Animal Drug User Fee Cover Sheet

ICR 200411-0910-004

OMB: 0910-0539

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
IC ID
Document
Title
Status
6258 Migrated
ICR Details
0910-0539 200411-0910-004
Historical Active 200409-0910-003
HHS/FDA
Animal Drug User Fee Cover Sheet
Extension without change of a currently approved collection   No
Regular
Approved without change 12/21/2004
Retrieve Notice of Action (NOA) 11/05/2004
  Inventory as of this Action Requested Previously Approved
12/31/2007 12/31/2007 12/31/2004
69 0 69
69 0 69
0 0 0

An animal drug application or supplemental animal drug application submitted by a person subject to appliction 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.

None
None


No

1
IC Title Form No. Form Name
Animal Drug User Fee Cover Sheet 3546

  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

$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected

  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.
11/05/2004


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