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About FDA
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FDA Forms
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| Form | Date | Food and Drug Administration Forms | Format | Contact Info |
|---|---|---|---|---|
| 0356h | 02/2012 | Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use | (PDF - 559KB) |
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
| 0356v | 03/2008 | New Animal Drug Application [VET] (Q&As on the Revised 356v Form) | (HTM - 0KB) |
Urvi Desai 240- 276-8297 |
| 0356v | 03/2008 | New Animal Drug Application [VET] | (PDF - 747KB) |
Urvi Desai 240- 276-8297 |
| 0358v | 03/1989 | NADA Folders (VET) | (PDF - 6KB) |
Steven D. Vaughn 240-276-8300 |
| 0359v | 06/1990 | INAD Folder (VET) | (PDF - 6KB) |
Steven D. Vaughn 240-276-8300 |
| 0421 | 07/2003 | Sample Accountability Record (ORA) | (PDF - 389KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 0431 | 09/2010 | Analyst Worksheet (ORA) | (PDF - 547KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 0431a | 05/1984 | General Continuation Sheet | (PDF - 722KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 0431d | 09/1974 | Bacteriological Record | (PDF - 8KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 0431e | 09/2011 | Industrial Chemicals Worksheet | (PDF - 389KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 0431f | 10/1989 | Quantity of Contents | (PDF - 4KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 0431g | 07/1985 | Salmonella Record | (PDF - 4KB) |
William Campanaro 301-827-1036 |
| 0431h | 06/1985 | Shigella Record | (PDF - 57KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 0431i | 09/1985 | Canned Food Continuation Sheet | (PDF - 4KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 0431j | 07/1985 | Botulism Continuation Sheet | (PDF - 6KB) |
William Campanaro 301-827-1036 |
| 0431k | 07/1985 | Shellfish Bacteriological Record | (PDF - 8KB) |
William Campanaro 301-827-1036 |
| 0431m | 11/1979 | Elemental Analysis Worksheet | (PDF - 6KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 0433 | 06/1982 | Tomato Inspection Report | (PDF - 12KB) |
Norman Fogg 301-796-5448 |
| 0465 | 07/1985 | Sample Summary | (DOC - 125KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 0766 | 01/2011 | Application for Authorization to Re label or to Perform Other Action of the Federal Food, Drug, and Cosmetic Act and Other Related Acts | (PDF - 386KB) |
Domenic Veneziano 301-443-6553 |
| 1533 | 10/2001 | Results of Sediment Pad Grading | (PDF - 268KB) |
Norman Fogg 301-796-5448 |
| 1551 | 05/2011 | Report of Sample Analysis | (PDF - 353KB) |
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 - 302KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 1570a | 03/1978 | Bacteriological Definitions | (PDF - 6KB) |
William Campanaro 301-827-1036 |
| 1571 | 04/2006 | {FDA has OMB approval to use the form until 8/31/2011}. Investigational New Drug Application | (PDF - 221KB) |
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
| 1571 | 10/2005 | Investigational New Drug Application (IND) [Instructions] | (HTM - 0KB) |
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
| 1572 | 02/2012 | Statement of Investigator (Title 21, Code of Federal Regulations (CFR) Part 312) (Guidance) | (HTM - 0KB) |
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
| 1572 | 05/2006 | (Use this if the newer version does not work for you) Statement of Investigator | (PDF - 219KB) |
CDER Drug Info 301-796-3400 |
| 1572 | 02/2012 | Statement of Investigator Statement of Investigator (Title 21, Code of Federal Regulations (CFR) Part 312) | (PDF - 1.1MB) |
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 | 12/2010 | Certificate/ Transmittal for an Application | (PDF - 294KB) |
Esther Lazar 240-402-1485 |
| 1932 | 12/2009 | Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Rep | (PDF - 436KB) |
Margarita Brown 240-276-9048 |
| 1932a | 12/2009 | Veterinary Adverse Drug Reaction, Lack of Effectiveness or Product Defect | (PDF - 526KB) |
Margarita Brown 240-276-9048 |
