[Federal Register Volume 60, Number 246 (Friday, December 22, 1995)]
[Rules and Regulations]
[Page 66496]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-31198]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 558


New Animal Drugs; Change of Sponsor

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect a change of sponsor for two new animal drug 
applications (NADA's) from Farmland Industries, Inc., to A. L. Pharma, 
Inc.
EFFECTIVE DATE: December 22, 1995.

FOR FURTHER INFORMATION CONTACT: Thomas J. McKay, Center for Veterinary 
Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0213.

SUPPLEMENTARY INFORMATION: Farmland Industries, Inc., Kansas City, MS 
64116, has informed FDA that it has transferred the ownership of, and 
all rights and interests in, approved NADA's 46-415 (Tylosin Premixes) 
and 91-749 (Tylosin-Sulfa Premixes) to A. L. Pharma, Inc., One 
Executive Dr., Fort Lee, NJ 07024. Accordingly, the agency is amending 
the regulations in 21 CFR 558.625 and 558.630.

List of Subject in 21 CFR Part 558

    Animal drugs, Animal feeds.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR part 558 is 
amended as follows:

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

    1. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: Secs. 512, 701 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b, 371).


Sec. 558.625  [Amended]

    2. Section 558.625 Tylosin is amended in paragraph (b)(83) by 
removing ``021676'' and adding in its place ``046573''.


Sec. 558.630  [Amended]

    3. Section 558.630 Tylosin and sulfamethazine is amended in 
paragraph (b)(10) by removing ``021676'' and by adding ``046573'' in 
numerical order.

    Dated: December 14, 1995.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 95-31198 Filed 12-21-95; 8:45 am]
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