[Federal Register Volume 62, Number 58 (Wednesday, March 26, 1997)]
[Rules and Regulations]
[Pages 14301-14302]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-7544]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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 a supplemental new animal drug 
application (NADA) filed by Merck Research Laboratories, Division of 
Merck & Co., Inc. The supplemental NADA provides for persistent control 
of gastrointestinal roundworms and lungworms following use of 
ivermectin and clorsulon injection for cattle.

EFFECTIVE DATE: March 26, 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.


[[Page 14302]]


SUPPLEMENTARY INFORMATION: Merck Research Laboratories, Division of 
Merck & Co., Inc., P.O. Box 2000, Rahway, NJ 07065, is sponsor of NADA 
140-833, which provides for the use of Ivomec Plus Injection 
(1 perecent ivermectin and 10 percent clorsulon) for cattle for the 
treatment and control of gastrointestinal roundworm, lungworm, grub, 
lice, and mange mites. The supplement provides for control of 
infections of Dictyocaulus viviparus and Ostertagia ostertagi for 21 
days after treatment, and Haemonchus placei, Trichostrongylus axei, 
Cooperia punctata, C. oncophora, and Oesophagostomum radiatum for 14 
days after treatment. The supplement is approved as of February 24, 
1997, and the regulations are amended in 21 CFR 522.1193(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 February 24, 1997, because the supplement 
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 522

    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 522 is 
amended as follows:

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

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

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

    2. Section 522.1193 is amended by adding a new sentence to the end 
of paragraph (d)(2) to read as follows:


Sec. 522.1193  Ivermectin and clorsulon injection.

 * * * * *
    (d) * * *
    (2) * * * It is also used to control infections of D. viviparus and 
O. ostertagi for 21 days after treatment, and H. placei, T. axei, C. 
punctata, C. oncophora, and O. radiatum for 14 days after treatment.
 * * * * *

    Dated: March 17, 1997.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 97-7544 Filed 3-25-97; 8:45 am]
BILLING CODE 4160-01-F