[Federal Register Volume 63, Number 148 (Monday, August 3, 1998)]
[Rules and Regulations]
[Page 41188]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-20531]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 510
Animal Drugs, Feeds, 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 the change of sponsor for an approved new
animal drug application (NADA) from Ohmeda Pharmaceutical Products
Division, Inc., to Baxter Pharmaceutical Products, Inc.
EFFECTIVE DATE: August 3, 1998.
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: Ohmeda Pharmaceutical Products Division,
Inc., Liberty Corner, NJ 07938-0804, has informed FDA that it has
transferred the ownership of, and all rights and interests in, approved
NADA 135-773 (isoflurane) to Baxter Pharmaceutical Products, Inc., 110
Allen Rd., P.O. Box 804, Liberty Corner, NJ 07938. The new sponsor will
retain the drug labeler code for Ohmeda, Pharmaceutical Products, Inc.
The agency is amending the regulations in 21 CFR 510.600(c)(1) and
(c)(2) to reflect the new sponsor name.
List of Subject in 21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
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 510 is
amended as follows:
PART 510--NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 510 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
Sec. 510.600 [Amended]
2. Section 510.600 Names, addresses, and drug labeler codes of
sponsors of approved applications is amended in the table in paragraph
(c)(1) by removing the entry for ``Ohmeda Pharmaceutical Products
Division, Inc.,'' and by alphabetically adding an entry for ``Baxter
Pharmaceutical Products, Inc., 110 Allen Rd., Liberty Corner, NJ
07938''; and in the table in paragraph (c)(2) in the entry for
``010019'' by removing the sponsor name ``Ohmeda Pharmaceutical
Products Division, Inc.,'' and adding in its place ``Baxter
Pharmaceutical Products, Inc., 110 Allen Rd.,''.
Dated: July 10, 1998.
Margaret Ann Miller,
Acting Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 98-20531 Filed 7-31-98; 8:45 am]
BILLING CODE 4160-01-F
