US Food and Drug Administration US FDA Forms

US Food and Drug Administration US FDA Forms

Compilation of US Food and Drug Administration US FDA Forms

Below is a compilation of FDA forms with links to the PDF formats. The data table also includes a contact number for questions.

3662 12/2015 A Guide for Submission of an Abbreviated Radiation Safety Reports on Cephalometric Devices Intended for Diagnostic Use (PDF)  (PDF – 729KB) DRH
301-796-5790
3662 04/2011 A Guide for Submission of an Abbreviated Radiation Safety Reports on Cephalometric Devise Intended for Diagnostic Use (HTML)  (HTM – 0KB) DRH
301-796-5790
3626 01/2014 A Guide for the Submission of Initial Reports on Diagnostic X-ray Systems and Their Major Components (PDF)  (PDF – 1.1MB) DRH
301-796-5790
3626 04/2011 A Guide for the Submission of Initial Reports on Diagnostic X-ray Systems and their Major Components (HTML)  (HTM – 0KB) DRH
301-796-5790
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) DRH
301-796-5790
3661 06/2015 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 – 694KB) DRH
301-796-5790
3546 09/2014 ADUFA User Fee Cover Sheet (HTML)  (HTM – 0KB) Lisa Kable
240-276-9718
3629 04/2011 Abbreviated Report (HTML)  (HTM – 0KB) DRH
301-796-5790
3663 04/2011 Abbreviated Reports on Radiation Safety for Microwave Products (Other than Microwave Ovens) (HTML)  (HTM – 0KB) DRH
301-796-5790
3663 03/2016 Abbreviated Reports on Radiation Safety for Microwave Products (Other than Microwave Ovens) (PDF)  (PDF – 742KB) DRH
301-796-5790
3759 04/2011 Abbreviated Reports on Radiation Safety of Non Medical Ultrasonic Products (HTML)  (HTM – 0KB) DRH
301-796-5790
3759 05/2014 Abbreviated Reports on Radiation Safety of Non Medical Ultrasonic Products (PDF)  (PDF – 762KB) DRH
301-796-5790
3069 10/1980 Above Table X-Ray Source Fluoroscopic & Spot Film 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
3649 04/2011 Accidental Radiation Occurrence Report (HTML)  (HTM – 0KB) DRH
301-796-5790
3649 06/2014 Accidental Radiation Occurrence Report (PDF)  (PDF – 766KB) DRH
301-796-5790
3623a 11/2014 Additional Water Sources (PDF)  (PDF – 2.2MB) Rina Vora
562-256-9292
3480a 03/2016 Amendment to an Existing Food Contact Notification Pre-Notification Consultation Food Master File (Instructions)  (PDF – 64KB) Elizabeth Furukawa
650-529-9908
3480a 03/2016 Amendment to an Existing Food Contact Notification Pre-Notification Consultation Food Master File (PDF)  (PDF – 154KB) Elizabeth Furukawa
650-529-9908
0431 01/2015 Analyst Worksheet (ORA) (PDF)  (PDF – 1MB) William Campanaro
240 821 6667
3728 09/2014 Animal Generic Drug User Fee Cover Sheet (HTML)  (HTM – 0KB) Lisa Kable
240-276-9718
3744 04/2014 Antimicrobial Animal Drug Distribution Report (PDF)  (PDF – 2.1MB) Sue Dessai
240-276-9075
2400n 10/2013 Appendix N Bulk Milk Tanker Screening Procedures – General Requirements  (PDF – 720KB) William Northeimer, PhD
708-924-0629
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) John Verbeten
301-796-6677
1993 10/2015 Application for Permit to Ship or Transport Milk and/or Cream into US (PDF)  (PDF – 727KB) Esther Lazar
240-402-1485
3147 04/2011 Application for a Variance From 21 CFR 1040.11(c) for a Laser Light Show, Display, or Device (HTML)  (HTM – 0KB) DRH
301-796-5790
3147 08/2016 Application for a Variance From 21 CFR 1040.11(c) for a Laser Light Show, Display, or Device (PDF)  (PDF – 715KB) DRH
301-796-5790
0356h 08/2015 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 08/2015 Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use (Instructions Supplement)  (PDF – 122KB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
3511-3 11/2014 Aseptic Processing & Packaging Report (PDF)  (PDF – 988KB) Bob Neligan
706-485-2725
3611 09/2003 Audit Report (PDF)  (PDF – 353KB) Caleb Michaud
301-796-5932
2359f 11/2015 Audit Report of IMS Listed Single-Service Containers and/or Closures for Milk and/or Milk Products Manufacturers (PDF)  (PDF – 654KB) Robert Hennes
240-402-2175
0431d 08/2012 Bacteriological Record (PDF)  (PDF – 1.2MB) William Campanaro
240 821 6667
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) Maya Johnson-Nimo
