Biologics License Applications; Procedures & Requirements

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form 356h Application for FDA Approval to Market a New Drug	Form and Instruction	Modified	Available
Form FDA 3674 Certification of Compliance	Form	Modified	Available
Form FDA 3989 PMR/PMC Annual Status Report for Drugs and Biological Products	Form	Modified	Available
Form FDA 3988 Transmittal of PMR/PMC Submissions for Drugs and Biological Products	Form	Modified	Available
Form Form FDA 2252 TRANSMITTAL OF ANNUAL REPORTS FOR DRUGS AND BIOLOGICS FOR HUMAN USE	Form	Modified	Available
Form Form FDA 2252 TRANSMITTAL OF ANNUAL REPORTS FOR DRUGS AND BIOLOGICS FOR HUMAN USE	Form and Instruction	Modified	Available
Form Form FDA 2253 TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE	Form and Instruction	Modified	Available
Form FDA 3674 Certification of Compliance (42 CFR part 11)	Form and Instruction	New	Available
0338 BLAs Supporting Statement 2026 Ext.docx	Supporting Statement A	Uploaded 2026-10-15	Available
83-C 0338 adding 0206 samples IC SEP 2024.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2024-09-17	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
5935	Applications, including labeling and requests for samples	Form and Instruction	Modified	Application for FDA Approval to Market a New Drug
5935	Applications, including labeling and requests for samples	Form	Modified	Certification of Compliance
5935	Applications, including labeling and requests for samples	Form	Modified	PMR/PMC Annual Status Report for Drugs and Biological Products
5935	Applications, including labeling and requests for samples	Form	Modified	Transmittal of PMR/PMC Submissions for Drugs and Biological Products
5935	Applications, including labeling and requests for samples	Form	Modified	TRANSMITTAL OF ANNUAL REPORTS FOR DRUGS AND BIOLOGICS FOR HUMAN USE
5935	Applications, including labeling and requests for samples	Form and Instruction	Modified	TRANSMITTAL OF ANNUAL REPORTS FOR DRUGS AND BIOLOGICS FOR HUMAN USE
5935	Applications, including labeling and requests for samples	Form and Instruction	Modified	TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
5935	Applications, including labeling and requests for samples	Other-Agency Guidance	Modified
280875	PHS Section 402 Submission Certification	Form and Instruction	New	Certification of Compliance (42 CFR part 11)
280875	PHS Section 402 Submission Certification	Other-Statutory Authority	New
280874	Requests for exceptions under 610.15		New
280873	Part 680 additional standards		New
271003	Changes to an approved application		Modified
261932	Guidance documents issued in accordance with 601.29	Other-Agency Guidance	Modified
209328	DISCLOSURE: Notifications of suspensions		Modified

ICR Details

OMB Control No: 0910-0338	ICR Reference No: 202606-0910-003
Status: Received in OIRA	Previous ICR Reference No: 202407-0910-010
Agency/Subagency: HHS/FDA	Agency Tracking No: CBER
Title: Biologics License Applications; Procedures & Requirements
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 10/15/2026

table that charts list comparision

	Requested	Previously Approved
Expiration Date	36 Months From Approved	10/31/2026
Responses	70,966	73,134
Time Burden (Hours)	860,177	831,044
Cost Burden (Dollars)	0	924

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Abstract: 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.

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Authorizing Statute(s): US Code: 42 USC 262 Name of Law: PHS Act; Regulation of Biological Products
   US Code: 21 USC 356b Name of Law: FFDCA
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	91 FR 41046	07/06/2026
30-day Notice:	Federal Register Citation:	Citation Date:
	91 FR 64654	10/09/2026
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 7

table that charts list of burden

IC Title	Form No.	Form Name
Applications, including labeling and requests for samples	Form FDA 2252, Form FDA 2253, Form FDA 2252, FDA 3988, FDA 3989, FDA 3674, 356h	TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE ,   TRANSMITTAL OF ANNUAL REPORTS FOR DRUGS AND BIOLOGICS FOR HUMAN USE ,   TRANSMITTAL OF ANNUAL REPORTS FOR DRUGS AND BIOLOGICS FOR HUMAN USE ,   Transmittal of PMR/PMC Submissions for Drugs and Biological Products ,   PMR/PMC Annual Status Report for Drugs and Biological Products ,   Certification of Compliance ,   Application for FDA Approval to Market a New Drug
Changes to an approved application
DISCLOSURE: Notifications of suspensions
Guidance documents issued in accordance with 601.29
PHS Section 402 Submission Certification	FDA 3674	Certification of Compliance (42 CFR part 11)
Part 680 additional standards
Requests for exceptions under 610.15

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ICR Summary of Burden

table that charts list of burden

	Total Request	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	70,966	73,134	0	0	-2,168	0
Annual Time Burden (Hours)	860,177	831,044	0	0	29,133	0
Annual Cost Burden (Dollars)	0	924	0	0	-924	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $20,830,410

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 10/15/2026

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