone, (202) 619-
6829.
SUPPLEMENTARY INFORMATION: Au pair programs, whereby European youths
are placed with American host families seeking child care, have been
overseen by the Agency since 1986. Originally begun as a pilot project,
the au pair program has expanded over the past ten years to now
encompass eight Agency-designated sponsors who facilitated the entry of
some 11,000 au pair participants in 1995. Congress, in enacting Public
Law 104-72, extended temporarily the Agency's authority to oversee this
activity. As discussed below, the Congress also addressed two long-
standing programmatic matters of concern to the Agency.
Since begun in 1986, au pair participants have only been selected
from the countries of Western Europe. This limitation was set forth in
initial pilot-project guidelines but remained in place pursuant to
subsequent legislation that directed the Agency to continue its
oversight of au pair activities under the ``same terms and conditions''
of the pilot guidelines. Public Law 104-72 removes this programmatic
limitation by directing the Agency to oversee au pair activities
conducted on a ``world-wide basis.''
Accordingly, the Agency has advised au pair sponsors that, unless
otherwise prohibited by law, au pair participants may be recruited from
all world countries. The Agency construes ``world-wide'' basis to not
include nationals of countries lacking diplomatic relations with the
United States. Further, the Agency is of the opinion that ``World wide
basis'' would allow a national of one country, resident in another, to
be recruited and issued a visa in the country of residence.
The Agency concludes that Public Law 104-72 renders inoperative,
the ``same terms and conditions'' requirement of prior legislation.
Accordingly, the Agency will accept applications from United States
organizations seeking designation as an au pair sponsor. Due to the
time-limited authority given the Agency in Public-Law 104-72, all
designated au pair sponsors will continue to be given temporary, not
permanent, program designations. Such designations will be made by the
Agency under the authority of Public Law 104-72 and not under the
Agency's Fulbright-Hays Act authorities as set forth at 22 U.S.C. 1474
et seq.
Finally, the Agency hereby gives notice of its intent to limit the
number of au pair participants to not more than 22,720. The Agency does
not believe that currently designated sponsors, and those organizations
receiving new designations, will be affected by this numerical
limitation. This belief is based upon the past history of au pair
activities and the Agency's knowledge of the growth rates of similar
programs overseen by the Agency.
The Agency specifically reserves the right to limit the number of
participants sponsored by an individual organization. Participant
levels for newly designated au pair sponsors will be determined by the
Agency in consultation with the sponsor. The organization's prior
experience, organizational capacity, and resources will be specifically
considered in determining participant levels.
List of Subjects in 22 CFR Part 514
Cultural exchange programs.
[[Page 8216]]
Dated: February 28, 1996.
Les Jin,
General Counsel.
[FR Doc. 96-4973 Filed 3-1-96; 8:45 am]
BILLING CODE 8230-01-M
Complete official Federal Register PDF
FR Doc. 96-4958 Prohibition on Gasoline Containing Lead or Lead Additives for Highway Use
[Federal Register Volume 61, Number 43 (Monday, March 4, 1996)]
[Rules and Regulations]
[Page 8221]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-4958]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 80
[FRL-5433-8]
RIN 2060-AD55
Prohibition on Gasoline Containing Lead or Lead Additives for
Highway Use
AGENCY: Environmental Protection Agency (EPA).
ACTION: Partial withdrawal of direct final rule.
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SUMMARY: On February 2, 1996, EPA published a direct final rule (61 FR
3832) revising EPA regulations to reflect the Clean Air Act's statutory
prohibition of the introduction into commerce of gasoline containing
lead or lead additives for use as a motor vehicle fuel after December
31, 1995. This action was published without prior proposal. Because EPA
has received adverse comment with respect to paragraph 40 CFR 80.24(b)
of this action, EPA withdraws this paragraph from the direct final
rule. The withdrawal of this paragraph does not otherwise affect the
February 2, 1996 direct final rule, for which all other actions will
become effective March 4, 1996.
EFFECTIVE DATE: March 4, 1996.
FOR FURTHER INFORMATION CONTACT: Richard Babst, U.S. Environmental
Protection Agency, Office of Air and Radiation, (202) 233-9473.
SUPPLEMENTARY INFORMATION: On February 2, 1996, EPA published in the
Federal Register a direct final rule revising its regulations in
accordance with the Clean Air Act prohibition of the introduction of
gasoline containing lead or lead additives into commerce for use as a
motor vehicle fuel after December 31, 1995. Among other actions, the
direct final rule would have revised paragraph 40 CFR 80.24(b), which
contains a specification regarding gasoline tank filler inlets for
motor vehicles. The direct final rule was published without prior
proposal in the Federal Register with a provision for a 15 day comment
period. In addition, EPA published a proposed rule, also on February 2,
1996 (61 FR 3894). EPA announced in both rules that, should EPA receive
adverse comment on the direct final rule, the Agency would withdraw the
direct final rule and address the comments received in a subsequent
final rule based on the related proposed rule. EPA received adverse
comment within the prescribed comment period specifically addressing a
revision that would have been made to 40 CFR 80.24(b). With this
document, EPA is withdrawing revisions to 40 CFR 80.24(b) from the
February 2, 1996 direct final rule (61 FR 3832). The withdrawal of this
paragraph does not affect the other actions in the February 2, 1996
direct final rule, and all other actions will become effective March 4,
1996 as indicated in the direct final rule. The adverse comment
received will be addressed in a subsequent final rule based on the
related proposed rule (61 FR 3894).
List of Subjects in 40 CFR Part 80
Environmental protection, Air pollution control, Fuel additives,
Gasoline, Leaded gasoline, Unleaded gasoline, Motor vehicle pollution.
For the reasons set forth in the preamble, the amendment revising
40 CFR 80.24(b) published at 61 FR 3838 (February 2, 1996) is
withdrawn.
Dated: February 27, 1996.
Carol M. Browner,
Administrator.
[FR Doc. 96-4958 Filed 3-1-96; 8:45 am]
BILLING CODE 6560-50-P
Complete official Federal Register PDF
FR Doc. 96-4953 Regulatory Reform Initiative
[Federal Register Volume 61, Number 43 (Monday, March 4, 1996)]
[Rules and Regulations]
[Pages 8207-8208]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-4953]
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DEPARTMENT OF AGRICULTURE
Commodity Credit Corporation
7 CFR Parts 1487, 1491, 1492 and 1495
Regulatory Reform Initiative
AGENCY: Commodity Credit Corporation (CCC), USDA.
ACTION: Final rule.
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SUMMARY: In response to the President's Regulatory Reform Initiative,
the Commodity Credit Corporation is issuing this final rule to amend
its regulations to eliminate the following programs: Noncommercial Risk
Assurance Program (GSM-101); CCC Intermediate Credit Export Sales
Program for Breeding Animals (GSM-201); CCC Intermediate Credit Export
Sales Program for Foreign Market Development Facilities (GSM-301); and
Disposition of Agricultural Commodities under the CCC Barter Program
(Barter Program). These programs are inactive or obsolete and have not
been used in 15 years or more.
EFFECTIVE DATE: April 3, 1996.
FOR FURTHER INFORMATION CONTACT: L.T. McElvain, Director, CCC
Operations Division, Foreign Agricultural Service, U.S. Department of
Agriculture, AG Box 1035, Washington D.C., 20250-1035; Fax (202) 720-
2949; Telephone (202) 720-6211. The U.S. Department of Agriculture
(USDA) prohibits
[[Page 8208]]
discrimination in its programs on the basis of race, color, national
origin, sex, religion, age, disability, political beliefs and marital
or familial status. Persons with disabilities who require alternative
means for communication of program information (braille, large print,
audiotape, etc.) should contact the USDA Office of Communications at
(202) 720-5881 (voice) or (202) 720-7808 (TDD).
SUPPLEMENTARY INFORMATION:
Executive Order 12866
This final rule is issued in conformance with Executive Order
12866. It has been determined to be neither significant nor
economically significant for the purposes of E.O. 12866 and, therefore,
has not been reviewed by the Office of Management and Budget (OMB).
Regulatory Flexibility Act
It has been determined that the Regulatory Flexibility Act is not
applicable to this final rule since CCC is not required by 5 U.S.C. 553
or any other provision of law to publish a notice of rulemaking with
respect to the subject matter of this rule.
Executive Order 12372
These programs are not subject to the provisions of Executive Order
12372, which requires intergovernmental consultation with State and
local officials. See notice related to 7 CFR part 3015, subpart V,
published at 48 FR 29115 (June 24, 1983).
Environmental Evaluation
It has been determined by an environmental evaluation that this
action will not have a significant impact on the quality of the human
environment. Therefore, neither an Environmental Assessment nor an
Environmental Impact Statement is needed.
Paperwork Reduction Act
The amendment to 7 CFR parts 1487, 1491, 1492 and 1495 set forth in
this final rule does not contain information collections that require
clearance by the OMB under the provisions of 44 U.S.C. 35.
Executive Order 12778
This final rule has been reviewed under Executive Order 12778,
Civil Justice Reform. The final rule would not have preemptive effect
with respect to any state or local laws, regulations, or policies which
conflict with such provisions or which otherwise impede their full
implementation. The rule would not have retroactive effect.
The Department of Agriculture is committed to carrying out its
statutory and regulatory mandates in a manner that best serves the
public interest. Therefore, where legal discretion permits, the
Department actively seeks to promulgate regulations that promote
economic growth, create jobs, are minimally burdensome, and are easy
for the public to understand, use or comply with. In short, the
Department is committed to issuing regulations that maximize net
benefits to society and minimize costs imposed by those regulations.
Background
CCC published a proposed rule in the Federal Register on December
13, 1995, in response to the President's Regulatory Reform Initiative,
that would amend Title 7 of the Code of Federal Regulations to remove
the following parts:
Part 1487--Noncommercial Risk Assurance Program (GSM-101);
Part 1491--CCC Intermediate Credit Export Sales Program
for Breeding Animals (GSM-201);
Part 1492--CCC Intermediate Credit Export Sales Program
for Foreign Market Development Facilities (GSM-301); and
Part 1495--Disposition of Agricultural Commodities under
the CCC Barter Program (Barter Program).
Reasons for Removal
CCC proposed to remove these parts for the following reasons:
GSM-101--This risk assurance program, implemented in 1979,
covered only non-commercial or political risk and became obsolete when
the CCC Export Credit Guarantee Program (GSM-102) was introduced in
1980 to cover political and commercial risk. The GSM-101 program was
last used in 1981.
GSM-201--This direct credit program has been used only
once (a transaction for livestock exports to Spain in 1979). The terms
available under the program--3 to 10 year direct credits--could be made
available under a modified GSM-5 Program (7 CFR Part 1488) Financing of
Sales of Agricultural Commodities Program.
GSM-301--This direct credit program was intended to
facilitate commodity exports which would be sold to generate funds to
finance the construction of a market development project. The program
was used only once (in connection with a bulk grain discharge and
storage facility developed at Ashdod, Israel). That project began in
1978 and was completed in the early 1980's. For a number of years,
funding has not been made available for this program.
Barter Program--From 1950 through 1973, CCC exchanged CCC-
owned agricultural commodities for strategic and critical materials for
the National Defense Stockpile. The program could also be used to
obtain foreign-produced supplies and services used in Department of
Defense construction projects and Agency for International Development
projects. The program was terminated in 1973 when CCC stocks were
depleted. The National Defense Stockpile is now liquidating many
strategic materials. Also, CCC has authority, which it has at times
used, to enter into direct barter arrangements under the CCC Charter
Act in order to obtain strategic materials for defense stock piles.
Comments
The deadline for submitting comments on the proposed rule was
January 12, 1996. CCC did not receive any comments on this proposed
rule. CCC has determined to make the changes to 7 CFR Part 1487, Part
1491, Part 1492, and Part 1495 as proposed.
List of Subjects
7 CFR Part 1487
Agricultural commodities, Exports, Insurance, Reporting and
recordkeeping requirements.
7 CFR Part 1491 and 1492
Exports, Livestock, Loan programs--agriculture, Reporting and
recordkeeping requirements.
7 CFR Part 1495
Agricultural commodities, Exports, Government procurement,
Strategic and critical materials.
PARTS 1487, 1491, 1492, 1495--[REMOVED]
For the reasons set out in the preamble under the authority at 5
U.S.C. Section 552(a)(1)(E), 7 CFR Chapter XIV is amended by removing
and reserving parts 1487, 1491, 1492 and 1495.
Signed at Washington, DC, on February 27, 1996.
Christopher E. Goldthwait,
General Sales Manager and Vice President, Commodity Credit Corporation.
[FR Doc. 96-4953 Filed 3-1-96; 8:45 am]
BILLING CODE 3410-10-P
Complete official Federal Register PDF
FR Doc. 96-4952 Importation of Citrus Fruits From Australia
[Federal Register Volume 61, Number 43 (Monday, March 4, 1996)]
[Rules and Regulations]
[Pages 8205-8207]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-4952]
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DEPARTMENT OF AGRICULTURE
7 CFR Part 319
[Docket No. 93-119-2]
Importation of Citrus Fruits From Australia
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Final rule.
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SUMMARY: We are amending the Fruits and Vegetables regulations to allow
oranges, lemons, limes, mandarins, and grapefruit from the Riverina and
[[Page 8206]]
Sunraysia districts of Australia to be imported into the United States.
We are taking this action because we have determined that the citrus
may be imported without presenting a significant risk of introducing
injurious plant pests into the United States. This rule provides
importers and consumers in the United States with an additional source
of citrus fruit.
EFFECTIVE DATE: March 4, 1996.
FOR FURTHER INFORMATION CONTACT: Mr. Peter M. Grosser, Senior
Operations Officer, Port Operations, PPQ, APHIS, 4700 River Road Unit
139, Riverdale, MD 20737-1236, (301) 734-8891.
SUPPLEMENTARY INFORMATION:
Background
The Fruits and Vegetables regulations in 7 CFR 319.56 through
319.56-8 (referred to below as ``the regulations'') prohibit or
restrict the importation of fruits and vegetables to prevent the
introduction and dissemination of injurious insects, including fruit
flies, that are new to or not widely distributed in the United States.
Paragraphs (e) and (f) of Sec. 319.56-2 contain requirements for the
importation of certain fruits and vegetables based on their origin in a
definite area or district. The definite area or district must meet
certain criteria, including criteria designed to ensure that the area
or district is free from all or certain injurious insects. Section
319.56-2v contains provisions for importing citrus fruit from
Australia.
On September 11, 1995, we published in the Federal Register (60 FR
47101-47103, Docket No. 93-119-1) a proposal to amend the regulations
to allow oranges, lemons, limes, mandarins, and grapefruit from the
Riverina and Sunraysia districts of Australia to be imported into the
United States. We proposed to allow importation of the citrus fruit
without cold treatment for fruit flies, provided that the districts
remain free of fruit flies that attack citrus. If any such fruit flies
were detected in the districts, we proposed to allow importation of the
citrus fruit subject to the completion of an Animal and Plant Health
Inspection Service authorized cold treatment and subject to all other
applicable requirements of the regulations.
We solicited comments concerning our proposal for 30 days ending
October 11, 1995. We received 12 comments by that date. They were from
growers, packers, producers, shippers, grocery chains, and an
independent distributor. Nine of the commenters completely supported
the proposed rule. The remarks of the three remaining commenters are
discussed below by topic. Two of the comments were on reciprocal trade
agreements and were nearly identical.
Disease Risk
Comment: The proposed importation into the United States of citrus
fruits from the Riverina and Sunraysia districts of Australia could
introduce several serious citrus diseases, including Australian scab,
citrus black spot, and diseases of the species Guignardia, into the
United States. Disease surveys for these pathogens should be performed
in the Riverina and Sunraysia districts of Australia prior to allowing
citrus fruits from these districts to be imported into the United
States. Additionally, provisions should be made for ongoing disease
surveys in these districts before the proposed importation is allowed.
Response: We do not believe that citrus fruits from the Riverina
and Sunraysia districts of Australia are likely to introduce serious
diseases into the United States. Citrus black spot, Guignardia
citricarpa, and Australian citrus scab, Sphaceloma fawcetti var.
scabiosa, occur where abundant rainfall and a suitable temperature
range favor development of infection, not in inland areas such as the
arid, hot Riverina and Sunraysia districts. We do not believe that
these pathogens could survive in the irrigated horticultural areas of
the Riverina and Sunraysia districts. Additionally, no other species of
Guignardia has been reported as the cause for a disease on citrus.
These facts, plus the pest and disease monitoring system continuously
maintained by the plant pest authorities in the Riverina and Sunraysia
districts, convince us that the disease risk posed by citrus fruits
from the Riverina and Sunraysia districts of Australia is
insignificant. If either Guignardia citricarpa or Sphaceloma fawcetti
var. scabiosa were detected in citrus fruits from the Riverina and
Sunraysia districts of Australia, our importation program would cease
immediately.
Reciprocal Trade Agreements
Comment: More than 3 years ago, Florida's citrus industry
petitioned the Australian Quarantine and Inspection Service (AQIS) to
allow Florida citrus fruits to be imported into Australia. AQIS should
respond to Florida's petition before a decision is reached regarding
the importation into the United States of citrus fruits from the
Riverina and Sunraysia districts of Australia.
Response: Our proposal and decision to allow importation of citrus
fruits from the Riverina and Sunraysia districts of Australia are based
solely on whether these importations can be made without significant
risk of pest introduction. We have no authority to base these decisions
on the presence or absence of reciprocal arrangements.
Therefore, based on the rationale set forth in the proposed rule
and in this document, we are adopting the provisions of the proposal as
a final rule with a minor editorial change for clarity.
Effective Date
This is a substantive rule that relieves restrictions and, pursuant
to the provisions of 5 U.S.C. 553, may be made effective less than 30
days after publication in the Federal Register. Immediate
implementation of this rule is necessary to provide relief to those
persons who are adversely affected by restrictions we no longer find
warranted. Therefore, the Administrator of the Animal and Plant Health
Inspection Service has determined that this rule should be effective
upon publication in the Federal Register.
Executive Order 12866 and Regulatory Flexibility Act
This rule has been reviewed under Executive Order 12866. The rule
has been determined to be not significant for the purposes of Executive
Order 12866 and, therefore, has not been reviewed by the Office of
Management and Budget.
We are amending the Fruits and Vegetables regulations by allowing
the importation of oranges, lemons, limes, mandarins, and grapefruit
from the Riverina and Sunraysia districts of Australia.
According to a U.S. Department of Agriculture estimate, the total
U.S. production of citrus fruits was approximately 11.172 million
metric tons in 1992. Approximately 1.1 million metric tons of citrus
fruits were exported from the United States in 1992, with about 9,741
metric tons exported to Australia.
According to an estimate offered by the Australian Office of the
Counsellor, Australia produced approximately 592,000 metric tons of
citrus fruits in 1992. Citrus production in Australia is oriented
primarily to domestic consumption, with exports accounting for
approximately 79,000 metric tons, or only about 13 percent of the total
production, in 1992. Of the total quantity exported, 2,517 metric tons
(about 3 percent) went to the United States.
The U.S. entities who will be most affected by this rule include
citrus fruit producers, exporters, and importers. It is estimated that
93 percent of the U.S. farms that produce citrus fruit,
[[Page 8207]]
approximately 21,225 farms in all, qualify as small businesses. While
this rule provides an additional supply of citrus fruit in the United
States, domestic citrus fruit producers, including small entities, can
expect a very insignificant decline in the price of citrus fruits. Due
to the seasonal difference in availability, U.S. and Australian
producers will not be in direct competition for the domestic citrus
market. Both exporters and importers are expected to benefit from the
rule. The projected benefit to exporters may accrue from the expanded
export opportunities that may result from a favorable reciprocal trade
treatment given by Australia. Importers may also benefit from the
increased availability of citrus fruit, especially navel oranges,
during the time of year when U.S. production is lowest. However, the
economic benefits to importers and exporters are not expected to be
significant.
Under these circumstances, the Administrator of the Animal and
Plant Health Inspection Service has determined that this action will
not have a significant economic impact on a substantial number of small
entities.
Executive Order 12778
This rule allows oranges, lemons, limes, mandarins, and grapefruit
to be imported into the United States from the Riverina and Sunraysia
districts of Australia. State and local laws and regulations regarding
citrus fruit imported under this rule will be preempted while the fruit
is in foreign commerce. Fresh citrus fruits are generally imported for
immediate distribution and sale to the consuming public, and will
remain in foreign commerce until sold to the ultimate consumer. The
question of when foreign commerce ceases in other cases must be
addressed on a case-by-case basis. No retroactive effect will be given
to this rule, and this rule will not require administrative proceedings
before parties may file suit in court challenging this rule.
Paperwork Reduction Act
This rule contains no new information collection or recordkeeping
requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
et seq.).
List of Subjects in 7 CFR Part 319
Bees, Coffee, Cotton, Fruits, Honey, Imports, Incorporation by
reference, Nursery stock, Plant diseases and pests, Quarantine,
Reporting and recordkeeping requirements, Rice, Vegetables.
Accordingly, 7 CFR part 319 is amended as follows:
PART 319--FOREIGN QUARANTINE NOTICES
1. The authority citation for part 319 continues to read as
follows:
Authority: 7 U.S.C. 150dd, 150ee, 150ff, 151-167, 450, 2803, and
2809; 21 U.S.C. 136 and 136a; 7 CFR 2.22, 2.80, and 371.2(c).
2. Section 319.56-2v is revised to read as follows:
Sec. 319.56-2v Conditions governing the entry of citrus from
Australia.
(a) The Administrator has determined that the irrigated
horticultural areas within the following districts of Australia meet
the criteria of Sec. 319.56-2 (e) and (f) with regard to the
Mediterranean fruit fly (Ceratitis capitata [Wiedemann]), the
Queensland fruit fly (Dacus tryoni [Frogg]), and other fruit flies
destructive of citrus:
(1) The Riverland district of South Australia, defined as the
county of Hamley and the geographical subdivisions, called
``hundreds,'' of Bookpurnong, Cadell, Gordon, Holder, Katarapko,
Loveday, Markaranka, Morook, Murtho, Parcoola, Paringa, Pooginook,
Pyap, Stuart, and Waikerie;
(2) The Riverina district of New South Wales, defined as:
(i) The shire of Carrathool; and
(ii) The Murrumbidgee Irrigation Area, which is within the
administrative boundaries of the city of Griffith and the shires of
Leeton, Narrendera, and Murrumbidgee; and
(3) The Sunraysia district, defined as the shires of Wentworth and
Balranald in New South Wales and the shires of Mildura, Swan Hill,
Wakool, and Kerang, the cities of Mildura and Swan Hill, and the
borough of Kerang in Victoria.
(b) Oranges (Citrus sinensis [Osbeck]); lemons (C. limonia [Osbeck]
and meyeri [Tanaka]); limes (C. aurantiifolia [Swingle] and latifolia
[Tanaka]); mandarins, including satsumas, tangerines, tangors, and
other fruits grown from this species or its hybrids (C. reticulata
[Blanco]); and grapefruit (C. paradisi [MacFad.]) may be imported from
the Riverland, Riverina, and Sunraysia districts without treatment for
fruit flies, subject to paragraph (c) of this section and all other
applicable requirements of this subpart.
