81 FR 84594 - Nonprescription Sunscreen Drug Products-Safety and Effectiveness Data; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 226 (November 23, 2016)

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Nonprescription Sunscreen Drug Products--Safety and Effectiveness Data.'' This guidance addresses FDA's current thinking on the safety and effectiveness data needed to determine whether a nonprescription sunscreen active ingredient or combination of active ingredients evaluated under the Sunscreen Innovation Act (SIA) is generally recognized as safe and effective (GRASE) and not misbranded when used under specified conditions. The guidance also addresses FDA's current thinking about an approach to safety-related final formulation testing that the Agency anticipates adopting in the future.

[Federal Register Volume 81, Number 226 (Wednesday, November 23, 2016)]
[Notices]
[Pages 84594-84595]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-28124]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Nonprescription Sunscreen Drug Products--Safety and Effectiveness 
Data; 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--Safety and Effectiveness Data.'' This guidance 
addresses FDA's current thinking on the safety and effectiveness data 
needed to determine whether a nonprescription sunscreen active 
ingredient or combination of active ingredients evaluated under the 
Sunscreen Innovation Act (SIA) is generally recognized as safe and 
effective (GRASE) and not misbranded when used under specified 
conditions. The guidance also addresses FDA's current thinking about an 
approach to safety-related final formulation testing that the Agency 
anticipates adopting in the future.

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-4021 for ``Nonprescription Sunscreen Drug Products--Safety 
and Effectiveness Data; 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/regulatory&information/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 20993-0002, 240-
402-4246.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Nonprescription Sunscreen Drug Products--Safety and 
Effectiveness Data.'' This guidance replaces a draft

[[Page 84595]]

guidance entitled ``Over-the-Counter Sunscreens: Safety and 
Effectiveness Data'' that was issued on November 23, 2015 (see 80 FR 
72975) 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-4021.
    This guidance addresses the current thinking of FDA about the 
safety and effectiveness data needed to determine whether a 
nonprescription sunscreen active ingredient or combination of active 
ingredients evaluated under the SIA (Pub. L. 113-195), enacted November 
26, 2014, which amended the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) (21 U.S.C. 351 et seq.), is GRASE and not misbranded when 
used under specified conditions. The guidance also addresses FDA's 
current thinking about an approach to safety-related final formulation 
testing that it anticipates adopting in the future. FDA is issuing this 
guidance in partial implementation of the SIA which, among other 
things, established new procedures and review timelines for FDA to 
determine whether a nonprescription sunscreen active ingredient or 
combination of active ingredients is GRASE and not misbranded when used 
under the conditions specified in a final sunscreen order, in 
accordance with sections 586A, 586B, and 586C of the FD&C Act (21 
U.S.C. 360fff-1, 360fff-2, and 360fff-3). The SIA directed FDA to issue 
guidance on four topics, including guidance regarding safety and 
effectiveness data in accordance with section 586D of the FD&C Act (21 
U.S.C. 360ffff-4). Many of the safety topics addressed in this guidance 
were discussed at a public Nonprescription Drug Advisory Committee 
meeting held on September 4 and 5, 2014, http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/NonprescriptionDrugsAdvisoryCommittee/ucm380890.htm.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents FDA's 
current thinking on the topics it addresses. This guidance does not 
establish any rights for any person and is not binding on FDA or the 
public. You can use an alternative approach if 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 (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 made 
for purposes of guidance under that subsection.

III. Electronic Access

    Persons with access to the Internet may obtain the guidance 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. 2016-28124 Filed 11-22-16; 8:45 am]
 BILLING CODE 4164-01-P