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The United States and European Union will be able to use each other’s Pharmaceutical Inspections

The United States and the European Union (EU)  amended the  1998 U.S.-EU Mutual Recognition Agreement for Pharmaceutical Inspections. The US and the EU will now be able to use each other’s  inspections of pharmaceutical manufacturers which will enable the FDA and EU to avoid the duplication of drug inspections, lower inspection costs and enable regulators to devote more resources to other parts of the world where there may be greater risk.

Since May 2014, the FDA and the EU have been evaluating the way they each inspect drug manufacturers.. The FDA was invited to observe the EU’s Joint Audit Programme, in which two EU nations audit the regulatory authority of another EU country.

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US FDA Issues Warning Letter to DeGrave Dairy for Illegal Drug Residue

On February 27, 2017, an US Food and Drug Administration (USFDA) Warning Letter was issued to the two owners of DeGrave Dairy. This Warning Letter was issued  for violations of the Federal Food, Drug, and Cosmetic Act (the Act).

DeGrave Dairy is a dairy operation that the Minneapolis District inspected for three days .  The violations included

–Presence of Penicillin Residues above limits.

View the full Hospira US FDA Warning Letter

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US FDA Issues Warning Letter to Lucky Pacific Corp and Kamli International Co. Ltd.

On March 2, 2017, an US Food and Drug Administration (USFDA) Warning Letter was issued to seafood importers,  Lucky Pacific Corp and Kamli International Co. Ltd. This Warning Letter was issued for serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation.  These violations cuased the ready-to-eat dried fish snacks and ready-to-eat dried fish skin snacks to be adulterated.

The New York District Office  inspected Lucky Pacific Corp and Kamli International Co. Lt  for two days in October.  The violation was for the firms not providing the required affirmative step to  ensure that imported fish products are processed in accordance with the seafood HACCP Regulation.

View the Full US FDA Warning Letter

 

 

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Hospira Warning Letter Issued by US FDA

On February 14, 2017, an US Food and Drug Administration (USFDA) Warning Letter was issued to Hospira. This Warning Letter was issued  for significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.   These violations lead to the drug products beingadulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Hospira is a drug manufacturing facility owned by Pfizer.  The Kansas City District Office  inspected Hospira for nearly a month between May 16 to June 8, 2016. .  The violations included

–Failure to submit field alert reports to FDA

–Failure to thoroughly investigate unexplained discrepancies or failures of a drug batch to meet  specifications

–Failure to have valid in-process specifications

–Failure to follow  procedures to prevent microbiology contamination of  sterile drugs

–Failure to control rejected in-process materials

–Failure to establish laboratory controls

–Repeat violations at multiple facilities.

View the full Hospira US FDA Warning Letter

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FDA Warning Letter Issued to Hebei Yuxing Bio-Engineering Co Ltd

On September 6, 2016, an US Food and Drug Administration (USFDA) Warning Letter was issued to Hebei Yuxing Bio-Engineering Co Ltd. This Warning Letter was issued by the US FDA’s Center for Drug Evaluation and Research (CDER) for current Good Manufacturing Practices cGMP violations during manufacture of Active Pharmaceutical Ingredient (API) which resulted in in the API’s being adulterated under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetics Act (FD&C Act).

Hebei Yuxing is a firm in China that was inspected between August 17 to 21, 2015. Because of the violations, the firm was placed on Import Detention on July 8, 2016. The violations included

          The quality system does not adequately ensure the accuracy and integrity of data.
          Failure to follow and document laboratory controls at the time of performance, and failure to document and explain any departures from laboratory procedures.
      Failure of the quality unit to ensure that all critical deviations are investigated and resolved.
      The quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs
The full US Food and Drug Administration Warning Letter maybe viewed here:  http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm521098.htm

 

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US Food and Drug Administration US FDA Forms

US Food and Drug Administration US FDA Forms

US Food and Drug Administration US FDA Forms

Compilation of US Food and Drug Administration US FDA Forms

Below is a compilation of FDA forms with links to the PDF formats. The data table also includes a contact number for questions.

