[Federal Register Volume 69, Number 155 (Thursday, August 12, 2004)]
[Rules and Regulations]
[Pages 49808-49809]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-18406]


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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 supplemental new animal drug 
application (NADA) filed by Merial Ltd. The supplemental NADA provides 
revised labeling for ivermectin and praziquantel oral paste used in 
horses for the treatment and control of various internal parasites.

DATES: This rule is effective August 12, 2004.

FOR FURTHER INFORMATION CONTACT: Martine Hartogensis, Center for 
Veterinary Medicine (HFV-216), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 301-827-7815, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Merial Ltd., 3239 Satellite Blvd., Bldg. 
500, Duluth, GA 30096-4640, filed a supplement to NADA 141-214 for 
ZIMECTERIN GOLD (ivermectin 1.55 percent/praziquantel 7.75 percent) 
Paste for horses. This supplement amends product labeling to separate 
parasite life stages in the indications section, to remove the 8-week 
retreatment interval from the dosage and administration section, and to 
add a new precaution statement. The supplemental NADA is approved as of 
July 13, 2004, and 21 CFR 520.1198 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.

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 amended by revising paragraphs (d)(2)(i) and 
(d)(3) to read as follows:


Sec.  520.1198   Ivermectin and praziquantel paste.

* * * * *
    (d) * * *
    (2) * * *

[[Page 49809]]

    (i) For treatment and control of the following parasites in horses: 
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 (adults, including those resistant to some benzimidazole 
class compounds)--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, and Petrovinema poculatum; Small 
Strongyles--fourth-stage larvae; 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.
* * * * *
    (3) Limitations. For oral use only. Do not use in horses intended 
for human consumption.

    Dated: July 27, 2004.
Daniel G. McChesney,
Director, Office of Surveillance and Compliance, Center for Veterinary 
Medicine.
[FR Doc. 04-18406 Filed 8-11-04; 8:45 am]
BILLING CODE 4160-01-S