New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship; Correction

Federal Register, Volume 81 Issue 82 (Thursday, April 28, 2016)

Federal Register Volume 81, Number 82 (Thursday, April 28, 2016)

Rules and Regulations

Page 25328

From the Federal Register Online via the Government Publishing Office www.gpo.gov

FR Doc No: 2016-09865

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 524

Docket No. FDA-2016-N-0002

New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment; correcting amendments.

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SUMMARY: The Food and Drug Administration (FDA) published a document in the Federal Register of April 18, 2016 (81 FR 22520), amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January and February 2016. That rule included two amendatory instructions that cited incorrect sections of 21 CFR part 524.

DATES: Effective: April 28, 2016.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5689, george.haibel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In FR Doc. 2016-08827, appearing on page 22520 in the Federal Register of Monday, April 18, 2016, the following corrections are made:

On page 22524, in the third column, remove amendatory instructions 35 and 36.

List of Subjects in 21 CFR Part 524

Animal drugs.

Accordingly, 21 CFR part 524 is corrected by making the following correcting amendments:

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

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1. The authority citation for part 524 continues to read as follows:

   Authority: 21 U.S.C. 360b.

   Sec. 524.1193 Amended

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2. In paragraph (b)(2) of Sec. 524.1193, remove ``000859'' and in its place add ``016592''.

   Sec. 524.1484k Amended

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3. In Sec. 524.1484k, revise the section heading to read: Neomycin and prednisolone suspension.

   Dated: April 22, 2016.

   Tracey Forfa,

   Acting Director, Center for Veterinary Medicine.

   FR Doc. 2016-09865 Filed 4-27-16; 8:45 am

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