[Federal Register Volume 80, Number 4 (Wednesday, January 7, 2015)]
[Notices]
[Pages 892-893]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-00002]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2005-N-0453, FDA-2003-N-0196, and FDA-2006-O-0314]


Sunscreen Feedback Letters; Notice of Availability Under the 
Sunscreen Innovation Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of letters containing FDA's initial determinations and 
feedback on safety and effectiveness data submitted to demonstrate that 
certain active ingredients are generally recognized as safe and 
effective (GRASE) and not misbranded for use in over-the-counter (OTC) 
sunscreen drug products (sunscreen feedback letters). We are taking 
this action under the Sunscreen Innovation Act (SIA).

DATES: Submit either electronic or written comments by February 23, 
2015. Sponsors may submit written requests for a meeting with FDA to 
discuss these proposed sunscreen orders by February 6, 2015.

ADDRESSES: Submit electronic comments to http://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should clearly identify the specific 
active ingredient(s) and docket number(s) to which the comments apply.

FOR FURTHER INFORMATION CONTACT: Kristen Hardin, Division of 
Nonprescription Drug Products, Center for Drug Evaluation and Research, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 
5491, Silver Spring, MD 20993-0002, 240-402-4246.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of six sunscreen feedback 
letters on its Web site that contain the Agency's tentative 
determinations and feedback on safety and effectiveness data submitted 
to demonstrate that certain active ingredients are GRASE and not 
misbranded for use in OTC sunscreen drug products. We are taking this 
action under the SIA (Pub. L. 113-195), enacted November 26, 2014. 
Before the SIA was enacted, these sunscreen feedback letters were 
issued to persons seeking OTC monograph status for nonprescription 
sunscreen active ingredients using the Time and Extent Application 
(TEA) process under FDA regulations in 21 CFR 330.14, and were also 
previously made available to the public in the docket.
    The SIA amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
to, among other things, provide an alternative process for FDA to 
review the safety and effectiveness of nonprescription sunscreen active 
ingredients. The SIA establishes new procedures for establishing the 
conditions under which sunscreens containing active ingredients that 
have been reviewed through the SIA process and found in a final 
sunscreen order to be GRASE and not misbranded may be marketed in the 
United States.
    Section 586C(b)(3) of the FD&C Act, as added by the SIA, provides 
that sunscreen feedback letters issued before the SIA was enacted are 
deemed to be proposed sunscreen orders. Proposed sunscreen orders 
contain FDA's tentative determination that a nonprescription sunscreen 
active ingredient or combination of nonprescription sunscreen active 
ingredients: (A) Is GRASE and not misbranded if marketed in accordance 
with such order; (B) is not GRASE and is misbranded; or (C) is not 
GRASE and is misbranded because the data are insufficient to classify 
the active ingredient or combination of ingredients as GRASE and not 
misbranded, and additional data are necessary to allow FDA to determine 
otherwise. All of the proposed sunscreen orders addressed in this 
notice have been tentatively classified under category (C), as 
described in the previous sentence. Accordingly, additional data will 
be needed to support a determination that any or all of the active 
ingredients they address are GRASE and not misbranded.

II. Sunscreen Feedback Letters Deemed To Be SIA Proposed Orders

    The six feedback letters that are deemed to be proposed orders 
under the SIA are identified in Table 1. They can be viewed 
electronically on FDA's Web site at http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingOver-the-CounterMedicines/ucm239463.htm, under the heading ``FDA Regulatory 
Action on Sunscreen.'' Related documents, including safety and efficacy 
data submissions, can be accessed in the corresponding dockets, 
identified in Table 1, at http://www.regulations.gov. The letters and 
associated information may also be viewed by visiting FDA's Division of 
Dockets Management (see ADDRESSES).

                    Table 1--OTC Sunscreen Feedback Letters Deemed To Be SIA Proposed Orders
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             Active ingredient                          Sponsor                Date issued       Docket No. \1\
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Bemotrizinol...............................  Ciba Specialty Chemicals Corp         11/13/2014    FDA-2005-N-0453
Bisoctrizole...............................  Ciba Specialty Chemicals Corp           9/3/2014    FDA-2005-N-0453
Drometrizole Trisiloxane...................  L'Oreal USA Products, Inc....          8/29/2014    FDA-2003-N-0196
Octyl Triazone.............................  BASF AG......................          6/23/2014    FDA-2003-N-0196
Amiloxate..................................  Symrise, Inc.................          2/25/2014    FDA-2003-N-0196
                                             Ego Pharmaceuticals Pty. Ltd.
Diethylhexyl Butamido Triazone.............  3V Inc.......................          2/21/2014    FDA-2006-O-0314
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\1\ Each letter was previously posted in the docket shown in Table 1 on the date that it was issued.


[[Page 893]]

    Sponsors may submit a written request for a meeting with FDA to 
discuss any of these proposed sunscreen orders (see DATES). Submit 
meeting requests electronically to www.regulations.gov or in writing to 
the Division of Dockets Management (see ADDRESSES), identified with the 
active ingredient name(s), the corresponding docket number(s) shown in 
Table 1, and the heading ``Sponsor Meeting Request.'' To facilitate 
your request, please also send a copy to Kristen Hardin (see FOR 
FURTHER INFORMATION CONTACT).

III. Comments

    Interested persons may submit either electronic comments about the 
proposed orders discussed in this document to http://www.regulations.gov or written comments to the Division of Dockets 
Management (see ADDRESSES). It is only necessary to send one set of 
comments. Identify comments with the appropriate docket number(s) and 
active ingredient name(s) shown in Table 1 for the proposed order(s) 
that the comments address. Comments on this notice may be viewed in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday, and will be posted to the appropriate docket(s) at 
http://www.regulations.gov.

    Dated: December 31, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-00002 Filed 1-6-15; 8:45 am]
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