83_FR_24017 83 FR 23917 - Enforcement Policy-Over-the-Counter Sunscreen Drug Products Marketed Without an Approved Application; Guidance for Industry; Availability

83 FR 23917 - Enforcement Policy-Over-the-Counter Sunscreen Drug Products Marketed Without an Approved Application; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 100 (May 23, 2018)

Page Range23917-23918
FR Document2018-10994

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Enforcement Policy--OTC Sunscreen Drug Products Marketed Without an Approved Application.'' This guidance describes FDA's approach to enforcement for over-the-counter (OTC) sunscreen products marketed without approved applications before a final OTC sunscreen drug monograph becomes effective. This guidance finalizes the draft guidance of the same name issued June 17, 2011.

Federal Register, Volume 83 Issue 100 (Wednesday, May 23, 2018)
[Federal Register Volume 83, Number 100 (Wednesday, May 23, 2018)]
[Notices]
[Pages 23917-23918]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-10994]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICE

Food and Drug Administration

[Docket No. FDA-2010-D-0509]


Enforcement Policy--Over-the-Counter Sunscreen Drug Products 
Marketed Without an Approved Application; Guidance for Industry; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a guidance for industry entitled ``Enforcement 
Policy--OTC Sunscreen Drug Products Marketed Without an Approved 
Application.'' This guidance describes FDA's approach to enforcement 
for over-the-counter (OTC) sunscreen products marketed without approved 
applications before a final OTC sunscreen drug monograph becomes 
effective. This guidance finalizes the draft guidance of the same name 
issued June 17, 2011.

DATES: The announcement of the guidance is published in the Federal 
Register on May 23, 2018.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the 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

[[Page 23918]]

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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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-2010-D-0509 for ``Enforcement Policy--Over-the-Counter Sunscreen 
Drug Products Marketed Without an Approved Application; Guidance for 
Industry; Availability.'' 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 Dockets 
Management Staff 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 Dockets Management Staff. 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.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    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 20993-0002, 240-
402-4246.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Enforcement Policy--OTC Sunscreen Drug Products Marketed 
Without an Approved Application.'' This guidance applies to OTC 
sunscreen products marketed without approved applications and describes 
FDA's approach to enforcement for these products until a final OTC 
sunscreen monograph becomes effective. This guidance finalizes a draft 
guidance that was issued under the same title on June 17, 2011 (76 FR 
35665) and reflects FDA's consideration of public comments on the draft 
guidance.
    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 enforcement policy for OTC sunscreen 
drug products marketed without an approved application. 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. This guidance 
is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) and 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR 201.327 and 201.66, and 21 CFR 
part 330 have been approved under OMB control numbers 0910-0717, 0910-
0340, and 0910-0688, respectively.

III. Electronic Access

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

    Dated: May 17, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-10994 Filed 5-22-18; 8:45 am]
 BILLING CODE 4164-01-P



                                                                           Federal Register / Vol. 83, No. 100 / Wednesday, May 23, 2018 / Notices                                                   23917

