Guidance for Industry: Animal Drug User Fees and Fee Waivers and Reductions

ICR 200403-0910-001

OMB: 0910-0540

Federal Form Document

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Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
ICR Details
0910-0540 200403-0910-001
Historical Active
HHS/FDA
Guidance for Industry: Animal Drug User Fees and Fee Waivers and Reductions
New collection (Request for a new OMB Control Number)   No
Emergency 03/15/2004
Approved without change 03/15/2004
Retrieve Notice of Action (NOA) 03/12/2004
  Inventory as of this Action Requested Previously Approved
09/30/2004 09/30/2004
30 0 0
60 0 0
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. The purpose of collecting this information is to provide persons subject to fees an opportunity to obtain a waiver or reduction of certain animal drug user fees in advance of the submission of certain applications or in advance of the invoicing of the other annual fees.

None
None


No

1
IC Title Form No. Form Name
Guidance for Industry: Animal Drug User Fees and Fee Waivers and Reductions

  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 30 0 0 30 0 0
Annual Time Burden (Hours) 60 0 0 60 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
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.
03/12/2004


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