General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, and Form FDA 356h

Forms and Documents

Document Name	Status
Form Form FDA 2253 601.2(a) - Applications for Biologics Licenses; procedures for filing and 610.60 through 610.65 - Container Label Form and Instruction	Unchanged
Form 356h Amendments/Resubmissions Form and Instruction	Unchanged
Form 356h 680.1(b)(3)(iv) - Allergenic Products Form and Instruction	Unchanged
Form 356h 680.1(c) - Allergenic Products Form and Instruction	Unchanged
Form 356h 610.15(d) - Constituent Materials Form and Instruction	Unchanged
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	Unchanged
Form 356h 601.27(c) - Pediatric Studies Form and Instruction	Unchanged
Form 356h 601.27(b) - Pediatric Studies - Deferred Submission Form and Instruction	Unchanged
Form Form FDA 2253 601.12(f)(4)/601.45 - Changes to an Approved Application Form and Instruction	Unchanged
Form 356h 601.12(f)(2) - Changes to an Approved Application Form and Instruction	Unchanged
Form 356h 601.12(f)(1) - Changes to an Approved Application Form and Instruction	Unchanged
Form 356h 601.12(d)(1)/(d)(3)/(f)(3) - Changes to an Application Form and Instruction	Unchanged
Form Form FDA 2253 601.12(c)(5) - Changes to an Approved Application Form and Instruction	Unchanged
Form 356h 601.12(c)(1) and (c)(3) - Changes to an Approved Application Form and Instruction	Unchanged
Form 356h 601.12(b)(1)/(b)(3)/(e) - Changes to an Approved Application Form and Instruction	Unchanged
Form 356h 601.12(a)(5) - Changes to an Approved Application Form and Instruction	Unchanged
Form 356h 601.6(a) - Suspension of License Form and Instruction	Unchanged
Form Form FDA 2253 601.5(a) - Revocation of License Form and Instruction	Unchanged
0338 Form FDA 356h.pdf Supplementary Document	2018-04-11
0338 Non sub change 2018.docx Justification for No Material/Nonsubstantive Change	2018-04-09
0338 Supporting Statement 2016 extension.pdf Supporting Statement A	2017-01-17

IC Document Collections

IC ID	Document Title	Status
5935	601.2(a) - Applications for Biologics Licenses; procedures for filing and 610.60 through 610.65 - Container Label Form and Instruction	Unchanged
209328	Amendments/Resubmissions Form and Instruction	Unchanged
209327	680.1(b)(3)(iv) - Allergenic Products Form and Instruction	Unchanged
209326	680.1(c) - Allergenic Products Form and Instruction	Unchanged
209325	610.15(d) - Constituent Materials Form and Instruction	Unchanged
209324	601.70(b) and (d)/601.28 - Annual Progress Reports of Postmarketing Studies and Annual reports of postmarketing pediatric studies Form and Instruction	Unchanged
209323	601.27(c) - Pediatric Studies Form and Instruction	Unchanged
209322	601.27(b) - Pediatric Studies - Deferred Submission Form and Instruction	Unchanged
209320	601.12(f)(4)/601.45 - Changes to an Approved Application Form and Instruction	Unchanged
209319	601.12(f)(2) - Changes to an Approved Application Form and Instruction	Unchanged
209318	601.12(f)(1) - Changes to an Approved Application Form and Instruction	Unchanged
209317	601.12(d)(1)/(d)(3)/(f)(3) - Changes to an Application Form and Instruction	Unchanged
209316	601.12(c)(5) - Changes to an Approved Application Form and Instruction	Unchanged
209315	601.12(c)(1) and (c)(3) - Changes to an Approved Application Form and Instruction	Unchanged
209314	601.12(b)(1)/(b)(3)/(e) - Changes to an Approved Application Form and Instruction	Unchanged
209313	601.12(a)(5) - Changes to an Approved Application Form and Instruction	Unchanged
193381	601.6(a) - Suspension of License Form and Instruction	Unchanged
193380	601.5(a) - Revocation of License Form and Instruction	Unchanged

ICR Details

OMB Control No: 0910-0338	ICR Reference No: 201804-0910-010
Status: Historical Active	Previous ICR Reference No: 201802-0910-017
Agency/Subagency: HHS/FDA	Agency Tracking No: CBER
Title: General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, and Form FDA 356h
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 04/27/2018
	Date Received in OIRA: 04/12/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2020	03/31/2020	03/31/2020
Responses	30,352	0	30,352
Time Burden (Hours)	334,039	0	334,039
Cost Burden (Dollars)	0	0	0

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Abstract: Manufacturers are required to submit a license application for review and approval prior to marketing a biological product in interstate commerce. In addition, manufacturers must submit to FDA advertising and promotional labeling. Manufacturers are also required to sbumit 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 (BLA), supplement to an approved application, or other similar submission is used to determin if a product is safe, effective, and not misbranded under prescribed, recommended, or suggested conditions of use. Forms FDA 356h and 3567 have been developed for use by the industry to insure that all the required and necessary information concerning licensing and labeling is submitted to FDA. The regulations also describe the types of postmarketing studies that reuqire 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 the reports of postmarketing studies to meet its reporting obligations under section 506B of the Federal Food, Drug, and Comsetic Act and section 130(b) of the Food and Drug Administration Modernization Act and corresponding regulations.

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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:
	81 FR 44868	07/11/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 75130	10/28/2016
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 18

IC Title	Form No.	Form Name
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
601.2(a) - Applications for Biologics Licenses; procedures for filing and 610.60 through 610.65 - Container Label	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
601.6(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(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(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
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(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
601.12(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
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
601.12(f)(4)/601.45 - Changes to an Approved Application	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
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
610.15(d) - Constituent Materials	Form FDA 2253, 356h	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(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
680.1(b)(3)(iv) - 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
Amendments/Resubmissions	356h	Application to Market a New Drug or Biologic 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

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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	30,352	30,352	0	0	0	0
Annual Time Burden (Hours)	334,039	334,039	0	0	0	0
Annual Cost Burden (Dollars)	0	0	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: This information collection reflects nominal changes in estimated burden. The agency made these adjustments to reflect corresponding changes in the number of respondents to the collection. This is discussed in our supporting statement.

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Annual Cost to Federal Government: $18,035,100

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: 04/12/2018

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