[Federal Register Volume 81, Number 226 (Wednesday, November 23, 2016)]
[Notices]
[Pages 84592-84594]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-28121]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Nonprescription Sunscreen Drug Products--Format and Content of 
Data Submissions; 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 guidance for industry entitled ``Nonprescription 
Sunscreen Drug Products--Format and Content of Data Submissions.'' This 
guidance addresses FDA's current thinking on the format and content of 
information provided to support a request for a determination whether a 
nonprescription sunscreen active ingredient is generally recognized as 
safe and effective (GRASE), as provided under the Federal Food, Drug, 
and Cosmetic Act (the FD&C Act), as amended by the Sunscreen Innovation 
Act (SIA).

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

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--Format 
and Content of Data Submissions; Guidance for Industry; Availability.'' 
Received comments will be placed in the docket

[[Page 84593]]

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 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 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 guidance for industry 
entitled ``Nonprescription Sunscreen Drug Products--Format and Content 
of Data Submissions.'' This guidance replaces a draft guidance that was 
issued on November 23, 2015, under the title ``Nonprescription 
Sunscreen Drug Products--Content and Format of Data Submissions to 
Support a GRASE Determination Under the Sunscreen Innovation Act'' (see 
80 FR 72973), and incorporates editorial changes and clarifying 
language based on FDA's consideration of comments received on that 
draft guidance. The draft guidance and related public comments are 
available at http://www.regulations.gov by searching Docket No. FDA-
2015-D-4033.
    This guidance addresses FDA's current thinking on the format and 
content of information provided to support a request submitted under 
section 586A (586A request) of the FD&C Act (21 U.S.C. 360fff-1), as 
amended by the Sunscreen Innovation Act (SIA) (21 U.S.C. Ch. 9 Sub. 5 
Part I, enacted November 26, 2014), or in support of a pending request, 
as defined under section 586(6) of the FD&C Act (21 U.S.C. 
360fff(6)).\1\ The requests addressed in this guidance seek a 
determination from FDA of whether an over-the-counter (nonprescription) 
sunscreen active ingredient,\2\ or a combination of nonprescription 
sunscreen active ingredients, is GRASE for use under specified 
conditions and should be included in the over-the-counter sunscreen 
drug monograph.\3\ The GRASE determination is primarily based on FDA's 
review of safety and effectiveness data and other information submitted 
by the request's sponsor (GRASE data submission) but also on 
information and comments submitted to the public docket by other 
interested parties.\4\ Before that review may begin, however, FDA must 
review the GRASE data submission for completeness and determine 
accordingly whether to file or refuse to file it for substantive 
review. If the submission is not sufficiently complete to enable the 
Agency to conduct a substantive GRASE review, including being formatted 
in a manner that will enable the Agency to evaluate the submission's 
completeness, FDA will refuse to file the submission (section 
586B(b)(2) of the FD&C Act).
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    \1\ The SIA defines a pending request to mean a request for a 
nonprescription sunscreen active ingredient to be included in the 
over-the-counter monograph that was originally submitted as a time 
and extent application under 21 CFR 330.14 and that was determined 
to be eligible for review and for which safety and effectiveness 
data were submitted prior to the enactment of the SIA (section 
586(6) of the FD&C Act).
    \2\ As defined in the SIA, sunscreen means a drug containing one 
or more sunscreen active ingredients (section 586(9) of the FD&C Act 
(21 U.S.C. 360fff(9)), and the term sunscreen active ingredient 
means an active ingredient that is intended for application to the 
skin of humans for purposes of absorbing, reflecting, or scattering 
ultraviolet radiation (section 586(10) of the FD&C Act (21 U.S.C. 
360fff(10)).
    \3\ See section 586(4) of the FD&C Act (21 U.S.C. 360fff(4) 
(definition of ``GRASE determination''). Under the SIA, FDA must 
also make an initial determination on whether a nonprescription 
sunscreen ingredient or combination of sunscreen ingredients that is 
the subject of a 586A request has been marketed for a material time 
and to a material extent and thus whether that ingredient or 
combination of sunscreen ingredients is eligible for review under 
the SIA (section 586B(a) of the FD&C Act (21 U.S.C. 360fff-2(a))).
    \4\ Section 586B(b)(1) of the FD&C Act. An SIA sponsor is a 
person who has submitted a 586A request, a pending request, or any 
other application subject to the SIA (section 586(8) of the FD&C Act 
(21 U.S.C. 360fff(8)).
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    FDA is issuing this guidance in partial implementation of the SIA, 
which, among other things, added section 586D(a)(1)(B) of the FD&C Act 
(21 U.S.C. 360fff-4(a)(1)(B)) and directed FDA to finalize guidance on 
the implementation of and compliance with the SIA requirements for 
nonprescription sunscreens, including the Agency's guidance on the 
format and content of information submitted by a sponsor in support of 
a 586A request or a pending request. The information in this guidance 
is intended to provide recommendations to help sponsors 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 guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents 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. A sponsor or member of 
the public can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.

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II. The Paperwork Reduction Act of 1995

    This guidance contains collections of information that are exempt 
from the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-
3520). Section 586D(a)(1)(C) of the FD&C Act, as amended by the SIA, 
states that the PRA shall not apply to collections of information for 
purposes of guidance under that subsection.

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 17, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-28121 Filed 11-22-16; 8:45 am]
 BILLING CODE 4164-01-P