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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  06/2014 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 - 2.5MB) 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- 276-8297
0356v  04/2008 New Animal Drug Application [VET] (Q&As on the Revised 356v Form)  (HTM - 0KB) Urvi Desai
240- 276-8297
0421  07/2003 Sample Accountability Record (ORA) (PDF)  (PDF - 389KB) At the warehouse
formsmanager@OC.FDA.GOV
0431  09/2010 Analyst Worksheet (ORA) (PDF)  (PDF - 547KB) 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  12/2010 Certificate/ Transmittal for an Application (PDF)  (PDF - 294KB) 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  08/2009 Application for Permit to Ship or Transport Milk and/or Cream into US (PDF)  (PDF - 672KB) Esther Lazar
240-402-1485
1994  08/2009 Report of Tuberculin Tests of Cattle (PDF)  (PDF - 404KB) Esther Lazar
240-402-1485
1995  08/2009 Report of Physical Examination of Cows (PDF)  (PDF - 1.1MB) Esther Lazar
240-402-1485
1996  04/2009 Farm Inspection Report (PDF)  (PDF - 554KB) Esther Lazar
240-402-1485
1997  08/2009 Score Card for Sanitation Inspections of Milk Plants (PDF)  (PDF - 370KB) Esther Lazar
240-402-1485
2096  03/2004 Regulation Certification for New Employee (PDF)  (PDF - 298KB) Vincent Tolino
301-827-5514
2097  01/2003 Regulation Certification for Separating Employees (PDF)  (PDF - 1MB) Vincent Tolino
301-827-5514
2098  11/2002 Regulation Certification for Special Government Employees (PDF)  (PDF - 603KB) Vincent Tolino
301-827-5514
2252  12/2013 Transmittal of Annual Report for Drugs and Biologics for Human Use (PDF)  (PDF - 771KB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
2253  01/2014 Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use (PDF)  (PDF - 1.7MB) DDMAC
301-796-1200
2253  04/2014 Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use (Instructions Supplement)  (PDF - 190KB) DDMAC
301-796-1200
2301  04/2012 Transmittal of Periodic Reports and Promotional Material New Animal Drugs (PDF)  (PDF - 492KB) Sue Dessai
240-276-9075
2359  10/2011 Milk Plant Inspection Report (PDF)  (PDF - 449KB) Robert Hennes
240-402-2175
2359a  10/2011 Dairy Farm Inspection Report (PDF)  (PDF - 468KB) Robert Hennes
240-402-2175
2359b  10/2011 Milk Plant Equipment Tests Report (PDF)  (PDF - 387KB) Robert Hennes
240-402-2175
2359c  10/2011 Manufacturing Plant Inspection Report (PDF)  (PDF - 453KB) Robert Hennes
240-402-2175
2359d  10/2010 Report of Certification (PDF)  (PDF - 431KB) Robert Hennes
240-402-2175
2359h  10/2011 Interstate Milk Shipper Check-Rating Report (PDF)  (PDF - 589KB) Robert Hennes
240-402-2175
2359i  10/2013 Interstate Milk Shipper Report (PDF)  (PDF - 1.1MB) Robert Hennes
240-402-2175
2359j  10/2013 Milk Sanitation Rating Report (PDF)  (PDF - 738KB) Robert Hennes
240-402-2175
2359k  10/2013 Status of Raw Milk for Pasteurization (PDF)  (PDF - 1.2MB) Robert Hennes
240-402-2175
2359l  10/2011 Status of Milk Plants (PDF)  (PDF - 614KB) Robert Hennes
240-402-2175
2359m  10/2013 Milk Plant, Receiving Station or Transfer Station NCIMS HACPP System Audit Report (PDF)  (PDF - 745KB) Robert Hennes
240-402-2175
2359n  10/2013 NCIMS HACCP System Regulatory Agency Review Report (PDF)  (PDF - 570KB) Robert Hennes
240-402-2175
2359o  10/2013 Permission for Publication Interstate Milk Shipper’s Listing (PDF)  (PDF - 660KB) Robert Hennes
240-402-2175
2359p  10/2011 NCIMS Aseptic Processing and Packaging Program Critical Listing Elements (PDF)  (PDF - 387KB) Robert Hennes
240-402-2175
2399  10/2008 Dairy Plant Sampling - Raw & Pasteurized Milk (PDF)  (PDF - 571KB) Robert Hennes
240-402-2175
2399a  10/2011 Bulk Milk Hauler/Sampler Evaluation Report (PDF)  (PDF - 428KB) Robert Hennes
240-402-2175
2399b  10/2008 Milk Tank Truck Inspection Report (PDF)  (PDF - 427KB) Robert Hennes
240-402-2175
2399c  10/2011 Farm Bulk Tank Milk Sampling Inspection Record (PDF)  (PDF - 713KB) Robert Hennes
240-402-2175
2399d  10/2008 Dairy Plant - Milk Sample Collector Evaluation Record (PDF)  (PDF - 457KB) Robert Hennes
240-402-2175
2400  03/2001 Cultural Procedures - General Requirements (PDF)  (PDF - 8KB) William W. Northeimer, Ph.D.
708-924-0629
2400a  03/2001 Milk Laboratory Evaluation Form: Standard Plate Count, Coliform, and Simplified Count Methods (PDF)  (PDF - 8KB) William W. Northeimer, Ph.D.
708-924-0629
2400a-1  03/2001 Milk Laboratory Evaluation Form: Spiral Plate Count Methods (PDF)  (PDF - 85KB) William W. Northeimer, Ph.D.
