[Federal Register Volume 81, Number 5 (Friday, January 8, 2016)]
[Notices]
[Pages 940-941]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-00128]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-4021]


Over-the-Counter Sunscreens: Safety and Effectiveness Data; Draft 
Guidance for Industry; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of the comment period.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is extending 
the comment period provided in the notice entitled ``Over-the-Counter 
Sunscreens: Safety and Effectiveness Data; Draft Guidance for Industry; 
Availability'' that appeared in the Federal Register on November 23, 
2015 (80 FR 72975). That notice announced the availability of a draft 
guidance for industry and requested comments to that draft guidance by 
January 22, 2016. FDA is extending the draft guidance's comment period 
by 30 days (to February 22, 2016) in response to a request for an 
extension to allow interested persons additional time to submit 
comments.

DATES: FDA is extending the comment period for the draft guidance by an 
additional 30 days. Although you can comment on any guidance at any 
time (see 21 CFR 10.115(g)(5)), to permit the Agency to consider your 
comments before issuing the final version of the guidance, submit 
either electronic or written comments on the draft guidance by February 
22, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2015-D-4021 for ``Over-the-Counter Sunscreens: Safety and 
Effectiveness Data; Draft Guidance for Industry.''

[[Page 941]]

Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper 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.
    Submit written requests for single copies of the draft guidance to 
the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one 
self-addressed adhesive label to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Kristen Hardin, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 5443, Silver Spring, MD 20993-0002, 240-
402-4246.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of November 23, 2015 (80 FR 72975), FDA 
published a notice of availability with a 60-day comment period for the 
draft guidance for industry entitled ``Over-the-Counter Sunscreens: 
Safety and Effectiveness Data.'' Publication of that draft guidance was 
mandated by the Sunscreen Innovation Act (SIA), which also requires FDA 
to publish the final guidance no later than November 26, 2016.
    The Agency has received a request for a 30-day extension of the 
comment period to provide more time for regulated industry to prepare a 
detailed and meaningful response to the draft guidance. FDA has 
considered the request and is extending the comment period for 30 days, 
until February 22, 2016. The Agency believes that a 30-day extension 
will allow adequate time for interested persons to submit comments 
without compromising timely publication of the final guidance as 
mandated by the SIA.

II. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: January 4, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-00128 Filed 1-7-16; 8:45 am]
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