Biologics License Applications; Procedures & Requirements

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
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 FDA 356h Application to Market a New Drug or Abbreviated New Drug or Biologic for Human Use	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 Form FDA 2253 Biologics; Licensing; General Biological Products Standards; and Additional Standards	Form and Instruction	Modified	Available
Form 356h Application to Market a New Drug or Biologic for Human Use	Form and Instruction	Unchanged	Repair queued
Form 356h Notifications of suspensions	Form and Instruction	Unchanged	Repair queued
0338 BLAs Supporting Statement 2023 REV.docx	Supporting Statement A	Uploaded 2023-02-26	Repair queued
0014 and 0338 PDUFA Forms Change Request Sept 2022.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2022-09-01	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
5935	Biologics; Licensing; General Biological Products Standards; and Additional Standards	Form	Modified	Certification of Compliance
5935	Biologics; Licensing; General Biological Products Standards; and Additional Standards	Form	Modified	PMR/PMC Annual Status Report for Drugs and Biological Products
5935	Biologics; Licensing; General Biological Products Standards; and Additional Standards	Form	Modified	Transmittal of PMR/PMC Submissions for Drugs and Biological Products
5935	Biologics; Licensing; General Biological Products Standards; and Additional Standards	Form	Modified	Application to Market a New Drug or Abbreviated New Drug or Biologic for Human Use
5935	Biologics; Licensing; General Biological Products Standards; and Additional Standards	Form	Modified	TRANSMITTAL OF ANNUAL REPORTS FOR DRUGS AND BIOLOGICS FOR HUMAN USE
5935	Biologics; Licensing; General Biological Products Standards; and Additional Standards	Form and Instruction	Modified	TRANSMITTAL OF ANNUAL REPORTS FOR DRUGS AND BIOLOGICS FOR HUMAN USE
5935	Biologics; Licensing; General Biological Products Standards; and Additional Standards	Form and Instruction	Modified	TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
5935	Biologics; Licensing; General Biological Products Standards; and Additional Standards	Form and Instruction	Modified
5935	Biologics; Licensing; General Biological Products Standards; and Additional Standards	Other-Agency Guidance	Modified
209328	Notifications of suspensions	Form and Instruction	Unchanged	Application to Market a New Drug or Biologic for Human Use
209328	Notifications of suspensions	Form and Instruction	Unchanged

ICR Details

OMB Control No: 0910-0338	ICR Reference No: 202302-0910-011
Status: Historical Active	Previous ICR Reference No: 202209-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No: CBER
Title: Biologics License Applications; Procedures & Requirements
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 03/31/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 02/28/2023
Terms of Clearance: Approved with the understanding that 0910-0614 is begin discontinued and relevant burden is being captured here instead.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2026	36 Months From Approved	03/31/2023
Responses	67,137	0	27,704
Time Burden (Hours)	813,024	0	439,907
Cost Burden (Dollars)	924	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: 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:
	87 FR 65776	11/01/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 10520	02/21/2023
Did the Agency receive public comments on this ICR? No

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

table that charts list of burden

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 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 ,   Transmittal of PMR/PMC Submissions for Drugs and Biological Products ,   PMR/PMC Annual Status Report for Drugs and Biological Products ,   Certification of Compliance
Notifications of suspensions	356h	Application to Market a New Drug or Biologic for Human Use

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ICR Summary of Burden

table that charts list of burden

	Total Approved	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	67,137	27,704	0	0	39,433	0
Annual Time Burden (Hours)	813,024	439,907	0	0	373,117	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: We have revised the information collection to add instruments for annual reporting elements; we have made adjustments in individual collection elements; and we are consolidating burden currently approved in 0910-0614. Cumulatively the result is an increase of 67,137 responses and 813,024 hours annually to the information collection.

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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: 02/28/2023

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