Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for two approved new animal drug applications (NADAs) from Zema Corp. to Virbac AH, Inc.
This rule is effective June 8, 2004.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: email@example.com.End Further Info End Preamble Start Supplemental Information
Zema Corp., P.O. Box 12803, Research Triangle Park, Durham, NC 27709, has informed FDA that it has transferred ownership of, and all rights and interest in, the following two approved NADAs to Virbac AH, Inc., 3200 Meacham Blvd., Ft. Worth, TX 76137:
|Application No.||21 CFR Section||Trade Name|
|NADA 102-942||520.580||PULVEX Multipurpose Worm Caps|
|NADA 091-260||520.1804||PULVEX Worm Caps|
Accordingly, the agency is amending the regulations in 21 CFR 520.580 and 520.1804 to reflect the transfer of ownership.
Following these changes of sponsorship, Zema Corp. is no longer the sponsor of an approved application. Accordingly, the agency is amending the regulations in 21 CFR 510.600(c) to remove the entries for Zema Corp.
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
- Administrative practice and procedure
- Animal drugs
- Reporting and recordkeeping requirements
- Animal drugs
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 parts 510 and 520 are amended as follows:End Amendment Part Start Part
PART 510—NEW ANIMAL DRUGSEnd Part Start Amendment Part
1. The authority citation for 21 CFR part 510 continues to read as follows:End Amendment Part
2. Section 510.600 is amended in the table in paragraph (c)(1) by removing the entry for “Zema Corp.” and in the table in paragraph (c)(2) by removing the entry for “050906”.End Amendment Part Start Part
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGSEnd Part Start Amendment Part
3. The authority citation for 21 CFR part 520 continues to read as follows:End Amendment Part
4. Section 520.580 is amended in paragraph (b)(1) by removing “050906” and by adding in its place “051311”.End Amendment Part
5. Section 520.1804 is amended in paragraph (b) by removing “050906” and by adding in its place “051311”.End Amendment Part Start Signature
Dated: May 19, 2004.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. 04-12840 Filed 6-7-04; 8:45 am]
BILLING CODE 4160-01-S