80_FR_73198 80 FR 72973 - Sunscreen Innovation Act: Nonprescription Sunscreen Drug Products-Content and Format of Data Submissions; Draft Guidance for Industry; Availability

80 FR 72973 - Sunscreen Innovation Act: Nonprescription Sunscreen Drug Products-Content and Format of Data Submissions; Draft Guidance for Industry; Availability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 Range72973-72975
FR Document2015-29637

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Nonprescription Sunscreen Drug Products--Content and Format of Data Submissions to Support a GRASE Determination Under the Sunscreen Innovation Act''. This draft guidance addresses FDA's current thinking on how we will determine whether a sponsor's submission of safety and efficacy data is sufficiently complete to support a substantive review and determination under the Sunscreen Innovation Act (SIA) that an active ingredient is or is not generally recognized as safe and effective (GRASE) for use in nonprescription sunscreen products. This guidance is being issued in accordance with the SIA.

Federal Register, Volume 80 Issue 225 (Monday, November 23, 2015) 
[Federal Register Volume 80, Number 225 (Monday, November 23, 2015)]
[Notices]
[Pages 72973-72975]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-29637]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-4033]


Sunscreen Innovation Act: Nonprescription Sunscreen Drug 
Products--Content and Format of Data Submissions; Draft Guidance for 
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft

[[Page 72974]]

guidance for industry entitled ``Nonprescription Sunscreen Drug 
Products--Content and Format of Data Submissions to Support a GRASE 
Determination Under the Sunscreen Innovation Act''. This draft guidance 
addresses FDA's current thinking on how we will determine whether a 
sponsor's submission of safety and efficacy data is sufficiently 
complete to support a substantive review and determination under the 
Sunscreen Innovation Act (SIA) that an active ingredient is or is not 
generally recognized as safe and effective (GRASE) for use in 
nonprescription sunscreen products. This guidance is being issued in 
accordance with the SIA.

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 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-4033 for ``Nonprescription Sunscreen Drug Products--Content 
and Format of Data Submissions; Draft 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/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 the 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 ``Nonprescription Sunscreen Drug Products--Content and Format 
of Data Submissions to Support a GRASE Determination Under the 
Sunscreen Innovation Act''.
    This draft guidance is being issued in accordance with the SIA (21 
U.S.C. Ch. 9 Sub. 5 Part I), enacted November 26, 2014, which amended 
the Federal Food, Drug, and Cosmetic Act (the FD&C Act). Section 
586D(a)(1)(A)(i) of the FD&C Act (21 U.S.C. 360fff-4(a)(1)(A)(i)), as 
added by the SIA, directs FDA to issue guidance on the format and 
content of information submitted to FDA in support of a request for a 
determination whether a sunscreen active ingredient or combination of 
active ingredients is GRASE and not misbranded for use in 
nonprescription sunscreen products. The information in this guidance is 
intended to help sponsors and manufacturers prepare a GRASE data 
submission that is sufficiently complete (including being formatted in 
a manner that enables FDA to determine its completeness) to enable FDA 
to conduct a substantive GRASE review, as required by section 
586B(b)(2) of the FD&C Act (21 U.S.C. 360fff-2(b)(2)).
    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 format and 
content of GRASE data submissions 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

[[Page 72975]]

