Sample formats for Form FDA 356h_2011

Administrative draft guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.

Draft — Not for implementation
Attachment II
Sample Formats—
Form FDA 356h
for
Ammonia N 13 Injection
Fludeoxyglucose F 18 Injection (FDG F 18)
and
Sodium Fluoride F 18 Injection
Date: 25-Jan-2011

Form Approved: OMS No. 0910-0338	DEPARTMENT OF HEALTH AND HUMAN SERVICES 	Expiration Date: September 30, 2008	FOOD AND DRUG ADMINISTRATION 	See OMS Statement on page 2.
APPLICATION TO MARKET A NEW DRUG, BIOLOGIC, 	FOR FDA USE ONLY
OR AN ANTIBIOTIC DRUG FOR HUMAN USE 	APPLICATION NUMBER
(Title 21, Code of Federal Regulations, Parts 314 & 601)
APPLICANT INFORMATION
DATE OF SUBMISSION	NAME OF APPLICANT
II 	I	I
TELEPHONE NO. (Include 	Area Code) 	FACSIMILE (FAX Number (Include 	Area Code)
I 	I
I 	I
AUTHORIZED U.S. AGENT NAME & 	ADDRESS (Number, Street, City, State,	APPLICANT ADDRESS (Number, Street, City, State, Country, zip Code or Mail
Code, and U.S. License number if oreviouslv issued): 	ZiP Code, telephone & FAX number) IF APPLICABLE
I 	I
I 	I
PRODUCT DESCRIPTION
NEW DRUG OR ANTIBIOTIC APPLICATION NUMBER, OR BIOLOGICS LICENSE APPLICATION NUMBER (If previously issued) 	I 	I
ESTABLISHED NAME Ie.". Proner name USP/USAN name) 	PROPRIETARY NAME (trade name) IF ANY
IFludeoxyglucose F 18 Injection 	liinone 	I
CHEMICAL/BIOCHEMICAL/BLOOD PRODUCT NAME (If anv) 	CODE NAME (If any!
I 	I 	I
ROUTE OF ADMINISTRATION:	pOSAGE FORM'
Intravenous
I 	)1 STRENGTHS: 	I I 	I	
Injection 	I
(PROPOSED) INDICATION(S) FOR USE: lin Positron Emission Tomography for ...
I
APPLICATION DESCRIPTION
APPLICATION TYPE .
(check one) IZNEW DR~G APPLICATION (CDA, 21 CFR 314.S0) o ABBREVIATED NEW DRUG APPLICATION (ANDA, 21 CFR 314.94)
D BIOLOGICS LICENSE APPLICATION (BLA, 21 CFR Part 601)
IF AN NDA, IDENTIFY THE APPROPRIATE TYPE 	DSOS(b)(1) 	12SOS (b)(2)
IF AN ANDA, OR SOS(b)(2), IDENTIFY THE REFERENCE LISTED DRUG PRODUCT THAT IS THE BASIS FOR THE SUBMISSION
I	Name of Drug I I Holder of Approved APPliCationl
TYPEOF SUBMISSION (check oneb IZORIGINAL APPLICATION . DAMENDMENTTO APENDING APPLICATION. DRESUBMISSION
o PRESUBMISSION .-c ANNUAL REPORT DESTABLISHMENT DESCRIPTION SUPPLEMENT DEFFICACY SUPPLEMENT
DLABELING SUPPLEMENT 0 CHEMISTRY MANUFACTURING AND CONTROLS SUPPLEMENT DOTHER I 	I
IF A SUBMISSION OF PARTIAL APPLICATION, PROVIDE LETTER DATE OF AGREEMENT TO PARTIAL SUBMISSION: I 	I
IF A SUPPLEMENT, IDENTIFY THE APPROPRIATE CATEGORY 	DCBE 	DCBE-30 	D Prior Approval (PA)
REASON FOR SUBMISSION fiComplete new application that has never before been submitted. 	I
PROPOSED MARKETING STATUS (check one) 	ø PRESCRIPTION PRODUCT (Rx) 	D OVER THE COUNTER PRODUCT (OTC)
THIS APPLICATION IS	NUMBER OF VOLUMES SUBMITTED I 	I 	DpAPER 	D PAPER AND ELECTRONIC 	D ELECTRONIC
ESTABLISHMENT INFORMATION (Full establishment information should be provided In the body of the Application.)
