Animal Drug User Fee Program

ICR 202309-0910-013

OMB: 0910-0540

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
0910-0540 202309-0910-013
Received in OIRA 202308-0910-015
HHS/FDA CVM
Animal Drug User Fee Program
No material or nonsubstantive change to a currently approved collection   No
Regular 09/29/2023
  Requested Previously Approved
09/30/2026 09/30/2026
236 236
327 327
0 0

This information collection supports FDA's Animal Drug User Fee Act program. Respondents to the collection are sponsors of applications submitted to the agency. The information is used to assess fees, as well as to grant a waiver from, or a reduction of those fees in certain circumstances.

PL: Pub.L. 108 - 130 740 Name of Law: Animal Drug User Fee Act
  
None

Not associated with rulemaking
Other Documents for OIRA Review

  88 FR 25658 04/27/2023
88 FR 54620 08/11/2023
Yes

3
IC Title Form No. Form Name
ADUFA Cover Sheets
AGDUFA Cover Sheets
Animal Drug User Fees and Fee Waivers and Reductions

  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 236 236 0 0 0 0
Annual Time Burden (Hours) 327 327 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$1,100,000
No
    Yes
    No
No
No
No
No
Rachel Showalter 202 693-2146 Showalter.Rachel@dol.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.
09/29/2023


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