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Form Date Description Format Contact Info
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
0356h  08/2018 Application to Market a New or Abbreviated New Drug or Biologic for Human Use(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 at 301-796-3400 / druginfo@fda.hhs.gov or CBER at 240-402-8020 / Industry.Biologics@fda.hhs.gov  (PDF - 2.4MB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
0421  07/2003 Sample Accountability Record (ORA) (PDF)  (PDF - 389KB) William Campanaro
240 821 6667
0431  01/2015 Analyst Worksheet (ORA) (PDF)  (PDF - 1MB) William Campanaro
240 821 6667
0431a  05/1984 General Continuation Sheet (PDF)  (PDF - 1.4MB) William Campanaro
240 821 6667
0431d  08/2012 Bacteriological Record (PDF)  (PDF - 1.2MB) William Campanaro
240 821 6667
0431e  09/2011 Industrial Chemicals Worksheet (PDF)  (PDF - 389KB) William Campanaro
240 821 6667
0431f  11/1989 Quantity of Contents (PDF)  (PDF - 337KB) William Campanaro
240 821 6667
0431j  08/1985 Botulism Continuation Sheet (PDF)  (PDF - 6KB) William Campanaro
301-827-1036
0431k  08/1985 Shellfish Bacteriological Record (PDF)  (PDF - 8KB) William Campanaro
301-827-1036
0431m  12/1979 Elemental Analysis Worksheet (PDF)  (PDF - 6KB) William Campanaro
240 821 6667
0465  08/1985 Sample Summary (DOC)  (PDF - 221KB) William Campanaro
240 821 6667
0482d  09/2017 Request for FSVP Records (PDF)  (PDF - 1MB) Brian Ravitch
619 941-3719
0483a  02/2016 FSVP Observations (PDF)  (PDF - 1.7MB) Brian Ravitch
619 941-3719
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
1551  05/2011 Report of Sample Analysis (PDF)  (PDF - 353KB) William Campanaro
240 821 6667
1551b  01/1993 Report of Sample Analysis (Aflatoxins) (PDF)  (PDF - 337KB) William Campanaro
240 821 6667
1570  04/1978 Summary of Bacteriological Results (PDF)  (PDF - 302KB) William Campanaro
240 821 6667
1571  03/2019 Investigational New Drug Application (IND) [Instructions]  (PDF - 178KB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
1571  03/2019 Investigational New Drug Application(IND)(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 at 301-796-3400 / druginfo@fda.hhs.gov or CBER at 240-402-8020 / Industry.Biologics@fda.hhs.gov  (PDF - 2MB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
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  03/2019 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 at 301-796-3400 / druginfo@fda.hhs.gov or CBER at 240-402-8020 / Industry.Biologics@fda.hhs.gov  (PDF - 1.4MB) CBER MATT at 240-402-8020
CDER Drug Info at 301-796-3400
1609  03/1986 Research Project Record (PDF)  (PDF - 337KB) William Campanaro
301-827-1036
1609a  03/1986 Research Progress Record (PDF)  (PDF - 349KB) William Campanaro
301-827-1036
1815  08/2018 Certificate/ Transmittal for an Application (PDF)  (PDF - 614KB) Esther Lazar
240-402-1485
1932  07/2016 Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report (PDF)  (PDF - 945KB) Margarita Brown
240-402-5740
1932a  08/2018 Veterinary Adverse Drug Reaction, Lack of Effectiveness or Product Defect Report (dynamic)(PDF)  (PDF - 171KB) Linda Walter-Grimm
240-402-5762
1932a  08/2018 Veterinary Adverse Drug Reaction, Lack of Effectiveness or Product Defect (PDF)  (PDF - 842KB) Linda Walter-Grimm
240-402-5762
1993  08/2018 Application for Permit to Ship or Transport Milk and/or Cream into US (PDF)  (PDF - 741KB) Esther Lazar
240-402-1485
1994  01/2019 Report of Tuberculin Tests of Cattle (PDF)  (PDF - 192KB) Esther Lazar
240-402-1485

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