[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]
BILLING CODE 4160-01-F
