[Federal Register Volume 72, Number 114 (Thursday, June 14, 2007)]
[Notices]
[Pages 32851-32852]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-11425]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0219]


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 animal drug user fees, fee waivers and reductions.

DATES: Submit written or electronic comments on the collection of 
information by August 13, 2007.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://www.fda.gov/dockets/ecomments. 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: Denver Presley, Jr., Office of the 
Chief Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1472.

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) 
(Public Law 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.'' This document 
provides guidance on the types of fees FDA is authorized to collect 
under ADUFA, and how to request waivers and reductions from FDA's 
animal drug user fees. Further, this guidance also describes the types 
of fees and fee waivers and reductions; what information FDA recommends 
be submitted in support of a request for a fee waiver or reduction; how 
to submit such a request; and FDA's process for reviewing requests. 
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.
    Respondents to this collection of information are new animal drug 
sponsors.
    FDA estimates the burden for this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                              No. of         Annual Frequency       Total Annual        Hours per
                    21 CFR Section                         Respondents         per Response          Responses           Response         Total Hours
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740(d)(1)(A) Significant barrier to innovation                          5       1 time for each                  5                  2                 10
                                                                                    application
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740(d)(1)(B) Fees exceed cost                                           1       1 time for each                  1                  2                  2
                                                                                    application
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740(d)(1)(C) Free choice feeds                                          5       1 time for each                  5                  2                 10
                                                                                    application
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740(d)(1)(D) Minor use or minor species                                10       1 time for each                 10                  2                 20
                                                                                    application
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740(d)(1)(E) Small business                                             2       1 time for each                  2                  2                  4
                                                                                    application
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Request for reconsideration of a decision                               5       1 time for each                  5                  2                 10
                                                                                    application
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Request for review--(user fee appeal officer)                           2       1 time for each                  2                  2                  4
                                                                                    application
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Total                                                                                                                                                 60
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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 2003. FDA's Center for Veterinary 
Medicine estimates 30 waiver requests that include the following: 5 
significant barriers to innovation, 1 fee exceed cost, 5 free choice 
feeds, 10 minor use or minor species, 2 small business waiver requests, 
5 requests for reconsideration of a decision, and 2 requests for user 
fee appeal officer. The estimated hours per response are based on past 
FDA experience with the various waiver requests in FDA's Center for 
Drug Evaluation and Research. The hours per response are based on the 
average of these estimates.

    Dated: June 7, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-11425 Filed 6-13-07; 8:45 am]
BILLING CODE 4160-01-S