[Federal Register Volume 67, Number 178 (Friday, September 13, 2002)]
[Rules and Regulations]
[Pages 57943-57944]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 02-23339]


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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 supplemental new animal drug 
application (NADA) filed by Fort Dodge Animal Health. The supplemental 
NADA provides for veterinary prescription use of a sustained-release 
injectable moxidectin formulation for treatment of existing hookworm 
(Uncinaria stenocephala) infections in dogs.

DATES: This rule is effective September 13, 2002.

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, e-mail: 
mberson@cvm.fda.gov.

SUPPLEMENTARY INFORMATION: Fort Dodge Animal Health, Div. of American 
Home Products Corp., 800 Fifth St. NW., Fort Dodge, IA 50501, filed a 
supplement to NADA 141-189 that provides for veterinary prescription 
use of PROHEART 6 (moxidectin) Sustained Release Injectable for Dogs 
for treatment of existing larval and adult hookworm (U. stenocephala) 
infections. The supplemental NADA is approved as of June 13, 2002, and 
the regulations are amended in Sec.  522.1451 (21 CFR 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)(iii) of the Federal Food, Drug, and 
Cosmetics Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental 
approval qualifies for 3 years of marketing exclusivity beginning June 
13, 2002.
    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 
the 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.

[[Page 57944]]

Sec.  522.1451   [Amended]

    2. Section 522.1451 Moxidectin is amended in paragraph (d)(2) by 
adding ``and Uncinaria stenocephala'' following ``caninum''.

    Dated: August 22, 2002.
Andrew J. Beaulieu,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 02-23339 Filed 9-12-02; 8:45 am]
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