[Federal Register Volume 70, Number 59 (Tuesday, March 29, 2005)]
[Rules and Regulations]
[Pages 15758-15759]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-6156]


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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; Zeranol

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 Schering-Plough Animal Health Corp. The 
supplemental NADA provides for the establishment of a tolerance for 
residues of zeranol in edible tissues of sheep. Accordingly, the 
analytical method for detecting residues of zeranol in uncooked edible 
tissues of sheep is being removed from the animal drug regulations.

DATES: This rule is effective March 29, 2005.

FOR FURTHER INFORMATION CONTACT: Eric S. Dubbin, Center for Veterinary 
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0232, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: Schering-Plough Animal Health Corp., 1095 
Morris Ave., Union, NJ 07083, filed a supplement to NADA 38-233 for 
RALGRO (zeranol), a subcutaneous implant used in cattle and in sheep 
for improved feed efficiency and/or increased rate of weight gain. The 
supplemental NADA provides for the establishment of a tolerance for 
residues of zeranol in edible tissues of sheep. Accordingly, the 
analytical method for detecting residues of zeranol in uncooked edible 
tissues of sheep is being removed from part 556 (21 CFR part 556). The 
supplemental application is approved as of March 4, 2005, and the 
regulations are amended in Sec.  556.760 to reflect the approval.
    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 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 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.

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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

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1. The authority citation for 21 CFR part 556 continues to read as 
follows:


[[Page 15759]]


    Authority: 21 U.S.C. 342, 360b, 371.

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2. Section 556.760 is amended by revising paragraph (b) and by adding 
paragraph (c) to read as follows:


Sec.  556.760  Zeranol.

* * * * *
    (b) Tolerances. The tolerances for residues of zeranol in edible 
tissues are:
    (1) Cattle. A tolerance is not needed.
    (2) Sheep. 20 parts per billion.
    (c) Related conditions of use. See Sec.  522.2680 of this chapter.

    Dated: March 21, 2005.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 05-6156 Filed 3-28-05; 8:45 am]
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