68 FR 53 pgs. 13225-13226 - New Animal Drugs; Change of Sponsor's Name
Type: RULEVolume: 68Number: 53Pages: 13225 - 13226
FR document: [FR Doc. 03-6492 Filed 3-18-03; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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.
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.
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.
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.
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 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:
§ 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications.
(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