| 1993 | 08/2009 | Application for Permit to Ship or Transport Milk and/or Cream into US | (PDF - 672KB) |
Esther Lazar 240-402-1485 |
| 1994 | 08/2009 | Report of Tuberculin Tests of Cattle | (PDF - 404KB) |
Esther Lazar 240-402-1485 |
| 1995 | 08/2009 | Report of Physical Examination of Cows | (PDF - 1.1MB) |
Esther Lazar 240-402-1485 |
| 1996 | 04/2009 | Farm Inspection Report | (PDF - 554KB) |
Esther Lazar 240-402-1485 |
| 1997 | 08/2009 | Score Card for Sanitation Inspections of Milk Plants | (PDF - 370KB) |
Esther Lazar 240-402-1485 |
| 2096 | 03/2004 | Regulation Certification for New Employee | (PDF - 298KB) |
Vincent Tolino 301-827-5514 |
| 2097 | 01/2003 | Regulation Certification for Separating Employees | (PDF - 602KB) |
Vincent Tolino 301-827-5514 |
| 2098 | 11/2002 | Regulation Certification for Special Government Employees | (PDF - 603KB) |
Vincent Tolino 301-827-5514 |
| 2252 | 12/2011 | Transmittal of Annual Report for Drugs and Biologics for Human Use | (PDF - 662KB) |
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
| 2253 | 09/2011 | Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use | (PDF - 1.4MB) |
DDMAC 301-796-1200 |
| 2301 | 03/2012 | Transmittal of Periodic Reports and Promotional Material New Animal Drugs | (PDF - 492KB) |
Sue Dessai 240-276-9075 |
| 2359 | 09/2008 | Milk Plant Inspection Report | (PDF - 435KB) |
Robert Hennes 240-402-2175 |
| 2359a | 09/2011 | Dairy Farm Inspection Report | (PDF - 468KB) |
Robert Hennes 240-402-2175 |
| 2359b | 10/2011 | Milk Plant Equipment Tests Report | (PDF - 387KB) |
Robert Hennes 240-402-2175 |
| 2359c | 10/2008 | Manufacturing Plant Inspection Report | (PDF - 692KB) |
Robert Hennes 240-402-2175 |
| 2359d | 10/2010 | Report of Certification | (PDF - 431KB) |
Robert Hennes 240-402-2175 |
| 2359h | 10/2011 | Interstate Milk Shipper Check-Rating Report | (PDF - 589KB) |
Robert Hennes 240-402-2175 |
| 2359i | 10/2011 | Interstate Milk Shipper Report | (PDF - 607KB) |
Robert Hennes 240-402-2175 |
| 2359j | 10/2011 | Milk Sanitation Rating Report | (PDF - 477KB) |
Robert Hennes 240-402-2175 |
| 2359k | 10/2008 | Status of Raw Milk for Pasteurization | (PDF - 703KB) |
Robert Hennes 240-402-2175 |
| 2359l | 10/2011 | Status of Milk Plants | (PDF - 614KB) |
Robert Hennes 240-402-2175 |
| 2359m | 10/2011 | Milk Plant, Receiving Station or Transfer Station NCIMS HACPP System Audit | (PDF - 469KB) |
Robert Hennes 240-402-2175 |
| 2359n | 10/2011 | NCIMS HACCP System Regulatory Agency Review Report | (PDF - 337KB) |
Robert Hennes 240-402-2175 |
| 2359o | 10/2010 | Permission for Publication Interstate Milk Shipper’s Listing | (PDF - 405KB) |
Robert Hennes 240-402-2175 |
| 2359p | 10/2011 | NCIMS Aseptic Processing and Packaging Program Critical Listing Elements | (PDF - 387KB) |
Robert Hennes 240-402-2175 |
| 2399 | 09/2008 | Dairy Plant Sampling - Raw & Pasteurized Milk | (PDF - 571KB) |
Robert Hennes 240-402-2175 |
| 2399a | 10/2011 | Bulk Milk Hauler/Sampler Evaluation Report | (PDF - 428KB) |
Robert Hennes 240-402-2175 |
| 2399b | 10/2008 | Milk Tank Truck Inspection Report | (PDF - 427KB) |
Robert Hennes 240-402-2175 |
| 2399c | 10/2011 | Farm Bulk Tank Milk Sampling Inspection Record | (PDF - 713KB) |
Robert Hennes 240-402-2175 |
| 2399d | 10/2008 | Dairy Plant - Milk Sample Collector Evaluation Record | (PDF - 457KB) |
Robert Hennes 240-402-2175 |
| 2400 | 03/2001 | Cultural Procedures - General Requirements | (PDF - 8KB) |
William Northeimer, PhD 708-728-4137 |
| 2400a | 03/2001 | Milk Laboratory Evaluation Form: Standard Plate Count, Coliform, and Simpl | (PDF - 8KB) |
William Northeimer, PhD 708-728-4137 |
| 2400a-1 | 02/2001 | Milk Laboratory Evaluation Form: Spiral Plate Count Methods | (PDF - 85KB) |
William Northeimer, PhD 708-728-4137 |
| 2400b-1 | 03/2001 | MLEF Detection of Inhibitory Substances in Milk Bacillus Stearothermophilus | (PDF - 8KB) |
William Northeimer, PhD 708-728-4137 |
| 2400b-3 | 03/2001 | MLEF Detection of Inhibitory Substances in Milk Delvotest 5 Pack | (PDF - 8KB) |
William Northeimer, PhD 708-728-4137. |
| 2400d | 03/2001 | MLEF Direct Microscopic Somatic Cell Count | (PDF - 8KB) |
