[Federal Register: June 7, 2004 (Volume 69, Number 109)]
[Rules and Regulations]
[Page 31734-31735]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07jn04-7]
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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:
janis.messenheimer@fda.gov.
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