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

ICR 201804-0910-010

OMB: 0910-0338

Federal Form Document

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Supplementary Document
2018-04-11
Justification for No Material/Nonsubstantive Change
2018-04-09
Supporting Statement A
2017-01-17
IC Document Collections
IC ID
Document
Title
Status
5935 Unchanged
209328 Unchanged
209327 Unchanged
209326 Unchanged
209325 Unchanged
209324 Unchanged
209323 Unchanged
209322 Unchanged
209320 Unchanged
209319 Unchanged
209318 Unchanged
209317 Unchanged
209316 Unchanged
209315 Unchanged
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209313 Unchanged
193381 Unchanged
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ICR Details
0910-0338 201804-0910-010
Historical Active 201802-0910-017
HHS/FDA CBER
General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, and Form FDA 356h
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 04/27/2018
Retrieve Notice of Action (NOA) 04/12/2018
  Inventory as of this Action Requested Previously Approved
03/31/2020 03/31/2020 03/31/2020
30,352 0 30,352
334,039 0 334,039
0 0 0

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.

US Code: 42 USC 262 Name of Law: PHS Act; Regulation of Biological Products
   US Code: 21 USC 356b Name of Law: FFDCA
  
None

Not associated with rulemaking

  81 FR 44868 07/11/2016
81 FR 75130 10/28/2016
No

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

  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
No
No
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.

$18,035,100
No
    No
    No
No
No
No
Uncollected
Ila Mizrachi 301 796-7726 [email protected]

  No

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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
04/12/2018


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