3662 12/2015 A Guide for Submission of an Abbreviated Radiation Safety Reports on Cephalometric Devices Intended for Diagnostic Use (PDF)  (PDF – 729KB) DRH
301-796-5790
3662 04/2011 A Guide for Submission of an Abbreviated Radiation Safety Reports on Cephalometric Devise Intended for Diagnostic Use (HTML)  (HTM – 0KB) DRH
301-796-5790
3626 01/2014 A Guide for the Submission of Initial Reports on Diagnostic X-ray Systems and Their Major Components (PDF)  (PDF – 1.1MB) DRH
301-796-5790
3626 04/2011 A Guide for the Submission of Initial Reports on Diagnostic X-ray Systems and their Major Components (HTML)  (HTM – 0KB) DRH
301-796-5790
3661 04/2011 A Guide for the Submission of an Abbreviated Report on X-ray Tables, Cradles, Film Changers or Cassette Holders Intended for Diagnostic (HTML)  (HTM – 0KB) DRH
301-796-5790
3661 06/2015 A Guide for the Submission of an Abbreviated Report on X-ray Tables, Cradles, Film Changers or Cassette Holders Intended for Diagnostic Use (PDF)  (PDF – 694KB) DRH
301-796-5790
3546 09/2014 ADUFA User Fee Cover Sheet (HTML)  (HTM – 0KB) Lisa Kable
240-276-9718
3629 04/2011 Abbreviated Report (HTML)  (HTM – 0KB) DRH
301-796-5790
3663 04/2011 Abbreviated Reports on Radiation Safety for Microwave Products (Other than Microwave Ovens) (HTML)  (HTM – 0KB) DRH
301-796-5790
3663 03/2016 Abbreviated Reports on Radiation Safety for Microwave Products (Other than Microwave Ovens) (PDF)  (PDF – 742KB) DRH
301-796-5790
3759 04/2011 Abbreviated Reports on Radiation Safety of Non Medical Ultrasonic Products (HTML)  (HTM – 0KB) DRH
301-796-5790
3759 05/2014 Abbreviated Reports on Radiation Safety of Non Medical Ultrasonic Products (PDF)  (PDF – 762KB) DRH
301-796-5790
3069 10/1980 Above Table X-Ray Source Fluoroscopic & Spot Film Systems Field Test Record (PDF)  (PDF – 19KB) Nick Walker
301-796-5910
2784 10/1980 Above Table X-Ray Source Radiographic Systems (PDF)  (PDF – 30KB) Nick Walker
301-796-5910
3649 04/2011 Accidental Radiation Occurrence Report (HTML)  (HTM – 0KB) DRH
301-796-5790
3649 06/2014 Accidental Radiation Occurrence Report (PDF)  (PDF – 766KB) DRH
301-796-5790
3623a 11/2014 Additional Water Sources (PDF)  (PDF – 2.2MB) Rina Vora
562-256-9292
3480a 03/2016 Amendment to an Existing Food Contact Notification Pre-Notification Consultation Food Master File (Instructions)  (PDF – 64KB) Elizabeth Furukawa
650-529-9908
3480a 03/2016 Amendment to an Existing Food Contact Notification Pre-Notification Consultation Food Master File (PDF)  (PDF – 154KB) Elizabeth Furukawa
650-529-9908
0431 01/2015 Analyst Worksheet (ORA) (PDF)  (PDF – 1MB) William Campanaro
240 821 6667
3728 09/2014 Animal Generic Drug User Fee Cover Sheet (HTML)  (HTM – 0KB) Lisa Kable
240-276-9718
3744 04/2014 Antimicrobial Animal Drug Distribution Report (PDF)  (PDF – 2.1MB) Sue Dessai
240-276-9075
2400n 10/2013 Appendix N Bulk Milk Tanker Screening Procedures – General Requirements  (PDF – 720KB) William Northeimer, PhD
708-924-0629
0766 06/2014 Application for Authorization to Re label or to Perform Other Action of the Federal Food, Drug, and Cosmetic Act and Other Related Acts (PDF)  (PDF – 647KB) John Verbeten
301-796-6677
1993 10/2015 Application for Permit to Ship or Transport Milk and/or Cream into US (PDF)  (PDF – 727KB) Esther Lazar
240-402-1485
3147 04/2011 Application for a Variance From 21 CFR 1040.11(c) for a Laser Light Show, Display, or Device (HTML)  (HTM – 0KB) DRH
301-796-5790
3147 08/2016 Application for a Variance From 21 CFR 1040.11(c) for a Laser Light Show, Display, or Device (PDF)  (PDF – 715KB) DRH
301-796-5790
0356h 08/2015 Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use (PDF) (Recommended for use with Adobe Acrobat 8 or 9)  (PDF – 2.5MB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
0356h 08/2015 Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use (Instructions Supplement)  (PDF – 122KB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
3511-3 11/2014 Aseptic Processing & Packaging Report (PDF)  (PDF – 988KB) Bob Neligan
706-485-2725
3611 09/2003 Audit Report (PDF)  (PDF – 353KB) Caleb Michaud
301-796-5932
2359f 11/2015 Audit Report of IMS Listed Single-Service Containers and/or Closures for Milk and/or Milk Products Manufacturers (PDF)  (PDF – 654KB) Robert Hennes
240-402-2175
0431d 08/2012 Bacteriological Record (PDF)  (PDF – 1.2MB) William Campanaro
240 821 6667
2681 02/2002 Bakery Inspection Report (PDF)  (PDF – 879KB) Maya Johnson-Nimo
301-827-2906
2682 10/1988 Beverage Plant Inspection Report (PDF)  (PDF – 857KB) Maya Johnson-Nimo
301-796-5885
3486a 01/2013 Biological Product Addition Information Deviation Report (Instructions to HTML)  (HTM – 0KB) CBER Blood and Tissue Compliance Branch
301-827-6223
3486a 11/2013 Biological Product Additional Information Deviation Report (HTML)  (HTM – 0KB) CBER Blood and Tissue Compliance Branch
301-827-6223
3486 11/2013 Biological Product Deviation Report (HTML)  (HTM – 0KB) CBER Program Surveillance Branch
240-402-9160
3486 05/2014 Biological Product Deviation Report (Instructions to HTML)  (HTM – 0KB) CBER PSB
240-402-9160
3486 01/2011 Biological Product Deviation Report (Instructions)  (HTM – 0KB) CBER Program Surveillance Branch
240-402-9160
3486 05/2014 Biological Product Deviation Report (PDF)  (PDF – 770KB) CBER Program Surveillance Branch
240-402-9160
3792 12/2015 Biosimilar User Fee Cover Sheet (HTML)  (HTM – 0KB) CDER Collections at 301.796.7900
2830 05/2015 Blood Establishment Registration and Product Listing (PDF)  (PDF – 767KB) bloodregis@fda.hhs.gov
0431j 08/1985 Botulism Continuation Sheet (PDF)  (PDF – 6KB) William Campanaro
301-827-1036
2399a 10/2011 Bulk Milk Hauler/Sampler Evaluation Report (PDF)  (PDF – 428KB) Robert Hennes
240-402-2175
3260 02/1983 C-Arm Fluoroscopic & Spot-Film Systems Field Test Record (PDF)  (PDF – 41KB) Nick Walker
301-796-5910
