General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, and Forms FDA 356h & 2567

ICR 201403-0910-005

OMB: 0910-0338

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Justification for No Material/Nonsubstantive Change
2014-02-28
IC Document Collections
IC ID
Document
Title
Status
5935 Modified
209329 Modified
209328 Modified
209327 Modified
209326 Modified
209325 Modified
209324 Modified
209323 Modified
209322 Modified
209321 Modified
209320 Modified
209319 Modified
209318 Modified
209317 Modified
209316 Modified
209315 Modified
209314 Modified
209313 Modified
193381 Modified
193380 Modified
ICR Details
0910-0338 201403-0910-005
Historical Active 201311-0910-007
HHS/FDA 21526
General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, and Forms FDA 356h & 2567
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 03/31/2014
Retrieve Notice of Action (NOA) 03/19/2014
  Inventory as of this Action Requested Previously Approved
01/31/2017 01/31/2017 01/31/2017
28,805 0 28,805
324,761 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: 42 USC 262 Name of Law: PHS Act
   US Code: 21 USC 356b Name of Law: FFDCA
  
None

Not associated with rulemaking

No

20
IC Title Form No. Form Name
601.5(a) - Revocation of License 2567, 356h Transmittal of Labels and Circulars ,   Application to Market a New Drug or Biologic for Human Use
601.6(a) - Suspension of License 356h, 2567 Application to Market a New Drug or Biologic for Human Use ,   Transmittal of Labels and Circulars
601.12(a)(5) - Changes to an Approved Application 356h, 2567 Application to Market a New Drug or Biologic for Human Use ,   Transmittal of Labels and Circulars
601.12(b)(1)/(b)(3)/(e) - Changes to an Approved Application 356h, 2567 Application to Market a New Drug or Biologic for Human Use ,   Transmittal of Labels and Circulars
601.12(c)(1) and (c)(3) - Changes to an Approved Application 356h, 2567 Application to Market a New Drug or Biologic for Human Use ,   Transmittal of Labels and Circulars
601.12(c)(5) - Changes to an Approved Application 2567, 356h Transmittal of Labels and Circulars ,   Application to Market a New Drug or Biologic for Human Use
601.12(d)(1)/(d)(3)/(f)(3) - Changes to an Application 356h, 2567 Application to Market a New Drug or Biologic for Human Use ,   Transmittal of Labels and Circulars
601.12(f)(1) - Changes to an Approved Application 356h, 2567 Application to Market a New Drug or Biologic for Human Use ,   Transmittal of Labels and Circulars
601.12(f)(2) - Changes to an Approved Application 356h, 2567 Application to Market a New Drug or Biologic for Human Use ,   Transmittal of Labels and Circulars
601.12(f)(4)/601.45 - Changes to an Approved Application 356h, 2567 Application to Market a New Drug or Biologic for Human Use ,   Transmittal of Labels and Circulars
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
601.27(b) - Pediatric Studies - Deferred Submission 356h, 2567 Application to Market a New Drug or Biologic for Human Use ,   Transmittal of Labels and Circulars
601.27(c) - Pediatric Studies 356h, 2568 Application to Market a New Drug or Biologic for Human Use ,   Transmittal of Labels and Circulars
601.70(b) and (d)/601.28 - Annual Progress Reports of Postmarketing Studies and Annual reports of postmarketing pediatric studies 356h, 2567 Application to Market a New Drug or Biologic for Human Use ,   Transmittal of Labels and Circulars
610.15(d) - Constituent Materials 356h, 2567 Application to Market a New Drug or Biologic for Human Use ,   Transmittal of Labels and Circulars
680.1(c) - Allergenic Products 356h, 2567 Application to Market a New Drug or Biologic for Human Use ,   Transmittal of Labels and Circulars
680.1(b)(3)(iv) - Allergenic Products 356h, 2567 Application to Market a New Drug or Biologic for Human Use ,   Transmittal of Labels and Circulars
Amendments/Resubmissions 356h 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 2567, 356h Transmittal of Labels and Circulars ,   Application to Market a New Drug or Biologic for Human Use
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 28,805 28,805 0 0 0 0
Annual Time Burden (Hours) 324,761 324,761 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$17,573,130
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.
03/19/2014


© 2022 OMB.report | Privacy Policy