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Form Date Description Format Contact Info
3454  03/2016 Certification: Financial Interest and Arrangements of Clinical Investigator (PDF)  (PDF - 673KB) Colleen LoCicero
301-796-1114
3455  03/2016 Disclosure: Financial Interest and Arrangements of Clinical Investigators (PDF)  (PDF - 673KB) Colleen LoCicero
301-796-1114
3479  03/2016 Notification for a Food Contact Substance Formulation (PDF)  (PDF - 2.6MB) 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
3480  03/2016 Notification For New Use Of A Food Contact Substance (Instructions)  (PDF - 95KB) Elizabeth Furukawa
650-529-9908
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
3486  01/2011 Biological Product Deviation Report (Instructions)  (HTM - 0KB) CBER Program Surveillance Branch
240-402-9160
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  06/2017 Biological Product Deviation Report (PDF)  (PDF - 772KB) CBER Program Surveillance Branch
240-402-9160
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
3500  10/2015 MedWatch: The FDA Safety Information and Adverse Reporting Program (PDF)  (PDF - 2.4MB) MEDWATCH
1-800-FDA-1088
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  10/2015 MedWatch: The FDA Safety Information and Adverse Event Reporting Program - Mandatory (PDF)  (PDF - 2.5MB) MEDWATCH
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
3500B  10/2015 MEDWATCH Consumer Voluntary Reporting (PDF)  (PDF - 1.3MB) MEDWATCH Saftey Alerts
1-800-FDA-1088
3502  01/2001 Importer Seafood HACCP Report (HTML)  (HTM - 0KB) Roshelle King
301-436-1416
3503  01/2017 Food Additive Petition Submission (PDF)  (PDF - 111KB) Berhane G. Girmay, Ph.D
240-402-1194
3503  08/2014 Food Additive Petition Submission (Instructions)  (PDF - 35KB) Berhane G. Girmay, Ph.D.
240-402-1194
3511  06/2013 FDA LACF Inspection Report (PDF)  (PDF - 939KB) Bob Neligan
706-485-2725
3511-2  07/2010 FDA Acidified Food Inspection Report (PDF)  (PDF - 465KB) Bob Neligan
706-485-2725
3511-3  11/2014 Aseptic Processing & Packaging Report (PDF)  (PDF - 988KB) Bob Neligan
706-485-2725
3511a  03/2014 Processing in Steam in Still Retorts (PDF)  (PDF - 914KB) Bob Neligan
706-485-2725
3511a-1  03/2014 Processing in Steam in Crateless Retorts (PDF)  (PDF - 1004KB) Bob Neligan
706-485-2725
3511b  03/2014 Processing in Water in Still Retorts (PDF)  (PDF - 935KB) Bob Neligan
706-485-2725
3511c  03/2014 Processing in Steam in Continuous Agitating Retorts (PDF)  (PDF - 966KB) Bob Neligan
706-485-2725

Page Last Updated: 08/17/2017
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