3514 01/2013 CDRH Premarket Review Submission Cover Sheet (PDF)  (PDF – 1.7MB) Edwena R. Jones
301-796-6308
3641 04/2011 Cabinet X-Ray Annual Report (HTML)  (HTM – 0KB) DRH
301-796-5790
3641 04/2014 Cabinet X-Ray Annual Report (PDF)  (PDF – 860KB) DRH
301-796-5790
3537a 11/2008 Cancellation of Food Facility Registration (HTML)  (HTM – 0KB) FDA Industry Systems Help Desk
800-216-7331
301-575-0156
3537a 11/2014 Cancellation of Food Facility Registration (PDF)  (PDF – 665KB) Industry Systems Help Desk
800-216-7331
301-575-0156
1815 10/2015 Certificate/ Transmittal for an Application (PDF)  (PDF – 602KB) Esther Lazar
240-402-1485
3674 02/2015 Certification of Compliance, under 42 U.S.C. , 282(j)(5)(B), with Requirements of ClinicalTrials.gov (PDF)  (PDF – 2.6MB) Patrick McNeilly
301- 796-2941
3674 02/2013 Certification of Compliance, under 42 U.S.C. , 282(j)(5)(B), with Requirements of ClinicalTrials.gov Data Bank (42 U.S.C., 282(j)) (Instructions/Supplemental)  (PDF – 129KB) Patrick McNeilly
301- 796-2941
3454 03/2016 Certification: Financial Interest and Arrangements of Clinical Investigator (PDF)  (PDF – 673KB) Colleen LoCicero
301-796-1114
3787h 08/2013 Cigarette Filler Report Worksheet (HTML)  (HTM – 0KB) CTP
1-877-CTP-1373
(1-877-287-1373)
3787a 07/2016 Cigarette Report (PDF)  (PDF – 1.5MB) CTP
1-877-CTP-1373
(1-877-287-1373)
3787e 08/2013 Cigarette Smoke (ISO Regimen) Report Worksheet (HTML)  (HTM – 0KB) CTP
1-877-CTP-1373
(1-877-287-1373)
3787g 08/2013 Cigarette Smoke (Other Regimen) Report Worksheet (HTML)  (HTM – 0KB) CTP
1-877-CTP-1373
(1-877-287-1373)
3787f 08/2013 Cigarette Smoke Report (Intense Regimen) Worksheet (HTML)  (HTM – 0KB) CTP
1-877-CTP-1373
(1-877-287-1373)
3671 01/2015 Common EMEA/FDA Application for Orphan Medicinal Product Designation (PDF)  (PDF – 850KB) Kathy Needleman
301-827-3666
3410 10/2001 Confidential Financial Disclosure Report (PDF)  (PDF – 492KB) Vincent Tolino
301-827-5514
3610 10/2003 Contract Audit (PDF)  (PDF – 540KB) Catherine Hosman
781-587-7443
3131 08/2001 Contract Property Administration Completion Report (PDF)  (PDF – 5KB) Mike McGrath
301-827-7105
2512 06/2009 Cosmetic Product Ingredient Statement (HTML)  (HTM – 0KB) VCRP
240-402-1130
2512 08/2014 Cosmetic Product Ingredient Statement (PDF)  (PDF – 1.1MB) VCRP
240-402-1130
2512a 08/2014 Cosmetic Product Ingredient Statement [CFSAN] (PDF)  (PDF – 1.5MB) VCRP
240-402-1130
2400 03/2001 Cultural Procedures – General Requirements (PDF)  (PDF – 8KB) William W. Northeimer, Ph.D.
708-924-0629
3316a 08/1985 DRUG MASTER FILE ARCHIVAL BINDER-Blue  (HTML – 14KB) CDER Drug Info at 301-796-3400
3316 08/1985 DRUG MASTER FILE REVIEW BINDER-Red  (HTML – 14KB) CDER Drug Info at 301-796-3400
2359a 10/2011 Dairy Farm Inspection Report (PDF)  (PDF – 468KB) Robert Hennes
240-402-2175
2399d 10/2008 Dairy Plant – Milk Sample Collector Evaluation Record (PDF)  (PDF – 457KB) Robert Hennes
240-402-2175
2399 10/2008 Dairy Plant Sampling – Raw & Pasteurized Milk (PDF)  (PDF – 571KB) Robert Hennes
240-402-2175
2877 08/2014 Declaration for Imported Electronic Products Subject to Radiation Control Standards (PDF)  (PDF – 670KB) DRH
301-796-5790
0482d 02/2016 Demand Request for FSVP Records (PDF)  (PDF – 628KB) Brian Ravitch
619 941-3719
2785 05/1982 Dental Radiographic Systems Field Test Record (PDF)  (PDF – 21KB) Nick Walker
301-796-5910
3627 04/2011 Diagnostic X-Ray CT Products Radiation Safety Report (HTML)  (HTM – 0KB) DRH
301-796-5790
3627 01/2014 Diagnostic X-Ray CT Products Radiation Safety Report (PDF)  (PDF – 836KB) DRH
301-796-5790
3455 03/2016 Disclosure: Financial Interest and Arrangements of Clinical Investigators (PDF)  (PDF – 673KB) Colleen LoCicero
301-796-1114
3911 12/2015 Drug Notification to FDA (Instructions Supplement)  (PDF – 126KB) CDER Drug Info
301-796-3400
3911 12/2015 Drug Notification to FDA (PDF)  (PDF – 2.1MB) CDER Drug Info
301-796-3400
3666 11/2015 Early Food Safety Evaluation of a New Protein Produced by a New Plant Variety (New Protein Consultation) (PDF)  (PDF – 93KB) Berhane G. Grimay
240-402-1194
3666 11/2015 Early Food Safety Evaluation of a New Protein Produced by a New Plant Variety New Protein Consultation (Instructions)  (PDF – 32KB) Berhane G. Grimay
240-402-1194
3880 05/2015 Electronic Submission Gateway for New Dietary Ingredient Notification (NDIN) Submission (HTM)  (HTM – 0KB) Office of Dietary Supplement Programs
(855) 543-3784
240-402-2375
3538 02/2014 Electronic Submission System Participant Password or Addition (PDF)  (PDF – 106KB) Margaret Zabriski
240-276-9143
0431m 12/1979 Elemental Analysis Worksheet (PDF)  (PDF – 6KB) William Campanaro
240 821 6667
3356 01/2011 Establishment Registration and Listing for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) (HTML)  (HTM – 0KB) tissuereg@fda.hhs.gov
3356 05/2014 Establishment Registration and Listing for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) (PDF)  (PDF – 922KB) tissuereg@fda.hhs.gov
3511-2 07/2010 FDA Acidified Food Inspection Report (PDF)  (PDF – 465KB) Bob Neligan
706-485-2725
3511 07/2010 FDA LACF Inspection Report (PDF)  (PDF – 649KB) Bob Neligan
706-485-2725
3519 11/2015 FDA National Registry Report (PDF)  (PDF – 1.2MB) Stephen Hughes
240-402-2833
3800 10/2014 FDA Safety Reporting Portal (HTML)  (HTM – 0KB) Debra Street
240-402-1817
3882 08/2014 FDA Scientific Achievement Awards Nomination Package (PDF)  (PDF – 2.1MB) Devin Thomas
240- 402-5263
0483a 02/2016 FSVP Observations (PDF)  (PDF – 1.7MB) Brian Ravitch
619 941-3719
3601a 08/2012 FURLS User Fee (HTM)  (HTM – 0KB) User Fees Financial Support Team
301-796-7200
3602a 07/2016 FY 2017 MDUFA Foreign Small Business Qualification and Certification For a Business Headquartered Outside the United States (PDF)  (PDF – 1.1MB) DICE
800-638-2041
3602 07/2016 FY 2017 MDUFA Small Business Qualification and Certification For a Business Headquartered in the United States (PDF)  (PDF – 1014KB) DICE
