2011-11762. Implantation or Injectable Dosage Form New Animal Drugs; Gonadotropin Releasing Factor-Diphtheria Toxoid Conjugate

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Pfizer, Inc. The NADA provides for the veterinary prescription use of gonadotropin releasing factor-diphtheria toxoid conjugate by subcutaneous injection for temporary immunological castration (suppression of testicular function) and reduction of boar taint in intact male pigs intended for slaughter.

DATES:

This rule is effective May 13, 2011.

FOR FURTHER INFORMATION CONTACT:

Matthew Lucia, Center for Veterinary Medicine (HFV-128), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8116, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Pfizer, Inc., 235 East 42d St., New York, NY 10017-5755, filed NADA 141-322 that provides for the veterinary prescription use of IMPROVEST (gonadotropin releasing factor-diphtheria toxoid conjugate) Sterile Solution for Injection for temporary immunological castration (suppression of testicular function) and reduction of boar taint in intact male pigs intended for slaughter. The application is approved as of March 22, 2011, and the regulations are amended in 21 CFR part 522 to reflect approval.

In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

Under section 512(c)(2)(F)(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(i)), this approval qualifies for 5 years of marketing exclusivity beginning on the date of approval.

The Agency has determined under 21 CFR 25.33 that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

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 522

• 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 part 522 is amended as follows:

PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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

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

2. Add § 522.1083 to read as follows:

§ 522.1083

Gonadotropin releasing factor-diphtheria toxoid conjugate.

(a) Specifications. Each milliliter (mL) of solution contains 0.2 milligrams (mg) gonadotropin releasing factor-diphtheria toxoid conjugate.

(b) Sponsor. See No. 000069 in § 510.600(c) of this chapter.

(c) Conditions of use in swine—(1) Amount. Administer 0.4 mg per intact male pig (2 mL) by subcutaneous injection no earlier than 9 weeks of age. A second subcutaneous injection of 0.4 mg per intact male pig (2 mL) should be administered at least 4 weeks after the first dose. Pigs should be slaughtered no earlier than 4 weeks and no later than 8 weeks after the second dose.

(2) Indications for use. For the temporary immunological castration (suppression of testicular function) and reduction of boar taint in intact male pigs intended for slaughter.

(3) Limitations. Not approved for use in female pigs and barrows. Do not use in intact male pigs intended for breeding because of the disruption of reproductive function. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Dated: May 4, 2011.

Bernadette Dunham,

Director, Center for Veterinary Medicine.