Animal Generic Drug User Fee Cover Sheet

ICR 201706-0910-012

OMB: 0910-0632

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Modified
Supporting Statement A
2017-06-21
IC Document Collections
ICR Details
0910-0632 201706-0910-012
Historical Active 201404-0910-017
HHS/FDA CVM
Animal Generic Drug User Fee Cover Sheet
Extension without change of a currently approved collection   No
Regular
Approved without change 07/24/2017
Retrieve Notice of Action (NOA) 06/23/2017
  Inventory as of this Action Requested Previously Approved
07/31/2020 36 Months From Approved 07/31/2017
40 0 40
3 0 3
0 0 0

The cover sheet (Form FDA 3728) is designed to provide the minimum necessary information to determine whether a fee is required, to determine the amount of the fee required, and to assure that each generic animal drug user fee payment is made appropriately. The form, when completed electronically, will result in the generation of a unique payment identification number used by FDA to track the payment. It will be used by FDA’s Center for Veterinary Medicine (CVM) and FDA’s Office of Financial Management to initiate the administrative screening of generic new animal drug applications to determine if payment has been received.

US Code: 21 USC 379j-21 Name of Law: Authority to assess and use drug fees
  
None

Not associated with rulemaking

  81 FR 60707 09/02/2016
82 FR 27512 06/15/2017
No

1
IC Title Form No. Form Name
Animal Generic Drug User Fee Cover Sheet; Form FDA 3728 3728 AGDUFA 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 40 40 0 0 0 0
Annual Time Burden (Hours) 3 3 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$201
No
No
No
No
No
Uncollected
Ila Mizrachi 301 796-7726 [email protected]

  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.
06/23/2017


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