Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process; Draft Guidance for Industry; Availability, 72972-72973 [2015-29635]

Download as PDF wgreen on DSK2VPTVN1PROD with NOTICES 72972 Federal Register / Vol. 80, No. 225 / Monday, November 23, 2015 / Notices Date and Time: The meeting will be held on Friday, February 19, 2016, from 8 a.m. to 6 p.m. Location: Hilton Washington, DC/ North, Salons A, B, C, and D, 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel telephone number is 301–9778900. Contact Person: Sara Anderson, Center for Devices and Radiological Health, Food and Drug Administration, Bldg. 66, Rm.1643, 10903 New Hampshire Ave., Silver Spring, MD 20993, Sara.Anderson@fda.hhs.gov, 301 796–7047, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. 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[FR Doc. 2015–29768 Filed 11–20–15; 8:45 am] BILLING CODE 4164–01–P PO 00000 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–D–3990] Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ‘‘Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process.’’ This draft guidance explains the process by which FDA intends to carry out the section of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Sunscreen Innovation Act (SIA), which governs the convening of advisory committees and the number of requests to be considered per meeting. The recommendations in this draft guidance apply to 586A requests submitted under the FD&C Act and to pending requests as defined by the SIA that seek a determination from FDA on whether a nonprescription sunscreen active ingredient, or a combination of nonprescription sunscreen active ingredients, is generally recognized as safe and effective for use under specified conditions and should be included in the over-the-counter (OTC) sunscreen drug monograph. The SIA describes specific circumstances under which FDA is ‘‘not’’ required to convene or submit requests to the Nonprescription Drugs Advisory Committee (NDAC). We are issuing this draft guidance pursuant to the SIA, which directs FDA to issue four guidances on various topics, including this draft guidance. 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. SUMMARY: ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the Frm 00028 Fmt 4703 Sfmt 4703 E:\FR\FM\23NON1.SGM 23NON1 Federal Register / Vol. 80, No. 225 / Monday, November 23, 2015 / Notices wgreen on DSK2VPTVN1PROD with NOTICES instructions for submitting comments. Comments submitted electronically, including attachments, to https:// 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 https://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–3990 for ‘‘Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process; Draft Guidance for Industry.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://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 VerDate Sep<11>2014 14:25 Nov 20, 2015 Jkt 238001 72973 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 https:// 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: https://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 https:// 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: 586A of the FD&C Act (21 U.S.C. 360fff– 1)) and for sponsors of pending requests (as defined by section 586(6) of the FD&C Act (21 U.S.C. 360fff (6))) to follow in requesting an NDAC meeting. This draft guidance also explains how FDA intends to process these requests and describes the factors the Agency may consider in determining whether and when to refer such requests to the NDAC. 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 process by which the Agency will carry out section 586C(c) of the SIA (Pub. L. 113–195). 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. I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process.’’ This draft guidance provides background information on the sunscreen OTC monograph process, as well as on the Agency’s intended process for convening the NDAC. It also recommends procedures for sponsors of 586A requests (submitted under section Sunscreen Innovation Act: Nonprescription Sunscreen Drug Products—Content and Format of Data Submissions; Draft Guidance for Industry; Availability PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 II. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// 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 SIA 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. 2015–29635 Filed 11–20–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–D–4033] AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft SUMMARY: E:\FR\FM\23NON1.SGM 23NON1

Agencies

[Federal Register Volume 80, Number 225 (Monday, November 23, 2015)]
[Notices]
[Pages 72972-72973]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-29635]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-3990]

Sunscreen Innovation Act: Section 586C(c) Advisory Committee
Process; 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 ``Sunscreen
Innovation Act: Section 586C(c) Advisory Committee Process.'' This
draft guidance explains the process by which FDA intends to carry out
the section of the Federal Food, Drug, and Cosmetic Act (the FD&C Act),
as amended by the Sunscreen Innovation Act (SIA), which governs the
convening of advisory committees and the number of requests to be
considered per meeting. The recommendations in this draft guidance
apply to 586A requests submitted under the FD&C Act and to pending
requests as defined by the SIA that seek a determination from FDA on
whether a nonprescription sunscreen active ingredient, or a combination
of nonprescription sunscreen active ingredients, is generally
recognized as safe and effective for use under specified conditions and
should be included in the over-the-counter (OTC) sunscreen drug
monograph. The SIA describes specific circumstances under which FDA is
``not'' required to convene or submit requests to the Nonprescription
Drugs Advisory Committee (NDAC). We are issuing this draft guidance
pursuant to the SIA, which directs FDA to issue four guidances on
various topics, including this draft guidance.

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: https://www.regulations.gov.
Follow the

[[Page 72973]]

instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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-3990 for ``Sunscreen Innovation Act: Section 586C(c)
Advisory Committee Process; Draft Guidance for Industry.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://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 https://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: https://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 https://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: Section 586C(c) Advisory Committee
Process.'' This draft guidance provides background information on the
sunscreen OTC monograph process, as well as on the Agency's intended
process for convening the NDAC. It also recommends procedures for
sponsors of 586A requests (submitted under section 586A of the FD&C Act
(21 U.S.C. 360fff-1)) and for sponsors of pending requests (as defined
by section 586(6) of the FD&C Act (21 U.S.C. 360fff (6))) to follow in
requesting an NDAC meeting. This draft guidance also explains how FDA
intends to process these requests and describes the factors the Agency
may consider in determining whether and when to refer such requests to
the NDAC.
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 process by
which the Agency will carry out section 586C(c) of the SIA (Pub. L.
113-195). 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 document at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://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 SIA 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. 2015-29635 Filed 11-20-15; 8:45 am]
BILLING CODE 4164-01-P

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