05-22752. Oral Dosage Form New Animal Drugs; Tylosin

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 Elanco Animal Health. The supplemental NADA provides for use of tylosin soluble powder in honey bees for the control of American foulbrood (Paenibacillus larvae).

DATES:

This rule is effective November 16, 2005.

FOR FURTHER INFORMATION CONTACT:

Joan C. Gotthardt, Center for Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Elanco Animal Health, A Division of Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a supplement to NADA 13 076 that provides for the use of TYLAN (tylosin tartrate) Soluble in honey bees for the control of American foulbrood (Paenibacillus larvae). The approval of this supplemental NADA relied on publicly available safety and effectiveness data contained in Public Master File (PMF) 5783 which were compiled under National Research Support Project 7 (NRSP 7), a national agricultural research program for obtaining clearances for use of new drugs in minor animal species and for special uses. The supplemental NADA is approved as of October 17, 2005, and the regulations in 21 CFR 520.2640 are amended 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.

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 520

• Animal drugs

Therefore, under the Federal Food, Drug, and Cosmetic Act and under the authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 520 is amended as follows:

PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

1. The authority citation for 21 CFR part 520 continues to read as follows:

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

2. In § 520.2640, revise paragraph (e) introductory text, and add paragraph (e)(4) to read as follows:

§ 520.2640

Tylosin.

* * * * *

(e) Conditions of use—

* * * * *

(4) Honey bees—(i) Amount. Mix 200 milligrams tylosin in 20 grams confectioners'/powdered sugar. Use immediately. Apply (dust) this mixture over the top bars of the brood chamber once weekly for 3 weeks.

(ii) Indications for use. For the control of American foulbrood (Paenibacillus larvae).

(iii) Limitations. The drug should be fed early in the spring or fall and consumed by the bees before the main honey flow begins, to avoid contamination of production honey. Complete treatments at least 4 weeks before main honey flow.

Dated: November 3, 2005.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.