[Federal Register Volume 68, Number 140 (Tuesday, July 22, 2003)]
[Rules and Regulations]
[Pages 43293-43294]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-18163]


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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 Paste; Technical 
Amendment

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 Merial, Ltd. The supplemental NADA provides 
for the addition of several new species of internal parasites to 
product labeling for ivermectin paste for horses. This action is being 
taken to ensure accuracy and clarity in the agency's regulations.

DATES:  This rule is effective July 22, 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 a supplement to NADA 134-314 for 
EQVALAN (ivermectin) Paste for Horses. The supplemental application 
provides for the use of ivermectin paste for the treatment and control 
of Craterostomum acuticaudatum, Petrovinema poculatum, and Coronocyclus 
spp., including: C. coronatus, and C. labratus. Also, the label 
descriptions of some currently- approved parasite genera are being 
revised to add included species for which data already exists in the 
NADA file and to reflect changes in scientific nomenclature. The 
supplemental NADA is approved as of April 2, 2003, and 21 CFR 520.1192 
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 part 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)(iii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental approval 
qualifies for 3 years of marketing exclusivity beginning April 2, 2003. 
This marketing exclusivity only applies to the parasites for which new 
data were required.
    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.

[[Page 43294]]

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 520.1192 is amended by revising paragraphs (a) and (b); by 
redesignating paragraph (d) as paragraph (e); by adding new paragraph 
(d); by removing the last sentence of newly redesignated paragraphs 
(e)(1)(iii) and (e)(2)(iii); by redesignating new paragraph (e)(1)(ii) 
as paragraph (e)(1)(ii)(B); in newly redesignated paragraph 
(e)(1)(ii)(B) by removing ``spp.'' after ``Onchocerca''and by adding in 
its place ``sp.''; and by adding new paragraph (e)(1)(ii)(A) to read as 
follows:


Sec.  520.1192  Ivermectin paste.

    (a) Specifications. Each milligram (mg) of paste contains 0.0187 mg 
(1.87 percent) or 0.00153 mg (0.153 percent) of ivermectin.
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter for 
use as in paragraph (e) of this section:
    (1) No. 050604 for use of a 1.87-percent paste as in (e)(1)(i), 
(e)(1)(ii)(A), and (e)(1)(iii) of this section and a 0.153-percent 
paste for use as in paragraph (e)(2) of this section.
    (2) Nos. 051311 and 059130 for use of a 1.87-percent paste for use 
as in paragraph (e)(1)(i), (e)(1)(ii)(B), and (e)(1)(iii) of this 
section.
* * * * *
    (d) Special considerations. See Sec.  500.25 of this chapter.
    (e) Conditions of use--(1) Horses--(i) Amount. 200 micrograms per 
kilogram (91 micrograms per pound) of body weight.
    (ii) Indications for use--(A) For treatment and control of 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; and 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; and dermatitis caused by 
neck threadworm microfilariae, Onchocerca sp.
* * * * *

    Dated: July 8, 2003.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 03-18163 Filed 7-21-03; 8:45 am]
BILLING CODE 4160-01-S