[Federal Register Volume 64, Number 72 (Thursday, April 15, 1999)]
[Rules and Regulations]
[Page 18572]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-9456]


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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 Soluble 
Powder

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 (SDM) soluble powder to make a 
medicated drinking water for the treatment of chickens and turkeys and 
to make a drinking water or drench for treatment of dairy calves and 
heifers and beef cattle.

EFFECTIVE DATE: April 15, 1999.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 
Standish Pl., 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, has filed ANADA 
200-258 that provides for use of SDM soluble powder in drinking water 
for the treatment of disease outbreaks of coccidiosis, fowl cholera, 
and infectious coryza in broiler and replacement chickens; and 
coccidiosis and fowl cholera in meat-producing turkeys. The ANADA also 
provides for use of SDM soluble powder in drinking water or as a drench 
for the treatment of shipping fever complex and bacterial pneumonia 
associated with Pasteurella spp. sensitive to sulfadimethoxine, and for 
calf diphtheria and foot rot associated with Sphaerophorus necrophorus 
sensitive to sulfadimethoxine, in dairy calves, dairy heifers, and beef 
cattle.
    ANADA 200-258 is approved as a generic copy of Pfizer's NADA 46-285 
Albon (sulfadimethoxine soluble powder). ANADA 200-258 is 
approved as of March 4, 1999, and the regulations in 21 CFR 
520.2220a(a)(2) are amended to 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, 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 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: 21 U.S.C. 360b.

Sec. 520.2220a  [Amended]

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

    Dated: April 1, 1999.
George A. Mitchell,
Acting Deputy Director, Center for Veterinary Medicine.
[FR Doc. 99-9456 Filed 4-14-99; 8:45 am]
BILLING CODE 4160-01-F