[Federal Register Volume 66, Number 131 (Monday, July 9, 2001)]
[Rules and Regulations]
[Page 35756]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-17049]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


Implantation or Injectable 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 new animal drug application 
(NADA) filed by Fort Dodge Animal Health. The NADA provides for 
veterinary prescription use of a sustained-release injectable 
moxidectin formulation for prevention of heartworm disease and 
treatment of existing hookworm infections in dogs.

DATES: This rule is effective July 9, 2001.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7540.

SUPPLEMENTARY INFORMATION: Fort Dodge Animal Health, Div. of American 
Home Products Corp., 800 Fifth St. NW., Fort Dodge, IA 50501, filed 
NADA 141-189 that provides for veterinary prescription use of 
ProHeart 6 (moxidectin) Sustained Release Injectable for Dogs 
for prevention of heartworm disease caused by Dirofilaria immitis and 
treatment of existing larval and adult hookworm (Ancylostoma caninum) 
infections. The NADA is approved as of June 6, 2001, and the 
regulations are amended in 21 CFR part 522 by adding new Sec. 522.1451 
to reflect the approval. The basis of approval is discussed in the 
freedom of information summary.
    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 for nonfood-
producing animals qualifies for 3 years of marketing exclusivity 
beginning June 6, 2001, because the application contains substantial 
evidence of effectiveness of the drug involved or any studies of animal 
safety required for approval of the application and conducted or 
sponsored by the applicant.
    The agency has determined under 21 CFR 25.33(d)(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 522

    Animal drugs.

    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 522 is 
amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 522 continues to read as 
follows:

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

    2. Section 522.1451 is added to read as follows:


Sec. 522.1451  Moxidectin.

    (a) Specifications. The drug product consists of two separate 
vials. One contains 10 percent moxidectin microspheres, and the other 
contains a vehicle for constitution of the moxidectin microspheres. 
Each milliliter of constituted, sustained-release suspension contains 
3.4 milligrams (mg) of moxidectin.
    (b) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use; dogs--(1) Amount. 0.17 mg per kilogram body 
weight (0.0773 mg per pound) as a single subcutaneous injection.
    (2) Indications for use. For prevention of heartworm disease caused 
by Dirofilaria immitis; for treatment of existing larval and adult 
hookworm (Ancylostoma caninum) infections.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

    Dated: June 25, 2001.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 01-17049 Filed 7-6-01; 8:45 am]
BILLING CODE 4160-01-S