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 (PRA) (44 U.S.C. 3501-3520). 
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 information collected under this 
guidance.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: November 16, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-29637 Filed 11-20-15; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 225 / Monday, November 23, 2015 / Notices 72973 instructions for submitting comments. its consideration of comments. The 586A of the FD&C Act (21 U.S.C. 360fff– Comments submitted electronically, second copy, which will have the 1)) and for sponsors of pending requests including attachments, to http:// claimed confidential information (as defined by section 586(6) of the www.regulations.gov will be posted to redacted/blacked out, will be available FD&C Act (21 U.S.C. 360fff (6))) to the docket unchanged. Because your for public viewing and posted on http:// follow in requesting an NDAC meeting. comment will be made public, you are www.regulations.gov. Submit both This draft guidance also explains how solely responsible for ensuring that your copies to the Division of Dockets FDA intends to process these requests comment does not include any Management. If you do not wish your and describes the factors the Agency confidential information that you or a name and contact information to be may consider in determining whether third party may not wish to be posted, made publicly available, you can and when to refer such requests to the such as medical information, your or provide this information on the cover NDAC. anyone else’s Social Security number, or sheet and not in the body of your This draft guidance is being issued confidential business information, such comments and you must identify this consistent with FDA’s good guidance as a manufacturing process. Please note information as ‘‘confidential.’’ Any practices regulation (21 CFR 10.115). that if you include your name, contact information marked as ‘‘confidential’’ The draft guidance, when finalized, will information, or other information that will not be disclosed except in represent the current thinking of FDA identifies you in the body of your accordance with 21 CFR 10.20 and other on the process by which the Agency comments, that information will be applicable disclosure law. For more will carry out section 586C(c) of the SIA posted on http://www.regulations.gov. information about FDA’s posting of (Pub. L. 113–195). It does not establish • If you want to submit a comment comments to public dockets, see 80 FR any rights for any person and is not with confidential information that you 56469, September 18, 2015, or access binding on FDA or the public. You can do not wish to be made available to the the information at: http://www.fda.gov/ use an alternative approach if it satisfies public, submit the comment as a regulatoryinformation/dockets/ the requirements of the applicable written/paper submission and in the default.htm. statutes and regulations. manner detailed (see ‘‘Written/Paper Docket: For access to the docket to Submissions’’ and ‘‘Instructions’’). II. Electronic Access read background documents or the electronic and written/paper comments Persons with access to the Internet Written/Paper Submissions received, go to http:// may obtain the document at either Submit written/paper submissions as www.regulations.gov and insert the http://www.fda.gov/Drugs/Guidance follows: docket number, found in brackets in the ComplianceRegulatoryInformation/ • Mail/Hand delivery/Courier (for Guidances/default.htm or http:// heading of this document, into