[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
