[Federal Register Volume 64, Number 234 (Tuesday, December 7, 1999)]
[Rules and Regulations]
[Page 68289]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-31571]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Trimethoprim and Sulfadiazine

AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.

-----------------------------------------------------------------------

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 Pharmacia & Upjohn Co. The ANADA provides 
for use of trimethoprim and sulfadiazine powder for control of 
bacterial infections of horses.

EFFECTIVE DATE: December 7, 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: Pharmacia & Upjohn Co., 7000 Portage Rd., 
Kalamazoo, MI 49001-0199, filed ANADA 200-244 that provides for use of 
Tucoprim (trimethoprim and sulfadiazine) powder for control 
of bacterial infections of horses during treatment of acute strangles, 
respiratory tract infections, acute urogenital infections, wound 
infections, and abscesses. ANADA 200-244 is approved as a generic copy 
of Macleod Pharmaceuticals, Inc.'s ANADA 200-033 UniprimTM 
(trimethoprim and sulfadiazine) powder for horses. The ANADA is 
approved as of October 22, 1999, and the regulations in 21 CFR 520.2613 
are amended to reflect the approval. The basis for 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.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801-808.

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. 520.2613  [Amended]

    2. Section 520.2613 Trimethoprim and sulfadiazine powder is amended 
in paragraph (b) by adding the phrase ``000009 and'' before ``058711''.

    Dated: November 29, 1999.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 99-31571 Filed 12-6-99; 8:45 am]
BILLING CODE 4160-01-F