80 FR 72975 - Over-the-Counter Sunscreens: Safety and Effectiveness Data; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 225 (November 23, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 225 (November 23, 2015)
| Page Range | 72975-72976 | |
| FR Document | 2015-29636 |
[Federal Register Volume 80, Number 225 (Monday, November 23, 2015)] [Notices] [Pages 72975-72976] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-29636] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-D-4021] Over-the-Counter Sunscreens: Safety and Effectiveness Data; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Over-the- Counter Sunscreens: Safety and Effectiveness Data.'' This draft guidance addresses FDA's current thinking about the safety and effectiveness data needed to determine whether a nonprescription sunscreen active ingredient or combination of active ingredients evaluated under the Sunscreen Innovation Act (SIA) is generally recognized as safe and effective (GRASE) and not misbranded when used under specified conditions. The guidance also addresses FDA's current thinking about an approach to safety-related final formulation testing that it anticipates adopting in the future. 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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by January 22, 2016.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-4021 for``Over-the-Counter Sunscreens: Safety and Effectiveness Data; 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 20993-0002, 240- 402-4246. SUPPLEMENTARY INFORMATION: [[Page 72976]] I. Background FDA is announcing the availability of a draft guidance for industry entitled ``Over-the-Counter Sunscreens: Safety and Effectiveness Data.'' This draft guidance addresses FDA's current thinking regarding the safety and effectiveness data needed to determine whether a nonprescription sunscreen active ingredient or combination of active ingredients evaluated under the SIA is GRASE and not misbranded when used under specified conditions. The guidance also addresses FDA's current thinking about an approach to safety-related final formulation testing that it anticipates adopting in the future. FDA is issuing this guidance in partial implementation of the SIA (Pub. L. 113-195), enacted November 26, 2014, which amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act). Among other things, the SIA established new procedures and review time lines for FDA to determine whether a nonprescription sunscreen active ingredient or combination of active ingredients is GRASE and not misbranded when used under the conditions specified in a final sunscreen order (GRASE determination) (21 U.S.C. 360fff-1, -2, and -3). The SIA also directed FDA to issue four guidances on various topics, including this guidance (21 U.S.C. 360ffff-4). Many of the safety topics addressed in this guidance were discussed at a public Nonprescription Drug Advisory Committee meeting held September 4 and 5, 2014 (http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/NonprescriptionDrugsAdvisoryCommittee/ucm380890.htm). 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 ``Over-the- Counter Sunscreens: Safety and Effectiveness Data; Draft Guidance for Industry; Availability.'' 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. 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)) as amended by the SIA states that the PRA shall not apply to collections of information made for purposes of guidance under that subsection. III. 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. Dated: November 16, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-29636 Filed 11-20-15; 8:45 am] BILLING CODE 4164-01-P
![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:
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![72976 Federal Register / Vol. 80, No. 225 / Monday, November 23, 2015 / Notices
I. Background made for purposes of guidance under for any additional information about the
FDA is announcing the availability of that subsection. President’s Advisory Council meeting at
a draft guidance for industry entitled partnerships@hhs.gov.
III. Electronic Access Agenda: Opening and Welcome from
‘‘Over-the-Counter Sunscreens: Safety Persons with access to the Internet the Chairperson and Executive Director
and Effectiveness Data.’’ This draft may obtain the draft guidance at either for the President’s Advisory Council for
guidance addresses FDA’s current http://www.fda.gov/Drugs/Guidance Faith-based and Neighborhood
thinking regarding the safety and ComplianceRegulatoryInformation/ Partnership; Updates for three working
effectiveness data needed to determine Guidances/default.htm or http:// groups; Deliberation of
whether a nonprescription sunscreen www.regulations.gov. recommendations (if necessary);
active ingredient or combination of
Dated: November 16, 2015. Conclusion from Chairperson and
active ingredients evaluated under the Executive Director.
SIA is GRASE and not misbranded Leslie Kux,
Public Comment: There will be an
when used under specified conditions. Associate Commissioner for Policy.
opportunity for public comment at the
The guidance also addresses FDA’s [FR Doc. 2015–29636 Filed 11–20–15; 8:45 am] end of the meeting. Comments and
current thinking about an approach to BILLING CODE 4164–01–P questions can be sent in advance to
safety-related final formulation testing partnerships@hhs.gov.
that it anticipates adopting in the future.
FDA is issuing this guidance in partial DEPARTMENT OF HEALTH AND Dated: November 17, 2015.
implementation of the SIA (Pub. L. 113– HUMAN SERVICES Ben O’Dell,
195), enacted November 26, 2014, Associate Director for Center for Faith-based
which amended the Federal Food, Drug, Meeting Notice for the President’s and Neighborhood Partnerships at U.S.
Advisory Council on Faith-Based and Department of Health and Human Services.
and Cosmetic Act (the FD&C Act).
