[Federal Register Volume 70, Number 120 (Thursday, June 23, 2005)]
[Rules and Regulations]
[Pages 36336-36337]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-12422]


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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; 
Embutramide, Chloroquine, and Lidocaine 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 new animal drug 
application (NADA) filed by Phoenix Scientific, Inc. The NADA provides 
for veterinary prescription use of a solution containing embutramide, 
chloroquine phosphate, and lidocaine by intravenous injection for 
euthanasia of dogs.

DATES: This rule is effective June 23, 2005.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7543, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Phoenix Scientific, Inc., 3915 South 48th 
Street Ter., St. Joseph, MO 64503, filed NADA 141 245 that provides for 
veterinary prescription use of TRIBUTAME Euthanasia Solution 
(embutramide; chloroquine phosphate, U.S.P.; and lidocaine, USP) by 
intravenous injection for euthanasia of dogs. The NADA is approved as 
of May 20, 2005, and the regulations are amended in 21 CFR part 522 by 
adding Sec.  522.810 to reflect the approval. The 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.
    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 approval qualifies for 
3 years of marketing exclusivity beginning May 20, 2005.

[[Page 36337]]

    FDA has determined under 21 CFR 25.33(d)(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 Subject 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 522.810 is added to read as follows:


Sec.  522.810  Embutramide, chloroquine, and lidocaine solution.

    (a) Specifications. Each milliliter (mL) of solution contains 135 
milligrams (mg) embutramide; 45 mg chloroquine phosphate, U.S.P.; and 
1.9 mg lidocaine, U.S.P.
    (b) Sponsor. See No. 059130 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. One mL per 5 pounds of 
body weight.
    (2) Indications for use. For euthanasia.
    (3) Limitations. Not for use in animals intended for food. Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.

    Dated: June 10, 2005.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 05-12422 Filed 6-22-05; 8:45 am]
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