[Federal Register Volume 81, Number 196 (Tuesday, October 11, 2016)]
[Notices]
[Pages 70119-70120]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-24459]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-4012]


Sunscreen Innovation Act: Withdrawal of a 586A Request or Pending 
Request; 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 ``Sunscreen 
Innovation Act: Withdrawal of a 586A Request or Pending Request.'' This 
guidance provides recommendations for the process for withdrawing a 
586A request submitted under the Federal Food, Drug, and Cosmetic Act 
(the FD&C Act), as amended by the Sunscreen Innovation Act (SIA), and 
withdrawing a pending request, as defined by the SIA. The 
recommendations in this guidance apply to 586A requests and pending 
requests that seek a determination from FDA of whether a 
nonprescription sunscreen active ingredient, or a combination of 
nonprescription sunscreen active ingredients, is generally recognized 
as safe and effective (GRASE) for use under specified conditions and 
should be included in the over-the-counter (OTC) sunscreen drug 
monograph. We are issuing this guidance under the SIA, which directs 
FDA to issue guidance on various topics, including guidance on the 
process by which a request under section 586A or a pending request is 
withdrawn. This guidance finalizes the draft guidance issued on 
November 23, 2015.

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.

[[Page 70120]]

     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-4012 for ``Sunscreen Innovation Act; Withdrawal of a 586A 
Request or Pending Request.'' 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 this 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 ``Sunscreen Innovation Act; Withdrawal of a 586A Request or 
Pending Request.'' This guidance provides background information on the 
sunscreen OTC monograph process and the new procedures under the SIA 
(21 U.S.C. 360fff), for reviewing 586A requests (requests made under 
section 586A of the FD&C Act (21 U.S.C. 360fff-1)) and pending requests 
for nonprescription sunscreen active ingredients (the SIA process). 
This guidance provides recommendations for the general withdrawal 
process for 586A requests and pending requests. At certain stages of 
the SIA process, a sponsor who submitted the 586A request or pending 
request might seek to have it withdrawn, or a request may be withdrawn 
due to the sponsor's failure to act on the request and failure to 
respond to communications from FDA. This guidance addresses the 
expected effect of a withdrawal on key phases of the SIA process, 
including withdrawals made prior to or after the initial eligibility 
determination, the submission of safety and efficacy data, the filing 
determination, or the GRASE determination. This guidance also discusses 
the submission of a new 586A request for the same sunscreen ingredient 
for which a 586A or pending request had been previously submitted and 
withdrawn.
    This guidance finalizes the draft guidance that was issued under 
the same title on November 23, 2015 (see 80 FR 72970), and reflects 
FDA's consideration of public comments on the draft guidance. The draft 
guidance and related public comments are publicly available in Docket 
No. FDA-2015-D-4012. In addition to minor editorial changes, we have 
clarified the use of publicly available data and information submitted 
to the docket as it pertains to the withdrawal process.
    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 withdrawal of 586A requests and pending 
requests 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 it satisfies the requirements of the applicable statutes 
and regulations.

II. 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.

III. Paperwork Reduction Act of 1995

    This guidance contains collections of information that are exempt 
from the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) (PRA). 
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 collections of information made 
for purposes of guidance under section 586D(a).

    Dated: October 5, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-24459 Filed 10-7-16; 8:45 am]
BILLING CODE 4164-01-P