[Federal Register Volume 69, Number 32 (Wednesday, February 18, 2004)]
[Notices]
[Pages 7652-7653]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-3413]


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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

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 
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://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