Provide locations of all manufacturing, packaging and control sites for drug substance and drug product (continuation sheets may be used if necessary). Include name,
address, contact, telephone number, registration number (CFN), DMF number, and manufacturing steps and/or type of testing (e.g. Final dosage form, Stabilty testing)
conducted at the site. Please .indicate whether the site is ready for inspection or, if not, when it wil be ready.
I	
I
Cross References (list related License Applications, INDs, NDAs, PMAs, 510(k)s, IDEs, BMFs, and DMFs referenced in the current application)
I	I
PAGE 1 OF4	FORM FDA 356h (10/05)

This application contains the following items: (Check all that apply)
ø 	1. Index
ø 	2. Labeling (check one) 	ø Draft Labeling 	D Final Printed Labeling
ø 	3. Summary (21 CFR 314.50 (c))
ø 	4. Chemistry section
0 	A. 	Chemistry, manufacturing, and controls information (e.g., 21 CFR 314.50(d)(1); 21 CFR 601.2)
0 	B. 	Samples (21 CFR 314.50 (e)(1); 21 CFR 601.2 (a)) (Submit only upon FDA's request)
0 	c. 	Methods validation package (e.g., 21 CFR 314.50(e)(2)(i); 21 CFR 601.2)
5. Nonclinical pharmacology and toxicology section (e.g., 21 CFR 314.50(d)(2); 21 CFR 601.2)	
D 6. Human pharmacokinetics and bioavailability section (e.g., 21 CFR 314.50(d)(3); 21 CFR 601.2)	D
0 	7. Clinical Microbiology (e.g., 21 CFR 314.50(d)(4))
0 .	8. Clinical data section (e.g., 21 CFR 314.50(d)(5); 21 CFR 601.2)	0 9. Safety update report (e.g., 21 CFR 314.50(d)(5)(vi)(b); 21 CFR 601.2)
0 	10. Statistical section (e.g., 21 CFR 314.50(d)(6); 21 CFR 601.2)
0 	11. Case report tabulations (e.g., 21 CFR 314.50(f)(1); 21 CFR 601.2)
0 	12. Case report forms (e.g., 21 CFR 314.50 (f)(2); 21 CFR 601.2)
ø 	13. Patent information on any patent which claims the drug (21 U.S.C. 355(b) or (c))
ø 	14. A patent certification with respect to any patent which claims the drug (21 U.S.C. 355 (b)(2) or ü)(2)(A))
0 	15. Establishment description (21 CFR Part 600, if applicable)
ø 	16. Debarment certification (FD&C Act 306 (k)(1))
ø 	17. Field copy certification (21 CFR 314.50 (1)(3))
ø 	18. User Fee Cover Sheet (Form FDA 3397)
0 	19. Financial Information (21 CFR Part 54)
0 	20. OTHER (Specify) I 	I
CERTIFICATION
I agree to update this application with new safety information about the product that may reasonably affect the statement of contraindications,
warnings, precautions, or adverse reactions in the draft labeling. I agree to submit safety update reports as provided for by regulation or as
requested by FDA. If this application is approved, I agree to comply with all applicable laws and regulations that apply to approved applications,
including, but not limited to the following:
1. Good manufacturing practice regulations in 21 CFR Parts 210, 211 or applicable regulations, Parts 606, and/or 820.
2. Biological establishment standards in 21 CFR Part 600.
3. Labeling regulations in 21 CFR Parts 201, 606, 610,660, and/or 809.
4. In the case of a prescription drug or biological product, prescription drug advertising regulations in 21 CFR Part 202.
