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U.S. Department of Health and Human Services

About FDA

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FDA Forms

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Form Date Food and Drug Administration Forms Format Contact Info
0356h  12/2014 Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use (PDF) (Recommended for use with Adobe Acrobat 8 or 9)  (PDF - 2MB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
0356h  09/2014 Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use (Instructions Supplement)  (PDF - 137KB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
0356v  09/2013 New Animal Drug Application [VET] (PDF)  (PDF - 844KB) Urvi Desai
240-402-0689
0356v  04/2008 New Animal Drug Application [VET] (Q&As on the Revised 356v Form)  (HTM - 0KB) Urvi Desai
240-402-0689
0421  07/2003 Sample Accountability Record (ORA) (PDF)  (PDF - 389KB) William Campanaro
240 821 6667
0431  01/2015 Analyst Worksheet (ORA) (PDF)  (PDF - 1MB) William Campanaro
240 821 6667
0431a  05/1984 General Continuation Sheet (PDF)  (PDF - 722KB) William Campanaro
240 821 6667
0431d  08/2012 Bacteriological Record (PDF)  (PDF - 1.2MB) William Campanaro
240 821 6667
0431e  09/2011 Industrial Chemicals Worksheet (PDF)  (PDF - 389KB) William Campanaro
240 821 6667
0431f  11/1989 Quantity of Contents (PDF)  (PDF - 337KB) William Campanaro
240 821 6667
0431j  08/1985 Botulism Continuation Sheet (PDF)  (PDF - 6KB) William Campanaro
301-827-1036
0431k  08/1985 Shellfish Bacteriological Record (PDF)  (PDF - 8KB) William Campanaro
301-827-1036
0431m  12/1979 Elemental Analysis Worksheet (PDF)  (PDF - 6KB) William Campanaro
240 821 6667
0433  06/1982 Tomato Inspection Report (PDF)  (PDF - 12KB) Rina Bhikha
301-796-5483
0465  08/1985 Sample Summary (DOC)  (PDF - 221KB) William Campanaro
240 821 6667
0766  06/2014 Application for Authorization to Re label or to Perform Other Action of the Federal Food, Drug, and Cosmetic Act and Other Related Acts (PDF)  (PDF - 647KB) Domenic Veneziano
301-443-6553
1533  10/2001 Results of Sediment Pad Grading (PDF)  (PDF - 268KB) Rina Bhikha
301-796-5483
1551  05/2011 Report of Sample Analysis (PDF)  (PDF - 353KB) William Campanaro
240 821 6667
1551b  01/1993 Report of Sample Analysis (Aflatoxins) (PDF)  (PDF - 337KB) William Campanaro
240 821 6667
1570  04/1978 Summary of Bacteriological Results (PDF)  (PDF - 302KB) William Campanaro
240 821 6667
1571  10/2014 Investigational New Drug Application (IND) [Instructions]  (PDF - 137KB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
1571  01/2013 Investigational New Drug Application (IND) (PDF) (Recommended for use with Adobe Acrobat 8 or 9)  (PDF - 830KB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
1572  07/2013 Statement of Investigator Statement of Investigator (Title 21, Code of Federal Regulations (CFR) Part 312) (PDF)  (PDF - 897KB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
1572  07/2013 Statement of Investigator (Title 21, Code of Federal Regulations (CFR) Part 312) (Guidance)  (PDF - 108KB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
1609  03/1986 Research Project Record (PDF)  (PDF - 337KB) William Campanaro
301-827-1036
1609a  03/1986 Research Progress Record (PDF)  (PDF - 349KB) William Campanaro
301-827-1036
1815  10/2014 Certificate/ Transmittal for an Application (PDF)  (PDF - 599KB) Esther Lazar
240-402-1485
1932  10/2013 Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report (PDF)  (PDF - 946KB) Margarita Brown
240-276-9048
1932a  10/2013 Veterinary Adverse Drug Reaction, Lack of Effectiveness or Product Defect (PDF)  (PDF - 809KB) Margarita Brown
240-276-9048
1993  10/2014 Application for Permit to Ship or Transport Milk and/or Cream into US (PDF)  (PDF - 727KB) Esther Lazar
240-402-1485

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