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Form Date Description Format Contact Info
3662  08/2017 A Guide for Submission of an Abbreviated Radiation Safety Reports on Cephalometric Devices Intended for Diagnostic Use (PDF)  (PDF - 744KB) 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  08/2017 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  08/2017 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 - 708KB) DRH
301-796-5790
3546  09/2017 ADUFA User Fee Cover Sheet (HTML)  (HTM - 0KB) Lisa Kable
240- 402-6888
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  08/2017 Abbreviated Reports on Radiation Safety for Microwave Products (Other than Microwave Ovens) (PDF)  (PDF - 755KB) 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  08/2017 Abbreviated Reports on Radiation Safety of Non Medical Ultrasonic Products (PDF)  (PDF - 745KB) DRH
301-796-5790
3649  04/2011 Accidental Radiation Occurrence Report (HTML)  (HTM - 0KB) DRH
301-796-5790
3649  08/2017 Accidental Radiation Occurrence Report (PDF)  (PDF - 786KB) DRH
301-796-5790
3623a  11/2014 Additional Water Sources (PDF)  (PDF - 2.2MB) Rina Vora
561-416-1065 ext 1117
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  01/2017 Amendment to an Existing Food Contact Notification Pre-Notification Consultation Food Master File (PDF)  (PDF - 171KB) Elizabeth Furukawa
650-529-9908
0431  01/2015 Analyst Worksheet (ORA) (PDF)  (PDF - 1MB) William Campanaro
240 821 6667
3728  09/2017 Animal Generic Drug User Fee Cover Sheet (HTML)  (HTM - 0KB) Lisa Kable
240- 402-6888
3744  01/2018 Antimicrobial Animal Drug Distribution Report (HTML)  (HTM - 1KB) Sue Dessai
240-402-5761
3744  12/2016 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  01/2018 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 - 660KB) John Verbeten
301-796-6677
1993  08/2018 Application for Permit to Ship or Transport Milk and/or Cream into US (PDF)  (PDF - 741KB) 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  08/2017 Application for a Variance From 21 CFR 1040.11(c) for a Laser Light Show, Display, or Device (PDF)  (PDF - 733KB) DRH
301-796-5790
0356h  08/2018 Application to Market a New or Abbreviated New Drug or Biologic for Human Use (PDF)  (PDF - 2.4MB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
0356h  08/2018 Application to Market a New or Abbreviated New Drug or Biologic for Human Use (Instructions Supplement)  (PDF - 185KB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
3511-3  11/2014 Aseptic Processing & Packaging Report (PDF)  (PDF - 988KB) Brian Yaun
240-402-2922
3942a  08/2018 Attestation by a Qualified Facility CFSAN (PDF)  (PDF - 1.1MB) Sylvia Kim
301-796-7599
3942b  08/2018 Attestation by a Qualified Facility CVM (PDF)  (PDF - 1.1MB) Sylvia Kim
301-796-7599
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) Frank Flores
240-402-1494
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
240-402-9157
3486a  11/2013 Biological Product Additional Information Deviation Report (HTML)  (HTM - 0KB) CBER Blood and Tissue Compliance Branch
240-402-9157
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  06/2017 Biological Product Deviation Report (PDF)  (PDF - 772KB) 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  08/2018 Blood Establishment Registration and Product Listing (PDF)  (PDF - 798KB) 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) Frank Flores
240-402-1494