(c) If surveys conducted in accordance with Sec. 319.56-2d(f)
detect, in a district listed in paragraph (a) of this section, the
Mediterranean fruit fly (Ceratitis capitata [Wiedemann]), the
Queensland fruit fly (Dacus tryoni [Frogg]), or other fruit flies that
attack citrus and for which a treatment is listed in the Plant
Protection and Quarantine (PPQ) Treatment Manual, citrus fruit from
that district will remain eligible for importation into the United
States in accordance with Sec. 319.56-2(e)(2), provided the fruit
undergoes cold treatment in accordance with the PPQ Treatment Manual,
which is incorporated by reference at Sec. 300.1 of this chapter, and
provided the fruit meets all other applicable requirements of this
subpart. Entry is limited to ports listed in Sec. 319.56-2d(b)(1) of
this subpart if the treatment is to be completed in the United States.
Entry may be through any port if the treatment has been completed in
Australia or in transit to the United States. If no approved treatment
for the detected fruit fly appears in the PPQ Treatment Manual,
importation of citrus from the affected district or districts is
prohibited.
Done in Washington, DC, this 28th day of February 1996.
Lonnie J. King,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 96-4952 Filed 3-1-96; 8:45 am]
BILLING CODE 3410-34-P
Complete official Federal Register PDF
FR Doc. 96-4951 Mediterranean Fruit Fly
[Federal Register Volume 61, Number 43 (Monday, March 4, 1996)]
[Rules and Regulations]
[Page 8205]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-4951]
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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. 43 / Monday, March 4, 1996 / Rules
and Regulations
[[Page 8205]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
7 CFR Part 301
[Docket 91-155-18]
Mediterranean Fruit Fly
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Affirmation of interim rules as final rule.
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SUMMARY: We are adopting as a final rule, without change, the
Mediterranean fruit fly regulations, as established and amended by a
series of interim rules published in the Federal Register between
November 1991 and August 1995. The regulations quarantine portions of
California and restrict the interstate movement of regulated articles
for those areas to help prevent the spread of the Mediterranean fruit
fly into noninfested areas of the United States.
EFFECTIVE DATE: April 3, 1996.
FOR FURTHER INFORMATION CONTACT: Mr. Michael B. Stefan, Operations
Officer, Domestic and Emergency Operations, PPQ, APHIS, 4700 River Road
Unit 134, Riverdale, MD 20737-1236; (301) 734-8247.
SUPPLEMENTARY INFORMATION:
Background
The Mediterranean fruit fly, Ceratitis capitata (Wiedemann), is one
of the world's most destructive pests of numerous fruits and
vegetables. The Mediterranean fruit fly (Medfly) can cause serious
economic losses. Heavy infestations can cause complete loss of crops,
and losses of 25 to 50 percent are not uncommon. The short life cycle
of this pest permits the rapid development of serious outbreaks.
In an interim rule effective November 5, 1991, and published in the
Federal Register on November 13, 1991 (56 FR 57573-57579, Docket No.
91-155), we established the Mediterranean fruit fly (Medfly)
regulations (7 CFR 301.78 through 301.78-10; referred to below as the
regulations) and quarantined the Hancock Park area of Los Angeles
County, CA. The regulations impose restrictions on the interstate
movement of regulated articles from quarantined areas in order to
prevent the spread of the Medfly to noninfested areas of the United
States. We have published a series of interim rules amending these
regulations by adding to or removing from the list of quarantined areas
certain portions of Los Angeles, Santa Clara, Orange, Riverside, San
Bernardino, San Diego, and Ventura Counties, CA, and by adding three
treatments for fruit. Amendments affecting the quarantined areas in
California were made effective on September 10 and November 12, 1992;
and on January 19, July 16, August 3, September 15, October 8, November
22, and December 16, 1993; and on January 10, February 14, March 4,
July 7, August 2, and October 12, 1994; and on August 1, 1995 (57 FR
42485-42486, Docket No. 91-155-2; 57 FR 54166-54169, Docket No. 91-155-
3; 58 FR 6343-6346, Docket No. 91-155-4; 58 FR 39123-39124, Docket No.
91-155-5; 58 FR 42489-42491, Docket No. 91-155-6; 58 FR 49186-49190,
Docket No. 91-155-7; 58 FR 53105-53109, Docket No. 91-155-8; 58 FR
63027-63031, Docket No. 91-155-9; 58 FR 67627-67630, Docket No. 91-155-
10; 59 FR 2281-2283, Docket No. 91-155-11; 59 FR 7895-7896, Docket No.
91-155-12; 59 FR 11177-11180, Docket No. 91-155-13; 59 FR 35611-35612,
Docket No. 91-155-14; 59 FR 40207-40209, Docket No. 91-155-15; and 59
FR 52405-52407, Docket No. 91-155-16; 60 FR 40053-40054, Docket No. 91-
155-17).
Comments on these interim rules were required to be received on or
before 60 days after the date of publication in the Federal Register.
We did not receive any comments. The facts presented in the interim
rules still provide a basis for these rules.
This action also affirms the information contained in the interim
rules concerning Executive Orders 12291 and 12866 and Regulatory
Flexibility Act, Executive Orders 12372 and 12778, and the Paperwork
Reduction Act.
Further, for this action, the Office of Management and Budget has
waived the review process required by Executive Order 12866.
List of Subjects in 7 CFR Part 301
Agricultural commodities, Plant diseases and pests, Quarantine,
Reporting and recordkeeping requirements, Transportation.
PART 301--DOMESTIC QUARANTINE NOTICES
Accordingly, we are adopting as a final rule, without change, the
regulations at 7 CFR 301.78 through 301.78-10, as amended by interim
rules that were published at 56 FR 57573-57579 on November 13, 1991; 57
FR 42485-42486 on September 15, 1992; 57 FR 54166-54169 on November 17,
1992; 58 FR 6343-6346 on January 28, 1993; 58 FR 39123-39124 on July
22, 1993; 58 FR 42489-42491 on August 10, 1993; 58 FR 49186-49190 on
September 22, 1993; 58 FR 53105-53109 on October 14, 1993; 58 FR 63027-
63031 on November 30, 1993; 58 FR 67627-67630 on December 22, 1993; 59
FR 2281-2283 on January 14, 1994; 59 FR 7895-7896 on February 17, 1994;
59 FR 11177-11180 on March 10, 1994; 59 FR 35611-35612 on July 13,
1994; 59 FR 40207-40208 on August 8, 1994; and 59 FR 52405-52407 on
October 18, 1994; 60 FR 40053-40054 on August 7, 1995.
Authority: 7 U.S.C. 150bb, 150dd, 150ee, 150ff, 161, 162, and
164-167; 7 CFR 2.22, 2.80, and 371.2(c).
Done in Washington, DC, this 26th day of February 1996.
Lonnie J. King,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 96-4951 Filed 3-1-96; 8:45 am]
BILLING CODE 3410-34-P
Complete official Federal Register PDF
FR Doc. 96-4930 National Flood Insurance Program; Insurance Rates
[Federal Register Volume 61, Number 43 (Monday, March 4, 1996)]
[Rules and Regulations]
[Pages 8222-8223]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-4930]
=======================================================================
-----------------------------------------------------------------------
FEDERAL EMERGENCY MANAGEMENT AGENCY
44 CFR Part 61
RIN 3067-AC42
National Flood Insurance Program; Insurance Rates
AGENCY: Federal Insurance Administration, FEMA.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This final rule increases the National Flood Insurance Program
(NFIP) chargeable (subsidized) rates, which apply to all structures
located in communities participating in the Emergency Program of the
NFIP and to certain structures in communities in the Regular Program of
the NFIP. The rule is promulgated in order to bring subsidized premiums
more in line with the risk. This rule will help the NFIP increase the
capability to build reserves for catastrophic loss years.
EFFECTIVE DATE: April 30, 1996.
FOR FURTHER INFORMATION CONTACT: Charles M. Plaxico, Jr., Federal
Emergency Management Agency, Federal Insurance Administration, 500 C
Street SW., Washington, DC 20472, (202) 646-3422.
SUPPLEMENTARY INFORMATION: FEMA published a proposed rule (60 FR 56552,
November 9, 1995) to increase the National Flood Insurance Program
(NFIP) chargeable (subsidized) rates. Comments were solicited from the
public with the comment period ending January 8, 1996. During this
period, no comments were received. As a result, this final rule
contains no changes from the proposed rule.
This rule increases the NFIP chargeable (subsidized) rates. The
increase results from an ongoing review and reappraisal of the NFIP and
of continuing efforts to maintain a business-like approach to its
administration by emulating successful property insurance programs in
the private sector and, at the same time, to achieve greater
administrative and fiscal effectiveness in its operations. The
amendments in the rates will help the NFIP increase the capability to
build reserves for catastrophic loss years. Coverage changes and
optional deductibles, in addition to rate increases, are part of the
ongoing effort to achieve these goals.
The chargeable (subsidized) rates, to which this rule applies, are
the rates applicable to structures located in communities participating
in the Emergency Program of the NFIP and to certain structures in
communities in the Regular Program of the NFIP.
These rates are countrywide rates for two broad building type
classifications which, when applied to the amount of insurance
purchased and added to the expense constant and Federal policy fee,
produce a premium income less than the expense and loss payments that
can be expected on the flood insurance policies issued on that basis.
Funds needed to supplement the inadequate premium income are provided
by the National Flood Insurance Fund. The subsidized rates are
promulgated by the Administrator for use under the Emergency Program
(added to the NFIP by the Congress in Section 408 of the Housing and
Urban Development Act of 1969) and for use in the Regular Program on
construction or substantial improvement started before the effective
date of the initial Flood Insurance Rate Map (FIRM) or on or before
December 31, 1974 (this additional grandfathering was added to the NFIP
by Congress in section 103 of the Flood Disaster Protection Act of
1973), whichever is later.
It should be noted that over the NFIP's history, the Program has
not been subjected to a truly catastrophic flood event. Thus, the
historical average is substantially less than could be expected over
the long term when the influence of the extremely infrequent, truly
catastrophic flood would result in a significant increase in the
average historical year's losses. It is because of these fortuitous
conditions, the lack of market penetration in areas suffering very
large floods, and relatively high market penetration in the
southeastern part of the United States, which has not suffered a
catastrophic flood event recently, that the Program remained self-
supporting since 1986 relying only on policyholder funding. However,
the chargeable (subsidized) rates are significantly less than those
that would be charged on a full risk basis.
Using current subsidized rates and projected full risk loss costs
at 1995 levels, it is expected that the average annual shortfall in the
risk portion of premiums needed to fund loss expenses, including the
catastrophic potential, is over $400.00 for each subsidized
policyholder.
The statutory mandate to establish chargeable rates requires the
Federal Emergency Management Agency (FEMA) to balance the need for
providing reasonable rates to encourage potential insureds to purchase
flood insurance with the requirement that the NFIP be a flexible
program that minimizes cost and distributes burdens equitably among
those who will be protected by flood insurance and the general public.
In the past, appropriations were required to replenish the
program's borrowing authority when income was not sufficient due to the
subsidy. Since 1986, FEMA has not asked Congress to appropriate any
taxpayer funds to pay for this subsidy. Recent years have been
extremely high loss years starting with Hurricane Hugo in 1989,
Hurricanes Andrew and Iniki in 1992, the great Midwest flooding of
1993, and several other major flooding events, including the recent
flooding in Louisiana. The Louisiana flooding has resulted in the most
losses the Program has ever had and will result in the biggest payout
the Program has ever had from a single event. Because of this mounting
loss experience, we must reduce the subsidy.
Section 1308(e) of the National Flood Insurance Act of 1968, as
amended, contains an annual rate increase limitation of 10 percent. The
rates to accomplish the increase are in the following table. It should
be noted that
[[Page 8223]]
although the rates in the table have been increased more than 10
percent, the entire premium, which also includes an expense constant,
increases only by 10 percent.
------------------------------------------------------------------------
Rates per year per
$100 coverage on
Type of structure --------------------
Structure Contents
------------------------------------------------------------------------
(1) Residential.................................... $0.68 $0.79
(2) All other (including hotels and motels with
normal occupancy of less than 6 months in
duration)......................................... .79 1.58
------------------------------------------------------------------------
For comparison, the subsidized rates being replaced by the
preceding rates are as follows:
------------------------------------------------------------------------
Rates per year per
$100 coverage on
Type of structure --------------------
Structure Contents
------------------------------------------------------------------------
(1) Residential.................................... $0.60 $0.70
(2) All other (including hotels and motels with
normal occupancy of less than 6 months in
duration)......................................... .70 1.40
------------------------------------------------------------------------
The increase is balanced between the provisions of the statute for
chargeable rates that are less than actuarial rates, consistent with
the objective of making flood insurance available at reasonable rates
so as to encourage prospective insureds to purchase flood insurance,
and the need to decrease the subsidy.
The projected average annual premium for subsidized policies using
the revised chargeable rates and purchasing 1995 amounts of insurance
is $441.00, a $40.00 increase over the present average. Despite this
increase, the new rates produce only an estimated 39 percent of the
premium that would have to be charged if these policies were
actuarially rated (i.e., not subsidized).
National Environmental Policy Act
Pursuant to section 102(2)(C) of the National Environmental Policy
Act of 1969, 42 U.S.C. 4371 et seq., and the implementing regulations
of the Council on Environmental Quality, 40 CFR parts 1500-1508, FEMA
prepared an environmental assessment for this rule. The assessment
concludes that there will be no significant impact on the human
environment as a result of the issuance of the proposed rule. This
final rule is not a major Federal action significantly affecting the
quality of the human environment. An Environmental Impact Statement has
not been prepared. Copies of the environmental assessment are available
for inspection through the Rules Docket Clerk, Federal Emergency
Management Agency, room 840, 500 C Street SW., Washington, DC 20472.
Executive Order 12866, Regulatory Planning and Review
This rule is not a significant regulatory action as defined under
Executive Order 12866 of September 30, 1993, Regulatory Planning and
Review, 58 FR 51735, October 4, 1993. To the extent possible, this rule
adheres to the principles of regulation as set forth in Executive Order
12866. This rule has not been reviewed by the Office of Management and
Budget under the provisions of Executive Order 12866.
Paperwork Reduction Act
This rule does not contain a collection of information and is
therefore not subject to the provisions of the Paperwork Reduction Act
of 1995.
Executive Order 12612, Federalism
This rule involves no policies that have federalism implications
under Executive Order 12612, Federalism, dated October 26, 1987.
Executive Order 12778, Civil Justice Reform
This rule meets the applicable standards of section 2(b)(2) of
Executive Order 12778, Civil Justice Reform.
List of Subjects in 44 CFR Part 61
Flood insurance.
Accordingly, 44 CFR part 61 is amended as follows:
PART 61-- INSURANCE COVERAGE AND RATES
1. The authority citation for part 61 continues to read as follows:
Authority: 42 U.S.C. 4001 et seq.; Reorganization Plan No. 3 of
1978, 43 FR 41943, 3 CFR, 1978 Comp., p. 329; E.O. 12127 of Mar. 31,
1979, 44 FR 19367, 3 CFR, 1979 Comp., p. 376.
2. Section 61.9 is revised to read as follows:
Sec. 61.9 Establishment of chargeable rates.
(a) Pursuant to section 1308 of the Act, chargeable rates per year
per $100 of flood insurance are established as follows for all areas
designated by the Administrator under part 64 of this subchapter for
the offering of flood insurance.
Rates for New and Renewal Policies
------------------------------------------------------------------------
Rates per year per
$100 coverage on
Type of structure --------------------
Structure Contents
------------------------------------------------------------------------
(1) Residential.................................... $0.68 $0.79
(2) All other (including hotels and motels with
normal occupancy of less than 6 months in duration .79 1.58
------------------------------------------------------------------------
(b) The contents rate shall be based upon the use of the individual
premises for which contents coverage is purchased.
(Catalog of Federal Domestic Assistance No. 83.100, ``Flood
Insurance'').
Dated: February 27, 1996.
Elaine A. McReynolds,
Administrator, Federal Insurance Administration.
[FR Doc. 96-4930 Filed 3-1-96; 8:45 am]
BILLING CODE 6718-03-P
Complete official Federal Register PDF
FR Doc. 96-4925 Project Cost and Annual Limits
[Federal Register Volume 61, Number 43 (Monday, March 4, 1996)]
[Rules and Regulations]
[Page 8213]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-4925]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF ENERGY
Federal Energy Regulatory Commission
18 CFR Part 157
[Docket No. RM81-19-000]
Project Cost and Annual Limits
Issued: February 27, 1996.
AGENCY: Federal Energy Regulatory Commission, DOE.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: Pursuant to the authority delegated by 18 CFR 375.307(e)(1),
the Director of the Office of Pipeline Regulation computes and
publishes the project cost and annual limits specified in Table I of
Sec. 157.208(d) and Table II of Sec. 157.215(a) for each calendar year.
EFFECTIVE DATE: January 1, 1996.
FOR FURTHER INFORMATION CONTACT:
Michael J. McGehee, Division of Pipeline Certificates, OPR, (202) 208-
2257.
SUPPLEMENTARY INFORMATION:
Order of the Director, OPR
Section 157.208(d) of the Commission's Regulations provides for
project cost limits applicable to construction, acquisition, operation
and miscellaneous rearrangement of facilities (Table I) authorized
under the blanket certificate procedure (Order No. 234, 19 FERC para.
61,216). Section 157.215(a) specifies the calendar year dollar limit
which may be expended on underground storage testing and development
(Table II) authorized under the blanket certificate. Section 157.208(d)
requires that the ``limits specified in Tables I and II shall be
adjusted each calendar year to reflect the `GNP implicit price
deflator' published by the Department of Commerce for the previous
calendar year.''
Pursuant to Sec. 375.307(e)(1) of the Commission's Regulations, the
authority for the publication of such cost limits, as adjusted for
inflation, is delegated to the Director of the Office of Pipeline
Regulation. The cost limits for calendar years 1982 through 1996, as
published in Table I of Sec. 157.208(d) and Table II of
Sec. 157.215(a), are hereby issued.
Note that these inflation adjustments are based on the Gross
Domestic Product (GDP) Implicit Price Deflator, and include the
Commerce Department's estimated fourth quarter GDP Implicit Price
Deflator rather than the annual GDP Implicit Price Deflator or Gross
National Product (GNP) Implicit Price Deflator, which are not yet
available for 1995. The Commerce Department advises that in recent
years the annual change has been virtually the same for both indices.
Further adjustments will be made, if necessary.
List of Subjects in 18 CFR Part 157
Natural Gas.
Kevin P. Madden,
Director, Office of Pipeline Regulation.
Accordingly, 18 CFR Part 157 is amended as follows:
PART 157--[AMENDED]
1. The authority citation for Part 157 continues to read as
follows:
Authority: 15 U.S.C. 717-717w, 3301-3432; 42 U.S.C. 7101-7352.
Sec. 157.208 [Amended]
2. Table I in Sec. 157.208(d) is revised to read as follows:
Table I
------------------------------------------------------------------------
Limit
---------------------------
Prior notice
Year Auto. proj. pro. cost
cost limit limit (col.
(col. 1) 2)
------------------------------------------------------------------------
1982........................................ $4,200,000 $12,000,000
1983........................................ 4,500,000 12,800,000
1984........................................ 4,700,000 13,300,000
1985........................................ 4,900,000 13,800,000
1986........................................ 5,100,000 14,300,000
1987........................................ 5,200,000 14,700,000
1988........................................ 5,400,000 15,100,000
1989........................................ 5,600,000 15,600,000
1990........................................ 5,800,000 16,000,000
1991........................................ 6,000,000 16,700,000
1992........................................ 6,200,000 17,300,000
1993........................................ 6,400,000 17,700,000
1994........................................ 6,600,000 18,100,000
1995........................................ 6,700,000 18,400,000
1996........................................ 6,900,000 18,800,000
------------------------------------------------------------------------
Sec. 157.215 [Amended]
3. Table II in Sec. 157.215(a) is revised to read as follows:
Table II
------------------------------------------------------------------------
Year Limit
------------------------------------------------------------------------
1982...................................................... $2,700,000
1983...................................................... 2,900,000
1984...................................................... 3,000,000
1985...................................................... 3,100,000
1986...................................................... 3,200,000
1987...................................................... 3,300,000
1988...................................................... 3,400,000
1989...................................................... 3,500,000
1990...................................................... 3,600,000
1991...................................................... 3,800,000
1992...................................................... 3,900,000
1993...................................................... 4,000,000
1994...................................................... 4,100,000
1995...................................................... 4,200,000
1996...................................................... 4,300,000
------------------------------------------------------------------------
[FR Doc. 96-4925 Filed 3-1-96; 8:45 am]
BILLING CODE 6717-01-M
Complete official Federal Register PDF
FR Doc. 96-4922 Special Local Regulations; Parker 500 Enduro
[Federal Register Volume 61, Number 43 (Monday, March 4, 1996)]
[Rules and Regulations]
[Pages 8218-8219]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-4922]
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
33 CFR Part 100
[CG11-96-002]
RIN 2115-AE46
Special Local Regulations; Parker 500 Enduro
AGENCY: Coast Guard, DOT.
ACTION: Notice of implementation.
-----------------------------------------------------------------------
SUMMARY: This notice implements 33 CFR 100.1102, ``Marine Events on the
Colorado River, between Davis Dam (Bullhead City, Arizona) and Headgate
Dam (Parker, Arizona),'' for the Parker 500 Enduro'' listed as ``Parker
Enduro.''
This event consists of circle races and a marathon race by
powerboats 12 to 22 feet in length. These regulations will be effective
in the area of the Colorado River known as Parker Strip from Headgate
Dam to Badenochs Marina approximately 2.5 miles north. This is a
smaller area than that published in 33 CFR 100.1102. Implementation of
section 33 CFR 100.1102 is necessary to control vessel traffic in the
regulated areas during the event to ensure the safety of participants
and spectators.
EFFECTIVE DATE: Section 33 CFR 100.1102 is effective from 11 a.m., on
March 9, 1996 and until 6 p.m. on March 10, 1996, unless cancelled
earlier by the San Diego Activities Commander.
FOR FURTHER INFORMATION CONTACT:
QMC Paul Appleton, U.S. Coast Guard Activities San Diego, California;
Tel: (619) 683-6309.
Discussion of Notice
The Parker 500 Enduro is scheduled to occur on March 9 and 10,
1996. These
[[Page 8219]]
Special Local Regulations permit Coast Guard control of vessel traffic
in order to ensure the safety of spectators and participant vessels. In
accordance with the regulations in 33 CFR 100.1102, no spectators shall
anchor, block, loiter in, or impede the through transit of participants
or official patrol vessels in the regulated area during the effective
dates and times, unless cleared for such entry by or through an
official patrol vessel.
