[Federal Register Volume 80, Number 225 (Monday, November 23, 2015)]
[Notices]
[Pages 72973-72975]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-29637]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-4033]


Sunscreen Innovation Act: Nonprescription Sunscreen Drug 
Products--Content and Format of Data Submissions; Draft Guidance for 
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft

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guidance for industry entitled ``Nonprescription Sunscreen Drug 
Products--Content and Format of Data Submissions to Support a GRASE 
Determination Under the Sunscreen Innovation Act''. This draft guidance 
addresses FDA's current thinking on how we will determine whether a 
sponsor's submission of safety and efficacy data is sufficiently 
complete to support a substantive review and determination under the 
Sunscreen Innovation Act (SIA) that an active ingredient is or is not 
generally recognized as safe and effective (GRASE) for use in 
nonprescription sunscreen products. This guidance is being issued in 
accordance with the SIA.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by January 22, 2016.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-4033 for ``Nonprescription Sunscreen Drug Products--Content 
and Format of Data Submissions; Draft Guidance for Industry; 
Availability''. 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, 240-402-
4246.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Nonprescription Sunscreen Drug Products--Content and Format 
of Data Submissions to Support a GRASE Determination Under the 
Sunscreen Innovation Act''.
    This draft guidance is being issued in accordance with the SIA (21 
U.S.C. Ch. 9 Sub. 5 Part I), enacted November 26, 2014, which amended 
the Federal Food, Drug, and Cosmetic Act (the FD&C Act). Section 
586D(a)(1)(A)(i) of the FD&C Act (21 U.S.C. 360fff-4(a)(1)(A)(i)), as 
added by the SIA, directs FDA to issue guidance on the format and 
content of information submitted to FDA in support of a request for a 
determination whether a sunscreen active ingredient or combination of 
active ingredients is GRASE and not misbranded for use in 
nonprescription sunscreen products. The information in this guidance is 
intended to help sponsors and manufacturers prepare a GRASE data 
submission that is sufficiently complete (including being formatted in 
a manner that enables FDA to determine its completeness) to enable FDA 
to conduct a substantive GRASE review, as required by section 
586B(b)(2) of the FD&C Act (21 U.S.C. 360fff-2(b)(2)).
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on the format and 
content of GRASE data submissions under the SIA. It does not establish 
any rights for any person and is not binding on FDA or the public. You 
can use an alternative approach if

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it satisfies the requirements of the applicable statutes and 
regulations.

II. The Paperwork Reduction Act of 1995

    This guidance contains collections of information that are exempt 
from the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). 
Section 586D(a)(1)(C) of the FD&C Act (21 U.S.C. 360fff-4(a)(1)(C)) 
states that the PRA shall not apply to information collected under this 
guidance.

III. Electronic Access

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

    Dated: November 16, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-29637 Filed 11-20-15; 8:45 am]
BILLING CODE 4164-01-P