Document ID: FDA-2011-N-0003-0017
Agency: fda
Document Type: Rule
Title: Implantation or Injectable Dosage Form New Animal Drugs: Gonadotropin Releasing Factor-Diphtheria Toxoid Conjugate
Posted Date: 2011-05-13T04:00Z

[Federal Register Volume 76, Number 93 (Friday, May 13, 2011)]
[Rules and Regulations]
[Pages 27888-27889]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-11762]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

[Docket No. FDA-2011-N-0003]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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[[Page 27889]]

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: matthew.lucia@fda.hhs.gov.

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

0
1. The authority citation for 21 CFR part 522 continues to read as 
follows:

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

0
2. Add Sec.  522.1083 to read as follows:

Sec.  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 Sec.  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.
[FR Doc. 2011-11762 Filed 5-12-11; 8:45 am]
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