[Federal Register Volume 65, Number 237 (Friday, December 8, 2000)]
[Rules and Regulations]
[Page 76930]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-31248]


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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; Moxidectin

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is updating the animal 
drug regulations to correctly reflect the tolerance for moxidectin in 
cow's milk. This document amends the regulations to state the correct 
tolerance is 40 parts per billion (ppb). This action is being taken to 
improve the accuracy of the agency's regulations. Changes to a current 
format are also being made.

DATES: This rule is effective December 8, 2000.

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: Moxidectin solution is approved for topical 
use in cattle for the treatment and control of infections and 
infestations of certain internal and external parasites. When the 
November 2, 1999, approval of the use of moxidectin in lactating dairy 
cows was published in the Federal Register of June 9, 2000 (65 FR 
36616), the tolerance for parent moxidectin in the milk of cattle was 
incorrectly listed. At this time, the regulations are being amended in 
21 CFR 556.426 to state the correct tolerance is 40 ppb and, 
editorially, to reflect current format.
    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 556.426 is amended by revising paragraph (b) to read as 
follows:


Sec. 556.426  Moxidectin.

* * * * *
    (b) Tolerances--(1) Cattle--(i) Liver (the target tissue). The 
tolerance for parent moxidectin (the marker residue) is 200 parts per 
billion (ppb).
    (ii) Muscle. The tolerance for parent moxidectin (the marker 
residue) is 50 ppb.
    (iii) Milk. The tolerance for parent moxidectin (the marker residue 
in cattle milk) is 40 ppb.
    (2) [Reserved]

    Dated: November 29, 2000.
David R. Newkirk,
Acting Deputy Director, Office of New Animal Drug Evaluation, Center 
for Veterinary Medicine.
[FR Doc. 00-31248 Filed 12-7-00; 8:45 am]
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