800-638-2041
2399c 10/2011 Farm Bulk Tank Milk Sampling Inspection Record (PDF)  (PDF – 713KB) Robert Hennes
240-402-2175
1996 10/2015 Farm Inspection Report (PDF)  (PDF – 3MB) Esther Lazar
240-402-1485
3623 11/2014 Farm Investigation Questionnaire (PDF)  (PDF – 3MB) Rina Vora
562-256-9292
2814 08/1993 Field Equipment Request (PDF)  (PDF – 1.1MB) William Campanaro
301-827-1086
2782 09/1998 Field Test Record Continuation Sheet (PDF)  (PDF – 1MB) Nick Walker
301-796-5910
3665 05/2015 Final Consultation for Food Derived From a New Plant Variety (Biotechnology Final Consultation) (PDF)  (PDF – 96KB) Dr. Mary Ditto
240-402-1165
3665 05/2015 Final Consultation for Food Derived From a New Plant Variety (Instructions)  (PDF – 33KB) Dr. Mary Ditto
240-402-1165
3503 08/2014 Food Additive Petition Submission (Instructions)  (PDF – 35KB) Berhane G. Girmay, Ph.D.
240-402-1194
3503 08/2014 Food Additive Petition Submission (PDF)  (PDF – 112KB) Berhane G. Girmay, Ph.D
240-402-1194
2541 12/2010 Food Canning Registration (HTML)  (HTM – 0KB) LACF Coordinator
301/436-2411
2541 06/2013 Food Canning Registration (Instructions-HTML)  (PDF – 1.4MB) LACF Coordinator
240-402-2411
2541 06/2013 Food Canning Registration (Instructions-PDF)  (HTML – 0KB) LACF Coordinator
LACF@FDA.HHS.GOV
2541 06/2016 Food Canning Registration (PDF)  (PDF – 683KB) LACF Coordinator
LACF@FDA.HHS.GOV
3613e 03/2012 Food Export Certificate Application (HTML)  (HTM – 0KB) Export Team
3613e 06/2015 Food Export Certificate Application (PDF)  (PDF – 727KB) Export Team
3537 02/2011 Food Facility Registration (HTML)  (HTM – 0KB) FDA Industry Systems Help Desk
800-216-7331
301-575-0156
3537 11/2014 Food Facility Registration (PDF)  (PDF – 1.8MB) FDA Industry Systems Help Desk
800-216-7331
301-575-0156
2966 03/2013 Food GMP Inspection Report (PDF)  (PDF – 893KB) Wendy Campbell
615-310-0483
2541e 06/2016 Food Process Filing For Acidified Method  (PDF – 1.1MB) LACF Coordinator
240-402-2411
2541g 06/2016 Food Process Filing For Low-Acid Aseptic Systems  (PDF – 935KB) LACF Coordinator
240-402-2411
2541d 06/2016 Food Process Filing For Low-Acid Retorted Method  (PDF – 1.1MB) LACF Coordinator
240-402-2411
2541f 06/2016 Food Process Filing For Water Activity/Formulation Control Method (PDF)  (PDF – 1.1MB) LACF Coordinator
240-402-2411
2679 08/2001 Food Warehouse Inspection Report (PDF)  (PDF – 533KB) Maya Johnson-Nimo
301-827-2906
3907 03/2014 Food and Cosmetics Information Center (FCIC) Inquiry (HTML)  (HTM – 0KB) Deborah Price
240-402-1746
3628 04/2011 General Annual Report (Includes Medical, Analytical, and Industrial X-Ray Products Annual Report) (HTML)  (HTM – 0KB) DRH
301-796-5790
3628 02/2016 General Annual Report (Includes Medical, Analytical, and Industrial X-Ray Products Annual Report) (PDF)  (PDF – 801KB) DRH
301-796-5790
0431a 05/1984 General Continuation Sheet (PDF)  (PDF – 1.4MB) William Campanaro
240 821 6667
3642 04/2011 General Correspondence Report for CDRH Electronic Submissions (HTML)  (HTM – 0KB) DRH
301-796-5790
3429 10/2015 General Device Classification Questionnaire (PDF)  (PDF – 718KB) Marjorie Shulman
301-796-6572
3071 04/2001 General Information Field Test Record (PDF)  (PDF – 20KB) Nick Walker
301-796-5910
3633 04/2011 General Variance Request (HTML)  (HTM – 0KB) DRH
301-796-5790
3667 05/2016 Generally Recognized as Safe (GRAS) Notice (Instructions)  (PDF – 32KB) Berhane G. Grimay
240-402-1194
3667 05/2016 Generally Recognized as Safe (GRAS) Notice (PDF)  (PDF – 137KB) Berhane G. Grimay
240-402-1194
3794 02/2016 Generic Drug User Fee Cover Sheet (HTML)  (HTM – 0KB) CDER Collections at 301.796.7900
3794 08/2013 Generic Drug User Fee Cover Sheet (Instructions)  (PDF – 650KB) CDER Collections at 301.796.7900
3422 08/2013 Government Entity Declaration (PDF)  (PDF – 727KB) Denise Robinson
301-796-5919
3660 04/2011 Guidance for Preparing Reports on Radiation Safety of Microwave Ovens (HTML)  (HTM – 0KB) DRH
301-796-5790
3660 07/2007 Guidance for Preparing Reports on Radiation Safety of Microwave Ovens (PDF)  (PDF – 2.5MB) DRH
301-796-5790
3639 04/2011 Guidance for Submission of Cabinet X-Ray System Reports Pursuant to 21 CFR 1020.40 (HTML)  (HTM – 0KB) DRH
301-796-5790
3639 03/2014 Guidance for Submission of Cabinet X-Ray System Reports Pursuant to 21 CFR 1020.40 (PDF)  (PDF – 988KB) DRH
301-796-5790
3638 04/2011 Guide for Filling Annual Reports for X-Ray Components and Systems (HTML)  (HTM – 0KB) DRH
301-796-5790
3638 03/2014 Guide for Filling Annual Reports for X-Ray Components and Systems (PDF)  (PDF – 871KB) DRH
301-796-5790
3645 04/2011 Guide for Preparing Annual Reports for Ultrasonic Therapy Products (HTML)  (HTM – 0KB) DRH
301-796-5790
3645 06/2015 Guide for Preparing Annual Reports for Ultrasonic Therapy Products (PDF)  (PDF – 761KB) DRH
301-796-5790
3636 04/2011 Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show (HTML)  (HTM – 0KB) DRH
301-796-5790
3636 03/2014 Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show (PDF)  (PDF – 811KB) DRH
301-796-5790
3647 04/2011 Guide for Preparing Annual Reports on Radiation Safety Testing of Mercury Vapor Lamps (HTML)  (HTM – 0KB) DRH
301-796-5790
3647 05/2014 Guide for Preparing Annual Reports on Radiation Safety Testing of Mercury Vapor Lamps (PDF)  (PDF – 888KB) DRH
301-796-5790
3631 04/2011 Guide for Preparing Annual Reports on Radiation Safety Testing of Sunlamps and Sunlamp Products (HTML)  (HTM – 0KB) DRH
301-796-5790
3631 02/2014 Guide for Preparing Annual Reports on Radiation Safety Testing of Sunlamps and Sunlamp Products (PDF)  (PDF – 823KB) DRH
301-796-5790
3801 06/2014 Guide for Preparing Initial Reports and Model Change Reports on Medical Ultraviolet Lamps and Products Containing Such Lamps (PDF)  (PDF – 1010KB) DRH
301-796-5790
3760 06/2014 Guide for Preparing Product Reports for Medical Ultrasound Products (PDF)  (PDF – 771KB) DRH
