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About FDA
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FDA Forms
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| Form | Date | Food and Drugs Administration Forms | Format | Contact Info |
|---|---|---|---|---|
| 0356h | 10/2005 | {FDA has OMB approval to use the form until 6/30/2010} Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use | (PDF - 264KB) |
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
| 0356v | 04/2008 | New Animal Drug Application [VET] | (PDF - 527KB) |
Katherine Weld 240-276-8301 |
| 0356v | 04/2008 | New Animal Drug Application [VET] (Q&As on the Revised 356v Form) | (HTM - 0KB) |
Katherine Weld 240-276-8301 |
| 0358v | 03/1989 | NADA Folders (VET) | (PDF - 11KB) |
David Newkirk 301-827-6967 |
| 0359v | 06/1990 | INAD Folder (VET) | (PDF - 11KB) |
David Newkirk 301-827-6967 |
| 0421 | 07/2003 | Sample Accountability Record (ORA) | (PDF - 74KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 0431 | 05/1984 | Analyst Worksheet (ORA) | (DOC - 45KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 0431a | 05/1984 | General Continuation Sheet | (PDF - 46KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 0431d | 10/1974 | Bacteriological Record | (PDF - 8KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 0431e | 03/1980 | Industrial Chemicals Worksheet | (PDF - 57KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 0431f | 11/1989 | Quantity of Contents | (PDF - 4KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 0431g | 08/1985 | Salmonella Record | (PDF - 4KB) |
William Campanaro 301-827-1036 |
| 0431h | 07/1985 | Shigella Record | (PDF - 57KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 0431i | 10/1985 | Canned Food Continuation Sheet | (PDF - 4KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 0431j | 08/1985 | Botulism Continuation Sheet | (PDF - 6KB) |
William Campanaro 301-827-1036 |
| 0431k | 08/1985 | Shellfish Bacteriological Record | (PDF - 8KB) |
William Campanaro 301-827-1036 |
| 0431m | 12/1979 | Elemental Analysis Worksheet | (PDF - 6KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 0433 | 06/1982 | Tomato Inspection Report | (PDF - 12KB) |
Norman Fogg 301-827-5645 |
| 0465 | 08/1985 | Sample Summary | (DOC - 125KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 0766 | 12/2004 | Application for Authorization to Re label or to Perform Other Action of the Federal Food, Drug, and Cosmetic Act and Other Related Acts | (PDF - 91KB) |
Domenic Veneziano 301-443-6553 |
| 1533 | 10/2001 | Results of Sediment Pad Grading | (PDF - 269KB) |
Norman Fogg 301-827-5645 |
| 1551 | 02/2006 | Report of Sample Analysis | (PDF - 331KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 1551b | 01/1993 | Report of Sample Analysis (Aflatoxins) | (PDF - 337KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 1570 | 04/1978 | Summary of Bacteriological Results | (PDF - 249KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 1570a | 04/1978 | Bacteriological Definitions | (PDF - 6KB) |
William Campanaro 301-827-1036 |
| 1571 | 04/2006 | Investigational New Drug Application | (PDF - 221KB) |
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
| 1572 | 05/2006 | Statement of Investigator | (PDF - 208KB) |
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
| 1572 | 05/2006 | Statement of Investigator (CDER/CBER) | (PDF - 208KB) |
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
| 1609 | 03/1986 | Research Project Record | (PDF - 337KB) |
William Campanaro 301-827-1036 |
| 1609a | 03/1986 | Research Progress Record | (PDF - 349KB) |
