81_FR_70315 81 FR 70119 - Sunscreen Innovation Act: Withdrawal of a 586A Request or Pending Request; Guidance for Industry; Availability

81 FR 70119 - Sunscreen Innovation Act: Withdrawal of a 586A Request or Pending Request; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 196 (October 11, 2016)

Page Range70119-70120
FR Document2016-24459

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on various topics, including guidance on the process by which a request under section 586A or a pending request is withdrawn. This guidance finalizes the draft guidance issued on November 23, 2015.

Federal Register, Volume 81 Issue 196 (Tuesday, October 11, 2016) 
[Federal Register Volume 81, Number 196 (Tuesday, October 11, 2016)]
[Notices]
[Pages 70119-70120]
From the Federal Register Online  [www.thefederalregister.org]
[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

Federal Register / Vol. 81, No. 196 / Tuesday, October 11, 2016 / Notices 70119 56469, September 18, 2015, or access editorial changes, we have clarified the amended by the Sunscreen Innovation the information at: http://www.fda.gov/ information in section III of the Act (SIA), and withdrawing a pending regulatoryinformation/dockets/ guidance on when to submit a request request, as defined by the SIA. The default.htm. for an NDAC meeting. recommendations in this guidance Docket: For access to the docket to This guidance is being issued apply to 586A requests and pending read background documents or the consistent with FDA’s good guidance requests that seek a determination from electronic and written/paper comments practices regulation (21 CFR 10.115). FDA of whether a nonprescription received, go to http:// The guidance represents the current sunscreen active ingredient, or a www.regulations.gov and insert the thinking of FDA on the process by combination of nonprescription docket number, found in brackets in the which the Agency will carry out section sunscreen active ingredients, is heading of this document, into the 586C(c) of the SIA (21 U.S.C. 360fff–3). generally recognized as safe and ‘‘Search’’ box and follow the prompts It does not establish any rights for any effective (GRASE) for use under and/or go to the Division of Dockets person and is not binding on FDA or the specified conditions and should be Management, 5630 Fishers Lane, Rm. public. You can use an alternative included in the over-the-counter (OTC) 1061, Rockville, MD 20852. approach if it satisfies the requirements sunscreen drug monograph. We are Submit written requests for single of the applicable statutes and issuing this guidance under the SIA, copies of this guidance to the Division regulations. which directs FDA to issue guidance on of Drug Information, Center for Drug various topics, including guidance on II. Electronic Access the process by which a request under Evaluation and Research, Food and Drug Administration, 10001 New Persons with access to the Internet section 586A or a pending request is Hampshire Ave., Hillandale Building, may obtain the guidance at either http:// withdrawn. This guidance finalizes the 4th Floor, Silver Spring, MD 20993– www.fda.gov/Drugs/Guidance draft guidance issued on November 23, 0002. Send one self-addressed adhesive ComplianceRegulatoryInformation/ 2015. label to assist that office in processing Guidances/default.htm or http:// DATES: Submit either electronic or your requests. See the SUPPLEMENTARY www.regulations.gov. written comments on Agency guidances INFORMATION section for electronic III. Paperwork Reduction Act of 1995 at any time. access to the guidance document. ADDRESSES: You may submit comments This guidance contains collections of FOR FURTHER INFORMATION CONTACT: as follows: information that are exempt from the Kristen Hardin, Center for Drug Paperwork