OMB control number
Biologics License Applications; Procedures & Requirements
OMB 0910-0338 · HHS/FDA.
OMB 0910-0338
This information collection helps support implementation of statutory and regulatory requirements under the Public Health Service Act (PHS) and the Federal Food, Drug, and Cosmetic Act (FD&C Act) that govern biologics product licensing. Respondents to the information collection are biologic product sponsors.
The latest form for Biologics License Applications; Procedures & Requirements expires 2026-10-31 and can be found here.
Latest Forms, Documents, and Supporting Material
Biologics; Licensing; General Biological Products Standards; and Additional Standards All Historical Document Collections
OMB Details
Biologics; Licensing; General Biological Products Standards; and Additional Standards
Federal Enterprise Architecture: Health - Consumer Health and Safety
| Form Form FDA 2252 | TRANSMITTAL OF ANNUAL REPORTS FOR DRUGS AND BIOLOGICS FOR HUMAN USE | Fillable Fileable | Form |
| Form FDA 3674 | Certification of Compliance | Fillable Fileable | Form |
| Form FDA 3989 | PMR/PMC Annual Status Report for Drugs and Biological Products | Fillable Fileable | Form |
| Form FDA 3988 | Transmittal of PMR/PMC Submissions for Drugs and Biological Products | Fillable Fileable | Form |
| Form FDA 356h | Application to Market a New Drug or Abbreviated New Drug or Biologic for Human Use | Fillable Fileable | Form |
| Form | www.fda.gov/media/70712/download | Other | |
| Form Form FDA 2252 | TRANSMITTAL OF ANNUAL REPORTS FOR DRUGS AND BIOLOGICS FOR HUMAN USE | Fillable Fileable | Form and instruction |
| Form Form FDA 2253 | TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE | Fillable Fileable | Form and instruction |
Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.