William Campanaro 301-827-1036 |
| 1815 | 02/2006 | Certificate/ Transmittal for an Application | (PDF - 59KB) |
Esther Lazar 301-436-1485 |
| 1932 | 01/2007 | Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Rep | (PDF - 505KB) |
Elizabeth Grove 240-276-9076 |
| 1932a | 03/2007 | Veterinary Adverse Drug Reaction, Lack of Effectiveness or Product Defect | (PDF - 126KB) |
Elizabeth Grove 240-276-9076 |
| 1993 | 08/2009 | Application for Permit to Ship or Transport Milk and/or Cream into US | (PDF - 672KB) |
Esther Lazar 301-436-1485 |
| 1994 | 02/2006 | Report of Tuberculin Tests of Cattle | (PDF - 248KB) |
Esther Lazar 301-436-1485 |
| 1995 | 02/2006 | Report of Physical Examination of Cows | (PDF - 116KB) |
Esther Lazar 301-436-1485 |
| 1996 | 02/2006 | Dairy Farm Sanitation Report | (PDF - 313KB) |
Esther Lazar 301-436-1485 |
| 1997 | 02/2006 | Score Card for Sanitation Inspections of Milk Plants | (PDF - 89KB) |
Esther Lazar 301-436-1485 |
| 2096 | 03/2004 | Regulation Certification for New Employee | (PDF - 21KB) |
Vincent Tolino 301-827-5514 |
| 2097 | 01/2003 | Regulation Certification for Separating Employees | (PDF - 12KB) |
Vincent Tolino 301-827-5514 |
| 2098 | 11/2002 | Regulation Certification for Special Government Employees | (PDF - 8KB) |
Vincent Tolino 301-827-5514 |
| 2196 | 07/1987 | Laboratory Management Coding Sheet | (PDF - 10KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 2252 | 06/2008 | Transmittal of Annual Report for Drugs and Biologics for Human Use | (PDF - 339KB) |
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
| 2253 | 06/2008 | Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use | (PDF - 351KB) |
DDMAC 301-796-1200 |
| 2301 | 03/2007 | Transmittal of Periodic Reports and Promotional Material for New Animal Dru | (PDF - 97KB) |
Pamela Esposito 240-276-9067 |
| 2359 | 10/2008 | Milk Plant Inspection Report | (PDF - 435KB) |
Robert Hennes 301-436-2175 |
| 2359a | 10/2008 | Dairy Farm Inspection Report | (PDF - 448KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 2359b | 10/2008 | Milk Plant Equipment Tests Report | (PDF - 370KB) |
Robert Hennes 301-436-2175 |
| 2359c | 10/2008 | Manufacturing Plant Inspection Report | (PDF - 692KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 2359d | 10/2008 | Report of Certification | (PDF - 405KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 2359h | 10/2008 | Interstate Milk Shipper Check-Rating Report | (PDF - 558KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 2359i | 10/2008 | Interstate Milk Shipper Report | (PDF - 594KB) |
Robert Hennes 301-436-2175 |
| 2359j | 10/2008 | Milk Sanitation Rating Report | (PDF - 431KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 2359k | 10/2008 | Status of Raw Milk for Pasteurization | (PDF - 706KB) |
Robert Hennes 301-436-2175 |
| 2359l | 10/2008 | Status of Milk Plants | (PDF - 606KB) |
Robert Hennes 301-436-2175 |
| 2359m | 10/2008 | Milk Plant, Receiving Station or Transfer Station NCIMS HACPP System Audit | (PDF - 443KB) |
Robert Hennes 301-436-2175 |
| 2359n | 10/2008 | NCIMS HACCP System Regulatory Agency Review Report | (PDF - 288KB) |
Robert Hennes 301-436-2175 |
| 2399 | 10/2008 | Dairy Plant Sampling - Raw & Pasteurized Milk | (PDF - 571KB) |
Robert Hennes 301-436-2175 |
| 2399a | 10/2008 | Bulk Milk Hauler/Sampler Evaluation Report | (PDF - 404KB) |
Robert Hennes 301-436-2175 |
| 2399b | 10/2008 | Milk Tank Truck Inspection Report | (PDF - 435KB) |
Robert Hennes 301-436-2175 |
| 2399c | 10/2008 | Farm Bulk Tank Milk Sampling Inspection Record | (PDF - 698KB) |