Reduction Act of 1995 (44 Electronic Submissions Evaluation and Research, Food and U.S.C. 3501–3520) (PRA). Section Drug Administration, 10903 New Submit electronic comments in the 586D(a)(1)(C) of the FD&C Act (21 U.S.C following way: Hampshire Ave., Bldg. 22, Rm. 5443, Silver Spring, MD 20993, 240–402– 360fff–4(a)(1)(C)) states that the PRA • Federal eRulemaking Portal: http:// shall not apply to collections of www.regulations.gov. Follow the 4246. information made for purposes of instructions for submitting comments. SUPPLEMENTARY INFORMATION: guidance under section 586D(a). Comments submitted electronically, I. Background Dated: October 5, 2016. including attachments, to http:// Leslie Kux, www.regulations.gov will be posted to FDA is announcing the availability of the docket unchanged. Because your a guidance for industry entitled Associate Commissioner for Policy. [FR Doc. 2016–24460 Filed 10–7–16; 8:45 am] comment will be made public, you are ‘‘Sunscreen Innovation Act: Section solely responsible for ensuring that your 586C(c) Advisory Committee Process.’’ BILLING CODE 4164–01–P comment does not include any This guidance provides background confidential information that you or a information on the sunscreen OTC third party may not wish to be posted, monograph process, as well as on the DEPARTMENT OF HEALTH AND HUMAN SERVICES such as medical information, your or Agency’s intended process for anyone else’s Social Security number, or convening the NDAC. It also confidential business information, such Food and Drug Administration recommends procedures for sponsors of as a manufacturing process. Please note 586A requests (submitted under section [Docket No. FDA–2015–D–4012] that if you include your name, contact 586A of the FD&C Act (21 U.S.C. 360fff– information, or other information that 1)) and for sponsors of pending requests Sunscreen Innovation Act: Withdrawal of a 586A Request or Pending identifies you in the body of your (as defined by section 586(6) of the comments, that information will be FD&C Act (21 U.S.C. 360fff (6))) to Request; Guidance for Industry; Availability posted on http://www.regulations.gov. follow in requesting an NDAC meeting. • If you want to submit a comment This guidance also explains how FDA AGENCY: Food and Drug Administration, with confidential information that you intends to process these requests and HHS. do not wish to be made available to the describes the factors the Agency may ACTION: Notice of availability. public, submit the comment as a consider in determining whether and written/paper submission and in the when to refer such requests to the SUMMARY: The Food and Drug manner detailed (see ‘‘Written/Paper NDAC. Administration (FDA or Agency) is Submissions’’ and ‘‘Instructions’’). This guidance finalizes the draft announcing the availability of a asabaliauskas on DSK3SPTVN1PROD with NOTICES guidance that was issued under the guidance for industry entitled Written/Paper Submissions same title on November 23, 2015 (see 80 ‘‘Sunscreen Innovation Act: Withdrawal Submit written/paper submissions as FR 72972), and reflects FDA’s of a 586A Request or Pending Request.’’ follows: consideration of public comments on This guidance provides • Mail/Hand delivery/Courier (for the draft guidance. The draft guidance recommendations for the process for written/paper submissions): Division of and related public comments are withdrawing a 586A request submitted Dockets Management (HFA–305), Food publicly available in Docket No. FDA– under the Federal Food, Drug, and and Drug Administration, 5630 Fishers 2015–D–3990. In addition to minor Cosmetic Act (the FD&C Act), as Lane, Rm. 1061, Rockville, MD 20852. VerDate Sep<11>2014 20:12 Oct 07, 2016 Jkt 241001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\11OCN1.SGM 11OCN1

