[Federal Register Volume 69, Number 79 (Friday, April 23, 2004)]
[Rules and Regulations]
[Page 21956]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-9182]


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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 and Praziquantel 
Gel

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 
Wyeth. The supplemental NADA provides for oral use of a moxidectin and 
praziquantel gel in horses and ponies for the treatment and control of 
an additional species of small strongyles.

DATES:  This rule is effective April 23, 2004.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7543, 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-
216 for QUEST PLUS (moxidectin 2.0%/praziquantel 12.5%) Gel, used for 
the treatment and control of various species of internal parasites in 
horses and ponies. The supplement provides for the speciation of adult 
small strongyles in product labeling. The supplemental NADA is approved 
as of March 17, 2004, and 21 CFR 520.1453 is amended 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 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 Division of Dockets Management 
(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 520.1453 is amended by revising paragraph (d)(2) to read as 
follows:


Sec.  520.1453  Moxidectin and praziquantel gel.

* * * * *
    (d) * * *
    (2) Indications for use. For the treatment and control of large 
strongyles: Strongylus vulgaris (adults and L4/L5 arterial stages), S. 
edentatus (adult and tissue stages), Triodontophorus brevicauda 
(adults), and T. serratus (adults); small strongyles (adults): 
(Cyathostomum spp., including C. catinatum and C. pateratum; 
Cylicocyclus spp., including C. insigne, C. leptostomum, and C. 
nassatus; Cylicostephanus spp., including C. calicatus, C. goldi, C. 
longibursatus, and C. minutus; Coronocyclus spp., including C. 
coronatus, C. labiatus, and C. labratus; and Gyalocephalus capitatus; 
small strongyles: undifferentiated lumenal larvae; encysted 
cyathostomes (late L3 and L4 mucosal cyathostome larvae); ascarids: 
Parascaris equorum (adults and L4 larval stages); pinworms: Oxyuris 
equi (adults and L4 larval stages); hairworms: Trichostrongylus axei 
(adults); large-mouth stomach worms: Habronema muscae (adults); horse 
stomach bots: Gasterophilus intestinalis (2nd and 3rd instars) and G. 
nasalis (3rd instars); and tapeworms: Anoplocephala perfoliata 
(adults). One dose also suppresses strongyle egg production for 84 
days.
* * * * *

    Dated: April 2, 2004.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 04-9182 Filed 4-22-04; 8:45 am]
BILLING CODE 4160-01-Sst