[Federal Register: May 3, 2005 (Volume 70, Number 84)]
[Notices]
[Page 22884-22885]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03my05-62]
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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://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,
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