301-796-5885
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
3486 11/2013 Biological Product Deviation Report (HTML)  (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 01/2011 Biological Product Deviation Report (Instructions)  (HTM – 0KB) CBER Program Surveillance Branch
240-402-9160
3486 05/2014 Biological Product Deviation Report (PDF)  (PDF – 770KB) CBER Program Surveillance Branch
240-402-9160
3792 12/2015 Biosimilar User Fee Cover Sheet (HTML)  (HTM – 0KB) CDER Collections at 301.796.7900
2830 05/2015 Blood Establishment Registration and Product Listing (PDF)  (PDF – 767KB) bloodregis@fda.hhs.gov
0431j 08/1985 Botulism Continuation Sheet (PDF)  (PDF – 6KB) William Campanaro
301-827-1036
2399a 10/2011 Bulk Milk Hauler/Sampler Evaluation Report (PDF)  (PDF – 428KB) Robert Hennes
240-402-2175
3260 02/1983 C-Arm Fluoroscopic & Spot-Film Systems Field Test Record (PDF)  (PDF – 41KB) Nick Walker
301-796-5910
3514 01/2013 CDRH Premarket Review Submission Cover Sheet (PDF)  (PDF – 1.7MB) Edwena R. Jones
301-796-6308
3641 04/2011 Cabinet X-Ray Annual Report (HTML)  (HTM – 0KB) DRH
301-796-5790
3641 04/2014 Cabinet X-Ray Annual Report (PDF)  (PDF – 860KB) DRH
301-796-5790
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
1815 10/2015 Certificate/ Transmittal for an Application (PDF)  (PDF – 602KB) Esther Lazar
240-402-1485
3674 02/2015 Certification of Compliance, under 42 U.S.C. , 282(j)(5)(B), with Requirements of 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
3454 03/2016 Certification: Financial Interest and Arrangements of Clinical Investigator (PDF)  (PDF – 673KB) Colleen LoCicero
301-796-1114
3787h 08/2013 Cigarette Filler Report Worksheet (HTML)  (HTM – 0KB) CTP
1-877-CTP-1373
(1-877-287-1373)
3787a 07/2016 Cigarette Report (PDF)  (PDF – 1.5MB) CTP
1-877-CTP-1373
(1-877-287-1373)
3787e 08/2013 Cigarette Smoke (ISO Regimen) Report Worksheet (HTML)  (HTM – 0KB) CTP
1-877-CTP-1373
(1-877-287-1373)
3787g 08/2013 Cigarette Smoke (Other Regimen) Report Worksheet (HTML)  (HTM – 0KB) CTP
1-877-CTP-1373
(1-877-287-1373)
3787f 08/2013 Cigarette Smoke Report (Intense Regimen) Worksheet (HTML)  (HTM – 0KB) CTP
1-877-CTP-1373
(1-877-287-1373)
3671 01/2015 Common EMEA/FDA Application for Orphan Medicinal Product Designation (PDF)  (PDF – 850KB) Kathy Needleman
301-827-3666
3410 10/2001 Confidential Financial Disclosure Report (PDF)  (PDF – 492KB) Vincent Tolino
301-827-5514
3610 10/2003 Contract Audit (PDF)  (PDF – 540KB) Catherine Hosman
781-587-7443
3131 08/2001 Contract Property Administration Completion Report (PDF)  (PDF – 5KB) Mike McGrath
301-827-7105
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
2400 03/2001 Cultural Procedures – General Requirements (PDF)  (PDF – 8KB) William W. Northeimer, Ph.D.
708-924-0629
3316a 08/1985 DRUG MASTER FILE ARCHIVAL BINDER-Blue  (HTML – 14KB) CDER Drug Info at 301-796-3400
3316 08/1985 DRUG MASTER FILE REVIEW BINDER-Red  (HTML – 14KB) CDER Drug Info at 301-796-3400
2359a 10/2011 Dairy Farm Inspection Report (PDF)  (PDF – 468KB) Robert Hennes
240-402-2175
2399d 10/2008 Dairy Plant – Milk Sample Collector Evaluation Record (PDF)  (PDF – 457KB) Robert Hennes
240-402-2175
2399 10/2008 Dairy Plant Sampling – Raw & Pasteurized Milk (PDF)  (PDF – 571KB) Robert Hennes
240-402-2175
2877 08/2014 Declaration for Imported Electronic Products Subject to Radiation Control Standards (PDF)  (PDF – 670KB) DRH
301-796-5790
0482d 02/2016 Demand Request for FSVP Records (PDF)  (PDF – 628KB) Brian Ravitch
619 941-3719
2785 05/1982 Dental Radiographic Systems Field Test Record (PDF)  (PDF – 21KB) Nick Walker
301-796-5910
3627 04/2011 Diagnostic X-Ray CT Products Radiation Safety Report (HTML)  (HTM – 0KB) DRH
301-796-5790
3627 01/2014 Diagnostic X-Ray CT Products Radiation Safety Report (PDF)  (PDF – 836KB) DRH
301-796-5790
3455 03/2016 Disclosure: Financial Interest and Arrangements of Clinical Investigators (PDF)  (PDF – 673KB) Colleen LoCicero
301-796-1114
3911 12/2015 Drug Notification to FDA (Instructions Supplement)  (PDF – 126KB) CDER Drug Info
301-796-3400
3911 12/2015 Drug Notification to FDA (PDF)  (PDF – 2.1MB) CDER Drug Info
