[Federal Register Volume 60, Number 185 (Monday, September 25, 1995)]
[Rules and Regulations]
[Page 49339]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-23600]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 522
Implantation or Injectable Dosage Form New Animal Drugs; Ketamine
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 Fermenta Animal Health Co. The ANADA
provides for intramuscular use of ketamine hydrochloride injection in
cats for restraint and to produce anesthesia that is suitable for
diagnostic or minor surgical procedures that do not require skeletal
muscle relaxation and in nonhuman primates for restraint.
EFFECTIVE DATE: September 25, 1995.
FOR FURTHER INFORMATION CONTACT: Sandra K. Woods, Center for Veterinary
Medicine (HFV-110), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-594-1616.
SUPPLEMENTARY INFORMATION: Fermenta Animal Health Co., P.O. Box 338,
15th and Oak Sts., Elwood, KS 66024, filed ANADA 200-029, which
provides for intramuscular use of ketamine hydrochloride injection
(equivalent to 100 milligrams/milliliter (mg/mL) ketamine) in cats for
restraint and to produce anesthesia that is suitable for diagnostic or
minor surgical procedures that do not require skeletal muscle
relaxation and in nonhuman primates for restraint. The drug is limited
to use by or on the order of a licensed veterinarian.
Fermenta Animal Health's ANADA 200-029 for ketamine hydrochloride
injection (equivalent to 100 mg/mL ketamine) is approved as a generic
copy of Fort Dodge Laboratories' NADA 045-290 for Vetalar /
Ketaset (ketamine hydrochloride injection equivalent to 100
mg/mL ketamine). The ANADA is approved as of August 16, 1995, and the
regulations are amended in 21 CFR 522.1222a(c) to reflect the approval.
The basis of approval is discussed in the freedom of information
summary.
In addition, Sec. 522.1222a is amended by removing and reserving
paragraphs (a) and (d).
In accordance with the freedom of information provisions of part 20
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (21 CFR 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, rm. 1-23,
12420 Parklawn Dr., Rockville, MD 20855, from 9 a.m. to 4 p.m., Monday
through Friday.
The agency has carefully considered the potential environmental
effects of this action. FDA has concluded that the action will not have
a significant impact on the human environment, and that an
environmental impact statement is not required. The agency's finding of
no significant impact and the evidence supporting that finding,
contained in an environmental assessment, may be seen in the Dockets
Management Branch (address above), between 9 a.m. and 4 p.m., Monday
through Friday.
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: Sec. 512 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b).
2. Section 522.1222a is amended by removing and reserving
paragraphs (a) and (d), and by revising paragraph (c) to read as
follows:
Sec. 522.1222a Ketamine hydrochloride injection.
(a) [Reserved]
* * * * *
(c) Sponsors. See Nos. 000856, 045984, 054273, and 057319 in
Sec. 510.600(c) of this chapter.
(d) [Reserved]
* * * * *
Dated: September 8, 1995.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 95-23600 Filed 9-22-95; 8:45 am]
BILLING CODE 4160-01-F
