[Federal Register: December 5, 2005 (Volume 70, Number 232)]
[Page 72447-72448]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2005N-0445]

Over-the-Counter Drug Products; Safety and Efficacy Review; 
Additional Acne 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: Triclosan, 0.2 to 0.5 percent and 0.3 to 1.0 percent, as 
a topical acne 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 March 6, 2006.

ADDRESSES: You may submit comments, identified by Docket No. 2005N-
0445, by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following ways:
     Federal eRulemaking Portal: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov. 

Follow the instructions for submitting comments.
     Agency Web site: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. 

Follow the instructions for submitting comments on the agency Web site.

Written Submissions

    Submit written submissions in the following ways:
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier (for paper, disk, or CD-ROM 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of comments, FDA is no longer 
accepting comments submitted to the agency by e-mail. FDA encourages 
you to continue to submit electronic comments by using the Federal 
eRulemaking Portal or the agency Web site, as described in the 
Electronic Submissions portion of this paragraph.
    Instructions: All submissions received must include the agency name 
and docket number. All comments received may be posted without change 
to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm, including any personal 

information provided. For additional information on submitting 
comments, see the ``Request for Comments, Data, and Information'' 
heading of the SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm 

and insert the docket number, found in brackets in the heading of this 
document, into the ``Search'' box and follow the prompts and/or go to 
the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Michael L. Koenig, Center for Drug 
Evaluation and Research (mail stop 5411), Food and Drug Administration, 
10903 New Hampshire Ave., bldg. 22, Silver Spring, MD 20993, 301-796-


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)

[[Page 72448]]

(section 301(j) of the Federal Food, Drug, and Cosmetic Act) was 
deleted from the TEA before it was placed on public display.

II. Request for Comments, Data, and Information

    FDA has determined that the information submitted in this TEA 
satisfies the criteria of Sec.  330.14(b). FDA will evaluate both 
leave-on formulations containing 0.2 to 0.5 percent triclosan and 
rinse-off formulations containing 0.3 to 1.0 percent triclosan for 
inclusion in the monograph for OTC topical acne drug products (21 CFR 
part 333, subpart D). 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 this use, so 
that FDA can determine whether it can be GRAS/E and not misbranded 
under recommended conditions of OTC use.
    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments, data, and information. 
Submit three copies of all comments, data, and information. 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. Amended TEA for triclosan as an acne active ingredient 
submitted by CIBA Specialty Chemicals Corp., on April 22, 2004.
    2. FDA's evaluation and comments on the TEA for triclosan.

    Dated: November 22, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-23570 Filed 12-2-05; 8:45 am]