• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

About FDA

  • Print
  • Share
  • E-mail
-

FDA Forms

If your PDF form is not working you may need to upgrade your software to a newer version of Adobe Reader.  Adobe Reader can be downloaded for Free at  http://get.adobe.com/reader/ 

Form Date Food and Drug Administration Forms Format Contact Info
0356h  01/2013 Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use (Instructions Supplement)  (PDF - 107KB) CBER MATT at 301-827-2000
CDER Drug Info at 301-796-3400
0356h  01/2013 Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use (Recommended for use with Adobe Acrobat 8 or 9)  (PDF - 1MB) CBER MATT at 301-827-2000
CDER Drug Info at 301-796-3400
0356v  04/2008 New Animal Drug Application [VET] (Q&As on the Revised 356v Form)  (HTM - 0KB) Urvi Desai
240- 276-8297
0356v  04/2008 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  10/1974 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  11/1989 Quantity of Contents  (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
301-796-5448
0465  08/1985 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
1571  01/2013 Investigational New Drug Application (IND) [Instructions]  (PDF - 134KB) CBER MATT at 301-827-2000
CDER Drug Info at 301-796-3400
1571  01/2013 Investigational New Drug Application (IND) (Recommended for use with Adobe Acrobat 8 or 9)  (PDF - 771KB) 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  01/2010 Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Rep  (PDF - 436KB) Margarita Brown
240-276-9048
1932a  01/2010 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  04/2012 Transmittal of Periodic Reports and Promotional Material New Animal Drugs  (PDF - 492KB) Sue Dessai
240-276-9075
2359  10/2011 Milk Plant Inspection Report  (PDF - 449KB) Robert Hennes
240-402-2175
2359a  10/2011 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  10/2011 Manufacturing Plant Inspection Report  (PDF - 453KB) 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  10/2008 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  03/2001 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  03/2001 MLEF Flat Lid Methods  (PDF - 68KB) William Northeimer, PhD
708-728-4137.
2400l  03/2001 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.
2481  03/2007 Medicated Feeds Inspection Report  (PDF - 800KB) Jo W. Gulley
240-453-6858
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  12/2010 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  04/2012 Food Process Filing For All Methods Except Low-Acid Aseptic  (PDF - 520KB) LACF Coordinator
LACF@FDA.HHS.GOV
2541a  04/2010 Food Process Filing For All Methods Except Low-Acid Aseptic (HTML)  (HTM - 0KB) LACF Coordinator
LACF@FDA.HHS.GOV
2541c  04/2010 Food Process Filing For Low-Acid Aseptic Systems (HTML)  (HTM - 0KB) LACF Coordinator
LACF@FDA.HHS.GOV
2541c  04/2012 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  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 - 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  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 - 281KB) Maya Johnson-Nimo
301-827-2906
2681  02/2002 Bakery Inspection Report  (PDF - 879KB) Maya Johnson-Nimo
301-827-2906
2682  10/1988 Beverage Plant Inspection Report  (PDF - 857KB) At the warehouse
Elizabeth.Sands@fda.hhs.gov
2684  10/2012 State Contract Monthly Food Report  (PDF - 376KB) Anita MacMullan
301-796-5875
2684a  04/2011 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  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  10/1980 Above Table X-Ray Source Radiographic Systems  (PDF - 30KB) At the warehouse
Elizabeth.Sands@fda.hhs.gov
2785  05/1982 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) Nick Walker
301-796-5910
2814  08/1993 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  10/2012 Food GMP Inspection Report  (PDF - 595KB) 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  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
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  04/2011 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
3147  11/2010 Application for a Variance From 21 CFR 1040.11(c) for a Laser Light Show, Display, or Device  (PDF - 485KB) DMQRP
301-796-5710
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  12/2012 NDA Field Alert Report  (PDF - 1.9MB) 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 PDUFA 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  09/2010 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  06/2012 Supplemental Data Sheet  (PDF - 420KB) Marjorie Shulman
301-796-6572