William Northeimer, PhD 708-728-4137. |
| 2400h | 03/2001 | Optical Somatic Cell Count | (PDF - 8KB) |
William Northeimer, PhD 708-728-4137. |
| 2400h-1 | 03/2001 | MLEF Electronic Somatic Cell Count Foss 250/300/360/400 | (PDF - 8KB) |
William Northeimer, PhD 708-728-4137. |
| 2400h-2 | 03/2001 | MLEF Electronic Somatic Cell Count Bentley Somacount 150/300/500 | (PDF - 8KB) |
William Northeimer, PhD 708-728-4137. |
| 2400h-3 | 03/2001 | MLEF Electronic Somatic Cell Count Fossmatic 5000 | (PDF - 8KB) |
William Northeimer, PhD 708-728-4137. |
| 2400i | 03/2001 | Pasteurized Milk Containers | (PDF - 8KB) |
William Northeimer, PhD 708-728-4137. |
| 2400j | 03/2001 | Phosphatase Test | (PDF - 8KB) |
William Northeimer, PhD 708-728-4137. |
| 2400k | 02/2001 | MLEF Flat Lid Methods | (PDF - 68KB) |
William Northeimer, PhD 708-728-4137. |
| 2400l | 02/2001 | MLEF Disintegration Method for Paper, etc. | (PDF - 45KB) |
William Northeimer, PhD 708-728-4137. |
| 2400m | 03/2001 | MLEF Dairy Waters | (PDF - 8KB) |
William Northeimer, PhD 708-728-4137. |
| 2511 | 06/2009 | Registration of Cosmetic Product Establishment (HTML) | (HTM - 0KB) |
VCRP 240-402-1130 |
| 2511 | 09/2011 | Registration of Cosmetic Product Establishment | (PDF - 839KB) |
VCRP 240-402-1130 |
| 2512 | 09/2011 | Cosmetic Product Ingredient Statement | (PDF - 821KB) |
VCRP 240-402-1130 |
| 2512 | 06/2009 | Cosmetic Product Ingredient Statement (HTML) | (HTM - 0KB) |
VCRP 240-402-1130 |
| 2512a | 09/2011 | Cosmetic Product Ingredient Statement (CFSAN) | (PDF - 981KB) |
VCRP 240-402-1130 |
| 2514 | 09/2011 | Notice of Discontinuance of Commercial Distribution of Cosmetic Product Formulation | (PDF - 797KB) |
VCRP 240-402-1130 |
| 2541 | 12/2010 | Food Canning Registration (Instructions) | (HTM - 0KB) |
LACF Coordinator LACF@FDA.HHS.GOV |
| 2541 | 11/2010 | Food Canning Registration (HTML) | (HTM - 0KB) |
LACF Coordinator 301/436-2411 |
| 2541 | 04/2012 | Food Canning Registration | (PDF - 400KB) |
LACF Coordinator LACF@FDA.HHS.GOV |
| 2541a | 03/2012 | Food Process Filing For All Methods Except Low-Acid Aseptic | (PDF - 520KB) |
LACF Coordinator LACF@FDA.HHS.GOV |
| 2541a | 03/2010 | Food Process Filing For All Methods Except Low-Acid Aseptic (HTML) | (HTM - 0KB) |
LACF Coordinator LACF@FDA.HHS.GOV |
| 2541c | 03/2010 | Food Process Filing For Low-Acid Aseptic Systems (HTML) | (HTM - 0KB) |
LACF Coordinator LACF@FDA.HHS.GOV |
| 2541c | 03/2012 | Food Process Filing For Low-Acid Aseptic Systems (PDF) | (PDF - 711KB) |
LACF Coordinator LACF@FDA.HHS.GOV |
| 2567 | 01/2011 | Transmittal of Labels and Circulars | (PDF - 424KB) | CBER MATT at 301-827-2000 |
| 2579 | 12/2011 | Report of Assembly of a Diagnostic X-Ray System (Paper) | (PDF - 18KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 2579 | 04/2011 | Report of Assembly of a Diagnostic X-Ray System (HTML) | (HTM - 0KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 2589 | 07/2001 | Inspection Summary - Bus Service Area Sanitation | (PDF - 16KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 2591 | 08/2001 | Inspection Summary Equipment Evaluation | (PDF - 378KB) |
Bruce Kummer 240-402-2142 |
| 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 |
| 2675 | 07/1990 | Investigational New Drug Folder (Red) | (HTML - 14KB) | CDER Drug Info at 301-796-3400 |
| 2675a | 09/1986 | Investigational New Drug Folder (Green) | (HTML - 14KB) | CDER Drug Info at 301-796-3400 |
| 2675b | 09/1986 | Investigational New Drug Folder (Orange) | (HTML - 14KB) | CDER Drug Info at 301-796-3400 |
| 2679 | 08/2001 | Food Warehouse Inspection Report | (PDF - 281KB) |
Maya Johnson-Nimo 301-827-2906 |
| 2681 | 02/2002 | Bakery Inspection Report | (PDF - 879KB) |
Maya Johnson-Nimo 301-827-2906 |
| 2682 | 08/2001 | Beverage Plant Inspection Report | (PDF - 857KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 2684 | 03/2011 | State Contract Monthly Food Report | (PDF - 374KB) |
Joe Reardon 301-827-9508 |
| 2684a | 03/2011 | State Contract Monthly Feed Establishment Report | (PDF - 374KB) |
Joe Reardon 301-827-9508 |
