Oral Dosage Form New Animal Drugs; Trimethoprim and Sulfadiazine Oral Paste, 30802 [E6-8303]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 71, Number 104 (Wednesday, May 31, 2006)]
[Rules and Regulations]
[Page 30802]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-8303]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Trimethoprim and Sulfadiazine 
Oral Paste

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 a supplemental new animal drug 
application (NADA) filed by Schering-Plough Animal Health Corp. The 
supplemental NADA provides for revised food safety labeling for 
trimethoprim and sulfadiazine oral paste, administered to horses as a 
systemic antibacterial.

DATES: This rule is effective May 31, 2006.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7540, e-mail: 
melanie.berson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Schering-Plough Animal Health Corp., 556 
Morris Ave., Summit, NJ 07901, filed a supplement to NADA 131-918 for 
use of TRIBRISSEN (trimethoprim and sulfadiazine) 400 Paste, 
administered orally to horses as a systemic antibacterial. The 
supplement provides for revised food safety labeling. The supplemental 
NADA is approved as of April 25, 2006, and the regulations are amended 
in 21 CFR 520.2611 to reflect the approval and a current format. 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 21 CFR 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 Division of Dockets Management 
(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.

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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

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1. The authority citation for 21 CFR part 520 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.

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2. Revise Sec.  520.2611 to read as follows:


Sec.  520.2611  Trimethoprim and sulfadiazine paste.

    (a) Specifications. Each gram (g) of paste contains 67 milligrams 
(mg) trimethoprim and 333 mg sulfadiazine.
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter:
    (1) No. 000856 for product administered as in paragraph (c)(1)(i) 
of this section.
    (2) No. 000061 for product administered as in paragraph (c)(1)(ii) 
of this section.
    (c) Conditions of use in horses--(1) Amount. Administer orally as a 
single daily dose for 5 to 7 days:
    (i) 5 g of paste (335 mg trimethoprim and 1,665 mg sulfadiazine) 
per 150 pounds (68 kilograms) of body weight per day.
    (ii) 3.75 g of paste (250 mg trimethoprim and 1,250 mg 
sulfadiazine) per 110 pounds (50 kilograms) of body weight per day.
    (2) Indications for use. For use where systemic antibacterial 
action against sensitive organisms is required during treatment of 
acute strangles, respiratory infections, acute urogenital infections, 
and wound infections and abscesses.
    (3) Limitations. Not for use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

    Dated: May 18, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. E6-8303 Filed 5-30-06; 8:45 am]
BILLING CODE 4160-01-S