80_FR_73195 80 FR 72970 - Sunscreen Innovation Act; Withdrawal of a 586A Request or Pending Request; Draft Guidance for Industry; Availability

80 FR 72970 - Sunscreen Innovation Act; Withdrawal of a 586A Request or Pending Request; Draft Guidance for Industry; Availability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

Page Range72970-72971
FR Document2015-29634

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Sunscreen Innovation Act: Withdrawal of a 586A Request or Pending Request.'' This draft guidance provides recommendations for the process for withdrawing a 586A request submitted under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by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 We are issuing this draft guidance under the SIA, which directs FDA to issue guidance on various topics, including guidance on the process by which a request under section 586A or a pending request is withdrawn.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 Issue 225 (Monday, November 23, 2015) 
[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Request; Draft Guidance for Industry; Availability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.

-----------------------------------------------------------------------

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the availability of a draft guidance for industry entitled ``Sunscreen 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draft guidance provides recommendations for the process for withdrawing 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]
BILLING CODE 4164-01-P

72970 Federal Register / Vol. 80, No. 225 / Monday, November 23, 2015 / Notices EXISTING ANNUAL BURDEN ESTIMATES Annual Number of re- Average bur- Total number Annual burden Instrument number of sponses per den hours per of respondents hours respondents respondent response Baseline Information Form ................................................... 8,000 4,000 1 0.2 800 Implementation Study Site Visits ......................................... 150 75 1 1 75 JSA Staff Survey .................................................................. 440 220 1 0.33 73 Total Previously Approved Annual Burden: 948. PROPOSED NEW ANNUAL BURDEN ESTIMATES Annual Number of re- Average bur- Total number Annual burden Instrument number sponses per den hours per of respondents hours of respondents respondent response 6 Month Follow-Up Survey .................................................. 6,400 3,200 1 0.333 1,066 Participant Contact Update Form ........................................ 1,200 600 1 0.083 50 Tracking Surveys ................................................................. 2,800 1,400 5 0.167 1,169 Estimated Total NEW Annual Burden DEPARTMENT OF HEALTH AND request under section 586A or a pending Hours: 2285. HUMAN SERVICES request is withdrawn. Additional Information: Copies of the DATES: Although you can comment on Food and Drug Administration proposed collection may be obtained by any guidance at any time (see 21 CFR writing to the Administration for [Docket No. FDA–2015–D–4012] 10.115(g)(5)), to ensure that the Agency Children and Families, Office of considers your comment on this draft Planning, Research and Evaluation, 370 Sunscreen Innovation Act; Withdrawal guidance before it begins work on the L’Enfant Promenade SW., Washington, of a 586A Request or Pending final version of the guidance, submit Request; Draft Guidance for Industry; either electronic or written comments DC 20447, Attn: OPRE Reports Availability on the draft guidance by January 22, Clearance Officer. All requests should be identified by the title of the AGENCY: Food and Drug Administration, 2016. information collection. Email address: HHS. ADDRESSES: You may submit comments OPREinfocollection@acf.hhs.gov. ACTION: Notice. as follows: OMB Comment: OMB is required to SUMMARY: The Food and Drug Electronic Submissions make a decision concerning the Administration (FDA or Agency) is collection of information between 30 Submit electronic comments in the announcing the availability of a draft and 60 days after publication of this following way: guidance for industry entitled document in the Federal Register. ‘‘Sunscreen Innovation Act: Withdrawal • Federal eRulemaking Portal: http:// Therefore, a comment is best assured of of a 586A Request or Pending Request.’’ www.regulations.gov. Follow the having its full effect if OMB receives it This draft guidance provides instructions for submitting comments. within 30 days of publication. Written recommendations for the process for Comments submitted electronically, comments and recommendations for the withdrawing a 586A request submitted including attachments, to http:// proposed information collection should under the Federal Food, Drug, and www.regulations.gov will be posted to be sent directly to the following: Cosmetic Act (the FD&C Act), as the docket unchanged. Because your Office of Management and Budget, amended by the Sunscreen Innovation comment will be made public, you are Paperwork Reduction Project, Email: Act (SIA), and withdrawing a pending solely responsible for ensuring that your request, as defined by the SIA. The comment does not include any OIRA_SUBMISSION@OMB.EOP.GOV, recommendations in this guidance confidential information that you or a Attn: Desk Officer for the apply to 586A requests and pending third party may not wish to be posted, Administration for Children and requests that seek a determination from such as medical information, your or Families. anyone else’s Social Security number, or FDA of whether a nonprescription Robert Sargis, sunscreen active ingredient, or a confidential business information, such ACF Reports Clearance Officer. combination of nonprescription as a manufacturing process. Please note [FR Doc. 2015–29749 Filed 11–20–15; 8:45 am] sunscreen active ingredients, is that if you include your name, contact generally recognized as safe and information, or other information that BILLING CODE 4184–07–P effective (GRASE) for use under identifies you in the body of your wgreen on DSK2VPTVN1PROD with NOTICES specified conditions and should be comments, that information will be included in the over-the-counter (OTC) posted on http://www.regulations.gov. sunscreen drug monograph. We are • If you want to submit a comment issuing this draft guidance under the with confidential information that you SIA, which directs FDA to issue do not wish to be made available to the guidance on various topics, including public, submit the comment as a guidance on the process by which a written/paper submission and in the VerDate Sep<11>2014 17:41 Nov 20, 2015 Jkt 238001 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 E:\FR\FM\23NON1.SGM 23NON1