" 	5. Regulations on making changes in application in FD&C Act section 506A, 21 CFR 314.71,314.72,314.97,314.99, and 601.12.
6. Regulations on Reports in 21 CFR 314.80,314.81,600.80, and 600.81.
7. Local, state and Federal environmental impact laws.
If this application applies to a drug product that FDA has proposed for scheduling under the Controlled Substances Act, I agree not to market the
product until the Drug Enforcement Administration makes a final scheduling decision.
The data and information in this submission have been reviewed and, to the best of my knowledge are certified to be true and accurate.
Warning: A wilfully false statement is a criminal offense, U.S. Code, title 18, section 1001.
SIGNATURE OF RESPONSIBLE OFFICIAL OR AGENT
I 	JI rATE: 	I	II TYPED NAME AND TITLE
I Telephone Number	ADDRESS (Street City State. and zip Code)
I 	II
Public reporting burden for this collection of information is estimated to average 24 hours per response, including the time for reviewing
instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.
Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to:
Department of Health and Human Services 	Department of Health and Human Services
Food and Drug Administration 	Food and Drug Administration 	An agency may not conduct or sponsor, and
Center for Drug Evaluation and Research 	Center for Biologics Evaluation and Research (HFM-99) 	a person is not required to respond to, a
Central Document Room 	1401 Rockville Pike 	collection of information unless it displays a
Rockville, MD 20852-1448	5901-B Ammendale Road 	currently valid OMB control number.
Beltsville, MD 20705-1266
PAGE 2 OF 4	FORM FDA 356h (10/05)

Form Approved: OMB No. 0910-0338	DEPARTMENT OF HEALTH AND HUMAN SERVICES Expiration Date: September 30, 2008	FOOD AND DRUG ADMINISTRATION See OMB Statement on page 2.
APPLICATION TO MARKET A NEW DRUG, BIOLOGIC, 	FOR FDA USE ONLY
OR AN ANTIBIOTIC DRUG FOR HUMAN USE APPLICATION NUMBER
Federal Regulations, Parts 314 & 601)	(Title 21, Code of
APPLICANT INFORMATION
NAME OF APPLICANT 	DATE OF SUBMISSION
II 	I	I
TELEPHONE NO. (Include 	Area Code) 	FACSIMILE (FAX) Number (Include Area Code)
I 	I
I 	I
APPLICANT ADDRESS (Number, Street, City, State, Country, zip Code or Mail 	AUTHORIZED U.S. AGENT NAME & ADDRESS (Number, Street, City, State,
Code, and U.S. LIcense number if oreviouslv issued!: 	ZiP Code, telephone & FAX number) IF APPLICABLE
I 	I
I 	I
PRODUCT DESCRIPTION
NEW DRUG OR ANTIBIOTIC APPLICATION NUMBER, OR BIOLOGICS LICENSE APPLICATION NUMBER (If previously issued) 	r 	I
ESTABLISHED NAME Ie.". Pronername USP/USAN name! 	PROPRIETARY NAME Ifrade namellF ANY
Iinone 	I	
IISodium Fluoride F 18 Injection
CHEMICALIBIOCHEMICAL/BLOOD PRODUCT NAME Ilf anvl 	CODE NAME (If any)
I 	I 	I
pOSAGE FORM' 	ROUTE OF ADMINISTRATION:
Injection 	Intravenous
i 	IISTRENGTHS: 	I i 	I
(PROPOSED) INDICATION(S) FOR USE: In Positron Emission Tomography for ...
