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Form Number Date Description Format Contact Center
1932 Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report (PDF) pdf (970.99 KB) Linda Walter-Grimm 240-402-5762 Center for Veterinary Medicine
FDA 1932a Veterinary Adverse Drug Reaction, Lack of Effectiveness or Product Defect pdf (170.53 KB) Linda Walter-Grimm 240-402-5762 Center for Veterinary Medicine
3397 PDUFA User Fee Cover Sheet (HTML) htm (151 bytes) CDER Collections at 301-796-7900
CDERCollections@fda.hhs.gov
Center for Drug Evaluation and Research
3794 Generic Drug User Fee Cover Sheet (HTML) htm (110 bytes) CDER Collections at 301-796-7900
CDERCollections@fda.hhs.gov
Center for Drug Evaluation and Research
3667 Generally Recognized as Safe (GRAS) Notice (PDF) pdf (181.78 KB) Berhane G. Grimay 240-402-1194 Center for Food Safety and Applied Nutrition
1571 Investigational New Drug Application (IND) (PDF) pdf (2.12 MB) CBER MATT at 240-402-8020/ industry.biologics@fda.gov
CDER Drug Info at 301-796-3400/ druginfo@fda.hhs.gov
Center for Drug Evaluation and Research
Veterinary Adverse Drug Reaction, Lack of Effectiveness or Product Defect Report (dynamic)(PDF) Center for Veterinary Medicine
3480a Amendment to an Existing Food Contact Notification Pre-Notification Consultation Food Master File pdf (171.22 KB) Elizabeth Furukawa 650-529-9908 Center for Food Safety and Applied Nutrition
1572 Statement of Investigator (Title 21, Code of Federal Regulations (CFR) Part 312) (PDF) pdf (1.42 MB) CBER MATT at 240-402-8020/ industry.biologics@fda.gov
CDER Drug Info at 301-796-3400/ druginfo@fda.hhs.gov
Center for Drug Evaluation and Research
3480 Notification For New Use Of A Food Contact Substance (Instructions) pdf (99.81 KB) Elizabeth Furukawa 650-529-9908 Center for Food Safety and Applied Nutrition
3480a Amendment to an Existing Food Contact Notification Pre-Notification Consultation Food Master File (Instructions) pdf (70.39 KB) Elizabeth Furukawa 650-529-9908 Center for Food Safety and Applied Nutrition
3480 Notification For New Use Of A Food Contact Substance (PDF) pdf (417.8 KB) Elizabeth Furukawa 650-529-9908 Center for Food Safety and Applied Nutrition
1571 Investigational New Drug Application (IND) [Instructions] pdf (178.17 KB) CBER MATT at 240-402-8020/ industry.biologics@fda.gov
CDER Drug Info at 301-796-3400/ druginfo@fda.hhs.gov
Center for Drug Evaluation and Research
3480a Amendment to an Existing Food Contact Notification Pre-Notification Consultation Food Master File (PDF) pdf (172.11 KB) Elizabeth Furukawa 650-529-9908 Center for Food Safety and Applied Nutrition
3666 Early Food Safety Evaluation of a New Protein Produced by a New Plant Variety New Protein Consultation (Instructions) pdf (32.18 KB) Berhane G. Grimay 240-402-1194 Center for Food Safety and Applied Nutrition
3500b MEDWATCH Denuncia Voluntaria del Consumidor pdf (837.26 KB) MEDWATCH Saftey Alerts 1-800-FDA-1088 Center for Drug Evaluation and Research
3792 Biosimilar User Fee Cover Sheet (HTML) htm (140 bytes) CDER Collections
CDERCollections@fda.hhs.gov
or call 301.796.7900
Center for Drug Evaluation and Research
3500B MEDWATCH Consumer Voluntary Reporting (PDF) pdf (1.28 MB) MEDWATCH Saftey Alerts 1-800-FDA-1088 Office of the Commissioner
3666 Early Food Safety Evaluation of a New Protein Produced by a New Plant Variety (New Protein Consultation) (PDF) pdf (103.41 KB) Berhane G. Grimay 240-402-1194 Center for Food Safety and Applied Nutrition
3613a Supplementary Information Certificate of Exportability Requests (PDF) pdf (1.28 MB) Import/Export Team CBER 301-827-6201 or CDRH 301-796-7400 or CVM 240-402-5637 Center for Biologics Evaluation and Research
3511-2 FDA Acidified Food Inspection Report (PDF) pdf (753.98 KB) Brian Yaun 240-402-2922 Office of Regulatory Affairs
3908 Outsourcing Facilities for Human Drug Compounding Small Business Establishment Fee Reduction Request (PDF) pdf (1.74 MB) CDERCollections@fda.hhs.gov CDER Collections Center for Drug Evaluation and Research
