Document ID: FDA-2008-N-0039-0070
Agency: fda
Document Type: Rule
Title: Oral Dosage Form New Animal Drugs; Sulfadiazine/Pyrimethamine Suspension
Posted Date: 2008-09-17T04:00Z

[Federal Register: September 17, 2008 (Volume 73, Number 181)]
[Rules and Regulations]               
[Page 53685-53686]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17se08-2]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

[Docket No. FDA-2008-N-0039]

 
Oral Dosage Form New Animal Drugs; Sulfadiazine/Pyrimethamine 
Suspension

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 Animal Health Pharmaceuticals, LLC. The 
supplemental NADA provides for a revised human food safety warning on 
labeling for an oral suspension of sulfadiazine and pyrimethamine used 
for the treatment of equine protozoal myeloencephalitis (EPM).

DATES: This rule is effective September 17, 2008.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8337, e-mail: 
melanie.berson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Animal Health Pharmaceuticals, LLC, 1805 Oak 
Ridge Circle, suite 101, St. Joseph, MO 64506, filed a supplement to 
NADA 141-240 for use of REBALANCE (sulfadiazine/pyrimethamine) 
Antiprotozoal Oral Suspension for the treatment of EPM caused by 
Sarcocystis neurona. The supplement provides for a revised human food 
safety warning on labeling. The supplemental NADA is approved as of 
August 27, 2008, and 21 CFR 520.2215 is amended to reflect the 
approval.
    Approval of this supplemental NADA did not require review of 
additional safety or effectiveness data or

[[Page 53686]]

information. Therefore, a freedom of information summary is not 
required.
    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.

0
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

0
1. The authority citation for 21 CFR part 520 continues to read as 
follows:

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

0
2. In 520.2215, revise paragraph (c)(3) to read as follows:

Sec.  520.2215  Sulfadiazine/pyrimethamine suspension.

* * * * *
    (c) * * *
    (3) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.

    Dated: September 5, 2008.
William T. Flynn,
Acting Director, Center for Veterinary Medicine.
[FR Doc. E8-21625 Filed 9-16-08; 8:45 am]

BILLING CODE 4160-01-S