I
APPLICATION DESCRIPTION
APPLICATION TYPE
(check one) IZNEW DRUG APPLICATION (CDA, 21 CFR 314.S0) o ABBREVIATED NEW DRUG APPLICATION (ANDA, 21 CFR 314.94)
DBIOLOGICS LICENSE APPLICATION (BLA, 21 CFR Part 601)
IF AN NDA, IDENTIFY THE APPROPRIATE TYPE 	DS05(b)(1) 	0S0S (b)(2)
IF AN ANDA, OR SOS(b)(2), IDENTIFY THE REFERENCE LISTED DRUG PRODUCT THAT IS THE BASIS FOR THE SUBMISSION
I	Name of Drug I I Holder of Approved APPlicationl
TYPE OF SUBMISSION (check oneb 1Z0RIGINAL APPLICATION . ..' DAMENDMENTTO APENDING APPLICATION. DRESUBMISSION
o PRESUBMISSION i ANNUAL REPORT DESTABLISHMENT DESCRIPTION SUPPLEMENT DEFFICACY SUPPLEMENT
DLABEUNG SUPPLEMENT DCHEMISTRY MANUFACTURING AND CONTROLS SUPPLEMENT DOTHER I 	,
IF A SUBMISSION OF PARTIAL APPLICATION, PROVIDE LETTER DATE OF AGREEMENT TO PARTIAL SUBMISSION: I 	I
IF A SUPPLEMENT, IDENTIFY THE APPROPRIATE CATEGORY 	D Prior Approval (PA)	DCBE 	DCBE-30
REASON FOR SUBMISSION IIComplete new application that has never before been submitted. 	I
PROPOSED MARKETING STATUS (check one) 	ø PRESCRIPTION PRODUCT (Rx) 	(OTC)	DOVER THE COUNTER PRODUCT
NUMBER OF VOLUMES SUBMITTED 	THIS APPLICATION IS	
I 	I 	DPAPER 	D PAPER AND ELECTRONIC 	D ELECTRONIC
ESTABLISHMENT INFORMATION (Full establishment information should be provided In the body of the Application.)
Provide locations of all manufacturing, packaging and control sites for drug substance and drug product (continuation sheets may be used if necessary). Include name,
address, contact, telephone number, registration number (CFN), DMF number, and manufacturing steps andlor type of testing (e.g. Final dosage form, Stability testing)
conducted at the site. Please indicate whether the site is ready for inspection or, if not, when it wil be ready.
I	I
Cross References (list related License Applications, INDs, NDAs, PMAs, 510(k)s, IDEs, BMFs, and DMFs referenced in the current application)
I	I
FORM FDA 	356h (10/05) 	PAGE 1 OF4

This application contains the following items: (Check all that apply)
0 	1. Index
2. Labeling (check one)	
0 	o Draft Labeling 	o Final Printed Labeling
3. Summary (21 CFR 314.50 (c))	0
ø 	4. Chemistry section
0 	A. 	Chemistry, manufacturing, and controls information (e.g., 21 CFR 314.50(d)(1); 21 CFR 601.2)
B. 	Samples (21 CFR 314.50 (e)(1); 21 CFR 601.2 (a)) (Submit only upon FDA's request)	IZ
C. 	Methods validation package (e.g., 21 CFR 314.50(e)(2)(i); 21 CFR 601.2)	IZ
0 	5. Nonclinical pharmacology and toxicology section (e.g., 21 CFR 314.50(d)(2); 21 CFR 601.2)
0 	6. Human pharmacokinetics and bioavailability section (e.g., 21 CFR 314.50(d)(3); 21 CFR 601.2)
0 	7. Clinical Microbiology (e.g., 21 CFR 314.50(d)(4))
0 	8. Clinical data section (e.g., 21 CFR 314.50(d)(5); 21 CFR 601.2)
0 	9. Safety update report (e.g., 21 CFR 314.50(d)(5)(vi)(b); 21 CFR 601.2)
0 	10. Statistical section (e.g., 21 CFR 314.50(d)(6); 21 CFR 601.2)
0 	11. Case report tabulations (e.g., 21 CFR 314.50(f)(1); 21 CFR 601.2)
0 	12. Case report forms (e.g., 21 CFR 314.50 (f)(2); 21 CFR 601.2)
13. Patent information on any patent which claims the drug (21 U.S.C. 355(b) or (c))	IZ 14. A patent certification with respect to any patent which claims the drug (21 U.S.C. 355 (b)(2) or U)(2)(A))	IZ 15. Establishment description (21 CFR Part 600, if applicable)	0 16. Debarment certification (FD&C Act 306 (k)(1))	IZ
ø 	17. Field copy certification (21 CFR 314.50 (1)(3))
ø 	18. User Fee Cover Sheet (Form FDA 3397)
0 	19. Financial Information (21 CFR Part 54)
0 	20. OTHER (Specify) I 	I
CERTIFICATION
I agree to update this application with new safety information about the product that may reasonably affect the statement of contraindications,
warnings, precautions, or adverse reactions in the draft labeling. I agree to submit safety update reports as provided for by regulation or as
requested by FDA. If this application is approved, i agree to comply with all applicable laws and regulations that apply to approved applications,
including, but not limited to the following:
1. Good manufacturing practice regulations in 21 CFR Parts 210, 211 or applicable regulations, Parts 606, and/or 820.
2. Biological establishment standards in 21 CFR Part 600.
3. Labeling regulations in 21 CFR Parts 201, 606, 610, 660, and/or 809.
4. In the case of a prescription drug or biological product, prescription drug advertising regulations in 21 CFR Part 202.
5. Regulations on making changes in application in FD&C Act section 506A, 21 CFR 314.71,314.72,314.97,314.99, and 601.12.
6. Regulations on Reports in 21 CFR 314.80,314.81,600.80, and 600.81.
7. Local, state and Federal environmental impact laws.
If this application applies to a drug product that FDA has proposed for scheduling under the Controlled Substances Act, I agree not to market the
product until the Drug Enforcement Administration makes a final scheduling decision.
The data and information in this submission have been reviewed and, to the best of my knowledge are certified to be true and accurate.
Warning: A willfully false statement is a criminal offense, U.S. Code, title 18, section 1001.
I TYPED NAME AND TITLE 	I DATE:	SIGNATURE OF RESPONSIBLE OFFICIAL OR AGENT
II 	III 	I
ADDRESS (Street Citv State and zip Codel 	I Telephone Number
I 	II
Public reporting burden for this collection of information is estimated to average 24 hours per response, including the time for reviewing
instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.
Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to:
Department of Health and Human Services 	Department of Health and Human Services
Food and Drug Administration 	Food and Drug Administration 	An agency may not conduct or sponsor, and
Center for Drug Evaluation and Research 	Center for Biologics Evaluation and Research (H FM-99) 	a person is not required to respond to, a
Central Document Room 	1401 Rockville Pike 	collection of information unless it displays a
Rockville, MD 20852-1448	5901-B Ammendale Road 	currently valid OMB control number.
Beltsville, MD 20705-1266
PAGE20F4	FORM FDA 356h (10/05)

Form Approved: OMB No. 0910-0338	DEPARTMENT OF HEALTH AND HUMAN SERVICES Expiration Date: September 30, 2008	FOOD AND DRUG ADMINISTRATION See OMS Statement on page 2.
APPLICATION TO MARKET A NEW DRUG, BIOLOGIC, 	FOR FDA USE ONLY
OR AN ANTIBIOTIC DRUG FOR HUMAN USE APPLICATION NUMBER
(Tite 21, Code of Federal Regulations, Parts 314 & 601)
APPLICANT INFORMATION
NAME OF APPLICANT 	DATE OF SUBMISSION
I
TELEPHONE NO. (Include
I
APPLICANT ADDRESS (
Code, and U. S. License n
Area Code)
Number, Street, Ci
umber if Dreviouslv
I
ty, State, Country, zip Code or Mail
issued):
II FACSIMILE (FAX) Number (Include
AUTHORIZED U.S. AGENT NAM
ZiP Code, telephone & FAX numb
Area Code)
E & ADDRESS
er) IF APPLICABLE
I
I 	I
(Number, Street, City, State,
I 	I
I 	I
PRODUCT DESCRIPTION
NEW DRUG OR ANTIBIOTIC APPLICATION NUMBER, OR BIOLOGICS LICENSE APPLICATION NUMBER (If previously issued) I 	I
ESTABLISHED NAME (e.a. ProDer name USP/USAN name) 	I PROPRIETARY NAME Itrade name) IF ANY
Illnone 	I	IIAmmonia N 13 Injection
CHEMICALIBIOCHEMICAL/BLOOD PRODUCT NAME (If anv) 	CODE NAME (If any!
