Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's name from Summit Hill Laboratories to Putney, Inc.
This rule is effective May 5, 2009.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, 240-276-8307, e-mail: email@example.com.End Further Info End Preamble Start Supplemental Information
Summit Hill Laboratories, P.O. Box 535, Navesink, NJ 07752, has informed FDA that it has transferred ownership of, and all rights and interest in, NADA 8-760 for ADRENOMONE (repository corticotropin injection U.S.P.) to Putney, Inc., 400 Congress St., suite 200, Portland, ME 04101. Accordingly, the regulations are amended in 21 CFR 522.480 to reflect this change of sponsorship.
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 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 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGSEnd Part Start Amendment Part
1. The authority citation forEnd Amendment Part
2. In paragraph (a)(2) of § 522.480, remove “037990” and add in its place “026637”.End Amendment Part Start Signature
Dated: April 30, 2009.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. E9-10291 Filed 5-4-09; 8:45 am]
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