3429  07/2012 General Device Classification Questionnaire  (PDF - 442KB) 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) Colleen LoCicero
301-796-1114
3455  10/2009 Disclosure: Financial Interest and Arrangements of Clinical Investigators  (PDF - 400KB) Colleen LoCicero
301-796-1114
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 - 1.3MB) Francis Lin
240-402-1215
3486  10/2012 Biological Product Deviation Report  (PDF - 483KB) CBER Program Surveillance Branch
301-827-6220
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
3500  02/2006 MedWatch: The FDA Safety Information and Adverse Event Reporting Program (HTML)  (HTM - 0KB) MEDWATCH
1-800-FDA-1088
3500  01/2009 MedWatch: The FDA Safety Information and Adverse Reporting Program  (PDF - 1.7MB) 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  07/2010 FDA LACF Inspection Report  (PDF - 649KB) Bob Nelligan
706-485-2725
3511-2  07/2010 FDA Acidified Food Inspection Report  (PDF - 465KB) Bob Nelligan
706-485-2725
3511-3  07/2010 Aseptic Processing & Packaging Report  (PDF - 727KB) Bob Nelligan
706-485-2725
3511a  07/2010 Processing in Steam in Still Retorts  (PDF - 618KB) Bob Nelligan
706-485-2725
3511a-1  07/2010 Processing in Steam in Crateless Retorts  (PDF - 712KB) Bob Nelligan
706-485-2725
3511b  01/2011 Processing in Water in Still Retorts  (PDF - 640KB) Bob Nelligan
706-485-2725
3511c  03/2007 Processing in Steam in Continuous Agitating Retorts  (PDF - 657KB) Bob Nelligan
706-485-2725
3511d  01/2011 Processing in Steam in Discontinuous Agitating Retorts  (PDF - 586KB) Bob Nelligan
706-485-2725
3511e  01/2011 Processing in Water in Discontinuous Agitating Retorts  (PDF - 676KB) Bob Nelligan
706-485-2725
3511f  01/2011 Processing in Steam in Hydrostatic Retorts  (PDF - 519KB) Bob Nelligan
706-485-2725
3511g  01/2011 Processing in Cascading/Spray Water Retort  (PDF - 697KB) Bob Nelligan
706-485-2725
3511h  01/2011 Processing in Steam-Air Retorts  (PDF - 674KB) Bob Nelligan
706-485-2725
3511i  01/2011 Processing in Other Unique Retort Systems  (PDF - 599KB) Bob Nelligan
706-485-2725
3514  01/2013 CDRH Premarket Review Submission Cover Sheet  (PDF - 1.7MB) Ashley Boam
301-796-6341
3519  04/2011 FDA National Registry Report  (PDF - 418KB) Glenda Lewis
240-402-2150
3520  04/2011 Release Record and Agreement - Permission to Publish in National Registry  (PDF - 387KB) Glenda Lewis
240-402-2150
3537  09/2012 Food Facility Registration  (PDF - 1.5MB) FDA Industry Systems Help Desk
800-216-7331
301-575-0156
3537  02/2011 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 (HTML)  (HTM - 0KB) 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
3538  10/2010 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  05/2007 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  10/2010 Patent Information Submitted Upon and After Approval of An NDA or Supplemen  (PDF - 412KB) Mary Ann Holovac, R.Ph.
240-276-8971
3542a  10/2010 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  08/2012 FY 2013 MDUFMA Small Business Qualification Certification For a Business Headquarter in the United States  (PDF - 731KB) DSMICA
301-796-7100
800-638-2041
3602a  08/2012 FY 2013 MDUFMA Small Business Qualification Certification For a Business Headquarter Outside the United States  (PDF - 799KB) 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  03/2012 Supplementary Information Certificate to Foreign Government Requests  (PDF - 506KB) Import/Export Team
CBER 301-827-6201 or
CDRH 301-796-7400 or
CVM 240-276-9227.
3613a  03/2012 Supplementary Information Certificate of Exportability Requests  (PDF - 527KB) Import/Export Team
CBER 301-827-6201 or
CDRH 301-796-7400 or
CVM 240-276-9227.
3613b  03/2012 Supplementary Information Certificate of a Pharmaceutical Product  (PDF - 585KB) Import/Export Team
CBER 301-827-6201 or
CDRH 301-796-7400 or
CVM 240-276-9227.
3613c  03/2012 Supplementary Information Non-Clinical Research Use Only Certificate  (PDF - 467KB) Import/Export Team
CBER 301-827-6201 or
CDRH 301-796-7400
3613d  03/2012 Office of Cosmetics and Colors "Certificate" Export Application  (PDF - 709KB) Export Team
240-402-1178
3613e  03/2012 Food Export Certificate Application  (PDF - 454KB) Export Team
240-402-1178
3623  11/2005 Farm Investigation Questionnaire  (PDF - 662KB) Norman Fogg
301-796-5448
3623a  11/2005 Additional Water Sources  (PDF - 191KB) Norman Fogg
301-796-5448
3623b  11/2005 Additional Sets of Workers  (PDF - 296KB) Norman Fogg
301-796-5448
3626  04/2011 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  04/2011 Diagnostic X-Ray CT Products Radiation Safety Report (HTML)  (HTM - 0KB) DMQRP
