[Federal Register: February 21, 2008 (Volume 73, Number 35)]
[Rules and Regulations]
[Page 9455-9456]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21fe08-14]
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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; technical amendment.
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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 IVX Animal Health, Inc. The
supplemental ANADA provides revised labeling for ivermectin oral liquid
used in horses.
DATES: This rule is effective February 21, 2008.
FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail:
john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: IVX Animal Health, Inc., 3915 South 48th
Street Ter., St. Joseph, MO 64503, filed a supplement to ANADA 200-202
for PHOENECTIN (ivermectin) Liquid for Horses. The supplemental
application provides for the addition of indications for use and minor
revisions to product labeling that conform to the pioneer product
labeling. The supplemental ANADA is approved as of January 24, 2008,
and 21 CFR 520.1195 is amended to reflect the approval.
In addition, the regulation is being amended to add the drug
labeler code for another approved generic product (69 FR 24958, May 5,
2004), which was removed in error in the Federal Register of September
24, 2004 (69 FR 57173). This action is being taken to improve the
accuracy of the regulations.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 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 Division of Dockets Management
(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
[[Page 9456]]
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.
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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
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1. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
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2. In Sec. 520.1195, revise paragraphs (b)(1) and (b)(2) to read as
follows:
Sec. 520.1195 Ivermectin liquid.
* * * * *
(b) * * *
(1) Nos. 050604, 054925, and 059130 for use of product described in
paragraph (a)(1) of this section as in paragraphs (e)(1)(i),
(e)(1)(ii)(A), and (e)(1)(iii) of this section.
(2) Nos. 058005 and 058829 for use of product described in
paragraph (a)(1) of this section as in paragraphs (e)(1)(i),
(e)(1)(ii)(B), and (e)(1)(iii) of this section.
* * * * *
Dated: February 11, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-3266 Filed 2-20-08; 8:45 am]
BILLING CODE 4160-01-S