[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