                                               please reference the document identifier                quality, accessibility, and affordability             37,407; Total Annual Hours: 44,817.
                                               or OMB control number. To be assured                    in healthcare. CMS also aims to put                   (For policy questions regarding this
                                               consideration, comments and                             patients first in the delivery of their               collection contact William Long at 410–
                                               recommendations must be received by                     health care needs.                                    786–7927.)
                                               the OMB desk officer via one of the                        The Medicare Current Beneficiary                      Dated: May 18, 2018.
                                               following transmissions: OMB, Office of                 Survey (MCBS) is the most
                                                                                                                                                             William N. Parham, III,
                                               Information and Regulatory Affairs,                     comprehensive and complete Survey
                                                                                                       available on the Medicare population                  Director, Paperwork Reduction Staff, Office
                                               Attention: CMS Desk Officer, Fax                                                                              of Strategic Operations and Regulatory
                                               Number: (202) 395–5806 OR, Email:                       and is essential in capturing data not
                                                                                                                                                             Affairs.
                                               OIRA_submission@omb.eop.gov.                            otherwise collected through our
                                                                                                                                                             [FR Doc. 2018–11056 Filed 5–22–18; 8:45 am]
                                                 To obtain copies of a supporting                      operations. The MCBS is an in-person,
                                                                                                                                                             BILLING CODE 4120–01–P
                                               statement and any related forms for the                 nationally-representative, longitudinal
                                               proposed collection(s) summarized in                    survey of Medicare beneficiaries that we
                                               this notice, you may make your request                  sponsor and is directed by the Office of
                                                                                                                                                             DEPARTMENT OF HEALTH AND
                                               using one of following:                                 Enterprise Data and Analytics (OEDA).
                                                                                                       The survey captures beneficiary                       HUMAN SERVICE
                                                 1. Access CMS’ website address at
                                               http://www.cms.hhs.gov/                                 information whether aged or disabled,                 Food and Drug Administration
                                               PaperworkReductionActof1995.                            living in the community or facility, or
                                                 2. Email your request, including your                 serviced by managed care or fee-for-                  [Docket No. FDA–2010–D–0509]
                                               address, phone number, OMB number,                      service. Data produced as part of the
                                               and CMS document identifier, to                         MCBS are enhanced with our                            Enforcement Policy—Over-the-Counter
                                               Paperwork@cms.hhs.gov.                                  administrative data (e.g., fee-for-service            Sunscreen Drug Products Marketed
                                                 3. Call the Reports Clearance Office at               claims, prescription drug event data,                 Without an Approved Application;
                                               (410) 786–1326.                                         enrollment, etc.) to provide users with               Guidance for Industry; Availability
                                               FOR FURTHER INFORMATION CONTACT:                        more accurate and complete estimates of               AGENCY:   Food and Drug Administration,
                                               Reports Clearance Office at (410) 786–                  total health care costs and utilization.              HHS.
                                               1326.                                                   The MCBS has been continuously
                                                                                                                                                             ACTION:   Notification of availability.
                                                                                                       fielded for more than 25 years,
                                               SUPPLEMENTARY INFORMATION:     Under the                encompassing over 1 million interviews
                                               Paperwork Reduction Act of 1995 (PRA)                                                                         SUMMARY:   The Food and Drug
                                                                                                       and more than 100,000 survey                          Administration (FDA or Agency) is
                                               (44 U.S.C. 3501–3520), federal agencies                 participants. Respondents participate in
                                               must obtain approval from the Office of                                                                       announcing the availability of a
                                                                                                       up to 11 interviews over a three and a                guidance for industry entitled
                                               Management and Budget (OMB) for each                    half year period. This gives a
                                               collection of information they conduct                                                                        ‘‘Enforcement Policy—OTC Sunscreen
                                                                                                       comprehensive picture of health care                  Drug Products Marketed Without an
                                               or sponsor. The term ‘‘collection of                    costs and utilization over a period of
                                               information’’ is defined in 44 U.S.C.                                                                         Approved Application.’’ This guidance
                                                                                                       time.                                                 describes FDA’s approach to
                                               3502(3) and 5 CFR 1320.3(c) and                            The MCBS continues to provide
                                               includes agency requests or                                                                                   enforcement for over-the-counter (OTC)
                                                                                                       unique insight into the Medicare                      sunscreen products marketed without
                                               requirements that members of the public                 program and helps CMS and our
                                               submit reports, keep records, or provide                                                                      approved applications before a final
                                                                                                       external stakeholders better understand               OTC sunscreen drug monograph
                                               information to a third party. Section                   and evaluate the impact of existing
                                               3506(c)(2)(A) of the PRA (44 U.S.C.                                                                           becomes effective. This guidance
                                                                                                       programs and significant new policy
                                               3506(c)(2)(A)) requires federal agencies                                                                      finalizes the draft guidance of the same
                                                                                                       initiatives. In the past, MCBS data have
                                               to publish a 30-day notice in the                                                                             name issued June 17, 2011.
                                                                                                       been used to assess potential changes to
                                               Federal Register concerning each                        the Medicare program. For example, the                DATES: The announcement of the
                                               proposed collection of information,                     MCBS was instrumental in supporting                   guidance is published in the Federal
                                               including each proposed extension or                    the development and implementation of                 Register on May 23, 2018.
                                               reinstatement of an existing collection                 the Medicare prescription drug benefit                ADDRESSES: You may submit either
                                               of information, before submitting the                   by providing a means to evaluate                      electronic or written comments on
                                               collection to OMB for approval. To                      prescription drug costs and out-of-                   Agency guidances at any time as
                                               comply with this requirement, CMS is                    pocket burden for these drugs to                      follows:
                                               publishing this notice that summarizes                  Medicare beneficiaries. Beginning in
                                               the following proposed collection(s) of                                                                       Electronic Submissions
                                                                                                       2019, this proposed revision to the
                                               information for public comment:                         clearance will eliminate or streamline                  Submit electronic comments in the
                                                 1. Type of Information Collection                     some questionnaire sections, add a few                following way:
                                               Request: Revision of a currently                        new measures, take advantage of                         • Federal eRulemaking Portal:
                                               approved collection; Title of                           administrative data to reduce the                     https://www.regulations.gov. Follow the
                                               Information Collection: Medicare                        number of survey questions in some                    instructions for submitting comments.
                                               Current Beneficiary Survey; Use: CMS is                 long term care facilities, and                        Comments submitted electronically,
                                               the largest single payer of health care in              discontinue the 12th interview as had                 including attachments, to https://
                                               the United States. The agency plays a                   previously been collected. The revisions              www.regulations.gov will be posted to
                                               direct or indirect role in administering                will result in an overall reduction in                the docket unchanged. Because your
daltland on DSKBBV9HB2PROD with NOTICES




