Animal Drug User Fee Cover Sheet

ICR 200712-0910-009

OMB: 0910-0539

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Modified
Supporting Statement A
2007-12-12
IC Document Collections
IC ID
Document
Title
Status
6258 Modified
ICR Details
0910-0539 200712-0910-009
Historical Active 200411-0910-004
HHS/FDA
Animal Drug User Fee Cover Sheet
Extension without change of a currently approved collection   No
Regular
Approved without change 02/11/2008
Retrieve Notice of Action (NOA) 12/18/2007
  Inventory as of this Action Requested Previously Approved
02/28/2011 36 Months From Approved 02/29/2008
69 0 69
69 0 69
0 0 0

An animal drug application or supplemental 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 have been paid. Section 740(e) of the FD&C Act. ADUFA requires the submisssion 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 necessary to either initiate or defer the application review.

US Code: 21 USC 379h Name of Law: null
  
None

Not associated with rulemaking

  72 FR 33231 06/15/2007
72 FR 65341 11/20/2007
No

1
IC Title Form No. Form Name
Animal Drug User Fee Cover Sheet 3546 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 69 69 0 0 0 0
Annual Time Burden (Hours) 69 69 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$42,346
No
No
Uncollected
Uncollected
Uncollected
Uncollected
Denver Presley 3018271462

  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.
12/18/2007


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