[Federal Register Volume 71, Number 104 (Wednesday, May 31, 2006)]
[Rules and Regulations]
[Pages 30802-30803]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-8309]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


Implantation or Injectable Dosage Form New Animal Drugs; 
Trimethoprim and Sulfadiazine

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

[[Page 30803]]

revised food safety labeling for trimethoprim and sulfadiazine 
injectable suspension, 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: 
[email protected].

SUPPLEMENTARY INFORMATION: Schering-Plough Animal Health Corp., 556 
Morris Ave., Summit, NJ 07901, filed a supplement to NADA 106-965 for 
use of TRIBRISSEN (trimethoprim and sulfadiazine) 48% Injection 
administered to horses as a systemic antibacterial. The supplement 
provides for revised food safety labeling. The supplemental NADA is 
approved as of April 26, 2006, and the regulations are amended in Sec.  
522.2610 (21 CFR 522.2610) to reflect the approval and a current 
format. The basis of approval is discussed in the freedom of 
information summary.
    In addition, FDA has found that a 1997 change of sponsorship for 
NADA 106-965 (62 FR 61625, November 19, 1997) is not reflected in the 
Code of Federal Regulations. Accordingly, Sec.  522.2610 is being 
revised to reflect the correct sponsor drug labeler code. This action 
is being taken to improve the accuracy of the regulations.
    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 522

    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 522 is 
amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 522 continues to read as 
follows:

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

0
2. Revise Sec.  522.2610 to read as follows:


Sec.  522.2610  Trimethoprim and sulfadiazine.

    (a) Specifications. Each milliliter (mL) contains:
    (1) 40 milligrams (mg) trimethoprim suspended in a solution 
containing 200 mg sulfadiazine; or
    (2) 80 mg trimethoprim suspended in a solution containing 400 mg 
sulfadiazine (as the sodium salt).
    (b) Sponsors. See Nos. 000061 and 000856 in Sec.  510.600(c) of 
this chapter.
    (c) Special considerations. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.
    (d) Conditions of use--(1) Dogs--(i) Amount. 1 mL of the product 
described in paragraph (a)(1) of this section (40 mg trimethoprim and 
200 mg sulfadiazine) per 20 pounds (9 kilograms) of body weight per day 
by subcutaneous injection.
    (ii) Indications for use. For the treatment of acute urinary tract 
infections, acute bacterial complications of distemper, acute 
respiratory tract infections, acute alimentary tract infections, and 
acute septicemia due to Streptococcus zooepidemicus.
    (2) Horses--(i) Amount. 2 mL of the product described in paragraph 
(a)(2) of this section (160 mg trimethoprim and 800 mg sulfadiazine) 
per 100 pounds (45 kilograms) of body weight per day by intravenous 
injection as single, daily dose for 5 to 7 days. The daily dose may 
also be halved and given morning and evening.
    (ii) Indications for use. For use where systemic antibacterial 
action against sensitive organisms is required during treatment of 
acute strangles, respiratory tract infections, acute urogenital 
infections, and wound infections and abscesses.
    (iii) Limitations. Not for use in horses intended for human 
consumption.

    Dated: May 18, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. E6-8309 Filed 5-30-06; 8:45 am]
BILLING CODE 4160-01-S