| 2767 | 01/2011 | Notice of Availability of Sample Electronic Product | (PDF - 364KB) |
DMQRP 301-796-5710 |
| 2782 | 08/1998 | Field Test Record Continuation Sheet | (PDF - 4KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 2783 | 09/1980 | Mobile Radiographic Systems Field Test Record | (PDF - 19KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 2784 | 04/1982 | Above Table X-Ray Source Radiographic Systems | (PDF - 30KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 2785 | 04/2002 | 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) |
Mei-Ying Li 301-827-2913. |
| 2814 | 07/1993 | Field Equipment Request | (PDF - 57KB) |
William Campanaro 301-827-1086 |
| 2830 | 03/2012 | Blood Establishment Registration and Product Listing | (PDF - 463KB) | bloodregis@fda.hhs.gov |
| 2877 | 01/2011 | Declaration for Imported Electronic Products Subject to Radiation Control Standards | (PDF - 399KB) |
DMQRP 301-796-5710 |
| 2914 | 05/2011 | Radioactive Drug Research Committee (RDRC) Report on Research Use of Radioactive Drugs Membership Summary | (PDF - 747KB) |
RDRC 301-796-2050 |
| 2915 | 05/2011 | Radioactive Drug Research Committee (RDRC) Report on Research Use of Radioactive Drugs Study Summary | (PDF - 1.8MB) |
RDRC 301-796-2050 |
| 2966 | 09/1988 | Food GMP Inspection Report | (PDF - 17KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 3038 | 07/2010 | Interstate Shellfish Dealer's Certificate | (PDF - 373KB) |
Charlotte Epps 240-402-2154 |
| 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 240-402-2154 |
| 3068 | 07/1992 | Peak Kilovoltage Determination Field Test Record | (PDF - 57KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 3069 | 09/1980 | 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) |
Mei-Ying Li 301-827-2913 |
| 3071 | 03/2001 | General Information Field Test Record | (PDF - 20KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 3131 | 07/2001 | Contract Property Administration Completion Report | (PDF - 5KB) |
Mike McGrath 301-827-7105 |
| 3147 | 10/2010 | Application for a Variance From 21 CFR 1040.11(c) for a Laser Light Show, Display, or Device | (PDF - 485KB) |
DMQRP 301-796-5710 |
| 3147 | 03/2011 | Application for a Variance From 21 CFR 1040.11(c) for a Laser Light Show, Display, or Device (HTML) | (HTM - 0KB) |
DMQRP 301-796-5710 |
| 3260 | 01/1983 | C-Arm Fluoroscopic & Spot-Film Systems Field Test Record | (PDF - 41KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 3261 | 01/1983 | Vertical Mount Cassette Holder Radiographic Systems Field Test Record | (PDF - 23KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 3297 | 03/2001 | Head and Neck Radiographic Systems Field Test Record | (PDF - 29KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 3316 | 07/1985 | DRUG MASTER FILE REVIEW BINDER-Red | (HTML - 14KB) | CDER Drug Info at 301-796-3400 |
| 3316a | 07/1985 | DRUG MASTER FILE ARCHIVAL BINDER-Blue | (HTML - 14KB) | CDER Drug Info at 301-796-3400 |
| 3331 | 10/2011 | NDA Field Alert Report | (PDF - 1.7MB) |
Surveillance Programs Team 301-796-3130 |
| 3356 | 11/2011 | Establishment Registration and Listing for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) | (PDF - 635KB) | tissuereg@fda.hhs.gov |
| 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 |
| 3397 | 01/2007 | User Fee Cover Sheet | (HTM - 0KB) |
Mike Jones 301-796-3602 |
| 3410 | 10/2001 | Confidential Financial Disclosure Report | (PDF - 492KB) |
Vincent Tolino 301-827-5514 |
| 3419 | 08/2010 | Medical Device Reporting Annual User Facility Report | (PDF - 418KB) |
OSB/CDRH/RSMB 301-796-6104 |
| 3422 | 01/2011 | Government Entity Declaration | (PDF - 439KB) |
Denise Robinson 301-796-5919 |
| 3427 | 08/2010 | Supplemental Data Sheet | (PDF - 360KB) |
Marjorie Shulman 301-796-6572 |
| 3429 | 08/2010 | General Device Classification Questionnaire | (PDF - 392KB) |
Marjorie Shulman 301-796-6572 |
| 3448 | 08/2010 | Medicated Feed Mill License Application | (PDF - 308KB) |
Jo W. Gulley 240-453-6858 |
| 3454 | 10/2009 | Certification: Financial Interest and Arrangements of Clinical Investigator | (PDF - 384KB) |