301-796-3400
3666 11/2015 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
3666 11/2015 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
3880 05/2015 Electronic Submission Gateway for New Dietary Ingredient Notification (NDIN) Submission (HTM)  (HTM – 0KB) Office of Dietary Supplement Programs
(855) 543-3784
240-402-2375
3538 02/2014 Electronic Submission System Participant Password or Addition (PDF)  (PDF – 106KB) Margaret Zabriski
240-276-9143
0431m 12/1979 Elemental Analysis Worksheet (PDF)  (PDF – 6KB) William Campanaro
240 821 6667
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
3511-2 07/2010 FDA Acidified Food Inspection Report (PDF)  (PDF – 465KB) Bob Neligan
706-485-2725
3511 07/2010 FDA LACF Inspection Report (PDF)  (PDF – 649KB) Bob Neligan
706-485-2725
3519 11/2015 FDA National Registry Report (PDF)  (PDF – 1.2MB) Stephen Hughes
240-402-2833
3800 10/2014 FDA Safety Reporting Portal (HTML)  (HTM – 0KB) Debra Street
240-402-1817
3882 08/2014 FDA Scientific Achievement Awards Nomination Package (PDF)  (PDF – 2.1MB) Devin Thomas
240- 402-5263
0483a 02/2016 FSVP Observations (PDF)  (PDF – 1.7MB) Brian Ravitch
619 941-3719
3601a 08/2012 FURLS User Fee (HTM)  (HTM – 0KB) User Fees Financial Support Team
301-796-7200
3602a 07/2016 FY 2017 MDUFA Foreign Small Business Qualification and Certification For a Business Headquartered Outside the United States (PDF)  (PDF – 1.1MB) DICE
800-638-2041
3602 07/2016 FY 2017 MDUFA Small Business Qualification and Certification For a Business Headquartered in the United States (PDF)  (PDF – 1014KB) DICE
800-638-2041
2399c 10/2011 Farm Bulk Tank Milk Sampling Inspection Record (PDF)  (PDF – 713KB) Robert Hennes
240-402-2175
1996 10/2015 Farm Inspection Report (PDF)  (PDF – 3MB) Esther Lazar
240-402-1485
3623 11/2014 Farm Investigation Questionnaire (PDF)  (PDF – 3MB) Rina Vora
562-256-9292
2814 08/1993 Field Equipment Request (PDF)  (PDF – 1.1MB) William Campanaro
301-827-1086
2782 09/1998 Field Test Record Continuation Sheet (PDF)  (PDF – 1MB) Nick Walker
301-796-5910
3665 05/2015 Final Consultation for Food Derived From a New Plant Variety (Biotechnology Final Consultation) (PDF)  (PDF – 96KB) Dr. Mary Ditto
240-402-1165
3665 05/2015 Final Consultation for Food Derived From a New Plant Variety (Instructions)  (PDF – 33KB) Dr. Mary Ditto
240-402-1165
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
2541 12/2010 Food Canning Registration (HTML)  (HTM – 0KB) LACF Coordinator
301/436-2411
2541 06/2013 Food Canning Registration (Instructions-HTML)  (PDF – 1.4MB) LACF Coordinator
240-402-2411
2541 06/2013 Food Canning Registration (Instructions-PDF)  (HTML – 0KB) LACF Coordinator
LACF@FDA.HHS.GOV
2541 06/2016 Food Canning Registration (PDF)  (PDF – 683KB) LACF Coordinator
LACF@FDA.HHS.GOV
3613e 03/2012 Food Export Certificate Application (HTML)  (HTM – 0KB) Export Team
3613e 06/2015 Food Export Certificate Application (PDF)  (PDF – 727KB) Export Team
3537 02/2011 Food Facility Registration (HTML)  (HTM – 0KB) FDA Industry Systems Help Desk
800-216-7331
301-575-0156
3537 11/2014 Food Facility Registration (PDF)  (PDF – 1.8MB) FDA Industry Systems Help Desk
800-216-7331
301-575-0156
2966 03/2013 Food GMP Inspection Report (PDF)  (PDF – 893KB) Wendy Campbell
615-310-0483
2541e 06/2016 Food Process Filing For Acidified Method  (PDF – 1.1MB) LACF Coordinator
240-402-2411
2541g 06/2016 Food Process Filing For Low-Acid Aseptic Systems  (PDF – 935KB) LACF Coordinator
240-402-2411
2541d 06/2016 Food Process Filing For Low-Acid Retorted Method  (PDF – 1.1MB) LACF Coordinator
240-402-2411
2541f 06/2016 Food Process Filing For Water Activity/Formulation Control Method (PDF)  (PDF – 1.1MB) LACF Coordinator
240-402-2411
2679 08/2001 Food Warehouse Inspection Report (PDF)  (PDF – 533KB) Maya Johnson-Nimo
301-827-2906
3907 03/2014 Food and Cosmetics Information Center (FCIC) Inquiry (HTML)  (HTM – 0KB) Deborah Price
240-402-1746
3628 04/2011 General Annual Report (Includes Medical, Analytical, and Industrial X-Ray Products Annual Report) (HTML)  (HTM – 0KB) DRH
301-796-5790
