[Federal Register Volume 76, Number 93 (Friday, May 13, 2011)]
[Rules and Regulations]
[Pages 27888-27889]
From the Federal Register Online via the Government Publishing 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: [email protected].
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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