2011-20182. New Animal Drugs; Change of Sponsor; Moxidectin

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 approved new animal drug applications (NADAs) for dosage form products containing moxidectin from Fort Dodge Animal Health, Division of Wyeth, a wholly owned subsidiary of Pfizer, Inc., to Boehringer Ingelheim Vetmedica, Inc.

DATES:

This rule is effective August 9, 2011.

FOR FURTHER INFORMATION CONTACT:

Steven D. Vaughn, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7520 Standish Pl., Rockville, MD 20855, 240-276-8300, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Fort Dodge Animal Health, Division of Wyeth, a wholly owned subsidiary of Pfizer, Inc., 235 East 42d St., New York, NY 10017 has informed FDA that it has transferred ownership of, and all rights and interest in, the following three approved NADAs for dosage form products containing moxidectin to Boehringer Ingelheim Vetmedica, Inc., 2621 North Belt Highway, St. Joseph, MO 64506-2002: NADA 141-099, NADA 141-220, and NADA 141-247. Accordingly, the Agency is amending the regulations in 21 CFR parts 520, 522, and 524 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, 522, 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, 522, 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.

2. In § 520.1454, revise paragraphs (b) and (d) to read as follows:

§ 520.1454

Moxidectin solution.

* * * * *

(b) Sponsor. See No. 000010 in § 510.600(c) of this chapter.

* * * * *

(d) Special considerations. See § 500.25 of this chapter.

* * * * *

PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

3. The authority citation for 21 CFR part 522 continues to read as follows:

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

4. In § 522.1450, redesignate paragraph (d) as paragraph (e); add new paragraph (d); and revise paragraph (b) and newly redesignated paragraphs (e)(1) and (e)(3) to read as follows:

§ 522.1450

Moxidectin solution.

* * * * *

(b) Sponsor. See No. 000010 in § 510.600(c) of this chapter.

* * * * *

(d) Special considerations. See § 500.25 of this chapter.

(e) * * *

(1) Amount. Administer 0.2 mg/kg of body weight (0.2 mg/2.2 pound) as a single, subcutaneous injection.

* * * * *

(3) Limitations. Do not slaughter cattle within 21 days of treatment. Because a withholding time for milk has not been established, do not use in female dairy cattle 20 months of age and older. A withdrawal period has not been established for pre-ruminating calves. Do not use in calves to be processed for veal.

PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

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

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

§ 524.1451

[Redesignated as § 524.1450 and Amended]

6. Redesignate § 524.1451 as § 524.1450 and revise paragraphs (a), (b), and (e)(1) to read as follows:

§ 524.1450

Moxidectin.

(a) Specifications. Each milliliter contains 5 milligrams (mg) moxidectin (0.5 percent solution).

(b) Sponsor. See No. 000010 in § 510.600(c) of this chapter.

* * * * *

(e) * * *

(1) Amount. Administer topically 0.5 mg per kilogram of body weight.

* * * * *

Dated: August 3, 2011.

Elizabeth Rettie,

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