[Federal Register Volume 59, Number 59 (Monday, March 28, 1994)]
[Unknown Section]
[Page ]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-7201]
[Federal Register: March 28, 1994]
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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 Fort Dodge Laboratories, Inc. The ANADA
provides for intravenous and intramuscular use in horses and
intramuscular use in Cervidae spp. of xylazine injection to produce
sedation accompanied by a shorter period of analgesia.
EFFECTIVE DATE: March 28, 1994.
FOR FURTHER INFORMATION CONTACT: Charles W. Francis, Center For
Veterinary Medicine (HFV-114), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1617.
FOR FURTHER INFORMATION: Fort Dodge Laboratories, Inc. (Fort Dodge),
P.O. Box 518, Fort Dodge, IA 50501, filed ANADA 200-088 which provides
for intravenous and intramuscular use in horses and intramuscular use
in Cervidae spp. (fallow deer, mule deer, Sika deer, white-tailed deer,
and elk) of SedazineTM (xylazine 100 milligrams per milliliter
(mg/mL)) injectable 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.
ANADA 200-088 for Fort Dodge's SedazineTM (xylazine 100 mg/mL)
injectable is as a generic copy of Miles' new animal drug application
(NADA 047-956) for Rompun (xylazine 100 mg/mL) injectable.
The ANADA is approved as of February 24, 1994, and the regulations are
amended in 21 CFR 522.2662 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 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 20857, between 9 a.m. and 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 522.2662 is amended in paragraph (b) by adding a new
sentence after the paragraph heading to read as follows:
Sec. 522.2662 Xylazine hydrochloride injection.
* * * * *
(b) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter for
use in horses, wild deer, and elk. * * *
* * * * *
Dated: March 21, 1994.
Richard H. Teske,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 94-7201 Filed 3-25-94; 8:45 am]
BILLING CODE 4160-01-F
