Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 10 new animal drug applications (NADAs) from Merial Ltd. to Huvepharma AD.
This rule is effective November 23, 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: 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 10 approved NADAs to Huvepharma AD, 33 James Boucher Blvd., Sophia 1407, Bulgaria: NADA 036-304, 049-179, 049-180, 118-507, 040-264, 041-541, 044-016, 046-209, 049-934, and 099-150. Accordingly, the agency is amending the regulations 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 558
- Animal drugs
- Animal feeds
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 558 is amended as follows:End Amendment Part Start Part
PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDSEnd Part Start Amendment Part
1. The authority citation for 21 CFR part 558 continues to read as follows:End Amendment Part
2. In § 558.55, in paragraph (d)(2)(iv), in the table, in the entry for “Carbarsone 227 to 340.5”, in the “Sponsor” column, remove “000006” and in its place add “016592”.End Amendment Part Start Amendment Part
3. Amend § 558.58 as follows:End Amendment Part
a. Remove paragraphs (a)(3), (b)(1), and (b)(2);
b. In paragraph (e)(1)(i), in the table, in the “Sponsor” column, remove “050604”;
c. In paragraphs (e)(1)(ii) and (e)(1)(iii), in the table, in the “Limitations” column, remove “050604” wherever it occurs and in its place add “016592”; and
d. Revise paragraph (b).
The revisions are to read as follows:
(b) Approvals. See No. 016592 in § 510.600(c) of this chapter.
4. In § 558.175, in paragraph (b) and in the table in paragraph (d), in the “Sponsor” column, remove “050604” wherever it occurs and in its place add “016592”.End Amendment Part Start Signature
Dated: November 16, 2009.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. E9-28009 Filed 11-20-09; 8:45 am]
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