[Federal Register Volume 68, Number 139 (Monday, July 21, 2003)]
[Rules and Regulations]
[Pages 42968-42969]
From the Federal Register Online via the Government Publishing 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: [email protected].
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