Leah W. Ripper 301-796-1282 |
| 3455 | 10/2009 | Disclosure: Financial Interest and Arrangements of Clinical Investigators | (PDF - 400KB) |
Leah W. Ripper 301-796-1282 |
| 3463 | 07/2000 | EDI Gateway Training Partner Agreement | (PDF - 8KB) |
Michael Fauntleroy 301-827-5132 |
| 3479 | 09/2009 | Notification for a Food Contact Substance Formulation | (PDF - 505KB) |
Francis Lin 240-402-1215 |
| 3480 | 08/2010 | Notification For New Use Of A Food Contact Substance | (PDF - 1.4MB) |
Francis Lin 240-402-1215 |
| 3486 | 01/2011 | Biological Product Deviation Report (HTML) | (HTM - 0KB) |
CBER Program Surveillance Branch 301-827-6220 |
| 3486 | 01/2011 | Biological Product Deviation Report (Instructions) | (HTM - 0KB) |
CBER PSB 301-827-6220 |
| 3486 | 01/2011 | Biological Product Deviation Report | (PDF - 421KB) |
CBER Program Surveillance Branch 301-827-6220 |
| 3500 | 01/2009 | MedWatch: The FDA Safety Information and Adverse Reporting Program | (PDF - 1.7MB) |
MEDWATCH 1-800-FDA-1088 |
| 3500 | 01/2006 | MedWatch: The FDA Safety Information and Adverse Event Reporting Program (HTML) | (HTM - 0KB) |
MEDWATCH 1-800-FDA-1088 |
| 3500A | 06/2010 | MedWatch: The FDA Safety Information and Adverse Event Reporting Program - | (PDF - 1.4MB) |
MEDWATCH 1-800-FDA-1088 |
| 3500A | 06/2010 | MedWatch: The FDA Safety Information and Adverse Event Reporting Program - Mandatory (Instructions) | (HTM - 0KB) |
MedWatch 1-800-332-1088 |
| 3502 | 01/2001 | Importer Seafood HACCP Report | (HTM - 0KB) |
Roshelle King 301-436-1416 |
| 3503 | 06/2011 | Food Additive Petition Submission | (PDF - 1.3MB) |
Berhane G. Girmay, Ph.D 240-402-1194 |
| 3503 | 06/2011 | Food Additive Petition Submission (Instructions) | (PDF - 39KB) |
Berhane G. Girmay, Ph.D. 240-402-1194 |
| 3511 | 06/2010 | FDA LACF Inspection Report | (PDF - 649KB) |
Norman Fogg 301-796-5448 |
| 3511-2 | 06/2010 | FDA Acidified Food Inspection Report | (PDF - 465KB) |
Norman Fogg 301-796-5448 |
| 3511-3 | 06/2010 | Aseptic Processing & Packaging Report | (PDF - 727KB) |
Norman Fogg 301-796-5448 |
| 3511a | 06/2010 | Processing in Steam in Still Retorts | (PDF - 618KB) |
Norman Fogg 301-796-5448 |
| 3511a-1 | 06/2010 | Processing in Steam in Crateless Retorts | (PDF - 712KB) |
Norman Fogg 301-796-5448 |
| 3511b | 12/2010 | Processing in Water in Still Retorts | (PDF - 640KB) |
Norman Fogg 301-796-5448 |
| 3511c | 02/2007 | Processing in Steam in Continuous Agitating Retorts | (PDF - 657KB) |
Norman Fogg 301-796-5448 |
| 3511d | 12/2010 | Processing in Steam in Discontinuous Agitating Retorts | (PDF - 586KB) |
Norman Fogg 301-796-5448 |
| 3511e | 12/2010 | Processing in Water in Discontinuous Agitating Retorts | (PDF - 676KB) |
Norman Fogg 301-796-5448 |
| 3511f | 12/2010 | Processing in Steam in Hydrostatic Retorts | (PDF - 519KB) |
Norman Fogg 301-796-5448 |
| 3511g | 12/2010 | Processing in Cascading/Spray Water Retort | (PDF - 697KB) |
Norman Fogg 301-796-5448 |
| 3511h | 12/2010 | Processing in Steam-Air Retorts | (PDF - 674KB) |
Norman Fogg 301-796-5448 |
| 3511i | 12/2010 | Processing in Other Unique Retort Systems | (PDF - 599KB) |
Norman Fogg 301-796-5448 |
| 3514 | 12/2010 | CDRH Premarket Review Submission Cover Sheet | (PDF - 3MB) |
Bob Gatling 301-796-6560 |
| 3519 | 03/2011 | FDA National Registry Report | (PDF - 418KB) |
Glenda Lewis 240-402-2150 |
| 3520 | 03/2011 | Release Record and Agreement - Permission to Publish in National Registry | (PDF - 387KB) |
Glenda Lewis 240-402-2150 |
| 3537 | 02/2011 | Food Facility Registration (HTML) | (HTM - 0KB) |
FDA Industry Systems Help Desk 800-216-7331 301-575-0156 |
| 3537 | 08/2011 | Food Facility Registration | (PDF - 555KB) |
FDA Industry Systems Help Desk 800-216-7331 301-575-0156 |
| 3537a | 08/2011 | Cancellation of Food Facility Registration | (PDF - 403KB) |
Industry Systems Help Desk 800-216-7331 301-575-0156 |
| 3537a | 10/2008 | Cancellation of Food Facility Registration (HTML) | (HTM - 0KB) |
FDA Industry Systems Help Desk 800-216-7331 301-575-0156 |
| 3538 | 09/2010 | Electronic Submission System Participant Password or Addition | (PDF - 78KB) |
