Document ID: FDA-2022-N-1128-0017
Agency: fda
Document Type: Rule
Title: Defining Small Number of Animals for Minor Use Determination; Periodic Reassessment; Confirmation of Effective Date
Posted Date: 2022-12-14T05:00Z

[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 [www.gpo.gov]
[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: [email protected].

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]
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