[Federal Register Volume 69, Number 97 (Wednesday, May 19, 2004)]
[Notices]
[Pages 28932-28933]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-11248]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0050]


Over-the-Counter Drug Products; Safety and Efficacy Review; 
Additional Dandruff Control Ingredient; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

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

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SUMMARY: The Food and Drug Administration (FDA) is extending to August 
16, 2004, the comment period for the safety and effectiveness review of 
piroctone olamine, 0.05 percent to 0.5 percent and 0.1 percent to 1.0 
percent, for use as a dandruff control single active ingredient in 
leave-on and rinse-off dosage forms, respectively. FDA published a 
notice of eligibility and call-for-data for safety and effectiveness 
data and information on piroctone olamine in the Federal Register of 
February 18, 2004. FDA is taking this action in response to a request 
for extension of the comment period to allow interested persons 
additional time to submit data and information on the safety and 
effectiveness of piroctone olamine as a dandruff control single active 
ingredient.

DATES: Submit data, information, and general comments by August 16, 
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 February 18, 2004 (69 FR 7652), FDA 
published a notice of eligibility and call-for-data for safety and 
effectiveness information on piroctone olamine, 0.05 percent to 0.5 
percent and 0.1 percent to 1.0 percent, for use as a dandruff control 
single active ingredient in leave-on and rinse-off dosage forms, 
respectively. FDA requested that all data, information, and general 
comments be submitted by May 18, 2004.

II. Extension of Time

    On April 16, 2004, Keller and Heckman LLP, on behalf of Clariant 
GmbH, requested a 90-day extension beyond the May 18, 2004, deadline 
for the submission of safety and effectiveness data concerning 
piroctone olamine (Ref. 1). The request stated that additional time is 
needed to assemble a comprehensive submission for this ingredient. FDA 
considers an extension of time for submission of data, information, and 
general comments concerning the safety and effectiveness of piroctone 
olamine to be in the public interest. Accordingly, FDA is extending the 
comment period for 90 days to August 16, 2004, as requested.

III. Comments

    Interested persons should submit comments, data, and general 
information to the Division of Dockets Management (see ADDRESSES) by 
August 16, 2004. Submit three copies of all

[[Page 28933]]

comments, data, and information. Individuals submitting written 
information, or any individuals or entities 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.

IV. Marketing Policy

    Under Sec.  330.14(h), any product containing the conditions 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.

V. Reference

    The following reference is 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.
    1. Comment No. EXT1.

    Dated: May 12, 2004.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 04-11248 Filed 5-18-04; 8:45 am]
BILLING CODE 4160-01-S