Robert Hennes 301-436-2175 |
| 2399d | 10/2008 | Dairy Plant - Milk Sample Collector Evaluation Record | (PDF - 459KB) |
Robert Hennes 301-436-2175 |
| 2400 | 03/2001 | Cultural Procedures - General Requirements | (PDF - 105KB) |
Thomas E. Graham, Ph.D. 708-728-4114 |
| 2400a | 03/2001 | Milk Laboratory Evaluation Form: Standard Plate Count, Coliform, and Simpl | (PDF - 108KB) |
Thomas E. Graham, Ph.D. 708-728-4114 |
| 2400a-1 | 03/2001 | Milk Laboratory Evaluation Form: Spiral Plate Count Methods | (PDF - 85KB) |
Thomas E. Graham, Ph.D. 708-728-4114 |
| 2400b | 05/1987 | MLEF Detention of Inhibitory Substances in Milk | (PDF - 11KB) |
Thomas E. Graham, Ph.D. 708-728-4114 |
| 2400b-1 | 03/2001 | MLEF Detection of Inhibitory Substances in Milk Bacillus Stearothermophilus | (PDF - 92KB) |
Thomas E. Graham, Ph.D. 708-728-4114 |
| 2400b-3 | 03/2001 | MLEF Detection of Inhibitory Substances in Milk Delvotest 5 Pack | (PDF - 77KB) |
Thomas E. Graham, Ph.D. 708-728-4114 |
| 2400d | 03/2001 | MLEF Direct Microscopic Somatic Cell Count | (PDF - 71KB) |
Thomas E. Graham, Ph.D. 708-728-4114 |
| 2400h | 03/2001 | Optical Somatic Cell Count | (PDF - 78KB) |
Thomas E. Graham, Ph.D. 708-728-4114 |
| 2400h-1 | 03/2001 | MLEF Electronic Somatic Cell Count Foss 250/300/360/400 | (PDF - 67KB) |
Thomas E. Graham, Ph.D. 708-728-4114 |
| 2400h-2 | 03/2001 | MLEF Electronic Somatic Cell Count Bentley Somacount 150/300/500 | (PDF - 66KB) |
Thomas E. Graham, Ph.D. 708-728-4114 |
| 2400h-3 | 03/2001 | MLEF Electronic Somatic Cell Count Fossmatic 5000 | (PDF - 87KB) |
Thomas E. Graham, Ph.D. 708-728-4114 |
| 2400i | 03/2001 | Pasteurized Milk Containers | (PDF - 70KB) |
Thomas E. Graham, Ph.D. 708-728-4114 |
| 2400j | 03/2001 | Phosphatase Test | (PDF - 77KB) |
Thomas E. Graham, Ph.D. 708-728-4114 |
| 2400k | 03/2001 | MLEF Flat Lid Methods | (PDF - 68KB) |
Thomas E. Graham, Ph.D. 708-728-4114 |
| 2400l | 03/2001 | MLEF Disintegration Method for Paper, etc. | (PDF - 45KB) |
Thomas E. Graham, Ph.D. 708-728-4114 |
| 2400m | 03/2001 | MLEF Dairy Waters | (PDF - 88KB) |
Thomas E. Graham, Ph.D. 708-728-4114 |
| 2511 | 06/2006 | Registration of Cosmetic Product Establishment | (PDF - 74KB) |
VCRP 301-436-1130 |
| 2512 | 06/2006 | Cosmetic Product Ingredient Statement | (PDF - 91KB) |
VCRP 301-436-1130 |
| 2512a | 06/2006 | Cosmetic Product Ingredient Statement | (PDF - 116KB) |
VCRP 301-436-1130 |
| 2514 | 06/2006 | Notice of Discontinuance of Commercial Distribution of Cosmetic Product Formulation | (PDF - 43KB) |
VCRP 301-436-1130 |
| 2541 | 10/2008 | Food Canning Registration | (PDF - 378KB) |
LACF Coordinator LACF@FDA.HHS.GOV |
| 2541a | 10/2008 | Food Process Filing For All Methods Except Low-Acid Aseptic | (PDF - 518KB) |
LACF Coordinator LACF@FDA.HHS.GOV |
| 2541a | 10/2008 | Food Process Filing For All Methods Except Low-Acid Aseptic (HTML) | (HTM - 0KB) |
LACF Coordinator LACF@FDA.HHS.GOV |
| 2541c | 08/2005 | Food Process Filing For Low-Acid Aseptic Systems (HTML) | (HTM - 0KB) |
LACF Coordinator LACF@FDA.HHS.GOV |
| 2541c | 10/2008 | Food Process Filing For Low-Acid Aseptic Systems (PDF) | (PDF - 426KB) |
LACF Coordinator LACF@FDA.HHS.GOV |
| 2567 | 10/2005 | Transmittal of Labels and Circulars | (PDF - 161KB) | CBER MATT at 301-827-2000 |
| 2579 | 06/2008 | Report of Assembly of a Diagnostic X-Ray System | (DOC - 28KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 2589 | 08/2001 | Inspection Summary - Bus Service Area Sanitation | (PDF - 16KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 2591 | 08/2001 | Inspection Summary Equipment Evaluation | (PDF - 14KB) |