Dated: February 16, 1996.
R.A. Appelbaum,
Rear Admiral, U.S. Coast Guard, Commander, Eleventh Coast Guard
District.
[FR Doc. 96-4922 Filed 3-1-96; 8:45 am]
BILLING CODE 4910-14-M
Complete official Federal Register PDF
FR Doc. 96-4920 Special Local Regulations; City of Augusta, GA
[Federal Register Volume 61, Number 43 (Monday, March 4, 1996)]
[Rules and Regulations]
[Pages 8217-8218]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-4920]
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
33 CFR Part 100
[CGD07-96-004]
RIN 2115-AE46
Special Local Regulations; City of Augusta, GA
AGENCY: Coast Guard, DOT.
ACTION: Temporary final rule.
-----------------------------------------------------------------------
SUMMARY: Temporary special local regulations are being adopted for the
Augusta Port Authority Invitational Rowing Regatta. The event will be
held from 7 a.m. to 5 p.m. edt (Eastern Daylight Time) on March 21-24,
1996 on the Savannah River at August, GA. These regulations are
necessary to
[[Page 8218]]
provide for the safety of life on navigable waters during the event.
EFFECTIVE DATE: This rule is effective from 6:30 a.m. to 5:30 p.m. edt
on March 21-24, 1996.
ADDRESSES: Unless otherwise indicated, documents referred to in this
preamble are available for copying and inspection at U.S. Coast Guard
Group Charleston, 196 Tradd Street, Charleston, SC 29401-1817, between
8 a.m. and 3 p.m. edt, Monday through Friday, except federal holidays.
FOR FURTHER INFORMATION CONTACT:
ENS M. Daponte, U.S. Coast Guard Group Charleston, SC at (803) 724-
7621.
SUPPLEMENTARY INFORMATION: In accordance with 5 U.S.C. 553, a notice of
proposed rulemaking was not published for these regulations. Following
normal rulemaking procedures would have been impracticable. The
information necessary to hold the event was not received until January
10 1996, and there was not sufficient time remaining to publish
proposed rules in advance of the event or to provide for a delayed
effective date.
Discussion of Regulations
There will be 1000 participants racing 4 and 8 man rowing shells on
a fixed course. The event will take place on the portion of the
Savannah River at Augusta, Georgia between U.S. Highway 1/78/278
Bridge, at mile marker 199.45, and mile marker 197, on March 21-24,
1996. This rule is required to provide for the safety of life on the
navigable waters during the running of the Invitational Rowing Regatta.
Regulatory Evaluation
This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866 and does not require an assessment of
potential costs and benefits under section 6(a)(f) of that order. It
has not been reviewed review by the Office of Management and Budget
under that order. It is not significant under the regulatory policies
and procedures of the Department of Transportation (DOT) (44 FR 11040;
February 26, 1979). The Coast Guard expects the economic impact of this
proposal to be so minimal that a full Regulatory Evaluation under
paragraph 10e of the regulatory policies and procedures of DOT is
unnecessary. The regulated area encompasses less than 1.5 nautical
miles on the Savannah River between U.S. Highway 1/78/278 Bridge, at
mile marker 199.45, and mile marker 197, entry into which is prohibited
only for eleven hours on each day of the event.
Since the impact of this proposal is expected to be minimal, the
Coast Guard certifies that, if adopted, it will not have a significant
economic impact on a substantial number of small entities.
Collection of Information
These regulations contain no collection of information requirements
under the Paperwork Reduction Act (44 U.S.C. 3501 et seq.).
Federalism
The Coast Guard has analyzed this rule in accordance with the
principles and criteria contained in Executive Order 12612 and has
determined that this regulation does not have sufficient federalism
implications to warrant the preparation of a Federalism Assessment.
Environmental Assessment
The Coast Guard has considered the environmental impact of this
action consistent with Section 2.B.2. of Commandant Instruction
M16475.1B. In accordance with that section, this action has been
environmentally assessed (EA completed), and the Coast Guard has
determined that it will not significantly affect the quality of the
human environment. An environmental assessment and finding of no
significant impact have been prepared and are available for inspection
and copying at the address listed under ADDRESSES. As a condition to
the permit, the applicant is required to educate the operators of
spectator craft and parade participants regarding the possible presence
of manatees and the appropriate precautions to take if the animals are
sighted.
List of Subjects in 33 CFR Part 100
Marine safety, Navigation (water), Reporting and recordkeeping
requirements, Waterways.
Temporary Final Regulations
In consideration of the foregoing, part 100 of title 33, Code of
Federal Regulations, is amended as follows:
PART 100--[AMENDED]
1. The authority citation for part 100 continues to read as
follows:
Authority: 33 U.S.C. 1233, 49 CFR 1.46 and 33 CFR 100.35.
2. A temporary Sec. 100.35-07-004 is added as follows:
Sec. 100.35-07-004 Special Local Regulations; Savannah River at
Augusta, GA.
(a) Regulated area. A regulated area is established on that portion
of the Savannah River at Augusta, Georgia between U.S. Highway 1/78/278
Bridge, at mile marker 199.45, and mile marker 197. The regulated area
encompasses the width of the Savannah River between these two points.
(b) Special local regulations. (1) Entry into the regulated area by
other than event participants is prohibited, unless otherwise
authorized by the Patrol Commander. After termination of the Augusta
Invitational Rowing Regatta on March 24, 1996, all vessels may resume
normal operation.
(2) Four temporary overhead cables will be used to delineate the
course's racing lanes, and floats will be used on the surface of the
river to mark lane separations.
(c) Effective dates. This section is effective from 6:30 a.m. to
5:30 p.m. est on March 21-24, 1996.
Dated: February 20, 1996.
Roger T. Rufe, Jr.,
Rear Admiral, U.S. Coast Guard, Commander, Seventh Coast Guard
District.
[FR Doc. 96-4920 Filed 3-1-96; 8:45 am]
BILLING CODE 4910-14-M
Complete official Federal Register PDF
FR Doc. 96-4918 Safety Zone: Atlantic Intracoastal Waterway, Vicinity of Marine Corps Base Camp Lejeune, NC
[Federal Register Volume 61, Number 43 (Monday, March 4, 1996)]
[Rules and Regulations]
[Pages 8220-8221]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-4918]
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
33 CFR Part 165
[CGD 05-96-007]
RIN 2115-AA97
Safety Zone: Atlantic Intracoastal Waterway, Vicinity of Marine
Corps Base Camp Lejeune, NC
AGENCY: Coast Guard, DOT.
ACTION: Temporary rule.
-----------------------------------------------------------------------
SUMMARY: The Coast Guard Captain of the Port, Wilmington, has
established a safety zone in the Atlantic Intracoastal Waterway (AICW)
along Marine Corps Base Camp Lejeune (Marine Corps Base), North
Carolina. The safety zone encompasses the waters of the Atlantic
Intracoastal Waterway between lighted dayboards 64 and 65A. The safety
zone is needed to protect people, vessels, and property from safety
hazards associated with the launching of insert line charges in support
of amphibious assault training. Entry of vessels or persons into this
zone is prohibited unless specifically authorized by the Captain of the
Port.
EFFECTIVE DATE: This rule is effective from 8 a.m. March 8 to 6 a.m.
March 14 1996 unless sooner terminated by the Captain of the Port.
FOR FURTHER INFORMATION CONTACT:
LTJG K.J. DELOOFF, USCG, Project Officer, c/o Commanding Officer, U.S.
Coast Guard Marine Safety Office, 272 North Front Street, Wilmington,
North Carolina 28401-3907. Phone: (910) 343-4895, Extension 108.
SUPPLEMENTARY INFORMATION:
Discussion of Regulation
Marine Corps Base Camp Lejeune will conduct training assaults on a
simulated mined beach. Up to three exercises will be held each day and
each exercise will last 30-45 minutes. Each assault involves firing an
inert line charge which clears the simulated minefield. The inert
charge is propelled by a 5 foot solid fuel rocket from which the inert
explosives trail. The rocket is typically prevented from flying its
full flight by a cable attached to the firing point. If this cable
breaks, the rocket motor, and possibly the inert line charge could
impact in the Atlantic Intracoastal Waterway. The Coast Guard is
establishing a safety zone to prevent damage or injury which could
result from this training exercise and will prevent vessels from
transiting during the firing of the line charge.
The safety zone will be effective from 8 a.m. on March 8, 1996 to 6
a.m. on March 14, 1996 unless terminated sooner by the Captain of the
Port Wilmington (COTP). The actual times the waterway will be closed
will be approximately 30-45 minute periods one to three times per day.
Before firing the inert line charge, the COTP will announce via VHF
channel 16 that this section will be enforced and the waterway will be
closed to traffic. Vessels from either the U.S. Coast Guard or U.S.
Navy will patrol each end of the safety zone to inform and control
vessel traffic.
The safety zone includes:
The waters of the Atlantic Intracoastal Waterway from lighted
dayboard number 64 at approximately 34 deg.33' 59.7'' North,
077 deg.16' 50.5'' West to lighted dayboard 65A at approximately
34 deg.32' 40.0'' North, 077 deg.19' West.
In accordance with 5 U.S.C. 553, a notice of proposed rulemaking
was not published for this regulation and good cause exists for making
this regulation effective in less than 30 days after Federal Register
publication. Publishing a NPRM and delaying the effective date would be
contrary to the public interest since immediate action is needed to
protect mariners from potential hazards associated with potential
flight of an rocket propelled inert line charge over navigable waters.
The final schedule for this event and other related activities was not
finalized and communicated to the Coast Guard in sufficient time to
allow for a period for comments.
Assessment
This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866 and does not require an assessment of
potential costs and benefits under section 6(a)(3) of that order. It
has not been reviewed by the Office of Management and Budget under that
order. It is not significant under the regulatory policies and
procedures of the Department of Transportation (DOT) (44 FR 11040;
February 26, 1979).
The Coast Guard expects the economic impact of this rule to be so
minimal that a full Regulatory Evaluation under paragraph 10e of the
regulatory policies and procedures of DOT is unnecessary.
Collection of Information
This rule contains no information collection requirements under the
Paperwork Reduction Act (44 U.S.C. 3501 et seq.).
Federalism
The Coast Guard has analyzed this rule under the principles and
criteria contained in Executive Order 12612 and has determined that
this rule does not have sufficient federalism implications to warrant
the preparation of a Federalism Assessment.
Environment
The Coast Guard considered the environmental impact of this rule
and concluded that, under paragraph 2.B.2.e(34) of Commandant
Instruction M16475.1B (amended by 59 FR 38654), this rule is
categorically excluded from further environmental documentation.
List of Subjects in 33 CFR Part 165
Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.
For the reasons set out in the preamble, the Coast Guard amends 33
CFR part 165 as follows:
PART 165--[AMENDED]
1. The authority citation for Part 165 continues to read as
follows:
Authority: 33 U.S.C. 1231; 50 U.S.C. 191; and 33 CFR 1.05-1(g),
6.04-1, 6.04-6, and 160.5; 49 CFR 1.46.
2. A new temporary Sec. 165.T05.007 is added to read as follows:
Sec. 165.T05.007 Safety Zone: Atlantic Intracoastal Waterway, Marine
Corps Base Camp Lejeune, North Carolina.
(a) Location. The following area is a safety zone:
[[Page 8221]]
(1) The waters of the Atlantic Intracoastal Waterway from lighted
dayboard number 64 at approximately 34 deg.33'59.7'' North,
077 deg.16'50.5'' West to lighted dayboard 65A at approximately
34 deg.32'40.0'' North, 077 deg.19' West.
(b) This section is effective from 8 a.m., March 8, 1996 to 6 a.m.,
March 14, 1996, unless terminated earlier by the Captain of the Port
(COTP), Wilmington, NC.
(c) No person or vessel may enter the safety zone without the
permission of the COTP or his designated representative.
(d) The COTP or his designated representative will announce times
during which this section will be enforced.
(e) The COTP or his designated representative may be contacted at
the Marine Safety Office, Wilmington, NC by telephone at (910) 343-4895
or by radio on VHF-FM channel 16.
Dated: February 12, 1996.
T.L. Rice,
Captain, U.S. Coast Guard, Captain of the Port, Wilmington, NC.
[FR Doc. 96-4918 Filed 3-1-96; 8:45 am]
BILLING CODE 4910-14-M
Complete official Federal Register PDF
FR Doc. 96-4917 Special Local Regulations: Manatee River, Palmetto, FL
[Federal Register Volume 61, Number 43 (Monday, March 4, 1996)]
[Rules and Regulations]
[Pages 8216-8217]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-4917]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
Coast Guard
33 CFR Part 100
[CGD07-96-003]
RIN 2115-AE46
Special Local Regulations: Manatee River, Palmetto, FL
AGENCY: Coast Guard, DOT.
ACTION: Temporary final rule.
-----------------------------------------------------------------------
SUMMARY: Special local regulations are being adopted for the A.P.B.A.
(American Power Boat Association) Green Bridget Regatta. This event
will be held on Saturday, March 23, and Sunday, March 24, 1996 between
10 a.m. and 6 p.m. edt (eastern daylight time). This event will attract
large spectator crowds and create congestion. Therefore, these
regulations are needed to provide for the safety of life on navigable
waters during the event.
EFFECTIVE DATE: This rule is effective from 9 a.m. to 7 p.m. edt on
March 23 and 24, 1996.
[[Page 8217]]
ADDRESSES: Unless otherwise indicated, documents referred to in this
preamble are available for inspection or copying at U.S. Coast Guard
Group ST. Petersburg, 600 8th Avenue SE., St. Petersburg, FL 33701-
5099, between 8 a.m. and 3 p.m. edt, Monday through Friday, except
federal holidays.
FOR FURTHER INFORMATION CONTACT:
LTJG J.W. Nelson, U.S. Coast Guard Group St. Petersburg, FL at (813)
824-7533.
SUPPLEMENTARY INFORMATION: In accordance with 5 U.S.C. 553, a notice of
proposed rulemaking has not been published for these regulations. The
permit application was not received until late January. Following
normal rulemaking procedures would have been impracticable, as there
was insufficient time to publish the proposed rule in advance of the
event or to provide for a delayed effective date.
Discussion of Regulations
This rule is needed to provide for the safety of life on navigable
waters, to protect the vessels participating in the races, and to
protect marine mammals during the A.P.B.A. (American Power Boat
Association) Green Bridge Regatta. There will be approximately 50-75
power boats, 21 to 50 feet in length, engaged in a power boat race, and
no spectator craft are expected. A regulated area is established
between daybecacons #1 (27 deg.30.6N, 82 deg.34.6W, LLNR 19525) and
#21A (27 deg.30.5N, 82 deg.34.7W, LLNR 19570) in the Manatee River. All
coordinates referenced are datum: NAD 83. The Manatee River will be
closed to all inbound and outbound vessel traffic, other than spectator
craft, at various times between the hours of 10 a.m. and 6 p.m. edt,
March 23 and 24, 1996. Vessel traffic will be allowed to transit the
area during intermissions.
Regulatory Evaluation
These regulations are not a significant regulatory action under
section 3(f) of Executive Order 12866 and does not require an
assessment of potential costs and benefits under section 6(a)(3) of
that order. It has not been reviewed by the Office of Management and
Budget under that order. It is not significant under the regulatory
policies and procedures of the Department of Transportation (DOT) (44
FR 11040; February 26, 1979). The Coast Guard expects the economic
impact of this rule to be so minimal that a full Regulatory Evaluation
under paragraph 10e of the regulatory policies and procedures of DOT is
unnecessary. Entry into the area is prohibited for only 10 hours each
day of the event.
Since the impact of these regulations is to be minimal, the Coast
Guard certifies that it will not have a significant economic impact on
a substantial number of small entities.
Collection of Information
These regulations contain no collection-of-information requirements
under the Paperwork Reduction Act (44 U.S.C. 3501 et seq.).
Federalism
This action has been analyzed in accordance with the principles and
criteria contained in Executive Order 12612, and it has been determined
that these regulations do not have sufficient federalism implications
to warrant the preparation of a Federalism Assessment.
Environmental Assessment
The Coast Guard has considered the environmental impact of this
action consistent with Section 2.B.2. of Commandant Instruction
M16475.1B (as revised by 59 FR 38654, July 29m, 1994). In accordance
with that section, this action has been environmentally assessed (EA
completed), and the Coast Guard has determined that it will not
significantly affect the quality of the human environment. An
environmental assessment and finding of no significant impact have been
prepared and are available for inspection and copying at the address
listed under Addresses. Specifically, the Coast Guard has consulted
with the U.S. Fish and Wildlife Service and the National Marine
Fisheries Service regarding the environmental impact of this event, and
it was determined that the event does not jeopardize the continued
existence of protected species. As a condition to this permit, the
applicant is required to educate the operators of spectator craft and
race participants regarding the possible presence of manatees and the
appropriate precautions to take if the animals are sighted.
List of Subjects in 33 CFR Part 100
Marine safety, Navigation (water), Reporting and recordkeeping
requirements, Waterways.
Temporary Final Regulations
In consideration of the foregoing, Part 100 of Title 33, Code of
Federal Regulations, is amended as follows:
PART 100--[AMENDED]
1. The authority citation for part 100 continues to read as
follows:
Authority: 33 U.S.C. 1233; 49 CFR 1.46 and 33 CFR 100.35.
2. A temporary Sec. 100.35-T07-003 is added to read as follows:
Sec. 100.35-T07-003 Manatee River, Palmetto, FL.
(a) Regulated area. A regulated area is established in the Manatee
River with the northwest corner point at Pt Ogden, position
27 deg.30'41'' N, 82 deg.34'47'' W, extending to the northeast corner
point at northern approach to Green Bridge, position 27 deg.30'35'' N,
82 deg.34'22'' W, then extending to the southeast corner point at
southern approach to Green Bridge, position 27 deg.29'58'' N,
82 deg.34'17'' W, and then to the southwest corner point at Point
Pleasant, position 27 deg.30'07'' N, 82 deg.34'42'' W. All coordinates
referenced use Datum: NAD 83.
(b) Special local regulations (1) In accordance with these
regulations, the regulated area is designated as a no entry zone.
Vessel traffic is permitted into the area during intermission, but is
prohibited from entering the course area described in paragraph (b)(2)
of this section during the race.
(2) Inside the no entry zone is a designated area surrounding the
race course. The course consists of two \1/2\ mile straight-aways and
two \1/3\ mile turns. The course is bounded by a line connecting the
northeast corner point at position 27 deg.30'10'' N, 82 deg.34'30'' W,
a southeast corner point at position 27 deg.30'10'' N, 82 deg.34'27''
W, a southwest corner point at position 27 deg.30'15'' N,
82 deg.34'38'' W, and a northwest corner point at position
27 deg.30'30'' N, 82 deg.34'40'' W. All coordinates referenced use
Datum: Nad 83.
(c) Effective dates. This section is effective at 9 a.m. and
terminate at 7 p.m. edt on March 23 and 24, 1996.
Dated: February 20, 1996.
Roger T. Rufe, Jr.,
Rear Admiral, U.S. Coast Guard, Commander, Seventh Coast Guard
District.
[FR Doc. 96-4917 Filed 3-1-96; 8:45 am]
BILLING CODE 4910-14-M
Complete official Federal Register PDF
FR Doc. 96-4916 Regulated Navigation Area Regulations; Fort Pierce, FL
[Federal Register Volume 61, Number 43 (Monday, March 4, 1996)]
[Rules and Regulations]
[Pages 8219-8220]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-4916]
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
33 CFR Part 165
[CGD07-96-009]
RIN 2115-AE84
Regulated Navigation Area Regulations; Fort Pierce, FL
AGENCY: Coast Guard, DOT.
ACTION: Temporary final rule.
-----------------------------------------------------------------------
SUMMARY: The Coast Guard is establishing a temporary regulated
navigation area at the Peter P. Cobb bridge in Fort Pierce, Florida.
This regulated navigation area is needed to protect all vessels from a
safety hazard created by damage to the Peter P. Cobb bridge and
associated debris in the surrounding area. Entry into this zone is
prohibited unless authorized by the Captain of the Port, Miami,
Florida.
EFFECTIVE DATE: This regulation is effective from 12 p.m. on February
24, 1996 and terminates at 12 p.m. on March 31, 1996.
FOR FURTHER INFORMATION CONTACT:
BMC J. L. Belk, Port Management and Response Department, USCG Marine
Safety Office Miami, Florida at (305) 536-5693.
SUPPLEMENTARY INFORMATION:
Background and Purpose
At approximately 4 p.m. on November 7, 1995, a vessel allided with
the east side of the fender system of the Peter P. Cobb Bridge (also
known as the South Bridge) on the Indian River South Section at Fort
Pierce, Florida. The center section of the east fender system was
destroyed leaving the bridge support piling unprotected. Construction
crews are replacing the fender system which was destroyed.
A regulated navigation area has been established on the Indian
River South Section which includes the area under the main span of the
bridge extending 100 feet either side of the bridge within the main
channel. A previous regulated navigation area (CGD07-95-073) was
established for this area. This regulation will terminate at 12 p.m. on
February 24, 1996. Since repairs on the Peter P. Cobb bridge have not
been completed, a new regulation is needed to continue the repairs
without creating unusual hazards on the waterway for vessels traversing
the area. This area will have the following restrictions and conditions
for vessel traffic.
All barge traffic must obtain permission from the Captain of the
Port or his designated representative prior to transiting. Any barges
allowed to transit the zone by the Captain of the Port will be required
to meet the following conditions: the barge must be assisted by two
tugs made fast fore and aft; tugs must be of adequate horse power to
fully maneuver the barge; and the zone shall be transited by barge
traffic at slack water only. All other vessel traffic shall stay clear
of the damaged section of the bridge and the repair work underway.
In accordance with 5 U.S.C. 553, a notice of proposed rulemaking
was not published for this regulation and good cause exists for making
it effective in less than 30 days after Federal Register publication.
Publication of notice of proposed rulemaking and delay of effective
date would be contrary to public interest because immediate action is
necessary to prevent vessels from alliding with the bridge support
pilings, causing potential danger to the public.
Regulatory Evaluation
This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866 and does not require an assessment of
potential costs and benefits under section 6(a)(3) of that order. It
has been exempted from review by the Office of Management and Budget
under that order. It is not significant under the regulatory policies
and procedures of the Department of Transportation (DOT) (44FR 11040;
February 26, 1979). The Coast Guard expects the economic impact of this
proposal to be so minimal that a full Regulatory Evaluation under
paragraph 10e of the regulatory policies and procedures of DOT is
unnecessary.
Small Entities
Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), the
Coast Guard must consider whether this rule will have a significant
economic impact on a substantial number of small entities. ``Small
entities'' include independently owned and operated businesses that are
not dominant in their field and that otherwise qualify as ``small
business concerns'' under section 3 of the Small Business Act (15
U.S.C. 632).
For reasons set forth in the above Regulatory Evaluation, the Coast
Guard certifies under section 605(b) of the Regulatory Flexibility Act
(5 U.S.C. 601 et seq.) that this rule will not have a significant
economic impact on a substantial number of small entities.
