[Federal Register: December 5, 2001 (Volume 66, Number 234)]
[Rules and Regulations]
[Page 63166]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05de01-9]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Ivermectin Liquid
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 an abbreviated new animal drug
application (ANADA) filed by First Priority, Inc. The ANADA provides
for oral use of ivermectin solution in horses for the treatment and
control of various species of internal and cutaneous parasites.
DATES: This rule is effective December 5, 2001.
FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-0209.
SUPPLEMENTARY INFORMATION: First Priority, Inc., 1585 Todd Farm Dr.,
Elgin, IL 60123, filed ANADA 200-321 for PRIMECTINTM
(ivermectin) Equine Oral Liquid. The application provides for oral use
of a 1.0 percent ivermectin solution in horses for the treatment and
control of various species of gastrointestinal nematodes, lungworms,
stomach bots, and cutaneous larvae and microfilariae. First Priority's
PRIMECTINTM Equine Oral Liquid is approved as a generic copy
of Merial Ltd.'s EQVALAN (ivermectin) Oral Liquid for Horses,
approved under NADA 140-439. ANADA 200-321 is approved as of September
7, 2001, and 21 CFR 520.1195 is amended 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, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852,
between 9 a.m. and 4 p.m., Monday through Friday.
The agency has determined under 21 CFR 25.33(a)(1) 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.
This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to congressional review requirements in 5
U.S.C. 801-808.
List of Subjects in 21 CFR Part 520
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 520 is
amended as follows:
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
2. Section 520.1195 is amended in paragraph (b) by adding
``058829,'' after ``051259''; by revising the heading of paragraph (c)
and paragraph (c)(1); in paragraph (c)(2) by removing ``It is used in
horses''; and in paragraph (c)(3) by removing the first sentence to
read as follows:
Sec. 520.1195 Ivermectin liquid.
* * * * *
(c) Conditions of use in horses--(1) Amount. 200 micrograms per
kilogram of body weight as a single dose by stomach tube or as an oral
drench.
Dated: November 9, 2001.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 01-30076 Filed 12-4-01; 8:45 am]
BILLING CODE 4160-01-S