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

ICR 201407-0910-004

OMB: 0910-0540

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2014-07-07
IC Document Collections
ICR Details
0910-0540 201407-0910-004
Historical Active 201405-0910-025
HHS/FDA CVM
Guidance for Industry: Animal Drug User Fees and Fee Waivers and Reductions
Revision of a currently approved collection   No
Regular
Approved without change 08/27/2014
Retrieve Notice of Action (NOA) 07/08/2014
  Inventory as of this Action Requested Previously Approved
08/31/2017 36 Months From Approved 08/31/2014
139 0 83
277 0 166
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 submissin of certain applications or in advance of the invoicing of the other annual fees.

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

Not associated with rulemaking

  79 FR 10532 02/25/2014
79 FR 28523 05/16/2014
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 139 83 0 56 0 0
Annual Time Burden (Hours) 277 166 0 111 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
There is an increase in burden for this collection of information data as more sponsors are taking advantage of the waiver benefit.

$47,485
No
No
No
No
No
Uncollected
Domini Bean 301 796-5733 [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.
07/08/2014


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