New Animal Drugs; Change of Sponsor's Address

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Federal RegisterAug 5, 2004
69 Fed. Reg. 47360 (Aug. 5, 2004)

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 address for Hess & Clark, Inc., a wholly-owned company of the Neogen Corp.

DATES:

This rule is effective August 5, 2004.

FOR FURTHER INFORMATION CONTACT:

David R. Newkirk, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-6967, e-mail: david.newkirk@fda.gov.

SUPPLEMENTARY INFORMATION:

Hess & Clark, Inc., Seventh and Orange Sts., Ashland, OH 44805, has informed FDA of a change of sponsor's address to 944 Nandino Blvd., Lexington, KY 40511. Accordingly, the agency is amending the regulations in 21 CFR 510.600(c) to reflect the change.

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. 801-808.

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.

2. Section 510.600 is amended in the table in paragraph (c)(1) by revising the entry for “Hess & Clark, Inc.”; and in the table in paragraph (c)(2) by revising the entry for “050749” to read as follows:

§ 510.600
Names, addresses, and drug labeler codes of sponsors of approved applications.

(c) * * *

(1) * * *

Firm name and address Drug labeler code
*    *    *    *    *
Hess & Clark, Inc., 944 Nandino Blvd., Lexington, KY 40511 050749
*    *    *    *    *

(2) * * *

Drug labeler code Firm name and address
*    *    *    *    *
050749 Hess & Clark, Inc., 944 Nandino Blvd., Lexington, KY 40511
*    *    *    *    *

Dated: June 23, 2004.

Steven D. Vaughn,

Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.

[FR Doc. 04-17893 Filed 8-4-04; 8:45 am]

BILLING CODE 4160-01-S