708-924-0629
2400b-1  03/2001 MLEF Detection of Inhibitory Substances in Milk Bacillus Stearothermophilus (PDF)  (PDF - 8KB) William W. Northeimer, Ph.D.
708-924-0629
2400b-3  03/2001 MLEF Detection of Inhibitory Substances in Milk Delvotest 5 Pack (PDF)  (PDF - 8KB) William W. Northeimer, Ph.D.
708-924-0629
2400d  03/2001 MLEF Direct Microscopic Somatic Cell Count (PDF)  (PDF - 8KB) William W. Northeimer, Ph.D.
708-924-0629
2400h  03/2001 Optical Somatic Cell Count (PDF)  (PDF - 8KB) William W. Northeimer, Ph.D.
708-924-0629
2400h-1  03/2001 MLEF Electronic Somatic Cell Count Foss 250/300/360/400 (PDF)  (PDF - 8KB) William W. Northeimer, Ph.D.
708-924-0629
2400h-2  03/2001 MLEF Electronic Somatic Cell Count Bentley Somacount 150/300/500 (PDF)  (PDF - 8KB) William W. Northeimer, Ph.D.
708-924-0629
2400h-3  03/2001 MLEF Electronic Somatic Cell Count Fossmatic 5000 (PDF)  (PDF - 8KB) William W. Northeimer, Ph.D.
708-924-0629
2400i  03/2001 Pasteurized Milk Containers (PDF)  (PDF - 8KB) William W. Northeimer, Ph.D.
708-924-0629
2400j  03/2001 Phosphatase Test (PDF)  (PDF - 8KB) William W. Northeimer, Ph.D.
708-924-0629
2400k  03/2001 MLEF Flat Lid Methods (PDF)  (PDF - 68KB) William W. Northeimer, Ph.D.
708-924-0629
2400l  03/2001 MLEF Disintegration Method for Paper, etc. (PDF)  (PDF - 45KB) William W. Northeimer, Ph.D.
708-924-0629
2400m  03/2001 MLEF Dairy Waters (PDF)  (PDF - 8KB) William W. Northeimer, Ph.D.
708-924-0629
2400n  10/2013 Appendix N Bulk Milk Tanker Screening Procedures - General Requirements  (PDF - 699KB) William Northeimer, PhD
708-924-0629
2481  03/2007 Medicated Feeds Inspection Report (PDF)  (PDF - 800KB) Jo W. Gulley
240-453-6858
2511  08/2014 Registration of Cosmetic Product Establishment (PDF)  (PDF - 1.1MB) VCRP
240-402-1130
2511  06/2009 Registration of Cosmetic Product Establishment (HTML)  (HTM - 0KB) VCRP
240-402-1130
2512  06/2009 Cosmetic Product Ingredient Statement (HTML)  (HTM - 0KB) VCRP
240-402-1130
2512  08/2014 Cosmetic Product Ingredient Statement (PDF)  (PDF - 1.1MB) VCRP
240-402-1130
2512a  08/2014 Cosmetic Product Ingredient Statement [CFSAN] (PDF)  (PDF - 1.5MB) VCRP
240-402-1130
2514  08/2014 Notice of Discontinuance of Commercial Distribution of Cosmetic Product Formulation (PDF)  (PDF - 1MB) VCRP
240-402-1130
2541  12/2010 Food Canning Registration (HTML)  (HTM - 0KB) LACF Coordinator
301/436-2411
2541  06/2013 Food Canning Registration (Instructions-PDF)  (HTML - 0KB) LACF Coordinator
LACF@FDA.HHS.GOV
2541  06/2013 Food Canning Registration (Instructions-HTML)  (PDF - 1.4MB) LACF Coordinator
240-402-2411
2541  04/2012 Food Canning Registration (PDF)  (PDF - 400KB) LACF Coordinator
LACF@FDA.HHS.GOV
2541a  04/2010 Food Process Filing For All Methods Except Low-Acid Aseptic (HTML)  (HTM - 0KB) LACF Coordinator
LACF@FDA.HHS.GOV
2541c  04/2012 Food Process Filing For Low-Acid Aseptic Systems (PDF)  (PDF - 711KB) LACF Coordinator
LACF@FDA.HHS.GOV
2541c  04/2010 Food Process Filing For Low-Acid Aseptic Systems (HTML)  (HTM - 0KB) LACF Coordinator
LACF@FDA.HHS.GOV
2579  06/2011 Report of Assembly of a Diagnostic X-Ray System (FAQ & Instructions)  (HTM - 0KB) Mammography Quality and Radiation Programs
301-796-5710
2579  02/2014 Report of Assembly of a Diagnostic X-Ray System (Paper)  (HTM - 0KB) At the warehouse
formsmanager@OC.FDA.GOV
2579  04/2011 Report of Assembly of a Diagnostic X-Ray System (HTML)  (HTM - 0KB) Mammography Quality and Radiation Programs
301-796-5710
2589  08/2001 Inspection Summary - Bus Service Area Sanitation (PDF)  (PDF - 380KB) Rina Bhikha
301-796-5483
2591  08/2001 Inspection Summary Equipment Evaluation (PDF)  (PDF - 378KB) Bruce Kummer
240-402-2142
2626  07/2004 New Drug Application/Biologic Licensing Application (Blue Folder) Archival  (HTML - 14KB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
2626a  07/2004 New Drug Application/Biologic Licensing Application (Red Folder) Chemistry  (HTML - 14KB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
2626b  07/2004 New Drug Application/Biologic Licensing Application (Yellow Folder) Pharmacology  (HTML - 14KB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
2626c  07/2004 New Drug Application/Biologic Licensing Application (Orange Folder) Pharmacokinetic  (HTML - 14KB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
