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 |