[Federal Register: July 5, 2006 (Volume 71, Number 128)]
[Rules and Regulations]
[Page 38071-38072]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05jy06-9]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a supplemental abbreviated new
animal drug application (ANADA) filed by Med-Pharmex, Inc. The
supplemental ANADA provides for revisions to labeling for ivermectin
liquid, administered by mouth or nasogastric tube to horses for
treatment and control of various internal parasites or parasitic
conditions.
DATES: This rule is effective July 5, 2006.
FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-9808, e-mail:
john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Med-Pharmex, Inc., 2727 Thompson Creek Rd.,
Pomona, CA 91767-1861, filed a
[[Page 38072]]
supplement to ANADA 200-292 for IVERSOL (ivermectin) Liquid for Horses
for the oral treatment and control of various species of internal
parasites or parasitic conditions. The supplement provides for
revisions to label indications and to the food safety warning. The
supplemental ANADA is approved as of May 30, 2006, and 21 CFR 520.1195
is amended to reflect the approval.
Approval of this supplemental ANADA did not require review of
additional safety or effectiveness data or information. Therefore, a
freedom of information summary is not required.
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 the congressional review requirements
in 5 U.S.C. 801-808.
List of Subjects in 21 CFR Part 520
Animal drugs.
0
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
0
1. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 520.1195 [Amended]
0
2. In Sec. 520.1195, in paragraph (b)(1) remove ``No. 050604'' and add
in its place ``Nos. 050604 and 054925''; and in paragraph (b)(2) remove
``054925, 058829,'' and add in its place ``058829''.
Dated: June 22, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. E6-10444 Filed 7-3-06; 8:45 am]
BILLING CODE 4160-01-S