[Federal Register Volume 65, Number 198 (Thursday, October 12, 2000)]
[Rules and Regulations]
[Page 60585]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-26023]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 510


New Animal Drugs; Change of Sponsor's 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's name from Carl S. 
Akey, Inc., to Akey, Inc.

DATES: This rule is effective October 12, 2000.

FOR FURTHER INFORMATION CONTACT: Thomas J. McKay, Center for Veterinary 
Medicine (HFV09102), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0213.

SUPPLEMENTARY INFORMATION: Carl S. Akey, Inc., P.O. Box 607, Lewisburg, 
OH 45338, has informed FDA of a change of sponsor's name to Akey, Inc. 
Accordingly, the agency is amending the regulations in 21 CFR 
510.600(c)(1) and (c)(2) to reflect the change of sponsor's name.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 80109808.

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) in the entry for ``Carl S. Akey, Inc.'' and in paragraph (c)(2) 
in the entry for ``017790'' by removing the sponsor's name and adding 
in its place ``Akey, Inc.''.

    Dated: September 28, 2000.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Food Safety 
and Applied Nutrition.
[FR Doc. 00-26023 Filed 10-11-00; 8:45 am]
BILLING CODE 4160-01-F