[Federal Register Volume 68, Number 94 (Thursday, May 15, 2003)]
[Rules and Regulations]
[Pages 26205-26206]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-12120]


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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; Xylazine

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 use of a 300 milligram per milliliter strength of xylazine 
hydrochloride solution in elk and wild deer to produce sedation, 
accompanied by a shorter period of analgesia. A food safety cautionary 
statement regarding the use of xylazine in elk and wild deer (Cervidae) 
is also being codified for currently approved products.

DATES: This rule is effective May 15, 2003.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl.,

[[Page 26206]]

Rockville, MD 20855, 301-827-7543, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: Lloyd, Inc., 604 West Thomas Ave., 
Shenandoah, IA 51601, filed a supplement to NADA 139-236 that provides 
for use of CERVIZINE 300 (xylazine hydrochloride) solution in elk and 
wild deer to produce sedation, accompanied by a shorter period of 
analgesia. The supplemental NADA is approved as of February 10, 2003, 
and the regulations are amended in Sec.  522.2662 (21 CFR 522.2662) to 
reflect the approval. The basis of approval is discussed in the freedom 
of information summary.
    Section 522.2662 is also being amended to revise a codified food 
safety limitation and to add a food safety cautionary statement 
regarding the use of xylazine in elk and wild deer (Cervidae). Both 
statements are currently used in labeling for both pioneer and generic 
xylazine products. Section 522.2662 is also revised to reflect a 
current format.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 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, 5630 Fishers Lane, 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(d)(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.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 522

    Animal drugs.

0
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

0
1. The authority citation for 21 CFR part 522 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.

0
2. Section 522.2662 and the section heading are revised to read as 
follows:


Sec.  522.2662  Xylazine.

    (a) Specifications. Each milliliter (mL) of solution contains 
xylazine hydrochloride equivalent to:
    (1) 20 milligrams (mg) xylazine.
    (2) 100 mg xylazine.
    (3) 300 mg xylazine.
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter for 
uses as in paragraph (d) of this section.
    (1) No. 000010 for use of product described in paragraph (a)(2) of 
this section as in paragraph (d)(2) of this section.
    (2) No. 000856 for use of product described in paragraph (a)(2) of 
this section as in paragraphs (d)(2), (d)(3)(i), (d)(3)(ii)(A), and 
(d)(3)(iii) of this section.
    (3) Nos. 000859 and 061651 for use of product described in 
paragraph (a)(1) of this section as in paragraph (d)(1); and product 
described in paragraph (a)(2) of this section as in paragraphs (d)(2), 
(d)(3)(i), (d)(3)(ii)(A), and (d)(3)(iii) of this section.
    (4) No. 061690 for use of product described in paragraph (a)(1) of 
this section as in paragraph (d)(1) of this section; product described 
in paragraph (a)(2) of this section as in paragraphs (d)(2), (d)(3)(i), 
(d)(3)(ii)(A), and (d)(3)(iii) of this section; and product described 
in paragraph (a)(3) of this section as in paragraphs (d)(3)(i), 
(d)(3)(ii)(B), and (d)(3)(iii) of this section.
    (c) Special considerations. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.
    (d) Conditions of use--(1) Dogs and cats--(i) Amount. 0.5 mg/pound 
(lb) intravenously or 1.0 mg/lb subcutaneously.
    (ii) Indications for use. To produce sedation, as an analgesic, and 
as a preanesthetic to local or general anesthesia.
    (2) Horses--(i) Amount. 0.5 mg/lb intravenously or 1.0 mg/lb 
intramuscularly.
    (ii) Indications for use. To produce sedation, as an analgesic, and 
as a preanesthetic to local or general anesthesia.
    (iii) Limitations. Not for use in horses intended for food.
    (3) Elk and deer--(i) Amount. Administer intramuscularly, by hand 
syringe, or by syringe dart, in the heavy muscles of the croup or 
shoulder as follows:
    (A) Elk (Cervus canadensis): 0.25 to 0.5 mg/lb.
    (B) Mule deer (Odocoileus hemionus), sika deer (Cervus nippon), and 
white-tailed deer (Odocoileus virginianus): 1 to 2 mg/lb.
    (C) Fallow deer (Dama dama): 2 to 4 mg/lb.
    (ii) Indications for use.
    (A) To produce sedation, as an analgesic, and as a preanesthetic to 
local anesthesia.
    (B) To produce sedation, accompanied by a shorter period of 
analgesia. May be used to calm and facilitate handling of fractious 
animals for diagnostic procedures, for minor surgical procedures, for 
therapeutic medication for sedation and relief of pain following injury 
or surgery, and as a preanesthetic to local anesthetic. At the 
recommended dosages, can be used in conjunction with local anesthetics, 
such as procaine or lidocaine.
    (iii) Limitations. Do not use in domestic food-producing animals. 
Do not use in Cervidae less than 15 days before or during the hunting 
season.

    Dated: April 2, 2003.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 03-12120 Filed 5-14-03; 8:45 am]
BILLING CODE 4160-01-S