00-26023. New Animal Drugs; Change of Sponsor's 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 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.

§ 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.