[Federal Register Volume 60, Number 129 (Thursday, July 6, 1995)]
[Rules and Regulations]
[Page 35123]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-16626]



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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 a supplemental new animal drug 
application (NADA) filed by Lloyd, Inc. The supplemental NADA provides 
for intramuscular use in Cervidae spp. of xylazine injection to produce 
sedation accompanied by a shorter period of analgesia.

EFFECTIVE DATE: July 6, 1995.

FOR FURTHER INFORMATION CONTACT: Marcia K. Larkins, Center For 
Veterinary Medicine (HFV-112), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-0614.

SUPPLEMENTARY INFORMATION: Lloyd Inc., 604 West Thomas Ave., 
Shenandoah, IA 51601, has filed supplemental NADA 139-236, which 
provides for use of AnaSed Xylazine Injection containing 
xylazine hydrochloride equivalent to 100 milligrams (mg) xylazine per 
milliliter (mL) in horses, and 20 mg/mL in dogs and cats. The 
supplemental NADA provides for intramuscular use of 100 mg/mL xylazine 
injection in Cervidae spp. (fallow deer, mule deer, sika deer, white-
tailed deer, and elk) 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.
    Supplemental NADA 139-236 is approved as a generic copy of Bayer's 
NADA 47-956 for Rompun (xylazine 100 mg/mL) injectable. The 
supplemental NADA is approved as of May 16, 1995, and the regulations 
are amended in 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, 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).


Sec. 522.2662  [Amended]

    2. Section 522.2662 Xylazine hydrochloride injection is amended in 
paragraph (b) by revising the statement ``See 061690 in Sec. 510.600(c) 
of this chapter for use in horses, dogs, and cats'' by adding after 
``horses'' the words ``wild deer, elk,''.

    Dated: June 28, 1995.
Andrew J. Beaulieau,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 95-16626 Filed 7-5-95; 8:45 am]
BILLING CODE 4160-01-F