Federal Register / Vol. 80, No. 225 / Monday, November 23, 2015 / Notices 72971 manner detailed (see ‘‘Written/Paper Docket: For access to the docket to ingredient for which a 586A or pending Submissions’’ and ‘‘Instructions’’). read background documents or the request had been previously submitted electronic and written/paper comments and withdrawn. Written/Paper Submissions received, go to http:// This draft guidance is being issued Submit written/paper submissions as www.regulations.gov and insert the consistent with FDA’s good guidance follows: docket number, found in brackets in the practices regulation (21 CFR 10.115). • Mail/Hand delivery/Courier (for heading of this document, into the The draft guidance, when finalized, will written/paper submissions): Division of ‘‘Search’’ box and follow the prompts represent the current thinking of FDA Dockets Management (HFA–305), Food and/or go to the Division of Dockets on the withdrawal of 586A requests and and Drug Administration, 5630 Fishers Management, 5630 Fishers Lane, Rm. pending requests under the SIA. It does Lane, Rm. 1061, Rockville, MD 20852. 1061, Rockville, MD 20852. not establish any rights for any person • For written/paper comments Submit written requests for single and is not binding on FDA or the public. submitted to the Division of Dockets copies of this draft guidance to the You can use an alternative approach if Management, FDA will post your Division of Drug Information, Center for it satisfies the requirements of the comment, as well as any attachments, Drug Evaluation and Research, Food applicable statutes and regulations. except for information submitted, and Drug Administration, 10001 New marked and identified, as confidential, Hampshire Ave., Hillandale Building, II. Electronic Access if submitted as detailed in 4th Floor, Silver Spring, MD 20993– Persons with access to the Internet ‘‘Instructions.’’ 0002. Send one self-addressed adhesive may obtain the draft guidance at either Instructions: All submissions received label to assist that office in processing http://www.fda.gov/Drugs/Guidance must include the Docket No. FDA– your requests. See the SUPPLEMENTARY ComplianceRegulatoryInformation/ 2015–D–4012 for ‘‘Sunscreen INFORMATION section for electronic Guidances/default.htm or http:// Innovation Act: Withdrawal of a 586A access to the draft guidance document. www.regulations.gov. Request or Pending Request; Draft Guidance for Industry.’’ Received FOR FURTHER INFORMATION CONTACT: III. Paperwork Reduction Act of 1995 comments will be placed in the docket Kristen Hardin, Center for Drug Evaluation and Research, Food and This draft guidance contains and, except for those submitted as collections of information that are ‘‘Confidential Submissions,’’ publicly Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5443, exempt from the Paperwork Reduction viewable at http://www.regulations.gov Silver Spring, MD 20993, 240–402– Act of 1995 (44 U.S.C. 3501–3520) or at the Division of Dockets 4246. (PRA). Section 586D(a)(1)(C) of the Management between 9 a.m. and 4 p.m., FD&C Act (21 U.S.C 360fff–4(a)(1)(C)) Monday through Friday. SUPPLEMENTARY INFORMATION: • Confidential Submissions—To states that the PRA shall not apply to submit a comment with confidential I. Background collections of information made for information that you do not wish to be FDA is announcing the availability of purposes of guidance under section made publicly available, submit your a draft guidance for industry entitled 586D(a). comments only as a written/paper ‘‘Sunscreen Innovation Act: Withdrawal Dated: November 16, 2015. submission. You should submit two of a 586A Request or Pending Request.’’ Leslie Kux, copies total. One copy will include the This draft guidance provides Associate Commissioner for Policy. information you claim to be confidential background information on the [FR Doc. 2015–29634 Filed 11–20–15; 8:45 am] with a heading or cover note that states sunscreen OTC monograph process and BILLING CODE 4164–01–P ‘‘THIS DOCUMENT CONTAINS the new procedures under the SIA (Pub. CONFIDENTIAL INFORMATION’’. The L. 113–195, enacted November 26, Agency will review this copy, including 2014), for reviewing 586A requests DEPARTMENT OF HEALTH AND the claimed confidential information, in (requests made under section 586A of HUMAN SERVICES its consideration of comments. The the FD&C Act (21 U.S.C. 360fff–1) and second copy, which will have the pending requests for nonprescription Food and Drug Administration claimed confidential information sunscreen active ingredients (the SIA redacted/blacked out, will be available process). This draft guidance provides [Docket No. FDA–2015–N–0001] for public viewing and posted on http:// recommendations for the general Orthopaedic and Rehabilitation www.regulations.gov. Submit both withdrawal process for 586A requests Devices Panel of the Medical Devices copies to the Division of Dockets and pending requests. At certain stages Advisory Committee; Notice of Meeting Management. If you do not wish your of the SIA process, a sponsor who name and contact information to be submitted the 586A request or pending AGENCY: Food and Drug Administration, made publicly available, you can request might seek to have it HHS. provide this information on the cover withdrawn, or a request may be ACTION: Notice. sheet and not in the body of your withdrawn due to the sponsor’s failure comments and you must identify this to act on the request and failure to This notice announces a forthcoming information as ‘‘confidential.’’ Any respond to communications from FDA. meeting of a public advisory committee information marked as ‘‘confidential’’ This draft guidance addresses the of the Food and Drug Administration will not be disclosed except in expected effect of a withdrawal on key (FDA). The meeting will be open to the accordance with 21 CFR 10.20 and other phases of the SIA process, including public. wgreen on DSK2VPTVN1PROD with NOTICES applicable disclosure law. For more withdrawals made prior to or after the Name of Committee: Orthopaedic and information about FDA’s posting of initial eligibility determination, the Rehabilitation Devices Panel of the comments to public dockets, see 80 FR submission of safety and efficacy data, Medical Devices Advisory Committee. 56469, September 18, 2015, or access the filing determination, or the GRASE General Function of the Committee: the information at: http://www.fda.gov/ determination. This draft guidance also To provide advice and regulatoryinformation/dockets/ discusses the submission of a new 586A recommendations to the Agency on default.htm. request for the same sunscreen FDA’s regulatory issues. VerDate Sep<11>2014 14:25 Nov 20, 2015 Jkt 238001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 E:\FR\FM\23NON1.SGM 23NON1


Document Created: 2018-03-01 11:17:41
Document Modified: 2018-03-01 11:17:41
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesAlthough 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.
ContactKristen 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.
FR Citation80 FR 72970 
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