Collection of Information
This rule contains no information collection requirements under the
Paperwork Reduction Act (44 U.S.C. 3501 et seq.)
Federalism
The action has been analyzed under the principles and criteria
contained in executive order 12612 and has determined that the
rulemaking does not have sufficient federalism implications to warrant
the preparation of a Federalism Assessment.
Environmental Assessment
The Coast Guard has considered the environmental impact of this
action and has determined pursuant to Section 2.B.2. of Commandant
Instruction M16475.1B that this action is categorically excluded from
further environmental documentation. A categorical exclusion checklist
and categorical exclusion determination have been completed and are
available for inspection and copying.
List of Subjects in 33 CFR Part 165
Harbors, Marine safety, Navigation (waters), Reporting and
recordkeeping requirements, Safety measures, Waterways.
Final Regulations
For the reasons set out in the preamble the Coast Guard amends 33
CFR Part 165 as follows:
PART 100--[AMENDED]
1. The authority citation for Part 165 continues to read as
follows:
Authority: 33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1(g),
6.04-1, 6.04-6, and 160.5; 49 CFR 1.46.
2. A new temporary Sec. 165.T07-009 is added to read as follows:
Sec. 165.T07-009 Regulated Navigation Area; Indian River South
Section, Peter P. Cobb Bridge, Fort Pierce, FL.
(a) Location. The following area is a regulated navigation area:
All waters under the main bridge span extending 100 feet either
side of the bridge within the main channel.
(b) Regulations. In accordance with general regulations in
Sec. 165.11 of this
[[Page 8220]]
part, no vessel may operate within the regulated navigation area
contrary to this regulation. All barge traffic must obtain permission
from the Captain of the Port or his designated representative prior to
transiting. Any barges allowed to transit the zone by the Captain of
the Port will be required to meet the following conditions: the barge
must be assisted by two tugs made fast fore and aft; tugs must be of
adequate horsepower to fully maneuver the barge; and the zone shall be
transited by barge traffic at slack water only. All other vessel
traffic shall stay clear of the damaged section of the bridge and
repair work underway. The Captain of the Port will notify the public of
changes in the status of this zone by Marine Safety Radio Broadcast on
VHF Marine Band Radio, Channel 22 (157.1 MHz).
(c) Effective dates. This section is effective at 12 p.m. on
February 24, 1996 and terminates at 12 p.m. on March 31, 1996.
Dated: February 23, 1996.
Roger T. Rufe, Jr.,
Rear Admiral, U.S. Coast Guard, Commander, Seventh Coast Guard
District.
[FR Doc. 96-4916 Filed 3-1-96; 8:45 am]
BILLING CODE 4910-14-M
Complete official Federal Register PDF
FR Doc. 96-4914 Delegations of Authority and Organization; Issuance of Notices Relating to Debarment
[Federal Register Volume 61, Number 43 (Monday, March 4, 1996)]
[Rules and Regulations]
[Pages 8214-8215]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-4914]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 5
Delegations of Authority and Organization; Issuance of Notices
Relating to Debarment
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the
regulations for delegations of authority to FDA officials in the Center
for Drug Evaluation and Research (CDER), the Center for Veterinary
Medicine (CVM), and the Center for Biologics Evaluation and Research
(CBER) by adding a new delegations section concerning the issuance of
notices relating to proposals and orders for debarment and denial of an
application to terminate debarment. Additionally, FDA is amending the
regulations regarding petitions so that certain officials of CDER, CVM,
and CBER are authorized to respond to petitions concerning debarment
and refusal to terminate debarment. This action will make the process
of issuing such notices and responses to petitions more efficient.
EFFECTIVE DATE: March 4, 1996.
FOR FURTHER INFORMATION CONTACT: Ellen Rawlings, Division of Management
Systems and Policy (HFA-340), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-443-4976.
SUPPLEMENTARY INFORMATION: New section 306 of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C. 335a), created by the Generic
Drug Enforcement Act of 1992, authorizes the Secretary of Health and
Human Services and, by previous delegation, the Commissioner of Food
and Drugs (the Commissioner) to take actions relating to debarment
proposals and orders as well as proposals and orders to deny an
application to terminate a debarment order. Certain aspects of this
authority are being redelegated in new Sec. 5.98 from the Commissioner
to the Directors of CDER, CVM, and CBER, to the Deputy Directors of
CDER and CVM, and the Associate Director for Policy Coordination and
Public Relations, CBER, as appropriate. In addition, FDA is amending
Sec. 5.31 (21 CFR 5.31) by delegating authority to the Directors of
CDER, CVM, and CBER, to the Deputy Directors of CDER and CVM, and the
Associate Director for Policy Coordination and Public Relations of CBER
to respond to petitions concerning actions they are authorized to take
under new Sec. 5.98. The redelegations will make the process of issuing
such notices and responses to petitions more efficient.
Further redelegation of the authority delegated is not authorized.
Authority delegated to a position by title may be exercised by a person
officially designated to serve in such position in an acting capacity
or on a temporary basis.
List of Subjects in 21 CFR Part 5
Authority delegations (Government agencies), Imports, Organization
and functions (Government agencies).
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
5 is amended as follows:
PART 5--DELEGATIONS OF AUTHORITY AND ORGANIZATION
1. The authority citation for 21 CFR part 5 continues to read as
follows:
Authority: 5 U.S.C. 504, 552, App. 2; 7 U.S.C. 138a, 2271; 15
U.S.C. 638, 1261-1282,
[[Page 8215]]
3701-3711a; secs. 2-12 of the Fair Packaging and Labeling Act (15
U.S.C. 1451-1461); 21 U.S.C. 41-50, 61-63, 141-149, 467f, 679(b),
801-886, 1031-1309; secs. 201-903 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321-394); 35 U.S.C. 156; secs. 301, 302,
303, 307, 310, 311, 351, 352, 361, 362, 1701-1706, 2101, 2125, 2127,
2128 of the Public Health Service Act (42 U.S.C. 241, 242, 242a,
242l, 242n, 243, 262, 263, 264, 265, 300u-300u-5, 300aa-1, 300aa-25,
300aa-27, 300aa-28); 42 U.S.C. 1395y, 3246b, 4332, 4831(a), 10007-
10008; E.O. 11490, 11921, and 12591; secs. 312, 313, 314 of the
National Childhood Vaccine Injury Act of 1986, Pub. L. 99-660 (42
U.S.C. 300aa-1 note).
2. Section 5.31 is amended by adding new paragraphs (f)(1)(vi),
(f)(2)(x), and (f)(8) to read as follows:
Sec. 5.31 Petitions under part 10.
* * * * *
(f) * * *
(1) * * *
(vi) Section 5.98 Issuance of notices relating to proposals and
orders for debarment and denial of an application to terminate
debarment.
(2) * * *
(x) Section 5.98 Issuance of notices relating to proposals and
orders for debarment and denial of an application to terminate
debarment.
* * * * *
(8) The Director and Deputy Director, CVM, are authorized to grant
or deny citizen petitions submitted under Sec. 10.30 of this chapter
concerning actions they are authorized to take under Sec. 5.98 Issuance
of notices relating to proposals and orders for debarment and denial of
an application to terminate debarment.
3. New Sec. 5.98 is added to subpart B to read as follows:
Sec. 5.98 Issuance of notices relating to proposals and orders for
debarment and denial of an application to terminate debarment.
The Director and Deputy Director, Center for Drug Evaluation and
Research (CDER), the Director and Deputy Director, Center for
Veterinary Medicine (CVM), and the Director and Associate Director for
Policy Coordination and Public Relations, Center for Biologics
Evaluation and Research (CBER) are authorized to issue the following
notices under section 306 of the Federal Food, Drug, and Cosmetic Act
(the act) which relate to the assigned functions of their
organizations:
(a) Notices of opportunity for hearing on proposals for mandatory
or permissive debarment.
(b) Notices ordering debarment when opportunity for a hearing has
been waived.
(c) Notices ordering debarment where the person notifies the agency
that the person acquiesces to debarment under section 306(c)(2)(B) of
the act.
(d) Notices of opportunity for hearing on proposals denying an
application to terminate debarment under section 306(d)(3) of the act.
(e) Orders denying an application to terminate debarment under
section 306(d)(3) of the act when opportunity for a hearing has been
waived.
Dated: February 26, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-4914 Filed 3-1-96; 8:45 am]
BILLING CODE 4160-01-F
Complete official Federal Register PDF
FR Doc. 96-4911 Education Department General Administrative RegulationsDirect Grant Programs
[Federal Register Volume 61, Number 43 (Monday, March 4, 1996)]
[Rules and Regulations]
[Pages 8454-8455]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-4911]
[[Page 8453]]
_______________________________________________________________________
Part VIII
Department of Education
_______________________________________________________________________
34 CFR Part 75
Education Department General Administrative Regulations--Direct Grant
Programs; Final Rule
Federal Register / Vol. 61, No. 43 / Monday, March 4, 1996 / Rules
and Regulations
[[Page 8454]]
DEPARTMENT OF EDUCATION
34 CFR Part 75
RIN 1880-AA68
Education Department General Administrative Regulations--Direct
Grant Programs
AGENCY: Department of Education.
ACTION: Final Regulations.
-----------------------------------------------------------------------
SUMMARY: The Secretary amends the Education Department General
Administrative Regulations (EDGAR) that govern discretionary grant
programs. These regulations clarify that the Secretary may reject
applications that propose project funding levels that exceed the
maximum award amount established in an application notice published in
the Federal Register. The Secretary issues these regulations to clarify
the meaning of existing regulations that govern the application review
process.
EFFECTIVE DATE: These regulations take effect on April 3, 1996.
FOR FURTHER INFORMATION CONTACT: Mary A. Smith, Office of the General
Counsel, U.S. Department of Education, 600 Independence Avenue SW.,
Room 5113, FB10, Washington, D.C. 20202-2241. Individuals who use a
telecommunications device for the deaf may call the Federal Information
Relay Service (FIRS) at 1-800-877-8339 between 8 a.m. and 8 p.m.,
Eastern time, Monday through Friday.
SUPPLEMENTARY INFORMATION: The Secretary takes this action to implement
a recommendation made by a quality improvement team for improving the
discretionary grant award process.
Under current practice, the Department reviews applications that
exceed the upper dollar limit of the estimated range of grant awards
expected to be made under a competition but, when the awards are made,
in most cases, the Department funds the projects at amounts within the
funding range.
In conducting competitions, the Department generally publishes
application notices that specify the estimated amounts or estimated
ranges of awards. However, because these amounts or ranges are
estimated, applicants often request funding at levels above the
estimated levels. Under most competitions, the practice of the
Department has been to establish grant award amounts for successful
applicants that are at or below the amounts specified in the estimates.
However, in some cases, the Department has made awards that exceeded
the estimates specified in the application notice.
The Department has been guided by the underlying principle that
applicants for discretionary grants must be afforded basic fairness in
the competitive grant award process. Most of the time applicants who
propose projects that exceed the upper limit of the specified range of
awards can propose to do significantly more than applicants who propose
funding consistent with the estimates. In these circumstances,
applicants who request funds that exceed these amounts are likely to
receive better scores from reviewers. If those applicants are then
selected for funding, the Department, in most cases, negotiates with
the applicants to reduce the cost of the projects to bring them within
the estimated funding range. As a result, many of the activities in
these applications have to be significantly modified, reduced, or
eliminated. The result is that the projects negotiated for final award
often differ substantially from the applications that were highly rated
by the reviewers. This practice has the potential of rewarding
applicants who originally request funding above the funding range and
penalizing applicants who follow the estimates.
However, this is not always the case. Sometimes the Department is
unsure what a highly qualified project should cost. This is especially
true when an educational technology is being explored or the Department
is supporting research in a new field. In these situations, the
Department may not have confidence that it has correctly estimated what
the funded projects will cost. Thus, the Secretary would not put a
maximum limitation on the competition to account for the possibility
that applicants might need more funds than specified in the expected
range in order to successfully implement the program's goals.
These regulations would clarify that the Secretary has discretion
to establish funding limits for awards, and provide for the inclusion
of information on maximum funding levels in application notices.
Under Sec. 75.101(a)(2), the Secretary may include in an
application notice the amount of funds available for grants and the
estimated number and amounts of those grants. Some application notices
have included the estimated amount of funds available for each grant,
and some application notices have given an estimated award amount. As
the provision in Sec. 75.101(a)(2) is currently worded, it is unclear
whether the application notice may include a maximum award amount.
These amendments to Sec. 75.101 clarify that the Secretary may include
an estimated amount of funds available for each grant and, if
appropriate, a maximum amount of funds available for each grant.
The Secretary also amends 34 CFR 75.104 to require that if a
maximum award amount is established, the Secretary may reject
applications that propose a budget that would exceed the maximum award
amount.
These amendments will ensure better service to the Department's
customers by permitting the Department to reject applications that
exceed a maximum amount. This process will enable the Department to
make awards more quickly and at less cost.
Executive Order 12866
These regulations have been reviewed in accordance with Executive
Order 12866. Under the terms of the order the Secretary has assessed
the potential costs and benefits of the regulatory action.
In assessing the potential costs and benefits--both quantitative
and qualitative--the Secretary has determined that the benefits of the
regulations in clarifying and improving the Department's grant
application review process justify the costs.
The Secretary has also determined that this regulatory action does
not unduly interfere with State, local, and tribal governments in the
exercise of their governmental functions.
Summary of potential costs and benefits: There are no identified
costs associated with these regulations. The potential benefits of
these regulations are discussed elsewhere in this preamble under the
following heading: Supplementary Information.
Regulatory Flexibility Act Certification
The Secretary certifies that these regulations would not have a
significant economic impact on a substantial number of small entities.
The small entities affected would be small local educational agencies,
community-based organizations, nonprofit organizations, and
institutions of higher education. However, these regulations would have
no economic impact on any of the entities affected and would merely
ensure a fairer application review process.
Paperwork Reduction Act of 1995
These regulations have been examined under the Paperwork Reduction
Act of 1995 and have been found to contain no information collection
requirements.
[[Page 8455]]
Waiver of Rulemaking
It is the practice of the Secretary to offer interested parties the
opportunity to comment on proposed regulations in accordance with the
Administrative Procedure Act (5 U.S.C. 553). However, because the
Secretary is interpreting existing regulations to allow an application
notice to include an estimated amount of funds available for each grant
or a maximum amount of funds available for each grant and because the
Secretary is establishing a procedural rule necessary for the
Department to conduct grant application review processes, the Secretary
has determined, pursuant to 5 U.S.C. 553(b)(A), that proposed
rulemaking requirements do not apply.
List of Subjects in 34 CFR Part 75
Education Department, Grant programs--education, Grant
administration, Incorporation by reference.
Dated: February 28, 1996.
Richard W. Riley,
Secretary of Education.
(Catalog of Federal Domestic Assistance Number does not apply)
The Secretary amends Part 75 of Title 34 of the Code of Federal
Regulations as follows:
PART 75--DIRECT GRANT PROGRAMS
1. The authority citation for Part 75 continues to read as follows:
Authority: 20 U.S.C. 1221e-3 and 3474, unless otherwise noted.
2. Section 75.101 is amended by revising paragraph (a)(2) to read
as follows:
Sec. 75.101 Information in the application notice that helps an
applicant apply.
(a) * * *
(2) The amount of funds available for grants, the estimated number
of those grants, the estimated amounts of those grants and, if
appropriate, the maximum award amounts of those grants.
* * * * *
3. Section 75.104 is revised to read as follows:
Sec. 75.104 Applicants must meet procedural rules.
(a) The Secretary may make a grant only to an eligible party that
submits an application.
(b) If a maximum award amount is established in a notice published
in the Federal Register, the Secretary may reject without consideration
or evaluation any application that proposes a project funding level
that exceeds the stated maximum award amount.
(Authority: 20 U.S.C. 1221e-3 and 3474)
[FR Doc. 96-4911 Filed 3-1-96; 8:45 am]
BILLING CODE 4000-01-P
Complete official Federal Register PDF
FR Doc. 96-4909 Approval of Lending Institutions and Mortgagees Streamlining
[Federal Register Volume 61, Number 43 (Monday, March 4, 1996)]
[Rules and Regulations]
[Pages 8458-8459]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-4909]
[[Page 8457]]
_______________________________________________________________________
Part IX
Department of Housing and Urban Development
_______________________________________________________________________
Office of the Assistant Secretary for Housing--Federal Housing
Commissioner
_______________________________________________________________________
24 CFR Part 202
Approval of Lending Institutions and Mortgagees Streamlining; Final
Rule
Federal Register / Vol. 61, No. 43 / Monday, March 4, 1996 / Rules
and Regulations
[[Page 8458]]
DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT
Office of the Assistant Secretary for Housing-Federal Housing
Commissioner
24 CFR Part 202
[Docket No. FR-4036-F-01]
RIN 2502-AG68
Approval of Lending Institutions and Mortgagees Streamlining
AGENCY: Office of the Assistant Secretary for Housing-Federal Housing
Commissioner, HUD.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This final rule amends HUD's regulations at 24 CFR part 202
relating to Approval of Lending Institutions and Mortgagees. In an
effort to comply with the President's regulatory reform initiatives,
this rule will streamline subparts A & B, which relate to approval of
Title I Lending Institutions and Approval of Mortgagees, respectively,
because certain provisions are not necessary.
EFFECTIVE DATE: April 3, 1996.
FOR FURTHER INFORMATION CONTACT: Karen Garner-Wing, Director, Lender
Approval and Recertification Division, Office of Lender Activities and
Land Sales Registration, Room 9146, Department of Housing and Urban
Development, 451 Seventh Street SW., Washington, DC 20410. Telephone:
(202) 708-3976. (This is not a toll-free number.) For hearing- and
speech-impaired persons, this number may be accessed via TDD by calling
the Federal Information Relay Service at 1-800-877-8339.
SUPPLEMENTARY INFORMATION: 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
Approval of Lending Institutions and Mortgagees can be streamlined to
remove provisions which are no longer necessary to be codified in the
Code of Federal Regulations. This rule will not change the substantive
requirements of the part but will eliminate redundant provisions.
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 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.
Other Matters
Regulatory Flexibility Act
The Secretary, in accordance with the Regulatory Flexibility Act (5
U.S.C. 605(b)), has reviewed and approved this final rule, and in so
doing certifies that this rule will not have a significant economic
impact on a substantial number of small entities. This rule merely
streamlines regulations by removing unnecessary provisions. The rule
will have no adverse or disproportionate economic impact on small
businesses.
Environmental Impact
This rulemaking does not have an environmental impact. This
rulemaking simply amends an existing regulation by eliminating
administrative 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 regulations regarding the Approval of Lending
Institutions and Mortgagees. 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, Office of
General Counsel, Room 10276, Department of Housing and Urban
Development, 451 Seventh Street SW., Washington, DC.
Executive Order 12612, Federalism
The General Counsel, as the Designated Official under section 6(a)
of Executive Order 12612, Federalism, has determined that this rule
will not have substantial direct effects on States or their political
subdivisions, or the relationship between the Federal government and
the States, or on the distribution of power and responsibilities among
the various levels of government. No programmatic or policy changes
will result from this rule that would affect the relationship between
the Federal Government and State and local governments.
Executive Order 12606, The Family
The General Counsel, as the Designated Official under Executive
Order 12606, The Family, has determined that this rule will not have
the potential for significant impact on family formation, maintenance,
or general well-being, and thus is not subject to review under the
Order. No significant change in existing HUD policies or programs will
result from promulgation of this rule.
List of Subjects in 24 CFR Part 202
Administrative practice and procedure, Home improvement,
Manufactured homes, Mortgage insurance, Reporting and recordkeeping
requirements.
Accordingly, 24 CFR part 202 is amended as follows:
PART 202--APPROVAL OF LENDING INSTITUTIONS AND MORTGAGES
1. The authority citation for part 202 continues to read as
follows:
Authority: 12 U.S.C. 1703, 1709, and 1715b; 42 U.S.C. 3535(d).
Subpart A--Approval of Title I Lending Institutions
2. Section 202.3 is amended by:
a. Removing and reserving paragraph (d); and
b. Revising paragraph (j) to read as follows:
Sec. 202.3 General approval requirements.
* * * * *
(d) [Reserved]
* * * * *
(j) Except for Government Institutions as defined in Sec. 202.2, it
shall pay an application fee and annual fee, including an additional
fee for each branch office authorized by the Secretary to originate
Title I loans. These fees shall be in such amounts as the Secretary may
require.
* * * * *
Sec. 202.4 [Amended]
3. Section 202.4 is amended by removing and reserving paragraph
(b).
Sec. 202.5 [Amended]
4. Section 202.5 is amended by removing and reserving paragraph
(b).
5. Section 202.9 is revised to read as follows:
[[Page 8459]]
Sec. 202.9 Administrative actions.
(a) General. The provisions of 24 CFR part 25 shall be applicable
to a lender participating in the Title I program. Administrative
actions which may be applied are set forth in 24 CFR 25.5. Civil money
penalties may also be imposed against Title I lenders pursuant to 24
CFR 25.13 and part 30 of this title. For purposes of this section the
term ``lender'' shall also include loan correspondents as defined in
Sec. 202.2(b) of this subpart A.
(b) Grounds for administrative actions. Administrative actions
shall be based upon both the grounds set forth in 24 CFR 25.9 and as
follows:
(1) Failure to properly supervise and monitor dealers under the
provisions of 24 CFR part 201;
(2) Exhaustion of the general insurance reserve established under
24 CFR part 201;
(3) Maintenance of a claims/loan ratio representing an unacceptable
risk to the Department; or
(4) Transfer of a Title I loan to a party that does not have a
valid Contract of Insurance.
Subpart B--Approval of Mortgagees
6. Section 202.11 is amended by:
a. Revising paragraphs (a)(1) introductory text, (a)(1)(i), and
(b); and
b. Removing and reserving paragraphs (a)(3) and (c), to read as
follows:
Sec. 202.11 Approval, recertification, withdrawal of approval and
termination of approval agreement.
(a) Approval. (1) A mortgagee may be approved for participation in
the mortgage insurance programs authorized by the National Housing Act
upon filing a request for approval on a form prescribed by the
Secretary and signed by the applicant. The approval form shall be
accompanied by such documentation as may be prescribed by the Secretary
to support the request for approval. Approval of the application shall
constitute:
(i) The Secretary's agreement that the mortgagee shall be
considered an approved mortgagee unless suspended or withdrawn pursuant
to 24 CFR part 25, or unless the mortgagee voluntarily relinquishes its
approval;
* * * * *
(3) [Reserved]
* * * * *
(b) Recertification of approval. On each anniversary of the
approval of a mortgagee, the Secretary shall undertake a
recertification procedure to determine whether continued approval is
appropriate. The Secretary shall review the yearly verification report
required by Sec. 202.12(h)(2) and other pertinent documents, determine
whether all application and annual fees which are due have been paid,
and request any additional information needed to make a determination
regarding continuation of approval.