3260  02/1983 C-Arm Fluoroscopic & Spot-Film Systems Field Test Record (PDF)  (PDF - 41KB) Nick Walker
301-796-5910
4002  02/2018 CDER Patient Stakeholders Meeting Request (HTML)  (HTM - 0KB) Chris Melton
301-796-7381
3514  09/2017 CDRH Premarket Review Submission Cover Sheet (PDF)  (PDF - 3MB) Edwena R. Jones
301-796-6308
3641  04/2011 Cabinet X-Ray Annual Report (HTML)  (HTM - 0KB) DRH
301-796-5790
3641  04/2018 Cabinet X-Ray Annual Report (PDF)  (PDF - 877KB) 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  08/2016 Cancellation of Food Facility Registration (PDF)  (PDF - 670KB) Industry Systems Help Desk
800-216-7331
301-575-0156
3613k  10/2018 Certificate Application Process for Certification Issued Pursuant To Section 801(e) (HTML)  (HTM - 1KB) CFSAN EXPORT
1815  08/2018 Certificate/ Transmittal for an Application (PDF)  (PDF - 614KB) Esther Lazar
240-402-1485
3674  04/2018 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  07/2017 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 - 153KB) Patrick McNeilly
301- 796-2941
3975  06/2017 Certification of Identity (PDF)  (PDF - 1.1MB) Sarah B. Kotler, JD
301-796-3900
3454  03/2016 Certification: Financial Interest and Arrangements of Clinical Investigator (PDF)  (PDF - 673KB) Liz Chen
240-402-3729
4032  11/2017 Certified Mail - Return Receipt (PDF)  (PDF - 1MB) Maurille C. Beheton
301-796-4689
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)
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
2512a  09/2017 Cosmetic Product Ingredient Statement (CFSAN HTML)  (HTML - 0KB) VCRP
240-402-1345
2512  09/2017 Cosmetic Product Ingredient Statement (HTML)  (HTML - 0KB) VCRP
240-402-1130
2512  09/2017 Cosmetic Product Ingredient Statement (PDF)  (PDF - 1.1MB) VCRP
240-402-1130
2512a  09/2017 Cosmetic Product Ingredient Statement [CFSAN] (PDF)  (PDF - 643KB) 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) Frank Flores
240-402-1494
3972  07/2018 Dairy Labeling Module (HTML)  (HTM - 0KB) Esther Lazar
240-402-1485
2399d  10/2008 Dairy Plant - Milk Sample Collector Evaluation Record (PDF)  (PDF - 457KB) Frank Flores
240-402-1494
2399  10/2008 Dairy Plant Sampling - Raw & Pasteurized Milk (PDF)  (PDF - 571KB) Frank Flores
240-402-1494
2877  08/2017 Declaration for Imported Electronic Products Subject to Radiation Control Standards (PDF)  (PDF - 685KB) DRH
301-796-5790
3627  04/2011 Diagnostic X-Ray CT Products Radiation Safety Report (HTML)  (HTM - 0KB) DRH
301-796-5790
3627  08/2017 Diagnostic X-Ray CT Products Radiation Safety Report (PDF)  (PDF - 853KB) DRH
301-796-5790
3455  03/2016 Disclosure: Financial Interest and Arrangements of Clinical Investigators (PDF)  (PDF - 673KB) Liz Chen
240-402-3729
3501  06/2017 Domestic Inspection/Foreign Inspection (HTML)  (HTML - 0KB) Roshelle King
240-402-1416
3911  05/2017 Drug Notification to FDA (Instructions Supplement)  (PDF - 162KB) Drug Notifications
3911  02/2019 Drug Notification to FDA (PDF) **Note: For best form functionality, Right-click 3911 link and click Save Link As… to save to your desktop and then open the file. (Recommended for use with Adobe Acrobat or Pro)**  (PDF - 2.1MB) Drug Notifications
3666  02/2019 Early Food Safety Evaluation of a New Protein Produced by a New Plant Variety (New Protein Consultation) (PDF)  (PDF - 103KB) Berhane G. Grimay
240-402-1194
