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

ICR 201701-0910-012

OMB: 0910-0338

Federal Form Document

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Supporting Statement A
2017-01-17
IC Document Collections
IC ID
Document
Title
Status
5935 Modified
209329 Removed
209328 Modified
209327 Modified
209326 Modified
209325 Modified
209324 Modified
209323 Modified
209322 Modified
209321 Removed
209320 Modified
209319 Modified
209318 Modified
209317 Modified
209316 Modified
209315 Modified
209314 Modified
209313 Modified
193381 Modified
193380 Modified
ICR Details
0910-0338 201701-0910-012
Historical Active 201403-0910-005
HHS/FDA CBER
General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, and Form FDA 356h
Extension without change of a currently approved collection   No
Regular
Approved without change 03/15/2017
Retrieve Notice of Action (NOA) 01/18/2017
  Inventory as of this Action Requested Previously Approved
03/31/2020 36 Months From Approved 03/31/2017
30,352 0 28,805
334,039 0 324,761
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: 21 USC 356b Name of Law: FFDCA
   US Code: 42 USC 262 Name of Law: PHS Act; Regulation of Biological Products
  
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
601.2(a) - Applications for Biologics Licenses; procedures for filing and 610.60 through 610.65 - Container Label 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
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
601.6(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 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
601.70(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
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
601.26(f) - Additional Studies and Labeling 356h, 2567 Application to Market a New Drug or Biologic for Human Use ,   Transmittal of Labels and Circulars
601.6(a) - Suspension of License 356h Application to Market a New Drug or Biologic 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 28,805 0 1,568 -21 0
Annual Time Burden (Hours) 334,039 324,761 0 9,286 -8 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
Yes
Miscellaneous Actions
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
Uncollected
Domini Bean 301 796-5733 [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.
01/18/2017


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