[Federal Register Volume 66, Number 90 (Wednesday, May 9, 2001)]
[Rules and Regulations]
[Page 23589]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-11584]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 556


Tolerances for Residues of New Animal Drugs in Food; Narasin

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 which provides for 
establishing a tolerance for residues of narasin in edible tissues of 
chickens.

DATES: This regulation is effective May 9, 2001.

FOR FURTHER INFORMATION CONTACT: Janis R. Messenheimer, Center for 
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7578.

SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli 
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a 
supplement to NADA 118-980 that provides for the use of 
Monteban<Register> (36, 45, 54, 72, or 90 grams per pound narasin 
activity), a Type A medicated article. The supplement provides for 
establishing a tolerance for residues of narasin in the abdominal fat 
of chickens. The supplement is approved as of April 11, 2001, and 21 
CFR 556.428 is amended to reflect the approval. The basis of approval 
is discussed in the freedom of information summary.
    In addition, FDA is taking the opportunity to codify the acceptable 
daily intake for total residues of narasin which was previously 
established.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 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(a)(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 556

    Animal drugs, Foods.

    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 556 is 
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. Section 556.428 is revised to read as follows:


Sec. 556.428  Narasin.

    (a) Acceptable daily intake (ADI). The ADI for total residues of 
narasin is 5 micrograms per kilogram of body weight per day.
    (b) Tolerances--(1) Chickens (abdominal fat). The tolerance for 
parent narasin (the marker residue) is 480 parts per billion.
    (2) [Reserved]

    Dated: May 1, 2001.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 01-11584 Filed 5-8-01; 8:45 am]
BILLING CODE 4160-01-S