the written/paper submissions): Division of www.regulations.gov. ‘‘Search’’ box and follow the prompts Dockets Management (HFA–305), Food and/or go to the Division of Dockets III. Paperwork Reduction Act of 1995 and Drug Administration, 5630 Fishers Management, 5630 Fishers Lane, Rm. Lane, Rm. 1061, Rockville, MD 20852. This draft guidance contains • For written/paper comments 1061, Rockville, MD 20852. Submit written requests for single collections of information that are submitted to the Division of Dockets exempt from the Paperwork Reduction copies of this draft guidance to the Management, FDA will post your Act of 1995 (44 U.S.C. 3501–3520) Division of Drug Information, Center for comment, as well as any attachments, (PRA). Section 586D(a)(1)(C) of the SIA Drug Evaluation and Research, Food except for information submitted, states that the PRA shall not apply to and Drug Administration, 10001 New marked and identified, as confidential, collections of information made for Hampshire Ave., Hillandale Building, if submitted as detailed in purposes of guidance under section 4th Floor, Silver Spring, MD 20993– ‘‘Instructions.’’ 586D(a). Instructions: All submissions received 0002. Send one self-addressed adhesive label to assist that office in processing Dated: November 16, 2015. must include the Docket No. FDA– 2015–D–3990 for ‘‘Sunscreen your requests. See the SUPPLEMENTARY Leslie Kux, INFORMATION section for electronic Associate Commissioner for Policy. Innovation Act: Section 586C(c) Advisory Committee Process; Draft access to the draft guidance document. [FR Doc. 2015–29635 Filed 11–20–15; 8:45 am] Guidance for Industry.’’ Received FOR FURTHER INFORMATION CONTACT: BILLING CODE 4164–01–P comments will be placed in the docket Kristen Hardin, Center for Drug and, except for those submitted as Evaluation and Research, Food and ‘‘Confidential Submissions,’’ publicly Drug Administration, 10903 New DEPARTMENT OF HEALTH AND viewable at http://www.regulations.gov Hampshire Ave., Bldg. 22, Rm. 5443, HUMAN SERVICES or at the Division of Dockets Silver Spring, MD 20993, 240–402– 4246. Food and Drug Administration Management between 9 a.m. and 4 p.m., Monday through Friday. SUPPLEMENTARY INFORMATION: [Docket No. FDA–2015–D–4033] • Confidential Submissions—To submit a comment with confidential I. Background Sunscreen Innovation Act: information that you do not wish to be FDA is announcing the availability of Nonprescription Sunscreen Drug made publicly available, submit your a draft guidance for industry entitled Products—Content and Format of Data comments only as a written/paper ‘‘Sunscreen Innovation Act: Section Submissions; Draft Guidance for submission. You should submit two 586C(c) Advisory Committee Process.’’ Industry; Availability wgreen on DSK2VPTVN1PROD with NOTICES copies total. One copy will include the This draft guidance provides AGENCY: Food and Drug Administration, information you claim to be confidential background information on the HHS. with a heading or cover note that states sunscreen OTC monograph process, as ACTION: Notice of availability. ‘‘THIS DOCUMENT CONTAINS well as on the Agency’s intended CONFIDENTIAL INFORMATION.’’ The process for convening the NDAC. It also SUMMARY: The Food and Drug Agency will review this copy, including recommends procedures for sponsors of Administration (FDA or Agency) is the claimed confidential information, in 586A requests (submitted under section announcing the availability of a draft VerDate Sep<11>2014 14:25 Nov 20, 2015 Jkt 238001 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 E:\FR\FM\23NON1.SGM 23NON1

