[Federal Register Volume 60, Number 203 (Friday, October 20, 1995)]
[Rules and Regulations]
[Page 54193]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-25958]
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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 from Miles, Inc.,
Agriculture Division, Animal Health Products to Bayer Corp.,
Agriculture Division, Animal Health.
EFFECTIVE DATE: October 20, 1995.
FOR FURTHER INFORMATION CONTACT: Benjamin A. Puyot, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1646.
SUPPLEMENTARY INFORMATION: Miles, Inc., Agriculture Division, Animal
Health Products, P.O. Box 390, Shawnee Mission, KS 66201-0390, has
informed FDA of a change of sponsor name to Bayer Corp., Agriculture
Division, Animal Health. 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 ``Miles, Inc., Agriculture Division,
Animal Health Products,'' and by alphabetically adding a new entry for
``Bayer Corp., Agriculture Division, Animal Health,'' and in the table
in paragraph (c)(2) in the entry for ``000859'' by removing the sponsor
name ``Miles, Inc., Agriculture Division, Animal Health Products'' and
adding in its place ``Bayer Corp., Agriculture Division, Animal
Health.''
Dated: October 5, 1995.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 95-25958 Filed 10-19-95; 8:45 am]
BILLING CODE 4160-01-F