3911 Drug Notification to FDA (PDF) **Note: For best form functionality, Right-click 3911 link and click Save Link As… to save to your desktop and then open the file. (Recommended for use with Adobe Acrobat or Pro)** pdf (2.06 MB) DrugNotifications@fda.hhs.gov Drug Notifications Center for Drug Evaluation and Research
3613b Supplementary Information Certificate of a Pharmaceutical Product (PDF) pdf (1.22 MB) Import/Export Team CBER 301-827-6201 or CDRH 301-796-7400 or CVM 240-402-5637 Center for Biologics Evaluation and Research
1994 Report of Tuberculin Tests of Cattle (PDF) pdf (191.84 KB) Esther Lazar 240-402-1485 Center for Food Safety and Applied Nutrition
3660 Guidance for Preparing Reports on Radiation Safety of Microwave Ovens (PDF) pdf (1.71 MB) Center for Devices and Radiological Health
FDA National Registry Report (PDF) Office of Regulatory Affairs
4056 Produce Farm Inspection Observations (PDF) pdf (2.2 MB) Erin Nagel 716-846-6233 x6233 Office of Regulatory Affairs
1996 Farm Inspection Report (PDF) pdf (2.95 MB) Esther Lazar 240-402-1485 Center for Food Safety and Applied Nutrition
3914 User Fee Payment Transfer Request (PDF) pdf (2.06 MB) CDERCollections@fda.hhs.gov CDER Collections at 301-796-7900 Center for Drug Evaluation and Research
3913 User Fee Payment Refund Request (PDF) pdf (2.07 MB) CDERCollections@fda.hhs.gov, CDER Collections at 301-796-7900 Center for Drug Evaluation and Research
3613d Office of Cosmetics and Colors “Certificate” Export Application (HTML) htm (90 bytes) CFSAN Export Certification Team
CFSANExportCertification@fda.hhs.gov
or 240-402-2307
Center for Food Safety and Applied Nutrition
VAERS-1 Vaccine Adverse Event Reporting System (PDF) pdf (3.4 MB) VAERS 800-822-7967 Center for Biologics Evaluation and Research
VAERS-1 Vaccine Adverse Event Reporting System (HTML) htm (85 bytes) VAERS 800-822-7967 Center for Biologics Evaluation and Research
4005 Forms Request Program (PDF) pdf (618.93 KB) FormsManager@OC.FDA.GOV Office of the Commissioner
2359m Milk Plant, Receiving Station or Transfer Station NCIMS HACPP System Audit Report (PDF) pdf (1.17 MB) Frank Flores 240-402-1494 Center for Food Safety and Applied Nutrition
2399 Dairy Plant Sampling - Raw & Pasteurized Milk (PDF) pdf (571.1 KB) Frank Flores 240-402-1494 Center for Food Safety and Applied Nutrition
2359 Milk Plant Inspection Report (PDF) pdf (448.59 KB) Frank Flores 240-402-1494 Center for Food Safety and Applied Nutrition
3613e Food Export Certificate Application (HTML) htm (90 bytes) Export Team 240-402-1178 Center for Food Safety and Applied Nutrition
3958 VNRFRPS FDA National Registry Report (PDF) pdf (1.19 MB) Glenda Lewis 240-402-2150 Center for Food Safety and Applied Nutrition
2359l Status of Milk Plants (PDF) pdf (171.26 KB) Frank Flores 240-402-1494 Center for Food Safety and Applied Nutrition
2359i Interstate Milk Shipper Report (PDF) pdf (1.11 MB) Frank Flores 240-402-1494 Center for Food Safety and Applied Nutrition
3613c Supplementary Information Non-Clinical Research Use Only Certificate (PDF) pdf (1.19 MB) Import/Export Team CBER 301-827-6201 or CDRH 301-796-7400 Center for Biologics Evaluation and Research
2359h Interstate Milk Shipper Check-Rating Report (PDF) pdf (589.12 KB) Frank Flores 240-402-1494 Center for Food Safety and Applied Nutrition
3511a Processing in Steam in Still Retorts (PDF) pdf (913.62 KB) Brian Yaun 240-402-2922 Office of Regulatory Affairs
3882 FDA Scientific Achievement Awards Nomination Package (PDF) pdf (2.07 MB) Devin Thomas 240- 402-5263 Office of the Commissioner
1997 Score Card for Sanitation Inspections of Milk Plants (PDF) pdf (671.58 KB) Esther Lazar 240-402-1485 Center for Food Safety and Applied Nutrition
3646 Mercury Vapor Lamp Products Radiation Safety Report (PDF) pdf (906.48 KB) DRH 301-796-5790 Center for Devices and Radiological Health
3602a MDUFA Foreign Small Business Qualification and Certification For a Business Headquartered Outside the United States (PDF) pdf (1.52 MB) DICE 800-638-2041 Center for Devices and Radiological Health
3942a Attestation by a Qualified Facility CFSAN (PDF) pdf (1.12 MB) Sylvia Kim 301-796-7599 Center for Veterinary Medicine