301-796-5790
3644 04/2011 Guide for Preparing Product Reports for Ultrasonic Therapy Products (HTML)  (HTM – 0KB) DRH
301-796-5790
3644 02/2015 Guide for Preparing Product Reports for Ultrasonic Therapy Products (PDF)  (PDF – 815KB) DRH
301-796-5790
3632 04/2011 Guide for Preparing Product Reports on Lasers and Products Containing Lasers (HTML)  (HTM – 0KB) DRH
301-796-5790
3632 02/2013 Guide for Preparing Product Reports on Lasers and Products Containing Lasers (PDF)  (PDF – 1MB) DRH
301-796-5790
3630 04/2011 Guide for Preparing Product Reports on Sunlamps and Sunlamp Products (HTML)  (HTM – 0KB) DRH
301-796-5790
3630 10/2014 Guide for Preparing Product Reports on Sunlamps and Sunlamp Products (PDF)  (PDF – 1.2MB) DRH
301-796-5790
3297 04/1984 Head and Neck Radiographic Systems Field Test Record (PDF)  (PDF – 29KB) Nick Walker
301-796-5910
3502 01/2001 Importer Seafood HACCP Report (HTML)  (HTM – 0KB) Roshelle King
301-436-1416
3881 08/2014 Indications for Use (PDF)  (PDF – 1.7MB) Diane Garcia
301-796-6559
3926 02/2016 Individual Patient Expanded Access Investigational New Drug Application (IND) (PDF)**Note: For best form functionality, Right-click 3926 link and click Save Link As… to save to your desktop and then open the file.  (PDF – 2.1MB) CDER Drug Info at 301-796-3400
3926 03/2016 Individual Patient Expanded Access Investigational New Drug Application (IND) (instructions)  (PDF – 123KB) CDER Drug Info at 301-796-3400
0431e 09/2011 Industrial Chemicals Worksheet (PDF)  (PDF – 389KB) William Campanaro
240 821 6667
2589 08/2001 Inspection Summary – Bus Service Area Sanitation (PDF)  (PDF – 380KB) Rina Vora
562-256-9292
2591 08/2001 Inspection Summary Equipment Evaluation (PDF)  (PDF – 378KB) Bruce Kummer
240-402-2142
2359h 10/2011 Interstate Milk Shipper Check-Rating Report (PDF)  (PDF – 589KB) Robert Hennes
240-402-2175
2359i 10/2013 Interstate Milk Shipper Report (PDF)  (PDF – 1.1MB) Robert Hennes
240-402-2175
3038 04/2016 Interstate Shellfish Dealer’s Certificate (PDF)  (PDF – 660KB) Charlotte Epps
240-402-2154
3038 06/2013 Interstate Shellfish Dealer’s Certificate {Not for public use, only for approved State shellfish officials to log into to set up a shellfish shipper user account to be able to fill out and submit the FDA 3038 electronically} (HTML)  (HTM – 0KB) Charlotte Epps
240-402-2154
1571 02/2016 Investigational New Drug Application (IND) (PDF) (Recommended for use with Adobe Acrobat 8 or 9)  (PDF – 1.1MB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
1571 10/2014 Investigational New Drug Application (IND) [Instructions]  (PDF – 137KB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
2675a 10/1986 Investigational New Drug Folder (Green)  (HTML – 14KB) CDER Drug Info at 301-796-3400
2675b 10/1986 Investigational New Drug Folder (Orange)  (HTML – 14KB) CDER Drug Info at 301-796-3400
2675 08/1990 Investigational New Drug Folder (Red)  (HTML – 14KB) CDER Drug Info at 301-796-3400
3635 04/2011 Laser Light Show Notification (HTML)  (HTM – 0KB) DRH
301-796-5790
3637 04/2011 Laser Original Equipment Manufacture Report (HTML)  (HTM – 0KB) DRH
301-796-5790
3742 04/2016 Listing of Ingredients in Tobacco Products (PDF)  (PDF – 883KB) CTP
1-877-CTP-1373
(1-877-287-1373)
3891 05/2014 Livestock Net (HTML)  (HTM – 0KB) Jenny Murphy
240-453-6845
3500B 10/2015 MEDWATCH Consumer Voluntary Reporting (PDF)  (PDF – 1.2MB) MEDWATCH Saftey Alerts
1-800-FDA-1088
2400m 03/2001 MLEF Dairy Waters (PDF)  (PDF – 8KB) William W. Northeimer, Ph.D.
708-924-0629
2400b-1 03/2001 MLEF Detection of Inhibitory Substances in Milk Bacillus Stearothermophilus (PDF)  (PDF – 8KB) William W. Northeimer, Ph.D.
708-924-0629
2400b-3 03/2001 MLEF Detection of Inhibitory Substances in Milk Delvotest 5 Pack (PDF)  (PDF – 8KB) William W. Northeimer, Ph.D.
708-924-0629
2400d 03/2001 MLEF Direct Microscopic Somatic Cell Count (PDF)  (PDF – 8KB) William W. Northeimer, Ph.D.
708-924-0629
2400l 03/2001 MLEF Disintegration Method for Paper, etc. (PDF)  (PDF – 45KB) William W. Northeimer, Ph.D.
708-924-0629
2400h-2 03/2001 MLEF Electronic Somatic Cell Count Bentley Somacount 150/300/500 (PDF)  (PDF – 8KB) William W. Northeimer, Ph.D.
708-924-0629
2400h-1 03/2001 MLEF Electronic Somatic Cell Count Foss 250/300/360/400 (PDF)  (PDF – 8KB) William W. Northeimer, Ph.D.
708-924-0629
2400h-3 03/2001 MLEF Electronic Somatic Cell Count Fossmatic 5000 (PDF)  (PDF – 8KB) William W. Northeimer, Ph.D.
708-924-0629
2400k 03/2001 MLEF Flat Lid Methods (PDF)  (PDF – 68KB) William W. Northeimer, Ph.D.
708-924-0629
2359c 11/2015 Manufacturing Plant Inspection Report (PDF)  (PDF – 733KB) Robert Hennes
240-402-2175
3670 11/2014 MedSun (Medical Product Surveillance Network) (HTML)  (HTM – 0KB) Jill Marion
301- 796-6128
3500 02/2006 MedWatch: The FDA Safety Information and Adverse Event Reporting Program (HTML)  (HTM – 0KB) MEDWATCH
1-800-FDA-1088
3500A 02/2013 MedWatch: The FDA Safety Information and Adverse Event Reporting Program – Mandatory (Instructions)  (PDF – 217KB) MedWatch
1-800-332-1088
3500A 10/2015 MedWatch: The FDA Safety Information and Adverse Event Reporting Program – Mandatory (PDF)  (PDF – 2.7MB) MEDWATCH
1-800-FDA-1088
3500 10/2015 MedWatch: The FDA Safety Information and Adverse Reporting Program (PDF)  (PDF – 3.5MB) MEDWATCH
1-800-FDA-1088
3608 06/2005 Medical Device Fellowship Program Student Application (HTML)  (HTM – 0KB) DMQRP
301-796-5696
3419 03/2016 Medical Device Reporting Annual User Facility Report (PDF)  (PDF – 699KB) OSB/CDRH/RSMB
301-796-6104
3601 08/2012 Medical Device User Fee Cover Sheet (HTML)  (HTM – 0KB) User Fees Financial Support Team
301-796-7200
3448 03/2014 Medicated Feed Mill License Application (PDF)  (PDF – 550KB) Isabel W. Pocurull
240-402-5877
2481 03/2007 Medicated Feeds Inspection Report (PDF)  (PDF – 800KB) Isabel W. Pocurull
240-402-5877
