[Federal Register Volume 60, Number 168 (Wednesday, August 30, 1995)]
[Rules and Regulations]
[Page 45041]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-21454]
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Rules and Regulations
Federal Register
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Federal Register / Vol. 60, No. 168 / Wednesday, August 30, 1995 /
Rules and Regulations
[[Page 45041]]
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 supplement provides for subcutaneous use of
ivermectin injection as an antiparasitic in ranch-raised foxes.
EFFECTIVE DATE: August 30, 1995.
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
(ivermectin) as an antiparasitic for horses, cattle, reindeer, and
swine. The supplement provides for use of 0.27 percent ivermectin as an
antiparasitic for treatment and control of ear mites (Otodectes
cynotis) in ranch-raised foxes. Approval is based in part on data and
information in Public Master File (PMF) 5307 established under the
National Research Support Project No. 7 (NRSP-7) (formerly the
Interregional Research Project No. 4 (IR-4)), Northcentral Region,
Michigan State University, East Lansing, MI 48824. The supplemental
NADA is approved as of July 13, 1995, and the regulations are amended
in Sec. 522.1192 (21 CFR 522.1192) to reflect the approval. The basis
of approval is discussed in the freedom of information summary. Also,
the heading of Sec. 522.1192 is amended to read ''Ivermectin
injection.''
In accordance with the freedom of information provisions of part 20
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (21 CFR 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, rm. 1-23,
12420 Parklawn Dr., 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 supplement does not
qualify for marketing exclusivity because the supplement does not
contain reports of new clinical or field investigations (other than
bioequivalence or residue studies) essential to the approval 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 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 522.1192 is amended by revising the section heading, the
heading for paragraph (a)(3), and by adding new paragraph (d)(5) to
read as follows:
Sec. 522.1192 Ivermectin injection.
(a) * * *
(3) Piglets 70 pounds or less and ranch-raised foxes. * * *
* * * * *
(d) * * *
(5) Ranch-raised foxes. (i) Amount. 200 micrograms per kilogram
body weight. Repeat in 3 weeks.
(ii) Indications for use. For treatment and control of ear mites
(Otodectes cynotis).
(iii) Limitations. For subcutaneous use only. Consult your
veterinarian for assistance in the diagnosis, treatment, and control of
parasitism.
Dated: August 14, 1995.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 95-21454 Filed 8-29-95; 8:45 am]
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