[Federal Register Volume 70, Number 36 (Thursday, February 24, 2005)]
[Rules and Regulations]
[Pages 8928-8929]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-3595]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


Implantation or Injectable Dosage Form New Animal Drugs; 
Euthanasia Solution

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 an original abbreviated new 
animal drug application (ANADA) filed by Med-Pharmex, Inc. The ANADA 
provides for use of an injectable solution of pentobarbital sodium and 
phenytoin sodium for humane, painless, and rapid euthanasia of dogs.

DATES: This rule is effective February 24, 2005.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 301-827-8549, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Med-Pharmex, Inc., 2727 Thompson Creek Rd., 
Pomona, CA 91767-1861, filed ANADA 200-280 that provides for use of 
EUTHANASIA III (pentobarbital sodium and phenytoin sodium) Solution for 
humane, painless, and rapid euthanasia of dogs. Med-Pharmex, Inc.'s 
EUTHANASIA-III Solution is approved as a generic copy of Schering-
Plough Animal Health Corp.'s BEUTHANASIA-D Special, approved under NADA 
119-807. The ANADA is approved as of February 3, 2005, and the 
regulations are amended in 21 CFR 522.900 to reflect the approval. The

[[Page 8929]]

basis of approval is discussed in the freedom of information summary.
    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.
    The agency has determined under 21 CFR 25.33(a)(1) 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.

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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

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

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

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2. Section 522.900 is amended by revising paragraph (b)(1) to read as 
follows:


Sec.  522.900  Euthanasia solution.

* * * * *
    (b) * * *
    (1) Nos. 000061, 051259, and 051311 for use of product described in 
paragraph (a)(1) of this section.
* * * * *

    Dated: February 15, 2005.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 05-3595 Filed 2-23-05; 8:45 am]
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