72974 Federal Register / Vol. 80, No. 225 / Monday, November 23, 2015 / Notices guidance for industry entitled Dockets Management (HFA–305), Food ‘‘Search’’ box and follow the prompts ‘‘Nonprescription Sunscreen Drug and Drug Administration, 5630 Fishers and/or go to the Division of Dockets Products—Content and Format of Data Lane, Rm. 1061, Rockville, MD 20852. Management, 5630 Fishers Lane, Rm. Submissions to Support a GRASE • For written/paper comments 1061, Rockville, MD 20852. Determination Under the Sunscreen submitted to the Division of Dockets Submit written requests for single Innovation Act’’. This draft guidance Management, FDA will post your copies of the draft guidance to the addresses FDA’s current thinking on comment, as well as any attachments, Division of Drug Information, Center for how we will determine whether a except for information submitted, Drug Evaluation and Research, Food sponsor’s submission of safety and marked and identified, as confidential, and Drug Administration, 10001 New efficacy data is sufficiently complete to if submitted as detailed in Hampshire Ave., Hillandale Building, support a substantive review and ‘‘Instructions’’. 4th Floor, Silver Spring, MD 20993– determination under the Sunscreen Instructions: All submissions received 0002. Send one self-addressed adhesive Innovation Act (SIA) that an active must include the Docket No. FDA– label to assist that office in processing ingredient is or is not generally 2015–D–4033 for ‘‘Nonprescription your requests. See the SUPPLEMENTARY recognized as safe and effective Sunscreen Drug Products—Content and INFORMATION section for electronic (GRASE) for use in nonprescription Format of Data Submissions; Draft access to the draft guidance document. sunscreen products. This guidance is Guidance for Industry; Availability’’. FOR FURTHER INFORMATION CONTACT: being issued in accordance with the Received comments will be placed in Kristen Hardin, Center for Drug SIA. the docket and, except for those Evaluation and Research, Food and submitted as ‘‘Confidential Drug Administration, 10903 New DATES: Although you can comment on Submissions,’’ publicly viewable at any guidance at any time (see 21 CFR Hampshire Ave., Bldg. 22, Rm. 5443, http://www.regulations.gov or at the 10.115(g)(5)), to ensure that the Agency Silver Spring, MD 20993, 240–402– Division of Dockets Management considers your comment on this draft 4246. between 9 a.m. and 4 p.m., Monday guidance before it begins work on the through Friday. SUPPLEMENTARY INFORMATION: final version of the guidance, submit • Confidential Submissions—To I. Background either electronic or written comments submit a comment with confidential on the draft guidance by January 22, information that you do not wish to be FDA is announcing the availability of 2016. made publicly available submit your a draft guidance for industry entitled ADDRESSES: You may submit comments comments only as a written/paper ‘‘Nonprescription Sunscreen Drug as follows: submission. You should submit two Products—Content and Format of Data copies total. One copy will include the Submissions to Support a GRASE Electronic Submissions information you claim to be confidential Determination Under the Sunscreen Submit electronic comments in the with a heading or cover note that states Innovation Act’’. following way: ‘‘THIS DOCUMENT CONTAINS This draft guidance is being issued in • Federal eRulemaking Portal: http:// CONFIDENTIAL INFORMATION’’. The accordance with the SIA (21 U.S.C. Ch. www.regulations.gov. Follow the Agency will review this copy, including 9 Sub. 5 Part I), enacted November 26, instructions for submitting comments. the claimed confidential information, in 2014, which amended the Federal Food, Comments submitted electronically, its consideration of comments. The Drug, and Cosmetic Act (the FD&C Act). including attachments, to http:// second copy, which will have the Section 586D(a)(1)(A)(i) of the FD&C Act www.regulations.gov will be posted to claimed confidential information (21 U.S.C. 360fff–4(a)(1)(A)(i)), as added the docket unchanged. Because your redacted/blacked out, will be available by the SIA, directs FDA to issue comment will be made public, you are for public viewing and posted on http:// guidance on the format and content of solely responsible for ensuring that your www.regulations.gov. Submit both information submitted to FDA in comment does not include any copies to the Division of Dockets support of a request for a determination confidential information that you or a Management. If you do not wish your whether a sunscreen active ingredient or third party may not wish to be posted, name and contact information to be combination of active ingredients is such as medical information, your or made publicly available, you can GRASE and not misbranded for use in anyone else’s Social Security number, or provide this information on the cover nonprescription sunscreen products. confidential business information, such sheet and not in the body of your The information in this guidance is as a manufacturing process. Please note comments and you must identify this intended to help sponsors and that if you include your name, contact information as ‘‘confidential.’’ Any manufacturers prepare a GRASE data information, or other information that information marked as ‘‘confidential’’ submission that is sufficiently complete identifies you in the body of your will not be disclosed except in (including being formatted in a manner comments, that information will be accordance with 21 CFR 10.20 and other that enables FDA to determine its posted on http://www.regulations.gov. applicable disclosure law. For more completeness) to enable FDA to conduct • If you want to submit a comment information about FDA’s posting of a substantive GRASE review, as with confidential information that you comments to public dockets, see 80 FR required by section 586B(b)(2) of the do not wish to be made available to the 56469, September 18, 2015, or access FD&C Act (21 U.S.C. 360fff–2(b)(2)). public submit the comment as a written/ the information at: http://www.fda.gov/ This draft guidance is being issued paper submission and in the manner regulatoryinformation/dockets/ consistent with FDA’s good guidance detailed (see ‘‘Written/Paper default.htm. practices regulation (21 CFR 10.115). wgreen on DSK2VPTVN1PROD with NOTICES Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to The draft guidance, when finalized, will read background documents or the represent the current thinking of FDA Written/Paper Submissions electronic and written/paper comments on the format and content of GRASE Submit written/paper submissions as received, go to http:// data submissions under the SIA. It does follows: www.regulations.gov and insert the not establish any rights for any person • Mail/Hand delivery/Courier (for docket number, found in brackets in the and is not binding on FDA or the public. written/paper submissions): Division of heading of this document, into the You can use an alternative approach if VerDate Sep<11>2014 14:25 Nov 20, 2015 Jkt 238001 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 E:\FR\FM\23NON1.SGM 23NON1