301-796-5710
3627  11/2010 Diagnostic X-Ray CT Products Radiation Safety Report  (PDF - 568KB) DMQRP
301-796-5710
3628  07/2007 General Annual Report (Includes Medical, Analytical, and Industrial X-Ray Products Annual Report) (PDF)  (PDF - 446KB) DMQRP
301-796-5710
3628  04/2011 General Annual Report (Includes Medical, Analytical, and Industrial X-Ray Products Annual Report)  (HTM - 0KB) DMQRP
301-796-5710
3629  04/2011 Abbreviated Report  (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
3630  04/2011 Guide for Preparing Product Reports on Sunlamps and Sunlamp Products (HTML)  (HTM - 0KB) 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  04/2011 Guide for Preparing Annual Reports on Radiation Safety Testing of Sunlamps and Sunlamp Products (HTML)  (HTM - 0KB) DMQRP
301-796-5710
3632  04/2011 Guide for Preparing Product Reports on Lasers and Products Containing Lasers (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
3633  04/2011 General Variance Request  (HTM - 0KB) DMQRP
301-796-5710
3635  04/2011 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 (HTML)  (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
3637  04/2011 Laser Original Equipment Manufacture Report  (HTM - 0KB) DMQRP
301-796-5710
3638  04/2011 Guide for Filling Annual Reports for X-Ray Components and Systems (HTML)  (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
3639  07/2007 Guidance for Submission of Cabinet X-Ray System Reports Pursuant to 21 CFR 1020.40  (PDF - 1MB) DMQRP
301-796-5710
3639  04/2011 Guidance for Submission of Cabinet X-Ray System Reports Pursuant to 21 CFR 1020.40 (HTML)  (HTM - 0KB) DMQRP
301-796-5710
3640  01/2012 Reporting Guide for Laser Light Shows and Displays  (PDF - 643KB) DMQRP
301-796-5710
3640  04/2011 Reporting Guide for Laser Light Shows and Displays (HTML)  (HTM - 0KB) DMQRP
301-796-5710
3641  04/2011 Cabinet X-Ray Annual Report (HTML)  (HTM - 0KB) DMQRP
301-796-5710
3641  09/2011 Cabinet X-Ray Annual Report  (PDF - 588KB) DMQRP
301-796-5710
3642  04/2011 General Correspondence Report for CDRH Electronic Submissions  (HTM - 0KB) DMQRP
301-796-5710
3643  04/2011 Microwave Oven Products Annual Report (HTML)  (HTM - 0KB) DMQRP
301-796-5710
3643  07/2007 Microwave Oven Products Annual Report  (PDF - 2.5MB) DMQRP
301-796-5710
3644  07/2007 Guide for Preparing Product Reports for Ultrasonic Therapy Products  (PDF - 805KB) DMQRP
301-796-5710
3644  04/2011 Guide for Preparing Product Reports for Ultrasonic Therapy Products (HTML)  (HTM - 0KB) DMQRP
301-796-5710
3645  04/2011 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  04/2011 Mercury Vapor Lamp Products Radiation Safety Report (HTML)  (HTM - 0KB) DMQRP
301-796-5710
3647  10/2012 Guide for Preparing Annual Reports on Radiation Safety Testing of Mercury Vapor Lamps  (PDF - 617KB) DMQRP
301-796-5710
3647  04/2011 Guide for Preparing Annual Reports on Radiation Safety Testing of Mercury Vapor Lamps (HTML)  (HTM - 0KB) DMQRP
301-796-5710
3649  04/2011 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 - 438KB) Scott A. Colburn
301-796-6287
3660  07/2007 Guidance for Preparing Reports on Radiation Safety of Microwave Ovens  (PDF - 2.5MB) DMQRP
301-796-5710
3660  04/2011 Guidance for Preparing Reports on Radiation Safety of Microwave Ovens (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
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) 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  04/2011 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  04/2011 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  03/2011 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 - 866KB) 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  07/2010 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  12/2010 Listing of Ingredients in Tobacco Products  (PDF - 566KB) Chris Colburn
301-796-8758
3743  10/2010 Tobacco Health Document Submission  (PDF - 473KB) Chris Colburn
301-796-8758
3744  12/2009 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  04/2011 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
3792  10/2012 Biosimilar User Fee Cover Sheet  (HTM - 0KB) User Fee Financial Support
301-796-7200
3794  10/2012 Generic Drug User Fee Cover Sheet (Instructions)  (PDF - 45KB) User Fee Helpdesk
301-796-7200
3794  10/2012 Generic Drug User Fee Cover Sheet  (HTM - 0KB) User Fee Helpdesk
301-796-7200
3799  06/2012 Publication Request  (HTM - 0KB) Marion Allen
240-402-1584
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-!  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
-
-
-
-