Glenda Lewis 301-436-2150 |
| 2626 | 07/2004 | New Drug Application/Biologic Licensing Application (Blue Folder) Archival | (HTML - 14KB) |
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
| 2626a | 07/2004 | New Drug Application/Biologic Licensing Application (Red Folder) Chemistry | (HTML - 14KB) |
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
| 2626b | 07/2004 | New Drug Application/Biologic Licensing Application (Yellow Folder) Pharmacology | (HTML - 14KB) |
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
| 2626c | 07/2004 | New Drug Application/Biologic Licensing Application (Orange Folder) Pharmacokinetic | (HTML - 14KB) |
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
| 2626d | 07/2004 | New Drug Application/Biologic Licensing Application (White Folder) Microbiology | (HTML - 14KB) |
CBER MATT at 301-827-2000 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 301-827-2000 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 301-827-2000 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 301-827-2000 CDER Drug Info at 301-796-3400 |
| 2656 | 06/2009 | Registration Of Drug Establishment/Labeler Code Assignment (HTML) | (HTM - 0KB) | eDRLS@fda.hhs.gov |
| 2657 | 06/2009 | Drug Product Listing (HTML) | (HTM - 0KB) | eDRLS@fda.hhs.gov |
| 2658 | 06/2009 | Registered Establishments Report of Private Label Distributors (HTML) | (HTM - 0KB) | eDRLS@fda.hhs.gov |
| 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 - 175KB) |
Preet Sudhaker 301-827-2908 |
| 2681 | 02/2002 | Bakery Inspection Report | (PDF - 798KB) |
Preet Sudhaker 301-827-2908 |
| 2682 | 08/2001 | Beverage Plant Inspection Report | (PDF - 20KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 2684 | 04/2002 | State Contract Monthly Food Report | (PDF - 64KB) |
Preet Sudhaker 301-827-2908 |
| 2684a | 04/2002 | State Contract Monthly Feed Establishment Report | (PDF - 70KB) |
Preet Sudhaker 301-827-2908 |
| 2767 | 05/2007 | Notice of Availability of Sample Electronic Product | (PDF - 470KB) |
DMQRP 301-796-5710 |
| 2782 | 09/1998 | Field Test Record Continuation Sheet | (PDF - 4KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 2783 | 10/1980 | Mobile Radiographic Systems Field Test Record | (PDF - 19KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 2784 | 05/1982 | Above Table X-Ray Source Radiographic Systems | (PDF - 30KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 2785 | 05/2002 | Dental Radiographic Systems Field Test Record | (PDF - 21KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 2786 | 05/1982 | Under Table X-Ray Source Fluoroscopic & Spot Film Systems Field Test Record | (PDF - 30KB) |
Richard Barnes 301-827-2905 |
| 2814 | 08/1993 | Field Equipment Request | (PDF - 57KB) |
William Campanaro 301-827-1086 |
| 2830 | 07/2006 | Blood Establishment Registration and Product Listing | (PDF - 312KB) | bloodregis@fda.hhs.gov |
| 2877 | 02/2008 | Declaration for Imported Electronic Products Subject to Radiation Control Standards | (PDF - 369KB) |
DMQRP 301-796-5710 |
| 2914 | 08/2008 | Radioactive Drug Research Committee (RDRC) Report on Research Use of Radioactive Drugs Membership Summary | (PDF - 429KB) |
RDRC 301-796-2050 |
| 2915 | 08/2008 | Radioactive Drug Research Committee (RDRC) Report on Research Use of Radioactive Drugs Study Summary | (PDF - 856KB) |
RDRC 301-796-2050 |
| 2966 | 10/1988 | Food GMP Inspection Report | (PDF - 17KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 3038 | 03/2007 | 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 301-436-2154 |
