[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