[Federal Register: May 3, 2004 (Volume 69, Number 85)]
[Page 24169-24170]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2004N-0186]

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.


SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
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 and fee waivers and reductions.

DATES: Submit written or electronic comments on the collection of 
information by July 2, 2004.

ADDRESSES: Submit electronic comments on the collection of information 
to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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, Office of Management 
Programs (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, 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 FDAs 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 
(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

[[Page 24170]]

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 for this collection of information as 

                                 Table 1.--Estimated Annual Reporting Burden\1\
 Section of the act  Types of        No. of        Frequency per     Total Annual      Hours per     Total Hours
 Waiver or Reduction Requests     Respondents        Responses        Responses        Response
740(d)(1)(A)                   5                  1 time for each  5                2               10
Significant barrier to                             application
740(d)(1)(B)                   1                  ``               1                2               2
Fees exceed cost
740(d)(1)(C)                   5                  ``               5                2               10
Free choice feeds
740(d)(1)(D)                   10                 ``               10               2               20
Minor use or minor species
740(d)(1)(E)                   2                  ``               2                2               4
Small business
Request for reconsideration    5                  ``               5                2               10
 of a decision
Request for Review--(user fee  2                  ``               2                2               4
 appeal officer)
Total                          .................  ...............  ...............  ..............  60
\1\ There are no capital costs or operating and maintenance costs associated with this collection of

    Based on FDA's data base 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: April 23, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-9970 Filed 4-30-04; 8:45 am]