Document ID: FDA-2010-N-0603-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Animal Drug User Fees and Fee Waivers and Reductions
Posted Date: 2010-12-02T05:00Z

[Federal Register: December 2, 2010 (Volume 75, Number 231)]
[Notices]               
[Page 75175-75176]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02de10-21]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0603]

 
Agency Information Collection Activities; Proposed Collection; 
Comment Request; Animal Drug User Fees and Fee Waivers and Reductions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the reporting requirements for 
the

[[Page 75176]]

animal drug user fees and fee waivers and reductions.

DATES: Submit either electronic or written comments on the collection 
of information by January 31, 2011.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Johnny Vilela, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, 
Rockville, MD 20850, 301-796-7651, Juanmanuel.Vilela@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Animal Drug User Fees and Fee Waivers and Reductions--(OMB Control 
Number 0910-0540--Extension)

    Enacted on November 18, 2003, the Animal Drug User Fee Act (ADUFA) 
(Pub. L. 108-130) amended the Federal Food, Drug, and Cosmetic Act and 
requires FDA to assess and collect user fees for certain applications, 
products, establishments, and sponsors. It also requires the Agency to 
grant a waiver from, or a reduction of those fees in certain 
circumstances. Thus, to implement this statutory provision of ADUFA, 
FDA developed a guidance entitled ``Guidance for Industry: Animal Drug 
User Fees and Fee Waivers and Reductions.'' It provides guidance on the 
types of fees FDA is authorized to collect under ADUFA, and on how to 
request waivers and reductions from FDA's animal drug user fees. The 
guidance also describes the types of fees and fee waivers and 
reductions, the information FDA recommends respondents submit in 
support of a request for a fee waiver or reduction, how respondents may 
submit such a request, and FDA's process for reviewing requests.
    Respondents to this collection of information are new animal drug 
sponsors. Requests for waivers or reductions may be submitted by a 
person paying any of the animal drug user fees assessed--application 
fees, product fees, establishment fees, or sponsor fees.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                      Annual
         21 CFR Section              Number of     frequency per   Total annual      Hours per      Total hours
                                    respondents      response        responses       response
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740(d)(1)(A) Significant barrier              22               1              22               2              44
 to innovation..................
740(d)(1)(B) Fees exceed cost...               0               1               0               2               0
740(d)(1)(C) Free choice feeds..               2               1               2               2               4
740(d)(1)(D) Minor use or minor               52               1              52               2             104
 species........................
740(d)(1)(E) Small business.....               0               1               0               0               0
Request for reconsideration of a               5               1               5               2              10
 decision.......................
Request for review--(user fee                  2               1               2               2               4
 appeal officer)................
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    Total.......................  ..............  ..............  ..............  ..............             166
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Based on FDA's database system, there are an estimated 250 sponsors 
of products subject to ADUFA. However, not all sponsors will have any 
submissions in a given year and some may have multiple submissions. The 
total number of waiver requests is based on the number of submission 
types received by FDA in fiscal year 2008.

    Dated: November 24, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-30264 Filed 12-1-10; 8:45 am]
BILLING CODE 4160-01-P