[Federal Register Volume 72, Number 95 (Thursday, May 17, 2007)]
[Rules and Regulations]
[Pages 27733-27734]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-9517]


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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

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 Norbrook Laboratories, Ltd. The ANADA 
provides for the use of an ivermectin and clorsulon solution by 
subcutaneous injection in cattle for control of various internal and 
external parasites.

DATES: This rule is effective May 17, 2007.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0169, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Norbrook Laboratories, Ltd., Station Works, 
Newry BT35 6JP, Northern Ireland, filed ANADA 200-436 that provides for 
use of NOROMECTIN Plus (ivermectin and clorsulon) Injection for Cattle 
by subcutaneous injection in cattle for control of various internal and 
external parasites. Norbrook Laboratories, Ltd.'s NOROMECTIN Plus 
Injection for Cattle

[[Page 27734]]

is approved as a generic copy of Merial, Ltd.'s IVOMEC Plus Injection 
for Cattle, approved under NADA 140-833. The ANADA is approved as of 
April 23, 2007, and the regulations are amended in 21 CFR 522.1193 to 
reflect the approval.
    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.
    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:

PART 522--IMPLANTATION OR 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. Amend Sec.  522.1193 as follows:
    a. Revise the section heading and paragraphs (a) and (b);
    b. Redesignate paragraph (d) as paragraph (e);
    c. Add new paragraph (d); and
    d. Revise newly redesignated paragraph (e).
    The revisions, redesignation, and addition read as follows:


Sec.  522.1193  Ivermectin and clorsulon.

    (a) Specifications. Each milliliter (mL) of solution contains 10 
milligrams (mg) (1 percent) ivermectin and 100 mg (10 percent) 
clorsulon.
    (b) Sponsors. See Nos. 050604 and 055529 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 in cattle--(1) Amount. Administer 1 mL (10 mg 
ivermectin and 100 mg clorsulon) per 50 kilograms (110 pounds) by 
subcutaneous injection.
    (2) 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); 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); and for control of infections of D. viviparus and O. radiatum 
for 28 days afer 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. 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 7, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-9517 Filed 5-16-07; 8:45 am]
BILLING CODE 4160-01-S