Document ID: FDA-2008-N-0312-0007
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Extralabel Drug Use in Animals
Posted Date: 2018-01-10T05:00Z

[Federal Register Volume 83, Number 7 (Wednesday, January 10, 2018)]
[Notices]
[Pages 1262-1263]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-00237]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Extralabel Drug Use in Animals

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing 
that a 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.

DATES: Fax written comments on the collection of information by 
February 9, 2018.

ADDRESSES: 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,

[[Page 1263]]

OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to 
[email protected]. All comments should be identified with the 
OMB control number 0910-0325. Also include the FDA docket number found 
in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[email protected].

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.

Extralabel Drug Use in Animals--21 CFR Part 530

OMB Control Number 0910-0325--Extension

    The Animal Medicinal Drug Use Clarification Act of 1994 (Pub. L. 
103-396) 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 (21 CFR 530.22(b)). 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 and/or State Agencies, 
academia, or individuals.
    In the Federal Register of June 26, 2017 (82 FR 28858), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of
                           21 CFR section                               Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
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530.22(b), Submission(s) of Analytical Method......................               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.

    The burden estimate has not changed, and remains the same.

    Dated: January 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-00237 Filed 1-9-18; 8:45 am]
 BILLING CODE 4164-01-P