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

ICR 201311-0910-007

OMB: 0910-0338

Federal Form Document

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Supporting Statement A
2013-11-07
IC Document Collections
IC ID
Document
Title
Status
5935 Modified
209329 New
209328 New
209327 New
209326 New
209325 New
209324 New
209323 New
209322 New
209321 New
209320 New
209319 New
209318 New
209317 New
209316 New
209315 New
209314 New
209313 New
193381 Modified
193380 Modified
ICR Details
0910-0338 201311-0910-007
Historical Active 201006-0910-001
HHS/FDA 20859
General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, and Forms FDA 356h & 2567
Extension without change of a currently approved collection   No
Regular
Approved without change 01/03/2014
Retrieve Notice of Action (NOA) 11/13/2013
  Inventory as of this Action Requested Previously Approved
01/31/2017 36 Months From Approved 01/31/2014
28,805 0 20,081
324,761 0 341,697
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

  78 FR 35273 06/12/2013
78 FR 65334 10/31/2013
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 Biologic or an Antibiotic Drug for Human Use
601.6(a) - Suspension of License 2567, 356h Transmittal of Labels and Circulars ,   Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
601.70(b) and (d)/601.28 - Annual Progress Reports of Postmarketing Studies and Annual reports of postmarketing pediatric studies 2567, 356h Transmittal of Labels and Circulars ,   Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
610.15(d) - Constituent Materials 2567, 356h Transmittal of Labels and Circulars ,   Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
680.1(c) - Allergenic Products 2567, 356h Transmittal of Labels and Circulars ,   Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
680.1(b)(3)(iv) - Allergenic Products 2567, 356h Transmittal of Labels and Circulars ,   Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
Amendments/Resubmissions 356h Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
601.6(a) - Suspension of License 356h Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
601.27(b) - Pediatric Studies - Deferred Submission 2567, 356h Transmittal of Labels and Circulars ,   Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
601.27(c) - Pediatric Studies 2568, 356h Transmittal of Labels and Circulars ,   Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
601.12(c)(5) - Changes to an Approved Application 356h, 2567 Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use ,   Transmittal of Labels and Circulars
601.12(d)(1)/(d)(3)/(f)(3) - Changes to an Application 2567, 356h Transmittal of Labels and Circulars ,   Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
601.12(f)(1) - Changes to an Approved Application 2567, 356h Transmittal of Labels and Circulars ,   Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
601.12(f)(2) - Changes to an Approved Application 2567, 356h Transmittal of Labels and Circulars ,   Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
601.2(a) - Applications for Biologics Licenses; procedures for filing and 610.60 through 610.65 - Container Label 356h, 2567 Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use ,   Transmittal of Labels and Circulars
601.12(f)(4)/601.45 - Changes to an Approved Application 2567, 356h Transmittal of Labels and Circulars ,   Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
601.26(f) - Additional Studies and Labeling 2567, 356h Transmittal of Labels and Circulars ,   Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
601.12(a)(5) - Changes to an Approved Application 2567, 356h Transmittal of Labels and Circulars ,   Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
601.12(b)(1)/(b)(3)/(e) - Changes to an Approved Application 2567, 356h Transmittal of Labels and Circulars ,   Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
601.12(c)(1) and (c)(3) - Changes to an Approved Application 2567, 356h Transmittal of Labels and Circulars ,   Application to Market a New Drug Biologic or an Antibiotic Drug 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 20,081 0 0 8,724 0
Annual Time Burden (Hours) 324,761 341,697 0 0 -16,936 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The previous burden estimate for 0910-0338 was 341,697. The slight overall decrease in burden to 324,758.60 (-16,938) is attibuted to the normal variation in the various submissions to FDA. A third party disclosure chart was added for a reporting element (i.e., notification of selling agents and distributors) under section 601.6(a) although there was no burden impact since it was previously included under the reporting burden chart. In addition, OMB Control Number 0910-0666 (section 610.15(d)) is being consolidated into this package (1 burden hour).

$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.
11/12/2013


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