(c) [Reserved]
* * * * *
7. Section 202.12 is amended by:
a. Removing and reserving paragraph (e), and
b. Redesignating paragraph (o) as paragraph (n)(5) and revising
newly redesignated paragraph (n)(5); and
c. Reserving paragraph (o), to read as follows:
Sec. 202.12 General approval requirements.
* * * * *
(e) [Reserved]
* * * * *
(n) * * *
(5) Mortgagees shall have the required net worth upon approval,
except that supervised and nonsupervised mortgagees may have a net
worth of $250,000 for the first year of approval.
(o) [Reserved]
* * * * *
8. Section 202.18 is revised to read as follows:
Sec. 202.18 Approval for servicing.
All mortgagees who wish to service FHA-insured mortgages must be
approved by the Secretary under Sec. 202.13, (supervised mortgagees),
Sec. 202.14, (nonsupervised mortgagees), or Sec. 202.17 (governmental
institutions).
9. Section 202.19 is revised to read as follows:
Sec. 202.19 Report requirements.
(a) Definitions. For the purpose of this section:
(1) Normal rate for early serious defaults and early claims means
the rate set forth in Sec. 202.11(d)(i).
(2) Early serious defaults or claims higher than the normal rate
means the rate set forth in Secs. 202.11(d)(ii) and 202.11(d)(iii).
(3) Endorsement means initial endorsement or initial/final
endorsement, as applicable, with respect to multifamily mortgages.
(b) Requirements. If a mortgagee approved for participation in the
insurance programs under Secs. 202.10 through 202.18 is notified by the
Secretary that it had a rate of early serious defaults or early claims
on HUD-insured mortgages during the preceding year, or during recent
years, which was higher than the normal rate for the geographic area or
areas in which it does business, it shall submit a report, within 60
days, containing an explanation for the above-normal rate of early
serious defaults or early claims and, if required by the Secretary, a
plan for corrective action with regard to mortgages in default and its
mortgage processing system in general. In determining whether a plan is
required, the Secretary may consider relevant information and
statements from the mortgagee.
10. Section 202.20 is amended by revising paragraph (i) to read as
follows:
Sec. 202.20 Tiered Pricing.
* * * * *
(i) Request for determination of compliance. Pursuant to section
539(a) of the National Affordable Housing Act, any person may file a
request that the Secretary determine whether a mortgagee or Title I
lender is in compliance with this section or with sections implementing
sections 223(a)(7) and 535 of the National Housing Act (12 U.S.C. 1701
et seq.) , such as Secs. 201.10(g), 203.18d, and 203.43(c)(5) of this
chapter (only Section 535 applies to Title I lenders). The request for
determination shall be made to the following address: Department of
Housing and Urban Development, Office of Lender Activities and Land
Sales Registration, 45l Seventh Street, SW, Washington, DC 204l0. The
Secretary shall inform the requestor of the disposition of the request.
The Secretary shall publish in the Federal Register the disposition of
any case referred by the Secretary to the Mortgagee Review Board.
Dated: February 22, 1996.
Nicolas P. Retsinas,
Assistant Secretary for Housing-Federal Housing Commissioner.
[FR Doc. 96-4909 Filed 3-1-96; 8:45 am]
BILLING CODE 4210-27-P
Complete official Federal Register PDF
FR Doc. 96-4899 Iranian Assets Control Regulations; Shams Pahlavi Assets Unblocked
[Federal Register Volume 61, Number 43 (Monday, March 4, 1996)]
[Rules and Regulations]
[Page 8216]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-4899]
=======================================================================
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DEPARTMENT OF THE TREASURY
Office of Foreign Assets Control
31 CFR Part 535
Iranian Assets Control Regulations; Shams Pahlavi Assets
Unblocked
AGENCY: Office of Foreign Assets Control, Treasury.
ACTION: Final rule; amendment to the list of persons whose assets are
subject to blocking.
-----------------------------------------------------------------------
SUMMARY: The Office of Foreign Assets Control of the U.S. Department of
the Treasury is amending section 535.217 of the Iranian Assets Control
Regulations, 31 CFR Sec. 535.217, to remove the name Shams Pahlavi from
Sec. 535.217(b). Shams Pahlavi, sister of Mohammed Reza Pahlavi, the
former Shah of Iran, previously was identified in Sec. 535.217(b) as a
person who had been served as a defendant in litigation brought by Iran
in a court within the United States seeking the return of property
alleged to belong to Iran. She therefore was identified as a person
whose United States assets were blocked pursuant to the provisions of
Sec. 535.217(a). Reference to Shams Pahlavi is now removed from
Sec. 535.217(b) based upon the final termination of all pertinent
litigation against her. Accordingly, her United States assets are no
longer blocked pursuant to Sec. 535.217(a).
EFFECTIVE DATE: March 1, 1996.
FOR FURTHER INFORMATION CONTACT: Regarding the status of blocked
assets, Loren L. Dohm, Blocked Assets Division (tel.: 202/622-2440);
regarding legal questions, William B. Hoffman, Chief Counsel (tel.:
202/622-2410); Office of Foreign Assets Control, Department of the
Treasury, Washington, D.C. 20220.
SUPPLEMENTARY INFORMATION:
Electronic Availability
This document is available as an electronic file on The Federal
Bulletin Board the day of publication in the Federal Register. By
modem, dial 202/515-1387 and type ``/GO FAC,'' or call 202/512-1530 for
disks or paper copies. This file is available for downloading without
charge in WordPerfect, ASCII, and Adobe AcrobatTM readable (*.PDF)
formats. The document is also accessible for downloading in ASCII
format without charge from Treasury's Electronic Library (``TEL'') in
the ``Business, Trade and Labor Mall'' of the FedWorld bulletin board.
By modem dial 703/321-3339, and select the appropriate self-expanding
file in TEL. For Internet access, use one of the following protocols:
Telnet = fedworld.gov (192.239.93.3); World Wide Web (Home Page) =
http://www.fedworld.gov; FTP = ftp.fedworld.gov (192.239.92.205).
Background
The Office of Foreign Assets Control is amending Sec. 535.217(b) of
the Iranian Assets Control Regulations, 31 CFR part 535, to reflect
changes in the status of litigation brought by Iran against close
relatives of the former Shah of Iran seeking the return of property
alleged to belong to Iran. In 1991, Shams Pahlavi was identified in
Sec. 535.217(b) based on proof of service upon her in litigation of the
type described in Sec. 535.217(a). Pursuant to that provision, all
property and assets located in the United States within the control of
Shams Pahlavi were blocked until all pertinent litigation against her
was finally terminated. Because that litigation has been finally
terminated, reference to Shams Pahlavi is deleted from Sec. 535.217(b).
Because the Regulations involve a foreign affairs function,
Executive Order 12866 and the provisions of the Administrative
Procedure Act, 5 U.S.C. 553, requiring notice of proposed rulemaking,
opportunity for public participation, and delay in effective date, are
inapplicable. Because no notice of proposed rulemaking is required for
this rule, the Regulatory Flexibility Act, 5 U.S.C. 601-612, does not
apply. Wherever possible, however, it is the practice of the Office of
Foreign Assets Control to receive written submissions or hold informal
consultations with interested parties before the issuance of any rule
or other public document.
List of Subjects in 31 CFR Part 535
Administrative practice and procedure, Banking, Banks, Blocking of
assets, Currency, Foreign investment in the United States, Iran,
Penalties, Reporting and recordkeeping requirements, Securities.
For the reasons set forth in the preamble, 31 CFR part 535 is
amended as follows:
PART 535--IRANIAN ASSETS CONTROL REGULATIONS
1. The authority citation for Part 535 continues to read as
follows:
Authority: 50 U.S.C. 1701-1706; E.O. 12710, 44 FR 65729, 3 CFR,
1979 Comp., p. 457; E.O. 12205, 45 FR 24099, 3 CFR, 1980 Comp., p. 248;
E.O. 12211, 45 FR 26685, 3 CFR, 1980, Comp., p. 253; E.O. 12276, 46 FR
7913, 3 CFR, 1981 Comp., p. 104; E.O. 12279, 46 FR 7919, 3 CFR 1981
Comp., p. 109; E.O. 12280, 46 FR 7921, 3 CFR 1981 Comp., p. 110; E.O.
12281, 46 FR 7923, 3 CFR, 1981 Comp., p. 112; E.O. 12282, 46 FR 7925, 3
CFR, 1981 Comp., p. 113; E.O. 12282, 46 FR 7927, 3 CFR, 1981 Comp., p.
113; E.O. 12283, 46 FR 7927, 3 CFR 1981 Comp., p. 114; and E.O. 12294,
46 FR 14111, 3 CFR, 1981 Comp., p. 139.
Subpart B--Prohibitions
2. Section 535.217 is amended by revising paragraph (b) to read as
follows:
Sec. 535.201 Blocking of property of the former Shah of Iran and of
certain Iranian nationals.
* * * * *
(b) [No persons presently listed].
* * * * *
Dated: February 1, 1996.
R. Richard Newcomb,
Director, Office of Foreign Assets Control.
Approved: February 8, 1996.
Dennis M. O'Connell,
Acting Deputy Assistant Secretary (Regulatory, Tariff & Law
Enforcement).
[FR Doc. 96-4899 Filed 3-1-96; 8:45 am]
BILLING CODE 4810-25-F
Complete official Federal Register PDF
FR Doc. 96-4876 Atlantic Tuna Fisheries; Bluefin Tuna Adjustments
[Federal Register Volume 61, Number 43 (Monday, March 4, 1996)]
[Rules and Regulations]
[Pages 8223-8224]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-4876]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric Administration
50 CFR Part 285
[I.D. 010496B]
Atlantic Tuna Fisheries; Bluefin Tuna Adjustments
AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA), Commerce.
ACTION: Fishery closure; catch limit adjustment.
-----------------------------------------------------------------------
SUMMARY: As of February 25, 1996, reported recreational fishery
landings of Atlantic bluefin tuna (ABT) larger than 73 inches (185 cm)
totalled 3.7 metric tons (mt). The annual quota allocated to
recreational catch of large medium and giant ABT is 4 mt. Therefore,
landing large medium and giant ABT under the Angling category is
prohibited effective at 11:30 p.m. on February 28, 1996. This action is
being taken to prevent overharvest of this category. In addition, the
daily catch limit for ABT is adjusted to one fish per vessel, which may
be from the school, large school, or small medium size class. This
action is being taken to lengthen the fishing season and ensure
reasonable fishing opportunities in all geographic areas.
EFFECTIVE DATES: The closure is effective 11:30 p.m., local time,
February 28,
[[Page 8224]]
1996, through December 31, 1996, or until the effective date of any
future adjustment, which will be published in the Federal Register. The
daily catch limit adjustment is effective 11:30 p.m., local time, March
11, 1996, through December 31, 1996, or until the effective date of any
future adjustment, which will be published in the Federal Register.
FOR FURTHER INFORMATION CONTACT: William Hogarth, 301-713-2347.
SUPPLEMENTARY INFORMATION: Regulations implemented under the authority
of the Atlantic Tunas Convention Act (16 U.S.C. 971 et seq.) governing
the harvest of ABT by persons and vessels subject to U.S. jurisdiction
are found at 50 CFR part 285.
Implementing regulations for the Atlantic tuna fisheries at 50 CFR
285.22 provide for a total annual quota of 4 mt of large medium and
giant ABT to be harvested from the regulatory area by vessels permitted
in the Angling category or the Charter/Headboat category. NMFS is
required, under Sec. 285.20(b)(1), to monitor the catch and landing
statistics and, on the basis of these statistics, to project a date
when the catch of ABT will equal the quota applicable to any period.
As of February 25, 1996, reported recreational fishery landings of
Atlantic bluefin tuna (ABT) larger than 73 inches (185 cm) totaled 3.7
metric tons (mt). Information on fishing effort available to NMFS
indicates that the remaining quota is likely to be taken within the
next few days. Therefore, fishing for, retention, possessing, or
landing large medium or giant ABT by vessels in the Angling category or
Charter/Headboat category must cease at 11:30 p.m., local time,
February 28, 1996. This action is to prevent overharvest of the quota
established for this category. Recreational anglers may continue to
fish for large medium and giant ABT under the NMFS tag and release
program (Sec. 285.27).
The Angling category fishery for school, large school, and small
medium size ABT remains open. Implementing regulations for the Atlantic
tuna fisheries at Sec. 285.24 allow for inseason adjustments to the
daily catch limits in order to lengthen the fishing season and ensure
reasonable fishing opportunities for all geographic areas. The
Assistant Administrator for Fisheries, NOAA, may increase or reduce the
per angler catch limit for any size class bluefin tuna or may change
the per angler limit to a per boat limit or a per boat limit to a per
angler limit.
Based on a review of daily landing trends, availability of ABT on
the fishing grounds, and anticipated fishing effort, the daily catch
limit is adjusted as follows: No more than one bluefin tuna may be
retained each day per Angling category vessel, which may be from the
school, large school, or small medium size class. Notice of adjustments
must be published at least 5 calendar days prior to a change in daily
catch limit becoming effective. Therefore, the catch limit adjustment
shall take effect at 11:30 p.m., local time on March 11, 1996.
Subsequent adjustments to the daily catch limit, if any, shall be
announced through publication in the Federal Register. Charter/Headboat
and General category vessels, when engaged in recreational fishing for
school ABT, are subject to the same rules as Angling category vessels.
Classification
This action is taken under 50 CFR 285.20(b) and 50 CFR 285.22 and
is exempt from review under E.O. 12866.
Authority: 16 U.S.C. 971 et seq.
Dated: February 27, 1996.
Richard W. Surdi,
Acting Director, Office of Fisheries Conservation and Management,
National Marine Fisheries Service.
[FR Doc. 96-4876 Filed 2-27-96; 4:44 pm]
BILLING CODE 3510-22-F
Complete official Federal Register PDF
FR Doc. 96-4841 Fishery Marketing Cooperatives; Issuance of Cease and Desist Orders; Removal of Regulation
[Federal Register Volume 61, Number 43 (Monday, March 4, 1996)]
[Rules and Regulations]
[Page 8224]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-4841]
-----------------------------------------------------------------------
DEPARTMENT OF COMMERCE
50 CFR Part 290
[Docket No. 960221042-6042-01; I.D. 122195B]
RIN 0648-A159
Fishery Marketing Cooperatives; Issuance of Cease and Desist
Orders; Removal of Regulation
AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA), Commerce.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: NMFS amends the Code of Federal Regulations (CFR) to remove a
regulation that is no longer needed concerning the issuance of cease
and desist orders to associations of aquatic products. This action is
consistent with the President's Regulatory Reform Initiative.
EFFECTIVE DATE: March 4, 1996.
FOR FURTHER INFORMATION CONTACT: Bruce C. Morehead, (301)713-2358.
SUPPLEMENTARY INFORMATION: On March 4, 1995, as part of the President's
Regulatory Reform Initiative, the President directed agencies to
conduct a page-by-page review of all regulations and eliminate or
revise those that are outdated or otherwise in need of reform. After
conducting a review of 50 CFR part 290, it was determined that it was
no longer needed and could be removed.
Part 290 of title 50 CFR provides a remedy under the authority of
The Act of June 25, 1934 (48 Stat. 1213) (Act), whereby an association
of producers of aquatic products (association) authorized by the Act
may be ordered by the Secretary of Commerce (Secretary) to cease and
desist from monopolizing or restraining trade to such an extent the
price of any aquatic product is unduly enhanced. The regulation
provides for a proceeding initiated by the filing of a complaint
against an association with the Secretary. Since the establishment of
NOAA 25 years ago under Reorganization Plan No. 4 of 1970 (84 Stat.
2090), no such complaints have been filed and NMFS is unaware of any
such complaints that may be filed. Therefore, 50 CFR part 290 is no
longer needed and is being removed.
Classification
Because this rule merely removes a regulation that is no longer
necessary, no useful purpose would be served by providing prior notice
and opportunity for public comment. Accordingly, under 5
U.S.C.553(b)(3)(B), for good cause, the Assistant Administrator for
Fisheries, NOAA (AA) finds that it is unnecessary to provide prior
notice and an opportunity for public comment for this rule. Also,
because this rule merely removes a regulation that is no longer needed,
the AA finds that no useful purpose would be served by delaying the
rule's effective date for 30 days. Therefore, this rule is made
effective upon publication.
This final rule has been determined to be not significant for the
purpose of E.O. 12866.
List of Subjects in 50 CFR Part 290
Administrative practice and procedure, Antitrust, Cooperatives,
Fisheries
Dated: February 26, 1996.
Gary Matlock,
Program Management Officer, National Marine Fisheries Service.
For the reasons set out in the preamble, under the authority of 70
Stat. 1121, as amended; 16 U.S.C. 742 (c), as amended; and
Reorganization No. 4 of 1970, 50 CFR part 290 is removed and Subchapter
J is vacated.
[FR Doc. 96-4841 Filed 3-1-96; 8:45 am]
BILLING CODE 3510-22-F
Complete official Federal Register PDF
FR Doc. 96-4829 Pesticide Reports for Pesticide-Producing Establishments; (EPA Form 3540-16); Additional Time To Report
[Federal Register Volume 61, Number 43 (Monday, March 4, 1996)]
[Rules and Regulations]
[Pages 8221-8222]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-4829]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 167
[OECA; FRL-5433-4]
Pesticide Reports for Pesticide-Producing Establishments; (EPA
Form 3540-16); Additional Time To Report
AGENCY: Environmental Protection Agency (EPA).
ACTION: Time extension for submission of reports.
-----------------------------------------------------------------------
SUMMARY: Because of delays in completing and distributing reporting
packages, EPA is announcing that it will extend the due date for
submission of annual pesticide production reports (EPA Form 3540-16)
for calendar year 1995 until two months after reporting packages are
mailed by EPA. These reports under Section 7 of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) and supporting
regulations at 40 CFR Part 167 would otherwise be due on or before
March 1, 1996.
DATES: Annual pesticide production reports for calendar year 1995 will
be due May 1, 1996.
FOR FURTHER INFORMATION CONTACT: Carol L. Buckingham, (202) 564-5008,
fax (202) 564-0085, Environmental Protection Agency, Mail Code 2225A,
401 M Street, SW., Washington, D.C. 20460.
SUPPLEMENTARY INFORMATION:
Background
Section 7 of the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) and the supporting regulations at 40 CFR Part 167 requires
certain facilities who manufacture, prepare, propagate, compound, or
process any pesticide, including any pesticide produced pursuant to
Section 5 of the Act, any active ingredient, or device, or to package,
repackage, label, relabel, or otherwise change the container of any
pesticide or device to report annually on the amounts and types, etc.
of pesticides produced.
Each year prior to the reporting deadline (March 1) EPA develops
and sends to facilities a reporting package containing the current
pesticide reporting forms (EPA Form 3540-16), and instructions for
reporting.
Because of delays in development of the reporting package, it will
not be distributed to the pesticide-producing establishments in time to
meet the March 1 reporting date. Therefore, EPA is extending the
reporting deadline to two (2) months after the packages are mailed out.
This allowance of additional time for reporting applies only to the
FIFRA section 7 and 40 CFR Part 167 reporting
[[Page 8222]]
obligations for pesticide reports otherwise due on March 1, 1996,
covering calendar year 1995. Nothing in this Notice shall be construed
to apply to any other FIFRA reporting obligations, or to any pesticide
reports (EPA Form 3540-16) due for past or future reporting years.
Further, this allowance of additional time for reporting applies only
to the Federal FIFRA section 7 and 40 CFR Part 167 reporting
obligation; it does not apply to independent obligations under State
laws which may require pesticide-production type reports.
To the extent that this action might be construed as rulemaking
subject to section 553 of the Administrative Procedures Act, for the
reasons stated above, EPA has determined that notice and an opportunity
for public comment are impracticable and unnecessary. Providing for
public comment might further delay reporting, and, because there is no
substantive change in the reporting obligation, the public will
continue to receive the same information, though slightly delayed.
List of Subjects in 40 CFR Part 167
Registration of pesticide and active ingredient producing
establishments, Submission of pesticide reports.
Dated: February 23, 1996.
Steven A. Herman,
Assistant Administrator, Office of Enforcement and Compliance
Assurance.
[FR Doc. 96-4829 Filed 3-1-96; 8:45 am]
BILLING CODE 6560-50-P
Complete official Federal Register PDF
FR Doc. 96-4719 Medical Devices; Protective Restraints; Revocation of Exemptions From the 510(k) Premarket Notification Procedures and Current Good Manufacturing Practice Regulations
[Federal Register Volume 61, Number 43 (Monday, March 4, 1996)]
[Rules and Regulations]
[Pages 8432-8439]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-4719]
[[Page 8431]]
_______________________________________________________________________
Part V
Department of Health and Human Services
_______________________________________________________________________
Food and Drug Administration
_______________________________________________________________________
21 CFR Parts 880 and 890
Medical Devices; Protective Restraints; Revocation of Exemptions From
the 510(k) Premarket Notification Procedures and Current Good
Manufacturing Practice Regulations; Final Rule and 510(k) Guidance
Document; Availability; Notice
Federal Register / Vol. 61, No. 43 / Monday, March 4, 1996 / Rules
and Regulations
=======================================================================
-----------------------------------------------------------------------
[[Page 8432]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 91N-0487]
21 CFR Parts 880 and 890
Medical Devices; Protective Restraints; Revocation of Exemptions
From the 510(k) Premarket Notification Procedures and Current Good
Manufacturing Practice Regulations
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is revising the
classification regulations for protective restraints and wheelchair
accessories intended for use as restraints, by revoking the existing
exemptions for these devices from premarket notification and current
good manufacturing practices (CGMP) regulations. FDA is also modifying
the classification regulations for protective restraints and for
wheelchair accessories to clarify the definitions of these devices. FDA
is taking these actions in response to a number of recent reports of
deaths and serious injuries that may have been associated with improper
supervision of restrained patients or improper application of
protective restraints. FDA believes that these actions will have
minimal economic effect and will not disrupt the supply of these
devices. In a notice published elsewhere in this issue of the Federal
Register, FDA is announcing the availability of a draft guidance
document for the preparation of premarket notification (510(k))
submissions for protective restraints.
DATES: Effective September 3, 1996.
FOR FURTHER INFORMATION CONTACT: Viola S. Hibbard, Center for Devices
and Radiological Health (HFZ-410), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-1287.
SUPPLEMENTARY INFORMATION:
I. Introduction
In the Federal Register of October 21, 1980 (45 FR 69678 at 69729),
FDA published a final rule, in accordance with the procedures contained
in section 513 of the Federal Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 360c), classifying as a device a protective restraint,
usually a wristlet, anklet, or other type of strap, that is intended
for medical purposes and that limits a patient's movement to the extent
necessary for treatment, examination, or protection of the patient. In
that regulation, FDA exempted manufacturers of protective restraints,
which are class I devices, from the premarket notification procedures
in part 807 (21 CFR part 807), and the CGMP regulations in part 820 (21
CFR part 820), with the exception of Secs. 820.180 and 820.198,
relating to general requirements concerning records and complaint
files, respectively. FDA granted these exemptions because, at that
time, FDA did not have information that caused serious concerns about
safety problems related to the use of protective restraint devices.