2626d  07/2004 New Drug Application/Biologic Licensing Application (White Folder) Microbiology  (HTML - 14KB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
2626e  07/2004 New Drug Application/Biologic Licensing Application (Tan Folder) Clinical Data  (HTML - 14KB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
2626f  07/2004 New Drug Application/Biologic Licensing Application (Light Green Folder) Statistics  (HTML - 14KB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
2626h  07/2004 New Drug Application/Biologic Licensing Application (Maroon Folder) Field Submission Chemistry  (HTML - 14KB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
2675  08/1990 Investigational New Drug Folder (Red)  (HTML - 14KB) CDER Drug Info at 301-796-3400
2675a  10/1986 Investigational New Drug Folder (Green)  (HTML - 14KB) CDER Drug Info at 301-796-3400
2675b  10/1986 Investigational New Drug Folder (Orange)  (HTML - 14KB) CDER Drug Info at 301-796-3400
2679  08/2001 Food Warehouse Inspection Report (PDF)  (PDF - 281KB) Maya Johnson-Nimo
301-827-2906
2681  02/2002 Bakery Inspection Report (PDF)  (PDF - 879KB) Maya Johnson-Nimo
301-827-2906
2682  10/1988 Beverage Plant Inspection Report (PDF)  (PDF - 857KB) At the warehouse
formsmanager@OC.FDA.GOV
2684  10/2012 State Contract Monthly Food Report (PDF)  (PDF - 376KB) Wendy Campbell
615-310-0483
2684a  04/2011 State Contract Monthly Feed Establishment Report (PDF)  (PDF - 374KB) Wendy Campbell
615-310-0483
2767  05/2014 Notice of Availability of Sample Electronic Product (PDF)  (PDF - 627KB) DMQRP
301-796-5790
2782  09/1998 Field Test Record Continuation Sheet (PDF)  (PDF - 1MB) Nick Walker
301-796-5910
2783  10/1980 Mobile Radiographic Systems Field Test Record (PDF)  (PDF - 19KB) Nick Walker
301-796-5910
2784  10/1980 Above Table X-Ray Source Radiographic Systems (PDF)  (PDF - 30KB) Nick Walker
301-796-5910
2785  05/1982 Dental Radiographic Systems Field Test Record (PDF)  (PDF - 21KB) Nick Walker
301-796-5910
2786  05/1982 Under Table X-Ray Source Fluoroscopic & Spot Film Systems Field Test Record (PDF)  (PDF - 30KB) Nick Walker
301-796-5910
2814  08/1993 Field Equipment Request (PDF)  (PDF - 1.1MB) William Campanaro
301-827-1086
2830  03/2012 Blood Establishment Registration and Product Listing (PDF)  (PDF - 463KB) bloodregis@fda.hhs.gov
2877  08/2014 Declaration for Imported Electronic Products Subject to Radiation Control Standards (PDF)  (PDF - 670KB) DMQRP
301-796-5710
2914  10/2014 Radioactive Drug Research Committee (RDRC) Report on Research Use of Radioactive Drugs Membership Summary (PDF)  (PDF - 3.3MB) RDRC
301-796-2050
2915  10/2014 Radioactive Drug Research Committee (RDRC) Report on Research Use of Radioactive Drugs Study Summary (PDF)  (PDF - 1.9MB) RDRC
301-796-2050
2966  03/2013 Food GMP Inspection Report (PDF)  (PDF - 893KB) Wendy Campbell
615-310-0483
3038  06/2013 Interstate Shellfish Dealer's Certificate (PDF)  (PDF - 656KB) Charlotte Epps
240-402-2154
3038  06/2013 Interstate Shellfish Dealer's Certificate {Not for public use, only for approved State shellfish officials to log into to set up a shellfish shipper user account to be able to fill out and submit the FDA 3038 electronically} (HTML)  (HTM - 0KB) Charlotte Epps
240-402-2154
3068  08/1992 Peak Kilovoltage Determination Field Test Record (PDF)  (PDF - 57KB) Nick Walker
301-796-5910
3069  10/1980 Above Table X-Ray Source Fluoroscopic & Spot Film Systems Field Test Record (PDF)  (PDF - 19KB) Nick Walker
301-796-5910
3071  04/2001 General Information Field Test Record (PDF)  (PDF - 20KB) Nick Walker
301-796-5910
3131  08/2001 Contract Property Administration Completion Report (PDF)  (PDF - 5KB) Mike McGrath
301-827-7105
3147  09/2014 Application for a Variance From 21 CFR 1040.11(c) for a Laser Light Show, Display, or Device (PDF)  (PDF - 711KB) DMQRP
301-796-5710
3147  04/2011 Application for a Variance From 21 CFR 1040.11(c) for a Laser Light Show, Display, or Device (HTML)  (HTM - 0KB) DMQRP
301-796-5790
3260  02/1983 C-Arm Fluoroscopic & Spot-Film Systems Field Test Record (PDF)  (PDF - 41KB) Nick Walker
301-796-5910
3261  02/1983 Vertical Mount Cassette Holder Radiographic Systems Field Test Record (PDF)  (PDF - 23KB) Nick Walker
301-796-5910
