[Federal Register Volume 61, Number 247 (Monday, December 23, 1996)]
[Rules and Regulations]
[Pages 67452-67453]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-32431]


-----------------------------------------------------------------------


DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 520


Oral Dosage Form New Animal Drugs; Ivermectin Bolus

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of a new animal drug application 
(NADA) filed by Merck Research Laboratories. The NADA provides for use 
of an ivermectin-containing, sustained-release bolus in cattle for 
treatment and control for approximately 135 days of certain internal 
and external parasitic infections throughout the grazing season.

EFFECTIVE DATE: December 23, 1996.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1643.

SUPPLEMENTARY INFORMATION: Merck Research Laboratories, Division of 
Merck & Co., Inc., P.O. Box 2000, Rahway, NJ 07065-0914, filed NADA 
140-988, which provides for the use of Ivomec (1.72 grams 
ivermectin) Sustained-Release Bolus for Cattle for the treatment and 
control of certain gastrointestinal roundworm, lungworm, mange mite, 
sucking lice, cattle grub, and tick infections in cattle weighing at 
least 275 pounds (lb) (125 kilograms (kg)) but not more than 660 lb 
(300 kg) of body weight on the day of administration. The NADA is 
approved as of November 18, 1996, and the regulations are amended in 21 
CFR part 520 by adding new Sec. 520.1197 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 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, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, 
between 9 a.m. and 4 p.m., Monday through Friday.
    Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval for food-
producing animals qualifies for 3 years of marketing exclusivity 
beginning November 18, 1996, because the application contains 
substantial evidence of the effectiveness of the drug involved, studies 
of animal safety, or in the case of food-producing animals, human food 
safety studies (other than bioequivalence or residue studies) required 
for approval of the application and conducted or sponsored by the 
applicant.
    The agency has carefully considered the potential environmental 
effects of this action. FDA has concluded that the action will not have 
a significant impact on the human environment, and that an 
environmental impact statement is not required. The agency's finding of 
no significant impact and the evidence supporting that finding, 
contained in an environmental assessment, may be seen in the Dockets 
Management Branch (address above) between 9 a.m. and 4 p.m., Monday 
through Friday.

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: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).

    2. New Sec. 520.1197 is added to read as follows:

Sec. 520.1197  Ivermectin sustained-release bolus.

    (a) Specifications. Each sustained-release bolus contains 1.72 
grams of ivermectin.
    (b) Sponsor. See No. 000006 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.344 of this chapter.
    (d) Conditions of use in ruminating calves--(1) Amount. Administer 
one bolus per calf weighing at least 275 pounds (lb) (125 kilograms 
(kg)) and not more than 660 lb (300 kg) on the day of administration.
    (2) Indications. For treatment and control, throughout the grazing 
season (approximately 135 days), of gastrointestinal roundworms 
Haemonchus placei, Ostertagia ostertagi (including inhibited fourth-
stage larvae), Trichostrongylus axei, T. colubriformis, Cooperia spp., 
Nematodirus helvetianus, Bunostomum phlebotomum, Oesophagostomum 
radiatum; lungworms Dictyocaulus viviparus; grubs Hypoderma spp.; 
sucking lice Linognathus vituli, Solenopotes capillatus; mange mites 
Psoroptes ovis, Sarcoptes scabiei, and ticks Amblyomma americanum.
    (3) Limitations. The bolus was specifically designed for use in 
cattle; do not use in other animal species. Calves must be ruminating 
and older than 12 weeks of age. Do not administer to calves weighing 
less than 275 lb (125 kg). Do not administer a damaged bolus. Because a 
milk withdrawal time has not been established, do not use in female 
dairy cattle of breeding age. Do not slaughter cattle within 180 days 
of treatment. Consult your veterinarian for assistance in the 
diagnosis, treatment, and control of parasitism.


[[Page 67453]]


    Dated: December 12, 1996.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 96-32431 Filed 12-20-96; 8:45 am]
BILLING CODE 4160-01-F