[Federal Register Volume 75, Number 105 (Wednesday, June 2, 2010)]
[Notices]
[Pages 30838-30839]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-13001]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2003-N-0196] (formerly Docket No. 2003N-0233)


Drometrizole Trisiloxane Eligibility for Potential Inclusion in 
Sunscreen Monograph; Over-the-Counter Sunscreen Drug Products for Human 
Use; Request for Safety, Effectiveness, and Environmental Data

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice of eligibility; request for data and information.

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SUMMARY:  As part of our ongoing review of over-the-counter (OTC) drug 
products, we (Food and Drug Administration, FDA) are announcing a call-
for-data for safety, effectiveness, and environmental information for 
drometrizole trisiloxane, in concentrations up to 15 percent, as a 
sunscreen single active ingredient and in combination with generally 
recognized as safe and effective (GRASE) sunscreen active ingredients 
found in the sunscreen monograph. We reviewed a time and extent 
application (TEA) for drometrizole trisiloxane and determined that it 
is eligible to be considered for inclusion in our OTC drug monograph 
system. We will evaluate the submitted safety and effectiveness data 
and information to determine whether drometrizole trisiloxane can be 
GRASE for its proposed OTC use. We also request data and information to 
assess the projected environmental effects of a potential GRASE 
determination in order to assist us in complying with the requirements 
of the National Environmental Policy Act of 1969 (NEPA).

DATES:  Submit data, information, and general comments by August 31, 
2010.

ADDRESSES:  You may submit comments, identified by Docket No. FDA-2003-
N-0196, by any of the following methods:
Electronic Submissions
    Submit electronic comments in the following way:
    <bullet> Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
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.
    Instructions: All submissions received must include the agency name 
and docket number. All comments received may be posted without change 
to http://www.regulations.gov, including any personal information 
provided.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov 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:  Anita Kumar, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 5445, Silver Spring, MD 20993, 301-796-
2090.

SUPPLEMENTARY INFORMATION:

I. Eligibility of Drometrizole Trisiloxane

    In January 2009, we received a TEA (Ref. 1) requesting that 
drometrizole trisiloxane be found eligible for review and potential 
inclusion in our OTC sunscreen drug monograph (part 352 (21 CFR part 
352)). After reviewing the TEA, we believe that it includes adequate 
data demonstrating that drometrizole trisiloxane has been marketed for 
the prevention of sunburn for a material time and to a material extent 
as required by Sec.  330.14 (21 CFR 330.14) (Ref. 2). Drometrizole 
trisiloxane-containing sunscreen products indicated for the prevention 
of sunburn have been marketed directly to consumers for over 5 
continuous years in 40 countries, with over 177 million dosage units 
marketed in 54 countries. Therefore, we conclude that drometrizole 
trisiloxane, in concentrations up to 15 percent, is eligible to be 
considered for potential inclusion in the OTC sunscreen drug monograph 
as a single active ingredient and in combination with GRASE sunscreen 
active ingredients found in Sec.  352.10.

II. Request for Data and Information

    We invite all interested persons to submit data and information, as 
described in Sec.  330.14(f), on the safety and effectiveness of 
drometrizole trisiloxane for use as an active ingredient in OTC 
sunscreen products. The data should be sufficient so that we can 
determine whether the ingredient can be GRASE and not misbranded under 
recommended conditions of OTC use. Interested parties may refer to 21 
CFR 330.10(a)(4) regarding the evidence necessary for establishing 
general recognition of safety and effectiveness.
    Because the TEA that we reviewed did not include an official or 
proposed United States Pharmacopeia-National Formulary (USP-NF) drug 
monograph for drometrizole trisiloxane, we are asking interested 
parties to provide such a monograph to us. An active ingredient must be 
recognized in an official USP-NF drug monograph that sets forth its 
standards of identity, strength, quality, and purity in order to be 
included in a final OTC monograph (Sec.  330.14(i)).
    In addition, as stated in 21 CFR 25.1, FDA regulations must comply 
with NEPA. To comply with NEPA, an environmental assessment (EA) of 
agency actions is required unless we determine that a categorical 
exclusion is warranted. Therefore, we also invite all interested 
persons to either submit data and information that would support a 
determination that the potential inclusion of drometrizole trisiloxane 
in the OTC monograph for sunscreen meets the requirements for any 
categorical exclusion found in 21 CFR 25.31, or to prepare an EA, if 
necessary. For additional information on the types of information that 
would support our environmental assessment, please refer to section IV 
(pages 9 through 27) of the Center for Drug Evaluation and Research 
Guidance on Environmental Assessment of Human Drug and Biologic 
Applications. The guidance document can be viewed at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070561.pdf.
    For all data and information submitted, we request that a submitter 
segregate any data or information that the submitter believes is 
protected from disclosure by 5 U.S.C. 552(b), 18 U.S.C. 1905, or 21 
U.S.C. 331(j) or 360j(c). If such data or information is included in 
the submission, we request that the submitter summarize the 
confidential information, to the extent possible, so that the summary 
can be publicly disclosed (see 21 CFR 25.50 and 25.51(a); Sec.  
330.14(f)).

[[Page 30839]]

III. Marketing Policy

    Under Sec.  330.14(h), any sunscreen product containing 
drometrizole trisiloxane 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) under Docket No. FDA-2003-N-0196 and may be 
seen by interested persons between 9 a.m. and 4 p.m., Monday through 
Friday.
    1. Redacted TEA for drometrizole trisiloxane submitted by L'Oreal 
USA Products, Inc., dated January 21, 2009.
    2. FDA's evaluation of the TEA for drometrizole trisiloxane.

    Dated: May 25, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-13001 Filed 6-1-10; 8:45 am]
BILLING CODE 4160-01-S