II 	II 	I
pOSAGE FORM' 	I STRENGTHS: 	ROUTE OF ADMINISTRATION:
Injection 	Intravenous
I 	III 	I I 	I
(PROPOSED) INDICATION(S) FOR USE: lin Positron Emission Tomography for...
I
APPLICATION DESCRIPTION
APPLICATION TYPE
(check one) ØNEW DRUG APPLICATION (CDA, 21 CFR 314.50) o ABBREVIATED NEW DRUG APPLICATION (ANDA, 21 CFR 314.94)
o BIOLOGICS LICENSE APPLICATION (BLA, 21 CFR Part 601)
IF AN NDA, IDENTIFY THE APPROPRIATE TYPE 	DSOS(b)(1) 	Ø50S (b)(2)
IF AN ANDA, OR SOS(b)(2), IDENTIFY THE REFERENCE LISTED DRUG PRODUCT THAT IS THE BASIS FOR THE SUBMISSION
Name of Drug I I Holder of Approved Application 	I 	I
TYPE OF SUBMISSION (check oneb ØORIGINAL APPLICATION . DAMENDMENTTO APENDING APPLICATION. DRESUBMISSION
EFFICACY SUPPLEMENT .	
o PRESUBMISSION ~ ANNUAL REPORT DESTABLISHMENT DESCRIPTION SUPPLEMENT o
CHEMISTRY MANUFACTURING 	AND CONTROLS SUPPLEMENT DOTHER I 	I	DLABELING SUPPLEMENT o
IF A SUBMISSION OF PARTIAL APPLICATION, PROVIDE LETTER DATE OF AGREEMENT TO PARTIAL SUBMISSION: I 	I
IF A SUPPLEMENT, IDENTIFY THE APPROPRIATE CATEGORY 	o Prior Approval (PA)	DCBE 	DCBE-30
REASON FOR SUBMISSION IIComplete new application that has never before been submitted. 	I
PROPOSED MARKETING STATUS (check one) 	IZ PRESCRIPTION PRODUCT (Rx) 	D OVER THE COUNTER PRODUCT (OTC)
THIS APPLICATION IS	NUMBER OF VOLUMES SUBMITTED I 	I 	DpAPER 	D PAPER AND ELECTRONIC D ELECTRONIC
ESTABLISHMENT INFORMATION (Full establishment Information should be provided in the body of the Application.)
Provide locations of all manufacturing, packaging and control sites for drug substance and drug product (continuation sheets may be used if necessary). Include name,
address, contact, telephone number, registration number (CFN), DMF number, and manufacturing steps andlor type of testing (e.g. Final dosage form, Stability testing)
conducted at the site. Please indicate whether the site is ready for inspection or, if not, when it will be ready.