3666  02/2019 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  05/2018 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  06/2017 Electronic Submission System Participant Management (PDF)  (PDF - 132KB) Margaret Zabriski
240-402-0561
0431m  12/1979 Elemental Analysis Worksheet (PDF)  (PDF - 6KB) William Campanaro
240 821 6667
4027  02/2018 Emergency Payment Request (PDF)  (PDF - 1.1MB) Maurille C. Beheton
301-796-4689
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
3511-2  07/2010 FDA Acidified Food Inspection Report (PDF)  (PDF - 465KB) Brian Yaun
240-402-2922
3511  06/2013 FDA LACF Inspection Report (PDF)  (PDF - 939KB) Brian Yaun
240-402-2922
4035  01/2018 FDA Orphan Drug Designation Request (PDF)  (PDF - 3.2MB) Yadira Batista-Colon
301-796-8660
4003a  05/2018 FDA Pre-Inspection Records Receipt Confirmation (PDF)  (PDF - 1MB) Steve Lettrich
240-402-6084
3800  10/2014 FDA Safety Reporting Portal (HTML)  (HTM - 0KB) MEDWATCH
1-800-FDA-1088
3882  09/2018 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
3997  06/2017 FURLS Third-Party Program - Accreditation Body Module (AB) (HTML)  (HTM - 1KB) Ken Nieves
240-402-2031
3997a  06/2017 FURLS Third-Party Program - Certification Body (CB) (HTML)  (HTM - 1KB) Ken Nieves
240-402-2031
3601a  08/2012 FURLS User Fee (HTM)  (HTM - 0KB) User Fees Financial Support Team
301-796-7200
2399c  10/2011 Farm Bulk Tank Milk Sampling Inspection Record (PDF)  (PDF - 713KB) Frank Flores
240-402-1494
1996  12/2018 Farm Inspection Report (PDF)  (PDF - 3MB) Esther Lazar
240-402-1485
3623  11/2014 Farm Investigation Questionnaire (PDF)  (PDF - 3MB) Rina Vora
561-416-1065 ext 1117
2814  08/1993 Field Equipment Request (PDF)  (PDF - 1.1MB) William Campanaro
301-827-1086
3665  05/2018 Final Consultation for Food Derived From a New Plant Variety (Biotechnology Final Consultation) (PDF)  (PDF - 97KB) Dr. Mary Ditto
240-402-1165
3665  05/2018 Final Consultation for Food Derived From a New Plant Variety (Instructions)  (PDF - 33KB) Dr. Mary Ditto
240-402-1165
3503  10/2017 Food Additive Petition Submission (Instructions)  (PDF - 35KB) Berhane G. Girmay, Ph.D.
240-402-1194
3503  10/2017 Food Additive Petition Submission (PDF)  (PDF - 110KB) 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  01/2018 Food Canning Registration (PDF)  (PDF - 682KB) LACF Coordinator
LACF@FDA.HHS.GOV
3613e  10/2018 Food Export Certificate Application (HTML)  (HTM - 0KB) Export Team
3537  02/2011 Food Facility Registration (HTML)  (HTM - 0KB) FDA Industry Systems Help Desk
800-216-7331
301-575-0156
3537  11/2016 Food Facility Registration (PDF)  (PDF - 2.1MB) FDA Industry Systems Help Desk
800-216-7331
301-575-0156
2541e  01/2018 Food Process Filing For Acidified Method (PDF)  (PDF - 1.2MB) LACF Coordinator
240-402-2411
2541g  01/2018 Food Process Filing For Low-Acid Aseptic Systems (PDF)  (PDF - 939KB) LACF Coordinator
240-402-2411
2541d  01/2018 Food Process Filing For Low-Acid Retorted Method (PDF)  (PDF - 1.1MB) LACF Coordinator
240-402-2411
2541f  01/2018 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
3966  10/2016 Foodborne Illness Risk Factor Study Restaurant Data Collection Record(PDF)  (PDF - 1.6MB) Mary Cartagena
240-402-2937
4005  10/2017 Forms Request Program (PDF)  (PDF - 619KB) Elizabeth Jones
301.796.7679
3628  04/2011 General Annual Report (Includes Medical, Analytical, and Industrial X-Ray Products Annual Report) (HTML)  (HTM - 0KB) DRH
301-796-5790
