[Federal Register Volume 69, Number 109 (Monday, June 7, 2004)]
[Rules and Regulations]
[Pages 31734-31735]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-12717]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


Implantation or Injectable Dosage Form New Animal Drugs; 
Ivermectin and Clorsulon Injection

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 an increased period of protection from reinfection with three 
species of internal parasites following administration of an ivermectin 
and clorsulon injectable solution to cattle.

DATES: This rule is effective June 7, 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 140-833 for 
IVOMEC Plus (ivermectin and clorsulon) Injection for cattle. The 
application extends the period of persistent effectiveness for 
Oesophagostomum radiatum to 28 days after treatment, and for Cooperia 
punctata and Trichostrongylus axei to 21 days after treatment. A veal 
calf warning statement is being added because residue depletion data 
for this class of cattle has not been submitted to the application. The 
supplemental NADA is approved as of April 21, 2004, and 21 CFR 522.1193 
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.
    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 April 21, 2004. 
Exclusivity applies only to the extension of the persistent 
effectiveness claims for the three species of parasites listed 
previously in this document.
    FDA 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 522

    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 522 is 
amended as follows:

[[Page 31735]]

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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1. The authority citation for 21 CFR part 522 continues to read as 
follows:

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

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2. Section 522.1193 is amended by revising paragraphs (d)(2) and (d)(3) 
to read as follows:


Sec.  522.1193  Ivermectin and clorsulon injection.

* * * * *
    (d) * * *
    (2) Indications for use. It is used in cattle for the treatment and 
control of gastrointestinal nematodes (adults and fourth-stage larvae) 
(Haemonchus placei, Ostertagia ostertagi (including inhibited larvae), 
O. lyrata, Trichostrongylus axei, T. colubriformis, Cooperia oncophora, 
C. punctata, C. pectinata, Oesophagostomum radiatum, Nematodirus 
helvetianus (adults only), N. spathiger (adults only), Bunostomum 
phlebotomum); lungworms (adults and fourth-stage larvae) (Dictyocaulus 
viviparus); liver flukes (adults only) (Fasciola hepatica); grubs 
(parasitic stages) (Hypoderma bovis, H. lineatum); lice (Linognathus 
vituli, Haematopinus eurysternus, Solenopotes capillatus); mites 
(Psoroptes ovis (syn. P. communis var. bovis), Sarcoptes scabiei var. 
bovis). It is also used to control infections of D. viviparus and O. 
radiatum for 28 days after treatment; O. ostertagi, T. axei, and C. 
punctata for 21 days after treatment; and H. placei and C. oncophora 
for 14 days after treatment.
    (3) Limitations. For subcutaneous use only. Not for intravenous or 
intramuscular use. Do not treat cattle within 49 days of slaughter. 
Because a withdrawal time in milk has not been established, do not use 
in female dairy cattle of breeding age. Do not use in other animal 
species because severe adverse reactions, including fatalities in dogs, 
may result. Consult your veterinarian for assistance in the diagnosis, 
treatment, and control of parasitism. A withdrawal period has not been 
established for this product in preruminating calves. Do not use in 
calves to be processed for veal.

    Dated: May 19, 2004.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 04-12717 Filed 6-4-04; 8:45 am]
BILLING CODE 4160-01-S