Margaret Zabriski 240-276-9143 |
| 3539 | 05/2009 | Review/Approval of Free Attendance at Widely Attended Gatherings (WAG) | (PDF - 431KB) |
Vincent Tolino 301-827-5514 |
| 3540 | 04/2007 | Prior Notice Submission | (HTM - 0KB) |
Prior Notice Center 866-521-2297 |
| 3541 | 12/2010 | Premarket Notification [510(K)] Status Request and Response | (PDF - 419KB) |
William Sutton 301-796-5849 |
| 3542 | 09/2010 | Patent Information Submitted Upon and After Approval of An NDA or Supplemen | (PDF - 412KB) |
Mary Ann Holovac, R.Ph. 240-276-8971 |
| 3542a | 09/2010 | Patent Information Submitted With the Filing of An NDA, Amendment, or Supp | (PDF - 409KB) |
Mary Ann Holovac, R.Ph. 240-276-8971 |
| 3546 | 02/2004 | ADUFA User Fee Cover Sheet | (HTM - 0KB) |
Lisa Kable 240-276-9718 |
| 3570 | 01/2011 | Model Small Business Food Labeling Exemption Notice | (HTM - 0KB) |
SBusiness 240-402-2375 |
| 3601 | 01/2007 | Medical Device User Fee Cover Sheet | (HTM - 0KB) |
User Fees Financial Support Team 301-796-7200 |
| 3602 | 10/2011 | FY 2012 MDUFMA Small Business Qualification Certification For a Business Headquarter in the United States | (HTM - 0KB) |
DSMICA 301-796-7100 800-638-2041 |
| 3602a | 10/2011 | FY 2012 MDUFMA Small Business Qualification Certification For a Business Headquarter Outside the United States | (HTM - 0KB) |
DSMICA 301-796-7100 800-638-2041 |
| 3608 | 06/2005 | Medical Device Fellowship Program Student Application | (HTM - 0KB) |
DMQRP 301-796-5696 |
| 3610 | 10/2003 | Contract Audit | (PDF - 540KB) |
Caleb Michaud 301-796-5932 |
| 3611 | 09/2003 | Audit Report | (PDF - 353KB) |
Caleb Michaud 301-796-5932 |
| 3613 | 02/2012 | Supplementary Information Certificate to Foreign Government Requests | (PDF - 506KB) |
Import/Export Team CBER 301-827-6201 or CDRH 301-796-7400 or CVM 240-276-9212 |
| 3613a | 02/2012 | Supplementary Information Certificate of Exportability Requests | (PDF - 527KB) |
Import/Export Team CBER 301-827-6201 or CDRH 301-796-7400 or CVM 240-276-9212 |
| 3613b | 02/2012 | Supplementary Information Certificate of a Pharmaceutical Product | (PDF - 585KB) |
Import/Export Team CBER 301-827-6201 or CDER 301-827-8940 or CDRH 301-796-7400 or CVM 240-276-9212 |
| 3613c | 02/2012 | Supplementary Information Non-Clinical Research Use Only Certificate | (PDF - 467KB) |
Import/Export Team CBER 301-827-6201 or CDRH 301-796-7400 |
| 3613d | 02/2012 | Office of Cosmetics and Colors "Certificate" Export Application | (PDF - 709KB) |
Export Team 240-402-1178 |
| 3613e | 02/2012 | Food Export Certificate Application | (PDF - 454KB) |
Export Team 240-402-1178 |
| 3623 | 10/2005 | Farm Investigation Questionnaire | (PDF - 668KB) |
Barbara Marcelletti 301-827-5635 |
| 3623a | 10/2005 | Additional Water Sources | (PDF - 191KB) |
Barbara Marcelletti 301-827-5635 |
| 3623b | 10/2005 | Additional Sets of Workers | (PDF - 296KB) |
Barbara Marcelletti 301-827-5635 |
| 3626 | 03/2011 | A Guide for the Submission of Initial Reports on Diagnostic X-ray Systems and their Major Components (HTML) | (HTM - 0KB) |
DMQRP 301-796-5710 |
| 3626 | 05/2011 | A Guide for the Submission of Initial Reports on Diagnostic X-ray Systems and Their Major Components | (PDF - 843KB) |
DMQRP 301-796-5710 |
| 3627 | 11/2010 | Diagnostic X-Ray CT Products Radiation Safety Report | (PDF - 568KB) |
DMQRP 301-796-5710 |
| 3627 | 03/2011 | Diagnostic X-Ray CT Products Radiation Safety Report (HTML) | (HTM - 0KB) |
DMQRP 301-796-5710 |
| 3628 | 06/2007 | General Annual Report (Includes Medical, Analytical, and Industrial X-Ray Products Annual Report) (PDF) | (PDF - 446KB) |
DMQRP 301-796-5710 |
| 3628 | 03/2011 | General Annual Report (Includes Medical, Analytical, and Industrial X-Ray Products Annual Report) | (HTM - 0KB) |
DMQRP 301-796-5710 |
| 3629 | 03/2011 | Abbreviated Report | (HTM - 0KB) |
DMQRP 301-796-5710 |
| 3630 | 03/2011 | Guide for Preparing Product Reports on Sunlamps and Sunlamp Products (HTML) | (HTM - 0KB) |
DMQRP 301-796-5710 |
| 3630 | 02/2011 | Guide for Preparing Product Reports on Sunlamps and Sunlamp Products | (PDF - 921KB) |
