[Federal Register Volume 65, Number 130 (Thursday, July 6, 2000)]
[Rules and Regulations]
[Page 41588]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-16976]


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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; Fenbendazole

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 Hoechst Roussel Vet. The supplemental NADA 
provides for establishing tolerances for residues of fenbendazole in 
edible tissues of cattle. Also, a tolerance for parent fenbendazole in 
goat muscle is established.

DATES: This rule is effective July 6, 2000.

FOR FURTHER INFORMATION CONTACT: Janis R. Messenheimer, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7578.

SUPPLEMENTARY INFORMATION: Hoechst Roussel Vet, Perryville Corporate 
Park III, P.O. Box 4010, Clinton, NJ 08809-4010, filed a supplement to 
NADA 128-620 that provides for use of Safe-Guard<Register> 
(fenbendazole) 10% Suspension for Cattle and Panacur<Register> 
(fenbendazole) 10% Suspension for Cattle. The supplement provides for 
establishing a tolerance for parent fenbendazole in cattle muscle. The 
supplement is approved as of May 9, 2000, and the regulations in 
Sec. 556.275 (21 CFR 556.275) are amended to reflect the approval. The 
basis of approval is discussed in the freedom of information summary.
    In addition, FDA is reviewing information in the application and it 
is establishing a tolerance for parent fenbendazole in goat muscle. The 
regulations are further amended in Sec. 556.275 to reflect this action.
    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 556.275 is amended by adding paragraphs (b)(1)(ii) and 
(b)(3)(ii) to read as follows:


Sec. 556.275  Fenbendazole.

* * * * *
    (b) * * *
    (1) * * *
    (ii) Muscle. The tolerance for parent fenbendazole (the marker 
residue) is 0.4 ppm.
* * * * *
    (3) * * *
    (ii) Muscle. The tolerance for parent fenbendazole (the marker 
residue) is 0.4 ppm.

    Dated: June 19, 2000.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 00-16976 Filed 7-5-00; 8:45 am]
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