Federal Register / Vol. 80, No. 225 / Monday, November 23, 2015 / Notices 72975 it satisfies the requirements of the either electronic or written comments information that you do not wish to be applicable statutes and regulations. on the draft guidance by January 22, made publicly available, submit your 2016. comments only as a written/paper II. The Paperwork Reduction Act of ADDRESSES: You may submit comments submission. You should submit two 1995 as follows: copies total. One copy will include the This guidance contains collections of information you claim to be confidential information that are exempt from the Electronic Submissions with a heading or cover note that states Paperwork Reduction Act of 1995 (PRA) Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS (44 U.S.C. 3501–3520). Section following way: CONFIDENTIAL INFORMATION.’’ The 586D(a)(1)(C) of the FD&C Act (21 • Federal eRulemaking Portal: http:// Agency will review this copy, including U.S.C. 360fff–4(a)(1)(C)) states that the www.regulations.gov. Follow the the claimed confidential information, in PRA shall not apply to information instructions for submitting comments. its consideration of comments. The collected under this guidance. Comments submitted electronically, second copy, which will have the III. Electronic Access including attachments, to http:// claimed confidential information www.regulations.gov will be posted to redacted/blacked out, will be available Persons with access to the Internet the docket unchanged. Because your for public viewing and posted on http:// may obtain the document at either comment will be made public, you are www.regulations.gov. Submit both http://www.fda.gov/Drugs/ solely responsible for ensuring that your copies to the Division of Dockets GuidanceComplianceRegulatory comment does not include any Management. If you do not wish your Information/Guidances/default.htm or confidential information that you or a name and contact information to be http://www.regulations.gov. third party may not wish to be posted, made publicly available, you can Dated: November 16, 2015. such as medical information, your or provide this information on the cover Leslie Kux, anyone else’s Social Security number, or sheet and not in the body of your Associate Commissioner for Policy. confidential business information, such comments and you must identify this as a manufacturing process. Please note information as ‘‘confidential.’’ Any [FR Doc. 2015–29637 Filed 11–20–15; 8:45 am] that if you include your name, contact information marked as ‘‘confidential’’ BILLING CODE 4164–01–P information, or other information that will not be disclosed except in identifies you in the body of your accordance with 21 CFR 10.20 and other comments, that information will be DEPARTMENT OF HEALTH AND applicable disclosure law. For more posted on http://www.regulations.gov. HUMAN SERVICES • If you want to submit a comment information about FDA’s posting of with confidential information that you comments to public dockets, see 80 FR Food and Drug Administration 56469, September 18, 2015, or access do not wish to be made available to the [Docket No. FDA–2015–D–4021] public, submit the comment as a the information at: http://www.fda.gov/ written/paper submission and in the regulatoryinformation/dockets/ Over-the-Counter Sunscreens: Safety manner detailed (see ‘‘Written/Paper default.htm. and Effectiveness Data; Draft Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to Guidance for Industry; Availability read background documents or the Written/Paper Submissions AGENCY: Food and Drug Administration, electronic and written/paper comments Submit written/paper submissions as received, go to http:// HHS. follows: www.regulations.gov and insert the ACTION: Notice of availability. • Mail/Hand delivery/Courier (for docket number, found in brackets in the written/paper submissions): Division of heading of this document, into the SUMMARY: The Food and Drug Dockets Management (HFA–305), Food Administration (FDA or Agency) is ‘‘Search’’ box and follow the prompts and Drug Administration, 5630 Fishers and/or go to the Division of Dockets announcing the availability of a draft Lane, Rm. 1061, Rockville, MD 20852. guidance for industry entitled ‘‘Over- Management, 5630 Fishers Lane, Rm. • For written/paper comments 1061, Rockville, MD 20852. the-Counter Sunscreens: Safety and submitted to the Division of Dockets Effectiveness Data.’’ This draft guidance Management, FDA will post your Submit written requests for single addresses FDA’s current thinking about comment, as well as any attachments, copies of the draft guidance to the the safety and effectiveness data needed except for information submitted, Division of Drug Information, Center for to determine whether a nonprescription marked and identified, as confidential, Drug Evaluation and Research, Food sunscreen active ingredient or if submitted as detailed in and Drug Administration, 10001 New combination of active ingredients ‘‘Instructions.’’ Hampshire Ave., Hillandale Building, evaluated under the Sunscreen Instructions: All submissions received 4th Floor, Silver Spring, MD 20993– Innovation Act (SIA) is generally must include the Docket No. FDA– 0002. Send one self-addressed adhesive recognized as safe and effective 2015–D–4021 for‘‘Over-the-Counter label to assist that office in processing (GRASE) and not misbranded when Sunscreens: Safety and Effectiveness your requests. See the SUPPLEMENTARY used under specified conditions. The Data; Draft Guidance for Industry; INFORMATION section for electronic guidance also addresses FDA’s current Availability.’’ Received comments will access to the draft guidance document. thinking about an approach to safety- be placed in the docket and, except for related final formulation testing that it FOR FURTHER INFORMATION CONTACT: those submitted as ‘‘Confidential Kristen Hardin, Center for Drug wgreen on DSK2VPTVN1PROD with NOTICES anticipates adopting in the future. Submissions,’’ publicly viewable at Evaluation and Research, Food and DATES: Although you can comment on http://www.regulations.gov or at the Drug Administration, 10903 New any guidance at any time (see 21 CFR Division of Dockets Management Hampshire Ave., Bldg. 22, Rm. 5443, 10.115(g)(5)), to ensure that the Agency between 9 a.m. and 4 p.m., Monday Silver Spring, MD 20993–0002, 240– considers your comment on this draft through Friday. 402–4246. guidance before it begins work on the • Confidential Submissions—To final version of the guidance, submit submit a comment with confidential SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 14:25 Nov 20, 2015 Jkt 238001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 E:\FR\FM\23NON1.SGM 23NON1


Document Created: 2018-03-01 11:18:28
Document Modified: 2018-03-01 11:18:28
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.
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 72973 
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