3297  04/1984 Head and Neck Radiographic Systems Field Test Record (PDF)  (PDF - 29KB) Nick Walker
301-796-5910
3316  08/1985 DRUG MASTER FILE REVIEW BINDER-Red  (HTML - 14KB) CDER Drug Info at 301-796-3400
3316a  08/1985 DRUG MASTER FILE ARCHIVAL BINDER-Blue  (HTML - 14KB) CDER Drug Info at 301-796-3400
3331  03/2013 NDA Field Alert Report (PDF)  (PDF - 2.7MB) Surveillance Programs Team
301-796-3130
3331a  05/2013 NDA Field Alert Report Automated (Instructions)  (HTM - 0KB) Surveillance Programs Team
301-796-3130
3331a  03/2013 NDA Field Alert Report Automated (PDF)  (PDF - 1.7MB) Surveillance Programs Team
301-796-3130
3356  01/2011 Establishment Registration and Listing for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) (HTML)  (HTM - 0KB) tissuereg@fda.hhs.gov
3356  05/2014 Establishment Registration and Listing for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) (PDF)  (PDF - 922KB) tissuereg@fda.hhs.gov
3397  03/2012 PDUFA User Fee Cover Sheet (HTML)  (HTM - 0KB) CDER Collections at 301.796.7900
3410  10/2001 Confidential Financial Disclosure Report (PDF)  (PDF - 492KB) Vincent Tolino
301-827-5514
3419  10/2014 Medical Device Reporting Annual User Facility Report (PDF)  (PDF - 698KB) OSB/CDRH/RSMB
301-796-6104
3422  08/2013 Government Entity Declaration (PDF)  (PDF - 727KB) Denise Robinson
301-796-5919
3427  06/2012 Supplemental Data Sheet (PDF)  (PDF - 420KB) Marjorie Shulman
301-796-6572
3429  07/2012 General Device Classification Questionnaire (PDF)  (PDF - 442KB) Marjorie Shulman
301-796-6572
3448  03/2014 Medicated Feed Mill License Application (PDF)  (PDF - 550KB) Jo W. Gulley
240-453-6858
3454  04/2013 Certification: Financial Interest and Arrangements of Clinical Investigator (PDF)  (PDF - 673KB) Colleen LoCicero
301-796-1114
3455  04/2013 Disclosure: Financial Interest and Arrangements of Clinical Investigators (PDF)  (PDF - 674KB) Colleen LoCicero
301-796-1114
3463  07/2000 EDI Gateway Training Partner Agreement  (PDF - 8KB) Michael Fauntleroy
301-827-5132
3479  09/2009 Notification for a Food Contact Substance Formulation (PDF)  (PDF - 505KB) Francis Lin
240-402-1215
3480  02/2013 Notification For New Use Of A Food Contact Substance (Instructions)  (PDF - 95KB) Francis Lin
240-402-1215
3480  02/2013 Notification For New Use Of A Food Contact Substance (PDF)  (PDF - 311KB) Francis Lin
240-402-1215
3480a  03/2013 Amendment to an Existing Food Contact Notification Pre-Notification Consultation Food Master File (Instructions)  (PDF - 64KB) Francis Lin
240-402-1215
3480a  02/2013 Amendment to an Existing Food Contact Notification Pre-Notification Consultation Food Master File (PDF)  (PDF - 153KB) Francis Lin
240-402-1215
3486  05/2014 Biological Product Deviation Report (PDF)  (PDF - 767KB) CBER Program Surveillance Branch
240-402-9160
3486  01/2011 Biological Product Deviation Report (Instructions)  (HTM - 0KB) CBER Program Surveillance Branch
240-402-9160
3486  05/2014 Biological Product Deviation Report (Instructions to HTML)  (HTM - 0KB) CBER PSB
240-402-9160
3486  11/2013 Biological Product Deviation Report (HTML)  (HTM - 0KB) CBER Program Surveillance Branch
240-402-9160
3486a  01/2013 Biological Product Addition Information Deviation Report (Instructions to HTML)  (HTM - 0KB) CBER Blood and Tissue Compliance Branch
301-827-6223
3486a  11/2013 Biological Product Additional Information Deviation Report (HTML)  (HTM - 0KB) CBER Blood and Tissue Compliance Branch
301-827-6223
3500  02/2013 MedWatch: The FDA Safety Information and Adverse Reporting Program (PDF)  (PDF - 1.6MB) MEDWATCH
1-800-FDA-1088
3500  02/2006 MedWatch: The FDA Safety Information and Adverse Event Reporting Program (HTML)  (HTM - 0KB) MEDWATCH
1-800-FDA-1088
3500A  02/2013 MedWatch: The FDA Safety Information and Adverse Event Reporting Program - Mandatory (Instructions)  (PDF - 217KB) MedWatch
1-800-332-1088
3500A  02/2013 MedWatch: The FDA Safety Information and Adverse Event Reporting Program - Mandatory (PDF)  (PDF - 1.3MB) MEDWATCH
1-800-FDA-1088
3500B  04/2013 MEDWATCH Consumer Voluntary Reporting (PDF)  (PDF - 1.2MB) MEDWATCH Saftey Alerts
1-800-FDA-1088
3502  01/2001 Importer Seafood HACCP Report (HTML)  (HTM - 0KB) Roshelle King
301-436-1416
3503  08/2014 Food Additive Petition Submission (Instructions)  (PDF - 35KB) Berhane G. Girmay, Ph.D.