| 3038 | 03/2007 | Interstate Shellfish Dealer's Certificate | (PDF - 600KB) |
Charlotte Epps 301-436-2154 |
| 3068 | 08/1992 | Peak Kilovoltage Determination Field Test Record | (PDF - 57KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 3069 | 10/1980 | Above Table X-Ray Source Fluoroscopic & Spot Film Systems Field Test Record | (PDF - 19KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 3070 | 08/1992 | Mammography Systems Field Test Record | (PDF - 17KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 3071 | 04/2001 | General Information Field Test Record | (PDF - 20KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 3131 | 08/2001 | Contract Property Administration Completion Report | (PDF - 5KB) |
Mike McGrath 301-827-7105 |
| 3147 | 05/2007 | Application for a Variance From 21 CFR 1040.11(c) for a Laser Light Show, Display, or Device | (PDF - 486KB) |
DMQRP 301-796-5710 |
| 3260 | 02/1983 | C-Arm Fluoroscopic & Spot-Film Systems Field Test Record | (PDF - 41KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 3261 | 02/1983 | Vertical Mount Cassette Holder Radiographic Systems Field Test Record | (PDF - 23KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 3297 | 04/2001 | Head and Neck Radiographic Systems Field Test Record | (PDF - 29KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 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 | 01/2009 | NDA Field Alert Report | (PDF - 425KB) |
Juliaette Johnson 301-827-8928 |
| 3356 | 04/2008 | Establishment Registration and Listing for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) | (PDF - 647KB) | tissuereg@fda.hhs.gov |
| 3356 | 04/2008 | Establishment Registration and Listing for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) (HTML) | (HTM - 0KB) | tissuereg@fda.hhs.gov |
| 3397 | 01/2007 | User Fee Cover Sheet | (HTM - 0KB) |
Mike Jones 301-443-5151 |
| 3410 | 10/2001 | Confidential Financial Disclosure Report | (PDF - 689KB) |
Vincent Tolino 301-827-5514 |
| 3419 | 10/2007 | Medical Device Reporting Annual User Facility Report | (PDF - 518KB) |
OSB/CDRH/RSMB 301-796-6104 |
| 3422 | 08/2007 | Government Entity Declaration | (PDF - 405KB) |
Denise Robinson 301-796-5919 |
| 3427 | 01/2009 | Supplemental Data Sheet | (PDF - 625KB) |
Marjorie Shulman 301-796-6572 |
| 3429 | 01/2009 | General Device Classification Questionnaire | (PDF - 656KB) |
Marjorie Shulman 301-796-6572 |
| 3437 | 06/1996 | CDER Pediatric Use Supplement | (PDF - 36KB) |
CDR 301-827-4210 |
| 3448 | 09/2007 | Medicated Feed Mill License Application | (PDF - 317KB) |
Jo W. Gulley 240-453-6858 |
| 3454 | 04/2006 | Certification: Financial Interest and Arrangements of Clinical Investigator | (PDF - 47KB) |
Leah W. Ripper 301-796-1282 |
| 3455 | 04/2006 | Disclosure: Financial Interest and Arrangements of Clinical Investigators | (PDF - 56KB) |
Leah W. Ripper 301-796-1282 |
| 3458 | 10/2008 | Notice of Claimed Investigational Exemption | (PDF - 228KB) |
Margaret Zabriski 240-276-9143 |
| 3463 | 07/2000 | EDI Gateway Training Partner Agreement | (PDF - 11KB) |
Bill Taylor 301-827-6504 |
| 3479 | 03/2005 | Notification for a Food Contact Substance Formulation | (PDF - 538KB) |
Mitchell Cheeseman 301- 436-1162 |
| 3480 | 09/2005 | Notification For New Use Of A Food Contact Substance | (PDF - 1031KB) |
Mitchell Cheeseman 301- 436-1162 |
| 3486 | 04/2008 | Biological Product Deviation Report | (PDF - 412KB) |
CBER Program Surveillance Branch 301-827-6220 |
| 3486 | 04/2008 | Biological Product Deviation Report (HTML) | (HTM - 0KB) |
CBER Program Surveillance Branch 301-827-6220 |
