Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for a new animal drug application (NADA) from Boehringer Ingelheim Vetmedica, Inc. to Phoenix Scientific, Inc.
This rule is effective February 18, 2005.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
Boehringer Ingelheim Vetmedica, Inc., 2621 North Belt Hwy., St. Joseph, MO 64506-2002, has informed FDA that it has transferred ownership of, and all rights and interest in, NADA 140-270 for Sulfamethazine Sustained Release Bolus to Phoenix Scientific, Inc., 3915 South 48th St. Terr., St. Joseph, MO 64503.
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 in 21 CFR Part 520
- 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 part 520 is amended as follows:End Amendment Part Start Part
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGSEnd Part Start Amendment Part
1. The authority citation for 21 CFR part 520 continues to read as follows:End Amendment Part
2. Section 520.2260b is amended in paragraph (f)(1) by removing “000010” and by adding in its place “059130”.End Amendment Part Start Signature
Dated: February 8, 2005.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. 05-3178 Filed 2-17-05; 8:45 am]
BILLING CODE 4160-01-S