240-402-1194
3503  08/2014 Food Additive Petition Submission (PDF)  (PDF - 112KB) Berhane G. Girmay, Ph.D
240-402-1194
3511  07/2010 FDA LACF Inspection Report (PDF)  (PDF - 649KB) Bob Nelligan
706-485-2725
3511-2  07/2010 FDA Acidified Food Inspection Report (PDF)  (PDF - 465KB) Bob Nelligan
706-485-2725
3511-3  07/2010 Aseptic Processing & Packaging Report (PDF)  (PDF - 727KB) Bob Nelligan
706-485-2725
3511a  03/2014 Processing in Steam in Still Retorts (PDF)  (PDF - 914KB) Bob Nelligan
706-485-2725
3511a-1  03/2014 Processing in Steam in Crateless Retorts (PDF)  (PDF - 1004KB) Bob Nelligan
706-485-2725
3511b  03/2014 Processing in Water in Still Retorts (PDF)  (PDF - 935KB) Bob Nelligan
706-485-2725
3511c  03/2014 Processing in Steam in Continuous Agitating Retorts (PDF)  (PDF - 966KB) Bob Nelligan
706-485-2725
3511d  03/2014 Processing in Steam in Discontinuous Agitating Retorts (PDF)  (PDF - 876KB) Bob Nelligan
706-485-2725
3511e  03/2014 Processing in Water in Discontinuous Agitating Retorts (PDF)  (PDF - 972KB) Bob Nelligan
706-485-2725
3511f  05/2014 Processing in Steam in Hydrostatic Retorts (PDF)  (PDF - 844KB) Bob Nelligan
706-485-2725
3511g  01/2011 Processing in Cascading/Spray Water Retort (PDF)  (PDF - 697KB) Bob Nelligan
706-485-2725
3511h  01/2011 Processing in Steam-Air Retorts (PDF)  (PDF - 674KB) Bob Nelligan
706-485-2725
3511i  12/2013 Processing in Other Unique Retort Systems (PDF)  (PDF - 926KB) Bob Nelligan
706-485-2725
3514  01/2013 CDRH Premarket Review Submission Cover Sheet (PDF)  (PDF - 1.7MB) Edwena R. Jones
301-796-6308
3519  10/2014 FDA National Registry Report (PDF)  (PDF - 1.2MB) Glenda Lewis
240-402-2150
3520  10/2014 Release Record and Agreement - Permission to Publish in National Registry (PDF)  (PDF - 1.2MB) Glenda Lewis
240-402-2150
3537  11/2014 Food Facility Registration (PDF)  (PDF - 1.8MB) FDA Industry Systems Help Desk
800-216-7331
301-575-0156
3537  02/2011 Food Facility Registration (HTML)  (HTM - 0KB) FDA Industry Systems Help Desk
800-216-7331
301-575-0156
3537a  11/2008 Cancellation of Food Facility Registration (HTML)  (HTM - 0KB) FDA Industry Systems Help Desk
800-216-7331
301-575-0156
3537a  11/2014 Cancellation of Food Facility Registration (PDF)  (PDF - 665KB) Industry Systems Help Desk
800-216-7331
301-575-0156
3538  02/2014 Electronic Submission System Participant Password or Addition (PDF)  (PDF - 106KB) Margaret Zabriski
240-276-9143
3539  05/2009 Review/Approval of Free Attendance at Widely Attended Gatherings (WAG) (PDF)  (PDF - 431KB) Vincent Tolino
301-827-5514
3540  05/2007 Prior Notice Submission (HTML)  (HTM - 0KB) Prior Notice Center
866-521-2297
3542  11/2013 Patent Information Submitted Upon and After Approval of An NDA or Supplement (PDF)  (PDF - 703KB) Kendra S. Stewart
240-402-8797
3542a  11/2013 Patent Information Submitted With the Filing of An NDA, Amendment, or Supplement (PDF)  (PDF - 700KB) Kendra S. Stewart
240-402-8797
3546  02/2004 ADUFA User Fee Cover Sheet (HTML)  (HTM - 0KB) Lisa Kable
240-276-9718
3570  01/2011 Model Small Business Nutrition Labeling Exemption Notice (HTML)  (HTM - 0KB) SBusiness
240-402-2375
3601  05/2013 Medical Device User Fee Cover Sheet (HTML)  (HTM - 0KB) User Fees Financial Support Team
301-796-7200
3602  08/2014 FY 2015 MDUFMA Small Business Qualification and Certification For a Business Headquarter in the United States (PDF)  (PDF - 1010KB) DSMICA
301-796-7100
800-638-2041
3602a  08/2014 FY 2015 MDUFMA Foreign Small Business Qualification and Certification for a Business Headquartered Outside the United States (PDF)  (PDF - 1MB) DSMICA
301-796-7100
800-638-2041
3608  06/2005 Medical Device Fellowship Program Student Application (HTML)  (HTM - 0KB) DMQRP
301-796-5696
3610  10/2003 Contract Audit (PDF)  (PDF - 540KB) Catherine Hosman
781-587-7443
3611  09/2003 Audit Report (PDF)  (PDF - 353KB) Caleb Michaud
301-796-5932
3613  03/2012 Supplementary Information Certificate to Foreign Government Requests (PDF)  (PDF - 506KB) Import/Export Team
CBER 301-827-6201 or
CDRH 301-796-7400 or
CVM 240-276-9227.
3613a  03/2012 Supplementary Information Certificate of Exportability Requests (PDF)  (PDF - 527KB) Import/Export Team
CBER 301-827-6201 or
CDRH 301-796-7400 or
CVM 240-276-9227.
3613b  03/2012 Supplementary Information Certificate of a Pharmaceutical Product (PDF)  (PDF - 585KB) Import/Export Team
CBER 301-827-6201 or
CDRH 301-796-7400 or
CVM 240-276-9227.