DMQRP 301-796-5710 |
| 3631 | 11/2010 | Guide for Preparing Annual Reports on Radiation Safety Testing of Sunlamps and Sunlamp Products | (PDF - 548KB) |
DMQRP 301-796-5710 |
| 3631 | 03/2011 | Guide for Preparing Annual Reports on Radiation Safety Testing of Sunlamps and Sunlamp Products (HTML) | (HTM - 0KB) |
DMQRP 301-796-5710 |
| 3632 | 07/2011 | Guide for Preparing Product Reports on Lasers and Products Containing Lasers | (PDF - 785KB) |
DMQRP 301-796-5710 |
| 3632 | 03/2011 | Guide for Preparing Product Reports on Lasers and Products Containing Lasers (HTML) | (HTM - 0KB) |
DMQRP 301-796-5710 |
| 3633 | 03/2011 | General Variance Request | (HTM - 0KB) |
DMQRP 301-796-5710 |
| 3634 | 03/2011 | Television Products Annual Report (HTML) | (HTM - 0KB) |
DMQRP 301-796-5710 |
| 3634 | 07/2007 | Television Products Annual Report | (PDF - 2.4MB) |
DMQRP 301-796-5710 |
| 3635 | 03/2011 | Laser Light Show Notification | (HTM - 0KB) |
DMQRP 301-796-5710 |
| 3636 | 04/2011 | Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show | (PDF - 540KB) |
DMQRP 301-796-5710 |
| 3636 | 03/2011 | Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show (HTML) | (HTM - 0KB) |
DMQRP 301-796-5710 |
| 3637 | 03/2011 | Laser Original Equipment Manufacture Report | (HTM - 0KB) |
DMQRP 301-796-5710 |
| 3638 | 12/2011 | Guide for Filling Annual Reports for X-Ray Components and Systems | (PDF - 599KB) |
DMQRP 301-796-5710 |
| 3638 | 03/2011 | Guide for Filling Annual Reports for X-Ray Components and Systems (HTML) | (HTM - 0KB) |
DMQRP 301-796-5710 |
| 3639 | 03/2011 | Guidance for Submission of Cabinet X-Ray System Reports Pursuant to 21 CFR 1020.40 (HTML) | (HTM - 0KB) |
DMQRP 301-796-5710 |
| 3639 | 07/2007 | Guidance for Submission of Cabinet X-Ray System Reports Pursuant to 21 CFR 1020.40 | (PDF - 1MB) |
DMQRP 301-796-5710 |
| 3640 | 03/2011 | Reporting Guide for Laser Light Shows and Displays (HTML) | (HTM - 0KB) |
DMQRP 301-796-5710 |
| 3640 | 07/2007 | Reporting Guide for Laser Light Shows and Displays | (PDF - 1003KB) |
DMQRP 301-796-5710 |
| 3641 | 09/2011 | Cabinet X-Ray Annual Report | (PDF - 588KB) |
DMQRP 301-796-5710 |
| 3641 | 03/2011 | Cabinet X-Ray Annual Report (HTML) | (HTM - 0KB) |
DMQRP 301-796-5710 |
| 3642 | 03/2011 | General Correspondence Report for CDRH Electronic Submissions | (HTM - 0KB) |
DMQRP 301-796-5710 |
| 3643 | 07/2007 | Microwave Oven Products Annual Report | (PDF - 2.5MB) |
DMQRP 301-796-5710 |
| 3643 | 03/2011 | Microwave Oven Products Annual Report (HTML) | (HTM - 0KB) |
DMQRP 301-796-5710 |
| 3644 | 03/2011 | Guide for Preparing Product Reports for Ultrasonic Therapy Products (HTML) | (HTM - 0KB) |
DMQRP 301-796-5710 |
| 3644 | 07/2007 | Guide for Preparing Product Reports for Ultrasonic Therapy Products | (PDF - 805KB) |
DMQRP 301-796-5710 |
| 3645 | 03/2011 | Guide for Preparing Annual Reports for Ultrasonic Therapy Products (HTML) | (HTM - 0KB) |
DMQRP 301-796-5710 |
| 3645 | 07/2007 | Guide for Preparing Annual Reports for Ultrasonic Therapy Products | (PDF - 516KB) |
DMQRP 301-796-5710 |
| 3646 | 07/2007 | Mercury Vapor Lamp Products Radiation Safety Report | (PDF - 1020KB) |
DMQRP 301-796-5710 |
| 3646 | 03/2011 | Mercury Vapor Lamp Products Radiation Safety Report (HTML) | (HTM - 0KB) |
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 |
| 3647 | 03/2011 | Guide for Preparing Annual Reports on Radiation Safety Testing of Mercury Vapor Lamps (HTML) | (HTM - 0KB) |
DMQRP 301-796-5710 |
| 3649 | 03/2011 | Accidental Radiation Occurrence Report | (HTM - 0KB) |
DMQRP 301-796-5710 |
| 3649 | 02/2012 | Accidental Radiation Occurrence Report (PDF) | (PDF - 538KB) |
DMQRP 301-796-5710 |
| 3654 | 06/2011 | Standards Data Report for 510(K)s | (PDF - 706KB) |
Scott A. Colburn 301-796-6287 |
| 3659 | 07/2007 | Reporting and Compliance Guide for Television Products | (PDF - 2.4MB) |
DMQRP 301-796-5710 |
| 3659 | 03/2011 | Reporting and Compliance Guide for Television Products (HTML) | (HTM - 0KB) |
DMQRP 301-796-5710 |
| 3660 | 07/2007 | Guidance for Preparing Reports on Radiation Safety of Microwave Ovens | (PDF - 2.5MB) |
