[Federal Register: October 14, 2004 (Volume 69, Number 198)]
[Notices]               
[Page 61023-61024]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14oc04-58]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0186]

 
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 the 
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 (the PRA).

DATES: Fax written comments on the collection of information by 
November 15, 2004.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. 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: Fumie 
Yokota, Desk Officer for FDA, FAX 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
rm. 4B-41, 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 (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 
(the 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. 
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.
    In the Federal Register of May 3, 2004 (69 FR 24169), FDA published 
a 60-day notice requesting comment on the collection of information. In 
response to that notice, no comments were received regarding the 
collection of information.
    FDA estimates the burden for this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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   Section of the Act Types of Waiver or Reduction          No. of         Annual Frequency      Total Annual          Hours per
                      Requests                            Respondents        per Response          Responses           Response           Total Hours
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740(d)(1)(A)                                                          5     1 time for each                   5                   2                  10
Significant barrier to innovation                                               application
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740(d)(1)(C)                                                          5                  ``                   5                   2                  10
Free choice feeds
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[[Page 61024]]


740(d)(1)(D)                                                         10                  ``                  10                   2                  20
Minor use or minor species
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740(d)(1)(E)                                                          2                  ``                   2                   2                   4
Small business
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Request for reconsideration of a decision                             5                  ``                   5                   2                  10
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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 submissions 
types received by FDA in fiscal year 2003. The 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 officers. The estimated hours per response are based on past 
FDA experience with the various waiver requests in the Center for Drug 
Evaluation and Research. The hours per response are based on the 
average of these estimates.

    Dated: October 8, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-23104 Filed 10-13-04; 8:45 am]

BILLING CODE 4160-01-S