83_FR_61879 83 FR 61648 - Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

83 FR 61648 - Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 231 (November 30, 2018)

Page Range61648-61650
FR Document2018-26034

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance for industry and FDA staff entitled ``Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use.'' This draft guidance document describes studies and criteria that FDA recommends be used when submitting premarket notifications (510(k)s) for blood glucose monitoring systems (BGMSs) that are for prescription point-of-care use. This draft guidance is not final nor is it in effect at this time.

Federal Register, Volume 83 Issue 231 (Friday, November 30, 2018)
[Federal Register Volume 83, Number 231 (Friday, November 30, 2018)]
[Notices]
[Pages 61648-61650]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-26034]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1445]


Blood Glucose Monitoring Test Systems for Prescription Point-of-
Care Use; Draft Guidance for Industry and Food and Drug Administration 
Staff; 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the availability of the draft guidance for industry and FDA staff 
entitled ``Blood Glucose Monitoring Test Systems for Prescription 
Point-of-Care Use.'' This draft guidance document describes studies and 
criteria that FDA recommends be used when submitting premarket 
notifications (510(k)s) for blood glucose monitoring systems (BGMSs) 
that are for prescription point-of-care use. This draft guidance is not 
final nor is it in effect at this time.

DATES: Submit either electronic or written comments on the draft 
guidance by February 28, 2019 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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 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

[[Page 61649]]

information submitted, marked and identified, as confidential, if 
submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2013-D-1445 for ``Blood Glucose Monitoring Test Systems for 
Prescription Point-of-Care Use.'' 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)).
    An electronic copy of the draft guidance document is available for 
download from the internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the draft guidance. Submit 
written requests for a single hard copy of the draft guidance document 
entitled ``Blood Glucose Monitoring Test Systems for Prescription 
Point-of-Care Use'' to the Office of the Center Director, Guidance and 
Policy Development, Center for Devices and Radiological Health, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, 
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to 
assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Leslie Landree, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4623, Silver Spring, MD 20993-0002, 301-796-6147.

SUPPLEMENTARY INFORMATION:

I. Background

    On October 11, 2016, FDA published a final guidance entitled, 
``Blood Glucose Monitoring Test Systems for Prescription Point-of-Care 
Use.'' That guidance document described studies and information that 
FDA recommends be used when submitting 510(k)s for BGMSs that are for 
prescription point-of-care use. FDA is now proposing to make 
modifications to the guidance based on feedback received from 
stakeholders, which the Agency believes will better align with the 
evolving understanding and development of these types of devices. When 
finalized, this draft guidance will replace the final guidance of the 
same title issued on October 11, 2016.

II. Significance of Guidance

    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 ``Blood 
Glucose Monitoring Test Systems for Prescription Point-of-Care Use.'' 
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.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by downloading an electronic copy from the internet. A search 
capability for all Center for Devices and Radiological Health guidance 
documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This draft 
guidance document is also available at https://www.regulations.gov. 
Persons unable to download an electronic copy of ``Blood Glucose 
Monitoring Test Systems for Prescription Point-of-Care Use'' may send 
an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic 
copy of the document. Please use the document number GUD 1755 to 
identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information. These collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 
the following FDA guidances and regulations have been approved by OMB 
as listed in the following table:

------------------------------------------------------------------------
                                                            OMB Control
      21 CFR part or guidance               Topic               No.
------------------------------------------------------------------------
807, subpart E....................  Premarket                  0910-0120
                                     Notification.
``Requests for Feedback on Medical  Q-Submissions.......       0910-0756
 Device Submissions: The Pre-
 Submission Program and Meetings
 with Food and Drug Administration
 Staff``.
800, 801, and 809.................  Medical Device             0910-0485
                                     Labeling
                                     Regulations.
820...............................  Current Good               0910-0073
                                     Manufacturing
                                     Practice (CGMP);
                                     Quality System (QS)
                                     Regulation.
Recommendations for Clinical        CLIA Waiver                0910-0598
 Laboratory Improvement Amendments   Applications.
 of 1988 (CLIA) Waiver
 Applications for Manufacturers of
 In Vitro Diagnostic Devices--
 Guidance for Industry and Food
 and Drug Administration Staff.

