Biologics License Applications; Procedures & Requirements

ICR 202308-0910-021

OMB: 0910-0338

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
0910-0338 202308-0910-021
Received in OIRA 202302-0910-011
HHS/FDA CBER
Biologics License Applications; Procedures & Requirements
Revision of a currently approved collection   No
Regular 08/30/2023
  Requested Previously Approved
36 Months From Approved 03/31/2026
67,146 67,137
813,051 813,024
924 924

This information collection helps support implementation of statutory and regulatory requirements under the Public Health Service Act (PHS) and the Federal Food, Drug, and Cosmetic Act (FD&C Act) that govern biologics product licensing. Respondents to the information collection are biologic product sponsors.

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
Other Documents for OIRA Review

  87 FR 36327 06/12/2022
88 FR 55463 08/15/2023
Yes

3
IC Title Form No. Form Name
Biologics; Licensing; General Biological Products Standards; and Additional Standards Form FDA 2252, Form FDA 2253, Form FDA 2252, FDA 356h, FDA 3988, FDA 3989, FDA 3674 TRANSMITTAL OF ANNUAL REPORTS FOR DRUGS AND BIOLOGICS FOR HUMAN USE ,   TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE ,   TRANSMITTAL OF ANNUAL REPORTS FOR DRUGS AND BIOLOGICS FOR HUMAN USE ,   Transmittal of PMR/PMC Submissions for Drugs and Biological Products ,   PMR/PMC Annual Status Report for Drugs and Biological Products ,   Certification of Compliance ,   Application to Market a New Drug or Abbreviated New Drug or Biologic for Human Use
Notifications of suspensions 356h Application to Market a New Drug or Biologic for Human Use
Voluntary Consensus Standards

  Total Request 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 67,146 67,137 0 0 9 0
Annual Time Burden (Hours) 813,051 813,024 0 0 27 0
Annual Cost Burden (Dollars) 924 924 0 0 0 0
No
No
We have revised the information collection to add agency guidance and we have made nominal adjustments in burden as enumerated in Question-12a. The result is an increase of 9 responses and 27 hours annually to the information collection.

$20,830,410
No
    No
    No
No
No
No
No
Domini Bean 301 796-5733 domini.bean@fda.hhs.gov

  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.
08/30/2023


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