[Federal Register Volume 72, Number 222 (Monday, November 19, 2007)]
[Notices]
[Pages 65037-65038]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-22495]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0219]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
December 19, 2007.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-6974, or e-mailed to [email protected]. All comments 
should be identified with the OMB control number 0910-0540. Also 
include the FDA 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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Animal Drug User Fees and Fee Waivers and Reductions-21 CFR Part 740 
(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.
    In the Federal Register of June 14, 2007 (72 FR 32851), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    Respondents to this collection of information are new animal drug 
sponsors.
    FDA estimates the burden for this collection of information as 
follows:

[[Page 65038]]



                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                              Annual
    21 CFR Section           No. of         Frequency       Total Annual        Hours per         Total Hours
                          Respondents      per Response      Responses           Response
----------------------------------------------------------------------------------------------------------------
740(d)(1)(A)                           5  1 time for                     5                  2                 10
 Significant barrier                       each
 to innovation                             application
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740(d)(1)(B) Fees                      1  do.                            1                  2                  2
 exceed cost
----------------------------------------------------------------------------------------------------------------
740(d)(1)(C) Free                      5  do.                            5                  2                 10
 choice feeds
----------------------------------------------------------------------------------------------------------------
740(d)(1)(D) Minor                    10  do.                           10                  2                 20
 use or minor species
----------------------------------------------------------------------------------------------------------------
740(d)(1)(E) Small                     2  do.                            2                  2                  4
 business
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Request for                            5  do.                            5                  2                 10
 reconsideration of a
 decision
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Request for review--                   2  do.                            2                  2                  4
 (user fee appeal
 officer)
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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: November 13, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-22495 Filed 11-16-07; 8:45 am]
BILLING CODE 4160-01-S