[[Page 61650]]

 
Administrative Procedures for CLIA  Administrative             0910-0607
 Categorization--Guidance for        Procedures for
 Industry and Food and Drug          Clinical Laboratory
 Administration Staff.               Improvement
                                     Amendments of 1988
                                     Categorization (42
                                     CFR 493.17).
------------------------------------------------------------------------


    Dated: November 26, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-26034 Filed 11-29-18; 8:45 am]
 BILLING CODE 4164-01-P



                                              61648                        Federal Register / Vol. 83, No. 231 / Friday, November 30, 2018 / Notices

                                              appropriate oversight of their clinical                   and biological products, medical                      recordkeeping provisions cover general
                                              investigations to ensure adequate                         devices, and combinations thereof. The                elements. The guidance discusses other
                                              protection of the rights, welfare, and                    guidance describes strategies for                     elements sponsors and investigators
                                              safety of human subjects and to ensure                    monitoring activities performed by                    should consider and include in
                                              the quality and integrity of the resulting                sponsors or by contract research                      developing a monitoring plan. As
                                              data submitted to FDA. As part of this                    organizations (CROs) that focus on the                explained in the guidance,
                                              oversight, sponsors of clinical                           conduct, oversight, and reporting of                  documentation of monitoring should
                                              investigations are required to monitor                    findings of an investigation by clinical              include sufficient detail to allow
                                              the conduct and progress of their                         investigators. The guidance also                      verification that the monitoring plan
                                              clinical investigations. The regulations                  recommends strategies that reflect a
                                                                                                                                                              was followed. The plan should provide
                                              do not specify how sponsors are to                        risk-based approach to monitoring that
                                                                                                                                                              adequate information to those involved
                                              conduct monitoring of clinical                            focuses on critical study parameters and
                                              investigations and are, therefore,                        relies on a combination of monitoring                 with monitoring to effectively carry out
                                              compatible with a range of approaches                     activities to oversee a study effectively.            their duties. All sponsor and CRO
                                              to monitoring.                                            Finally, the guidance specifically                    personnel who may be involved with
                                                 Accordingly, we developed the                          encourages greater reliance on                        monitoring (including those who review
                                              guidance document entitled, ‘‘Guidance                    centralized monitoring methods where                  appropriate action, determine
                                              for Industry—Oversight of Clinical                        appropriate.                                          appropriate action, or both) regarding
                                              Investigations: A Risk-Based Approach                        Information collections for reports                potential issues identified through
                                              to Monitoring.’’ The guidance is                          and records associated with clinical                  monitoring should review the
                                              intended to assist sponsors of clinical                   investigations under parts 312 and 812                monitoring plan.
                                              investigations in developing strategies                   are currently approved under OMB                        We estimate the burden of this
                                              for risk-based monitoring and plans for                   control numbers 0910–0014 and 0910–                   collection of information as follows:
                                              clinical investigations of human drug                     0078 respectively. These reporting and

                                                                                           TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
                                                                                                                                            Number of                              Average
                                                                                                                       Number of                            Total Annual
                                                                           Activity                                                        records per                            burden per    Total hours
                                                                                                                     recordkeepers                            Records
                                                                                                                                          recordkeeper                          recordkeeping

                                              Documentation included in comprehensive monitoring plan                                88               1.5              132                  4            528
                                                 1 There   are no capital costs or operating and maintenance costs associated with this collection of information.


