Biologics License Applications; Procedures & Requirements

Forms and Documents

Document Name	Status

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

IC ID	Document Title	Status
5935	Biologics; Licensing; General Biological Products Standards; and Additional Standards Form	Unchanged
271003	Requests for samples and protocols	New
261932	Voluntary Consensus Standards Other-Agency Guidance	Unchanged
209328	Notifications of suspensions Form and Instruction	Unchanged

ICR Details

OMB Control No: 0910-0338	ICR Reference No: 202407-0910-010
Status: Received in OIRA	Previous ICR Reference No: 202308-0910-021
Agency/Subagency: HHS/FDA	Agency Tracking No: CBER
Title: Biologics License Applications; Procedures & Requirements
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 09/19/2024

	Requested	Previously Approved
Expiration Date	10/31/2026	10/31/2026
Responses	73,134	67,146
Time Burden (Hours)	831,044	813,051
Cost Burden (Dollars)	924	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
	Other Documents for OIRA Review

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 36327	06/12/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 55463	08/15/2023
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Biologics; Licensing; General Biological Products Standards; and Additional Standards	Form FDA 2252, Form FDA 2253, Form FDA 2252, FDA 356h, FDA 3988, FDA 3989, FDA 3674	TRANSMITTAL OF ANNUAL REPORTS FOR DRUGS AND BIOLOGICS FOR HUMAN USE ,   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 PMR/PMC Submissions for Drugs and Biological Products ,   PMR/PMC Annual Status Report for Drugs and Biological Products ,   Certification of Compliance ,   Application to Market a New Drug or Abbreviated New Drug or Biologic for Human Use
Notifications of suspensions	356h	Application to Market a New Drug or Biologic for Human Use
Requests for samples and protocols
Voluntary Consensus Standards

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ICR Summary 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	73,134	67,146	0	5,988	0	0
Annual Time Burden (Hours)	831,044	813,051	0	17,993	0	0
Annual Cost Burden (Dollars)	924	924	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

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

Burden Reduction Due to:

Short Statement: For efficiency of agency operations, we are requesting to add the information collection elements now approved in 0910-0206 to the scope of activity in this collection of information, and account for the attendant burden accordingly. Relatedly, we are requesting to discontinue OMB control no. 0910-0206 upon approval of the modification to 0910-0338.

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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: 09/19/2024

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