[Federal Register Volume 70, Number 220 (Wednesday, November 16, 2005)]
[Rules and Regulations]
[Pages 69438-69439]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-22752]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Tylosin

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 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: 
[email protected].

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

[[Page 69439]]

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.

0
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

0
1. The authority citation for 21 CFR part 520 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.
0
2. In Sec.  520.2640, revise paragraph (e) introductory text, and add 
paragraph (e)(4) to read as follows:


Sec.  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.
[FR Doc. 05-22752 Filed 11-15-05; 8:45 am]
BILLING CODE 4160-01-S