                                               health insurance coverage for more than                 respondent burden by 25%. Form                        comment will be made public, you are
                                               120 million people across the Medicare,                 Number: CMS–P–0015A (OMB control                      solely responsible for ensuring that your
                                               Medicaid, CHIP, and Exchange                            number: 0938–0568); Frequency:                        comment does not include any
                                               populations. A critical aim for CMS is                  Occasionally; Affected Public: Business               confidential information that you or a
                                               to be an effective steward, major force,                or other for-profits and Not-for-profit               third party may not wish to be posted,
                                               and trustworthy partner in supporting                   institutions; Number of Respondents:                  such as medical information, your or
                                               innovative approaches to improving                      14,146; Total Annual Responses:                       anyone else’s Social Security number, or


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                                               23918                       Federal Register / Vol. 83, No. 100 / Wednesday, May 23, 2018 / Notices

                                               confidential business information, such                 must identify this information as                     policy for OTC sunscreen drug products
                                               as a manufacturing process. Please note                 ‘‘confidential.’’ Any information marked              marketed without an approved
                                               that if you include your name, contact                  as ‘‘confidential’’ will not be disclosed             application. It does not establish any
                                               information, or other information that                  except in accordance with 21 CFR 10.20                rights for any person and is not binding
                                               identifies you in the body of your                      and other applicable disclosure law. For              on FDA or the public. You can use an
                                               comments, that information will be                      more information about FDA’s posting                  alternative approach if it satisfies the
                                               posted on https://www.regulations.gov.                  of comments to public dockets, see 80                 requirements of the applicable statutes
                                                 • If you want to submit a comment                     FR 56469, September 18, 2015, or access               and regulations. This guidance is not
                                               with confidential information that you                  the information at: https://www.gpo.gov/              subject to Executive Order 12866.
                                               do not wish to be made available to the                 fdsys/pkg/FR-2015-09-18/pdf/2015-
                                               public, submit the comment as a                                                                               II. Paperwork Reduction Act of 1995
                                                                                                       23389.pdf.
                                               written/paper submission and in the                        Docket: For access to the docket to                  This guidance refers to previously
                                               manner detailed (see ‘‘Written/Paper                    read background documents or the                      approved collections of information
                                               Submissions’’ and ‘‘Instructions’’).                    electronic and written/paper comments                 found in FDA regulations. These
                                               Written/Paper Submissions                               received, go to https://                              collections of information are subject to
                                                                                                       www.regulations.gov and insert the                    review by the Office of Management and
                                                  Submit written/paper submissions as                  docket number, found in brackets in the               Budget (OMB) and under the Paperwork
                                               follows:                                                heading of this document, into the                    Reduction Act of 1995 (44 U.S.C. 3501–
                                                  • Mail/Hand delivery/Courier (for                                                                          3520). The collections of information in
                                                                                                       ‘‘Search’’ box and follow the prompts
                                               written/paper submissions): Dockets                                                                           21 CFR 201.327 and 201.66, and 21 CFR
                                                                                                       and/or go to the Dockets Management
                                               Management Staff (HFA–305), Food and                                                                          part 330 have been approved under
                                                                                                       Staff, 5630 Fishers Lane, Rm. 1061,
                                               Drug Administration, 5630 Fishers                                                                             OMB control numbers 0910–0717,
                                                                                                       Rockville, MD 20852.
                                               Lane, Rm. 1061, Rockville, MD 20852.                                                                          0910–0340, and 0910–0688,
                                                  • For written/paper comments                            You may submit comments on any
                                                                                                       guidance at any time (see 21 CFR                      respectively.
                                               submitted to the Dockets Management
                                               Staff, FDA will post your comment, as                   10.115(g)(5)).                                        III. Electronic Access
                                               well as any attachments, except for                        Submit written requests for single
                                                                                                       copies of this guidance to the Division                 Persons with access to the internet
                                               information submitted, marked and                                                                             may obtain the guidance at either http://
                                               identified, as confidential, if submitted               of Drug Information, Center for Drug
                                                                                                       Evaluation and Research, Food and                     www.fda.gov/Drugs/Guidance
                                               as detailed in ‘‘Instructions.’’                                                                              ComplianceRegulatoryInformation/
                                                  Instructions: All submissions received               Drug Administration, 10001 New
                                                                                                       Hampshire Ave., Hillandale Building,                  Guidances/default.htm or https://