| 3487 | 10/2008 | Notice of Final Disposition of Animals Not Intended for Immediate Slaughter | (PDF - 117KB) |
Margaret Zabriski 240-276-9143 |
| 3488 | 10/2008 | Notice of Intent to Slaughter for Human Food Purposes | (PDF - 132KB) |
Margaret Zabriski 240-276-9143 |
| 3489 | 10/2008 | Request for a Meeting or Teleconference | (PDF - 221KB) |
Margaret Zabriski 240-276-9143 |
| 3500 | 01/2009 | MedWatch: The FDA Safety Information and Adverse Reporting Program | (PDF - 1097KB) |
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 | 01/2009 | MedWatch: The FDA Safety Information and Adverse Event Reporting Program - | (PDF - 1079KB) |
MEDWATCH 1-800-FDA-1088 |
| 3501 | 07/2008 | Domestic Seafood (HACCP) Report | (HTM - 0KB) |
Roshelle King 301-436-1416 |
| 3502 | 01/2001 | Importer Seafood HACCP Report | (PDF - 6KB) |
Roshelle King 301-436-1416 |
| 3503 | 09/2007 | Food Additive Petition Submission | (PDF - 256KB) |
Maribeth LaVecchi 301-436-1211 |
| 3504 | 09/2007 | Color Additive Petition Submission | (PDF - 245KB) |
Maribeth LaVecchi 301-436-1211 |
| 3511 | 03/2007 | FDA LACF Inspection Report | (DOC - 244KB) |
Brian Hendrickson 317-226-6500 Ext. 104 |
| 3511-2 | 03/2007 | FDA Acidified Food Inspection Report | (PDF - 589KB) |
Brian Hendrickson 317-226-6500 Ext. 104 |
| 3511-3 | 03/2007 | Aseptic Processing & Packaging Report | (DOC - 380KB) |
Brian Hendrickson 317-226-6500 Ext. 104 |
| 3511a | 03/2007 | Processing in Steam in Still Retorts | (PDF - 848KB) |
Brian Hendrickson 317-226-6500 Ext. 104 |
| 3511b | 03/2007 | Processing in Water in Still Retorts | (PDF - 836KB) |
Brian Hendrickson 317-226-6500 Ext. 104 |
| 3511c | 03/2007 | Processing in Steam in Continuous Agitating Retorts | (PDF - 893KB) |
Brian Hendrickson 317-226-6500 Ext. 104 |
| 3511d | 03/2007 | Processing in Steam in Discontinuous Agitating Retorts | (PDF - 736KB) |
Brian Hendrickson 317-226-6500 Ext. 104 |
| 3511e | 03/2007 | Processing in Water in Discontinuous Agitating Retorts | (PDF - 922KB) |
Brian Hendrickson 317-226-6500 Ext. 104 |
| 3511f | 03/2007 | Processing in Steam in Hydrostatic Retorts | (PDF - 677KB) |
Brian Hendrickson 317-226-6500 Ext. 104 |
| 3511g | 03/2007 | Processing in Cascading/Spray Water Retort | (PDF - 1000KB) |
Brian Hendrickson 317-226-6500 Ext. 104 |
| 3511h | 03/2007 | Processing in Steam-Air Retorts | (PDF - 917KB) |
Brian Hendrickson 317-226-6500 Ext. 104 |
| 3511i | 03/2006 | Processing in Other Unique Retort Systems | (PDF - 491KB) |
Brian Hendrickson 317-226-6500 Ext. 104 |
| 3514 | 03/2008 | CDRH Premarket Review Submission Cover Sheet | (PDF - 1434KB) |
Bob Gatling 301-796-6560 |
| 3536 | 10/2008 | Protocol for Non-Clinical and Effectiveness Studies | (PDF - 102KB) |
Margaret Zabriski 240-276-9143 |
| 3537 | 05/2007 | Food Facility Registration (HTML) | (HTM - 0KB) |
FDA Industry Systems Help Desk 800-216-7331 301-575-0156 |
| 3537 | 11/2008 | Food Facility Registration | (PDF - 537KB) |
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 | 11/2008 | Cancellation of Food Facility Registration | (PDF - 653KB) |
Industry Systems Help Desk 800-216-7331 301-575-0156 |
| 3538 | 10/2008 | Electronic Submission System Participant Password or Addition | (PDF - 75KB) |
Margaret Zabriski 240-276-9143 |
| 3539 | 04/2006 | Review/Approval of Free Attendance at Widely Attended Gatherings (WAG) | (PDF - 168KB) |
Vincent Tolino 301-827-5514 |
| 3540 | 05/2007 | Prior Notice Submission | (HTM - 0KB) |
Prior Notice Center 866-521-2297 |
| 3541 | 09/2007 | Premarket Notification [510(K)] Status Request and Response | (PDF - 54KB) |
John Stigi 301-796-5848 |
