[Federal Register Volume 74, Number 206 (Tuesday, October 27, 2009)]
[Notices]
[Pages 55245-55246]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-25803]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-N-0063] (formerly Docket No. 2004N-0346)


Saccharomyces boulardii Eligibility for Consideration To Be Added 
to the Over-the-Counter Drug Monograph for Antidiarrheal Drug Products; 
Request for Safety and Effectiveness Data; Withdrawal

AGENCY: Food and Drug Administration, HHS.

ACTION: Withdrawal of notice of eligibility and request for data and 
information.

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SUMMARY: We (Food and Drug Administration (FDA)) are withdrawing a 
notice of eligibility and call-for-data for safety and effectiveness 
information. The original notice published in the Federal Register of 
August 23, 2004 (69 FR 51852). In that notice, we announced that 
Saccharomyces boulardii (S. boulardii) was eligible for consideration 
to be added to the over-the-counter (OTC) monograph for antidiarrheal 
drug products.

FOR FURTHER INFORMATION CONTACT: Michael L. Koenig, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 5411, Silver Spring, MD 20993-0002, 301-
796-2090.

SUPPLEMENTARY INFORMATION: In 2004, we published a notice of 
eligibility for consideration of the yeast S. boulardii in the OTC drug 
monograph system. We announced our intention to evaluate S. boulardii 
for inclusion in the monograph for OTC antidiarrheal drug products (21 
CFR part 335). The notice also requested submission of data and 
information on the safety and effectiveness of S. boulardii for us to 
determine whether it could be generally recognized as safe and 
effective (GRAS/E) and not misbranded for its proposed OTC drug use.
    S. boulardii for antidiarrheal use meets the definition of a drug 
in the Federal Food, Drug, and Cosmetic Act.

[[Page 55246]]

(See section 201(g)(1) (21 U.S.C. 321(g)(1).) S. boulardii is a yeast 
or unicellular fungus and, therefore, also meets the definition of a 
biological product in the Public Health Service Act for this use. (See 
section 351(i) (42 U.S.C. 262(i) and 21 CFR 600.3(h)(1).) We have 
determined that this yeast is more appropriately regulated as a 
biological product under the biologics license application system than 
as an OTC drug product under the monograph system. Because we have 
decided to regulate S. boulardii as a biological product, S. boulardii 
is not eligible for consideration to be included in an OTC drug 
monograph. Therefore, this document withdraws the 2004 notice of 
eligibility permitting consideration of S. boulardii for addition to 
the monograph for OTC antidiarrheal drug products. This document also 
withdraws our 2004 request for submission of safety and effectiveness 
data and information on S. boulardii for OTC antidiarrheal use. Any 
further consideration of the potential therapeutic use(s) of this yeast 
should be addressed under regulations and procedures governing 
biological products.

    Dated: October 22, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-25803 Filed 10-26-09; 8:45 am]
BILLING CODE 4160-01-S