3628  04/2018 General Annual Report (Includes Medical, Analytical, and Industrial X-Ray Products Annual Report) (PDF)  (PDF - 1.2MB) 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
3633  04/2011 General Variance Request (HTML)  (HTM - 0KB) DRH
301-796-5790
3667  09/2016 Generally Recognized as Safe (GRAS) Notice (Instructions)  (PDF - 188KB) Berhane G. Grimay
240-402-1194
3667  01/2017 Generally Recognized as Safe (GRAS) Notice (PDF)  (PDF - 179KB) 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  11/2016 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  08/2017 Guidance for Submission of Cabinet X-Ray System Reports Pursuant to 21 CFR 1020.40 (PDF)  (PDF - 978KB) 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  08/2017 Guide for Filling Annual Reports for X-Ray Components and Systems (PDF)  (PDF - 886KB) DRH
301-796-5790
4004  04/2018 Guide for Preparing Abbreviated Reports of Microwave and RF Emitting Electronic Products Intended for Medical Use (PDF)  (PDF - 1.2MB) DRH
301-796-5790
3645  04/2011 Guide for Preparing Annual Reports for Ultrasonic Therapy Products (HTML)  (HTM - 0KB) DRH
301-796-5790
3645  04/2018 Guide for Preparing Annual Reports for Ultrasonic Therapy Products (PDF)  (PDF - 1.2MB) 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  04/2018 Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show (PDF)  (PDF - 1.3MB) 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  04/2018 Guide for Preparing Annual Reports on Radiation Safety Testing of Mercury Vapor Lamps (PDF)  (PDF - 913KB) 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  08/2017 Guide for Preparing Annual Reports on Radiation Safety Testing of Sunlamps and Sunlamp Products (PDF)  (PDF - 839KB) DRH
301-796-5790
3801  08/2017 Guide for Preparing Initial Reports and Model Change Reports on Medical Ultraviolet Lamps and Products Containing Such Lamps (PDF)  (PDF - 1MB) DRH
301-796-5790
3760  08/2017 Guide for Preparing Product Reports for Medical Ultrasound Products (PDF)  (PDF - 785KB) DRH
301-796-5790
3644  04/2011 Guide for Preparing Product Reports for Ultrasonic Therapy Products (HTML)  (HTM - 0KB) DRH
301-796-5790
3644  08/2017 Guide for Preparing Product Reports for Ultrasonic Therapy Products (PDF)  (PDF - 831KB) 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  08/2017 Guide for Preparing Product Reports on Lasers and Products Containing Lasers (PDF)  (PDF - 1.1MB) 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  08/2017 Guide for Preparing Product Reports on Sunlamps and Sunlamp Products (PDF)  (PDF - 1.2MB) DRH
301-796-5790
3502  06/2017 Importer Seafood HACCP Report (HTML)(PDF)  (HTML - 0KB) Roshelle King
240-402-1416
3881  07/2017 Indications for Use (PDF) **Note: For best form functionality, Right-click 3881 link and click Save Link As… to save to your desktop and then open the file**  (PDF - 1.7MB) Diane Garcia
301-796-6559
3926  07/2017 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  04/2017 Individual Patient Expanded Access Investigational New Drug Application (IND) (instructions)  (PDF - 155KB) 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
561-416-1065 ext 1117
2591  08/2001 Inspection Summary Equipment Evaluation (PDF)  (PDF - 378KB) Bruce Kummer
240-402-2142
2359h  10/2018 Interstate Milk Shipper Check-Rating Report (PDF)  (PDF - 1.5MB) Frank Flores
240-402-1494
2359i  10/2018 Interstate Milk Shipper Report (PDF)  (PDF - 1.6MB) Frank Flores
240-402-1494
