Document ID: FDA-2016-N-0002-0010
Agency: fda
Document Type: Rule
Title: New Animal Drugs: Approval of New Animal Drug Applications; Changes of Sponsorship; Correction
Posted Date: 2016-04-28T04:00Z

[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]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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

0
1. The authority citation for part 524 continues to read as follows:

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

Sec.  524.1193  [Amended]

0
2. In paragraph (b)(2) of Sec.  524.1193, remove ``000859'' and in its 
place add ``016592''.

Sec.  524.1484k  [Amended]

0
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]
 BILLING CODE 4164-01-P