Since the October 1980 publication of these classifications that
exempted protective restraints from premarket notification and CGMP
requirements, FDA has become aware of numerous reports of serious
injuries and deaths that have been attributed to incorrect supervision,
handling, or application of protective restraints. In the Federal
Register of June 19, 1992 (57 FR 27397), FDA, in response to these
adverse event reports, published a proposed rule to revoke the
exemptions from premarket notification procedures and CGMP regulations
for protective restraints and wheelchair accessories intended for use
as protective restraints. FDA's proposed revocations complement the
Health Care Financing Administration (HCFA) regulations (42 CFR part
483) and HCFA's February 5, 1992 (57 FR 4516), proposed rulemaking that
address clinical indications for use of restraints that protect
individuals from inappropriate use of restraints for discipline or
convenience. The revocation of the exemption from the premarket
notification procedures will permit the agency to monitor the marketing
of these devices, and review and identify unclear labeling that may
result in incorrect application of the devices. The revocation of the
exemption from CGMP requirements will help ensure that restraints are
safe by conforming to appropriate specifications for design, materials,
performance, and labeling. A 60-day comment period, ending on August
18, 1992, was provided to allow interested persons an opportunity to
submit comments on the proposed changes.
In addition to this rule, FDA has taken other steps to ensure that
protective restraints are used safely. On July 15, 1992, FDA issued a
Safety Alert on potential hazards with restraint devices (Ref. 1) to
hospital administrators, directors of nursing, directors of emergency
room services, and long-term care facilities. FDA also issued a letter
to manufacturers in February 1992 stating that FDA considered
restraints to be prescription devices which must bear a prescription
legend as prescribed in Sec. 801.109 (21 CFR 801.109) to help ensure
appropriate medical intervention in the application and use of
restraints (Ref. 2).
FDA received 24 comments in response to the proposal of June 19,
1992, from individuals, manufacturers, professional societies, and
consumer and health associations. The comments were primarily
supportive of FDA's proposed actions. Several comments, however, stated
that FDA should consider additional regulation of protective
restraints. These comments are discussed below.
II. Summary and Analysis of Comments and FDA's Response
A. General Comments
1. One comment stated that it would be helpful for FDA to recommend
that facilities use one standard brand of each type of restraint (e.g.,
vest) to provide consistency and increase the likelihood that the
restraint would be applied correctly. Another comment suggested
restraints be uniformly designed so the front and back are easily
identifiable.
Although standardization of brands in a facility may increase the
likelihood that restraints will be applied correctly, it is critical
that the correct type and size restraint be applied to maximize the
safety of these devices. Accordingly, FDA encourages standardization as
long as it can be achieved without compromising the use of the
appropriate restraint type and size. Ultimately, however, this decision
must be made by each facility. FDA cannot endorse one uniform design.
Restraints used under different circumstances must necessarily
incorporate different designs.
2. Several comments indicated support for a prescription
requirement by licensed health care practitioners, specifying the
appropriate restraint type, duration of application, and circumstances
for use. One comment stated that FDA has avoided the issue of whether
anyone other than a licensed health care worker should be permitted to
apply restraints. Another comment stated that FDA did not address the
issue of appropriate frequency of monitoring.
The determination of appropriate individuals to apply restraints or
appropriate frequency of monitoring is beyond the scope of this
regulation. However, FDA believes the use of restraints should be
limited to those circumstances when they are clearly clinically
indicated, and that they
[[Page 8433]]
should be used only for a strictly defined period of time and only
under the supervision of a licensed health care provider. For these
reasons, FDA informed protective restraint manufacturers in February
1992 that it considered these devices to be prescription devices that
may only be used under the direction of a licensed health care
practitioner. In addition, FDA strongly encourages that after
restraints are prescribed by a licensed health care practitioner, they
be applied only by adequately trained personnel, in accordance with
State licensure and Federal certification requirements for facilities.
3. While several comments were supportive of FDA's proposal to
revoke 510(k) and CGMP exemptions, three comments opposed the
revocation of the exemptions. One comment suggested withdrawing the
proposed regulations until more complete information is available.
Another comment stated that the revocations are unjustified based on
the relatively small number of associated deaths and injuries compared
to the large annual usage of restraints. Another comment by a
manufacturer stated that the revocations were unwarranted because it
was unaware of any deaths or serious injuries associated with its
restraint products.
FDA disagrees that it needs to have more complete information
before it revokes premarket notification and CGMP requirements.
Although complete information concerning the problems associated with
restraints is not available, FDA does have sufficient information about
these problems to warrant revocation of the exemptions from premarket
notification and CGMP requirements. As explained in the preamble to the
proposed rule, the revocation of these exemptions will allow FDA to
gather more information to help ensure the safety of these devices.
FDA believes that the exemption revocations are justified based on
the numbers of reports of deaths and injuries associated with
protective restraint use. FDA notes that since publication of the
proposed rule of June 19, 1992, the total numbers of deaths and serious
injuries reported under the Device Experience Network (DEN), which
includes the mandatory Medical Device Reporting Program and the
MedWatch Reporting Program, have increased from 41 deaths and 16
serious injuries to 130 deaths and 48 injuries. In addition, several
comments support FDA's belief that injuries and deaths associated with
protective restraints are seriously underreported.
FDA does not agree with the comment from one manufacturer that
revocations of the exemptions were not warranted for its restraints
because the manufacturer was not aware of any deaths or serious
injuries associated with its products. Reports of these problems
encompass many different restraint types, regardless of manufacturer or
design; various types of patient populations, regardless of clinical
indications for the use of the restraint; and various types of health
care facilities, including hospitals, home use situations, and nursing
homes. The fact that problems have been reported from a wide spectrum
of protective restraint types and situations indicates that the
problems associated with protective restraints are not specific to one
particular type of restraint. Moreover, given the probability of
underreporting of protective restraint-associated deaths and injuries,
the absence of complaints for one particular manufacturer does not
indicate that that manufacturer's devices are free of the problems
associated with other restraints.
4. One comment from a restraint manufacturer disagreed with the
economic impact analysis of the proposed rule and stated that
revocations of the exemptions would result in substantial economic
costs. To avoid incurring the costs associated with compliance with the
regulation, the manufacturer stated that their company may disavow the
``medical device'' classification of their product line and continue to
sell their restraint devices to interested members of the health care
industry.
FDA advises that protective restraints, within the meaning of
section 201(h) of the act (21 U.S.C. 321(h)), are medical devices
because they are intended for use in the cure, mitigation, treatment,
or prevention of disease. Therefore, on or after the effective date of
this final rule, any manufacturer distributing a restraint device not
meeting the provisions of this final rule would violate the act by
distributing devices that are: (1) Misbranded, in that no premarket
notification submission has been filed pursuant to section 510(k) of
the act (21 U.S.C. 360(k)); and (2) adulterated, if CGMP requirements
are not met under section 520(f) of the act (21 U.S.C. 360j(f)). FDA
strongly discourages any noncompliance with this regulation and is
prepared to take enforcement actions against persons who violate this
regulation. Such actions may include seizure, injunction, civil
penalties, and criminal prosecution.
Furthermore, FDA disagrees that a substantial economic impact would
result from these regulations. The comment estimated that the company
would incur costs of $200,000 for 100 510(k) applications and as much
as $500,000 to attain compliance with CGMP's, which could force the
company out of business. The comment did not present any data to
support claims of substantially higher costs for complying with CGMP's.
FDA has reconsidered its economic analysis and believes that the
costs of premarket notification submissions and compliance with CGMP's
are considerably lower than suggested in this comment. Also, FDA
expects to allow some grouping by product category in a 510(k)
submission as discussed in comment 10 of this document, which should
limit the number of 510(k)'s that have to be submitted by any
particular manufacturer.
5. One comment questioned the benefit of simply revoking the
exemptions, but believed that the revocations were necessary as an
interim measure while reclassification of the devices to a more
stringent regulatory category is considered. Three comments believed
the proposed revocations to be a totally inadequate response to
problems with restraints and inconsistent with requirements issued by
HCFA. These comments stated that FDA should convene a device
classification panel to determine whether restraint devices should be
reclassified to class II or III.
FDA is continuing to evaluate the need for reclassification of
these devices. However, FDA believes that revocation of the premarket
notification exemption will facilitate more immediate improvements in
the labeling of restraint devices that quickly will provide increased
safety and effectiveness in the use of restraints, and that revocation
of CGMP exemptions will facilitate improvements in the manufacture of
restraint devices. FDA believes that these measures will greatly reduce
the risk associated with use of protective restraints. FDA retains the
option to reclassify the devices at a later time, if such additional
action is believed necessary to protect the public health.
FDA disagrees that its actions are inconsistent with those of HCFA.
As stated in the preamble to FDA's June 19, 1992, proposed rule, the
intent of HCFA's requirements on use of restraints in nursing homes is
to protect nursing home residents from use of restraints for purposes
of convenience or discipline. FDA's actions complement these
requirements by ensuring that for those instances where
[[Page 8434]]
restraints are clinically indicated, the labeling and instructions for
use of the restraints will facilitate correct application by health
care providers.
6. One comment requested immediate recall action on restraints that
have a higher association with death and serious injury than others.
The comment believed that criss-crossed vests were the most dangerous,
although the comment acknowledged that the higher number of death
reports associated with vest restraints may be due to more frequent use
of those devices.
FDA does not believe that the criteria for requiring the recall of
any particular protective restraint have been met. Under section 518(e)
of the act (21 U.S.C. 360h(e)), FDA may order a recall of a device only
after finding that the device would cause serious adverse health
consequences or death. FDA does not have information that any type of
restraint, including criss-crossed vests if used properly, would cause
serious adverse health consequences or death. Furthermore, restraints
can provide benefits that outweigh the risks for some patients, for
example, by preventing patients with medically related cognitive
deficits from involuntarily discontinuing life-support or other needed
medical interventions, by temporarily reducing the mobility of agitated
patients who may otherwise hurt themselves or others, or by helping
patients feel safer in a bed or wheelchair. FDA does not believe that
recalling these restraints where the benefits outweigh the risks would
be in the best interest of the public health. Furthermore, FDA believes
that the risks associated with restraints will be further reduced by
the measures taken in this regulation. FDA, however, will certainly
initiate 518(e) recall action in the future if the agency determines
that individual circumstances warrant such action.
7. Four comments requested that FDA resume plans to conduct
clinical and human factors engineering tests on restraining devices to
assess their safety and effectiveness. Several comments stated that FDA
should gather and study information from other sources besides DEN,
including the Consumer Product Safety Commission, HCFA, State and local
agencies that regulate nursing homes, the courts, review of patient
records, review of the literature, and consultation with experts in the
field.
FDA notes that in developing its course of action regarding
protective restraints, the agency gathered considerable information
from many other sources besides DEN, including literature reviews,
interviews with health care professionals and professional
organizations, visits to user facilities, and discussions with
manufacturers of restraints. It is the manufacturers' responsibility to
conduct testing to assess safety and effectiveness. FDA, however, would
welcome any additional research information regarding restraint use
from health and consumer groups and encourages research by such groups
that would promote safer use of restraints. By revoking the premarket
notification and CGMP exemptions, FDA will gain further information
that will enable the agency to ensure safe use of these devices. FDA
will continue to evaluate information received from other available
sources.
8. One comment stated that FDA has ``exhibited confusion'' about
the appropriate circumstances for use of restraints. The comment noted
that the proposed rule states that restraints may be needed to keep
agitated patients from hurting themselves, but an FDA Medical Alert
warned that restraints may only add to this agitation and confusion and
therefore may place the patient in jeopardy.
Whether restraints should be used may vary depending on the
circumstances presented by the individual patient. While FDA realizes
that restraints can adversely affect a patient by increasing agitation,
they may sometimes be necessary under certain circumstances to restrain
agitated patients from harming themselves. The determination of whether
restraint use is appropriate should be made by clinicians for each
patient individually, after assessing the risks and benefits of
restraint use.
9. Several comments that supported the revocations suggested that
manufacturers who fail to submit a 510(k) or fail to adhere to CGMP's
should not only be prohibited from future sales of restraints, but
should be compelled to remove from use (at the manufacturers' expense)
all previously sold restraint products.
FDA disagrees that recalling devices is necessarily an appropriate
remedy for failure to comply with CGMP or premarket notification
requirements. As explained in comment 6 of this document, FDA will
initiate recalls only if the statutory criteria under section 518(e) of
the act are met, and will decide whether those criteria are met on a
case-by-case basis. As stated in FDA's response to comment 4 of this
document, manufacturers who fail to comply with CGMP and premarket
notification requirements are subject to various enforcement actions by
FDA.
10. Five comments requested that manufacturers be allowed to submit
510(k)'s by product category (e.g., vests, limb holders etc.), rather
than for each individual product, because some products differ only in
minor design aspects, while their function, application, and use is
identical.
FDA agrees that grouping of similar devices in a 510(k) submission
would be acceptable to a limited extent. For example, vests of similar
design but composed of different fabrics might be grouped into one
510(k). However, submissions for devices differing substantially in
design (and therefore risk) should not be grouped in a single 510(k).
FDA will review this issue on a case-by-case basis.
11. One comment expressed concern regarding what criteria FDA is
using to determine safety and effectiveness, and whether manufacturers
could be assured that 510(k)'s will not be delayed on the basis of
individual reviewers' perceptions of what constitutes safe and
effective.
FDA advises that there will be uniformity in the criteria that
reviewers consider to determine the safety and effectiveness of these
devices. Section 513(i) of the act (21 U.S.C. 360c(i)) and its
implementing regulations in part 807 (21 CFR part 807) describe the
criteria used by FDA to determine substantial equivalence. FDA provided
guidance that described labeling for restraints at an October 1991
meeting with a medical device trade organization. This guidance has
been incorporated into a draft 510(k) submission guidance that will be
used by FDA reviewers to assist in evaluating 510(k) submissions.
Additional general labeling guidance is available in the Human Health
Services (HHS) publication ``Labeling: Regulatory Requirements for
Medical Devices'' (Ref. 3), the Office of Device Evaluation's labeling
guidance document (Ref. 4), and the publication ``Write It Right,'' a
guidance on labeling for home use products (Ref. 5). The draft 510(k)
submission guidance recommends that manufacturers' 510(k) submissions
for restraints address the following: (1) Specific intended use of the
device; (2) ease of release of the device in the event of emergencies;
(3) tear strength of the materials; (4) potential for injury (e.g.,
whether there are abrasive materials, such as metal fasteners, that
would come in contact with the patient's skin, and similar
considerations); (5) ease of identification of size; (6) completeness,
conspicuousness, and simplicity of directions and labeling; (7) care/
cleaning instructions; (8) whether the material is biocompatible; and
(9) any safety testing data available for the device, including an
analysis of bench simulation testing data; and for certain
circumstances, (10) patient testing data.
[[Page 8435]]
Manufacturers may contact the reviewing division to discuss the
appropriate content of their submissions on a case-by-case basis. FDA,
elsewhere in this issue of the Federal Register, is publishing a notice
of availability of this draft guidance and requesting comments on it.
12. Five comments stated that to ensure that protective restraints
continue to be available for medical use, manufacturers need to be able
to continue to market their products during the interim period between
the effective date of the final rule revoking the 510(k) exemptions and
the date that products are cleared by FDA. The comments also stated
that manufacturers need to be given a reasonable amount of time (at
least 6 months) after their final labeling is approved to exhaust the
remaining existing supplies of their products and phase in products
with the new labeling. Additionally, three comments stated that
manufacturers need to be given a reasonable amount of time (for
example, 2 years) to attain compliance with CGMP's.
FDA realizes that there will be a time period between the filing of
a 510(k) submission required by this regulation, and FDA's
determination, based on that submission, of whether the device has
marketing clearance. During the time period between the filing of a
510(k) and the FDA's substantial equivalence decision, FDA, in
exercising its enforcement discretion, does not intend to initiate
enforcement action relating to the distribution of protective restraint
devices that are adulterated under 21 U.S.C. 351(f)(1)(B) because they
fail to have FDA marketing clearance if: (1) The devices were initially
introduced into interstate commerce prior to September 3, 1996; and (2)
the sponsor has filed a 510(k) submission as of September 3, 1996.
FDA, however, intends to exercise its enforcement discretion to
initiate regulatory action against protective restraint devices that
have not received marketing clearance after June 4, 1997 if FDA has
been unable to reach a decision determining substantial equivalence
because the 510(k) submission fails to contain sufficient information.
FDA will notify the sponsor if such additional information is
necessary.
FDA has extended the effective date of the final rule requiring
submission of 510(k)s and compliance with CGMP's from 90 days to 180
days. FDA believes this time period is appropriate.
FDA first informed restraint manufacturers about FDA's planned
actions regarding 510(k) and CGMP requirements at a meeting with a
medical device trade organization in October 1991. FDA again notified
manufacturers in FDA's June 19, 1992, proposed rule, that the agency
intended to revoke these exemptions. Given the fact that industry has
been on notice since 1991 of FDA's plans to revoke these exemptions,
FDA does not believe manufacturers need an additional 2 years to comply
with CGMP's or 6 months after their labeling is approved to exhaust
supplies of labeling.
B. Restraint Identification
13. Two comments agreed with FDA's identification of a protective
restraint as it was published in the proposed rule. Several comments
stated that the identification of restraint used in the proposed rule
is too narrow, leaving major gaps in the coverage of a growing list of
potentially dangerous devices that are routinely used to restrain
patients or residents and that are ``falsely marketed'' as alternatives
to restraints. To alleviate these concerns, several comments suggested
using the broader definition of restraint proposed by HCFA in order to
include the concept of a method of restriction of movement.
FDA disagrees that the identification of protective restraints is
too narrow and leaves major gaps that do not cover devices that are
``falsely marketed'' as alternatives to restraints. Although the
identification gives examples of protective restraints, such as
wristlets, vests, and straps, the identification of protective
restraints is not limited to those examples. The identification is
based on the product's intended use. Under Sec. 801.4, evidence of a
device's intended use is not limited to labeling claims or to verbal
representations. It may be shown by the circumstances that the device
is offered and used for a purpose for which it is neither labeled nor
advertised. FDA considers any actions that otherwise represent a
device's intended use, as well as labeling, to determine a device's
intended use. Therefore, even devices that are ``falsely marketed'' as
alternatives to restraints will fall under the identification of
protective restraint if their intended use is to function as a
protective restraint. If a manufacturer intends a device to be used as
a restraint or is aware that the device is used as a restraint, that
manufacturer must comply with requirements for protective restraints.
FDA encourages consumers or health care workers to report instances
where manufacturers of such products are not complying with the
requirements for protective restraints.
Other comments suggested that the identification should state that
a restraint is any device which a resident cannot remove easily and
which restricts freedom of movement or easy access to their body. FDA
does not agree that the protective restraint identification should be
this broad. FDA may only regulate as devices products that fall within
the definition under section 201(h) of the act. Many products that
restrict freedom of movement or easy access to the body do not fall
under FDA's jurisdiction (e.g., safety belts, car seats). Also, even if
products that restrict freedom or access are medical devices (e.g.,
geriatric chairs), FDA believes it is inappropriate to identify all
such devices as protective restraints where that is not the intended
use of such devices.
14. One comment objected to the use of ``or others'' after
``protection of the patient'' at the end of Sec. 880.6760 (21 CFR
880.6760) because it is an established rule that restraints may only be
used to ``ensure the physical safety of the resident or other
residents'' (Social Security Act, section 1919 (42 U.S.C. 1396q)). The
comment also objected to the use of the term ``patients'' in the
restraint identification, because it is not appropriate in many non-
hospital settings. The term ``patients or other residents'' was
suggested as a substitute.
FDA disagrees with the comments. Restraints are sometimes used in
situations to protect individuals other than the person in restraints.
For example, hospitals may use restraints in emergency rooms to protect
staff, or other patients/residents from harm (e.g., due to patient drug
abuse or comparable circumstances). With regard to the objection to the
term ``patients'' in the context of non-hospital settings, FDA believes
that since restraints are medical devices, any resident who is
restrained constitutes a patient within the broad meaning of the term
in this section while wearing the restraint. Therefore, FDA rejects
these comments.
15. One comment stated that FDA should define bedrails and
geriatric chairs as restraints.
FDA notes that bedrails and geriatric chairs are currently
classified under Secs. 880.5100, 880.5110, 880.5120, and 880.5140
(bedrails); and Secs. 890.3100 and 890.3110 (21 CFR 890.3100 and
890.3110) (geriatric chairs). For the reasons stated in response to
comment 13 of this document, FDA believes that the current definition
of restraints is appropriate.
16. One comment requested that FDA modify the restraint
identification to exclude from the regulation those restraints that are
used with radiotherapy linear accelerators and simulators, because of
the controlled
[[Page 8436]]
conditions under which such restraints are used and the benefit they
provide. The comment requested that the identification of a restraint
be modified as follows:
A protective restraint is a device * * * that is intended for
medical purposes and that limits the patient's movements to the
extent necessary for treatment, examination, or protection of the
patient or others, excluding restraints which are used for a short
duration under the continual supervision of qualified personnel.
FDA does not believe that it would be appropriate to modify the
restraint identification to exclude restraints which are used for a
short duration under continual supervision from 510(k) and CGMP
requirements. These requirements are necessary for restraints that are
intended to be used for short periods of time under supervision because
such restraints may pose risks to patients if they are not used in the
manner the manufacturer intended. FDA advises that ``restraints'' for
use with radiation therapy systems are included under the
classification regulations for radiation therapy systems in
Secs. 892.5050 and 892.5300 (21 CFR 892.5050 and 892.5300). Under those
classification regulations, such restraints are already subject to
510(k) and CGMP requirements. Manufacturers of restraints that are
accessories to other devices should submit their 510(k) submissions to
the appropriate reviewing division for the primary device.
C. Wheelchair Accessories
17. Two comments supported the proposal to revise the
classification regulation for wheelchair accessories labeled or
otherwise represented as restraints. One comment, however, stated that
restraints should not be classified as wheelchair accessories because
this minimizes the importance of decisions regarding whether a
restraint should be used at all and the selection of the appropriate
type of restraint.
FDA disagrees that the chosen classification of wheelchair
accessories intended for use as restraints diminishes the importance of
decisions regarding use of those devices. FDA specifically emphasized
in the proposed rule and in the July 1992 FDA Safety Alert that the
same safety considerations, including proper selection and labeling,
are equally important for wheelchair accessories that are used as
protective restraints.
18. Two comments recommended that FDA adopt an identification of
wheelchair accessories intended for use as restraints that includes all
accessories and all wheelchair components that are manufactured and
marketed with the intent of restricting the patients' movement,
regardless of whether the devices are labeled or represented as
restraints.
