[Federal Register Volume 62, Number 135 (Tuesday, July 15, 1997)]
[Rules and Regulations]
[Page 37712]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-18458]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Sulfaquinoxaline Drinking 
Water

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 a supplemental new animal drug 
application (NADA) filed by Solvay Animal Health, Inc. The supplemental 
NADA provides for revised conditions of use of sulfaquinoxaline sodium 
in the drinking water of chickens and turkeys to reflect compliance 
with the results of the National Academy of Sciences/National Research 
Council (NAS/NRC), Drug Efficacy Study Implementation (DESI) evaluation 
of the product and FDA's conclusions based on that evaluation.

EFFECTIVE DATE: July 15, 1997.

FOR FURTHER INFORMATION CONTACT: Dianne T. McRae, Center For Veterinary 
Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-594-1623.

SUPPLEMENTARY INFORMATION: Solvay Animal Health, Inc., 1201 Northland 
Dr., Mendota Heights, MN 55120-1149, filed supplemental NADA 6-707 that 
provides for use of 28.62-percent sulfaquinoxaline sodium solution to 
make 0.025- or 0.04-percent solution used in the drinking water of 
chickens and turkeys for control of coccidiosis, acute fowl cholera, 
and fowl typhoid.
    The supplement is approved as of June 2, 1997, and the regulations 
are amended by adding new 21 CFR 520.2325a(a)(4) to reflect the 
approval.
    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 25.24(d)(1)(i) 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 520

    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 520 is 
amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 520 continues to read as 
follows:

    Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).

    2. Section 520.2325a is amended by adding new paragraph (a)(4) to 
read as follows:


Sec. 520.2325a  Sulfaquinoxaline drinking water.

    (a) * * *
    (4) No. 053501 for use of a 28.62-percent sulfaquinoxaline sodium 
solution as provided in paragraphs (c)(1), (c)(2), and (c)(3) of this 
section.
* * * * *

    Dated: June 20, 1997.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 97-18458 Filed 7-14-97; 8:45 am]
BILLING CODE 4160-01-F