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

ICR 202008-0910-014

OMB: 0910-0338

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Modified
Form and Instruction
Unchanged
Justification for No Material/Nonsubstantive Change
2020-08-08
Supporting Statement A
2020-02-13
ICR Details
0910-0338 202008-0910-014
Active 202001-0910-011
HHS/FDA CBER
General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 08/17/2020
Retrieve Notice of Action (NOA) 08/10/2020
Approved consistent with the understanding that the agency will discontinue OMB control no. 0910-0629 upon approval of this change request.
  Inventory as of this Action Requested Previously Approved
02/28/2023 02/28/2023 02/28/2023
27,704 0 27,703
439,907 0 439,906
924 0 23,315,571

The Public Health Service Act and FDA regulations require manufacturers to submit a license application for review and approval prior to marketing a biological product in interstate commerce. In addition, applicants must submit to FDA advertising and promotional labeling. Manufacturers or applicants or are also required to submit 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, supplement to an approved application, or other similar submission is used to determine if a product is safe, effective, and not misbranded under prescribed, recommended, or suggested conditions of use. The regulations also describe the types of postmarketing studies (PMS) that require 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 PMS reports to meet its reporting obligations under section 506B of the Food Drug & Cosmetic Act and section 130(b) of the Food and Drug Administration Modernization Act.

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

  84 FR 49310 09/19/2019
85 FR 3053 01/17/2020
No

  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 27,704 27,703 0 0 1 0
Annual Time Burden (Hours) 439,907 439,906 0 0 1 0
Annual Cost Burden (Dollars) 924 23,315,571 0 0 -23,314,647 0
No
No
We are requesting a non-substantive change to include agency guidance that results in 1 annual response and 1 burden hour. We have also removed costs inadvertently uploaded in the burden table as they appear in 12b of our supporting statement.

$18,936,855
No
    No
    No
No
No
No
No
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.
08/10/2020


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