3628 02/2016 General Annual Report (Includes Medical, Analytical, and Industrial X-Ray Products Annual Report) (PDF)  (PDF – 801KB) DRH
301-796-5790
0431a 05/1984 General Continuation Sheet (PDF)  (PDF – 1.4MB) William Campanaro
240 821 6667
3642 04/2011 General Correspondence Report for CDRH Electronic Submissions (HTML)  (HTM – 0KB) DRH
301-796-5790
3429 10/2015 General Device Classification Questionnaire (PDF)  (PDF – 718KB) Marjorie Shulman
301-796-6572
3071 04/2001 General Information Field Test Record (PDF)  (PDF – 20KB) Nick Walker
301-796-5910
3633 04/2011 General Variance Request (HTML)  (HTM – 0KB) DRH
301-796-5790
3667 05/2016 Generally Recognized as Safe (GRAS) Notice (Instructions)  (PDF – 32KB) Berhane G. Grimay
240-402-1194
3667 05/2016 Generally Recognized as Safe (GRAS) Notice (PDF)  (PDF – 137KB) Berhane G. Grimay
240-402-1194
3794 02/2016 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
3422 08/2013 Government Entity Declaration (PDF)  (PDF – 727KB) Denise Robinson
301-796-5919
3660 04/2011 Guidance for Preparing Reports on Radiation Safety of Microwave Ovens (HTML)  (HTM – 0KB) DRH
301-796-5790
3660 07/2007 Guidance for Preparing Reports on Radiation Safety of Microwave Ovens (PDF)  (PDF – 2.5MB) DRH
301-796-5790
3639 04/2011 Guidance for Submission of Cabinet X-Ray System Reports Pursuant to 21 CFR 1020.40 (HTML)  (HTM – 0KB) DRH
301-796-5790
3639 03/2014 Guidance for Submission of Cabinet X-Ray System Reports Pursuant to 21 CFR 1020.40 (PDF)  (PDF – 988KB) DRH
301-796-5790
3638 04/2011 Guide for Filling Annual Reports for X-Ray Components and Systems (HTML)  (HTM – 0KB) DRH
301-796-5790
3638 03/2014 Guide for Filling Annual Reports for X-Ray Components and Systems (PDF)  (PDF – 871KB) DRH
301-796-5790
3645 04/2011 Guide for Preparing Annual Reports for Ultrasonic Therapy Products (HTML)  (HTM – 0KB) DRH
301-796-5790
3645 06/2015 Guide for Preparing Annual Reports for Ultrasonic Therapy Products (PDF)  (PDF – 761KB) DRH
301-796-5790
3636 04/2011 Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show (HTML)  (HTM – 0KB) DRH
301-796-5790
3636 03/2014 Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show (PDF)  (PDF – 811KB) DRH
301-796-5790
3647 04/2011 Guide for Preparing Annual Reports on Radiation Safety Testing of Mercury Vapor Lamps (HTML)  (HTM – 0KB) DRH
301-796-5790
3647 05/2014 Guide for Preparing Annual Reports on Radiation Safety Testing of Mercury Vapor Lamps (PDF)  (PDF – 888KB) DRH
301-796-5790
3631 04/2011 Guide for Preparing Annual Reports on Radiation Safety Testing of Sunlamps and Sunlamp Products (HTML)  (HTM – 0KB) DRH
301-796-5790
3631 02/2014 Guide for Preparing Annual Reports on Radiation Safety Testing of Sunlamps and Sunlamp Products (PDF)  (PDF – 823KB) DRH
301-796-5790
3801 06/2014 Guide for Preparing Initial Reports and Model Change Reports on Medical Ultraviolet Lamps and Products Containing Such Lamps (PDF)  (PDF – 1010KB) DRH
301-796-5790
3760 06/2014 Guide for Preparing Product Reports for Medical Ultrasound Products (PDF)  (PDF – 771KB) DRH
301-796-5790
3644 04/2011 Guide for Preparing Product Reports for Ultrasonic Therapy Products (HTML)  (HTM – 0KB) DRH
301-796-5790
3644 02/2015 Guide for Preparing Product Reports for Ultrasonic Therapy Products (PDF)  (PDF – 815KB) DRH
301-796-5790
3632 04/2011 Guide for Preparing Product Reports on Lasers and Products Containing Lasers (HTML)  (HTM – 0KB) DRH
301-796-5790
3632 02/2013 Guide for Preparing Product Reports on Lasers and Products Containing Lasers (PDF)  (PDF – 1MB) DRH
301-796-5790
3630 04/2011 Guide for Preparing Product Reports on Sunlamps and Sunlamp Products (HTML)  (HTM – 0KB) DRH
301-796-5790
3630 10/2014 Guide for Preparing Product Reports on Sunlamps and Sunlamp Products (PDF)  (PDF – 1.2MB) DRH
301-796-5790
3297 04/1984 Head and Neck Radiographic Systems Field Test Record (PDF)  (PDF – 29KB) Nick Walker
301-796-5910
3502 01/2001 Importer Seafood HACCP Report (HTML)  (HTM – 0KB) Roshelle King
301-436-1416
3881 08/2014 Indications for Use (PDF)  (PDF – 1.7MB) Diane Garcia
301-796-6559
