Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for sulfadiazine and pyrimethamine oral suspension from Animal Health Pharmaceuticals, LLC, to Pegasus Laboratories, Inc.
This rule is effective November 15, 2010.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Steven D. Vaughn, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7520 Standish Pl., Rockville, MD 20855, 240-276-8300, e-mail: email@example.com.End Further Info End Preamble Start Supplemental Information
Animal Health Pharmaceuticals, LLC, 1805 Oak Ridge Circle, suite 101, St. Joseph, MO 64506, has informed FDA that it has transferred ownership of, and all rights and interest in, NADA 141-240 for REBALANCE (sulfadiazine and pyrimethamine) Antiprotozoal Oral Suspension to Pegasus Laboratories, Inc., 8809 Ely Rd., Pensacola, FL 32514. Accordingly, the regulations are amended in 21 CFR 520.2215 to reflect this change of sponsorship.
Following this change of sponsorship, Animal Health Pharmaceuticals, LLC, is no longer the sponsor of an approved application. Accordingly, § 510.600 (21 Start Printed Page 69586CFR 510.600) is being amended to remove the entries for this firm.
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. In § 510.600, in the table in paragraph (c)(1) remove the entry for “Animal Health Pharmaceuticals, LLC”; and in the table in paragraph (c)(2) remove the entry for “068718”.End Amendment Part Start Part
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGSEnd Part Start Amendment Part
3. The authority citation forEnd Amendment Part
4. In paragraph (b) of § 520.2215, remove “068718” and add in its place “055246”.End Amendment Part Start Signature
Dated: November 8, 2010.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. 2010-28549 Filed 11-12-10; 8:45 am]
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