[Federal Register Volume 69, Number 170 (Thursday, September 2, 2004)]
[Rules and Regulations]
[Page 53617]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-19984]



[[Page 53617]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


Implantation and Injectable Dosage Form New Animal Drugs; 
Ivermectin 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 of cattle following administration of 
ivermectin solution by subcutaneous injection.

DATES:  This rule is effective September 2, 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 128-409 for 
IVOMEC (ivermectin) Injection for Cattle and Swine. The supplemental 
application provides for an increased period of protection from 
reinfection with three species of internal parasites of cattle 
following administration of ivermectin solution by subcutaneous 
injection. Specifically, the period of persistent effectiveness is 
increased from 14 days to 28 days for Oesophagostomum radiatum, and 
from 14 days to 21 days for Trichostrongylus axei and Cooperia 
punctata. 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 August 16, 2004, 
and 21 CFR 522.1192 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 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 August 16, 2004. 
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 T. axei and C. punctata from 14 days 
after treatment to 21 days after treatment, for which new data were 
required.
    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 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:

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

0
1. The authority citation for 21 CFR part 522 continues to read as 
follows:

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

0
2. Section 522.1192 is amended in paragraphs (a)(1), (a)(2), and (a)(3) 
by removing ``sterile aqueous''; and by revising paragraphs (b) and 
(d)(2)(i) through (d)(2)(iii) to read as follows:


Sec.  522.1192  Ivermectin injection.

* * * * *
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter for 
use as in paragraph (d) of this section.
    (1) No. 050604 for use as in paragraph (d) of this section.
    (2) No. 059130 for use as in paragraphs (d)(2), (d)(3), (d)(4), and 
(d)(6) of this section of this section.
* * * * *
    (d) * * *
    (2) * * *
    (i) Amount. 200 micrograms per kilogram of body weight by 
subcutaneous injection.
    (ii) Indications for use--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); grubs (parasitic stages) (Hypoderma bovis, H. lineatum); 
sucking lice (Linognathus vituli, Haematopinus eurysternus, Solenopotes 
capillatus); mites (scabies) (Psoroptes ovis (syn. P. communis var. 
bovis), Sarcoptes scabiei var. bovis). For No. 059130 in Sec.  
510.600(c) of this chapter: It is also used to control infections of D. 
viviparus for 28 days after treatment; O. ostertagi for 21 days after 
treatment; and H. placei, T. axei, C. punctata, C. oncophora, and O. 
radiatum for 14 days after treatment. For No. 050604 in Sec.  
510.600(c) of this chapter: To control infections and to protect from 
reinfection with D. viviparus and O. radiatum for 28 days after 
treatment; O. ostertagi, T. axei, and C. punctata for 21 days after 
treatment; H. placei and C. oncophora for 14 days after treatment.
    (iii) Limitations. Do not treat cattle within 35 days of slaughter. 
Because a withdrawal time in milk has not been established, do not use 
in female dairy cattle of breeding age. A withdrawal period has not 
been established for this product in pre-ruminating calves. Do not use 
in calves to be processed for veal. Not for intravenous or 
intramuscular use. 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.
* * * * *

    Dated: August 25, 2004.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 04-19984 Filed 9-1-04; 8:45 am]
BILLING CODE 4160-01-S