Among other things, the SIA established Neighborhood Partnerships [FR Doc. 2015–29826 Filed 11–20–15; 8:45 am]
new procedures and review time lines In accordance with section 10(a)(2) of
BILLING CODE 4154–07–P
for FDA to determine whether a the Federal Advisory Committee Act
nonprescription sunscreen active (Pub. L. 92–463), the President’s
ingredient or combination of active DEPARTMENT OF HEALTH AND
Advisory Council on Faith-based and HUMAN SERVICES
ingredients is GRASE and not Neighborhood Partnerships announces
misbranded when used under the the following webinar: National Institutes of Health
conditions specified in a final sunscreen Name: President’s Advisory Council
order (GRASE determination) (21 U.S.C. on Faith-based and Neighborhood National Heart, Lung, and Blood
360fff–1, –2, and –3). The SIA also Partnerships Council Meetings. Institute; Amended Notice of Meeting
directed FDA to issue four guidances on Time and Date: Wednesday,
various topics, including this guidance Notice is hereby given of a change in
December 9th, 2015 3:00 p.m.–4:30 p.m.
(21 U.S.C. 360ffff–4). Many of the safety the meeting of the National Heart, Lung,
(EST). and Blood Institute Special Emphasis
topics addressed in this guidance were Public Webinar: The meeting will be
discussed at a public Nonprescription Panel, December 7, 2015, 8:00 a.m.
available to the public through a
Drug Advisory Committee meeting held through December 8, 2015, 5:00 p.m.,
webinar system. Register to participate
September 4 and 5, 2014 (http:// The William F. Bolger Center, 9600
in the conference call on Wednesday,
www.fda.gov/AdvisoryCommittees/ Newbridge Drive, Potomac, MD, 20854
December 9th at the Web site https://
CommitteesMeetingMaterials/Drugs/ which was published in the Federal
attendee.gotowebinar.com/register/
NonprescriptionDrugsAdvisory Register on November 12, 2015, 2015–
831474153301651458.
Committee/ucm380890.htm). Status: Open to the public, limited 28656.
This draft guidance is being issued Dr. Joyce’s December 7–8, 2015 ZHL1
only by space available. Conference call
consistent with FDA’s good guidance meeting has been rescheduled to
limited only by lines available.
practices regulation (21 CFR 10.115). Purpose: The Council brings together January 4–5, 2016, at 8:00 a.m. The
The draft guidance, when finalized, will leaders and experts in fields related to meeting is closed to the public.
represent the current thinking of FDA the work of faith-based and Dated: November 17, 2015.
on ‘‘Over-the-Counter Sunscreens: neighborhood organizations in order to: Michelle Trout,
Safety and Effectiveness Data; Draft Identify best practices and successful Program Analyst, Office of Federal Advisory
Guidance for Industry; Availability.’’ It modes of delivering social services; Committee Policy.
does not establish any rights for any evaluate the need for improvements in [FR Doc. 2015–29735 Filed 11–20–15; 8:45 am]
person and is not binding on FDA or the the implementation and coordination of BILLING CODE 4140–01–P
public. You can use an alternative public policies relating to faith-based
approach if it satisfies the requirements and other neighborhood organizations;
of the applicable statutes and and make recommendations for changes DEPARTMENT OF HEALTH AND
regulations. in policies, programs, and practices. The HUMAN SERVICES
charge for this Council focuses on steps
II. The Paperwork Reduction Act of National Institutes of Health
the government should take to reduce
1995
poverty and inequality and create
This guidance contains collections of Center for Scientific Review; Notice of
opportunity for all, including changes in
Closed Meetings
wgreen on DSK2VPTVN1PROD with NOTICES
information that are exempt from the policies, programs, and practices that
Paperwork Reduction Act of 1995 (PRA) affect the delivery of services by faith- Pursuant to section 10(d) of the
(44 U.S.C. 3501–3520). Section based and community organizations and Federal Advisory Committee Act, as
586D(a)(1)(C) of the FD&C Act (21 the needs of low-income and other amended (5 U.S.C. App.), notice is
U.S.C. 360fff–4(a)(1)(C)) as amended by underserved persons. hereby given of the following meetings.
the SIA states that the PRA shall not Contact Person for Additional The meetings will be closed to the
apply to collections of information Information: Please contact Ben O’Dell public in accordance with the
VerDate Sep<11>2014 14:25 Nov 20, 2015 Jkt 238001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 E:\FR\FM\23NON1.SGM 23NON1](https://thefederalregister.org/doc/80_FR_73200/page/2.svg)
Document Created: 2018-03-01 11:18:25
Document Modified: 2018-03-01 11:18:25
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| 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. | |
| Contact | Kristen Hardin, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5443, Silver Spring, MD 20993-0002, 240- 402-4246. | |
| FR Citation | 80 FR 72975 |
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