Animal Drug User Fee Cover Sheet

ICR 201707-0910-003

OMB: 0910-0539

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2017-07-26
IC Document Collections
IC ID
Document
Title
Status
6258 Modified
ICR Details
0910-0539 201707-0910-003
Historical Active 201407-0910-007
HHS/FDA CVM
Animal Drug User Fee Cover Sheet
Extension without change of a currently approved collection   No
Regular
Approved without change 08/28/2017
Retrieve Notice of Action (NOA) 07/27/2017
  Inventory as of this Action Requested Previously Approved
08/31/2020 36 Months From Approved 08/31/2017
21 0 17
21 0 17
0 0 0

The cover sheet (Form FDA 3546) is designed to collect the minimum necessary information to determine whether a fee is required for the review of an application or supplement or whether an application fee waiver was granted, to determine the amount of the fee required, and to assure that each animal drug user fee payment is appropriately linked to the animal drug application for which payment is made. The form, when completed electronically, will result in the generation of a unique payment identification number used by FDA to track the payment. FDA’s Center for Veterinary Medicine and FDA’s Office of Financial Management will use the information collected to initiate the administrative screening of new animal drug applications and supplements to determine whether payment has been received.

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

Not associated with rulemaking

  81 FR 72810 10/21/2016
82 FR 32826 07/18/2017
No

1
IC Title Form No. Form Name
Animal Drug User Fee Cover Sheet

  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 21 17 0 0 4 0
Annual Time Burden (Hours) 21 17 0 0 4 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The collection includes an adjustment in the agency estimate. We have increased both the number of annual hours and responses by 4 to reflect an increase in submissions to the agency.

$39,860
No
    No
    No
No
No
No
Uncollected
Ila Mizrachi 301 796-7726 ila.mizrachi@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.
07/27/2017


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