Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for an approved new animal drug application (NADA) from Combe, Inc., to Farnham Companies, Inc.
This rule is effective June 4, 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: email@example.com.End Further Info End Preamble Start Supplemental Information
Combe, Inc., 1101 Westchester Ave., White Plains, NY 10604, has informed FDA that it has transferred ownership of, and all rights and interest in, NADA 5-236 for SULFODENE Medication for Dogs to Farnam Companies, Inc., 301 West Osborn, Phoenix, AZ 85013-3928. Accordingly, the agency is amending the regulations in 21 CFR 524.1376 to reflect the transfer of ownership.
Following this change of sponsorship, Combe, Inc., is no longer the sponsor of any approved application. Accordingly, § 510.600(c) is being amended to remove the entries for Combe, 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
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 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGSEnd Part Start Amendment Part
3. The authority citation forEnd Amendment Part
4. Section 524.1376End Amendment Part Start Signature
Dated: May 19, 2003.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. 03-14107 Filed 6-3-03; 8:45 am]
BILLING CODE 4160-01-S