[Federal Register Volume 89, Number 6 (Tuesday, January 9, 2024)]
[Notices]
[Pages 1099-1100]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-00219]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-3168]


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) 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 8, 2024.

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: Rachel Showalter, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399, 
<a href="/cdn-cgi/l/email-protection#5d0d0f1c0e293c3b3b1d3b393c7335352e733a322b"><span class="__cf_email__" data-cfemail="d484869587a0b5b2b294b2b0b5fabcbca7fab3bba2">[email protected]</span></a>.

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

    This information collection supports FDA implementation of section 
512 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 
360b), which governs new animal drugs. Agency regulations in 21 CFR 
part 530 permit FDA, if we find that there is a reasonable probability 
that the extralabel use of an animal drug may present a risk to public 
health, to establish a safe level for a residue from

[[Page 1100]]

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. This requirement is codified at Sec.  530.22(b) (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. Respondents to the 
information collection are private sector drug sponsors or veterinary 
associations, or veterinarians, State, local, and tribal governments, 
and Federal Agencies.
    In the Federal Register of August 31, 2023 (88 FR 60213), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    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 Section; activity                          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 4, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-00219 Filed 1-8-24; 8:45 am]
BILLING CODE 4164-01-P


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