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  07/2018 Investigational New Drug Application (IND) (PDF)  (PDF - 1.8MB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
1571  07/2018 Investigational New Drug Application (IND) [Instructions]  (PDF - 179KB) 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
4028  01/2018 Letter of Non-Receipt (PDF)  (PDF - 1MB) Maurille C. Beheton
301-796-4689
3742  11/2016 Listing of Ingredients in Tobacco Products (PDF)  (PDF - 1MB) CTP
1-877-CTP-1373
(1-877-287-1373)
3891  05/2017 Livestock Net (HTML)  (HTM - 0KB) Jenny Murphy
240-453-6845
3602a  08/2018 MDUFA Foreign Small Business Qualification and Certification For a Business Headquartered Outside the United States (PDF)  (PDF - 1.5MB) DICE
800-638-2041
3602  08/2018 MDUFA Small Business Qualification and Certification For a Business Headquartered in the United States (PDF)  (PDF - 1.5MB) DICE
800-638-2041
3500B  02/2019 MEDWATCH Consumer Voluntary Reporting (PDF)  (PDF - 1.3MB) 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) Frank Flores
240-402-1494
3670  05/2017 MedSun (Medical Product Surveillance Network) (HTML)  (HTM - 0KB) Jill Marion
301- 796-6128
3500  10/2015 MedWatch: Information and Adverse Event Reporting Program - Voluntary (HTML)  (HTM - 0KB) CDER Drug Info:
(888) 463-6332
3500  02/2006 MedWatch: The FDA Safety Information and Adverse Event Reporting Program (HTML)  (HTM - 0KB) MEDWATCH
1-800-FDA-1088
3500A  10/2015 MedWatch: The FDA Safety Information and Adverse Event Reporting Program - Mandatory (HTML)  (HTM - 0KB) MEDWATCH Saftey Alerts
1-800-FDA-1088
3500A  04/2016 MedWatch: The FDA Safety Information and Adverse Event Reporting Program - Mandatory (Instructions)  (PDF - 250KB) MedWatch
1-800-332-1088
3500A  10/2015 MedWatch: The FDA Safety Information and Adverse Event Reporting Program - Mandatory (PDF)  (PDF - 2.5MB) MEDWATCH
1-800-FDA-1088
3500  10/2015 MedWatch: The FDA Safety Information and Adverse Reporting Program (PDF)  (PDF - 2.4MB) MEDWATCH
1-800-FDA-1088
3608  06/2005 Medical Device Fellowship Program Student Application (HTML)  (HTM - 0KB) DMQRP
301-796-5696
3419  12/2018 Medical Device Reporting Annual User Facility Report (PDF)  (PDF - 713KB) 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  05/2017 Medicated Feed Mill License Application (PDF)  (PDF - 569KB) Isabel W. Pocurull
240-402-5877
2481  09/2016 Medicated Feeds Inspection Report (PDF)  (PDF - 2.1MB) Isabel W. Pocurull
240-402-5877
4033  12/2017 Memorandum (PDF)  (PDF - 1.1MB) Maurille C. Beheton
301-796-4689
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  08/2017 Mercury Vapor Lamp Products Radiation Safety Report (PDF)  (PDF - 906KB) DRH
301-796-5790
3643  04/2011 Microwave Oven Products Annual Report (HTML)  (HTM - 0KB) DRH
301-796-5790
3643  04/2018 Microwave Oven Products Annual Report (PDF)  (PDF - 1.3MB) 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
2400n-1  03/2015 Milk Laboratory Evaluation Record – Appendix N Bulk Milk Tanker Screening Test Procedures – Charm® SL/Charm 3 SL3, IMS #9-C-I3 (PDF)  (PDF - 691KB) William Northeimer, PhD
708-924-0629
2400n-2  03/2014 Milk Laboratory Evaluation Record – Appendix N Bulk Milk Tanker Screening Test Procedures – New Snap® Beta-Lactam Test, IMS #9-I1 (PDF)  (PDF - 647KB) William Northeimer, PhD
708-924-0629
2359b  10/2011 Milk Plant Equipment Tests Report (PDF)  (PDF - 387KB) Frank Flores
240-402-1494