I	I
Cross References (list related License Applications, INDs, NDAs, PMAs, 510(k)s, IDEs, BMFs, and DMFs referenced in the current application)
I	I
FORM FDA 356h (10/05) 	PAGE 1 OF 4

This application contains the following items: (Check all that apply)
ø 	1. Index
0 	2. Labeling (check one) 	ø Draft Labeling 	o Final Printed Labeling
ø 	3. Summary (21 CFR 314.50 (c))
4. Chemistry section	
12
0 	A. 	Chemistry, manufacturing, and controls information (e.g., 21 CFR 314.50(d)(1); 21 CFR 601.2)
0 	B. 	Samples (21 CFR 314.50 (e)(1); 21 CFR 601.2 (a)) (Submit only upon FDA's request)
C. 	Methods validation package (e.g., 21 CFR 314.50(e)(2)(i); 21 CFR 601.2)	IZ
0 	5. Nonclinical pharmacology and toxicology section (e.g., 21 CFR 314.50(d)(2); 21 CFR 601.2)
0 	6. Human pharmacokinetics and bioavailability section (e.g., 21 CFR 314.50(d)(3); 21 CFR 601.2)
0 	7. Clinical Microbiology (e.g., 21 CFR 314.50(d)(4))
8. Clinical data section (e.g., 21 CFR 314.50(d)(5); 21 CFR 601.2)	D 9. Safety update report (e.g., 21 CFR 314.50(d)(5)(vi)(b); 21 CFR 601.2)	0 10. Statistical section (e.g., 21 CFR 314.50(d)(6); 21 CFR 601.2)	D 11. Case report tabulations (e.g., 21 CFR 314.50(f)(1); 21 CFR 601.2)	0
0 	12. Case report forms (e.g., 21 CFR 314.50 (f)(2); 21 CFR 601.2)
ø 	13. Patent information on any patent which claims the drug (21 U.S.C. 355(b) or (c))
0 	14. A patent certification with respect to any patent which claims the drug (21 U.S.C. 355 (b)(2) or ü)(2)(A))
0 	15. Establishment description (21 CFR Part 600, if applicable)
ø 	16. Debarment certification (FD&C Act 306 (k)(1))
0 	17. Field copy certification (21 CFR 314.50 (1)(3))
ø 	18. User Fee Cover Sheet (Form FDA 3397)
0 	19. Financial Information (21 CFR Part 54)
0 	20. OTHER (Specify) I 	I
CERTIFICATION
i agree to update this application with new safety information about the product that may reasonably affect the statement of contraindications,
warnings, precautions, or adverse reactions in the draft labeling. i agree to submit safety update reports as provided for by regulation or as
requested by FDA. If this application is approved, i agree to comply with all applicable laws and regulations that apply to approved applications,
including, but not limited to the following:
1. Good manufacturing practice regulations in 21 CFR Parts 210,211 or applicable regulations, Parts 606, and/or 820.
2. Biological establishment standards in 21 CFR Part 600.
3. Labeling regulations in 21 CFR Parts 201, 606, 610, 660, and/or 809.
4. In the case of a prescription drug or biological product, prescription drug advertising regulations in 21 CFR Part 202.
5. Regulations on making changes in application in FD&C Act section 506A, 21 CFR 314.71,314.72,314.97,314.99, and 601.12.
6. Regulations on Reports in 21 CFR 314.80,314.81,600.80, and 600.81.
7. Local, state and Federal environmental impact laws.
If this application applies to a drug product that FDA has proposed for scheduling under the Controlled Substances Act, i agree not to market the
product until the Drug Enforcement Administration makes a final scheduling decision.
The data and information in this submission have been reviewed and, to the best of my knowledge are certified to be true and accurate.
Warning: A wilfully false statement is a criminal offense, U.S. Code, title 18, section 1001.
I TYPED NAME AND TITLE	SIGNATURE OF RESPONSIBLE OFFICIAL OR AGENT
II 	il rATE: 	I
I Teleohone Number	ADDRESS (Street Cit¥ State and zip Code)
I 	II
Public reporting burden for this collection of information is estimated to average 24 hours per response, including the time for reviewing
instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.
Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to:
Department of Health and Human Services 	Department of Health and Human Services
Food and Drug Administration 	Food and Drug Administration 	An agency may not conduct or sponsor, and
Center for Drug Evaluation and Research 	Center for Biologics Evaluation and Research (H FM-99) 	a person is not required to respond to, a
Central Document Room 	1401 Rockville Pike 	collection of information unless it displays a
Rockville, MD 20852-1448	5901-8 Ammendale Road 	currently valid OMB control number.
Beltsville, MD 20705-1266
PAGE20F4	FORM FDA 356h (10/05)