Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is amending the Start Printed Page 60552animal drug regulations to reflect a change of sponsor for seven approved new animal drug applications (NADAs) from Schering-Plough Animal Health Corp. to Huvepharma AD.
This rule is effective October 25, 2007.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
Schering-Plough Animal Health Corp., 556 Morris Ave., Summit NJ 07901, has informed FDA that it has transferred ownership of, and all rights and interest in, the following seven approved NADAs to Huvepharma AD, 33 James Boucher Blvd., Sophia 1407, Bulgaria:
|Application No.||Trade name(s)|
|140-951||CLINICOX (diclazuril) Type A Medicated Article|
|141-090||CLINICOX / STAFAC|
|141-153||CLINICOX / BMD|
|141-158||CLINICOX / FLAVOMYCIN|
|141-190||CLINICOX / BMD / 3-NITRO|
|141-194||CLINICOX / BMD|
|141-195||CLINICOX / FLAVOMYCIN|
Accordingly, the agency is amending the regulations in 21 CFR 558.198 to reflect the transfer of ownership.
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 558End 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 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDSEnd Part Start Amendment Part
1. The authority citation forEnd Amendment Part
2. In § 558.198, in paragraph (b), remove “000061” and in its place add “016592”; and in the tables in paragraphs (d)(1) and (d)(2), in the “Sponsor” column, remove “000061” wherever it occurs and in its place add “016592”.End Amendment Part Start Signature
Dated: October 17, 2007.
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-21059 Filed 10-24-07; 8:45 am]
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