| 3542 | 12/2008 | Patent Information Submitted Upon and After Approval of An NDA or Supplemen | (PDF - 420KB) |
Mary Ann Holovac 301-827-5846 |
| 3542a | 12/2008 | Patent Information Submitted With the Filing of An NDA, Amendment, or Supp | (PDF - 417KB) |
Mary Ann Holovac 301-827-5846 |
| 3546 | 02/2004 | ADUFA User Fee Cover Sheet | (HTM - 0KB) |
Lisa Kable 240-276-9718 |
| 3570 | 02/2007 | Model Small Business Food Labeling Exemption Notice | (HTM - 0KB) |
SBusiness 301-436-2375 |
| 3571 | 06/2006 | Infusion Pump Information Submission Report | (PDF - 186KB) |
Mary Brady 301-796-6089 |
| 3601 | 01/2007 | Medical Device User Fee Cover Sheet | (HTM - 0KB) |
User Fees Financial Support Team 301-827-9539 |
| 3602 | 10/2008 | FY MDUFMA Small Business Qualification Certification For a Business Headquarter in the United States | (PDF - 394KB) |
James Norman 301-796-5695 |
| 3602a | 10/2008 | FY MDUFMA Small Business Qualification Certification For a Business Headquarter Outside the United States | (PDF - 394KB) |
James Norman 301-796-5695 |
| 3608 | 06/2005 | Medical Device Fellowship Program Student Application | (HTM - 0KB) |
DMQRP 301-796-5696 |
| 3610 | 10/2003 | Contract Audit | (PDF - 398KB) |
Beverly Kent 716-541-0331 |
| 3611 | 09/2003 | Audit Report | (PDF - 270KB) |
Beverly Kent 716-541-0331 |
| 3613 | 06/2006 | Supplementary Information Certificate to Foreign Government Requests | (PDF - 201KB) |
Import/Export Team CBER 301-827-6201 or CDRH 301-796-7400 or CVM 240-276-0132 |
| 3613a | 09/2006 | Supplementary Information Certificate of Exportability Requests | (PDF - 403KB) |
Import/Export Team CBER 301-827-6201 or CDRH 301-796-7400 or CVM 240-276-0132 |
| 3613b | 06/2006 | Supplementary Information Certificate of a Pharmaceutical Product | (PDF - 328KB) |
Import/Export Team CBER 301-827-6201 or CDER 301-827-8940 or CDRH 301-796-7400 or CVM 240-276-0132 |
| 3613c | 06/2006 | Supplementary Information Non-Clinical Research Use Only Certificate | (PDF - 311KB) |
Import/Export Team CBER 301-827-6201 or CDRH 301-796-7400 or CVM 240-276-0132 |
| 3613d | 02/2006 | Office of Cosmetics and Colors "Certificate" Export Application | (PDF - 89KB) | Import/Export Team CFSAN 301-436-1130 |
| 3613e | 02/2006 | Food Export Certificate Application | (PDF - 86KB) | Import/Export Team CFSAN 301-436-1130 |
| 3623 | 11/2005 | Farm Investigation Questionnaire | (PDF - 668KB) |
Barbara Marcelletti 301-827-5635 |
| 3623a | 11/2005 | Additional Water Sources | (PDF - 191KB) |
Barbara Marcelletti 301-827-5635 |
| 3623b | 11/2005 | Additional Sets of Workers | (PDF - 296KB) |
Barbara Marcelletti 301-827-5635 |
| 3625 | 10/2008 | DSI Complaint Record | (PDF - 378KB) |
Joseph Salewski 301-796-3395 |
| 3626 | 07/2007 | A Guide for the Submission of Initial Reports on Diagnostic X-ray Systems and Their Major Components | (PDF - 3852KB) |
DMQRP 301-796-5710 |
| 3627 | 07/2007 | Diagnostic X-Ray CT Products Radiation Safety Report | (PDF - 477KB) |
DMQRP 301-796-5710 |
| 3628 | 07/2007 | General Annual Report (Includes Medical, Analytical, and Industrial X-Ray Products Annual Report) | (HTM - 0KB) |
DMQRP 301-796-5710 |
| 3629 | 07/2007 | Abbreviated Report | (HTM - 0KB) |
DMQRP 301-796-5710 |
| 3630 | 07/2007 | Guide for Preparing Product Reports on Sunlamps and Sunlamp Products | (PDF - 1251KB) |
DMQRP 301-796-5710 |
| 3631 | 07/2007 | Guide for Preparing Annual Reports on Radiation Safety Testing of Sunlamps and Sunlamp Products | (PDF - 670KB) |
DMQRP 301-796-5710 |
| 3632 | 07/2007 | Guide for Preparing Product Reports on Lasers and Products Containing Lasers | (PDF - 507KB) |
