Defining Small Number of Animals for Minor Use Determination; Periodic Reassessment; Confirmation of Effective Date
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Abstract
The Food and Drug Administration (FDA) is confirming the effective date of December 14, 2022, for the final rule that appeared in the Federal Register of September 15, 2022. The direct final rule revises the "small number of animals" definition for dogs and cats in our existing regulation for new animal drugs for minor use or minor species. This document confirms the effective date of the direct final rule.
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<title>Federal Register, Volume 87 Issue 239 (Wednesday, December 14, 2022)</title>
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[Federal Register Volume 87, Number 239 (Wednesday, December 14, 2022)]
[Rules and Regulations]
[Page 76425]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-27147]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 516
[Docket No. FDA-2022-N-1128]
Defining Small Number of Animals for Minor Use Determination;
Periodic Reassessment; Confirmation of Effective Date
AGENCY: Food and Drug Administration, HHS.
ACTION: Direct final rule; confirmation of effective date.
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SUMMARY: The Food and Drug Administration (FDA) is confirming the
effective date of December 14, 2022, for the final rule that appeared
in the Federal Register of September 15, 2022. The direct final rule
revises the ``small number of animals'' definition for dogs and cats in
our existing regulation for new animal drugs for minor use or minor
species. This document confirms the effective date of the direct final
rule.
DATES: The effective date of December 14, 2022, for the direct final
rule published September 15, 2022 (87 FR 56583) is confirmed.
FOR FURTHER INFORMATION CONTACT: Janah Maresca, Center for Veterinary
Medicine (HVF-50), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-796-5079, email: <a href="/cdn-cgi/l/email-protection#8de7ece3ece5a3e0ecffe8feeeeccdebe9eca3e5e5fea3eae2fb"><span class="__cf_email__" data-cfemail="2d474c434c4503404c5f485e4e4c6d4b494c0345455e034a425b">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In the Federal Register of September 15,
2022 (87 FR 56583), FDA solicited comments concerning the direct final
rule for a 60-day period ending November 14, 2022. FDA stated that the
effective date of the direct final rule would be on December 14, 2022,
30 days after the end of the comment period, unless any significant
adverse comment was submitted to FDA during the comment period. FDA did
not receive any significant adverse comments.
Authority: 21 U.S.C. 360ccc-1, 360ccc-2, 371. Accordingly, the
amendments issued thereby are effective.
Dated: December 9, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-27147 Filed 12-13-22; 8:45 am]
BILLING CODE 4164-01-P
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