3926 02/2016 Individual Patient Expanded Access Investigational New Drug Application (IND) (PDF)**Note: For best form functionality, Right-click 3926 link and click Save Link As… to save to your desktop and then open the file.  (PDF – 2.1MB) CDER Drug Info at 301-796-3400
3926 03/2016 Individual Patient Expanded Access Investigational New Drug Application (IND) (instructions)  (PDF – 123KB) CDER Drug Info at 301-796-3400
0431e 09/2011 Industrial Chemicals Worksheet (PDF)  (PDF – 389KB) William Campanaro
240 821 6667
2589 08/2001 Inspection Summary – Bus Service Area Sanitation (PDF)  (PDF – 380KB) Rina Vora
562-256-9292
2591 08/2001 Inspection Summary Equipment Evaluation (PDF)  (PDF – 378KB) Bruce Kummer
240-402-2142
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
3038 04/2016 Interstate Shellfish Dealer’s Certificate (PDF)  (PDF – 660KB) 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
1571 02/2016 Investigational New Drug Application (IND) (PDF) (Recommended for use with Adobe Acrobat 8 or 9)  (PDF – 1.1MB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
1571 10/2014 Investigational New Drug Application (IND) [Instructions]  (PDF – 137KB) CBER MATT at 240-402-8020
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
2675 08/1990 Investigational New Drug Folder (Red)  (HTML – 14KB) CDER Drug Info at 301-796-3400
3635 04/2011 Laser Light Show Notification (HTML)  (HTM – 0KB) DRH
301-796-5790
3637 04/2011 Laser Original Equipment Manufacture Report (HTML)  (HTM – 0KB) DRH
301-796-5790
3742 04/2016 Listing of Ingredients in Tobacco Products (PDF)  (PDF – 883KB) CTP
1-877-CTP-1373
(1-877-287-1373)
3891 05/2014 Livestock Net (HTML)  (HTM – 0KB) Jenny Murphy
240-453-6845
3500B 10/2015 MEDWATCH Consumer Voluntary Reporting (PDF)  (PDF – 1.2MB) MEDWATCH Saftey Alerts
1-800-FDA-1088
2400m 03/2001 MLEF Dairy Waters (PDF)  (PDF – 8KB) 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
2400l 03/2001 MLEF Disintegration Method for Paper, etc. (PDF)  (PDF – 45KB) 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-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-3 03/2001 MLEF Electronic Somatic Cell Count Fossmatic 5000 (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
2359c 11/2015 Manufacturing Plant Inspection Report (PDF)  (PDF – 733KB) Robert Hennes
240-402-2175
3670 11/2014 MedSun (Medical Product Surveillance Network) (HTML)  (HTM – 0KB) Jill Marion
301- 796-6128
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 10/2015 MedWatch: The FDA Safety Information and Adverse Event Reporting Program – Mandatory (PDF)  (PDF – 2.7MB) MEDWATCH
1-800-FDA-1088
3500 10/2015 MedWatch: The FDA Safety Information and Adverse Reporting Program (PDF)  (PDF – 3.5MB) MEDWATCH
1-800-FDA-1088
3608 06/2005 Medical Device Fellowship Program Student Application (HTML)  (HTM – 0KB) DMQRP
301-796-5696
3419 03/2016 Medical Device Reporting Annual User Facility Report (PDF)  (PDF – 699KB) OSB/CDRH/RSMB
301-796-6104
3601 08/2012 Medical Device User Fee Cover Sheet (HTML)  (HTM – 0KB) User Fees Financial Support Team
301-796-7200
3448 03/2014 Medicated Feed Mill License Application (PDF)  (PDF – 550KB) Isabel W. Pocurull
240-402-5877
2481 03/2007 Medicated Feeds Inspection Report (PDF)  (PDF – 800KB) Isabel W. Pocurull
240-402-5877
3757 06/2016 Menu and Vending Machine Labeling Voluntary Registration (PDF)  (PDF – 114KB) Ashley Rulffes
240-402-2820
3646 04/2011 Mercury Vapor Lamp Products Radiation Safety Report (HTML)  (HTM – 0KB) DRH
301-796-5790
3646 04/2014 Mercury Vapor Lamp Products Radiation Safety Report (PDF)  (PDF – 886KB) DRH
301-796-5790
3643 04/2011 Microwave Oven Products Annual Report (HTML)  (HTM – 0KB) DRH
301-796-5790
3643 03/2014 Microwave Oven Products Annual Report (PDF)  (PDF – 865KB) DRH
301-796-5790
2400a-1 03/2001 Milk Laboratory Evaluation Form: Spiral Plate Count Methods (PDF)  (PDF – 85KB) 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
2359b 10/2011 Milk Plant Equipment Tests Report (PDF)  (PDF – 387KB) Robert Hennes
240-402-2175
2359 10/2011 Milk Plant Inspection Report (PDF)  (PDF – 449KB) 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
2359j 10/2013 Milk Sanitation Rating Report (PDF)  (PDF – 738KB) Robert Hennes
