[Federal Register Volume 66, Number 43 (Monday, March 5, 2001)]
[Rules and Regulations]
[Page 13236]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-5221]


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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 
Pour-On

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 an abbreviated new animal drug 
application (ANADA) filed by Med-Pharmex, Inc. The ANADA provides for 
topical use of ivermectin on cattle for treatment and control of 
various species of external and internal parasites.

DATES: This rule is effective March 5, 2001.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0209.

SUPPLEMENTARY INFORMATION: Med-Pharmex, Inc., 2727 Thompson Creek Rd., 
Pomona, CA 91767-1861, filed ANADA 200-299 for Ivermectin Pour-On for 
Cattle. The application provides for topical use of 0.5 percent 
ivermectin solution on cattle for the treatment and control of various 
species of gastrointestinal nematodes, lungworms, grubs, horn flies, 
lice, and mites. Med-Pharmex's Ivermectin Pour-On for Cattle is 
approved as a generic copy of Merial Limited's IVOMEC<Register> 
(ivermectin) Pour-On for Cattle, approved under NADA 140-841. ANADA 
200-299 is approved as of December 28, 2000, and the regulations in 
Sec. 524.1193 (21 CFR 524.1193) are amended to reflect the approval. 
The basis of approval is discussed in the freedom of information 
summary. Section 524.1193 is further revised to reflect current format 
and to reflect the expiration of 3 years of marketing exclusivity 
granted to Merial Ltd,. in 1997 (62 FR 38907, July 21, 1997), for which 
revisions were made to Sec. 524.1193 (63 FR 44384, August 19, 1998).
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 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.
    The agency has determined under 21 CFR 25.33(a)(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 524

    Animal drugs.

    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

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

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

    2. Section 524.1193 is amended in paragraph (a) by adding ``(mL)'' 
after ``milliliter''; by revising paragraph (b); by redesignating 
paragraph (d) as paragraph (e) and by adding new paragraph (d); and by 
revising redesignated paragraph (e) to read as follows:


Sec. 524.1193  Ivermectin pour-on.

* * * * *
    (b) Sponsors. See Nos. 050604, 051259, and 059130 in 
Sec. 510.600(c) of this chapter for use as in paragraph (e) of this 
section.
* * * * *
    (d) Special considerations. See Sec. 500.25 of this chapter.
    (e) Conditions of use. (1) Amount. One mL per 22 pounds of body 
weight.
    (2) Indications for use in cattle. It is used topically 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 
spp., Oesophagostomum radiatum; (adults) O. venulosum, Strongyloides 
papillosus, Trichuris spp.; lungworms (adults and fourth-stage larvae) 
Dictyocaulus viviparus; cattle grubs (parasitic stages) Hypoderma 
bovis, H. lineatum; mites Chorioptes bovis, Sarcoptes scabei var. 
bovis; lice Linognathus vituli, Haematopinus eurysternus, Damalina 
bovis, Solenoptes capillatus; horn flies Haematobia irritans. It is 
also used to control infections of gastrointestinal roundworms O. 
ostertagi, O. radiatum, H. placei, T. axei, Cooperia punctata, and C. 
oncophora for 14 days after treatment.
    (3) Limitations. Do not treat cattle within 48 days of slaughter. 
Because a withdrawal time in milk has not been established, do not use 
in female dairy cattle of breeding age.

    Dated: February 12, 2001.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 01-5221 Filed 3-2-01; 8:45 am]
BILLING CODE 4160-01-S