[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:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
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.
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