[Federal Register: June 9, 2004 (Volume 69, Number 111)]
[Rules and Regulations]
[Page 32272-32273]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09jn04-15]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Clindamycin Capsules and
Tablets
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 two supplemental abbreviated
new animal drug applications (ANADAs) filed by Phoenix Scientific, Inc.
One supplemental ANADA provides for an expanded dose range and revised
indications wording for the oral use of clindamycin hydrochloride
capsules in dogs for the treatment of certain bacterial diseases. The
other supplemental ANADA provides for use of a 300-milligram capsule
size.
DATES: This rule is effective June 9, 2004.
FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for
Veterinary Medicine (HFV-104), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 301-827-8549, e-mail:
lluther@cvm.fda.gov.
SUPPLEMENTARY INFORMATION: Phoenix Scientific, Inc., 3915 South 48th
St. Terrace, P.O. Box 6457, St. Joseph, MO 64506-0457, filed two
supplements to ANADA 200-298 for Clindamycin Hydrochloride Capsules.
One supplemental ANADA provides for an expanded dose range and revised
indications wording for the oral use of clindamycin hydrochloride
capsules in dogs for the treatment of certain bacterial diseases. The
other supplemental ANADA provides for use of a 300-milligram capsule
size. The supplemental applications are approved as of April 21, 2004,
and the regulations are amended in 21 CFR 520.446 to reflect their
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 21 CFR 514.11(e)(2)(ii), summaries of safety and
effectiveness data and information submitted to support approval of
these applications 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 these
actions are of a type that do not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required for either.
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.
[[Page 32273]]
Sec. 520.446 [Amended]
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2. Section 520.446 is amended by removing paragraphs (a)(2) and (b)(2);
by redesignating paragraphs (a)(3) and (b)(3) as paragraphs (a)(2) and
(b)(2); in paragraph (b)(1) by removing ``No. 000009'' and by adding in
its place ``Nos. 000009 and 059130''; and in newly redesignated
paragraph (b)(2) by removing ``(a)(3)'' and by adding in its place
``(a)(2).''
Dated: May 19, 2004.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 04-12961 Filed 6-8-04; 8:45 am]
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