[Federal Register Volume 69, Number 3 (Tuesday, January 6, 2004)]
[Rules and Regulations]
[Pages 501-502]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-130]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 524


Ophthalmic and Topical Dosage Form New Animal Drugs; Ivermectin

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 
for topical use of ivermectin on cattle to control infections and 
prevent reinfection with certain species of external and internal 
parasites.

DATES: This rule is effective January 6, 2004.

FOR FURTHER INFORMATION CONTACT: Janis Messenheimer, Center for 
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7578, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Merial Ltd., 3239 Satellite Blvd., Bldg. 
500, Duluth, GA 30096-4640, filed a supplement to NADA 140-841 for 
IVOMEC (ivermectin) Pour-On for Cattle. The application provides for 
topical use of 0.5 percent ivermectin solution on cattle to control 
infections and prevent reinfection with Oesophagostomum radiatum and 
Dictyocaulus viviparus for 28 days after treatment, Cooperia punctata 
and Trichostrongylus axei for 21 days after treatment, C. surnabada for 
14 days after treatment, and Damalinia bovis for 56 days after 
treatment. The NADA is approved as of November 24, 2003, and Sec.  
524.1193 is amended to reflect the approval. The basis of approval is 
discussed in the freedom of information summary.
    In addition, the regulation is revised to remove two species of 
parasites, Oesophagostomum venulosum and Chorioptes bovis, which were 
codified in error during the original approval NADA 140-841 (55 FR 
50551, December 7, 1990). Also at this time, the indication for 
Cooperia spp. is speciated as Cooperia oncophora, C. punctata, and C. 
surnabada to conform with current labeling practices. A veal calf 
warning statement is being added because residue depletion data for 
this class of cattle has not been submitted to the application.
    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.
    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 approval qualifies 
for 3 years of marketing exclusivity beginning November 24, 2003. 
Exclusivity applies only to the extension of the persistent 
effectiveness claims for O. radiatum from 14 days after treatment to 28 
days after treatment and for C. punctata and T. axei from 14 days after 
treatment to 21 days after treatment, and to the new persistent 
effectiveness claims for D. viviparus, C. surnabada, and D. bovis for 
which new data were required.
    The agency has carefully considered the potential environmental 
impact of this action and has concluded that the action will not have a 
significant impact on the human environment and that an environmental 
impact statement is not required. FDA's finding of no significant 
impact and the evidence supporting that finding, contained in an 
environmental assessment, may be seen in the Division of Dockets 
Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through 
Friday.
    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 524

    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 524 is 
amended as follows:

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

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1. The authority citation for 21 CFR part 524 continues to read as 
follows:

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

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2. Section 524.1193 is amended by revising paragraphs (b), (e)(1), and 
(e)(2), and by adding two sentences to paragraph (e)(3) to read as 
follows:


Sec.  524.1193  Ivermectin topical solution.

* * * * *
    (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 as in paragraphs (e)(1), (e)(2)(i), 
(e)(2)(iii), and (e)(3) of this section.
    (2) Nos. 051259, 051311, 058829, 059130, and 066916 for use as in 
paragraphs (e)(1), (e)(2)(i), (e)(2)(ii), and (e)(3) of this section.
* * * * *
    (e) Conditions of use in cattle--(1) Amount. One mL per 22 pounds 
(0.5 milligram per kilogram) of body weight applied topically to the 
back of the animal.
    (2) Indications for use--(i) It is used for the treatment and 
control of: Gastrointestinal roundworms (adults and fourth-stage 
larvae) Ostertagia ostertagi (including inhibited stage), Haemonchus 
placei, Trichostrongylus axei, T. colubriformis, Cooperia oncophora, C. 
punctata, C. surnabada, Oesophagostomum radiatum; (adults) 
Strongyloides papillosus, Trichuris spp.; lungworms (adults and fourth-
stage larvae) Dictyocaulus viviparus; cattle grubs (parasitic stages) 
Hypoderma bovis, H. lineatum; mites Sarcoptes scabei var. bovis; lice 
Linognathus vituli, Haematopinus eurysternus, Damalinia bovis, 
Solenoptes capillatus; and horn flies Haematobia irritans.
    (ii) It controls infections and prevents reinfection with O. 
ostertagi, O. radiatum, H. placei, T. axei, C. punctata, and C. 
oncophora for 14 days after treatment.
    (iii) It controls infections and prevents reinfection with O. 
radiatum and D. viviparus for 28 days after treatment, C. punctata and 
T. axei for 21 days after treatment, H. placei, C. oncophora, and C. 
surnabada for 14 days after treatment, and D. bovis for 56 days after 
treatment.
    (3) * * * A withdrawal period has not been established for this 
product on preruminating calves. Do not use on calves to be processed 
for veal.


[[Page 502]]


    Dated: December 24, 2003.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 04-130 Filed 1-5-04; 8:45 am]
BILLING CODE 4160-01-S