[Federal Register Volume 63, Number 188 (Tuesday, September 29, 1998)]
[Rules and Regulations]
[Pages 51822-51823]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-25910]
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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; Ketamine
Hydrochloride Injection
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 abbreviated new animal drug
application (ANADA) filed by Lloyd, Inc. The ANADA provides for
veterinary prescription use of ketamine hydrochloride injection in cats
for restraint or as an anesthetic and in subhuman primates for
restraint.
EFFECTIVE DATE: September 29, 1998.
FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-0209.
SUPPLEMENTARY INFORMATION: Lloyd, Inc., 604 W. Thomas Ave., P.O. Box A,
Shenandoah, IA 51601-0130, filed ANADA 200-055 that provides for
veterinary prescription use of VetaKetTM ketamine
hydrochloride injection, intramuscularly, in cats for restraint or as
sole anesthetic agent for diagnostic or minor, brief surgical
procedures that do not require skeletal muscle relaxation and in
subhuman primates for restraint.
Lloyd, Inc.'s ANADA 200-055 ketamine hydrochloride injection is
approved as a generic copy of Fort Dodge Animal Health's NADA 45-290
Vetalar (ketamine hydrochloride injection). The ANADA is
approved as of August 3, 1998, and the regulations are amended in 21
CFR 522.1222a(c) 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 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 La., rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m.,
Monday through Friday.
The agency has determined under 21 CFR 25.33(a)(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. 522.1222a [Amended]
2. Section 522.1222a Ketamine hydrochloride injection is amended in
paragraph (c) by removing ``and
[[Page 51823]]
059130'' and by adding in its place ``059130, and 061690.''
Dated: August 27, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-25910 Filed 9-28-98; 8:45 am]
BILLING CODE 4160-01-F
