[Federal Register Volume 62, Number 249 (Tuesday, December 30, 1997)]
[Rules and Regulations]
[Pages 67724-67725]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-33920]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs And Related Products; 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 seven new animal
drug applications (NADA's) from Rhone-Poulenc, Inc., to Alpharma Inc.
EFFECTIVE DATE: December 30, 1997.
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: Rhone-Poulenc, Inc., P.O. Box 125, Black
Horse Lane, Monmouth Junction, NJ 08852, has informed FDA that it has
transferred ownership of, and all rights and interests in, the
following approved NADA's to Alpharma Inc., One Executive Dr., Fort
Lee, NJ 07024:
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NADA Ingredient
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039-417 Decoquinate
040-435 Decoquinate, roxarsone
045-348 Decoquinate, zinc bacitracin
045-444 Decoquinate, chlortetracycline
047-262 Decoquinate, lincomycin
091-326 Decoquinate, roxarsone, zinc bacitracin
092-953 Roxarsone
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[[Page 67725]]
The agency is amending 21 CFR part 558 to reflect the change of
sponsor.
List of Subjects 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: (21 U.S.C. 360b, 371).
Sec. 558.195 [Amended]
2. Section 558.195 Decoquinate is amended in paragraph (a) by
removing ``011526'' and adding in its place ``046573'' and in the table
in paragraph (d), under the ``sponsor column'' by removing ``011526''
wherever it appears and adding in its place ``046573''.
Sec. 558.530 [Amended]
3. Section 558.530 Roxarsone is amended in paragraph (a) by
removing ``011526'' and adding in its place ``046573''.
Dated: December 18, 1997.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 97-33920 Filed 12-29-97; 8:45 am]
BILLING CODE 4160-01-F