3613c  03/2012 Supplementary Information Non-Clinical Research Use Only Certificate (PDF)  (PDF - 467KB) Import/Export Team
CBER 301-827-6201 or
CDRH 301-796-7400
3613d  03/2012 Office of Cosmetics and Colors "Certificate" Export Application (PDF)  (PDF - 709KB) Export Team
240-402-1178
3613e  03/2012 Food Export Certificate Application (PDF)  (PDF - 454KB) Export Team
240-402-1178
3623  11/2005 Farm Investigation Questionnaire (PDF)  (PDF - 662KB) Rina Bhikha
301-796-5483
3623a  11/2005 Additional Water Sources (PDF)  (PDF - 191KB) Rina Bhikha
301-796-5483
3623b  11/2005 Additional Sets of Workers (PDF)  (PDF - 296KB) Rina Bhikha
301-796-5483
3626  01/2014 A Guide for the Submission of Initial Reports on Diagnostic X-ray Systems and Their Major Components (PDF)  (PDF - 1.1MB) DMQRP
301-796-5710
3626  04/2011 A Guide for the Submission of Initial Reports on Diagnostic X-ray Systems and their Major Components (HTML)  (HTM - 0KB) DMQRP
301-796-5790
3627  01/2014 Diagnostic X-Ray CT Products Radiation Safety Report (PDF)  (PDF - 836KB) DMQRP
301-796-5710
3627  04/2011 Diagnostic X-Ray CT Products Radiation Safety Report (HTML)  (HTM - 0KB) DMQRP
301-796-5790
3628  07/2007 General Annual Report (Includes Medical, Analytical, and Industrial X-Ray Products Annual Report) (PDF)  (PDF - 446KB) DMQRP
301-796-5710
3628  04/2011 General Annual Report (Includes Medical, Analytical, and Industrial X-Ray Products Annual Report) (HTML)  (HTM - 0KB) DMQRP
301-796-5710
3629  04/2011 Abbreviated Report (HTML)  (HTM - 0KB) DMQRP
301-796-5710
3630  04/2011 Guide for Preparing Product Reports on Sunlamps and Sunlamp Products (HTML)  (HTM - 0KB) DMQRP
301-796-5790
3630  10/2014 Guide for Preparing Product Reports on Sunlamps and Sunlamp Products (PDF)  (PDF - 1.2MB) DMQRP
301-796-5710
3631  02/2014 Guide for Preparing Annual Reports on Radiation Safety Testing of Sunlamps and Sunlamp Products (PDF)  (PDF - 823KB) DMQRP
301-796-5710
3631  04/2011 Guide for Preparing Annual Reports on Radiation Safety Testing of Sunlamps and Sunlamp Products (HTML)  (HTM - 0KB) DMQRP
301-796-5790
3632  04/2011 Guide for Preparing Product Reports on Lasers and Products Containing Lasers (HTML)  (HTM - 0KB) DMQRP
301-796-5790
3632  02/2013 Guide for Preparing Product Reports on Lasers and Products Containing Lasers (PDF)  (PDF - 1MB) DMQRP
301-796-5710
3633  04/2011 General Variance Request (HTML)  (HTM - 0KB) DMQRP
301-796-5710
3635  04/2011 Laser Light Show Notification (HTML)  (HTM - 0KB) DMQRP
301-796-5710
3636  03/2014 Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show (PDF)  (PDF - 811KB) DMQRP
301-796-5710
3636  04/2011 Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show (HTML)  (HTM - 0KB) DMQRP
301-796-5790
3637  04/2011 Laser Original Equipment Manufacture Report (HTML)  (HTM - 0KB) DMQRP
301-796-5710
3638  04/2011 Guide for Filling Annual Reports for X-Ray Components and Systems (HTML)  (HTM - 0KB) DMQRP
301-796-5790
3638  03/2014 Guide for Filling Annual Reports for X-Ray Components and Systems (PDF)  (PDF - 871KB) DMQRP
301-796-5710
3639  07/2007 Guidance for Submission of Cabinet X-Ray System Reports Pursuant to 21 CFR 1020.40 (PDF)  (PDF - 1MB) DMQRP
301-796-5710
3639  04/2011 Guidance for Submission of Cabinet X-Ray System Reports Pursuant to 21 CFR 1020.40 (HTML)  (HTM - 0KB) DMQRP
301-796-5790
3640  04/2011 Reporting Guide for Laser Light Shows and Displays (HTML)  (HTM - 0KB) DMQRP
301-796-5790
3640  03/2014 Reporting Guide for Laser Light Shows and Displays (PDF)  (PDF - 919KB) DMQRP
301-796-5790
3641  04/2011 Cabinet X-Ray Annual Report (HTML)  (HTM - 0KB) DMQRP
301-796-5790
3641  04/2014 Cabinet X-Ray Annual Report (PDF)  (PDF - 860KB) DMQRP
301-796-5710
3642  04/2011 General Correspondence Report for CDRH Electronic Submissions (HTML)  (HTM - 0KB) DMQRP
301-796-5710
3643  04/2011 Microwave Oven Products Annual Report (HTML)  (HTM - 0KB) DMQRP
301-796-5790
3643  03/2014 Microwave Oven Products Annual Report (PDF)  (PDF - 865KB) DMQRP
301-796-5710
3644  04/2011 Guide for Preparing Product Reports for Ultrasonic Therapy Products (HTML)  (HTM - 0KB) DMQRP
301-796-5790
3644  07/2007 Guide for Preparing Product Reports for Ultrasonic Therapy Products (PDF)  (PDF - 805KB) DMQRP
301-796-5710
3645  04/2011 Guide for Preparing Annual Reports for Ultrasonic Therapy Products (HTML)  (HTM - 0KB) DMQRP
