[Federal Register Volume 63, Number 103 (Friday, May 29, 1998)]
[Rules and Regulations]
[Pages 29352-29353]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-14183]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage Form New Animal Drugs;
Guaifenesin Injection
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 Phoenix Scientific, Inc. The ANADA
provides for intravenous use of guaifenesin injection in horses as a
skeletal muscle relaxant.
EFFECTIVE DATE: May 29, 1998.
FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center For
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500
Standish Place, Rockville, MD 20855, 301-827-0209.
SUPPLEMENTARY INFORMATION: Phoenix Scientific, Inc., 3915 South 48th
St. Terrace, P.O. Box 6457, St. Joseph, MO 64506-0457, filed ANADA 200-
230 that provides for intravenous use of guaifenesin injection in
horses as a skeletal muscle relaxant.
Approval of Phoenix Scientific, Inc.'s, ANADA 200-230 for
guaifenesin injection is as a generic copy of Summit Hill Laboratories'
NADA 48-854 for Gecolate (guaifenesin) Injection. The ANADA is approved
as of April 8, 1998, and the regulations are amended in 21 CFR
522.1086(b) to reflect the approval. The basis of approval is discussed
in the freedom of information summary.
In addition, paragraph (c) is redesignated as paragraph (d) and
paragraph (c) is reserved.
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, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857,
between 9 a.m. and 4 p.m., Monday through Friday.
The agency has determined under 21 CFR 25.33(d)(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.
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: 21 U.S.C. 360b.
Sec. 522.1086 [Amended]
2. Section 522.1086 Guaifenesin injection is amended in paragraph
(b) by removing ``No. 037990'' and adding in its place ``Nos. 037990
and 059130'', by redesignating paragraph (c) as paragraph (d), and by
reserving paragraph (c).
[[Page 29353]]
Dated: May 12, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-14183 Filed 5-28-98; 8:45 am]
BILLING CODE 4160-01-F
