General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension

Forms and Documents

Document Name	Status
Form Form FDA 2253 Biologics; Licensing; General Biological Products Standards; and Additional Standards Form and Instruction	Modified
Form 356h Notifications of suspensions Form and Instruction	Unchanged
0014 and 0338 PDUFA Forms Change Request Sept 2022.docx Justification for No Material/Nonsubstantive Change	2022-09-01
0338 BLAs Non sub to include 0629 GFI for Coop MFR Agreements November 2008.pdf Justification for No Material/Nonsubstantive Change	2020-08-08
0338 SSA 2020 EXT.pdf Supporting Statement A	2020-02-13

IC Document Collections

IC ID	Document Title	Status
5935	Biologics; Licensing; General Biological Products Standards; and Additional Standards Form and Instruction	Modified
209328	Notifications of suspensions Form and Instruction	Unchanged

ICR Details

OMB Control No: 0910-0338	ICR Reference No: 202209-0910-002
Status: Received in OIRA	Previous ICR Reference No: 202008-0910-014
Agency/Subagency: HHS/FDA	Agency Tracking No: CBER
Title: General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension
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: 09/07/2022

	Requested	Previously Approved
Expiration Date	02/28/2023	02/28/2023
Responses	27,704	27,704
Time Burden (Hours)	439,907	439,907
Cost Burden (Dollars)	924	924

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Abstract: The Public Health Service Act and FDA regulations require manufacturers to submit a license application for review and approval prior to marketing a biological product in interstate commerce. In addition, applicants must submit to FDA advertising and promotional labeling. Manufacturers or applicants or are also required to submit changes, including labeling, changes to an approved application, as well as advertising and promotional labeling changes. The information submitted to FDA in a biologics license application, supplement to an approved application, or other similar submission is used to determine if a product is safe, effective, and not misbranded under prescribed, recommended, or suggested conditions of use. The regulations also describe the types of postmarketing studies (PMS) that require status reports, the information to be included in the reports, and the type of information that FDA would consider appropriate for public disclosure. FDA uses the information submitted from PMS reports to meet its reporting obligations under section 506B of the Food Drug & Cosmetic Act and section 130(b) of the Food and Drug Administration Modernization Act.

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

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:
	84 FR 49310	09/19/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 3053	01/17/2020
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

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	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 ,   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

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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	27,704	27,704	0	0	0	0
Annual Time Burden (Hours)	439,907	439,907	0	0	0	0
Annual Cost Burden (Dollars)	924	924	0	0	0	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: $18,936,855

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: 09/07/2022

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