Document ID: FDA-2008-N-0312-0012
Agency: fda
Document Type: Notice
Title: Agency Information Collection
Activities; Submission for Office of Management and Budget Review; Comment Request; Extralabel Drug Use in Animals
Posted Date: 2021-01-13T05:00Z

[Federal Register Volume 86, Number 8 (Wednesday, January 13, 2021)]
[Notices]
[Pages 2673-2674]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-00475]

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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; 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 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: Submit written comments (including recommendations) on the 
collection of information by February 12, 2021.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0325. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
PRAStaff@fda.hhs.gov.

[[Page 2674]]

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 for Animals--21 CFR 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 prevent the 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, Federal, and/or State Agencies; 
academia; or individuals.
    In the Federal Register of August 6, 2020 (85 FR 47794), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment was received but was not 
responsive to topics solicited regarding the information collection.
    We estimate the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of
                            21 CFR part                                 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.

    Based on a review of the information collection since our last 
request for OMB approval, we have made no adjustments to our burden 
estimate.

    Dated: January 5, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-00475 Filed 1-12-21; 8:45 am]
BILLING CODE 4164-01-P