[Federal Register: February 18, 2004 (Volume 69, Number 32)]
[Notices]
[Page 7652-7653]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18fe04-56]
-----------------------------------------------------------------------
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
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of eligibility; request for data and information.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing a call-
for-data for safety and effectiveness information on the following
conditions as part of FDA's ongoing review of over-the-counter (OTC)
drug products: 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
has reviewed a time and extent application (TEA) for these conditions
and determined that they are eligible for consideration in its OTC drug
monograph system. FDA will evaluate the submitted data and information
to determine whether these conditions can be generally recognized as
safe and effective (GRAS/E) for their proposed OTC use.
DATES: Submit data, information, and general comments by May 18, 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 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 the agency
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
[[Page 7653]]
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
The conditions piroctone olamine, 0.05 percent to 0.5 percent and
0.1 percent to 1.0 percent, as a dandruff control single active
ingredient in leave-on and rinse-off dosage forms, respectively, will
be evaluated for inclusion in the monograph for OTC drug products for
the control of dandruff, seborrheic dermatitis, and psoriasis (21 CFR
part 358, subpart H). Accordingly, FDA invites all interested persons
to submit data and information, as described in Sec. 330.14(f), on the
safety and effectiveness of these conditions for FDA to determine
whether they 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 piroctone olamine. According to Sec. 330.14(i), an official or
proposed USP-NF monograph for piroctone olamine 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 and safety and effectiveness data for both leave-on and
rinse-off dosage forms containing this ingredient.
Interested persons should submit comments, data, and information to
the Division of Dockets Management (see ADDRESSES) by May 18, 2004.
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 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.
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.
1. TEA for piroctone olamine submitted by Keller and Heckman LLP
on behalf of Clariant Gmbh., dated July 11, 2003.
2. FDA's evaluation and comments on the TEA for piroctone
olamine.
Dated: February 10, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-3413 Filed 2-17-04; 8:45 am]
BILLING CODE 4160-01-S