[Federal Register Volume 64, Number 245 (Wednesday, December 22, 1999)]
[Rules and Regulations]
[Page 71640]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-33121]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 529
Certain Other Dosage Form New Animal Drugs; Sevoflurane
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 a new animal drug application
(NADA) filed by Abbott Laboratories. The NADA provides for use of
sevoflurane as an inhalant for induction and maintenance of general
anesthesia in dogs.
EFFECTIVE DATE: December 22, 1999.
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.
SUPPLEMENTARY INFORMATION: Abbott Laboratories, 1401 Sheridan Rd.,
North Chicago, IL 60064-4000, filed NADA 141-103 that provides for use
of SevoFloTM (sevoflurane) as an inhalant for induction and
maintenance of general anesthesia in dogs. The NADA is approved as of
November 17, 1999, and the regulations are amended by adding
Sec. 529.2150 to reflect the approval. The basis for approval is
discussed in the freedom of information summary.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 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 Dockets Management Branch (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 for nonfood
producing animals qualifies for 5 years of market exclusivity beginning
November 17, 1999, because no active ingredient (including any ester or
salt of the active ingredient) has been approved in any other
application.
The agency 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.
List of Subjects in 21 CFR Part 529
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 529 is
amended as follows:
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 529 continues to read as
follows:
Authority: 21 U.S.C. 360b.
2. Section 529.2150 is added to read as follows:
Sec. 529.2150 Sevoflurane.
(a) Specifications. The drug is a clear, colorless, stable liquid
containing no additives or chemical stabilizers.
(b) Sponsor. See No. 000074 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. For induction of surgical
anesthesia: 5 to 7 percent sevoflurane with oxygen. For maintenance of
surgical anesthesia: 3.7 to 4 percent sevoflurane with oxygen in the
absence of premedication and 3.3 to 3.6 percent in the presence of
premedication.
(2) Indications for use. For induction and maintenance of general
anesthesia in dogs.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Dated: December 13, 1999.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 99-33121 Filed 12-21-99; 8:45 am]
BILLING CODE 4160-01-F