[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]
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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.
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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 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
