[Federal Register Volume 70, Number 84 (Tuesday, May 3, 2005)]
[Notices]
[Pages 22884-22885]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-8738]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0148]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Extralabel Drug Use in Animals

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 for 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 
when development of an analytical method for residue detection is 
required by FDA for a drug prescribed for extralabel use in animals.

DATES: Submit written or electronic comments on the collection of 
information by July 5, 2005.

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, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
rm. 4B-41, 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.

Extralabel Drug Use in Animals--21 CFR Part 530 (OMB Control Number 
0910-0325)

    The Animal Medicinal Drug Use Clarification Act of 1994 allows a 
veterinarian to prescribe the extralabel use of approved new animal 
drugs. Also, it permits FDA, if it finds that there is a reasonable 
probability that the extralabel use of an animal drug may present a 
risk to the public health, to establish a safe level for a residue from 
the extralabel use of an animal drug, and to require the development of 
an analytical method for the detection of residues above that 
established safe level. Although to date, we have not established a 
safe level for a residue from the extralabel use of any new animal 
drug, and therefore have not required the development of analytical 
methodology, we believe that there may be instances when analytical 
methodology will be required. We are therefore estimating the reporting 
burden based on two methods being required annually. The requirement to 
establish an analytical method may be fulfilled by any interested 
person. We believe that the sponsor of the drug will be willing to 
develop the method in most cases. Alternatively, FDA, the sponsor, and 
perhaps a third party may cooperatively arrange for method development. 
The respondents may be sponsors of new animal drugs, State or Federal 
government, or individuals.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                          Annual Frequency     Total Annual        Hours per
  21 CFR Section    No. of Respondents      per Response        Responses           Response        Total Hours
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530.22(b)                             2                  1                  2              4,160           8,320
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.



[[Page 22885]]

    Dated: April 26, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-8738 Filed 5-2-05; 8:45 am]
BILLING CODE 4160-01-S