240-402-2175
2399b 10/2008 Milk Tank Truck Inspection Report (PDF)  (PDF – 427KB) Robert Hennes
240-402-2175
3677v 01/2006 Minor Species Index File (MIF) (PDF)  (PDF – 265KB) Dorothy Bailey
240-402-0565
2783 10/1980 Mobile Radiographic Systems Field Test Record (PDF)  (PDF – 19KB) Nick Walker
301-796-5910
3570 01/2011 Model Small Business Nutrition Labeling Exemption Notice (HTML)  (HTM – 0KB) SBusiness
240-402-2375
3570 10/2014 Model Small Business Nutrition Labeling Exemption Notice (PDF)  (PDF – 1.7MB) Sbusiness
240-402-2375
3664 03/2011 My Medicine Record (PDF)  (PDF – 466KB) Cindi Fitzpatrick
301-796-3115
2359p 10/2013 NCIMS Aseptic Processing and Packaging Program Critical Listing Elements (PDF)  (PDF – 649KB) Robert Hennes
240-402-2175
2359n 10/2013 NCIMS HACCP System Regulatory Agency Review Report (PDF)  (PDF – 570KB) Robert Hennes
240-402-2175
3331 03/2015 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
0356v 12/2015 New Animal Drug Application [VET] (PDF)  (PDF – 845KB) 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
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
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
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
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
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
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
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
2767 05/2014 Notice of Availability of Sample Electronic Product (PDF)  (PDF – 627KB) DRH
301-796-5790
2514 08/2014 Notice of Discontinuance of Commercial Distribution of Cosmetic Product Formulation (PDF)  (PDF – 1MB) VCRP
240-402-1130
3480 03/2016 Notification For New Use Of A Food Contact Substance (Instructions)  (PDF – 95KB) Elizabeth Furukawa
650-529-9908
3480 03/2016 Notification For New Use Of A Food Contact Substance (PDF)  (PDF – 311KB) Elizabeth Furukawa
650-529-9908
3479 03/2016 Notification for a Food Contact Substance Formulation (PDF)  (PDF – 2.6MB) Elizabeth Furukawa
650-529-9908
3951 09/2015 OHI Guest Worker Application (PDF)  (PDF – 1.1MB) Audrey Thomas
301-796-3520
3613d 06/2015 Office of Cosmetics and Colors “Certificate” (Exports) Application (PDF)  (PDF – 710KB) Export Team
3613d 03/2012 Office of Cosmetics and Colors “Certificate” Export Application (HTML)  (HTM – 0KB) Export Team
2400h 03/2001 Optical Somatic Cell Count (PDF)  (PDF – 8KB) William W. Northeimer, Ph.D.
708-924-0629
3908 12/2014 Outsourcing Facilities for Human Drug Compounding Small Business Establishment Fee Reduction Request (PDF)  (PDF – 1.7MB) CDER Collections
3397 03/2016 PDUFA User Fee Cover Sheet (HTML)  (HTM – 0KB) CDER Collections at 301.796.7900
3890 05/2014 PETNet (HTML)  (HTM – 0KB) Jenny Murphy
240-453-6845
2400i 03/2001 Pasteurized Milk Containers (PDF)  (PDF – 8KB) William W. Northeimer, Ph.D.
708-924-0629
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
3068 08/1992 Peak Kilovoltage Determination Field Test Record (PDF)  (PDF – 57KB) Nick Walker
301-796-5910
2359o 10/2013 Permission for Publication Interstate Milk Shipper’s Listing (PDF)  (PDF – 659KB) Robert Hennes
240-402-2175
2400j 03/2001 Phosphatase Test (PDF)  (PDF – 8KB) William W. Northeimer, Ph.D.
708-924-0629
3752 04/2013 Pre-Amendment Device Determination Request (PDF)  (PDF – 677KB) DPLC
301-796-5770
3540 05/2007 Prior Notice Submission (HTML)  (HTM – 0KB) Prior Notice Center
866-521-2297
3511g 05/2014 Processing in Cascading/Spray Water Retort (PDF)  (PDF – 995KB) Bob Neligan
706-485-2725
3511i 12/2013 Processing in Other Unique Retort Systems (PDF)  (PDF – 926KB) Bob Neligan
706-485-2725
3511c 03/2014 Processing in Steam in Continuous Agitating Retorts (PDF)  (PDF – 966KB) Bob Neligan
706-485-2725
3511a-1 03/2014 Processing in Steam in Crateless Retorts (PDF)  (PDF – 1004KB) Bob Neligan
706-485-2725
3511d 03/2014 Processing in Steam in Discontinuous Agitating Retorts (PDF)  (PDF – 876KB) Bob Neligan
706-485-2725
3511f 05/2014 Processing in Steam in Hydrostatic Retorts (PDF)  (PDF – 844KB) Bob Neligan
706-485-2725
3511a 03/2014 Processing in Steam in Still Retorts (PDF)  (PDF – 914KB) Bob Neligan
