[Federal Register Volume 61, Number 172 (Wednesday, September 4, 1996)]
[Rules and Regulations]
[Page 46548]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-22487]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 522
Implantation or Injectable Dosage Form New Animal Drugs; Xylazine
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 Chanelle Pharmaceuticals Manufacturing
Ltd. The ANADA provides for intravenous, intramuscular, or subcutaneous
use of xylazine injection in dogs and cats to produce sedation
accompanied by a shorter period of analgesia.
EFFECTIVE DATE: September 4, 1996.
FOR FURTHER INFORMATION CONTACT: Sandra K. Woods, Center For Veterinary
Medicine (HFV-114), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-594-1617.
SUPPLEMENTARY INFORMATION: Chanelle Pharmaceuticals Manufacturing Ltd.,
Loughrea, County Galway, Ireland, filed ANADA 200-184, which provides
for intravenous, intramuscular, and subcutaneous use of
Chanazine (20 milligrams/milliliter (mg/mL)) Injectable
(xylazine hydrochloride equivalent to 20 mg xylazine per mL) in dogs
and cats to produce sedation accompanied by a shorter period of
analgesia. The drug is limited to use by or on the order of a licensed
veterinarian.
Approval of ANADA 200-184 for Chanelle's Chanazine
(xylazine 20 mg/mL) Injectable is as a generic copy of Bayer's NADA 47-
955 for Rompun (xylazine 20 mg/mL) injectable. The ANADA is
approved as of July 12, 1996, and the regulations are amended by
revising 21 CFR 522.2662(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 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, 12420
Parklawn Dr., rm. 1-23, Rockville, MD 20857, between 9 a.m. and 4 p.m.,
Monday through Friday.
The agency has determined under 21 CFR 25.24(d)(1)(i) 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: Sec. 512 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b).
2. Section 522.2662 is amended by revising the first two sentences
in paragraph (b) to read as follows:
Sec. 522.2662 Xylazine hydrochloride injection.
* * * * *
(b) Sponsor. See 000856 in Sec. 510.600(c) of this chapter for use
in horses, wild deer, and elk. See 000859 and 061651 in Sec. 510.600(c)
of this chapter for use in horses, wild deer, elk, dogs, and cats. * *
*
* * * * *
Dated: August 20, 1996.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 96-22487 Filed 9-3-96; 8:45 am]
BILLING CODE 4160-01-F
