[Federal Register Volume 63, Number 214 (Thursday, November 5, 1998)]
[Rules and Regulations]
[Pages 59712-59713]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-29613]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Levamisole Hydrochloride 
Soluble Drench Powder

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 Agri Laboratories, Ltd. The ANADA provides 
for use of levamisole hydrochloride soluble drench powder for use in 
water as an anthelmintic for cattle and sheep.

EFFECTIVE DATE: November 5, 1998.

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: Agri Laboratories, Ltd., P.O. Box 3103, St. 
Joseph, MO 64503-0103, filed ANADA 200-225 that provides for use of 
ProhibitTM (levamisole hydrochloride) soluble drench powder, 
in 46.8 and 544.5 gram packages, in water, as an anthelmintic for 
cattle and sheep. Levamisole cattle and sheep drench is used to treat 
infections of stomach worms (Haemonchus, Trichostrongylus, Ostertagia), 
intestinal worms (Trichostrongylus, Cooperia, Nematodirus, Bunostomum, 
Oesophagostomum) (Chabertia, sheep only), and lung worms 
(Dictyocaulus). Agri Laboratories, Ltd.'s ANADA 200-225 is approved as 
a generic copy of the Schering-Plough Corp.'s NADA 112-051 
Levasole (levamisole) soluble drench. ANADA 200-225 is 
approved as

[[Page 59713]]

of August 27, 1998, and Sec. 520.1242a (21 CFR 520.1242a) is amended to 
reflect the approval. The basis for approval is discussed in the 
freedom of information summary.
    In the regulations, Sec. 520.1242a provides for use of levamisole 
hydrochloride soluble powder in a drench as an anthelmintic for cattle 
and sheep against stomach worms, intestinal worms, and lung worms, and 
in drinking water as an anthelmintic for swine against large 
roundworms, nodular worms, intestinal threadworms, and lungworms. The 
regulation states the drug's chemical name and assay, information that 
FDA has determined is better provided by other references. In addition, 
the rule fails to properly reflect the dosage. Thus, FDA is amending 
Sec. 520.1242a to remove the chemical name and assay and to better 
reflect the package sizes and dosage. Finally, FDA also is 
redesignating the paragraphs to reflect current style format.
    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.

List of Subjects in 21 CFR Part 520

    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 520 is 
amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 520 continues to read as 
follows:
    Authority: 21 U.S.C. 360b.
    2. Section 520.1242a is amended by removing paragraphs (a) and (d), 
by redesignating paragraphs (b), (c), (e), and (f) as paragraphs (a), 
(b), (c), and (d), respectively, by revising newly redesignated 
paragraphs (a), (b), (c), (d)(1)(i), (d)(1)(iii), (d)(2)(i), and by 
adding newly designated paragraph (d)(2)(iii) to read as follows:


Sec. 520.1242a   Levamisole hydrochloride drench and drinking water.

    (a)  Specifications. Each package contains either 9.075, 11.7, 
18.15, 46.8, or 544.5 grams of levamisole hydrochloride.
    (b)  Sponsors. Approval for sponsors in 21 CFR 510.600(c) for use 
as in paragraph (d) of this section as follows:
    (1) See 043781 for use of 46.8 gram package as in paragraph (d)(1) 
of this section, for 11.7 and 46.8 gram packages as in paragraph (d)(2) 
of this section, and for 9.075 and 18.15 gram packages as in paragraph 
(d)(3) of this section.
    (2) See 000061 for use of 46.8 and 544.5 gram packages as in 
paragraph (d)(1) of this section, for 11.7, 46.8, and 544.5 gram 
packages as in paragraph (d)(2) of this section, and for 18.15 gram 
package as in paragraph (d)(3) of this section.
    (3) See 057561 for use of 46.8 and 544.5 gram packages as in 
paragraphs (d)(1) and (d)(2) of this section.
    (c)  Related tolerances. See Sec. 556.350 of this chapter.
    (d)  Conditions of use. It is used as an anthelmintic at 0.365 gram 
per 100 pounds of body weight as follows:
    (1)  Cattle--(i)  Amount. As a single oral dose drench using 46.8 
or 544.5 gram packet.
* * * * *
    (iii)  Limitations. Conditions of constant helminth exposure may 
require retreatment within 2 to 4 weeks after the first treatment. Do 
not slaughter for food within 48 hours of treatment. Not for use in 
dairy animals of breeding age. Consult your veterinarian before using 
in severely debilitated animals. Consult your veterinarian for 
assistance in the diagnosis, treatment, and control of parasitism. 
Prepare solutions for use as follows:
    (a) Dissolve contents of 46.8 gram package in water to provide 1 
quart (32 fluid ounces) of drench solution and administer as a drench 
at 1/4 ounce per 100 pounds of body weight as a single oral dose.
    (b) Dissolve contents of 46.8 gram package in water to provide 8.75 
fluid ounces of concentrate solution and administer as a drench at 2 
milliliters per 100 pounds of body weight as a single oral dose by 
syringe.
    (c) Dissolve contents of 544.5 gram package in 3 liters of water 
and administer as a drench at 2 milliliters per 100 pounds of body 
weight as a single oral dose.
    (2)  Sheep--(i)  Amount. As a single oral dose drench using 11.7, 
46.8, or 544.5 gram packet.
* * * * *
    (iii)  Limitations. Conditions of constant helminth exposure may 
require retreatment within 2 to 4 weeks after the first treatment. Do 
not slaughter for food within 72 hours of treatment. Consult your 
veterinarian before using in severely debilitated animals. Consult your 
veterinarian for assistance in the diagnosis, treatment, and control of 
parasitism. Prepare solutions for use as follows:
    (a) Dissolve contents of 11.7 gram package in 1 quart (32 ounces) 
of water and administer as a drench at 1 ounce per 100 pounds of body 
weight, or dissolve in 10.9 fluid ounces of water and administer as a 
drench at 1 milliliter per 10 pounds of body weight as a single oral 
dose.
    (b) Dissolve contents of 46.8 gram package in 128 fluid ounces (1 
gallon) of water and administer as a drench at 1 ounce per 100 pounds 
of body weight as a single oral dose.
    (c) Dissolve contents of 544.5 gram package in 3 liters of water 
and administer as a drench at 2 milliliters per 100 pounds of body 
weight as a single oral dose.
* * * * *

    Dated: October 23, 1998.
 Stephen F. Sundlof,
 Director, Center for Veterinary Medicine.
[FR Doc. 98-29613 Filed 11-4-98; 8:45 am]
BILLING CODE 4160-01-F