DMQRP 301-796-5710 |
| 3660 | 03/2011 | Guidance for Preparing Reports on Radiation Safety of Microwave Ovens (HTML) | (HTM - 0KB) |
DMQRP 301-796-5710 |
| 3661 | 03/2011 | A Guide for the Submission of an Abbreviated Report on X-ray Tables, Cradles, Film Changers or Cassette Holders Intended for Diagnostic (HTML) | (HTM - 0KB) |
DMQRP 301-796-5710 |
| 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 |
| 3662 | 03/2011 | A Guide for Submission of an Abbreviated Radiation Safety Reports on Cephalometric Devise Intended for Diagnostic Use (HTML) | (HTM - 0KB) |
DMQRP 301-796-5710 |
| 3663 | 03/2011 | Abbreviated Reports on Radiation Safety for Microwave Products (Other than Microwave Ovens) (HTML) | (HTM - 0KB) |
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 | 02/2011 | My Medicine Record | (PDF - 466KB) |
Cindi Fitzpatrick 301-796-3115 |
| 3665 | 02/2012 | Final Consultation for Food Derived From a New Plant Variety (Instructions) | (PDF - 28KB) |
Dr. Mary Ditto 240-402-1165 |
| 3665 | 02/2012 | Final Consultation for Food Derived From a New Plant Variety (Biotechnology Final Consultation) | (PDF - 812KB) |
Dr. Mary Ditto 240-402-1165 |
| 3670 | 03/2008 | MedSun (Medical Product Surveillance Network) | (HTM - 0KB) |
Marilyn Flack 301-796-6118 |
| 3671 | 11/2011 | Common EMEA/FDA Application for Orphan Medicinal Product Designation | (PDF - 569KB) |
Kathy Needleman 301-827-3666 |
| 3674 | 03/2012 | Certification of Compliance, under 42 U.S.C. , 282(j)(5)(B), with Requireme | (PDF - 406KB) |
Jarilyn Dupont 301-796-4716 |
| 3677v | 01/2006 | Minor Species Index File (MIF) | (PDF - 265KB) |
Joan C. Gotthardt 240-276-9331 |
| 3719 | 10/2009 | Report of Inspection for Compliance with 21 CFR 589.2000 (CVM) | (PDF - 621KB) |
Shannon Jordre 240-276-9229 |
| 3719-1 | 10/2009 | Report of Inspection for Compliance with 21 CFR 589.2000 (CVM-1) | (PDF - 563KB) |
Shannon Jordre 240-276-9229 |
| 3728 | 06/2009 | Animal Generic Drug User Fee Cover Sheet | (HTM - 0KB) |
Lisa Kable 240-276-9718 |
| 3733 | 10/2011 | Shell Egg Producer Registration | (PDF - 2.1MB) |
Nancy Bufano 240-402-1493 |
| 3733 | 05/2010 | Shell Egg Producer Registration (HTML) | (HTM - 0KB) |
Nancy Bufano 240-402-1493 |
| 3734 | 06/2010 | Information Regarding Cigarettes with Characterizing Flavors | (HTM - 0KB) |
Chris Colburn 301-796-8758 |
| 3741 | 02/2011 | Registration and Listing for Owners and Operators of Domestic Tobacco Product Establishments | (PDF - 855KB) |
Chris Colburn 301-796-8758 |
| 3742 | 11/2010 | Listing of Ingredients in Tobacco Products | (PDF - 566KB) |
Chris Colburn 301-796-8758 |
| 3743 | 09/2010 | Tobacco Health Document Submission | (PDF - 473KB) |
Chris Colburn 301-796-8758 |
| 3744 | 11/2009 | Antimicrobial Animal Drug Distribution Report | (PDF - 438KB) |
Sue Dessai 240-276-9075 |
| 3752 | 06/2010 | Pre-Amendment Device Determination Request | (PDF - 402KB) |
Bryan Benesch 301.796.5506 |
| 3756 | 07/2010 | Pet Event Tracking Network (PETNet) | (HTM - 0KB) |
Jenny Murphy 240-453-6845 |
| 3757 | 07/2010 | Menu and Vending Machine Labeling Voluntary Registration | (PDF - 73KB) |
Felicia Billingslea 240-402-2371 |
| 3759 | 03/2011 | Abbreviated Reports on Radiation Safety of Non Medical Ultrasonic Products (HTML) | (HTM - 0KB) |
Cory Tylka 301-796-5869 |
| 3759 | 11/2010 | Abbreviated Reports on Radiation Safety of Non Medical Ultrasonic Products | (PDF - 487KB) |
Cory Tylka 301-796-5869 |
| 3760 | 11/2010 | Guide for Preparing Product Reports for Medical Ultrasound Products | (PDF - 497KB) |
Cory Tylka 301-796-5869 |
| 3800 | 08/2011 | FDA Safety Reporting Portal | (HTM - 0KB) |
Debra Street 240-402-1817 |
| 3801 | 03/2010 | Guide for Preparing Initial Reports and Model Change Reports on Medical Ultraviolet Lamps and Products Containing Such Lamps | (PDF - 716KB) |
Cory Tylka 301-796-5869 |
| VAERS-! | 01/2009 | Vaccine Adverse Event Reporting System | (PDF - 99KB) |
VAERS 800-822-7967 |
| VARES-1 | 01/2009 | Vaccine Adverse Event Reporting System (HTML) | (HTM - 0KB) |
VAERS 800-822-7967 |
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