E7-21057. New Animal Drugs; 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 five approved new animal drug applications (NADAs) from Merial Ltd., to Huvepharma AD.

DATES:

This rule is effective October 25, 2007.

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: [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 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.

List of Subjects

21 CFR Part 520

• Animal drugs

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 parts 520 and 558 are amended as follows:

PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

1. The authority citation for 21 CFR part 520 continues to read as follows:

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

§ 520.100

[Amended]

2. In paragraph (b)(1) of § 520.100, remove “050604” and in its place add “016592”.

PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

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

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

§ 558.55

[Amended]

4. In paragraph (a) of § 558.55, remove “050604” and in its place add “No. 016592”.

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:

§ 558.58

Amprolium and ethopabate.

(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.

§ 558.175

[Amended]

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”.

Dated: October 17, 2007.

Bernadette Dunham,

Deputy Director, Center for Veterinary Medicine.