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

Forms and Documents

Document Name	Status
Form Form FDA 2252 Biologics; Licensing; General Biological Products Standards; and Additional Standards Form and Instruction	Modified
Form 356h Notifications of suspensions Form and Instruction	Modified
Form Form FDA 2253 680.1(b)(3)(iv) - Allergenic Products Form and Instruction	Removed
Form 356h 680.1(c) - Allergenic Products Form and Instruction	Removed
Form 356h 610.15(d) - Constituent Materials Form and Instruction	Removed
Form 356h 601.70(b) and (d)/601.28 - Annual Progress Reports of Postmarketing Studies and Annual reports of postmarketing pediatric studies Form and Instruction	Removed
Form 356h 601.27(c) - Pediatric Studies Form and Instruction	Removed
Form 356h 601.27(b) - Pediatric Studies - Deferred Submission Form and Instruction	Removed
Form 356h 601.12(f)(4)/601.45 - Changes to an Approved Application Form and Instruction	Removed
Form 356h 601.12(f)(2) - Changes to an Approved Application Form and Instruction	Removed
Form 356h 601.12(f)(1) - Changes to an Approved Application Form and Instruction	Removed
Form 356h 601.12(d)(1)/(d)(3)/(f)(3) - Changes to an Application Form and Instruction	Removed
Form Form FDA 2253 601.12(c)(5) - Changes to an Approved Application Form and Instruction	Removed
Form 356h 601.12(c)(1) and (c)(3) - Changes to an Approved Application Form and Instruction	Removed
Form 356h 601.12(b)(1)/(b)(3)/(e) - Changes to an Approved Application Form and Instruction	Removed
Form 356h 601.12(a)(5) - Changes to an Approved Application Form and Instruction	Removed
Form 356h 601.6(a) - Suspension of License Form and Instruction	Removed
Form Form FDA 2253 601.5(a) - Revocation of License Form and Instruction	Removed
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	Modified
209327	680.1(b)(3)(iv) - Allergenic Products Form and Instruction	Removed
209326	680.1(c) - Allergenic Products Form and Instruction	Removed
209325	610.15(d) - Constituent Materials Form and Instruction	Removed
209324	601.70(b) and (d)/601.28 - Annual Progress Reports of Postmarketing Studies and Annual reports of postmarketing pediatric studies Form and Instruction	Removed
209323	601.27(c) - Pediatric Studies Form and Instruction	Removed
209322	601.27(b) - Pediatric Studies - Deferred Submission Form and Instruction	Removed
209320	601.12(f)(4)/601.45 - Changes to an Approved Application Form and Instruction	Removed
209319	601.12(f)(2) - Changes to an Approved Application Form and Instruction	Removed
209318	601.12(f)(1) - Changes to an Approved Application Form and Instruction	Removed
209317	601.12(d)(1)/(d)(3)/(f)(3) - Changes to an Application Form and Instruction	Removed
209316	601.12(c)(5) - Changes to an Approved Application Form and Instruction	Removed
209315	601.12(c)(1) and (c)(3) - Changes to an Approved Application Form and Instruction	Removed
209314	601.12(b)(1)/(b)(3)/(e) - Changes to an Approved Application Form and Instruction	Removed
209313	601.12(a)(5) - Changes to an Approved Application Form and Instruction	Removed
193381	601.6(a) - Suspension of License Form and Instruction	Removed
193380	601.5(a) - Revocation of License Form and Instruction	Removed

ICR Details

OMB Control No: 0910-0338	ICR Reference No: 202001-0910-011
Status: Historical Active	Previous ICR Reference No: 201804-0910-010
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: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 02/18/2020
	Date Received in OIRA: 02/13/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2023	36 Months From Approved	03/31/2020
Responses	27,703	0	30,352
Time Burden (Hours)	439,906	0	334,039
Cost Burden (Dollars)	23,315,571	0	0

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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
601.6(a) - Suspension of License	356h, Form FDA 2253	Application to Market a New Drug or Biologic for Human Use ,   TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
601.12(c)(5) - Changes to an Approved Application	Form FDA 2253, 356h	TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE ,   Application to Market a New Drug or Biologic for Human Use
601.12(f)(2) - Changes to an Approved Application	356h, Form FDA 2253	Application to Market a New Drug or Biologic for Human Use ,   TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
601.27(b) - Pediatric Studies - Deferred Submission	356h, Form FDA 2253	Application to Market a New Drug or Biologic for Human Use ,   TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
601.27(c) - Pediatric Studies	356h, Form FDA 2253	Application to Market a New Drug or Biologic for Human Use ,   TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
601.12(d)(1)/(d)(3)/(f)(3) - Changes to an Application	356h, Form FDA 2253	Application to Market a New Drug or Biologic for Human Use ,   TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
601.70(b) and (d)/601.28 - Annual Progress Reports of Postmarketing Studies and Annual reports of postmarketing pediatric studies	356h, Form FDA 2253	Application to Market a New Drug or Biologic for Human Use ,   TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
610.15(d) - Constituent Materials	356h, Form FDA 2253	Application to Market a New Drug or Biologic for Human Use ,   TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
601.12(c)(1) and (c)(3) - Changes to an Approved Application	356h, Form FDA 2253	Application to Market a New Drug or Biologic for Human Use ,   TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
Biologics; Licensing; General Biological Products Standards; and Additional Standards	FDA 356h, Form FDA 2253, Form FDA 2252, Form FDA 2252	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 or Abbreviated New Drug or Biologic For Human Use ,   TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
601.12(a)(5) - Changes to an Approved Application	356h, Form FDA 2253	Application to Market a New Drug or Biologic for Human Use ,   TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
601.12(b)(1)/(b)(3)/(e) - Changes to an Approved Application	356h, Form FDA 2253	Application to Market a New Drug or Biologic for Human Use ,   TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
601.12(f)(1) - Changes to an Approved Application	356h, Form FDA 2253	Application to Market a New Drug or Biologic for Human Use ,   TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
680.1(b)(3)(iv) - Allergenic Products	356h, Form FDA 2253	TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE ,   Application to Market a New Drug or Biologic for Human Use
680.1(c) - Allergenic Products	356h, Form FDA 2253	Application to Market a New Drug or Biologic for Human Use ,   TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
601.12(f)(4)/601.45 - Changes to an Approved Application	356h, Form FDA 2253	Application to Market a New Drug or Biologic for Human Use ,   TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
Notifications of suspensions	356h	Application to Market a New Drug or Biologic for Human Use
601.5(a) - Revocation of License	Form FDA 2253, 356h	TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE ,   Application to Market a New Drug or Biologic for Human Use

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ICR Summary 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	27,703	30,352	0	0	-2,649	0
Annual Time Burden (Hours)	439,906	334,039	0	0	105,867	0
Annual Cost Burden (Dollars)	23,315,571	0	0	0	23,315,571	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: FDA’s estimated burden for the information collection reflects an overall increase of 105,867 hours and a decrease of 2,649 responses. We attribute this adjustment to an increase in the number of submissions we have received under 21 CFR 601.12(f)(4) and 601.45, and 21 CFR 601.12(b)(1), (b)(3), and (e) over the last few years. We attribute the decrease in responses to a decrease in responses received under 21 CFR 601.12(a)(5) and 601.27(b) over the last few years. Also, while we have consolidated the IC elements as they appear at omb.report., we have retained the itemized burden table in Question 12 as included in our Federal Register notices.

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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? Uncollected

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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: 02/13/2020

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