Animal Drug User Fee Program

ICR 202107-0910-015

OMB: 0910-0540

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
IC ID
Document
Title
Status
6260
Unchanged
242668
Modified
242667
Modified
ICR Details
0910-0540 202107-0910-015
Active 202006-0910-009
HHS/FDA CVM
Animal Drug User Fee Program
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 10/01/2021
Retrieve Notice of Action (NOA) 09/28/2021
  Inventory as of this Action Requested Previously Approved
08/31/2023 08/31/2023 08/31/2023
223 0 223
303 0 303
0 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

  85 FR 3929 01/23/2020
85 FR 39917 07/02/2020
No

3
IC Title Form No. Form Name
ADUFA Cover Sheets 3546
AGDUFA Cover Sheets
Animal Drug User Fees and Fee Waivers and Reductions

  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 223 223 0 0 0 0
Annual Time Burden (Hours) 303 303 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$59,887
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.
09/28/2021


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