Document ID: FDA-2011-N-0003-0064
Agency: fda
Document Type: Rule
Title: Implantation or Injectable Dosage Form New Animal Drugs: Gonadotropin Releasing Factor Analog-Diphtheria Toxoid Conjugate
Posted Date: 2012-01-27T05:00Z

[Federal Register Volume 77, Number 18 (Friday, January 27, 2012)]
[Rules and Regulations]
[Page 4227]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-1754]

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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 Analog-Diphtheria Toxoid Conjugate

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of a supplemental new animal drug 
application (NADA) filed by Pfizer, Inc. The supplemental NADA extends 
the slaughter interval for intact male swine injected with gonadotropin 
releasing factor analog-diphtheria toxoid conjugate injectable 
solution.

DATES: This rule is effective January 27, 2012.

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, email: matthew.lucia@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY 
10017, filed a supplement to NADA 141-322 for IMPROVEST (gonadotropin 
releasing factor analog-diphtheria toxoid conjugate) Sterile Solution 
for Injection, administered as two doses 4 weeks apart to intact male 
pigs for the reduction of boar taint. The supplement extends the 
slaughter interval from 4 to 8 weeks after the second dose to 3 to 10 
weeks. The supplemental NADA is approved as of November 30, 2011, and 
the regulations in 21 CFR 522.1083 are amended to reflect the 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)(ii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this supplemental approval 
qualifies for 3 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. In Sec.  522.1083, revise paragraphs (c)(1) and (c)(3) to read as 
follows:

Sec.  522.1083  Gonadotropin releasing factor analog-diphtheria toxoid 
conjugate.

* * * * *
    (c) * * *
    (1) Amount. Administer 0.4 mg (2 milliliter (mL)) by subcutaneous 
injection no earlier than 9 weeks of age. A second subcutaneous 
injection of 0.4 mg (2 mL) should be administered at least 4 weeks 
after the first dose.
* * * * *
    (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. Pigs should be 
slaughtered no earlier than 3 weeks and no later than 10 weeks after 
the second dose.

    Dated: January 23, 2012.
William T. Flynn,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 2012-1754 Filed 1-26-12; 8:45 am]
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