Legal Status
Legal Status
Rule
New Animal Drugs; Change of Sponsor's Name
A Rule by the Food and Drug Administration on
Document Details
Information about this document as published in the Federal Register.
- Printed version:
- 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
-
Enhanced Content - Table of Contents
This tables of contents is a navigational tool, processed from the headings within the legal text of Federal Register documents. This repetition of headings to form internal navigation links has no substantive legal effect.
Enhanced Content - Table of Contents
-
Enhanced Content - Submit Public Comment
- This feature is not available for this document.
Enhanced Content - Submit Public Comment
-
Enhanced Content - Read Public Comments
- This feature is not available for this document.
Enhanced Content - Read Public Comments
-
Enhanced Content - Sharing
- Shorter Document URL
- https://www.federalregister.gov/d/03-6492 https://www.federalregister.gov/d/03-6492
Enhanced Content - Sharing
-
Enhanced Content - Document Tools
These tools are designed to help you understand the official document better and aid in comparing the online edition to the print edition.
-
These markup elements allow the user to see how the document follows the Document Drafting Handbook that agencies use to create their documents. These can be useful for better understanding how a document is structured but are not part of the published document itself.
Display Non-Printed Markup Elements
Enhanced Content - Document Tools
-
-
Enhanced Content - Developer Tools
This document is available in the following developer friendly formats:
- JSON: Normalized attributes and metadata
- XML: Original full text XML
- MODS: Government Publishing Office metadata
More information and documentation can be found in our developer tools pages.
Enhanced Content - Developer Tools
Published Document
This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.
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 InfoFOR 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 InformationSUPPLEMENTARY 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 SubjectsList 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 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 PartPART 510-NEW ANIMAL DRUGS
End Part Start Amendment Part1. The authority citation for 21 CFR part 510 continues to read as follows:
End Amendment Part Start AuthorityAuthority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
End Authority Start Amendment Part2. 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(c) * * *
(1) * * *
Firm name and address | Drug labeler code |
---|---|
* * * * * | |
Bioniche Animal Health USA, Inc., 119 Rowe Rd., Athens, GA 30601 | 064847 |
* * * * * |
(2) * * *
Drug labeler code | Firm name and address |
---|---|
* * * * * | |
064847 | Bioniche Animal Health USA, Inc., 119 Rowe Rd., Athens, GA 30601 |
* * * * * |
Dated: February 10, 2003.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. 03-6492 Filed 3-18-03; 8:45 am]
BILLING CODE 4160-01-S