80 FR 72970 - Sunscreen Innovation Act; Withdrawal of a 586A Request or Pending Request; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 225 (November 23, 2015)

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Sunscreen Innovation Act: Withdrawal of a 586A Request or Pending Request.'' This draft guidance provides recommendations for the process for withdrawing a 586A request submitted under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by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 We are issuing this draft guidance under the SIA, which directs FDA to issue guidance on various topics, including guidance on the process by which a request under section 586A or a pending request is withdrawn.

[Federal Register Volume 80, Number 225 (Monday, November 23, 2015)]
[Notices]
[Pages 72970-72971]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-29634]


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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Request; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled ``Sunscreen 
Innovation Act: Withdrawal of a 586A Request or Pending Request.'' This 
draft guidance provides recommendations for the process for withdrawing 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 draft 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.

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

[[Page 72971]]

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-4012 for ``Sunscreen Innovation Act: Withdrawal of a 586A 
Request or Pending Request; Draft Guidance for Industry.'' 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 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 ``Sunscreen Innovation Act: Withdrawal of a 586A Request or 
Pending Request.'' This draft guidance provides background information 
on the sunscreen OTC monograph process and the new procedures under the 
SIA (Pub. L. 113-195, enacted November 26, 2014), 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 draft 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 draft 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 draft 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 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 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 draft guidance 
at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

III. Paperwork Reduction Act of 1995

    This draft 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: November 16, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-29634 Filed 11-20-15; 8:45 am]
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