81 FR 70118 - Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 196 (October 11, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 196 (October 11, 2016)
| Page Range | 70118-70119 | |
| FR Document | 2016-24460 |
[Federal Register Volume 81, Number 196 (Tuesday, October 11, 2016)] [Notices] [Pages 70118-70119] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-24460] ----------------------------------------------------------------------- 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; 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 guidance for industry entitled ``Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process.'' This 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 to provide recommendations on requests submitted under the SIA regarding nonprescription sunscreen active ingredients and the number of requests to be considered per meeting. The recommendations in this 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 (GRASE) 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 guidance pursuant to the SIA, which directs FDA to issue guidance on four topics, including the topic discussed in this guidance. This guidance finalizes the draft guidance on the same topic issued on November 23, 2015.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. 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.'' 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 [[Page 70119]] 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: Section 586C(c) Advisory Committee Process.'' This 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 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 guidance finalizes the draft guidance that was issued under the same title on November 23, 2015 (see 80 FR 72972), 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-3990. In addition to minor editorial changes, we have clarified the information in section III of the guidance on when to submit a request for an NDAC meeting. 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 process by which the Agency will carry out section 586C(c) of the SIA (21 U.S.C. 360fff-3). 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. 2016-24460 Filed 10-7-16; 8:45 am] BILLING CODE 4164-01-P
![70118 Federal Register / Vol. 81, No. 196 / Tuesday, October 11, 2016 / Notices
number of hospitals that ultimately ‘‘Sunscreen Innovation Act: Section • If you want to submit a comment
need to appeal their MGCRB decisions 586C(c) Advisory Committee Process.’’ with confidential information that you
to the CMS Administrator. Form This guidance explains the process by do not wish to be made available to the
Number: CMS–R–138 (OMB control which FDA intends to carry out the public, submit the comment as a
number: 0938–0573); Frequency: section of the Federal Food, Drug, and written/paper submission and in the
Occasionally; Affected Public: Cosmetic Act (the FD&C Act), as manner detailed (see ‘‘Written/Paper
Businesses or other for-profits and Not- amended by the Sunscreen Innovation Submissions’’ and ‘‘Instructions’’).
for-profit institutions; Number of Act (SIA), which governs the convening Written/Paper Submissions
Respondents: 300; Total Annual of advisory committees to provide
Responses: 300; Total Annual Hours: recommendations on requests submitted Submit written/paper submissions as
300. (For policy questions regarding this under the SIA regarding follows:
collection contact Noel Manlove at 410– nonprescription sunscreen active • Mail/Hand delivery/Courier (for
786–5161.) ingredients and the number of requests written/paper submissions): Division of
2. Type of Information Collection to be considered per meeting. The Dockets Management (HFA–305), Food
Request: Reinstatement of a previously recommendations in this guidance and Drug Administration, 5630 Fishers
approved collection; Title of apply to 586A requests submitted under Lane, Rm. 1061, Rockville, MD 20852.
Information Collection: Notification of • For written/paper comments
the FD&C Act and to pending requests
FIs and CMS of co-located Medicare submitted to the Division of Dockets
as defined by the SIA that seek a
providers; Use: Many long-term care Management, FDA will post your
determination from FDA on whether a
hospitals (LTCHs) are co-located with comment, as well as any attachments,
nonprescription sunscreen active
other Medicare providers (acute care except for information submitted,
ingredient, or a combination of
hospitals, IRFs, SNFs, psychiatric marked and identified, as confidential,
nonprescription sunscreen active
facilities), which leads to potential if submitted as detailed in
ingredients, is generally recognized as
gaming of the Medicare system based on ‘‘Instructions.’’
