[Federal Register Volume 63, Number 85 (Monday, May 4, 1998)]
[Rules and Regulations]
[Page 24420]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-11740]
[[Page 24420]]
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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; Propofol
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 veterinary
prescription use of propofol emulsion for intravenous injection in dogs
as an anesthetic.
EFFECTIVE DATE: May 4, 1998.
FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center
ForVeterinary Medicine (HFV-110), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1612.
SUPPLEMENTARY INFORMATION: Abbott Laboratories, 1401 Sheridan Rd.,
North Chicago, IL 60064-4000, filed NADA 141-098 that provides for
veterinary prescription use of PropoFlo (propofol) emulsion
for intravenous injection in dogs for induction of anesthesia,
maintenance of anesthesia, or induction of anesthesia where maintenance
is provided by inhalation anesthetic. The NADA is approved as of March
13, 1998, and the regulations are amended in 21 CFR 522.2005(b) 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 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, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857,
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 for nonfood-
producing animals qualifies for 3 years of marketing exclusivity
beginning March 13, 1998, because the application contains substantial
evidence of the effectiveness of the drug involved and studies of
animal safety required for approval and conducted or sponsored by the
applicant.
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 522
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 522 is
amended as follows:
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 522.2005 [Amended]
2. Section 522.2005 Propofol injection is amended in paragraph (b)
by removing ``No. 000061'' and adding in its place ``Nos. 000061 and
000074''.
Dated: April 22, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-11740 Filed 5-1-98; 8:45 am]
BILLING CODE 4160-01-F
