[Federal Register Volume 66, Number 130 (Friday, July 6, 2001)]
[Rules and Regulations]
[Page 35544]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-16990]


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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; Clorsulon

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 Merial Ltd. The supplemental NADA provides 
for establishing a tolerance for residues of clorsulon in the muscle 
tissue of cattle.

DATES: This rule is effective July 6, 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: Merial Ltd., 2100 Ronson Rd., Iselin, NJ 
08830-3077, filed a supplement to NADA 136-742 that provides for the 
use of Curatrem (clorsulon) Drench in cattle for the 
treatment of liver fluke infestations. The supplement provides for 
establishing a tolerance for residues of clorsulon in the muscle tissue 
of cattle. The supplement is approved as of May 16, 2001, and 
Sec. 556.163 (21 CFR 556.163) is amended to reflect the approval. The 
basis of approval is discussed in the freedom of information summary.
    Section 556.163 is further amended by deleting references to safe 
concentrations and by adding the previously established acceptable 
daily intake of total residues of clorsulon.
    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 556.163 is revised to read as follows:


Sec. 556.163  Clorsulon.

    (a) Acceptable daily intake (ADI). The ADI for total residues of 
clorsulon is 8 micrograms per kilogram of body weight per day.
    (b) Tolerances--(1) Cattle--(i) Kidney (the target tissue). The 
tolerance for parent clorsulon (the marker residue) is 1.0 part per 
million.
    (ii) Muscle. The tolerance for parent clorsulon (the marker 
residue) is 0.1 part per million.
    (2) [Reserved]

    Dated: June 25, 2001.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 01-16990 Filed 7-5-01; 8:45 am]
BILLING CODE 4160-01-S