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FDA Forms Distribution Page for Center for Biologics Evaluation Research (CBER)
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| FDA Form # | Date | Title | Format | Paper Copy or Contact Info. |
|---|---|---|---|---|
| 356h | 10/05 | Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use | |
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
| 1571 | 04/06 | Investigational New Drug Application {Instructions} | |
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
| 1572 | 05/06 | Statement of Investigator {Instructions-CBER} | |
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
| 2252 | 06/08 | Transmittal of Annual Report for Drugs and Biologics for Human Use | |
CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
| 2253 | 06/08 | Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use | |
DDMAC 301-796-1200 |
| 2567 | 10/05 | Transmittal of Labels and Circulars | |
CBER MATT 301-827-2000 |
| 2656 | 04/06 | Registration of Drug Establishment/Labeler Code Assignment {Instructions} THIS FORM MUST BE SUBMITTED IN TRIPLICATE | |
DRLS drls@fda.hhs.gov or 301-210-2840 |
| 2657 | 02/05 | Drug Product Listing {Instructions} | |
DRLS drls@fda.hhs.gov or 301-210-2840 |
| 2830 | 07/06 | Blood Establishment Registration and Product Listing | |
bloodregis@fda.hhs.gov |
| 3356 | 04/08 | Establishment Registration and Listing for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) | |
tissuereg@fda.hhs.gov |
| 3397 | 1/03 | User Fee Cover Sheet | |
Mike Jones 301-443-5151 |
| 3454 | 04/06 | Certification: Financial Interest and Arrangements of Clinical Investigators | |
Leah W. Ripper 301-796-1282 |
| 3455 | 04/06 | Disclosure: Financial Interest and Arrangements of Clinical Investigators | |
Leah W. Ripper 301-796-1282 |
| 3486 | 08/07 | Biological Product Deviation Report {Instructions} | |
CBER Program Surveillance Branch 301-827-6220 |
| 3500 | 02/06 | MedWatch: The FDA Safety Information and Adverse Event Reporting Program {Instructions} |
|
MEDWATCH 1-800-FDA-1088 |
| 3500A | 02/06 | MedWatch: The FDA Safety Information and Adverse Event Reporting Program - Mandatory {Instructions} |
|
MEDWATCH 1-800-FDA-1088 |
| 3613 | 09/06 | Supplementary Information Certificate to Foreign Government Requests | |
Import/Export Team CBER 301-827-6201 |
| 3613a | 09/06 | Supplementary Information Certificate of Exportability Requests | |
Import/Export Team CBER 301-827-6201 |
| 3613b | 06/06 | Supplementary Information Certificate of a Pharmaceutical Product | |
Import/Export Team CBER 301-827-6201 |
| 3613c | 09/06 | Supplementary Information Non-Clinical Research Use Only Certificate | |
Import/Export Team CBER 301-827-6201 or CDER 301-827-8940 |
| VAERS-1 | Vaccine Adverse Event Reporting System{Instructions} | |
VAERS 800-822-7967 |
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Edition: December 16, 2008