E6-14899. New Animal Drugs; Zilpaterol

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 new animal drug application (NADA) filed by Intervet Inc. The NADA provides for use of a zilpaterol hydrochloride Type A medicated article to formulate Type B and Type C medicated feeds for cattle fed in confinement for slaughter.

DATES:

This rule is effective September 8, 2006.

FOR FURTHER INFORMATION CONTACT:

Eric S. Dubbin, Center for Veterinary Medicine (HFV-120), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301 827-1600, e-mail: eric.dubbin@.fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

Intervet Inc., P.O. Box 318, 29160 Intervet Lane, Millsboro, DE 19966, filed NADA 141-258 for the oral use of ZILMAX (zilpaterol hydrochloride 4.8%) Type A medicated article to formulate Type B (liquid and dry) and Type C medicated cattle feeds used for increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter during the last 20 to 40 days on feed. The NADA is approved as of August 10, 2006, and the regulations are amended in part 556 (21 CFR part 556) and part 558 (21 CFR part 558) by adding new §§ 556.765 and 558.665 and by amending § 558.4 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 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 Division of Dockets Management (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 carefully considered the potential environmental impact of this action and has concluded that the action will not have a significant impact on the human environment and that an environmental impact statement is not required. FDA's finding of no significant impact and the evidence supporting that finding, contained in an environmental assessment, may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

Under section 512(c)(2)(F)(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360b(c)(2)(F)(i)), this approval qualifies for 5 years of marketing exclusivity beginning August 10, 2006.

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

21 CFR Part 556

• Animal drugs
• Foods

21 CFR Part 558

• Animal drugs
• Animal feeds

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 parts 556 and 558 are amended as follows:

PART 556—TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

1. The authority citation for 21 CFR part 556 continues to read as follows:

Authority: 21 U.S.C. 342, 360b, 371.

2. Add § 556.765 to read as follows:

§ 556.765

Zilpaterol.

(a) Acceptable daily intake (ADI). The ADI for total residues of zilpaterol is 0.083 micrograms per kilogram of body weight per day.

(b) Tolerances—(1) Cattle—(i) Liver (the target tissue). The tolerance for zilpaterol freebase (the marker residue) is 12 parts per billion (ppb).

(ii) [Reserved]

(2) [Reserved]

PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

3. The authority citation for 21 CFR part 558 continues to read as follows:

Authority: 21 U.S.C. 360b, 371.

4. In paragraph (d) of § 558.4, in the “Category II” table, alphabetically add an entry for “Zilpaterol” to read as follows:

§ 558.4

Requirement of a medicated feed mill license.

* * * * *

(d) * * *

CATEGORY II

Drug	Assay limits percent1 Type A	Type B maximum (100x)	Assay limits percent1 Type B/C2
*         *         *         *         *         *         *
Zilpaterol	90-110	680 g/t (0.075%)	80-110/75-115
1 Percent of labeled amount.
2 Values given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two range limits, the first set is for a Type B medicated feed and the second set is for a Type C medicated feed. These values (ranges) have been assigned in order to provide for the possibility of dilution of a Type B medicated feed with lower assay limits to make Type C medicated feed.

* * * * *

5. Add § 558.665 to read as follows:

§ 558.665

Zilpaterol.

(a) Specifications. Type A medicated articles containing 21.77 grams (g) zilpaterol hydrochloride per pound.

(b) Approvals. See No. 057926 in § 510.600(c) of this chapter.

(c) Tolerances. See § 556.765 of this chapter.

(d) Special considerations—(1) Labeling of Type B and Type C cattle feeds shall bear the following:

(i) Do not allow horses or other equines access to feed containing zilpaterol.

(ii) Not for use in animals intended for breeding.

(iii) Do not use in veal calves.

(2) Type B Liquid Feeds can be manufactured containing 68 to 680 g zilpaterol hydrochloride/ton. The liquid Type B feeds must be maintained at a pH of 3.8 to 7.5. For liquid feeds stored in recirculating tank systems: Recirculate immediately prior to use for not less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used. For liquid feeds stored in mechanical, air or other agitation-type tank systems: Agitate immediately prior to use for not less than 10 minutes, creating a turbulence at the bottom of the tank that is visible at the top. Agitate daily as described even when not used.

(3) Do not pellet medicated feeds containing zilpaterol.

(e) Conditions of use in cattle—(1) Amount. 6.8 g/ton of feed to provide 60 to 90 milligrams zilpaterol hydrochloride per head per day.

(2) Indications for use. For increased rate of weight gain, improved feed efficiency and increased carcass leanness in cattle fed in confinement for slaughter during the last 20 to 40 days on feed.

(3) Limitations. Feed continuously as the sole ration during the last 20 to 40 days on feed. Withdrawal period: 3 days.

Dated: August 29, 2006.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.