safe and effective (GRASE) for use under Instructions: All submissions received
patient shifting. In regulations at 42 CFR specified conditions and should be
412.22(e)(3) and (h)(6) and 412.532(i), must include the Docket No. FDA–
included in the over-the-counter (OTC) 2015–D–3990 for ‘‘Sunscreen
CMS is requiring LTCHs to notify sunscreen drug monograph. The SIA
Medicare Administrative Contractors Innovation Act: Section 586C(c)
describes specific circumstances under Advisory Committee Process.’’ Received
(MACs) and CMS of co-located which FDA is not required to convene
providers in order to establish policies comments will be placed in the docket
or submit requests to the and, except for those submitted as
to limit payment abuse that will be Nonprescription Drugs Advisory
based on FIs tracking patient movement ‘‘Confidential Submissions,’’ publicly
Committee (NDAC). We are issuing this viewable at http://www.regulations.gov
among these co-located providers. Form guidance pursuant to the SIA, which
Number: CMS–10088 (OMB control or at the Division of Dockets
directs FDA to issue guidance on four Management between 9 a.m. and 4 p.m.,
number: 0938–0897); Frequency: topics, including the topic discussed in
Annually; Affected Public: Businesses Monday through Friday.
this guidance. This guidance finalizes • Confidential Submissions—To
or other for-profits and Not-for-profit the draft guidance on the same topic submit a comment with confidential
institutions; Number of Respondents: issued on November 23, 2015. information that you do not wish to be
25; Total Annual Responses: 25; Total
DATES: Submit either electronic or made publicly available, submit your
Annual Hours: 6. (For policy questions
written comments on Agency guidances comments only as a written/paper
regarding this collection contact Emily
at any time. submission. You should submit two
Lipkin at 410–786–3633.)
ADDRESSES: You may submit comments copies total. One copy will include the
Dated: October 4, 2016. as follows: information you claim to be confidential
William N. Parham, III, with a heading or cover note that states
Director, Paperwork Reduction Staff, Office Electronic Submissions ‘‘THIS DOCUMENT CONTAINS
of Strategic Operations and Regulatory Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
Affairs. following way: Agency will review this copy, including
[FR Doc. 2016–24415 Filed 10–7–16; 8:45 am] • Federal eRulemaking Portal: http:// the claimed confidential information, in
BILLING CODE 4120–01–P www.regulations.gov. Follow the its consideration of comments. The
instructions for submitting comments. second copy, which will have the
Comments submitted electronically, claimed confidential information
DEPARTMENT OF HEALTH AND including attachments, to http:// redacted/blacked out, will be available
HUMAN SERVICES www.regulations.gov will be posted to for public viewing and posted on http://
the docket unchanged. Because your www.regulations.gov. Submit both
Food and Drug Administration
comment will be made public, you are copies to the Division of Dockets
[Docket No. FDA–2015–D–3990] solely responsible for ensuring that your Management. If you do not wish your
comment does not include any name and contact information to be
Sunscreen Innovation Act: Section confidential information that you or a made publicly available, you can
586C(c) Advisory Committee Process; third party may not wish to be posted, provide this information on the cover
Guidance for Industry; Availability such as medical information, your or sheet and not in the body of your
asabaliauskas on DSK3SPTVN1PROD with NOTICES
AGENCY: Food and Drug Administration, anyone else’s Social Security number, or comments and you must identify this
HHS. confidential business information, such information as ‘‘confidential.’’ Any
ACTION: Notice of availability. as a manufacturing process. Please note information marked as ‘‘confidential’’
that if you include your name, contact will not be disclosed except in
SUMMARY: The Food and Drug information, or other information that accordance with 21 CFR 10.20 and other
Administration (FDA or Agency) is identifies you in the body of your applicable disclosure law. For more
announcing the availability of a comments, that information will be information about FDA’s posting of
guidance for industry entitled posted on http://www.regulations.gov. comments to public dockets, see 80 FR
VerDate Sep<11>2014 20:12 Oct 07, 2016 Jkt 241001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\11OCN1.SGM 11OCN1](https://thefederalregister.org/doc/81_FR_70314/page/1.svg)
![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](https://thefederalregister.org/doc/81_FR_70314/page/2.svg)
Document Created: 2018-02-13 16:34:02
Document Modified: 2018-02-13 16:34:02
| 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 | Submit either electronic or written comments on Agency guidances at any time. | |
| 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. | |
| FR Citation | 81 FR 70118 |
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