DMQRP 301-796-5710 |
| 3633 | 07/2007 | General Variance Request | (HTM - 0KB) |
DMQRP 301-796-5710 |
| 3634 | 07/2007 | Television Products Annual Report | (PDF - 2499KB) |
DMQRP 301-796-5710 |
| 3635 | 07/2007 | Laser Light Show Notification | (HTM - 0KB) |
DMQRP 301-796-5710 |
| 3636 | 07/2007 | Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show | (PDF - 399KB) |
DMQRP 301-796-5710 |
| 3637 | 07/2007 | Laser Original Equipment Manufacture Report | (HTM - 0KB) |
DMQRP 301-796-5710 |
| 3638 | 07/2007 | Guide for Filling Annual Reports for X-Ray Components and Systems | (PDF - 440KB) |
DMQRP 301-796-5710 |
| 3639 | 07/2007 | Guidance for Submission of Cabinet X-Ray System Reports Pursuant to 21 CFR 1020.40 | (PDF - 1031KB) |
DMQRP 301-796-5710 |
| 3640 | 07/2007 | Reporting Guide for Laser Light Shows and Displays | (PDF - 1003KB) |
DMQRP 301-796-5710 |
| 3641 | 07/2007 | Cabinet X-Ray Annual Report | (PDF - 437KB) |
DMQRP 301-796-5710 |
| 3642 | 07/2007 | General Correspondence Report for CDRH Electronic Submissions | (HTM - 0KB) |
DMQRP 301-796-5710 |
| 3643 | 07/2007 | Microwave Oven Products Annual Report | (PDF - 2578KB) |
DMQRP 301-796-5710 |
| 3644 | 07/2007 | Guide for Preparing Product Reports for Ultrasonic Therapy Products | (PDF - 805KB) |
DMQRP 301-796-5710 |
| 3645 | 07/2007 | Guide for Preparing Annual Reports for Ultrasonic Therapy Products | (PDF - 516KB) |
DMQRP 240-276-3332 |
| 3646 | 07/2007 | Mercury Vapor Lamp Products Radiation Safety Report | (PDF - 1020KB) |
DMQRP 301-796-5710 |
| 3647 | 07/2007 | Guide for Preparing Annual Reports on Radiation Safety Testing of Mercury Vapor Lamps | (PDF - 654KB) |
DMQRP 301-796-5710 |
| 3649 | 07/2007 | Accidental Radiation Occurrence Report | (HTM - 0KB) |
DMQRP 301-796-5710 |
| 3654 | 09/2007 | Standards Data Report for 510(K)s | (PDF - 515KB) |
Bob Gatling 301-796-6560 |
| 3659 | 07/2007 | Reporting and Compliance Guide for Television Products | (PDF - 2501KB) |
DMQRP 301-796-5710 |
| 3660 | 07/2007 | Guidance for Preparing Reports on Radiation Safety of Microwave Ovens | (PDF - 2579KB) |
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 - 691KB) |
DMQRP 301-796-5710 |
| 3662 | 07/2007 | A Guide for Submission of an Abbreviated Radiation Safety Reports on Cephalometric Devices Intended for Diagnostic Use | (PDF - 372KB) |
DMQRP 301-796-5710 |
| 3663 | 07/2007 | Abbreviated Reports on Radiation Safety for Microwave Products (Other than Microwave Ovens) | (PDF - 440KB) |
DMQRP 301-796-5710 |
| 3664 | 07/2007 | My Medicine Record | (PDF - 331KB) |
Cindi Fitzpatrick 301-796-3115 |
| 3670 | 03/2008 | MedSun (Medical Product Surveillance Network) | (HTM - 0KB) |
Marilyn Flack 301-796-6118 |
| 3671 | 02/2009 | Common EMEA/FDA Application for Orphan Medicinal Product Designation | (PDF - 554KB) |
Kathy Needleman 301-827-3666 |
| 3674 | 11/2008 | Certification of Compliance, under 42 U.S.C. , 282(j)(5)(B), with Requireme | (PDF - 411KB) |
Jarilyn Dupont 301-827-3360 |
| 3677v | 01/2006 | Minor Species Index File (MIF) | (PDF - 6KB) |
Joan C. Gotthardt 240-276-9331 |
| 3719 | 10/2009 | Report of Inspection for Compliance with 21 CFR 589.2000 (CVM) | (PDF - 545KB) |
Shannon Jordre 240-276-9229 |
| 3728 | 06/2009 | Animal Generic Drug User Fee Cover Sheet | (HTM - 0KB) |
Bryan Walsh 240-276-9730 |
| VAERS-! | 02/2009 | Vaccine Adverse Event Reporting System | (PDF - 99KB) |
VAERS 800-822-7967 |
| VARES-1 | 02/2009 | Vaccine Adverse Event Reporting System (HTML) | (HTM - 0KB) |
VAERS 800-822-7967 |
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