Document ID: FDA-2008-N-0312-0003
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection;
Comment Request; Extralabel Drug Use in Animals
Posted Date: 2014-11-04T05:00Z

[Federal Register Volume 79, Number 213 (Tuesday, November 4, 2014)]
[Notices]
[Pages 65408-65409]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-26143]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0312]

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 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 
associated with extralabel drug use in animals.

DATES: Submit electronic or written comments on the collection of 
information by January 5, 2015.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. 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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

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 530 (OMB Control Number--0910-
0325)--Extension

    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 the 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 Agencies, academia, 
or individuals.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
         21 CFR section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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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 65409]]

    Dated: October 29, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-26143 Filed 11-3-14; 8:45 am]
BILLING CODE 4164-01-P