301-796-5790
3645  07/2007 Guide for Preparing Annual Reports for Ultrasonic Therapy Products (PDF)  (PDF - 516KB) DMQRP
301-796-5710
3646  04/2014 Mercury Vapor Lamp Products Radiation Safety Report (PDF)  (PDF - 886KB) DMQRP
301-796-5710
3646  04/2011 Mercury Vapor Lamp Products Radiation Safety Report (HTML)  (HTM - 0KB) DMQRP
301-796-5790
3647  04/2011 Guide for Preparing Annual Reports on Radiation Safety Testing of Mercury Vapor Lamps (HTML)  (HTM - 0KB) DMQRP
301-796-5790
3647  05/2014 Guide for Preparing Annual Reports on Radiation Safety Testing of Mercury Vapor Lamps (PDF)  (PDF - 888KB) DMQRP
301-796-5710
3649  04/2011 Accidental Radiation Occurrence Report (HTML)  (HTM - 0KB) DMQRP
301-796-5710
3649  06/2014 Accidental Radiation Occurrence Report (PDF)  (PDF - 766KB) DMQRP
301-796-5710
3654  04/2014 Standards Data Report for 510(K)s (PDF)  (PDF - 2.4MB) Scott A. Colburn
301-796-6287
3660  04/2011 Guidance for Preparing Reports on Radiation Safety of Microwave Ovens (HTML)  (HTM - 0KB) DMQRP
301-796-5710
3660  07/2007 Guidance for Preparing Reports on Radiation Safety of Microwave Ovens (PDF)  (PDF - 2.5MB) DMQRP
301-796-5710
3661  07/2007 A Guide for the Submission of an Abbreviated Report on X-ray Tables, Cradles, Film Changers or Cassette Holders Intended for Diagnostic Use (PDF)  (PDF - 691KB) DMQRP
301-796-5710
3661  04/2011 A Guide for the Submission of an Abbreviated Report on X-ray Tables, Cradles, Film Changers or Cassette Holders Intended for Diagnostic (HTML)  (HTM - 0KB) DMQRP
301-796-5710
3662  04/2011 A Guide for Submission of an Abbreviated Radiation Safety Reports on Cephalometric Devise Intended for Diagnostic Use (HTML)  (HTM - 0KB) DMQRP
301-796-5790
3662  07/2007 A Guide for Submission of an Abbreviated Radiation Safety Reports on Cephalometric Devices Intended for Diagnostic Use (PDF)  (PDF - 372KB) DMQRP
301-796-5710
3663  07/2007 Abbreviated Reports on Radiation Safety for Microwave Products (Other than Microwave Ovens) (PDF)  (PDF - 440KB) DMQRP
301-796-5710
3663  04/2011 Abbreviated Reports on Radiation Safety for Microwave Products (Other than Microwave Ovens) (HTML)  (HTM - 0KB) DMQRP
301-796-5790
3664  03/2011 My Medicine Record (PDF)  (PDF - 466KB) Cindi Fitzpatrick
301-796-3115
3665  02/2012 Final Consultation for Food Derived From a New Plant Variety (Instructions)  (PDF - 28KB) Dr. Mary Ditto
240-402-1165
3665  07/2012 Final Consultation for Food Derived From a New Plant Variety (Biotechnology Final Consultation) (PDF)  (PDF - 97KB) Dr. Mary Ditto
240-402-1165
3666  07/2012 Early Food Safety Evaluation of a New Protein Produced by a New Plant Variety New Protein Consultation (Instructions)  (PDF - 32KB) Berhane G. Grimay
240-402-1194
3666  07/2012 Early Food Safety Evaluation of a New Protein Produced by a New Plant Variety (New Protein Consultation) (PDF)  (PDF - 93KB) Berhane G. Grimay
240-402-1194
3667  02/2013 Generally Recognized as Safe (GRAS) Notice (PDF)  (PDF - 137KB) Berhane G. Grimay
240-402-1194
3667  02/2013 Generally Recognized as Safe (GRAS) Notice (Instructions)  (PDF - 32KB) Berhane G. Grimay
240-402-1194
3670  11/2014 MedSun (Medical Product Surveillance Network) (HTML)  (HTM - 0KB) Jill Marion
301- 796-6128
3671  11/2011 Common EMEA/FDA Application for Orphan Medicinal Product Designation (PDF)  (PDF - 569KB) Kathy Needleman
301-827-3666
3674  02/2013 Certification of Compliance, under 42 U.S.C. , 282(j)(5)(B), with Requiremetsof ClinicalTrials.gov (PDF)  (PDF - 2.6MB) Patrick McNeilly
301- 796-2941
3674  02/2013 Certification of Compliance, under 42 U.S.C. , 282(j)(5)(B), with Requirements of ClinicalTrials.gov Data Bank (42 U.S.C., 282(j)) (Instructions/Supplemental)  (PDF - 129KB) Patrick McNeilly
301- 796-2941
3676  05/2013 Secure Supply Chain Pilot Program Application (PDF)  (PDF - 1.4MB) Huascar Batista
301-796-3411
3677v  01/2006 Minor Species Index File (MIF) (PDF)  (PDF - 265KB) Joan C. Gotthardt
240-276-9331
3719  10/2009 Report of Inspection for Compliance with 21 CFR 589.2000 (CVM) (PDF)  (PDF - 621KB) Shannon Jordre
240-276-9229
3719-1  10/2009 Report of Inspection for Compliance with 21 CFR 589.2000 (CVM-1) (PDF)  (PDF - 563KB) Shannon Jordre
240-276-9229
3728  09/2014 Animal Generic Drug User Fee Cover Sheet (HTML)  (HTM - 0KB) Lisa Kable
240-276-9718