                                               must include the Docket No. FDA–
                                                                                                       4th Floor, Silver Spring, MD 20993–                   www.regulations.gov.
                                               2010–D–0509 for ‘‘Enforcement Policy—
                                               Over-the-Counter Sunscreen Drug                         0002. Send one self-addressed adhesive                  Dated: May 17, 2018.
                                               Products Marketed Without an                            label to assist that office in processing             Leslie Kux,
                                               Approved Application; Guidance for                      your requests. See the SUPPLEMENTARY                  Associate Commissioner for Policy.
                                               Industry; Availability.’’ Received                      INFORMATION section for electronic
                                                                                                                                                             [FR Doc. 2018–10994 Filed 5–22–18; 8:45 am]
                                               comments will be placed in the docket                   access to the guidance document.
                                                                                                                                                             BILLING CODE 4164–01–P
                                               and, except for those submitted as                      FOR FURTHER INFORMATION CONTACT:
                                               ‘‘Confidential Submissions,’’ publicly                  Kristen Hardin, Center for Drug
                                               viewable at https://www.regulations.gov                 Evaluation and Research, Food and                     DEPARTMENT OF HEALTH AND
                                               or at the Dockets Management Staff                      Drug Administration, 10903 New                        HUMAN SERVICES
                                               between 9 a.m. and 4 p.m., Monday                       Hampshire Ave., Bldg. 22, Rm. 5443,
                                               through Friday.                                         Silver Spring, MD 20993–0002, 240–                    Food and Drug Administration
                                                  • Confidential Submissions—To                        402–4246.
                                               submit a comment with confidential                                                                            [Docket No. FDA–2018–D–1456]
                                                                                                       SUPPLEMENTARY INFORMATION:
                                               information that you do not wish to be
                                                                                                       I. Background                                         Maximal Usage Trials for Topical
                                               made publicly available, submit your
                                                                                                                                                             Active Ingredients Being Considered
                                               comments only as a written/paper                           FDA is announcing the availability of
                                                                                                                                                             for Inclusion in an Over-the-Counter
                                               submission. You should submit two                       a guidance for industry entitled
                                                                                                                                                             Monograph: Study Elements and
                                               copies total. One copy will include the                 ‘‘Enforcement Policy—OTC Sunscreen
                                                                                                                                                             Considerations; Draft Guidance for
                                               information you claim to be confidential                Drug Products Marketed Without an
                                                                                                                                                             Industry; Availability
                                               with a heading or cover note that states                Approved Application.’’ This guidance
                                               ‘‘THIS DOCUMENT CONTAINS                                applies to OTC sunscreen products                     AGENCY:   Food and Drug Administration,
                                               CONFIDENTIAL INFORMATION.’’ The                         marketed without approved                             HHS.
                                               Agency will review this copy, including                 applications and describes FDA’s                      ACTION:   Notice of availability.
                                               the claimed confidential information, in                approach to enforcement for these
                                               its consideration of comments. The                      products until a final OTC sunscreen                  SUMMARY:   The Food and Drug
                                               second copy, which will have the                        monograph becomes effective. This                     Administration (FDA or Agency) is
                                               claimed confidential information                        guidance finalizes a draft guidance that              announcing the availability of a draft
                                               redacted/blacked out, will be available                 was issued under the same title on June               guidance for industry entitled ‘‘Maximal
                                               for public viewing and posted on                        17, 2011 (76 FR 35665) and reflects                   Usage Trials for Topical Active
daltland on DSKBBV9HB2PROD with NOTICES




                                               https://www.regulations.gov. Submit                     FDA’s consideration of public                         Ingredients Being Considered for
                                               both copies to the Dockets Management                   comments on the draft guidance.                       Inclusion in an Over-the-Counter
                                               Staff. If you do not wish your name and                    This guidance is being issued                      Monograph: Study Elements and
                                               contact information to be made publicly                 consistent with FDA’s good guidance                   Considerations.’’ This draft guidance
                                               available, you can provide this                         practices regulation (21 CFR 10.115).                 addresses FDA’s current thinking on the
                                               information on the cover sheet and not                  The guidance represents the current                   conduct of in vivo absorption trials for
                                               in the body of your comments and you                    thinking of FDA on the enforcement                    topical active ingredients that are under


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Document Created: 2018-05-22 23:48:50
Document Modified: 2018-05-22 23:48:50
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
ActionNotification of availability.
DatesThe announcement of the guidance is published in the Federal Register on May 23, 2018.
ContactKristen 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 Citation83 FR 23917 

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