[Federal Register Volume 63, Number 56 (Tuesday, March 24, 1998)]
[Rules and Regulations]
[Pages 14035-14036]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-7504]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 524 and 556


Animal Drugs, Feeds, and Related Products; 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 new animal drug application 
(NADA) filed by Fort Dodge Animal Health. The NADA provides for topical 
use of a 0.5 percent solution of moxidectin on cattle for treatment and 
control of infections and infestations of certain internal and external 
parasites.

EFFECTIVE DATE:  March 24, 1998.

FOR FURTHER INFORMATION CONTACT: Estella Z. Jones, Center for 
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1643.

SUPPLEMENTARY INFORMATION: Fort Dodge Animal Health, P.O. Box 400, 
Princeton, NJ 08543-0400, filed NADA 141-099 that provides for use of 
Cydectin moxidectin 0.5 percent pour-on for beef and non-
lactating 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 NADA is approved as of January 28, 1998, and 
the regulations are amended by adding Sec. 524.1451 to reflect the 
approval. The basis for approval is discussed in the freedom of 
information summary.

[[Page 14036]]

    In addition, a tolerance for residues of moxidectin in edible 
tissues of cattle has not been previously established. At this time, a 
tolerance for moxidectin in edible cattle tissues is established in new 
section Sec. 556.426.
    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, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, 
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, this approval qualifies for 3 years of marketing 
exclusivity beginning January 28, 1998, 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.

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 
the 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:

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.
    2. Section 524.1451 is added to read as follows:


Sec. 524.1451   Moxidectin.

    (a) Specifications. Each milliliter contains 5 milligrams of 
moxidectin (0.5 percent solution).
    (b) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.426 of this chapter.
    (d) Conditions of use. (1) Amount. 0.5 milligrams moxidectin per 
kilogram (2.2 pounds) of body weight.
    (2) Indications for use. Beef and non-lactating dairy cattle for 
treatment and control of internal and external parasites: 
gastrointestinal roundworms (Ostertagia ostertagi (adult and L4, 
including inhibited larvae), Haemonchus placei (adult), 
Trichostrongylus axei (adult and L4), T. colubriformis (adult), 
Cooperia oncophora (adult), C. punctata (adult), Bunostomum phlebotomum 
(adult), Oesophagostomum radiatum (adult), Nematodirus helvetianus 
(adult)); lungworms (Dictyocaulus viviparus, adult and L4); cattle 
grubs (Hypoderma bovis, H. lineatum); mites (Chorioptes bovis, 
Psoroptes ovis (P. Communis var. bovis)); lice (Linognathus vituli, 
Haematopinus eurysternus, Solenopotes capillatus, Damalinia bovis); and 
horn flies (Haematobia irritans). To control infections and to protect 
from reinfection with O. ostertagi for 28 days after treatment and with 
D. viviparus for 42 days after treatment.
    (3) Limitations. Apply topically along the top of the back from the 
withers to the tailhead. Because a withdrawal time for milk has not 
been established, do not use on female dairy cattle of breeding age. A 
withdrawal period has not been established for this product on 
preruminating calves. Do not use on calves to be processed for veal. 
Consult your veterinarian for assistance in the diagnosis, treatment, 
and control of parasitism.

PART 556--TOLERANCES FOR RESIDUES OF NEW 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 added to read as follows:

Sec. 556.426   Moxidectin.

    An acceptable daily intake (ADI) of 4 micrograms per kilogram per 
day in tissue is established. A tolerance is established for parent 
moxidectin in edible tissues of cattle of 50 parts per billion in 
muscle and 200 parts per billion in liver.

    Dated: March 13, 1998.
 Stephen F. Sundlof,
 Director, Center for Veterinary Medicine.
[FR Doc. 98-7504 Filed 3-23-98; 8:45 am]
BILLING CODE 4160-01-F