[Federal Register Volume 63, Number 98 (Thursday, May 21, 1998)]
[Rules and Regulations]
[Page 27844]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-13162]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 510


Animal Drugs, Feeds, and Related Products; Change of Sponsor Name

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect the change of sponsor name from Protiva, a 
unit of Monsanto, to Monsanto Co.

EFFECTIVE DATE: May 21, 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: Protiva, a unit of Monsanto has informed FDA 
of a change of sponsor name to Monsanto Co. Accordingly, FDA is 
amending 21 CFR 510.600(c)(1) and (c)(2) to reflect the change of 
sponsor name.

List of Subjects 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 ``Protiva, A Unit of Monsanto Co.'' 
and by alphabetically adding a new entry for ``Monsanto Co., 800 North 
Lindbergh Blvd., St. Louis, MO 63167'' and in the table in paragraph 
(c)(2) in the entry for ``059945'' by removing the sponsor name 
``Protiva, A Division of Monsanto Co.'' and adding in its place 
``Monsanto Co.''

    Dated: May 8, 1998.
 Andrew J. Beaulieu,
 Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 98-13162 Filed 5-20-98; 8:45 am]
BILLING CODE 4160-01-F