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 new animal drug applications (NADAs) and three abbreviated new animal drug applications (ANADAs) from Delmarva Pharmaceuticals, Inc., to Virbac AH, Inc.
This rule is effective September 29, 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: firstname.lastname@example.org.End Further Info End Preamble Start Supplemental Information
Delmarva Laboratories, Inc., 1500 Huguenot Rd., suite 106, Midlothian, VA 23113, has informed FDA that it has transferred ownership of, and all rights and interest in, the following two approved NADAs and three approved ANADAs to Virbac AH, Inc., 3200 Meacham Blvd., Ft. Worth, TX 76137:
|Application No.||21 CFR Section||Trade Name|
|NADA 065-492||520.88f||ROBAMOX V (amoxicillin trihydrate) Tablets|
|NADA 065-495||520.88b||ROBAMOX V (amoxicillin trihydrate)|
|ANADA 200-071||522.900||EUTHASOL Solution|
|ANADA 200-291||520.447||CLINSOL (clindamycin hydrochloride) Liquid|
|ANADA 200-316||520.446||CLINTABS (clindamycin hydrochloride) Tablets|
Accordingly, the agency is amending the regulations in §§ 520.88b, 520.88f, 520.446, 520.447, and 522.900 to reflect the transfer of ownership.
Following these changes of sponsorship, Delmarva Laboratories, Inc., is no longer the sponsor of an approved application. Accordingly, 21 CFR 510.600(c) is being amended to remove the entries for Delmarva Laboratories, Inc.
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
and 522End List of Subjects Start Amendment Part
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,End Amendment Part Start Part
PART 510—NEW ANIMAL DRUGSEnd Part Start Amendment Part
1. The authority citation forEnd Amendment Part
2. Section 510.600End Amendment Part Start Part
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGSEnd Part Start Amendment Part
3. The authority citation forEnd Amendment Part
4. Section 520.88bEnd Amendment Part
5. Section 520.88fEnd Amendment Part
6. Section 520.446End Amendment Part
7. Section 520.447End Amendment Part Start Part
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGSEnd Part Start Amendment Part
8. The authority citation forEnd Amendment Part
9. Section 522.900End Amendment Part Start Signature
Dated: September 15, 2003.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. 03-24492 Filed 9-26-03; 8:45 am]
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