[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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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