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Form Date Description Format Contact Info
3665  05/2015 Final Consultation for Food Derived From a New Plant Variety (Instructions)  (PDF - 33KB) Dr. Mary Ditto
240-402-1165
3665  01/2017 Final Consultation for Food Derived From a New Plant Variety (Biotechnology Final Consultation) (PDF)  (PDF - 96KB) Dr. Mary Ditto
240-402-1165
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
3666  01/2017 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
3667  01/2017 Generally Recognized as Safe (GRAS) Notice (PDF)  (PDF - 179KB) Berhane G. Grimay
240-402-1194
3667  09/2016 Generally Recognized as Safe (GRAS) Notice (Instructions)  (PDF - 188KB) Berhane G. Grimay
240-402-1194
3670  05/2017 MedSun (Medical Product Surveillance Network) (HTML)  (HTM - 0KB) Jill Marion
301- 796-6128
3671  01/2015 Common EMEA/FDA Application for Orphan Medicinal Product Designation (PDF)  (PDF - 850KB) Kathy Needleman
301-827-3666
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
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
3677v  01/2006 Minor Species Index File (MIF) (PDF)  (PDF - 265KB) Dorothy Bailey
240-402-0565
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
3728  09/2014 Animal Generic Drug User Fee Cover Sheet (HTML)  (HTM - 0KB) Lisa Kable
240-276-9718
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
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)
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)
3742  11/2016 Listing of Ingredients in Tobacco Products (PDF)  (PDF - 1MB) CTP
1-877-CTP-1373
(1-877-287-1373)
3743  03/2017 Tobacco Health Document Submission (PDF)  (PDF - 830KB) CTP
1-877-CTP-1373
(1-877-287-1373)
3744  12/2016 Antimicrobial Animal Drug Distribution Report (PDF)  (PDF - 2.1MB) Sue Dessai
240-276-9075
3752  04/2013 Pre-Amendment Device Determination Request (PDF)  (PDF - 677KB) DPLC
301-796-5770
3757  06/2016 Menu and Vending Machine Labeling Voluntary Registration (PDF)  (PDF - 114KB) Ashley Rulffes
240-402-2820
3759  05/2014 Abbreviated Reports on Radiation Safety of Non Medical Ultrasonic Products (PDF)  (PDF - 762KB) DRH
301-796-5790
3759  04/2011 Abbreviated Reports on Radiation Safety of Non Medical Ultrasonic Products (HTML)  (HTM - 0KB) DRH
301-796-5790
3760  06/2014 Guide for Preparing Product Reports for Medical Ultrasound Products (PDF)  (PDF - 771KB) DRH
301-796-5790
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)
3787a  07/2016 Cigarette Report (PDF)  (PDF - 1.5MB) CTP
1-877-CTP-1373
(1-877-287-1373)
3787b  07/2016 Smokeless Tobacco Product Report (PDF)  (PDF - 902KB) CTP
1-877-CTP-1373
(1-877-287-1373)

Page Last Updated: 08/17/2017
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