[Federal Register Volume 62, Number 83 (Wednesday, April 30, 1997)]
[Rules and Regulations]
[Pages 23356-23357]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-11084]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Sulfadimethoxine Oral Solution

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 use of sulfadimethoxine oral solution for chickens, 
turkeys, and cattle for treatment of certain bacterial infections.

EFFECTIVE DATE: April 30, 1997.

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

SUPPLEMENTARY INFORMATION: Phoenix Scientific, Inc., 3915 South 48th 
Street Ter., P.O. Box 6457, St. Joseph, MO 64506-0457, filed ANADA 200-
192, which provides for use of sulfadimethoxine 12.5 percent oral 
solution for chickens, turkeys, and cattle. The oral solution is used 
to make medicated drinking water for broiler and replacement chickens 
for the treatment of outbreaks of coccidiosis, fowl cholera, and 
infectious coryza; meat-producing turkeys for disease outbreaks of 
coccidiosis and fowl cholera; dairy calves, dairy heifers, and beef 
cattle (in drinking water and as a drench) for shipping fever complex, 
bacterial pneumonia associated with Pasteurella spp. sensitive to 
sulfadimethoxine, calf diphtheria and foot-rot associated with 
Sphaerophorus necrophorus sensitive to sulfadimethoxine.
    Approval of Phoenix's ANADA 200-192 for sulfadimethoxine oral 
solution is as a generic copy of Pfizer's NADA 31-205 for 
Albon (sulfadimethoxine) 12.5 percent concentrated solution. 
The ANADA is approved as of March 24, 1997, and the regulations are 
amended by revising 21 CFR 520.2220a(b) to

[[Page 23357]]

reflect the 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 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).


Sec. 520.2220a   [Amended]

    2. Section 520.2220a Sulfadimethoxine oral solution and soluble 
powder is amended in paragraph (b) by removing ``000069, 054273, and 
057561'' and adding in its place ``000069, 054273, 057561, and 
059130''.

    Dated: April 8, 1997.
Michael J. Blackwell,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 97-11084 Filed 4-29-97; 8:45 am]
BILLING CODE 4160-01-F