E9-17356. 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 three new animal drug applications (NADAs) and one abbreviated new animal drug application (ANADA) from Virbac AH, Inc., to Cross Vetpharm Group Ltd.

DATES:

This rule is effective July 22, 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:

Virbac AH, Inc., 3200 Meacham Blvd., Ft. Worth, TX 76137, has informed FDA that it has transferred ownership of, and all rights and interest in, the following three approved NADAs and one approved ANADA to Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland:

Application No. (NADA/ANADA)	21 CFR Section	Product Name
007-076	520.2325a	Sulfa-Nox (sulfaquinoxaline) Liquid
008-244	520.2325a	Sulfa-Nox (sulfaquinoxaline) Concentrate
049-729	520.2261a	PURINA Sulfa (sulfamethazine)
200-318	524.1193	VIRBAMEC (ivermectin) Pour-On

Accordingly, the agency is amending the regulations in 21 CFR 520.2261a, 520.2325a, and 524.1193 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 Parts 520 and 524

• Animal drugs

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 524 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.

§ 520.2261a

[Amended]

2. In paragraph (a) of § 520.2261a, remove “051311 and 053501” and in its place add “053501 and 061623”.

§ 520.2325a

[Amended]

3. In paragraph (a)(2) of § 520.2325a, remove “051311” and in its place add “061623”.

PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

4. The authority citation for 21 CFR part 524 continues to read as follows:

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

§ 524.1193

[Amended]

5. In paragraph (b) of § 524.1193 remove “051311” and in numerical sequence add “061623”.

Dated: July 14, 2009.

Bernadette Dunham,

Director, Center for Veterinary Medicine.