Draft  Not for implementation 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 
 
 
 
 
  DEPARTMENT OF HEALTH AND HUMAN SERVICES  Form Approved: OMS No. 0910-0338
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
 
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)  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 
pOSAGE FORM'
  ROUTE OF ADMINISTRATION:
I Injection  )1 IS TRENGTHS:  I  I Intravenous  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
 
Name of Drug I I Holder of Approved APPliCationl 
I
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 fi 
Complete new application that has never before been submitted. 
I 
PROPOSED MARKETING STATUS (check one)   PRESCRIPTION PRODUCT (Rx)  D OVER THE COUNTER PRODUCT (OTC) 
NUMBER OF VOLUMES SUBMITTED  I  I  THIS APPLICATION IS 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
FORM FDA 356h (10/05)  PAGE 1 OF4 This application contains the following items: (Check all that apply) 
 
1. Index 
 
2. Labeling (check one)   Draft Labeling  D Final Printed Labeling 

 
3. Summary (21 CFR 314.50 (c))
 
 
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)
 
D  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) 
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))
 

 
14. A patent certification with respect to any patent which claims the drug (21 U.S.C. 355 (b)(2) or u)(2)(A))
 
0 
15. Establishment description (21 CFR Part 600, if applicable) 

 
16. Debarment certification (FD&C Act 306 (k)(1))
 

 
17. Field copy certification (21 CFR 314.50 (1)(3))
 

 
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 
III	  TYPED NAME AND TITLE  JI rATE:  I
ADDRESS (Street City State. and zip Code)  I Telephone Number
II 
I	 
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
5901-B Ammendale Road  Rockville, MD 20852-1448 currently valid OMB control number.

Beltsville, MD 20705-1266
 
PAGE 2 OF 4
FORM FDA 356h (10/05)  DEPARTMENT OF HEALTH AND HUMAN SERVICES  Form Approved: OMB No. 0910-0338
FOOD AND DRUG ADMINISTRATION  Expiration Date: September 30, 2008
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 
IISodium Fluoride F 18 Injection  Iinone  I
CHEMICALIBIOCHEMICAL/BLOOD PRODUCT NAME Ilf anvl  CODE NAME (If any) 
I  I I 
pOSAGE FORM'  ROUTE OF ADMINISTRATION: 
i Injection  IISTRENGTHS:  I  i Intravenous  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
 
Name of Drug I I Holder of Approved APPlicationl 
I
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  DCBE  DCBE-30  D Prior Approval (PA)
REASON FOR SUBMISSION II 
Complete new application that has never before been submitted. 
I 
PROPOSED MARKETING STATUS (check one)   PRESCRIPTION PRODUCT (Rx)  DOVER THE COUNTER PRODUCT  (OTC)
NUMBER OF VOLUMES SUBMITTED  I  I  THIS APPLICATION IS  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
 
0 
2. Labeling (check one)
 o Draft Labeling  o Final Printed Labeling 
0 
3. Summary (21 CFR 314.50 (c)) 
 
4. Chemistry section
 
0 
A.  Chemistry, manufacturing, and controls information (e.g., 21 CFR 314.50(d)(1); 21 CFR 601.2)
 
IZ  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)
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)
 
IZ  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)) 
0 
15. Establishment description (21 CFR Part 600, if applicable) 
IZ  16. Debarment certification (FD&C Act 306 (k)(1)) 

 
17. Field copy certification (21 CFR 314.50 (1)(3))
 

 
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.
 
SIGNATURE OF RESPONSIBLE OFFICIAL OR AGENT  I TYPED NAME AND TITLE  I DATE:
II  III I 
ADDRESS (Street Citv State and zip Codel  I Telephone Number 
II 
I 
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
5901-B Ammendale Road  Rockville, MD 20852-1448 currently valid OMB control number.

Beltsville, MD 20705-1266
 
PAGE20F4
FORM FDA 356h (10/05)  DEPARTMENT OF HEALTH AND HUMAN SERVICES  Form Approved: OMB No. 0910-0338
FOOD AND DRUG ADMINISTRATION  Expiration Date: September 30, 2008
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 
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 Dreviouslv 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 (e.a. ProDer name USP/USAN name)  I PROPRIETARY NAME Itrade name) IF ANY 
IIAmmonia N 13 Injection  Illnone  I
CHEMICALIBIOCHEMICAL/BLOOD PRODUCT NAME (If anv)  CODE NAME (If any! 
II 
II  I 
pOSAGE FORM'  I STRENGTHS:  ROUTE OF ADMINISTRATION: 
I Injection  III  I  I Intravenous  I 
(PROPOSED) INDICATION(S) FOR USE: lin Positron Emission Tomography for...
 
I 
APPLICATION DESCRIPTION 
APPLICATION TYPE
 
(check one) NEW 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)  50S (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 ORIGINAL APPLICATION . DAMENDMENTTO APENDING APPLICATION. DRESUBMISSION 
EFFICACY SUPPLEMENT . 
o PRESUBMISSION ~ ANNUAL REPORT DESTABLISHMENT DESCRIPTION SUPPLEMENT o 
DLABELING SUPPLEMENT o  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  o Prior Approval (PA)
REASON FOR SUBMISSION II 
Complete new application that has never before been submitted. 
I 
PROPOSED MARKETING STATUS (check one)  IZ PRESCRIPTION PRODUCT (Rx)  D OVER THE COUNTER PRODUCT (OTC) 
NUMBER OF VOLUMES SUBMITTED  I  I  THIS APPLICATION IS 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) 
 
1. Index 
0 
2. Labeling (check one)   Draft Labeling  o Final Printed Labeling 

 
3. Summary (21 CFR 314.50 (c))
 
12  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) 
IZ  C.  Methods validation package (e.g., 21 CFR 314.50(e)(2)(i); 21 CFR 601.2)
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))
 
D  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) 
D  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))
 
0 
14. A patent certification with respect to any patent which claims the drug (21 U.S.C. 355 (b)(2) or u)(2)(A))
0 
15. Establishment description (21 CFR Part 600, if applicable) 

 
16. Debarment certification (FD&C Act 306 (k)(1))
 
0 
17. Field copy certification (21 CFR 314.50 (1)(3)) 

 
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 TYPED NAME AND TITLE
II  il rATE:  I 
ADDRESS (Street Cit State and zip Code)  I Teleohone Number
II 
I 
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
5901-8 Ammendale Road  Rockville, MD 20852-1448 currently valid OMB control number.
Beltsville, MD 20705-1266 
PAGE20F4
FORM FDA 356h (10/05)