E9-28009. New Animal Drugs for Use in Animal Feeds; Change of Sponsor

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

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.

DATES:

This rule is effective November 23, 2009.

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: [e-mail].

SUPPLEMENTARY 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.

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:

PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

1. The authority citation for 21 CFR part 558 continues to read as follows:

Authority: 21 U.S.C. 360b, 371.

§ 558.55

[Amended]

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”.

3. Amend § 558.58 as follows:

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:

§ 558.58

Amprolium and ethopabate.

* * * * *

(b) Approvals. See No. 016592 in § 510.600(c) of this chapter.

* * * * *

§ 558.175

[Amended]

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”.

Dated: November 16, 2009.

Steven D. Vaughn,

Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.