2359  10/2018 Milk Plant Inspection Report (PDF)  (PDF - 717KB) Frank Flores
240-402-1494
2359m  10/2018 Milk Plant, Receiving Station or Transfer Station NCIMS HACPP System Audit Report (PDF)  (PDF - 1.2MB) Frank Flores
240-402-1494
2359j  10/2013 Milk Sanitation Rating Report (PDF)  (PDF - 738KB) Frank Flores
240-402-1494
2399b  10/2008 Milk Tank Truck Inspection Report (PDF)  (PDF - 427KB) Frank Flores
240-402-1494
3677v  01/2006 Minor Species Index File (MIF) (PDF)  (PDF - 265KB) Dorothy Bailey
240-402-0565
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) **Note: For best form functionality, Right-click 3664 link and click Save Link As… to save to your desktop and then open the file  (PDF - 466KB) Kris Baumgartner
240-402-4194
2359p  10/2013 NCIMS Aseptic Processing and Packaging Program Critical Listing Elements (PDF)  (PDF - 649KB) Frank Flores
240-402-1494
2359n  10/2013 NCIMS HACCP System Regulatory Agency Review Report (PDF)  (PDF - 570KB) Frank Flores
240-402-1494
3331a  03/2018 NDA/ANDA Field Alert Automated(PDF)  (PDF - 2.6MB) Surveillance Programs Team
301-796-3130
3331a  05/2017 NDA/ANDA Field Alert Report Automated (Instructions)  (PDF - 143KB) Surveillance Programs Team
301-796-3130
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
4029  02/2018 Non-Receipt of Direct Deposit (PDF)  (PDF - 1MB) Maurille C. Beheton
301-796-4689
2767  08/2017 Notice of Availability of Sample Electronic Product (PDF)  (PDF - 640KB) DRH
301-796-5790
3480  03/2016 Notification For New Use Of A Food Contact Substance (Instructions)  (PDF - 95KB) Elizabeth Furukawa
650-529-9908
3480  01/2017 Notification For New Use Of A Food Contact Substance (PDF)  (PDF - 417KB) 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  10/2018 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  02/2019 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  05/2017 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  08/2016 Patent Information Submitted Upon and After Approval of An NDA or Supplement (PDF)  (PDF - 3MB) Kendra S. Stewart
240-402-8797
3542  11/2016 Patent Information Submitted Upon and After Approval of An NDA or Supplement-CDER (Instructions)  (PDF - 137KB) Kendra Stewart
240-402-8797
3542a  08/2016 Patent Information Submitted With the Filing of An NDA, Amendment, or Supplement (PDF)  (PDF - 3MB) Kendra S. Stewart
240-402-8797
3542a  11/2016 Patent Information Submitted With the Filing of An NDA, Amendment, or Supplement-CDER (Instructions)  (PDF - 133KB) Kendra Stewart
240-402-8797
2359o  10/2013 Permission for Publication Interstate Milk Shipper’s Listing (PDF)  (PDF - 659KB) Frank Flores
240-402-1494
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
3511g  05/2014 Processing in Cascading/Spray Water Retort (PDF)  (PDF - 995KB) Brian Yaun
240-402-2922
3511i  12/2013 Processing in Other Unique Retort Systems (PDF)  (PDF - 926KB) Brian Yaun
240-402-2922
3511c  03/2014 Processing in Steam in Continuous Agitating Retorts (PDF)  (PDF - 966KB) Brian Yaun
240-402-2922
3511a-1  03/2014 Processing in Steam in Crateless Retorts (PDF)  (PDF - 1004KB) Brian Yaun
240-402-2922
3511d  03/2014 Processing in Steam in Discontinuous Agitating Retorts (PDF)  (PDF - 876KB) Brian Yaun
240-402-2922
3511f  05/2014 Processing in Steam in Hydrostatic Retorts (PDF)  (PDF - 844KB) Brian Yaun
240-402-2922
3511a  09/2018 Processing in Steam in Still Retorts (PDF)  (PDF - 919KB) Brian Yaun
