[Federal Register Volume 68, Number 166 (Wednesday, August 27, 2003)]
[Rules and Regulations]
[Page 51445]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-21834]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Moxidectin Gel

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule, technical amendment.

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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 
Wyeth. The supplemental NADA adds an age precaution to labeling for 
moxidectin gel used for the control of various species of internal 
parasites in horses and ponies.

DATES: This rule is effective August 27, 2003.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855; tel: 301-827-7543; e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Fort Dodge Animal Health, Division of Wyeth, 
800 Fifth St. NW., Fort Dodge, IA 50501, filed a supplement to NADA 
141-087 for QUEST (moxidectin) 2.0% Equine Oral Gel used for the 
control of various species of internal parasites in horses and ponies. 
The supplemental NADA adds a precaution to labeling that the product is 
for oral use in horses and ponies 6 months of age and older. The 
supplemental NADA is approved as of May 29, 2003, and the regulations 
are amended in 21 CFR 520.1452 to reflect the approval and to reflect 
current format. 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 21 CFR 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.
    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 520

    Animal drugs.

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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 520 is 
amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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1. The authority citation for 21 CFR part 520 continues to read as 
follows:

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

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2. Section 520.1452 is amended by revising paragraphs (a), (d)(3), and 
by adding paragraph (c) to read as follows:


Sec.  520.1452  Moxidectin gel.

    (a) Specifications. Each milliliter of gel contains 20 milligrams 
(2 percent) moxidectin.
* * * * *
    (c) Special considerations. See Sec.  500.25 of this chapter.
    (d) * * *
    (3) Limitations. For oral use in horses and ponies 6 months of age 
and older. Not for use in horses and ponies intended for food.

    Dated: August 13, 2003.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 03-21834 Filed 8-27-03; 8:45 am]
BILLING CODE 4160-01-S