Notice2024-00219
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Extralabel Drug Use in Animals
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
January 9, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 6 (Tuesday, January 9, 2024)</title>
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[Federal Register Volume 89, Number 6 (Tuesday, January 9, 2024)]
[Notices]
[Pages 1099-1100]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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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