706-485-2725
3511h 09/2014 Processing in Steam-Air Retorts (PDF)  (PDF – 951KB) Bob Neligan
706-485-2725
3511e 03/2014 Processing in Water in Discontinuous Agitating Retorts (PDF)  (PDF – 972KB) Bob Neligan
706-485-2725
3511b 03/2014 Processing in Water in Still Retorts (PDF)  (PDF – 935KB) Bob Neligan
706-485-2725
3799 06/2012 Publication Request (HTML)  (HTM – 0KB) Marion Allen
240-402-1584
3906 12/2013 Publication Request CFSAN (PDF)  (HTM – 0KB) CFSAN Publicaiotns
1-888-723-3366
0431f 11/1989 Quantity of Contents (PDF)  (PDF – 337KB) William Campanaro
240 821 6667
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
3741a 06/2016 Registration and Listing for Owners and Operators of Domestic Deemed Tobacco Product Establishments (PDF)  (PDF – 974KB) CTP
1-877-CTP-1373
(1-877-287-1373)
3741 06/2016 Registration and Listing for Owners and Operators of Domestic Tobacco Product Establishments (PDF)  (PDF – 889KB) CTP
1-877-CTP-1373
(1-877-287-1373)
2511 06/2009 Registration of Cosmetic Product Establishment (HTML)  (HTM – 0KB) VCRP
240-402-1130
2511 08/2014 Registration of Cosmetic Product Establishment (PDF)  (PDF – 1.1MB) VCRP
240-402-1130
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
3520 11/2015 Release Record and Agreement – Permission to Publish in National Registry (PDF)  (PDF – 1.2MB) Stephen Hughes
240-402-2833
2579 06/2011 Report of Assembly of a Diagnostic X-Ray System (FAQ & Instructions)  (HTM – 0KB) Division of Radiological Health
301-796-5790
2579 04/2014 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) James Graves at 301-796-4443
2359d 11/2015 Report of Certification (PDF)  (PDF – 708KB) Robert Hennes
240-402-2175
3719 08/2015 Report of Inspection for Compliance with 21 CFR 589.2000 (CVM) (PDF)  (PDF – 1.8MB) Shannon Jordre
240-402-5607
3719-1 10/2009 Report of Inspection for Compliance with 21 CFR 589.2000 (CVM-1) (PDF)  (PDF – 563KB) Shannon Jordre
240-402-5607
1995 10/2015 Report of Physical Examination of Cows (PDF)  (PDF – 1.1MB) Esther Lazar
240-402-1485
1551b 01/1993 Report of Sample Analysis (Aflatoxins) (PDF)  (PDF – 337KB) William Campanaro
240 821 6667
1551 05/2011 Report of Sample Analysis (PDF)  (PDF – 353KB) William Campanaro
240 821 6667
3852 06/2016 Report of Tobacco Product Removals Subject to Tax for Tobacco Product User Fee Assessments  (PDF – 1.1MB) CTP
1-877-CTP-1373
(1-877-287-1373)
1994 10/2015 Report of Tuberculin Tests of Cattle (PDF)  (PDF – 686KB) Esther Lazar
240-402-1485
3640 04/2011 Reporting Guide for Laser Light Shows and Displays (HTML)  (HTM – 0KB) DRH
301-796-5790
3640 08/2016 Reporting Guide for Laser Light Shows and Displays (PDF)  (PDF – 919KB) DRH
301-796-5790
3613f 07/2015 Request for Certificate of a Pharmaceutical Product for CDER Products (PDF)  (PDF – 781KB) CDER Export Certificate Program
1609a 03/1986 Research Progress Record (PDF)  (PDF – 349KB) William Campanaro
301-827-1036
1609 03/1986 Research Project Record (PDF)  (PDF – 337KB) William Campanaro
301-827-1036
1533 10/2001 Results of Sediment Pad Grading (PDF)  (PDF – 268KB) Rina Vora
562-256-9292
3539 05/2009 Review/Approval of Free Attendance at Widely Attended Gatherings (WAG) (PDF)  (PDF – 431KB) Vincent Tolino
301-827-5514
3787c 07/2016 Roll-Your-Own (RYO) Tobacco Products (PDF)  (PDF – 821KB) CTP
1-877-CTP-1373
(1-877-287-1373)
3787j 08/2013 Roll-Your-Own Tobacco Product Report Worksheet (HTML)  (HTM – 0KB) CTP
1-877-CTP-1373
(1-877-287-1373)
0421 07/2003 Sample Accountability Record (ORA) (PDF)  (PDF – 389KB) William Campanaro
240 821 6667
0465 08/1985 Sample Summary (DOC)  (PDF – 221KB) William Campanaro
240 821 6667
1997 10/2015 Score Card for Sanitation Inspections of Milk Plants (PDF)  (PDF – 648KB) Esther Lazar
240-402-1485
3676 05/2013 Secure Supply Chain Pilot Program Application (PDF)  (PDF – 1.4MB) Katie Neckers
301-796-3339
3733 05/2010 Shell Egg Producer Registration (HTML)  (HTM – 0KB) Nancy Bufano
240-402-1493
3733 08/2016 Shell Egg Producer Registration (PDF)  (PDF – 724KB) Nancy Bufano
240-402-1493
0431k 08/1985 Shellfish Bacteriological Record (PDF)  (PDF – 8KB) William Campanaro
301-827-1036
