[Federal Register Volume 70, Number 232 (Monday, December 5, 2005)]
[Notices]
[Pages 72449-72450]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-23576]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0446]


Over-the-Counter Drug Products; Safety and Efficacy Review; 
Additional Sunscreen Ingredients

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: Bisoctrizole, up to 10 percent, as a sunscreen single 
active ingredient and in combination with other sunscreen active 
ingredients; and bemotrizinol, up to 10 percent, as a sunscreen single 
active ingredient and in combination with other sunscreen active 
ingredients. FDA reviewed time and extent applications (TEAs) for these 
conditions and determined that they are eligible for consideration in 
our 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-
0446, by any of the following methods:
Electronic Submissions
    Submit electronic comments in the following ways:
    <bullet> Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
    <bullet> Agency Web site: 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:
    <bullet> FAX: 301-827-6870.
    <bullet> 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://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://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

[[Page 72450]]

Evaluation and Research (mail stop 5411), Food and Drug Administration, 
10903 New Hampshire Ave., bldg. 22, Silver Spring, MD 20993, 301-796-
2090.

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 TEAs that FDA reviewed 
(Refs. 1 and 2) and FDA's evaluation of the TEAs (Refs. 3 and 4) 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) (section 301(j) of 
the Federal Food, Drug, and Cosmetic Act) was deleted from the TEAs 
before they were 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 
bisoctrizole, up to 10 percent, and bemotrizinol, up to 10 percent, as 
sunscreen single active ingredients and in combination with other 
existing monograph sunscreen active ingredients, for inclusion in the 
monograph for OTC sunscreen drug products (21 CFR part 352). 
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 ingredients as single active ingredients for 
this use so that FDA can determine whether they can be GRAS/E and not 
misbranded under recommended conditions of OTC use. Additional data 
should be included to establish the safety and effectiveness of 
sunscreen drug products containing a combination of bisoctrizole and/or 
bemotrizinol with other existing sunscreen monograph active 
ingredients.
    Neither of the TEAs included an official or proposed United States 
Pharmacopeia-National Formulary (USP-NF) drug monograph. According to 
Sec.  330.14(i), an official or proposed USP-NF monograph for each 
ingredient must be included as part of the safety and effectiveness 
data for these ingredients. Interested parties should provide an 
official or proposed USP-NF monograph for each ingredient.
    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. TEA's for bisoctrizole submitted by CIBA Specialty Chemicals 
Corp., April 11, 2005.
    2. TEA's for bemotrizinol submitted by CIBA Specialty Chemicals 
Corp., April 11, 2005.
    3. FDA's evaluation and comments on the TEA for bisoctrizole.
    4. FDA's evaluation and comments on the TEA for bemotrizinol.

    Dated: November 22, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-23576 Filed 12-2-05; 8:45 am]
BILLING CODE 4160-01-S