FDA agrees with these comments. As discussed in paragraph 13 of
this document, the definition of protective restraint includes any
device that ``is intended for medical purposes and that limits the
patient's movements to the extent necessary for treatment, examination,
or protection of the patient or others.'' In stating in FDA's June 19,
1992, proposed regulation that FDA was exempting wheelchair accessories
from CGMP and premarket notification requirements that were not
``labeled or otherwise represented'' as a protective restraint, FDA did
not mean to imply that it was exempting those wheelchair accessories
that are not labeled or represented as restraints if they are intended
for use as restraints. To clarify that all wheelchair accessories which
are intended to be used as protective restraints must comply with
premarket notification and CGMP requirements, FDA is replacing the
words ``labeled or otherwise represented'' with ``intended for use'' in
the final regulation.
D. Labeling/Human Factors
19. Six comments requested that the agency consider the wide
variety of protective restraints available and evaluate each device
according to its intended use/size/design, without imposing a
``blanket'' labeling requirement for all restraints. For example,
devices such as vests should be labeled to clearly distinguish the
front and back of the restraint, whereas other restraints which have no
front and back should not be required to have such labeling.
FDA agrees that a ``blanket'' labeling requirement in this sense
should not be imposed and that the risks and benefits of each restraint
device should be reviewed individually in determining appropriate
specific labeling for restraint devices. FDA believes, however, that
similar protective restraints should have similar labeling. FDA also
believes that protective restraints should include step-by-step
instructions on how to apply the device and where to secure the ties,
have securely attached warning labels that clearly identify the front
and back of the restraints, and warn users of the dangers of reversal,
preferably using pictorials. Additional labeling instructions are
listed in the draft guidance document discussed in comment 12 of this
document.
20. Several comments expressed concern that the FDA regulation
implies that the only danger of restraints is in their potential
misapplication and that they are safe when used in accordance with the
manufacturer's instructions, and that HCFA's regulations will be
undermined.
FDA disagrees with these comments. FDA's regulation does not imply
that it alone will ensure safe and effective use of restraints. As
explained more fully in both the preamble to FDA's June 1992 proposed
rule and comment 5 of this final rule, FDA's regulations and HCFA's
regulations complement each other, they do not undermine each other.
HCFA laws and regulations ensure that restraints are only used on
persons who need restraints, and FDA's regulations will help ensure
that if clinically appropriate, such restraints will be applied safely.
21. Several comments requested that FDA require that restraint
labeling contain specific information including information about all
potentially harmful effects from the use of restraints, including
hazards, side effects, warnings/precautions, and contraindications for
their use. The comments also requested requiring clear delineation in
the device labeling as follows: (1) The front and back of the
restraint; (2) top and bottom of the restraint; (3) length of time the
restraint can be applied safely; (4) frequency with which the restraint
should be released; (5) frequency with which the patient should be
monitored; and (6) minimum standards or qualifications of personnel to
administer restraints. Several comments stated that labeling should be
required to be on the inside or underside of the device in as discrete
a manner as possible to convey necessary information and/or
instructions to users, in order to preserve the dignity and self-esteem
of the individual being restrained.
FDA advises that this regulation will allow FDA to review the
labeling for protective restraints, and that all labeling must provide
material information related to its safe use in accordance with section
502(a) of the act (21 U.S.C. 352(a)). In the preamble to the proposed
rule, FDA stated certain labeling practices that FDA believes are
necessary to help ensure the safe use of devices. Also, specific
suggested labeling is stated in the draft guidance document discussed
in comment 11 of this document. After receipt of individual premarket
notifications, FDA will review the labeling on a case-by-case basis.
With regard to placement of labeling, FDA encourages placement of
labeling in a manner that respects the patient's dignity, as long as
the placement does
[[Page 8437]]
not compromise the visibility of the labeling to the person applying
the restraint.
22. Several comments noted support for the utilization in all
product labeling of pictorials, languages other than English, and
textual information written for low language comprehension levels, in
sufficiently large type to clearly express the message. Several
comments suggested that the use of languages other than English is not
feasible and that the manufacturer's obligation should be limited to
adequate step-by-step instructions in English, with translations made
available by individual employers.
FDA agrees that pictorials and text materials written for low
language comprehension levels are important for effective conveyance of
application and hazard information. FDA also encourages manufacturers
that distribute devices for use by populations who do not use English
as a first language to provide instructions in foreign languages to the
extent possible and in accordance with the foreign language
requirements of Sec. 801.15(c). FDA has discussed human factors
considerations related to labeling with manufacturers, including the
selection of legible font types and sizes. Under 21 U.S.C. 352(c)
labeling statements required by or under the authority of the act must
be placed with conspicuousness and in such terms as to render them
likely to be read and understood by the ordinary individual under
customary conditions of purchase and use. See 21 CFR 801.15.
23. Several comments suggested that in addition to improved
labeling, posters should be made available for use and kept in
accessible view, such as in the restrained patient's room, nurses
stations, and physical therapy facilities.
FDA agrees that posters could be very helpful in promoting proper
use of restraints and has encouraged manufacturers to develop such
posters. Several manufacturers have already implemented instructions on
posters. Placement of such posters should be done in such a way that
they will be readily accessible to personnel but still comply with
nursing facility requirements for a homelike environment, in accordance
with provisions of 42 CFR 483.15(h)(1).
24. One comment noted that warnings and instructions for restraints
should be conveyed in a form suitable for home use as well as
institutional use.
FDA agrees with the comment and encourages use of FDA's guidance on
developing user instruction manuals for medical devices used in home
health care (Ref. 5). The document, entitled ``Write It Right,'' has
been distributed to all domestic and foreign medical device
manufacturers. Copies may be obtained from the Division of Small
Manufacturers Assistance, Center for Devices and Radiological Health,
800-638-2041.
25. One comment stated that experience demonstrates that product
labels and directions cannot in and of themselves protect patients from
injury or death. The comment stated that while the labeling guidelines
proposed by FDA represent a positive step in recognizing the potential
dangers of inappropriately applied or inappropriately supervised use of
restraints, such guidelines may do more to help shield manufacturers
involved in product liability suits than to protect patients from
avoidable accidents.
FDA agrees that product labeling alone cannot protect patients from
injury or death. However, well-presented labeling that is written in a
salient, informative, and concise manner can motivate the user to read
instructions, which can reinforce demonstration instruction and prevent
misuse of devices. Studies, as early as 1960, illustrate that behavior
can be affected by warnings and safety posters in the workplace (Ref.
6). More recent studies demonstrate that user behavior is clearly
influenced by the presence and location of warnings and adequate
instructions for use (Ref. 7).
FDA agrees that clearer labeling may in some instances help shield
manufacturers from product liability. However, regardless of any effect
on product liability, improved labeling, which may help reduce the
incidence of injury and death is important. To supplement the
beneficial effects of improved labeling, FDA advises that adequate
training and education of health care providers is necessary for safe
and effective use of restraints.
26. One comment stated that knots tied in some restraints are often
difficult to untie in the event of an emergency, and if it were at all
possible, restraints that tie should be replaced by those that release
with a clasp of some kind.
FDA supports the development of safe innovations that would improve
the ease of use of restraint devices.
E. Sizing/Color Coding
27. Several comments stated that a universal color coded sizing
system should be adopted throughout the industry to help facilitate
selection of the appropriate restraint size and reduce incidences of
misapplication of an incorrect size that could lead to deaths or
injuries.
FDA agrees with the comments. FDA also notes the availability of a
voluntary new sizing standard for women over the age of 55, which might
be of use in designing restraints for geriatric patients, who typically
have upper torso dimensions that are substantially different from
younger patients. The standard, entitled ``The Development of Body
Measurement Tables for Women 55 and Older and the Relationship to Ready
to Wear Garment Sizes,'' is available from the American Society for
Testing and Materials, 1916 Race St., Philadelphia, PA 19103.
28. One comment from a manufacturer noted that for 54 years their
company has manufactured restraints in accordance with a particular
color code for size, and that this color code has become the most
commonly used and understood color code by users of restraints. The
comment stated that if FDA decides to adopt a different color standard
than what the comment perceives as the ``prevailing standard,'' it will
create serious confusion among users because of the extensive user
familiarity with that color coding standard. Another comment stated
that color coding sizes for restraints would have a substantial
financial impact on industry.
This regulation is not requiring the adoption of a color-coded
sizing standard. However, FDA encourages manufacturers to develop an
industry-wide voluntary standard.
29. Two comments noted that manufacturers produce a selection of
sizes of certain types of restraints (e.g., vests), but that this does
not ensure that facilities have purchased adequate sizes or the entire
line of vest restraints for utilization in their facility.
FDA advises that selection of the appropriate size and type of
restraint is critical for safe and effective use of the device and that
clinicians and purchasing agents should consult medical practice
guidelines and instructions for use in determining the appropriate
size.
F. Flame Retardancy
30. FDA explicitly solicited comments regarding whether some or all
restraints should be made of flame resistant materials. Several
comments supported a universal requirement for flame resistant
restraints, citing the following reasons:
(1) There have been reports to FDA of at least six patients dying
or being injured as a result of deliberately or accidentally igniting
their restraints;
(2) Clinicians report having seen many restraints with ash and
cigarette burns in them, further indicating a
[[Page 8438]]
safety problem with respect to flammable materials;
(3) Many of the persons who are restrained may retain their right
to smoke in designated areas. These patients may have poor posture
control or hand dexterity, or may be confused, increasing the chances
of an accident. Also, visitors and other residents unaware of a
potential fire hazard may give smoking materials to the resident
without staff knowledge;
(4) Many nursing home residents may use oxygen, or be in close
proximity to other residents who use oxygen, increasing the danger of
fire.
Alternatively, multiple comments opposed requiring all protective
restraints to be constructed of flame resistant material, citing the
following reasons:
(1) Adequate and appropriate supervision is the best means of
prevention of burn and smoke inhalation injuries to individuals who are
being restrained;
(2) Many other items found on or near the bed are not flame
resistant, such as bed linens, pajamas, clothing, and even the
patient's hair, so having restraints made of flame resistant materials
would not serve a useful purpose. Residents might be better served
through establishment of a smoke-free environment;
(3) Labeling of restraints as flame resistant might actually
encourage smoking in bed by providing a false sense of security to both
residents and health care providers, who might relax smoking policies;
(4) The availability and effectiveness of flame resistant
restraints is limited by current technology. Some device components are
not readily available in flame resistant material, so requiring
restraints with this property might be prohibitively expensive. Also,
textile materials treated with flame resisting chemicals will burn if a
source of ignition is present, and the flame retardancy of some devices
is destroyed after the first laundering of the device. Warnings against
the exposure of protective restraints to ignition sources should
adequately address concerns related to burn injuries;
(5) Flame resistant vests are now marketed with very little success
due to the higher price (approximately 30 percent). This cost outweighs
the negligible benefit that might be derived with a universal
requirement for flame resistant restraints.
Several comments also stated that FDA should study the actual
contribution to patient safety that would be afforded by flame
resistant restraints versus the economic impact of replacing devices
currently in use. One comment suggested that the comfort and care of
the patient should be the primary concern and that secondary issues
should include whether fire resistant materials make the restraint less
flexible or more likely to cause rubbing or irritation; the effect on
safety features of the device; and the extent of protection flame
resistant materials would actually offer in the event of fire.
FDA has carefully considered the comments submitted and concluded
that although there are potential fire hazard concerns for some
patients, adequate and appropriate supervision is the most effective
and useful means of preventing fire-related injuries associated with
restrained patients. Some additional benefit, however, may occur by
using flame-resistant restraint material on patients who smoke.
Although FDA does not believe it is appropriate to require the use of
flame-resistant materials for all restraints, FDA recommends that
health care institutions develop and implement policies for the use of
flame-resistant restraints for patients who smoke while in restraints.
G. Training, Education, and Guidelines for Use
31. Several comments advocated increased training, education, and
FDA development of guidelines for restraint use to promote the safe
application of restraint devices. Several comments suggested that FDA
should publish a consumer (family) guide or brochure on the appropriate
use of restraints, the risks and benefits of restraint prescription and
application, and the potential side effects and hazards of restraint
use.
FDA agrees that adequate training and education for users of
restraints in all care scenarios is critical to the safe and effective
use of restraints and FDA strongly encouraged increased education about
restraint use in its July 1992 Safety Alert issued to health care
professionals. FDA has actively participated with health care
associations in the development of guidelines for use of medical
devices in the past and is willing to participate in such efforts for
protective restraints. FDA advises that in using restraints,
institutions are required to meet all State and local laws and HCFA
requirements, and are encouraged to meet guidelines developed by
professional health care organizations. With regard to publication of a
consumer guide, the FDA 1992 Safety Alert on restraints contains
information about restraint use specifically directed towards patients
and family members. Copies of FDA's Safety Alert are available upon
request from the Office of Surveillance and Biometrics (HFZ-500),
Center for Devices and Radiological Health, 5600 Fishers Lane,
Rockville, MD 20857.
32. One comment stated that because the liability burden for
patient morbidity and mortality caused by restraints is increasingly
shifted to nursing home staff, FDA should consider requiring
manufacturers to offer training and accessible advice to nursing homes
with device questions or problems, as a component of the new premarket
notification and CGMP rules.
Such requirements are beyond the scope of this rulemaking. However,
FDA encourages health care facilities to request training when
purchasing restraints and if such training is not made available, to
reconsider their purchasing policies. Manufacturers have already been
strongly urged by FDA to develop training videos and other materials to
assist health care facilities in training their staff in the proper
application and use of their products.
H. Chemical Restraints
33. Two comments noted that they do not support the use of
pharmaceutical options as chemical restraints in substitute for
physical restraints and stated that FDA is well positioned to address
the issue of the misuse of chemical restraints. The comments
recommended that FDA consider labeling recommendations for
manufacturers of drug products frequently used for chemical restraint.
FDA is advised that guidelines for the use of chemical restraints
in nursing homes are being finalized by HCFA, but such controls are
beyond the scope of this medical device rule. If the comments wish to
express concerns regarding labeling of specific drug products believed
to be misused as chemical restraints, those comments should be referred
to FDA's Center For Drug Evaluation and Research, Division of
Neuropharmacological Drug Products (HFD-120), 5600 Fishers Lane,
Rockville, MD 20857.
III. The Final Rule
Persons required to file premarket notification submissions under
section 510(k) of the act (21 U.S.C. 360(k)) and the procedures in
subpart E of 21 CFR part 807 must file a premarket notification
submission for any protective restraint device already marketed or
intended to be introduced or delivered for introduction into interstate
commerce for commercial distribution on or after September 3, 1996.
[[Page 8439]]
All protective restraints that are introduced or delivered for
introduction into interstate commerce on or after September 3, 1996,
are required to be manufactured in compliance with the CGMP regulations
in 21 CFR part 820.
In a notice published elsewhere in this issue of the Federal
Register, FDA is announcing the availability of a draft guidance
document for the preparation of a premarket notification (510(k))
submission.
IV. 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.
V. Analysis of Impacts
FDA has examined the impacts of the final rule under Executive
order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354).
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 final rule is consistent with the regulatory philosophy and
principles identified in the Executive Order. In addition, the final
rule is not a significant regulatory action as defined by the Executive
Order and so is not subject to review under the Executive Order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because this final rule only removes an exemption
and subjects manufacturers of patient restraints to the same
requirements as manufacturers of other devices, the agency certifies
that the final 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.
VI. References
The following references have been placed on display in the Dockets
Management Branch (HFA-305), Food and Drug Administration, 12420
Parklawn Dr., rm. 1-23, Rockville, MD 20857, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
1. ``FDA Safety Alert: Potential Hazards with Restraint
Devices,'' Food and Drug Administration, Rockville, MD, July 15,
1992.
2. Johnson, R., FDA, letter to restraint manufacturers,
February, 1992.
3. ``Labeling: Regulatory Requirements for Medical Devices,''
HHS Publication No. FDA 89-4203, Food and Drug Administration,
Rockville, MD, August, 1989.
4. Office of Device Evaluation, ``Device Labeling Guidance,''
No. G91-1, Food and Drug Administration, Rockville, MD, March 8,
1991.
5. ``Write It Right: Recommendations for Developing User
Instruction Manuals for Medical Devices Used in Home Health Care,''
Food and Drug Administration, Rockville, MD, August, 1993.
6. Laner, S., and R. G. Sell, ``An Experiment on the Effect of
Specially Designed Safety Posters,'' Occupational Psychology,
34:153-169, 1960.
7. Wolgalter, M. S. et al., ``Effectiveness of Warnings,'' Human
Factors, 29(5):599-612, 1987.
List of Subjects
21 CFR Parts 880 and 890
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
880 and 890 are amended as follows:
PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES
1. The authority citation for 21 CFR part 880 continues to read as
follows:
Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j,
371).
2. Section 880.6760 is revised to read as follows:
Sec. 880.6760 Protective restraint.
(a) Identification. A protective restraint is a device, including
but not limited to a wristlet, anklet, vest, mitt, straight jacket,
body/limb holder, or other type of strap, that is intended for medical
purposes and that limits the patient's movements to the extent
necessary for treatment, examination, or protection of the patient or
others.
(b) Classification. Class I (general controls).
PART 890--PHYSICAL MEDICINE DEVICES
3. The authority citation for 21 CFR part 890 continues to read as
follows:
Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j,
371).
4. Section 890.3910 is revised to read as follows:
Sec. 890.3910 Wheelchair accessory.
(a) Identification. A wheelchair accessory is a device intended for
medical purposes that is sold separately from a wheelchair and is
intended to meet the specific needs of a patient who uses a wheelchair.
Examples of wheelchair accessories include but are not limited to the
following: armboard, lapboard, pusher cuff, crutch and cane holder,
overhead suspension sling, head and trunk support, and blanket and leg
rest strap.
(b) Classification. Class I (general controls). If the device is
not intended for use as a protective restraint as defined in
Sec. 880.6760 of this chapter, it is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter, and
is also exempt from current good manufacturing practice regulations in
part 820 of this chapter, with the exception of Sec. 820.180, with
respect to general requirements concerning records, and Sec. 820.198,
with respect to complaint files.
Dated: February 15, 1996.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 96-4719 Filed 3-1-96; 8:45 am]
BILLING CODE 4160-01-F
Complete official Federal Register PDF
FR Doc. 96-4676 Prohibition of Cigarette Sales to Minors
[Federal Register Volume 61, Number 43 (Monday, March 4, 1996)]
[Rules and Regulations]
[Pages 8213-8214]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-4676]
=======================================================================
-----------------------------------------------------------------------
RAILROAD RETIREMENT BOARD
20 CFR Part 368
RIN 3220-AB20
Prohibition of Cigarette Sales to Minors
AGENCY: Railroad Retirement Board.
ACTION: Interim final rule.
-----------------------------------------------------------------------
SUMMARY: The Railroad Retirement Board (Board) adds regulations to
implement the Prohibition of Cigarette Sales to Minors in Federal
Buildings and Lands Act which prohibits the sale of tobacco through
vending machines and the distribution of free tobacco samples on
Federal property.
DATES: Effective Date: This regulation will be effective March 4, 1996.
Comment Date: Comments due on or before April 3, 1996.
ADDRESSES: Comments may be mailed to the Secretary to the Board,
Railroad Retirement Board, 844 Rush Street, Chicago, Illinois 60611.
FOR FURTHER INFORMATION CONTACT: Thomas W. Sadler, Assistant General
[[Page 8214]]
Counsel, Railroad Retirement Board, 844 Rush Street, Chicago, Illinois
60611, telephone (312) 751-4513, TTD (312) 751-4701.
SUPPLEMENTARY INFORMATION: The Board conducts its business in real
property owned or leased by the General Services Administration. All
property occupied or reserved for Board use must comply with Public Law
104-52. Tobacco products may not be sold in vending machines and free
samples of tobacco products may not be distributed in or around
property occupied and maintained by the Board. The Board will permit
the sale of tobacco products to individuals 18 and older by staffed
concession stands on property occupied and maintained by the Board.
Because of the importance of the subject matter of this rule, the
Board is publishing it as an interim final rule rather than as a
proposed rule. However, any person wishing to comment on this rule may
do so within 30 days of the date of this publication in the Federal
Register.
The agency has determined that this is not a significant regulatory
action for purposes of Executive Order 12866; therefore, no regulatory
impact analysis is required. There are no information collections
associated with this rule.
List of Subjects in 20 CFR Part 368
Railroad retirement, Smoking, Tobacco.
Title 20 CFR, chapter II is amended by adding a new part 368 to
read as follows:
PART 368--PROHIBITION OF CIGARETTE SALES TO MINORS
Sec.
368.1 Introduction.
368.2 Definitions.
368.3 Vending machines.
368.4 Concession stands.
368.5 Free tobacco samples.
Authority: Sec. 636, Pub. L. 104-52, 109 Stat. 507 (40 U.S.C.
486nt).
Sec. 368.1 Introduction.
This part implements Public Law 104-52, the ``Prohibition of
Cigarette Sales to Minors in Federal Buildings and Lands Act,'' which
prohibits the sale of tobacco products through vending machines and the
distribution of free samples of tobacco products on Federal property.
Sec. 368.2 Definitions.
As used in this part--
Federal property includes any building and real property occupied
and maintained by the Board.
Minor means an individual under the age of 18 years.
Tobacco product means cigarettes, cigars, little cigars, pipe
tobacco, smokeless tobacco, snuff, and chewing tobacco.
Sec. 368.3 Vending machines.
The sale of tobacco products in vending machines is prohibited in
or around Federal property occupied and maintained by the Railroad
Retirement Board.
Sec. 368.4 Concession stands.
Tobacco products may be sold on property occupied and maintained by
the Railroad Retirement Board only as authorized by the Railroad
Retirement Board or the General Services Administration or other
Federal agency. Concession stands may not sell tobacco products to
minors.
Sec. 368.5 Free tobacco samples.
The distribution of free samples of tobacco products is prohibited
in or around Federal property occupied and maintained by the Railroad
Retirement Board.
Dated: February 21, 1996.
By Authority of the Board.
For the Board.
Beatrice Ezerski,
Secretary to the Board.
[FR Doc. 96-4676 Filed 3-1-96; 8:45 am]
BILLING CODE 7905-01-M
Complete official Federal Register PDF
FR Doc. 96-4669 Airworthiness Directives; Fokker Model F28 Mark 0100 Series Airplanes
[Federal Register Volume 61, Number 43 (Monday, March 4, 1996)]
[Rules and Regulations]
[Pages 8211-8213]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-4669]
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
14 CFR Part 39
[Docket No. 94-NM-122-AD; Amendment 39-9527; AD 96-05-02]
Airworthiness Directives; Fokker Model F28 Mark 0100 Series
Airplanes
AGENCY: Federal Aviation Administration, DOT.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This amendment adopts a new airworthiness directive (AD),
applicable to certain Fokker Model F28 Mark 0100 series airplanes, that
requires modification of a certain galley; repetitive inspections to
detect damage and to determine the clearance of generator wires in the
auxiliary power unit (APU); and repair or replacement of the damaged
wires. This amendment is prompted by reports indicating that, during an
unscheduled removal of a galley from the production line, the
insulation of one of the generator wires of the APU was found damaged
due to inadequate clearance with the adjacent structure. The actions
specified by this AD are intended to prevent such damage, which could
result in a short in the electrical wiring of the APU and, thus, pose a
potential fire hazard.
