Implementation of the Animal Generic Drug User Fee Act of 2008; User Fee Cover Sheet Form FDA 3728 ( 21 U.S.C. 379j - 21)

ICR 201309-0910-012

OMB: 0910-0632

Federal Form Document

Forms and Documents
ICR Details
0910-0632 201309-0910-012
Historical Active 201208-0910-007
HHS/FDA 20640
Implementation of the Animal Generic Drug User Fee Act of 2008; User Fee Cover Sheet Form FDA 3728 ( 21 U.S.C. 379j - 21)
Revision of a currently approved collection   No
Emergency 10/01/2013
Approved without change 10/18/2013
Retrieve Notice of Action (NOA) 09/30/2013
  Inventory as of this Action Requested Previously Approved
04/30/2014 6 Months From Approved 05/31/2014
40 0 40
3 0 3
0 0 0

The Animal Generic Drug User Fee Act of 2008 (AGDUFA) (Title II of Public Law 110-316 signed by the President on August 14,2008), authorizes FDA to collect user fees for certain abbreviated applications for a generic new animal drug, on certain generic new animal drug products, and on certain sponsors of such abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs. A generic animal drug application submitted by a person subject to application fees is considered incomplete and will not be accepted for filing by FDA until all fees owed by such person has been paid. AGDUFA requires the submission of the user fees concurrently with applications. If the required fees are not submitted, the review of the application will not begin. The "User Fee Cover Sheet" provides the information to either initiate or defer the application review.
Must implement program change by beginning of fiscal year (October 1, 2013), and in advance of regularly scheduled revision request.

US Code: 21 USC 379j-21 Name of Law: null
  
None

Not associated with rulemaking

No

1
IC Title Form No. Form Name
Implementation of the Animal Generic Drug User Fee Act of 2008; User Fee Cover Sheet Form FDA 3728 FDA 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

$47,485
No
No
No
No
No
Uncollected
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.
09/30/2013


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