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Rule

New Animal Drugs; Change of Sponsor's Name

A Rule by the Food and Drug Administration on 03/19/2003

Document Details

Information about this document as published in the Federal Register.

Printed version:
PDF
Publication Date:
03/19/2003
Agencies:
Food and Drug Administration
Dates:
This rule is effective March 19, 2003.
Effective Date:
03/19/2003
Document Type:
Rule
Document Citation:
68 FR 13225
Page:
13225-13226 (2 pages)
CFR:
21 CFR 510
Document Number:
03-6492
Document Details
Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble

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 Vetrepharm Research, Inc., to Bioniche Animal Health USA, Inc.

DATES:

This rule is effective March 19, 2003.

Start Further Info

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: dnewkirk@cvm.fda.gov.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

Vetrepharm Research, Inc., 119 Rowe Rd., Athens, GA 30601, has informed FDA of a change of name to Bioniche Animal Health USA, Inc. Accordingly, the agency is amending the regulations in 21 CFR 510.600(c) to reflect this 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.

Start List of Subjects

List of Subjects in 21 CFR Part 510

  • Administrative practice and procedure
  • Animal drugs
  • Labeling
  • Reporting and recordkeeping requirements
End List of Subjects Start Amendment Part

Therefore, under the Federal Food, Drug, and Cosmetic Act and under Start Printed Page 13226authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 510 is amended as follows:

End Amendment Part Start Part

PART 510-NEW ANIMAL DRUGS

End Part Start Amendment Part

1. The authority citation for 21 CFR part 510 continues to read as follows:

End Amendment Part Start Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

End Authority Start Amendment Part

2. Section 510.600 is amended in the table in paragraph (c)(1) by removing the entry for “Vetrepharm Research, Inc.” and by alphabetically adding an entry for “Bioniche Animal Health USA, Inc.”; and in the table in paragraph (c)(2) by revising the entry for “064847” to read as follows:

End Amendment Part
Names, addresses, and drug labeler codes of sponsors of approved applications.
* * * * *

(c) * * *

(1) * * *

Firm name and addressDrug labeler code
*    *    *    *    *
Bioniche Animal Health USA, Inc., 119 Rowe Rd., Athens, GA 30601064847
*    *    *    *    *

(2) * * *

Drug labeler codeFirm name and address
*    *    *    *    *
064847Bioniche Animal Health USA, Inc., 119 Rowe Rd., Athens, GA 30601
*    *    *    *    *
Start Signature

Dated: February 10, 2003.

Steven D. Vaughn,

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

End Signature End Supplemental Information

[FR Doc. 03-6492 Filed 3-18-03; 8:45 am]

BILLING CODE 4160-01-S

Published Document