Animal Drug User Fee Program

ICR 202006-0910-009

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
ICR Details
0910-0540 202006-0910-009
Active 201707-0910-004
HHS/FDA CVM
Animal Drug User Fee Program
Revision of a currently approved collection   No
Regular
Approved without change 08/17/2020
Retrieve Notice of Action (NOA) 07/13/2020
Approved with the understanding that the agency will discontinue 0910-0539 and 0910-0632 upon approval.
  Inventory as of this Action Requested Previously Approved
08/31/2023 36 Months From Approved 08/31/2020
223 0 161
303 0 277
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
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 223 161 0 0 62 0
Annual Time Burden (Hours) 303 277 0 0 26 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The information collection reflects changes and adjustments. By revising the information collection to include related elements associated with animal drug user fees (approved under OMB control nos. 0539 – Animal Drug User Fee Cover Sheet and 0910-0632 – Animal Generic Drug User Fee Cover Sheet) there is an increase of 62 annual responses and 26 annual burden hours.

$59,887
No
    Yes
    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.
07/13/2020


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