[Federal Register Volume 65, Number 112 (Friday, June 9, 2000)]
[Rules and Regulations]
[Pages 36616-36617]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-14463]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 524 and 556


Ophthalmic and Topical Dosage Form New Animal Drugs; Moxidectin

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 Fort Dodge Animal Health, Division of 
American Home Products Corp. The supplemental NADA provides for topical 
use of a 0.5 percent moxidectin solution on dairy cattle of breeding 
age for treatment and control of infections and infestations of certain 
internal and external parasites. FDA is also amending the regulations 
to establish a tolerance for moxidectin residues in milk.

DATES: This rule is effective June 9, 2000.

FOR FURTHER INFORMATION CONTACT: Steven D. Vaughn, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7584.

SUPPLEMENTARY INFORMATION: Fort Dodge Animal Health, Division of 
American Home Products Corp., 800 Fifth St. NW., Fort Dodge, IA 50501, 
filed supplemental NADA 141-099 that provides for use of 
Cydectin<Register> (moxidectin) 0.5 percent pouron for dairy cattle at 
500 micrograms moxidectin per kilogram of body weight for treatment and 
control of infections and infestations of certain gastrointestinal 
roundworms, lungworms, cattle grubs, mites, lice, and horn flies. The 
supplemental NADA is approved as of November 2, 1999, and the 
regulations are amended in 21 CFR 524.1451 to reflect the approval. The 
basis for approval is discussed in the freedom of information summary.
    In addition, the regulations are amended in 21 CFR 556.426 to add a 
tolerance for residues of moxidectin in milk and, editorially, to 
reflect current format.
    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.
    Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for 
3 years of marketing exclusivity beginning November 2, 1999, because 
the application contains substantial evidence of the effectiveness of 
the drug involved, any studies of animal safety or, in the case of 
food-producing animals, human food safety studies (other than 
bioequivalence or residue studies) required for approval of the 
application and conducted or sponsored by the applicant.
    The agency has carefully considered the potential environmental 
effects of this action. FDA has concluded that the action will not have 
a significant impact on the human environment, and that an 
environmental impact statement is not required. The agency's finding of 
no significant impact and the evidence supporting that finding, 
contained in an environmental assessment, may be seen in the Dockets 
Management Branch (address above) between 9 a.m. and 4 p.m., Monday 
through Friday.
    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

21 CFR Part 524

    Animal drugs.

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 parts 524 and 
556 are amended as follows:

[[Page 36617]]

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 524 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.


Sec. 524.1451  [Amended]

    2. Section 524.1451 Moxidectin is amended in the first sentence of 
paragraph (d)(2) by removing the phrase ``Beef and non-lactating dairy 
cattle'' and by adding in its place the phrase ``Beef and dairy 
cattle'', and in paragraph (d)(3) by removing the first and second 
sentences.

PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

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

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


    4. Section 556.426 is revised to read as follows:


Sec. 556.426  Moxidectin.

    (a) Acceptable daily intake (ADI). The ADI for total residues of 
moxidectin is 4 micrograms per kilogram of body weight per day.
    (b) Tolerances. The tolerance for parent moxidectin (the marker 
residue) in edible tissues of cattle is 200 parts per billion (ppb) in 
liver (the target tissue) and 50 ppb in muscle. The tolerance for 
parent moxidectin is 50 ppb in milk.

    Dated: May 29, 2000.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 00-14463 Filed 6-8-00; 8:45 am]
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