[Federal Register Volume 62, Number 59 (Thursday, March 27, 1997)]
[Rules and Regulations]
[Pages 14633-14634]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-7789]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable 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 persistent control
of gastrointestinal roundworms and lungworms following use of
ivermectin injection for cattle for treatment and control of certain
harmful gastrointestinal roundworms,
[[Page 14634]]
lungworms, grubs, lice, and mange mites infections.
EFFECTIVE DATE: March 27, 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, is sponsor of NADA
128-409, which provides for the use of Ivomec Injection (1%
ivermectin) for cattle for the treatment and control of
gastrointestinal roundworm, lungworm, grub, lice, and mange mite
infections. 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 522.1192(d)(2)(ii) 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), approval of this supplement
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).
Sec. 522.1192 [Amended]
2. Section 522.1192 Ivermectin injection is amended in paragraph
(d)(2)(ii) by adding to the end of the paragraph the sentence ``It is
also used to control infections of D. viparus and O. ostertagi for 21
days after treatment, and H. placei, T. axei, C. punctata, C.
oncophora, and Oesophagostomum radiatum for 14 days after treatment.''
Dated: March 17, 1997.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 97-7789 Filed 3-26-97; 8:45 am]
BILLING CODE 4160-01-F
