[Federal Register Volume 62, Number 37 (Tuesday, February 25, 1997)]
[Rules and Regulations]
[Pages 8370-8371]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-4515]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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 Fermenta Animal Health. The ANADA provides 
for use of sulfadimethoxine oral solution to prepare medicated drinking 
water for animals to treat bacterial infections sensitive to 
sulfadimethoxine.

EFFECTIVE DATE: February 25, 1997.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center For 
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1643.

SUPPLEMENTARY INFORMATION: Fermenta Animal Health Co., 10150 North 
Executive Hills Blvd., Kansas City, MO 64153, filed ANADA 200-165, 
which provides for use of sulfadimethoxine 12.5 percent oral solution 
to prepare medicated drinking water for broiler and replacement 
chickens, meat-producing turkeys, and dairy calves, dairy heifers, and 
beef cattle for the treatment of bacterial diseases susceptible to 
sulfadimethoxine.
    Fermenta Animal Health's ANADA 200-165 for sulfadimethoxine oral 
solution 12.5 percent is approved as a generic copy of Hoffmann-
LaRoche's Albon/Agribon (sulfadimethoxine) 12.5 percent solution in 
NADA 31-205. The ANADA is approved as of December 4,

[[Page 8371]]

1996, and the regulations are amended by revising 21 CFR 520.2220a(b) 
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, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, 
between 9 a.m. and 4 p.m., Monday through Friday.
    FDA has determined under 21 CFR 25.24(d)(1)(i) that this action is 
of a type that does not individually of 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 and 057561'' 
and adding in its place ``000069, 054273, and 057561''.

    Dated: February 3, 1997.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 97-4515 Filed 2-24-97; 8:45 am]
BILLING CODE 4160-01-F