[Federal Register Volume 69, Number 162 (Monday, August 23, 2004)]
[Notices]
[Pages 51852-51853]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-19180]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0346]


Over-the-Counter Drug Products; Safety and Efficacy Review; 
Additional Antidiarrheal Ingredient

AGENCY:  Food and Drug Administration, HHS.

ACTION: Notice of eligibility; request for data and information.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a call-
for-data for safety and effectiveness information on the following 
condition as part of FDA's ongoing review of over-the-counter (OTC) 
drug products: Saccharomyces boulardii (S. boulardii), 250 milligrams 
(mg) (4.5 x 10\9\ lyophilized, viable yeast cells) taken 1 to 2 times 
daily with a maximum daily dose of 500 mg (9.0 x 10\9\ yeast cells), in 
capsule form as an antidiarrheal ingredient. FDA has reviewed a time 
and extent application (TEA) for this condition and determined that it 
is eligible for consideration in its OTC drug monograph system. FDA 
will evaluate the submitted data and information to determine whether 
this condition can be generally recognized as safe and effective (GRAS/
E) for its proposed OTC use.

DATES: Submit data, information, and general comments by November 22, 
2004.

ADDRESSES: Submit written comments, data, and information to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Submit electronic comments, data, and information to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Michael L. Koenig, Center for Drug 
Evaluation and Research (HFD-560), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-2222.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of January 23, 2002 (67 FR 3060), FDA 
published a final rule establishing criteria and procedures for 
additional conditions to become eligible for consideration in the OTC 
drug monograph system. These criteria and procedures, codified in Sec.  
330.14 (21 CFR 330.14), permit OTC drugs initially marketed in the 
United States after the OTC drug review began in 1972 and OTC drugs 
without any marketing experience in the United States to become 
eligible for FDA's OTC drug monograph system. The term ``condition'' 
means an active ingredient or botanical drug substance (or a 
combination of active ingredients or botanical drug substances), dosage 
form, dosage strength, or route of administration, marketed for a 
specific OTC use (Sec.  330.14(a)). The criteria and procedures also 
permit conditions that are regulated as cosmetics or dietary 
supplements in foreign countries but that would be regulated as OTC 
drugs in the United States to become eligible for the OTC drug 
monograph system.
    Sponsors must provide specific data and information in a TEA to 
demonstrate that the condition has been marketed for a material time 
and to a material extent to become eligible for consideration in the 
OTC drug monograph system. When the condition is found eligible, FDA 
publishes a notice of eligibility and request for safety and 
effectiveness data for the proposed OTC use. The TEA that FDA reviewed 
(Ref. 1) and FDA's evaluation of the TEA (Ref. 2) have been placed on 
public display in the Division of Dockets Management (see ADDRESSES) 
under the docket number found in brackets in the heading of this 
document. Information deemed confidential under 18 U.S.C. 1905, 5 
U.S.C. 552(b), or 21 U.S.C. 331(j) was deleted from the TEA before it 
was placed on public display.

II. Request for Data and Information

    FDA intends to evaluate the condition S. boulardii, 250 mg (4.5 x 
10\9\ lyophilized, viable yeast cells) taken 1 to 2 times daily with a 
maximum daily dose of 500 mg (9.0 x 10\9\ yeast cells), in capsule form 
for inclusion in the monograph for OTC antidiarrheal drug products (21 
CFR part 335). Accordingly, FDA invites all interested persons to 
submit data and information, as described in Sec.  330.14(f), on the 
safety and effectiveness of this active ingredient for FDA to determine 
whether it can be GRAS/E and not misbranded under recommended 
conditions of OTC use. The TEA did not include an official or proposed 
United States Pharmacopeia-National Formulary (USP-NF) drug monograph 
for S. boulardii. According to Sec.  330.14(i), an official or proposed 
USP-NF monograph for S. boulardii must be included as part of the 
safety and effectiveness data for this ingredient. Interested parties 
should provide an official or proposed USP-NF monograph for evaluation 
by FDA.
    Interested persons should submit comments, data, and information to 
the Division of Dockets Management. Three copies of all comments, data, 
and information are to be submitted. Individuals submitting written 
information or anyone submitting electronic comments may submit one 
copy. Submissions are to be identified with the docket number found in 
brackets in the heading of this document and may be accompanied by 
supporting information. Received submissions may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday. Information submitted after the closing date will not 
be considered except by petition under 21 CFR 10.30.

III. Marketing Policy

    Under Sec.  330.14(h), any product containing the condition for 
which data and information are requested may not be marketed as an OTC 
drug in the United States at this time unless it is the subject of an 
approved new drug application or abbreviated new drug application.

IV. References

    The following references are on display in the Division of Dockets 
Management (see ADDRESSES) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.

[[Page 51853]]

    1. TEA and addendum for S. boulardii as an antidiarrheal active 
ingredient submitted by Parexel.
    2. FDA's evaluation and comments on the TEA for S. boulardii.

    Dated: August 11, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-19180 Filed 8-20-04; 8:45 am]
BILLING CODE 4160-01-S