[Federal Register Volume 60, Number 177 (Wednesday, September 13, 1995)]
[Rules and Regulations]
[Page 47480]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-22638]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 510
New Animal Drugs; Change of Sponsor Name
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 name of approved
applications from Animal Sciences Division of Monsanto Co. to Protiva,
A Unit of Monsanto Co.
EFFECTIVE DATE: September 13, 1995.
FOR FURTHER INFORMATION CONTACT: Judith M. O'Haro, Center for
Veterinary Medicine (HFV-238), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1737.
SUPPLEMENTARY INFORMATION: Animal Sciences Division of Monsanto Co.,
800 North Lindbergh Blvd., St. Louis, MO 63167, has informed FDA of a
change of sponsor name to Protiva, A Unit of Monsanto Co. Accordingly,
FDA is amending the regulations in 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: Secs. 201, 301, 501, 502, 503, 512, 701, 721 of the
Federal Food, Drug, and Cosmetic Act (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 ``Animal Sciences Division of Monsanto
Co.'' and by alphabetically adding a new entry for ``Protiva, A Unit of
Monsanto Company,'' and in the table in paragraph (c)(2) in the entry
for ``059945'' by removing the sponsor name ``Animal Sciences Division
of Monsanto Co.'' and adding in its place ``Protiva, A Unit of Monsanto
Company.''
Dated: September 1, 1995.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 95-22638 Filed 9-12-95; 8:45 am]
BILLING CODE 4160-01-F
