[Federal Register Volume 62, Number 139 (Monday, July 21, 1997)]
[Rules and Regulations]
[Pages 38907-38908]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-19124]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 524


Ophthalmic and Topical Dosage Form New Animal Drugs; Ivermectin

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 supplemental new animal drug 
application (NADA) filed by Merck Research Laboratories, Division of 
Merck & Co., Inc. The supplemental NADA provides for topical use of 
ivermectin for control of infections of gastrointestinal roundworms for 
14 days following use on cattle.

EFFECTIVE DATE: July 21, 1997.

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, filed supplemental 
NADA 140-841 that provides for the use of Ivomec pour-on (5 
milligrams of ivermectin per milliliter) for cattle to control 
infections of gastrointestinal roundworms Ostertagia ostertagi, 
Oesophagostomum radiatum, Haemonchus placei, Trichostrongylus axei, 
Cooperia punctata, and C. oncophora for 14 days after treatment. The 
supplemental NADA is approved as of June 5, 1997, and the regulations 
are amended in 21 CFR 524.1193(d)(2) 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)(iii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental approval 
for food-producing animals qualifies for 3 years of marketing 
exclusivity beginning June 5, 1997, because the supplement

[[Page 38908]]

contains substantial evidence of effectiveness of the drug involved, 
any 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 supplement and conducted or 
sponsored by the applicant. Exclusivity applies only to the additional 
indications.
    The agency has determined under 21 CFR 25.24(d)(1)(i) 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 524

    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 524 is 
amended as follows:

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 524 continues to read as 
follows:

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

Sec. 524.1193   [Amended]

    2. Section 524.1193 Ivermectin pour-on is amended by adding to the 
end of paragraph (d)(2) the sentence ``It is also used to control 
infections of gastrointestinal roundworms O. ostertagi, O. radiatum, H. 
placei, T. axei, Cooperia punctata, and C. oncophora for 14 days after 
treatment.''

    Dated: July 8, 1997.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 97-19124 Filed 7-18-97; 8:45 am]
BILLING CODE 4160-01-F