DATES: Effective April 3, 1996.
The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of April 3, 1996.
ADDRESSES: The service information referenced in this AD may be
obtained from Fokker Aircraft USA, Inc., 1199 North Fairfax Street,
Alexandria, Virginia 22314. This information may be examined at the
Federal Aviation Administration (FAA), Transport Airplane Directorate,
Rules Docket, 1601 Lind Avenue, SW., Renton, Washington; or at the
Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC.
FOR FURTHER INFORMATION CONTACT: Tim Dulin, Aerospace Engineer,
Standardization Branch, ANM-113, FAA, Transport Airplane Directorate,
1601 Lind Avenue, SW., Renton, Washington 98055-4056; telephone (206)
227-2141; fax (206) 227-1149.
SUPPLEMENTARY INFORMATION: A proposal to amend part 39 of the Federal
Aviation Regulations (14 CFR part 39) to include an airworthiness
directive (AD) that is applicable to certain Fokker Model F28 Mark 0100
series airplanes was published in the Federal Register on December 9,
1994 (59 FR 236). That action proposed to require modification of a
Nordskog Galley Model 1-871galley. It also proposed to require
repetitive inspections to detect damage and determine the clearance of
generator wires in the auxiliary power unit (APU); and repair or
replacement of the damaged wires.
Interested persons have been afforded an opportunity to participate
in the making of this amendment. Due consideration has been given to
the single comment received.
The commenter requests that the rule be revised to delete proposed
paragraph (a)(2)(i), which would require operators to conduct
repetitive inspections if the initial inspection shows that no damage
to the feeder cables exists and that the cables adequately clear the
adjacent structure. This commenter, an operator, states that it has
conducted a boroscope inspection of the APU generator cables on all of
its airplanes, and has found nothing anywhere near the cables that
could cause damage to them. This operator notes that its initial
inspection, which was conducted using a flexible boroscope from the
cockpit, provided an excellent view of both the cables and the drain
enclosure. The inspection revealed that there is a clearance between
the wiring and adjacent structure (drain screws) on the order of six
inches.
[[Page 8212]]
The FAA concurs with the commenter's request. According to the
Rijksluchtvaartdienst (RLD), which is the airworthiness authority for
the Netherlands, the clearance between the drain screws and the APU
feeder cable (generator wires) found on airplanes on the production
line was on the order of one inch. This amount of clearance was
considered to be inadequate, such that chafing or damage of the wire
installation could occur. Also, according to the RLD, the reason that
the referenced service bulletin specifies that the inspection be
accomplished with a mirror is because the manufacturer considered that
a mirror would give a better estimate of the clearance than could a
boroscope inspection. However, the FAA, in consultation with the RLD,
recently has concluded that, since the clearance between the drain
screws and the wires has been determined to be on the order of 6 inches
on all affected airplanes that have not already been modified in
accordance with this AD, there is little reason to believe that chafing
would occur. In light of this, the FAA finds that there is no need for
a repetitive inspection of the wires. Therefore, the FAA has revised
paragraph (a)(2)(i) of the final rule to indicate that, if no wires are
found damaged as a result of the inspection and they adequately clear
the adjacent structure (positive clearance), no further inspections are
required.
After careful review of the available data, including the comments
noted above, the FAA has determined that air safety and the public
interest require the adoption of the rule with the change previously
described. The FAA has determined that this change will neither
increase the economic burden on any operator nor increase the scope of
the AD.
The FAA estimates that 52 airplanes of U.S. registry will be
affected by this proposed AD, that it will take approximately 2 work
hours per airplane to accomplish the required actions, and that the
average labor rate is $60 per work hour. Required parts will cost
approximately $1,000 per airplane. Based on these figures, the cost
impact of the AD on U.S. operators is estimated to be $58,240, or
$1,120 per airplane.
The cost impact figure discussed above is based on assumptions that
no operator has yet accomplished any of the requirements of this AD
action, and that no operator would accomplish those actions in the
future if this AD were not adopted.
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 final evaluation has been prepared for this action
and it is contained in the Rules Docket. A copy of it may be obtained
from 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 adding the following new
airworthiness directive:
96-05-02 Fokker: Amendment 39-9527. Docket 94-NM-122-AD.
Applicability: Model F28 Mark 0100 series airplanes; as listed
in Fokker Service Bulletin SBF100-24-029, dated June 28, 1993;
certificated in any category.
Note 1: This AD applies to each airplane 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 (c) 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 indicated, unless accomplished
previously.
To prevent a short in the electrical wiring of the auxiliary
power unit (APU) and a potential fire hazard, accomplish the
following:
(a) Within 250 flight hours after the effective date of this AD,
accomplish paragraphs (a)(1) and (a)(2) of this AD.
(1) Modify Nordskog Galley Model 1-871, in accordance with
paragraphs 2.A., 2.B., and 2.C. of the Accomplishment Instructions
of Fokker Service Bulletin SBF100-24-029, dated June 28, 1993.
(2) Perform an inspection to detect damage of and to determine
the adequacy of clearance of the generator wires, having part
numbers (P/N) AJC0001A, AJ0001B, and AJC0001C, of the auxiliary
power unit (APU), in accordance with Fokker Service Bulletin SBF100-
24-029, dated June 28, 1993.
(i) If no wires are found damaged and they adequately clear the
adjacent structure (positive clearance), no further action is
required by this paragraph.
(ii) If no wires are found damaged, but they do not adequately
clear the adjacent structure, repeat the inspection thereafter at
intervals not to exceed 250 flight hours.
(iii) If any wire is found damaged, prior to further flight,
modify the Nordskog Galley Model 1-871 in accordance with paragraph
(b) of this AD, and repair or replace the damaged wire in accordance
with the service bulletin. However, the modification and repair/
replacement actions may be postponed for a maximum of 10 days after
detection of the damage, provided that the APU generator is rendered
inoperative in accordance with the Master Minimum Equipment List
(MMEL), and that modification and repair/replacement actions are
accomplished prior to reactivation of the APU generator.
(b) At the next removal of the Nordskog Galley Model 1-871, or
within 9,000 flight hours after the effective date of this AD,
whichever occurs first, modify the Nordskog Galley in accordance
with Fokker Service Bulletin SBF100-24-029 (reference Nordskog
Engineering Change Order 43589 Attachment), dated June 28, 1993.
Accomplishment of this modification constitutes terminating action
for the repetitive inspection requirements of this AD.
(c) An alternative method of compliance or adjustment of the
compliance time that provides an acceptable level of safety may be
used if approved by the Manager, Standardization Branch, ANM-113,
FAA, Transport Airplane Directorate. Operators shall submit their
requests through an appropriate FAA Principal Maintenance Inspector,
who may add comments and then send it to the Manager,
Standardization Branch, ANM-113.
Note 2: Information concerning the existence of approved
alternative methods of compliance with this AD, if any, may be
obtained from the Standardization Branch, ANM-113.
[[Page 8213]]
(d) 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.
(e) The actions shall be done in accordance with Fokker Service
Bulletin SBF100-24-029, dated June 28, 1993, including Nordskog
Engineering Change Order 43589 Attachment. 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 Fokker Aircraft USA, Inc., 1199 North Fairfax Street,
Alexandria, Virginia 22314. Copies may be inspected at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton,
Washington; or at the Office of the Federal Register, 800 North
Capitol Street, NW., suite 700, Washington, DC.
(f) This amendment becomes effective on April 3, 1996.
Issued in Renton, Washington, on February 23, 1996.
Darrell M. Pederson,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 96-4669 Filed 3-1-96; 8:45 am]
BILLING CODE 4910-13-U
Complete official Federal Register PDF
FR Doc. 96-4508 Airworthiness Directives; McDonnell Douglas Model DC-9-80 Series Airplanes
[Federal Register Volume 61, Number 43 (Monday, March 4, 1996)]
[Rules and Regulations]
[Pages 8208-8211]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-4508]
=======================================================================
-----------------------------------------------------------------------
[[Page 8209]]
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 39
[Docket No. 95-NM-118-AD; Amendment 39-9525; AD 96-05-01]
Airworthiness Directives; McDonnell Douglas Model DC-9-80 Series
Airplanes
AGENCY: Federal Aviation Administration, DOT.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This amendment supersedes an existing airworthiness directive
(AD), applicable to certain McDonnell Douglas Model DC-9-80 series
airplanes, that currently requires inspection and replacement of
certain suspect horizontal stabilizer primary trim motors. That AD was
prompted by an analysis which revealed that certain incorrectly
manufactured motor shafts could fail prematurely and, in turn, cause
the primary trim motor to fail. The actions specified in that AD are
intended to prevent such failures of the primary trim motor, which
could ultimately result in reduced controllability of the airplane.
This amendment expands the applicability of the existing AD to include
additional affected airplanes.
DATES: Effective April 3, 1996.
The incorporation by reference of certain other publications listed
in the regulations is approved by the Director of the Federal Register
as of April 3, 1996.
The incorporation by reference of McDonnell Douglas MD-80 Alert
Service Bulletin A27-342, dated August 4, 1994, was approved previously
by the Director of the Federal Register as of April 3, 1996 (60 FR
15034, March 22, 1995).
ADDRESSES: The service information referenced in this AD may be
obtained from McDonnell Douglas Corporation, 3855 Lakewood Boulevard,
Long Beach, California 90846, Attention: Technical Publications
Business Administration, Department C1-L51 (2-60); or from Sundstrand
Aerospace, 4747 Harrison Avenue, P.O. Box 7002, Rockford, Illinois
61125-7002. This information may be examined at the Federal Aviation
Administration (FAA), Transport Airplane Directorate, Rules Docket,
1601 Lind Avenue, SW., Renton, Washington; or at the FAA, Los Angeles
Aircraft Certification Office, Transport Airplane Directorate, 3960
Paramount Boulevard, Lakewood, California; or at the Office of the
Federal Register, 800 North Capitol Street, NW., suite 700, Washington,
DC.
FOR FURTHER INFORMATION CONTACT: Walter Eierman, Aerospace Engineer,
Systems and Equipment Branch, ANM-130L, FAA, Los Angeles Aircraft
Certification Office, 3960 Paramount Boulevard, Lakewood, California
90712; telephone (310) 627-5336; fax (310) 627-5210.
SUPPLEMENTARY INFORMATION: A proposal to amend part 39 of the Federal
Aviation Regulations (14 CFR part 39) by superseding AD 95-06-04,
amendment 39-9174 (60 FR 15034, March 22, 1995), which is applicable to
McDonnell Douglas Model DC-9-80 series airplanes, was published in the
Federal Register on September 26, 1995 (60 FR 49525). That action
proposed to continue to require the current inspections and replacement
of certain suspect horizontal stabilizer primary trim motors. That
action also proposed to expand the applicability of the current AD to
include additional affected airplanes.
Interested persons have been afforded an opportunity to participate
in the making of this amendment. Due consideration has been given to
the comments received.
Three commenters support the proposal.
One commenter requests that the proposal be revised to allow
operators to conduct a records search, rather than a visual inspection,
to determine if the subject motor is installed on the airplane. This
commenter, an operator of affected airplanes, states that it tracks the
subject motors by the manufacturer's serial number, which enables it to
identify quickly the location of any of the subject motors at any given
time. Therefore, the commenter considers that, in lieu of requiring it
(and possibly other operators) to apply for an alternative method of
compliance with the AD, the final rule should provide for this
alternative action.
The FAA concurs with the commenter's request. The final rule has
been revised to provide for the option of conducting a records search
to determine if the motor installed on the airplane is identified with
one of the suspect serial numbers.
Two commenters request that the proposed AD be revised to preclude
operators from having to reinspect for units that were previously
modified and re-identified (i.e., in accordance with Sundstrand Service
Bulletin 9590-27-012). One of these commenters points out that these
units require an overhaul every 3,500 hours; at that time they are
removed from the airplane and, after overhaul, may be installed on a
different airplane or placed in spare status (pending installation on
another airplane). One commenter points out that the proposed AD does
not take into account the situation where a unit originally installed
on an airplane subject to AD 95-06-04 may be removed from that airplane
and later installed on another airplane that is subject to the proposed
AD. If this situation occurs, the commenter is concerned that operators
will be required to duplicate inspections and other actions
unnecessarily.
The FAA concurs that some clarification is necessary. As for motors
modified (and re-identified) in accordance with Sundstrand Service
Bulletin 9590-27-012, the final rule allows for their installation on
airplanes that are subject to either AD 95-06-04 or this new AD. If a
modified unit is installed on any of these airplanes no further action,
including any duplicating ``re-identification,'' is required by the AD.
In order to make this eminently clear, the FAA has revised paragraphs
(a) and (b) of the final rule to specify that, if the trim motor
installed on the airplane has been modified previously in accordance
with the applicable Sundstrand service bulletin, no further action is
required.
As for the possibility of suspect units being installed as spares,
the FAA is not certain that this possibility would occur, since the FAA
has been advised that apparently all motors affected by AD 95-06-04
have been modified. However, the FAA has added paragraph (c) to the
final rule to preclude the future installation, on any airplane, of a
motor having one of the suspect serial numbers.
As for duplicating inspections, as discussed above, the FAA has
revised the final rule to allow operators to conduct a records search,
in lieu of a visual inspection, to determine if the suspect motor is
installed. A records search would expedite the determination as to
whether or not a suspect unit is installed; it would also be far less
expensive to accomplish than a visual inspection of the airplane.
After careful review of the available data, including the comments
noted above, the FAA has determined that air safety and the public
interest require the adoption of the rule with the changes previously
described. The FAA has determined that these changes will neither
increase the economic burden on any operator nor increase the scope of
the AD.
There are approximately 142 Model DC-9-80 series airplanes of the
affected design in the worldwide fleet. The FAA estimates that a total
of 73 airplanes of
[[Page 8210]]
U.S. registry will be affected by this proposed AD.
The inspection of the horizontal stabilizer primary trim motor is
expected to take approximately 1 work hour per airplane to accomplish,
at an average labor rate of $60 per work hour. Based on these figures,
the cost impact of this requirement is estimated to be $60 per
airplane.
The inspection specified in this rule previously was required by AD
95-06-04, which was applicable to approximately 13 U.S.-registered
airplanes. Based on the figures discussed above, the cost impact of the
current inspection requirements of that AD on U.S. operators of those
13 airplanes is estimated to be $780. In consideration of the
compliance time and effective date of AD 95-06-04, the FAA assumes that
the operators of the 13 airplanes subject to that AD have already
initiated the required actions. This new AD action will add no new
costs associated with those airplanes.
This new AD is applicable to approximately 60 additional airplanes.
Based on the figures discussed above, the new (inspection) costs to
U.S. operators that will be imposed by this new AD are estimated to be
$3,600. This figure is based on assumptions that no operator of these
additional airplanes has yet accomplished any of the requirements of
this AD action, and that no operator would accomplish those actions in
the future if this AD were not adopted.
Should an operator elect to replace a suspect motor, that action
will require 5 work hours to accomplish, at an average labor rate of
$60 per work hour. Required parts will be provided by Sundstrand
Electric Power Systems (the manufacturer of the horizontal stabilizer
primary trim motors) at no charge to operators. Based on these figures,
the cost impact on U.S. operators for the replacement of a suspect
motor is estimated to be $300 per airplane.
Should an operator elect to modify a suspect motor, that action
will require 4 work hours to disassemble, modify, reassemble, and test
the motor (excluding removal and reinstallation of the motor from the
airplane). The average labor rate is $60 per work hour. Required parts
will be provided by Sundstrand at no charge to operators. Based on
these figures, the cost impact on U.S. operators for the modification
of a suspect motor is estimated to be $240 per airplane.
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 final evaluation has been prepared for this action
and it is contained in the Rules Docket. A copy of it may be obtained
from 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 amendment 39-9174 (60 FR
15034, March 22, 1995), and by adding a new airworthiness directive
(AD), amendment 39-9525, to read as follows:
96-05-01 McDonnell Douglas: Amendment 39-9525. Docket 95-NM-118-AD.
Supersedes AD 95-06-04, Amendment 39-9174.
Applicability: Model DC-9-80 series airplanes; as listed in
McDonnell Douglas MD-80 Alert Service Bulletin A27-342, dated August
4, 1994, and in McDonnell Douglas MD-80 Alert Service Bulletin A27-
342, Revision 1, dated May 15, 1995; certificated in any category.
Note 1: This AD applies to each airplane identified in the
preceding applicability provision, regardless of whether it has been
otherwise 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 indicated, unless accomplished
previously.
Note 2: Paragraph (a) of this AD merely restates the
requirements of paragraph (a) of AD 95-06-04, amendment 39-9174. As
allowed by the phrase, ``unless accomplished previously,'' if those
requirements of AD 95-06-04 have already been accomplished, this AD
does not require that those actions be repeated.
To prevent failure of the horizontal stabilizer primary trim
motor, accomplish the following:
(a) For airplanes listed in McDonnell Douglas MD-80 Alert
Service Bulletin A27-342, dated August 4, 1994: Within 6 months
after April 21, 1995 (the effective date of AD 95-06-04, amendment
39-9174), conduct either a visual inspection of the horizontal
stabilizer primary trim motor or a records search to determine if
the motor is identified with one of the suspect serial numbers
listed in McDonnell Douglas MD-80 Alert Service Bulletin A27-342,
dated August 4, 1994, or Revision 1, dated May 15, 1995. If a visual
inspection is conducted, it must be performed in accordance with the
procedures specified in the service bulletin.
(1) If the horizontal stabilizer primary trim motor is not
identified with a suspect serial number; or if the horizontal
stabilizer primary trim motor has been modified previously in
accordance with Sundstrand Service Bulletin 9590-27-012, dated
August 8, 1995; no further action is required by this AD.
(2) If the horizontal stabilizer primary trim motor is
identified with a suspect serial number and has not been modified
previously in accordance with Sundstrand Service Bulletin 9590-27-
012, dated August 8, 1995; prior to further flight, accomplish
either paragraph (a)(2)(i) or (a)(2)(ii) of this AD.
(i) Replace the motor in accordance with the McDonnell Douglas
alert service bulletin. Or
(ii) Modify the motor in accordance with Sundstrand Service
Bulletin 9590-27-012, dated August 8, 1995; and install the modified
motor in accordance with the McDonnell Douglas alert service
bulletin.
(b) For airplanes listed in McDonnell Douglas MD-80 Alert
Service Bulletin A27-342, Revision 1, dated May 15, 1995, and not
subject to paragraph (a) of this AD: Within 6 months after the
effective date of this AD, conduct either a visual inspection of the
horizontal stabilizer primary trim motor or a records search to
determine if the motor is identified with one of the suspect serial
numbers listed in McDonnell Douglas MD-80 Alert Service Bulletin
A27-342, Revision 1, dated May 15, 1995. If a visual inspection is
conducted, it must be performed in accordance with the procedures
specified in that service bulletin.
[[Page 8211]]
(1) If the horizontal stabilizer primary trim motor is not
identified with a suspect serial number; or if the horizontal
stabilizer primary trim motor has been modified previously in
accordance with Sundstrand Service Bulletin 9590-27-012, dated
August 8, 1995; no further action is required by this AD.
(2) If the horizontal stabilizer primary trim motor is
identified with a suspect serial number and has not been modified
previously in accordance with Sundstrand Service Bulletin 9590-27-
012, dated August 8, 1995; prior to further flight, accomplish
either paragraph (b)(2)(i) or (b)(2)(ii) of this AD.
(i) Replace the motor in accordance with the McDonnell Douglas
alert service bulletin. Or
(ii) Modify the motor in accordance with Sundstrand Service
Bulletin 9590-27-012, dated August 8, 1995; and install the modified
motor in accordance with the McDonnell Douglas alert service
bulletin.
(c) As of six months after the effective date of this AD, no
person shall install, on any airplane, a horizontal stabilizer
primary trim motor identified with one of the suspect serial numbers
listed in McDonnell Douglas MD-80 Alert Service Bulletin A27-342,
dated August 4, 1994, or Revision 1, dated May 15, 1995; unless that
motor has been modified in accordance with Sundstrand Service
Bulletin 9590-27-012, dated August 8, 1995.
(d) An alternative method of compliance or adjustment of the
compliance time that provides an acceptable level of safety may be
used if approved by the Manager, Los Angeles Aircraft Certification
Office (ACO), FAA, Transport Airplane Directorate. Operators shall
submit their requests through an appropriate FAA Principal
Maintenance Inspector, who may add comments and then send it to the
Manager, Los Angeles ACO.
Note 3: Information concerning the existence of approved
alternative methods of compliance with this AD, if any, may be
obtained from the Los Angeles ACO.
(e) 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.
(f) The inspection and replacement shall be done in accordance
with McDonnell Douglas MD-80 Alert Service Bulletin A27-342, dated
August 4, 1994; and McDonnell Douglas MD-80 Alert Service Bulletin
A27-342, Revision 1, dated May 15, 1995, which contains the
following list of effective pages:
------------------------------------------------------------------------
Revision level
Page No. shown on page Date shown on page
------------------------------------------------------------------------
1-5, 7-10...................... 1............... May 15, 1995.
6.............................. Original........ Aug. 4, 1994.
------------------------------------------------------------------------
The modification shall be done in accordance with Sundstrand Service
Bulletin 9590-27-012, dated August 8, 1995. The incorporation by
reference of McDonnell Douglas MD-80 Alert Service Bulletin A27-342,
dated August 4, 1994, was approved previously by the Director of the
Federal Register, in accordance with 5 U.S.C. 552(a) and 1 CFR part
51, as of April 21, 1995 (60 FR 15034, March 22, 1995). The
incorporation by reference of McDonnell Douglas MD-80 Alert Service
Bulletin A27-342, Revision 1, dated May 15, 1995; and Sundstrand
Service Bulletin 9590-27-012, dated August 8, 1995; 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 McDonnell
Douglas Corporation, 3855 Lakewood Boulevard, Long Beach, California
90846, Attention: Technical Publications Business Administration,
Department C1-L51 (2-60); or from Sundstrand Aerospace, 4747
Harrison Avenue, P.O. Box 7002, Rockford, Illinois 61125-7002.
Copies may be inspected at the FAA, Transport Airplane Directorate,
1601 Lind Avenue, SW., Renton, Washington; or at the FAA, Los
Angeles Aircraft Certification Office, Transport Airplane
Directorate, 3960 Paramount Boulevard, Lakewood, California; or at
the Office of the Federal Register, 800 North Capitol Street, NW.,
suite 700, Washington, DC.
(g) This amendment becomes effective on April 3, 1996.
Issued in Renton, Washington, on February 22, 1996.
Darrell M. Pederson,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 96-4508 Filed 3-1-96; 8:45 am]
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