Animal Drug User Fee Program

ICR 202308-0910-015

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 202308-0910-015
Received in OIRA 202107-0910-015
HHS/FDA CVM
Animal Drug User Fee Program
Extension without change of a currently approved collection   No
Regular 08/17/2023
  Requested Previously Approved
36 Months From Approved 08/31/2023
236 223
327 303
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 3546 Animal Drug User Fee Cover Sheet
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 236 223 0 0 13 0
Annual Time Burden (Hours) 327 303 0 0 24 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
We have adjusted our estimate of burden to reflect an increase of 24 hours and 13 responses annually to correspond with submissions to the agency.

$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.
08/17/2023


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