[Federal Register Volume 68, Number 125 (Monday, June 30, 2003)]
[Rules and Regulations]
[Pages 38600-38601]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-16493]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Ivermectin and Praziquantel 
Paste

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 Merial, Ltd. The NADA provides for use of an ivermectin 
and praziquantel oral paste for the control of various species of 
internal parasites in horses.

DATES: This rule is effective June 30, 2003.

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: Merial Ltd., 3239 Satellite Blvd., Bldg. 
500, Duluth, GA 30096-4640, filed NADA 141-214 for ZIMECTERIN GOLD

[[Page 38601]]

(ivermectin 1.55 percent/praziquantel 7.75 percent) Paste. The 
application provides for use of an ivermectin and praziquantel oral 
paste for the control of various species of internal parasites in 
horses. The NADA is approved as of April 17, 2003, and 21 CFR part 520 
is amended by adding new Sec.  520.1198 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 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 (the act) (21 U.S.C. 360b(c)(2)(F)(ii)), this approval 
qualifies for 3 years of marketing exclusivity beginning April 17, 
2003.
    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.

0
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

0
1. The authority citation for 21 CFR part 520 continues to read as 
follows:

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

0
2. Section 520.1198 is added to read as follows:


Sec.  520.1198  Ivermectin and praziquantel paste.

    (a) Specifications. Each milligram (mg) of paste contains 0.0155 mg 
(1.55 percent) ivermectin and 0.0775 mg (7.75 percent) praziquantel.
    (b) Sponsor. See No. 050604 in Sec.  510.600(c) of this chapter.
    (c) Special considerations. See Sec.  500.25 of this chapter.
    (d) Conditions of use in horses--(1) Amount. 200 micrograms ([mu]g) 
per kilogram (/kg) ivermectin (91 [mu]g per pound (/lb)) and 1 mg/kg 
praziquantel (454 [mu]g/lb) body weight.
    (2) Indications for use--For treatment and control of tapeworms 
Anoplocephala perfoliata; large strongyles (adults)--Strongylus 
vulgaris (also early forms in blood vessels), S. edentatus (also tissue 
stages), S. equinus; Triodontophorus spp., including T. brevicauda and 
T. serratus; and Craterostomum acuticaudatum; small strongyles 
including those resistant to some benzimidazole class compounds (adults 
and fourth-stage larvae)--Coronocyclus spp., including C. coronatus, C. 
labiatus, and C. labratus; Cyathostomum spp., including C. catinatum 
and C. pateratum; Cylicocyclus spp., including C. insigne, C. 
leptostomum, C. nassatus, and C. brevicapsulatus; Cylicodontophorus 
spp.; Cylicostephanus spp., including C. calicatus, C. goldi, C. 
longibursatus, and C. minutus; Petrovinema poculatum; pinworms (adults 
and fourth-stage larvae)--Oxyuris equi; ascarids (adults and third- and 
fourth-stage larvae)--Parascaris equorum; hairworms (adults)--
Trichostrongylus axei; large-mouth stomach worms (adults)--Habronema 
muscae; bots (oral and gastric stages)--Gasterophilus spp., including 
G. intestinalis and G. nasalis; lungworms (adults and fourth-stage 
larvae)--Dictyocaulus arnfieldi; intestinal threadworms (adults)--
Strongyloides westeri; summer sores caused by Habronema and Draschia 
spp. cutaneous third-stage larvae; dermatitis caused by neck threadworm 
microfilariae, Onchocerca sp.

    Dated: June 20, 2003.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 03-16493 Filed 6-27-03; 8:45 am]
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