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 is listed under ICR 202407-0910-010.

View the official OMB control history on Reginfo.gov.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
Document	Type
Form 356h Application for FDA Approval to Market a New Drug	Form and Instruction
Form FDA 3674 Certification of Compliance	Form
Form FDA 3989 PMR/PMC Annual Status Report for Drugs and Biological Products	Form
Form FDA 3988 Transmittal of PMR/PMC Submissions for Drugs and Biological Products	Form
Form Form FDA 2252 TRANSMITTAL OF ANNUAL REPORTS FOR DRUGS AND BIOLOGICS FOR HUMAN USE	Form
Form Form FDA 2252 TRANSMITTAL OF ANNUAL REPORTS FOR DRUGS AND BIOLOGICS FOR HUMAN USE	Form and Instruction
Form Form FDA 2253 TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE	Form and Instruction
Form FDA 3674 Certification of Compliance (42 CFR part 11)	Form and Instruction
0338 BLAs Supporting Statement 2026 Ext.docx	Supporting Statement A
83-C 0338 adding 0206 samples IC SEP 2024.docx	Justification for No Material/Nonsubstantive Change
Applications, including labeling and requests for samples	Form and Instruction
Applications, including labeling and requests for samples	Form
Applications, including labeling and requests for samples	Form
Applications, including labeling and requests for samples	Form
Applications, including labeling and requests for samples	Form
Applications, including labeling and requests for samples	Form and Instruction
Applications, including labeling and requests for samples	Form and Instruction
Applications, including labeling and requests for samples	Other-Agency Guidance
PHS Section 402 Submission Certification	Form and Instruction
PHS Section 402 Submission Certification	Other-Statutory Authority
Requests for exceptions under 610.15	Information collection
Part 680 additional standards	Information collection
Changes to an approved application	Information collection
Guidance documents issued in accordance with 601.29	Other-Agency Guidance
DISCLOSURE: Notifications of suspensions	Information collection

All Historical Document Collections

Historical document collections
Reference	Filing	Received	Action
202606-0910-003	Extension without change of a currently approved collection	2026-10-15
202407-0910-010	No material or nonsubstantive change to a currently approved collection	2024-09-19
202308-0910-021	Revision of a currently approved collection	2023-08-30	Approved without change
202302-0910-011	Revision of a currently approved collection	2023-02-28	Approved without change
202209-0910-002	No material or nonsubstantive change to a currently approved collection	2022-09-07	Approved without change
202008-0910-014	No material or nonsubstantive change to a currently approved collection	2020-08-10	Approved without change
202001-0910-011	Extension without change of a currently approved collection	2020-02-13	Approved without change
201804-0910-010	No material or nonsubstantive change to a currently approved collection	2018-04-12	Approved without change
201802-0910-017	No material or nonsubstantive change to a currently approved collection	2018-02-28	Approved without change
201709-0910-003	No material or nonsubstantive change to a currently approved collection	2017-09-21	Approved without change
201705-0910-004	No material or nonsubstantive change to a currently approved collection	2017-05-24	Approved without change
201701-0910-012	Extension without change of a currently approved collection	2017-01-18	Approved without change
201403-0910-005	No material or nonsubstantive change to a currently approved collection	2014-03-19	Approved without change
201311-0910-007	Extension without change of a currently approved collection	2013-11-13	Approved without change
201006-0910-001	Extension without change of a currently approved collection	2010-06-24	Approved without change
200703-0910-017	Revision of a currently approved collection	2007-03-30	Approved without change
200507-0910-004	Extension without change of a currently approved collection	2005-07-25	Approved without change
200206-0910-007	Extension without change of a currently approved collection	2002-06-19	Approved with change
200002-0910-002	Extension without change of a currently approved collection	2000-02-01	Approved without change
199703-0910-002	New collection (Request for a new OMB Control Number)	1997-03-07	Approved without change

OMB Details

Biologics; Licensing; General Biological Products Standards; and Additional Standards

Federal Enterprise Architecture: Health - Consumer Health and Safety

Information collection instruments
Form	Name	Electronic access	Type
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.