[Federal Register Volume 68, Number 139 (Monday, July 21, 2003)]
[Rules and Regulations]
[Pages 42968-42969]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 03-18352]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


Injectable or Implantable Dosage Form New Animal Drugs; 
Euthanasia Solution; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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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 Schering-Plough Animal Health Corp. and a 
supplemental abbreviated new animal drug application (ANADA) filed by 
Delmarva Laboratories, Inc. The supplemental applications add 
environmental warning statements to product labeling.

DATES: This rule is effective July 21, 2003.

FOR FURTHER INFORMATION CONTACT: Mohammad I. Sharar, Center for 
Veterinary Medicine (HFV-216), Food and Drug Administration, 7500 
Standish

[[Page 42969]]

Pl., Rockville, MD 20855, 301-827-0159; e-mail: msharar@cvm.fda.gov.

SUPPLEMENTARY INFORMATION: Schering-Plough Animal Health Corp., 1095 
Morris Ave., Union, NJ 07083, filed a supplement to NADA 119-807 for 
BEUTHANASIA-D-SPECIAL Solution and Delmarva Laboratories, Inc., 1500 
Huguenot Rd., suite 106, Midlothian, VA 23113, filed a supplement to 
ANADA 200-071 for EUTHASOL Solution. The supplemental applications 
provide for the addition of environmental warning statements to product 
labeling. The supplemental applications are approved as of May 2, 2003, 
and the regulations are amended in Sec.  522.900 (21 CFR 522.900) to 
reflect the approvals.
    In addition, the agency has found that the regulations do not 
reflect the 1996 change of sponsorship (61 FR 5505, February 13, 1996) 
of NADA 128-967 for REPOSE Euthanasia Solution from Syntex Animal 
Health, Division of Syntex Agri-business, Inc., to Fort Dodge Animal 
Health, Division of Wyeth. At this time, Sec.  522.900 is revised to 
reflect that change of sponsorship and a current format.
    The agency has determined under 21 CFR 25.33(d)(1) that these 
actions are of a type that do not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither 
environmental assessments nor environmental impact statements are 
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 the 
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 revised to read as follows:


Sec.  522.900  Euthanasia solution.

    (a) Specifications. Each milliliter (mL) of solution contains:
    (1) 390 milligrams (mg) of pentobarbital sodium and 50 mg phenytoin 
sodium.
    (2) 400 mg secobarbital sodium and 25 mg dibucaine hydrochloride.
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter:
    (1) Nos. 000061 and 059079 for use of product described in 
paragraph (a)(1) of this section.
    (2) No. 000856 for use of product described in paragraph (a)(2) of 
this section.
    (c) Special considerations. Product labeling shall bear the 
following warning statements: ``ENVIRONMENTAL HAZARD: This product is 
toxic to wildlife. Birds and mammals feeding on treated animals may be 
killed. Euthanized animals must be properly disposed of by deep burial, 
incineration, or other method in compliance with state and local laws, 
to prevent consumption of carcass material by scavenging wildlife.''
    (d) Conditions of use in dogs--(1) Indications for use. For humane, 
painless, and rapid euthanasia.
    (2) Amount. One mL per 10 pounds of body weight.
    (3) Limitations. Do not use in animals intended for food. Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.

    Dated: July 7, 2003.
Clifford Johnson,
Director, Office of Surveillance and Compliance, Center for Veterinary 
Medicine.
[FR Doc. 03-18352 Filed 7-18-03; 8:45 am]
BILLING CODE 4160-01-S