[Federal Register Volume 70, Number 210 (Tuesday, November 1, 2005)]
[Rules and Regulations]
[Page 65835]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-21641]



[[Page 65835]]

=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 Virbac AH, Inc. 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 November 1, 2005.

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: Virbac AH, Inc., 3200 Meacham Blvd., Ft. 
Worth, TX 76137, filed a supplement to NADA 141-215 for EQUIMAX 
(ivermectin 1.87%/praziquantel 14.03%) Paste for horses. This 
supplement amends product labeling to separate parasite life stages in 
the indications section. The supplemental NADA is approved as of 
September 16, 2005, and the regulations in 21 CFR 520.1198 are amended 
to reflect the approval. The basis of approval is discussed in the 
freedom of information summary. The current regulations for ivermectin 
and praziquantel paste are also being revised to remove redundant 
language. These changes are being made to improve the readability of 
the regulations.
    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)(2)(ii) to read as follows:


Sec.  520.1198  Ivermectin and praziquantel paste.

* * * * *
    (d) * * *
    (2) * * *
    (i) 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.
    (ii) Tapeworms--Anoplocephala perfoliata; Large Strongyles 
(adults)--Strongylus vulgaris (also early forms in blood vessels), 
S.edentatus (also tissue stages), S. equinus, Triodontophorus spp.; 
Small Strongyles (adults, including those resistant to some 
benzimidazole class compounds)--Cyathostomum spp., Cylicocyclus spp., 
Cylicostephanus spp., Cylicodontophorus spp.; 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.; 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: October 14, 2005.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 05-21641 Filed 10-31-05; 8:45 am]
BILLING CODE 4160-01-S