Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for five approved new animal drug applications (NADAs) from Merial Ltd., 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
Merial Ltd., 3239 Satellite Blvd., Bldg. 500, Duluth, GA 30096-4640 has informed FDA that it has transferred ownership of, and all rights and interest in, the following five approved NADAs to Huvepharma AD, 33 James Boucher Blvd., Sophia 1407, Bulgaria:
|Application No.||Trade name(s)|
|012-350||AMPROVINE (amprolium) 25% Type A Medicated Article; CORID (amprolium) 25% Type A Medicated Article|
|013-149||AMPROVINE (amprolium) 9.6% Solution|
|013-461||Broiler PMX No. 1620 (amprolium/ethopabate)|
|033-165||AMPROVINE (amprolium) 20% Soluble Powder; CORID (amprolium) 20% Soluble Powder|
|034-393||COYDEN 25 (clopidol); Lerbek 25|
Accordingly, the agency is amending the regulations in 21 CFR 520.100, 558.55, 558.58, and 558.175 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 SubjectsEnd 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 520—ORAL DOSAGE FORM NEW ANIMAL DRUGSEnd Part Start Amendment Part
1. The authority citation forEnd Amendment Part
2. In paragraph (b)(1) of § 520.100, remove “050604” and in its place add “016592”.End Amendment Part Start Part
PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDSEnd Part Start Amendment Part
3. The authority citation forEnd Amendment Part
4. In paragraph (a) of § 558.55, remove “050604” and in its place add “No. 016592”.End Amendment Part Start Amendment Part
5. In § 558.58, in the table in paragraph (e)(1)(i), in the first entry, in the “Sponsor” column, add “050604” and “016592”; add paragraph (a)(3); and revise paragraph (b) to read as follows:End Amendment Part
(a) * * *
(3) 25 percent amprolium and 0.8 percent ethopabate.
(b) Approvals. See § 510.600(c) of this chapter.
(1) No. 050604 for products described in paragraph (a) of this section.
(2) No. 016592 for product described in paragraph (a)(3) of this section.
6. In § 558.175, in paragraph (b) and in the table in paragraph (d)(1) in the “Sponsor” column, remove “050604” and in its place add “016592”.End Amendment Part Start Signature
Dated: October 17, 2007.
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-21057 Filed 10-24-07; 8:45 am]
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