Prescription Drug User Fee Program

ICR 202202-0910-010

OMB: 0910-0297

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2022-02-23
Justification for No Material/Nonsubstantive Change
2020-08-01
ICR Details
0910-0297 202202-0910-010
Received in OIRA 202008-0910-002
HHS/FDA CDER
Prescription Drug User Fee Program
Revision of a currently approved collection   No
Regular 02/23/2022
  Requested Previously Approved
36 Months From Approved 03/31/2022
411 445
3,626 2,761
0 0

This information collection supports implementation of the Food and Drug Administration (FDA, us or we) Prescription Drug User Fee program. Under the prescription drug user fee provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (sections 735 and 736 (21 U.S.C. 379g and 379h)), as amended, we have the authority to assess and collect user fees for certain new drug applications (NDAs) and new biologics license applications (BLAs)

US Code: 21 USC 379 Name of Law: Federal Food Drug and Cosmetic Act
  
None

Not associated with rulemaking

  86 FR 67958 11/30/2021
87 FR 7186 02/08/2022
No

  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 411 445 0 0 -34 0
Annual Time Burden (Hours) 3,626 2,761 0 0 865 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
Cumulative changes and adjustments result in a decrease of 34 responses and an increase in 865 hours annually. We believe this reflects expected fluctuations in the information collection.

$0
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.
02/23/2022


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