240-402-2922
3511h  09/2014 Processing in Steam-Air Retorts (PDF)  (PDF - 951KB) Brian Yaun
240-402-2922
3511e  03/2014 Processing in Water in Discontinuous Agitating Retorts (PDF)  (PDF - 972KB) Brian Yaun
240-402-2922
3511b  03/2014 Processing in Water in Still Retorts (PDF)  (PDF - 935KB) Brian Yaun
240-402-2922
4056  01/2019 Produce Farm Inspection Observations (PDF)  (PDF - 1.3MB) Erin Nagel
716-846-6233 x6233
4030  01/2018 Promissory Repayment Agreement, and Salary Offset Authorization (PDF)  (PDF - 1MB) Maurille C. Beheton
301-796-4689
4031  02/2018 Promissory Repayment Agreement, and Salary Offset Authorization OC (PDF)  (PDF - 1.1MB) Maurille C. Beheton
301-796-4689
3799  06/2012 Publication Request (HTML)  (PDF - 1MB) Leslie Davis
240-402-1735
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  10/2018 Radioactive Drug Research Committee (RDRC) Report on Research Use of Radioactive Drugs Membership Summary (PDF)  (PDF - 804KB) RDRC
301-796-2050
2915  01/2018 Radioactive Drug Research Committee (RDRC) Report on Research Use of Radioactive Drugs Study Summary (PDF)  (PDF - 1.9MB) RDRC
301-796-2050
3177  11/2018 Recall Audit Check Report (PDF)  (PDF - 703KB) Ashley McIntyre
240-402-6524
3741a  10/2016 Registration and Listing for Owners and Operators of Domestic Deemed Tobacco Product Establishments (PDF)  (PDF - 988KB) 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  09/2017 Registration of Cosmetic Product Establishment (HTML)  (HTML - 0KB) VCRP
240-402-1130
2511  04/2018 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
2579  06/2011 Report of Assembly of a Diagnostic X-Ray System (FAQ & Instructions)  (HTM - 0KB) James Graves
301-796-4443
2579  09/2017 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) Frank Flores
240-402-1494
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  08/2018 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  01/2019 Report of Tuberculin Tests of Cattle (PDF)  (PDF - 192KB) Esther Lazar
240-402-1485
3640  04/2011 Reporting Guide for Laser Light Shows and Displays (HTML)  (HTM - 0KB) DRH
301-796-5790
3640  08/2017 Reporting Guide for Laser Light Shows and Displays (PDF)  (PDF - 947KB) DRH
301-796-5790
3613f  05/2018 Request for Certificate of a Pharmaceutical Product for CDER Products (PDF)  (PDF - 1.2MB) CDER Export Certificate Program
0482d  09/2017 Request for FSVP Records (PDF)  (PDF - 1MB) Brian Ravitch
619 941-3719
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
3539  05/2009 Review/Approval of Free Attendance at Widely Attended Gatherings (WAG) (PDF)  (PDF - 431KB) Vincent Tolino
301-827-5514
3967  11/2017 Risk Factor Study – Retail Food Store (Deli) Data Collection (PDF)  (PDF - 1.6MB) Mary Cartagena
240-402-2937
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  09/2018 Score Card for Sanitation Inspections of Milk Plants (PDF)  (PDF - 672KB) Esther Lazar
240-402-1485
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
3971  01/2017 Small Business Waiver and Refund Request (Instructions)  (PDF - 217KB) Paul Gibney
240-402-4803
3971  12/2016 Small Business Waiver and Refund Request (PDF)  (PDF - 2.1MB) Paul Gibney
240-402-4803
3971  12/2016 Small Business Waiver and Refund Request-CDER (PDF)  (PDF - 2.1MB) Paul Gibney
240-402-4803
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)
