[Federal Register: May 19, 2004 (Volume 69, Number 97)]
[Notices]
[Page 28932-28933]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19my04-62]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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