[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