3757 06/2016 Menu and Vending Machine Labeling Voluntary Registration (PDF)  (PDF – 114KB) Ashley Rulffes
240-402-2820
3646 04/2011 Mercury Vapor Lamp Products Radiation Safety Report (HTML)  (HTM – 0KB) DRH
301-796-5790
3646 04/2014 Mercury Vapor Lamp Products Radiation Safety Report (PDF)  (PDF – 886KB) DRH
301-796-5790
3643 04/2011 Microwave Oven Products Annual Report (HTML)  (HTM – 0KB) DRH
301-796-5790
3643 03/2014 Microwave Oven Products Annual Report (PDF)  (PDF – 865KB) DRH
301-796-5790
2400a-1 03/2001 Milk Laboratory Evaluation Form: Spiral Plate Count Methods (PDF)  (PDF – 85KB) William W. Northeimer, Ph.D.
708-924-0629
2400a 03/2001 Milk Laboratory Evaluation Form: Standard Plate Count, Coliform, and Simplified Count Methods (PDF)  (PDF – 8KB) William W. Northeimer, Ph.D.
708-924-0629
2359b 10/2011 Milk Plant Equipment Tests Report (PDF)  (PDF – 387KB) Robert Hennes
240-402-2175
2359 10/2011 Milk Plant Inspection Report (PDF)  (PDF – 449KB) Robert Hennes
240-402-2175
2359m 10/2013 Milk Plant, Receiving Station or Transfer Station NCIMS HACPP System Audit Report (PDF)  (PDF – 745KB) Robert Hennes
240-402-2175
2359j 10/2013 Milk Sanitation Rating Report (PDF)  (PDF – 738KB) Robert Hennes
240-402-2175
2399b 10/2008 Milk Tank Truck Inspection Report (PDF)  (PDF – 427KB) Robert Hennes
240-402-2175
3677v 01/2006 Minor Species Index File (MIF) (PDF)  (PDF – 265KB) Dorothy Bailey
240-402-0565
2783 10/1980 Mobile Radiographic Systems Field Test Record (PDF)  (PDF – 19KB) Nick Walker
301-796-5910
3570 01/2011 Model Small Business Nutrition Labeling Exemption Notice (HTML)  (HTM – 0KB) SBusiness
240-402-2375
3570 10/2014 Model Small Business Nutrition Labeling Exemption Notice (PDF)  (PDF – 1.7MB) Sbusiness
240-402-2375
3664 03/2011 My Medicine Record (PDF)  (PDF – 466KB) Cindi Fitzpatrick
301-796-3115
2359p 10/2013 NCIMS Aseptic Processing and Packaging Program Critical Listing Elements (PDF)  (PDF – 649KB) Robert Hennes
240-402-2175
2359n 10/2013 NCIMS HACCP System Regulatory Agency Review Report (PDF)  (PDF – 570KB) Robert Hennes
240-402-2175
3331 03/2015 NDA Field Alert Report (PDF)  (PDF – 2.7MB) Surveillance Programs Team
301-796-3130
3331a 05/2013 NDA Field Alert Report Automated (Instructions)  (HTM – 0KB) Surveillance Programs Team
301-796-3130
3331a 03/2013 NDA Field Alert Report Automated (PDF)  (PDF – 1.7MB) Surveillance Programs Team
301-796-3130
0356v 12/2015 New Animal Drug Application [VET] (PDF)  (PDF – 845KB) Urvi Desai
240-402-0689
0356v 04/2008 New Animal Drug Application [VET] (Q&As on the Revised 356v Form)  (HTM – 0KB) Urvi Desai
240-402-0689
2626 07/2004 New Drug Application/Biologic Licensing Application (Blue Folder) Archival  (HTML – 14KB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
2626f 07/2004 New Drug Application/Biologic Licensing Application (Light Green Folder) Statistics  (HTML – 14KB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
2626h 07/2004 New Drug Application/Biologic Licensing Application (Maroon Folder) Field Submission Chemistry  (HTML – 14KB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
2626c 07/2004 New Drug Application/Biologic Licensing Application (Orange Folder) Pharmacokinetic  (HTML – 14KB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
2626a 07/2004 New Drug Application/Biologic Licensing Application (Red Folder) Chemistry  (HTML – 14KB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
2626e 07/2004 New Drug Application/Biologic Licensing Application (Tan Folder) Clinical Data  (HTML – 14KB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
2626d 07/2004 New Drug Application/Biologic Licensing Application (White Folder) Microbiology  (HTML – 14KB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
2626b 07/2004 New Drug Application/Biologic Licensing Application (Yellow Folder) Pharmacology  (HTML – 14KB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
2767 05/2014 Notice of Availability of Sample Electronic Product (PDF)  (PDF – 627KB) DRH
301-796-5790
2514 08/2014 Notice of Discontinuance of Commercial Distribution of Cosmetic Product Formulation (PDF)  (PDF – 1MB) VCRP
240-402-1130
3480 03/2016 Notification For New Use Of A Food Contact Substance (Instructions)  (PDF – 95KB) Elizabeth Furukawa
650-529-9908
3480 03/2016 Notification For New Use Of A Food Contact Substance (PDF)  (PDF – 311KB) Elizabeth Furukawa
650-529-9908
3479 03/2016 Notification for a Food Contact Substance Formulation (PDF)  (PDF – 2.6MB) Elizabeth Furukawa
650-529-9908
3951 09/2015 OHI Guest Worker Application (PDF)  (PDF – 1.1MB) Audrey Thomas
301-796-3520
3613d 06/2015 Office of Cosmetics and Colors “Certificate” (Exports) Application (PDF)  (PDF – 710KB) Export Team
3613d 03/2012 Office of Cosmetics and Colors “Certificate” Export Application (HTML)  (HTM – 0KB) Export Team
2400h 03/2001 Optical Somatic Cell Count (PDF)  (PDF – 8KB) William W. Northeimer, Ph.D.
708-924-0629
3908 12/2014 Outsourcing Facilities for Human Drug Compounding Small Business Establishment Fee Reduction Request (PDF)  (PDF – 1.7MB) CDER Collections
3397 03/2016 PDUFA User Fee Cover Sheet (HTML)  (HTM – 0KB) CDER Collections at 301.796.7900
3890 05/2014 PETNet (HTML)  (HTM – 0KB) Jenny Murphy
240-453-6845
2400i 03/2001 Pasteurized Milk Containers (PDF)  (PDF – 8KB) William W. Northeimer, Ph.D.
708-924-0629
3542 11/2013 Patent Information Submitted Upon and After Approval of An NDA or Supplement (PDF)  (PDF – 703KB) Kendra S. Stewart
240-402-8797
3542a 11/2013 Patent Information Submitted With the Filing of An NDA, Amendment, or Supplement (PDF)  (PDF – 700KB) Kendra S. Stewart
240-402-8797
3068 08/1992 Peak Kilovoltage Determination Field Test Record (PDF)  (PDF – 57KB) Nick Walker
301-796-5910
2359o 10/2013 Permission for Publication Interstate Milk Shipper’s Listing (PDF)  (PDF – 659KB) Robert Hennes
240-402-2175