3787b 07/2016 Smokeless Tobacco Product Report (PDF)  (PDF – 902KB) CTP
1-877-CTP-1373
(1-877-287-1373)
3787i 08/2013 Smokeless Tobacco Product Report Worksheet (HTML)  (HTM – 0KB) CTP
1-877-CTP-1373
(1-877-287-1373)

 

3654 04/2014 Standards Data Report for 510(K)s (PDF)  (PDF – 2.4MB) Scott A. Colburn
301-796-6287
2684a 04/2011 State Contract Monthly Feed Establishment Report (PDF)  (PDF – 374KB) Wendy Campbell
615-310-0483
2684 07/2016 State Contract Monthly Food Report (PDF)  (PDF – 637KB) Wendy Campbell
615-310-0483
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
1572 02/2016 Statement of Investigator (Title 21, Code of Federal Regulations (CFR) Part 312) (PDF)  (PDF – 1.1MB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
2359e 11/2015 Status of Manufacturing Plants (PDF)  (PDF – 645KB) Robert Hennes
240-402-2175
2359l 10/2011 Status of Milk Plants (PDF)  (PDF – 614KB) Robert Hennes
240-402-2175
2359k 10/2013 Status of Raw Milk for Pasteurization (PDF)  (PDF – 1.2MB) Robert Hennes
240-402-2175
3955 07/2016 Structure/Function Claims Notification (HTML)  (HTM – 0KB) Mariton Dos Santos (Daniel)
240-402-2818
1570 04/1978 Summary of Bacteriological Results (PDF)  (PDF – 302KB) William Campanaro
240 821 6667
3427 10/2015 Supplemental Data Sheet (PDF)  (PDF – 692KB) Marjorie Shulman
301-796-6572
3613a 08/2015 Supplementary Information Certificate of Exportability Requests (PDF)  (PDF – 840KB) Import/Export Team
CBER 301-827-6201 or
CDRH 301-796-7400 or
CVM 240-402-5508
3613b 04/2015 Supplementary Information Certificate of a Pharmaceutical Product (PDF)  (PDF – 794KB) Import/Export Team
CBER 301-827-6201 or
CDRH 301-796-7400 or
CVM 240-402-5508
3613 08/2015 Supplementary Information Certificate to Foreign Government Requests (PDF)  (PDF – 838KB) Import/Export Team
CBER 301-827-6201 or
CDRH 301-796-7400 or
CVM 240-402-5508
3613c 08/2015 Supplementary Information Non-Clinical Research Use Only Certificate (PDF)  (PDF – 759KB) Import/Export Team
CBER 301-827-6201 or
CDRH 301-796-7400
3743 05/2014 Tobacco Health Document Submission (PDF)  (PDF – 785KB) CTP
1-877-CTP-1373
(1-877-287-1373)
3787d 08/2013 Tobacco Product Identification Worksheet (HTML)  (HTM – 0KB) CTP
1-877-CTP-1373
(1-877-287-1373)
3779 07/2014 Tobacco Product Violations Reporting (HTML)  (HTM – 0KB) CTP
1-877-CTP-1373
(1-877-287-1373)
3779 05/2016 Tobacco Product Violations Reporting (PDF)  (PDF – 1.2MB) CTP
1-877-CTP-1373
(1-877-287-1373)
0433 06/1982 Tomato Inspection Report (PDF)  (PDF – 12KB) Rina Vora
562-256-9292
2253 04/2014 Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use (Instructions Supplement)  (PDF – 190KB) DDMAC
301-796-1200
2253 12/2014 Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use (PDF)  (PDF – 1.7MB) DDMAC
301-796-1200
2252 11/2014 Transmittal of Annual Report for Drugs and Biologics for Human Use (Instructions Supplement) (PDF)  (PDF – 116KB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
2252 12/2014 Transmittal of Annual Report for Drugs and Biologics for Human Use (PDF)  (PDF – 827KB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
2301 10/2015 Transmittal of Periodic Reports and Promotional Material New Animal Drugs (PDF)  (PDF – 781KB) Sue Dessai
240-402-5761
2786 05/1982 Under Table X-Ray Source Fluoroscopic & Spot Film Systems Field Test Record (PDF)  (PDF – 30KB) Nick Walker
301-796-5910
3913 12/2015 User Fee Payment Refund Request (PDF)  (PDF – 2.1MB) CDER Collections at 301-796-7900
3914 12/2015 User Fee Payment Transfer Request (PDF)  (PDF – 2.1MB) CDER Collections at 301-796-7900
VAERS-1 11/2014 Vaccine Adverse Event Reporting System (HTML)  (HTM – 0KB) VAERS
800-822-7967
VAERS-! 11/2014 Vaccine Adverse Event Reporting System (PDF)  (PDF – 99KB) VAERS
800-822-7967
3261 02/1983 Vertical Mount Cassette Holder Radiographic Systems Field Test Record (PDF)  (PDF – 23KB) Nick Walker
301-796-5910
1932a 10/2013 Veterinary Adverse Drug Reaction, Lack of Effectiveness or Product Defect (PDF)  (PDF – 809KB) Margarita Brown
240-402-5740
1932 10/2013 Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report (PDF)  (PDF – 946KB) Margarita Brown
240-402-5740