3733  05/2010 Shell Egg Producer Registration (HTML)  (HTM - 0KB) Nancy Bufano
240-402-1493
3733  08/2014 Shell Egg Producer Registration (PDF)  (PDF - 722KB) Nancy Bufano
240-402-1493
3741  05/2014 Registration and Listing for Owners and Operators of Domestic Tobacco Product Establishments (PDF)  (PDF - 898KB) Chris Colburn
301-796-8758
3742  05/2014 Listing of Ingredients in Tobacco Products (PDF)  (PDF - 886KB) Chris Colburn
301-796-8758
3743  05/2014 Tobacco Health Document Submission (PDF)  (PDF - 785KB) Chris Colburn
301-796-8758
3744  04/2014 Antimicrobial Animal Drug Distribution Report (PDF)  (PDF - 2.1MB) Sue Dessai
240-276-9075
3752  04/2013 Pre-Amendment Device Determination Request (PDF)  (PDF - 677KB) DPLC
301-796-5770
3757  07/2010 Menu and Vending Machine Labeling Voluntary Registration (PDF)  (PDF - 73KB) Felicia Billingslea
240-402-2371
3759  05/2014 Abbreviated Reports on Radiation Safety of Non Medical Ultrasonic Products (PDF)  (PDF - 762KB) Cory Tylka
301-796-5869
3759  04/2011 Abbreviated Reports on Radiation Safety of Non Medical Ultrasonic Products (HTML)  (HTM - 0KB) Cory Tylka
301-796-5869
3760  06/2014 Guide for Preparing Product Reports for Medical Ultrasound Products (PDF)  (PDF - 771KB) Cory Tylka
301-796-5869
3779  07/2014 Tobacco Product Violations Reporting (PDF)  (PDF - 1.2MB) Chris Colburn
301-796-8758
3787a  03/2013 Cigarette Report (PDF)  (PDF - 1.6MB) Chris Colburn
301-796-8758
3787b  05/2014 Smokeless Tobacco Product Report (PDF)  (PDF - 911KB) Chris Colburn
301-796-8758
3787c  05/2014 Roll-Your-Own (RYO) Tobacco Products (PDF)  (PDF - 828KB) Chris Colburn
301-796-8758
3787d  08/2013 Tobacco Product Identification Worksheet (HTML)  (HTM - 0KB) Chris Colburn
301-796-8758
3787e  08/2013 Cigarette Smoke (ISO Regimen) Report Worksheet (HTML)  (HTM - 0KB) Chris Colburn
301-796-8758
3787f  08/2013 Cigarette Smoke Report (Intense Regimen) Worksheet (HTML)  (HTM - 0KB) Chris Colburn
301-796-8758
3787g  08/2013 Cigarette Smoke (Other Regimen) Report Worksheet (HTML)  (HTM - 0KB) Chris Colburn
301-796-8758
3787h  08/2013 Cigarette Filler Report Worksheet (HTML)  (HTM - 0KB) Chris Colburn
301-796-8758
3787i  08/2013 Smokeless Tobacco Product Report Worksheet (HTML)  (HTM - 0KB) Chris Colburn
301-796-8758
3787j  08/2013 Roll-Your-Own Tobacco Product Report Worksheet (HTML)  (HTM - 0KB) Chris Colburn
301-796-8758
3792  10/2012 Biosimilar User Fee Cover Sheet (HTML)  (HTM - 0KB) CDER Collections at 301.796.7900
3794  08/2013 Generic Drug User Fee Cover Sheet (HTML)  (HTM - 0KB) CDER Collections at 301.796.7900
3794  08/2013 Generic Drug User Fee Cover Sheet (Instructions)  (PDF - 650KB) CDER Collections at 301.796.7900
3799  06/2012 Publication Request (HTML)  (HTM - 0KB) Marion Allen
240-402-1584
3800  10/2014 FDA Safety Reporting Portal (HTML)  (HTM - 0KB) Debra Street
240-402-1817
3801  06/2014 Guide for Preparing Initial Reports and Model Change Reports on Medical Ultraviolet Lamps and Products Containing Such Lamps (PDF)  (PDF - 1010KB) Cory Tylka
301-796-5869
3852  07/2014 Report of Tobacco Product Removals Subject to Tax for Tobacco Product User Fee Assessments  (PDF - 665KB) Chris Colburn
301-796-8758
3881  08/2014 Indications for Use (PDF)  (PDF - 1.7MB) Diane Garcia
301-796-6559
3882  08/2014 FDA Scientific Achievement Awards Nomination Package (PDF)  (PDF - 2.1MB) Bernadette Williamson-Taylor
301-796-8514
3889a  10/2013 Registration for November 21, 2013 Public Meeting (PDF)  (PDF - 1MB) Aleta Sindelar
301-502-7433
3889b  10/2013 Registration for November 25, 2013 Public Meeting (PDF)  (PDF - 1MB) Aleta Sindelar
301-502-7433
3889c  10/2013 Registration for December 6, 2013 Public Meeting (PDF)  (PDF - 1MB) Aleta Sindelar
301-502-7433
3890  05/2014 PETNet (HTML)  (HTM - 0KB) Jenny Murphy
240-453-6845
3891  05/2014 Livestock Net (HTML)  (HTM - 0KB) Jenny Murphy
240-453-6845
3906  12/2013 Publication Request CFSAN (PDF)  (HTM - 0KB) CFSAN Publicaiotns
1-888-723-3366
3907  03/2014 Food and Cosmetics Information Center (FCIC) Inquiry (HTML)  (HTM - 0KB) Deborah Price
240-402-1746
VAERS-!  11/2014 Vaccine Adverse Event Reporting System (PDF)  (PDF - 99KB) VAERS
800-822-7967
VARES-1  11/2014 Vaccine Adverse Event Reporting System (HTML)  (HTM - 0KB) VAERS
800-822-7967
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