70120 Federal Register / Vol. 81, No. 196 / Tuesday, October 11, 2016 / Notices • For written/paper comments Submit written requests for single editorial changes, we have clarified the submitted to the Division of Dockets copies of this guidance to the Division use of publicly available data and Management, FDA will post your of Drug Information, Center for Drug information submitted to the docket as comment, as well as any attachments, Evaluation and Research, Food and it pertains to the withdrawal process. except for information submitted, Drug Administration, 10001 New This guidance is being issued marked and identified, as confidential, Hampshire Ave., Hillandale Building, consistent with FDA’s good guidance if submitted as detailed in 4th Floor, Silver Spring, MD 20993– practices regulation (21 CFR 10.115). ‘‘Instructions.’’ 0002. Send one self-addressed adhesive The guidance represents the current Instructions: All submissions received label to assist that office in processing thinking of FDA on the withdrawal of must include the Docket No. FDA– your requests. See the SUPPLEMENTARY 586A requests and pending requests 2015–D–4012 for ‘‘Sunscreen INFORMATION section for electronic under the SIA. It does not establish any Innovation Act; Withdrawal of a 586A access to the guidance document. rights for any person and is not binding Request or Pending Request.’’ Received FOR FURTHER INFORMATION CONTACT: on FDA or the public. You can use an comments will be placed in the docket Kristen Hardin, Center for Drug alternative approach if it satisfies the and, except for those submitted as Evaluation and Research, Food and requirements of the applicable statutes ‘‘Confidential Submissions,’’ publicly Drug Administration, 10903 New and regulations. viewable at http://www.regulations.gov Hampshire Ave., Bldg. 22, Rm. 5443, II. Electronic Access or at the Division of Dockets Silver Spring, MD 20993, 240–402– Management between 9 a.m. and 4 p.m., 4246. Persons with access to the Internet Monday through Friday. may obtain the guidance at either http:// SUPPLEMENTARY INFORMATION: www.fda.gov/Drugs/Guidance • Confidential Submissions—To submit a comment with confidential I. Background ComplianceRegulatoryInformation/ information that you do not wish to be Guidances/default.htm or http:// FDA is announcing the availability of www.regulations.gov. made publicly available, submit your a guidance for industry entitled comments only as a written/paper ‘‘Sunscreen Innovation Act; Withdrawal III. Paperwork Reduction Act of 1995 submission. You should submit two of a 586A Request or Pending Request.’’ This guidance contains collections of copies total. One copy will include the This guidance provides background information that are exempt from the information you claim to be confidential information on the sunscreen OTC Paperwork Reduction Act of 1995 (44 with a heading or cover note that states monograph process and the new U.S.C. 3501–3520) (PRA). Section ‘‘THIS DOCUMENT CONTAINS procedures under the SIA (21 U.S.C. 586D(a)(1)(C) of the FD&C Act (21 U.S.C CONFIDENTIAL INFORMATION.’’ The 360fff), for reviewing 586A requests 360fff–4(a)(1)(C)) states that the PRA Agency will review this copy, including (requests made under section 586A of shall not apply to collections of the claimed confidential information, in the FD&C Act (21 U.S.C. 360fff–1)) and information made for purposes of its consideration of comments. The pending requests for nonprescription guidance under section 586D(a). second copy, which will have the sunscreen active ingredients (the SIA claimed confidential information Dated: October 5, 2016. process). This guidance provides redacted/blacked out, will be available Leslie Kux, recommendations for the general for public viewing and posted on http:// withdrawal process for 586A requests Associate Commissioner for Policy. www.regulations.gov. Submit both and pending requests. At certain stages [FR Doc. 2016–24459 Filed 10–7–16; 8:45 am] copies to the Division of Dockets of the SIA process, a sponsor who BILLING CODE 4164–01–P Management. If you do not wish your submitted the 586A request or pending name and contact information to be request might seek to have it made publicly available, you can withdrawn, or a request may be DEPARTMENT OF HEALTH AND provide this information on the cover withdrawn due to the sponsor’s failure HUMAN SERVICES sheet and not in the body of your to act on the request and failure to comments and you must identify this Food and Drug Administration respond to communications from FDA. information as ‘‘confidential.’’ Any This guidance addresses the expected [Docket No. FDA–2013–D–1446] information marked as ‘‘confidential’’ effect of a withdrawal on key phases of will not be disclosed except in the SIA process, including withdrawals Self-Monitoring Blood Glucose Test accordance with 21 CFR 10.20 and other made prior to or after the initial Systems for Over-the-Counter Use; applicable disclosure law. For more eligibility determination, the Guidance for Industry and Food and information about FDA’s posting of submission of safety and efficacy data, Drug Administration Staff; Availability comments to public dockets, see 80 FR the filing determination, or the GRASE AGENCY: Food and Drug Administration, 56469, September 18, 2015, or access determination. This guidance also HHS. the information at: http://www.fda.gov/ discusses the submission of a new 586A ACTION: Notice of availability. regulatoryinformation/dockets/ request for the same sunscreen default.htm. ingredient for which a 586A or pending SUMMARY: The Food and Drug Docket: For access to the docket to request had been previously submitted Administration (FDA or Agency) is read background documents or the and withdrawn. announcing the availability of the electronic and written/paper comments This guidance finalizes the draft guidance entitled ‘‘Self-Monitoring asabaliauskas on DSK3SPTVN1PROD with NOTICES received, go to http:// guidance that was issued under the Blood Glucose Test Systems for Over- www.regulations.gov and insert the same title on November 23, 2015 (see 80 the-Counter Use.’’ This document docket number, found in brackets in the FR 72970), and reflects FDA’s describes studies and criteria that FDA heading of this document, into the consideration of public comments on recommends be used when submitting ‘‘Search’’ box and follow the prompts the draft guidance. The draft guidance premarket notifications (510(k)s) for and/or go to the Division of Dockets and related public comments are self-monitoring blood glucose test Management, 5630 Fishers Lane, Rm. publicly available in Docket No. FDA– systems (SMBGs) intended for over-the- 1061, Rockville, MD 20852. 2015–D–4012. In addition to minor counter (OTC) home use by lay-users. VerDate Sep<11>2014 20:12 Oct 07, 2016 Jkt 241001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\11OCN1.SGM 11OCN1


Document Created: 2018-02-13 16:34:04
Document Modified: 2018-02-13 16:34:04
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 of availability.
DatesSubmit either electronic or written comments on Agency guidances at any time.
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 Citation81 FR 70119 
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