                                                Based on a review of the information                    SUMMARY:    The Food and Drug                         comment will be made public, you are
                                              collection, we have made no                               Administration (FDA or Agency) is                     solely responsible for ensuring that your
                                              adjustments to our burden estimate. We                    announcing the availability of the draft              comment does not include any
                                              estimate 88 sponsors will develop 132                     guidance for industry and FDA staff                   confidential information that you or a
                                              comprehensive monitoring plans in                         entitled ‘‘Blood Glucose Monitoring                   third party may not wish to be posted,
                                              accordance with the guidance. We                          Test Systems for Prescription Point-of-               such as medical information, your or
                                              believe the associated burden for each                    Care Use.’’ This draft guidance                       anyone else’s Social Security number, or
                                              plan is approximately 4 hours and                         document describes studies and criteria               confidential business information, such
                                              includes the time necessary to develop,                   that FDA recommends be used when                      as a manufacturing process. Please note
                                              and amend as appropriate, the                             submitting premarket notifications                    that if you include your name, contact
                                              monitoring plan.                                          (510(k)s) for blood glucose monitoring                information, or other information that
                                                Dated: November 26, 2018.                               systems (BGMSs) that are for                          identifies you in the body of your
                                              Leslie Kux,
                                                                                                        prescription point-of-care use. This draft            comments, that information will be
                                                                                                        guidance is not final nor is it in effect             posted on https://www.regulations.gov.
                                              Associate Commissioner for Policy.
                                                                                                        at this time.                                           • If you want to submit a comment
                                              [FR Doc. 2018–26032 Filed 11–29–18; 8:45 am]
                                                                                                        DATES: Submit either electronic or                    with confidential information that you
                                              BILLING CODE 4164–01–P
                                                                                                        written comments on the draft guidance                do not wish to be made available to the
                                                                                                        by February 28, 2019 to ensure that the               public, submit the comment as a
                                              DEPARTMENT OF HEALTH AND                                  Agency considers your comment on this                 written/paper submission and in the
                                              HUMAN SERVICES                                            draft guidance before it begins work on               manner detailed (see ‘‘Written/Paper
                                                                                                        the final version of the guidance.                    Submissions’’ and ‘‘Instructions’’).
                                              Food and Drug Administration                              ADDRESSES: You may submit comments                    Written/Paper Submissions
                                                                                                        on any guidance at any time as follows:
                                              [Docket No. FDA–2013–D–1445]                                                                                      Submit written/paper submissions as
                                                                                                        Electronic Submissions                                follows:
                                              Blood Glucose Monitoring Test                               Submit electronic comments in the                     • Mail/Hand Delivery/Courier (for
                                              Systems for Prescription Point-of-Care                    following way:                                        written/paper submissions): Dockets
amozie on DSK3GDR082PROD with NOTICES1




                                              Use; Draft Guidance for Industry and                        • Federal eRulemaking Portal:                       Management Staff (HFA–305), Food and
                                              Food and Drug Administration Staff;                       https://www.regulations.gov. Follow the               Drug Administration, 5630 Fishers
                                              Availability                                              instructions for submitting comments.                 Lane, Rm. 1061, Rockville, MD 20852.
                                              AGENCY:      Food and Drug Administration,                Comments submitted electronically,                      • For written/paper comments
                                              HHS.                                                      including attachments, to https://                    submitted to the Dockets Management
                                                                                                        www.regulations.gov will be posted to                 Staff, FDA will post your comment, as
                                              ACTION:   Notice of availability.
                                                                                                        the docket unchanged. Because your                    well as any attachments, except for


                                         VerDate Sep<11>2014    17:00 Nov 29, 2018    Jkt 247001   PO 00000   Frm 00050   Fmt 4703   Sfmt 4703   E:\FR\FM\30NON1.SGM   30NON1


                                                                                     Federal Register / Vol. 83, No. 231 / Friday, November 30, 2018 / Notices                                                                                     61649