2400j 03/2001 Phosphatase Test (PDF)  (PDF – 8KB) William W. Northeimer, Ph.D.
708-924-0629
3752 04/2013 Pre-Amendment Device Determination Request (PDF)  (PDF – 677KB) DPLC
301-796-5770
3540 05/2007 Prior Notice Submission (HTML)  (HTM – 0KB) Prior Notice Center
866-521-2297
3511g 05/2014 Processing in Cascading/Spray Water Retort (PDF)  (PDF – 995KB) Bob Neligan
706-485-2725
3511i 12/2013 Processing in Other Unique Retort Systems (PDF)  (PDF – 926KB) Bob Neligan
706-485-2725
3511c 03/2014 Processing in Steam in Continuous Agitating Retorts (PDF)  (PDF – 966KB) Bob Neligan
706-485-2725
3511a-1 03/2014 Processing in Steam in Crateless Retorts (PDF)  (PDF – 1004KB) Bob Neligan
706-485-2725
3511d 03/2014 Processing in Steam in Discontinuous Agitating Retorts (PDF)  (PDF – 876KB) Bob Neligan
706-485-2725
3511f 05/2014 Processing in Steam in Hydrostatic Retorts (PDF)  (PDF – 844KB) Bob Neligan
706-485-2725
3511a 03/2014 Processing in Steam in Still Retorts (PDF)  (PDF – 914KB) Bob Neligan
706-485-2725
3511h 09/2014 Processing in Steam-Air Retorts (PDF)  (PDF – 951KB) Bob Neligan
706-485-2725
3511e 03/2014 Processing in Water in Discontinuous Agitating Retorts (PDF)  (PDF – 972KB) Bob Neligan
706-485-2725
3511b 03/2014 Processing in Water in Still Retorts (PDF)  (PDF – 935KB) Bob Neligan
706-485-2725
3799 06/2012 Publication Request (HTML)  (HTM – 0KB) Marion Allen
240-402-1584
3906 12/2013 Publication Request CFSAN (PDF)  (HTM – 0KB) CFSAN Publicaiotns
1-888-723-3366
0431f 11/1989 Quantity of Contents (PDF)  (PDF – 337KB) William Campanaro
240 821 6667
2914 10/2014 Radioactive Drug Research Committee (RDRC) Report on Research Use of Radioactive Drugs Membership Summary (PDF)  (PDF – 3.3MB) RDRC
301-796-2050
2915 10/2014 Radioactive Drug Research Committee (RDRC) Report on Research Use of Radioactive Drugs Study Summary (PDF)  (PDF – 1.9MB) RDRC
301-796-2050
3741a 06/2016 Registration and Listing for Owners and Operators of Domestic Deemed Tobacco Product Establishments (PDF)  (PDF – 974KB) CTP
1-877-CTP-1373
(1-877-287-1373)
3741 06/2016 Registration and Listing for Owners and Operators of Domestic Tobacco Product Establishments (PDF)  (PDF – 889KB) CTP
1-877-CTP-1373
(1-877-287-1373)
2511 06/2009 Registration of Cosmetic Product Establishment (HTML)  (HTM – 0KB) VCRP
240-402-1130
2511 08/2014 Registration of Cosmetic Product Establishment (PDF)  (PDF – 1.1MB) VCRP
240-402-1130
2096 03/2004 Regulation Certification for New Employee (PDF)  (PDF – 298KB) Vincent Tolino
301-827-5514
2097 01/2003 Regulation Certification for Separating Employees (PDF)  (PDF – 1MB) Vincent Tolino
301-827-5514
3520 11/2015 Release Record and Agreement – Permission to Publish in National Registry (PDF)  (PDF – 1.2MB) Stephen Hughes
240-402-2833
2579 06/2011 Report of Assembly of a Diagnostic X-Ray System (FAQ & Instructions)  (HTM – 0KB) Division of Radiological Health
301-796-5790
2579 04/2014 Report of Assembly of a Diagnostic X-Ray System (Paper)  (HTM – 0KB) At the warehouse
formsmanager@OC.FDA.GOV
2579 04/2011 Report of Assembly of a Diagnostic X-Ray System (HTML)  (HTM – 0KB) James Graves at 301-796-4443
2359d 11/2015 Report of Certification (PDF)  (PDF – 708KB) Robert Hennes
240-402-2175
3719 08/2015 Report of Inspection for Compliance with 21 CFR 589.2000 (CVM) (PDF)  (PDF – 1.8MB) Shannon Jordre
240-402-5607
3719-1 10/2009 Report of Inspection for Compliance with 21 CFR 589.2000 (CVM-1) (PDF)  (PDF – 563KB) Shannon Jordre
240-402-5607
1995 10/2015 Report of Physical Examination of Cows (PDF)  (PDF – 1.1MB) Esther Lazar
240-402-1485
1551b 01/1993 Report of Sample Analysis (Aflatoxins) (PDF)  (PDF – 337KB) William Campanaro
240 821 6667
1551 05/2011 Report of Sample Analysis (PDF)  (PDF – 353KB) William Campanaro
240 821 6667
3852 06/2016 Report of Tobacco Product Removals Subject to Tax for Tobacco Product User Fee Assessments  (PDF – 1.1MB) CTP
1-877-CTP-1373
(1-877-287-1373)
1994 10/2015 Report of Tuberculin Tests of Cattle (PDF)  (PDF – 686KB) Esther Lazar
240-402-1485
3640 04/2011 Reporting Guide for Laser Light Shows and Displays (HTML)  (HTM – 0KB) DRH
301-796-5790
3640 08/2016 Reporting Guide for Laser Light Shows and Displays (PDF)  (PDF – 919KB) DRH
301-796-5790
3613f 07/2015 Request for Certificate of a Pharmaceutical Product for CDER Products (PDF)  (PDF – 781KB) CDER Export Certificate Program
1609a 03/1986 Research Progress Record (PDF)  (PDF – 349KB) William Campanaro
301-827-1036
1609 03/1986 Research Project Record (PDF)  (PDF – 337KB) William Campanaro
301-827-1036
1533 10/2001 Results of Sediment Pad Grading (PDF)  (PDF – 268KB) Rina Vora
562-256-9292
3539 05/2009 Review/Approval of Free Attendance at Widely Attended Gatherings (WAG) (PDF)  (PDF – 431KB) Vincent Tolino
301-827-5514
3787c 07/2016 Roll-Your-Own (RYO) Tobacco Products (PDF)  (PDF – 821KB) CTP
1-877-CTP-1373
(1-877-287-1373)
3787j 08/2013 Roll-Your-Own Tobacco Product Report Worksheet (HTML)  (HTM – 0KB) CTP
1-877-CTP-1373
(1-877-287-1373)
0421 07/2003 Sample Accountability Record (ORA) (PDF)  (PDF – 389KB) William Campanaro
240 821 6667
0465 08/1985 Sample Summary (DOC)  (PDF – 221KB) William Campanaro
240 821 6667
1997 10/2015 Score Card for Sanitation Inspections of Milk Plants (PDF)  (PDF – 648KB) Esther Lazar
240-402-1485
3676 05/2013 Secure Supply Chain Pilot Program Application (PDF)  (PDF – 1.4MB) Katie Neckers
301-796-3339
3733 05/2010 Shell Egg Producer Registration (HTML)  (HTM – 0KB) Nancy Bufano
240-402-1493
3733 08/2016 Shell Egg Producer Registration (PDF)  (PDF – 724KB) Nancy Bufano
240-402-1493
0431k 08/1985 Shellfish Bacteriological Record (PDF)  (PDF – 8KB) William Campanaro
301-827-1036
3787b 07/2016 Smokeless Tobacco Product Report (PDF)  (PDF – 902KB) CTP
1-877-CTP-1373
(1-877-287-1373)
3787i 08/2013 Smokeless Tobacco Product Report Worksheet (HTML)  (HTM – 0KB) CTP
1-877-CTP-1373
(1-877-287-1373)