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) At this time, the attached PDF document may not be fully accessible to readers using assistive technology. In the event you are unable to read and/or complete portions of the form, please contact CDER's Division of Drug Information at 301-796-3400 or druginfo@fda.hhs.gov  (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  10/2018 Status of Milk Plants (PDF)  (PDF - 171KB) Frank Flores
240-402-1494
2359k  10/2013 Status of Raw Milk for Pasteurization (PDF)  (PDF - 1.2MB) Frank Flores
240-402-1494
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  02/2019 Supplementary Information Certificate of Exportability Requests (PDF)  (PDF - 1.3MB) Import/Export Team
CBER 301-827-6201 or
CDRH 301-796-7400 or
CVM 240-402-5637
3613b  02/2019 Supplementary Information Certificate of a Pharmaceutical Product (PDF)  (PDF - 1.2MB) Import/Export Team
CBER 301-827-6201 or
CDRH 301-796-7400 or
CVM 240-402-5637
3613  02/2019 Supplementary Information Certificate to Foreign Government Requests (PDF)  (PDF - 1.3MB) Import/Export Team
CBER 301-827-6201 or
CDRH 301-796-7400 or
CVM 240-402-5637
3613c  10/2018 Supplementary Information Non-Clinical Research Use Only Certificate (PDF)  (PDF - 1.2MB) Import/Export Team
CBER 301-827-6201 or
CDRH 301-796-7400
3743  03/2017 Tobacco Health Document Submission (PDF)  (PDF - 830KB) 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  12/2017 Tobacco Product Violations Reporting (PDF)  (PDF - 1.2MB) CTP
1-877-CTP-1373
(1-877-287-1373)
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  03/2018 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  03/2018 Transmittal of Annual Report for Drugs and Biologics for Human Use (PDF)  (PDF - 853KB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
2301  03/2018 Transmittal of Periodic Reports and Promotional Material New Animal Drugs (PDF)  (PDF - 1.2MB) Sue Dessai
240-402-5761
2301  01/2018 Transmittal of Periodic Reports and Promotional Material for New Animal Drugs (HTML)  (HTM - 1KB) Sue Dessai
240-402-5761
3620  02/2006 UFMS Request for Receivable (OC) (PDF)  (PDF - 530KB) Nikol Williams
301-796-7158
2786  05/1982 Under Table X-Ray Source Fluoroscopic & Spot Film Systems Field Test Record (PDF)  (PDF - 30KB) Nick Walker
301-796-5910
3913  11/2018 User Fee Payment Refund Request (PDF)  (PDF - 2.1MB) CDER Collections at 301-796-7900
3914  11/2018 User Fee Payment Transfer Request (PDF)  (PDF - 2.1MB) CDER Collections at 301-796-7900
3958  10/2018 VNRFRPS FDA National Registry Report (PDF)  (PDF - 1.2MB) Glenda Lewis
240-402-2150
VAERS-1  10/2018 Vaccine Adverse Event Reporting System (HTML)  (PDF - 3.4MB) VAERS
800-822-7967
VAERS-1  10/2018 Vaccine Adverse Event Reporting System (VAERS)(PDF)  (PDF - 3.4MB) VAERS
800-877-721-0366
3261  02/1983 Vertical Mount Cassette Holder Radiographic Systems Field Test Record (PDF)  (PDF - 23KB) Nick Walker
301-796-5910
1932a  08/2018 Veterinary Adverse Drug Reaction, Lack of Effectiveness or Product Defect (PDF)  (PDF - 842KB) Linda Walter-Grimm
240-402-5762
1932a  08/2018 Veterinary Adverse Drug Reaction, Lack of Effectiveness or Product Defect Report (dynamic)(PDF)  (PDF - 171KB) Linda Walter-Grimm
240-402-5762
1932  07/2016 Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report (PDF)  (PDF - 945KB) Margarita Brown
240-402-5740
4041  04/2018 Voluntary Qualified Importer Program (VQIP) Application (HTML)  (HTM - 1KB) John Verbeten
301-796-6677

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