[Federal Register Volume 71, Number 143 (Wednesday, July 26, 2006)]
[Notices]
[Pages 42405-42407]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-11874]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006O-0231]


Over-the-Counter Drug Products; Safety and Efficacy Review; 
Additional Sunscreen 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 
condition as part of FDA's ongoing review of over-the-counter (OTC) 
drug products: Diethylhexyl butamido triazone, up to 3 percent, as a 
sunscreen single active

[[Page 42406]]

ingredient and in combination with other sunscreen active ingredients. 
FDA reviewed a time and extent application (TEA) for this condition and 
determined that it is eligible for consideration in our OTC drug 
monograph system. FDA will evaluate the submitted data and information 
to determine whether this condition can be generally recognized as safe 
and effective (GRASE) for its proposed OTC use.

DATES: Submit data, information, and general comments by October 24, 
2006.

ADDRESSES: You may submit comments, identified by Docket No. 2006O-
0231, by any of the following methods:
Electronic Submissions
    Submit electronic comments in the following ways:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     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:
     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 for this rulemaking. 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 
Evaluation and Research (mail stop 5411), Food and Drug Administration, 
bldg. 22, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 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 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) (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 determined that the information submitted in this TEA satisfies 
the criteria of Sec.  330.14(b). FDA will evaluate diethylhexyl 
butamido triazone, up to 3 percent, as a sunscreen single active 
ingredient and in combination with other existing monograph sunscreen 
active ingredients, for inclusion in the monograph for OTC sunscreen 
drug products (part 352 (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 this active 
ingredient for this use so that FDA can determine whether it can be 
GRASE 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 
diethylhexyl butamido triazone with other existing sunscreen monograph 
active ingredients in Sec.  352.10.
    The TEA did not include an official or proposed United States 
Pharmacopeia-National Formulary (USP-NF) drug monograph for 
diethylhexyl butamido triazone. According to Sec.  330.14(i), sponsors 
must include an official or proposed USP-NF monograph as part of the 
safety and effectiveness data for this 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 condition 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 diethylhexyl butamido triazone submitted by 3V, Inc., 
on September 16, 2005.

[[Page 42407]]

    2. FDA's evaluation and comments on the TEA for diethylhexyl 
butamido triazone.

    Dated: July 14, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-11874 Filed 7-25-06; 8:45 am]
BILLING CODE 4160-01-S