 

3654 04/2014 Standards Data Report for 510(K)s (PDF)  (PDF – 2.4MB) Scott A. Colburn
301-796-6287
2684a 04/2011 State Contract Monthly Feed Establishment Report (PDF)  (PDF – 374KB) Wendy Campbell
615-310-0483
2684 07/2016 State Contract Monthly Food Report (PDF)  (PDF – 637KB) Wendy Campbell
615-310-0483
1572 07/2013 Statement of Investigator (Title 21, Code of Federal Regulations (CFR) Part 312) (Guidance)  (PDF – 108KB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
1572 02/2016 Statement of Investigator (Title 21, Code of Federal Regulations (CFR) Part 312) (PDF)  (PDF – 1.1MB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
2359e 11/2015 Status of Manufacturing Plants (PDF)  (PDF – 645KB) Robert Hennes
240-402-2175
2359l 10/2011 Status of Milk Plants (PDF)  (PDF – 614KB) Robert Hennes
240-402-2175
2359k 10/2013 Status of Raw Milk for Pasteurization (PDF)  (PDF – 1.2MB) Robert Hennes
240-402-2175
3955 07/2016 Structure/Function Claims Notification (HTML)  (HTM – 0KB) Mariton Dos Santos (Daniel)
240-402-2818
1570 04/1978 Summary of Bacteriological Results (PDF)  (PDF – 302KB) William Campanaro
240 821 6667
3427 10/2015 Supplemental Data Sheet (PDF)  (PDF – 692KB) Marjorie Shulman
301-796-6572
3613a 08/2015 Supplementary Information Certificate of Exportability Requests (PDF)  (PDF – 840KB) Import/Export Team
CBER 301-827-6201 or
CDRH 301-796-7400 or
CVM 240-402-5508
3613b 04/2015 Supplementary Information Certificate of a Pharmaceutical Product (PDF)  (PDF – 794KB) Import/Export Team
CBER 301-827-6201 or
CDRH 301-796-7400 or
CVM 240-402-5508
3613 08/2015 Supplementary Information Certificate to Foreign Government Requests (PDF)  (PDF – 838KB) Import/Export Team
CBER 301-827-6201 or
CDRH 301-796-7400 or
CVM 240-402-5508
3613c 08/2015 Supplementary Information Non-Clinical Research Use Only Certificate (PDF)  (PDF – 759KB) Import/Export Team
CBER 301-827-6201 or
CDRH 301-796-7400
3743 05/2014 Tobacco Health Document Submission (PDF)  (PDF – 785KB) CTP
1-877-CTP-1373
(1-877-287-1373)
3787d 08/2013 Tobacco Product Identification Worksheet (HTML)  (HTM – 0KB) CTP
1-877-CTP-1373
(1-877-287-1373)
3779 07/2014 Tobacco Product Violations Reporting (HTML)  (HTM – 0KB) CTP
1-877-CTP-1373
(1-877-287-1373)
3779 05/2016 Tobacco Product Violations Reporting (PDF)  (PDF – 1.2MB) CTP
1-877-CTP-1373
(1-877-287-1373)
0433 06/1982 Tomato Inspection Report (PDF)  (PDF – 12KB) Rina Vora
562-256-9292
2253 04/2014 Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use (Instructions Supplement)  (PDF – 190KB) DDMAC
301-796-1200
2253 12/2014 Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use (PDF)  (PDF – 1.7MB) DDMAC
301-796-1200
2252 11/2014 Transmittal of Annual Report for Drugs and Biologics for Human Use (Instructions Supplement) (PDF)  (PDF – 116KB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
2252 12/2014 Transmittal of Annual Report for Drugs and Biologics for Human Use (PDF)  (PDF – 827KB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
2301 10/2015 Transmittal of Periodic Reports and Promotional Material New Animal Drugs (PDF)  (PDF – 781KB) Sue Dessai
240-402-5761
2786 05/1982 Under Table X-Ray Source Fluoroscopic & Spot Film Systems Field Test Record (PDF)  (PDF – 30KB) Nick Walker
301-796-5910
3913 12/2015 User Fee Payment Refund Request (PDF)  (PDF – 2.1MB) CDER Collections at 301-796-7900
3914 12/2015 User Fee Payment Transfer Request (PDF)  (PDF – 2.1MB) CDER Collections at 301-796-7900
VAERS-1 11/2014 Vaccine Adverse Event Reporting System (HTML)  (HTM – 0KB) VAERS
800-822-7967
VAERS-! 11/2014 Vaccine Adverse Event Reporting System (PDF)  (PDF – 99KB) VAERS
800-822-7967
3261 02/1983 Vertical Mount Cassette Holder Radiographic Systems Field Test Record (PDF)  (PDF – 23KB) Nick Walker
301-796-5910
1932a 10/2013 Veterinary Adverse Drug Reaction, Lack of Effectiveness or Product Defect (PDF)  (PDF – 809KB) Margarita Brown
240-402-5740
1932 10/2013 Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report (PDF)  (PDF – 946KB) Margarita Brown
240-402-5740