03-12120. Implantation or Injectable Dosage Form New Animal Drugs; Xylazine

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

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

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 § 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

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: 21 U.S.C. 360b.

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

§ 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 § 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.