[Federal Register Volume 66, Number 75 (Wednesday, April 18, 2001)]
[Rules and Regulations]
[Page 19854]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-9522]


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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; Lasalocid

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 Alpharma, Inc., which provides for 
establishing tolerances for residues of lasalocid in edible tissues of 
poultry.

DATES: This rule is effective April 18, 2001.

FOR FURTHER INFORMATION CONTACT: Charles J. Andres, Center for 
Veterinary Medicine (HFV-128), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-1600.

SUPPLEMENTARY INFORMATION: Alpharma, Inc., One Executive Dr., P.O. Box 
1399, Fort Lee, NJ 07024, filed a supplement to NADA 96-298 that 
provides for the use of Avatec (lasalocid sodium) Premix, a 
Type A medicated article. The supplement provides for establishing 
tolerances for residues of lasalocid in edible tissues of chickens and 
turkeys. The supplement is approved as of February 20, 2001, and the 
regulations in Sec. 556.347 (21 CFR 556.347) are amended to reflect the 
approval. The basis of approval is discussed in the freedom of 
information summary.
    In addition, the agency is taking the opportunity to codify the 
acceptable daily intake (ADI) for total residues of lasalocid which was 
previously established, and to establish a tolerance for residues of 
lasalocid in sheep liver. The regulations are further amended in 
Sec. 556.347 to reflect these actions.
    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 556.347 is revised to read as follows:


Sec. 556.347  Lasalocid.

    (a) Acceptable daily intake (ADI). The ADI for total residues of 
lasalocid is 10 micrograms per kilogram of body weight per day.
    (b) Tolerances--(1) Cattle. The tolerance for parent lasalocid (the 
marker residue) in liver (the target tissue) is 0.7 part per million 
(ppm).
    (2) Chickens--(i) Skin with adhering fat (the target tissue). The 
tolerance for parent lasalocid (the marker residue) is 1.2 ppm.
    (ii) Liver. The tolerance for parent lasalocid (the marker residue) 
is 0.4 ppm.
    (3) Turkeys--(i) Liver (the target tissue). The tolerance for 
parent lasalocid (the marker residue) is 0.4 ppm.
    (ii) Skin with adhering fat. The tolerance for parent lasalocid 
(the marker residue) is 0.4 ppm.
    (4) Rabbits. The tolerance for parent lasalocid (the marker 
residue) in liver (the target tissue) is 0.7 ppm.
    (5) Sheep. The tolerance for parent lasalocid (the marker residue) 
in liver (the target tissue) is 1.0 ppm.

    Dated: April 9, 2001.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 01-9522 Filed 4-17-01; 8:45 am]
BILLING CODE 4160-01-S