                                              information submitted, marked and                                           received, go to https://                                                guidance of the same title issued on
                                              identified, as confidential, if submitted                                   www.regulations.gov and insert the                                      October 11, 2016.
                                              as detailed in ‘‘Instructions.’’                                            docket number, found in brackets in the
                                                 Instructions: All submissions received                                   heading of this document, into the                                      II. Significance of Guidance
                                              must include the Docket No. FDA–                                            ‘‘Search’’ box and follow the prompts                                     This draft guidance is being issued
                                              2013–D–1445 for ‘‘Blood Glucose                                             and/or go to the Dockets Management                                     consistent with FDA’s good guidance
                                              Monitoring Test Systems for                                                 Staff, 5630 Fishers Lane, Rm. 1061,                                     practices regulation (21 CFR 10.115).
                                              Prescription Point-of-Care Use.’’                                           Rockville, MD 20852.                                                    The draft guidance, when finalized, will
                                              Received comments will be placed in                                            You may submit comments on any                                       represent the current thinking of FDA
                                              the docket and, except for those                                            guidance at any time (see 21 CFR                                        on ‘‘Blood Glucose Monitoring Test
                                              submitted as ‘‘Confidential                                                 10.115(g)(5)).                                                          Systems for Prescription Point-of-Care
                                              Submissions,’’ publicly viewable at                                            An electronic copy of the draft
                                                                                                                                                                                                  Use.’’ It does not establish any rights for
                                              https://www.regulations.gov or at the                                       guidance document is available for
                                                                                                                                                                                                  any person and is not binding on FDA
                                              Dockets Management Staff between 9                                          download from the internet. See the
                                                                                                                                                                                                  or the public. You can use an alternative
                                              a.m. and 4 p.m., Monday through                                             SUPPLEMENTARY INFORMATION section for
                                                                                                                                                                                                  approach if it satisfies the requirements
                                              Friday.                                                                     information on electronic access to the
                                                                                                                                                                                                  of the applicable statutes and
                                                 • Confidential Submissions—To                                            draft guidance. Submit written requests
                                                                                                                                                                                                  regulations. This guidance is not subject
                                              submit a comment with confidential                                          for a single hard copy of the draft
                                                                                                                          guidance document entitled ‘‘Blood                                      to Executive Order 12866.
                                              information that you do not wish to be
                                              made publicly available, submit your                                        Glucose Monitoring Test Systems for                                     III. Electronic Access
                                              comments only as a written/paper                                            Prescription Point-of-Care Use’’ to the
                                              submission. You should submit two                                           Office of the Center Director, Guidance                                    Persons interested in obtaining a copy
                                              copies total. One copy will include the                                     and Policy Development, Center for                                      of the draft guidance may do so by
                                              information you claim to be confidential                                    Devices and Radiological Health, Food                                   downloading an electronic copy from
                                              with a heading or cover note that states                                    and Drug Administration, 10903 New                                      the internet. A search capability for all
                                              ‘‘THIS DOCUMENT CONTAINS                                                    Hampshire Ave., Bldg. 66, Rm. 5431,                                     Center for Devices and Radiological
                                              CONFIDENTIAL INFORMATION.’’ The                                             Silver Spring, MD 20993–0002. Send                                      Health guidance documents is available
                                              Agency will review this copy, including                                     one self-addressed adhesive label to                                    at https://www.fda.gov/MedicalDevices/
                                              the claimed confidential information, in                                    assist that office in processing your                                   DeviceRegulationandGuidance/
                                              its consideration of comments. The                                          request.                                                                GuidanceDocuments/default.htm. This
                                              second copy, which will have the                                            FOR FURTHER INFORMATION CONTACT:
                                                                                                                                                                                                  draft guidance document is also
                                              claimed confidential information                                            Leslie Landree, Center for Devices and                                  available at https://
                                              redacted/blacked out, will be available                                     Radiological Health, Food and Drug                                      www.regulations.gov. Persons unable to
                                              for public viewing and posted on                                            Administration, 10903 New Hampshire                                     download an electronic copy of ‘‘Blood
                                              https://www.regulations.gov. Submit                                         Ave., Bldg. 66, Rm. 4623, Silver Spring,                                Glucose Monitoring Test Systems for
                                              both copies to the Dockets Management                                       MD 20993–0002, 301–796–6147.                                            Prescription Point-of-Care Use’’ may
                                              Staff. If you do not wish your name and                                                                                                             send an email request to CDRH-
                                                                                                                          SUPPLEMENTARY INFORMATION:
                                              contact information to be made publicly                                                                                                             Guidance@fda.hhs.gov to receive an
                                              available, you can provide this                                             I. Background                                                           electronic copy of the document. Please
                                              information on the cover sheet and not                                         On October 11, 2016, FDA published                                   use the document number GUD 1755 to
                                              in the body of your comments and you                                        a final guidance entitled, ‘‘Blood                                      identify the guidance you are
                                              must identify this information as                                           Glucose Monitoring Test Systems for                                     requesting.
                                              ‘‘confidential.’’ Any information marked                                    Prescription Point-of-Care Use.’’ That                                  IV. Paperwork Reduction Act of 1995
                                              as ‘‘confidential’’ will not be disclosed                                   guidance document described studies
                                              except in accordance with 21 CFR 10.20                                      and information that FDA recommends                                       This draft guidance refers to
                                              and other applicable disclosure law. For                                    be used when submitting 510(k)s for                                     previously approved collections of
                                              more information about FDA’s posting                                        BGMSs that are for prescription point-                                  information. These collections of
                                              of comments to public dockets, see 80                                       of-care use. FDA is now proposing to                                    information are subject to review by the
                                              FR 56469, September 18, 2015, or access                                     make modifications to the guidance                                      Office of Management and Budget
                                              the information at: https://www.gpo.gov/                                    based on feedback received from                                         (OMB) under the Paperwork Reduction
                                              fdsys/pkg/FR-2015-09-18/pdf/2015-                                           stakeholders, which the Agency believes                                 Act of 1995 (44 U.S.C. 3501–3520). The
                                              23389.pdf.                                                                  will better align with the evolving                                     collections of information in the
                                                 Docket: For access to the docket to                                      understanding and development of                                        following FDA guidances and
                                              read background documents or the                                            these types of devices. When finalized,                                 regulations have been approved by OMB
                                              electronic and written/paper comments                                       this draft guidance will replace the final                              as listed in the following table:

                                                                                                                                                                                                                                               OMB Control
                                                                           21 CFR part or guidance                                                                                         Topic                                                  No.

                                              807, subpart E ............................................................................          Premarket Notification ................................................................       0910–0120
                                              ‘‘Requests for Feedback on Medical Device Submissions: The                                           Q-Submissions ...........................................................................     0910–0756
                                                 Pre-Submission Program and Meetings with Food and Drug
amozie on DSK3GDR082PROD with NOTICES1




                                                 Administration Staff‘‘.
                                              800, 801, and 809 ......................................................................             Medical Device Labeling Regulations ........................................                  0910–0485
                                              820 ..............................................................................................   Current Good Manufacturing Practice (CGMP); Quality System                                    0910–0073
                                                                                                                                                     (QS) Regulation.
                                              Recommendations for Clinical Laboratory Improvement                                                  CLIA Waiver Applications ...........................................................          0910–0598
                                                Amendments of 1988 (CLIA) Waiver Applications for Manu-
                                                facturers of In Vitro Diagnostic Devices—Guidance for In-
                                                dustry and Food and Drug Administration Staff.



                                         VerDate Sep<11>2014         17:00 Nov 29, 2018          Jkt 247001       PO 00000        Frm 00051        Fmt 4703    Sfmt 4703      E:\FR\FM\30NON1.SGM            30NON1


                                              61650                       Federal Register / Vol. 83, No. 231 / Friday, November 30, 2018 / Notices

                                                                                                                                                                                        OMB Control
                                                                   21 CFR part or guidance                                                             Topic                               No.

                                              Administrative Procedures for CLIA Categorization—Guidance                Administrative Procedures for Clinical Laboratory Improvement      0910–0607
                                                for Industry and Food and Drug Administration Staff.                      Amendments of 1988 Categorization (42 CFR 493.17).



                                                Dated: November 26, 2018.                             11:59 p.m. Eastern Time at the end of                    Instructions: All submissions received
                                              Leslie Kux,                                             January 14, 2019. Comments received by                must include the Docket No. FDA–
                                              Associate Commissioner for Policy.                      mail/hand delivery/courier (for written/              2018–N–4116 for ‘‘Bone, Reproductive
                                              [FR Doc. 2018–26034 Filed 11–29–18; 8:45 am]            paper submissions) will be considered                 and Urologic Drugs Advisory
                                              BILLING CODE 4164–01–P
                                                                                                      timely if they are postmarked or the                  Committee; Notice of Meeting;
                                                                                                      delivery service acceptance receipt is on             Establishment of a Public Docket;
                                                                                                      or before that date.                                  Request for Comments.’’ Received
                                              DEPARTMENT OF HEALTH AND                                  Comments received on or before                      comments, those filed in a timely
                                              HUMAN SERVICES                                          December 31, 2018, will be provided to                manner (see ADDRESSES), will be placed
                                                                                                      the committee. Comments received after                in the docket and, except for those
                                              Food and Drug Administration                            that date will be taken into                          submitted as ‘‘Confidential
                                              [Docket No. FDA–2018–N–4116]
                                                                                                      consideration by FDA.                                 Submissions,’’ publicly viewable at
                                                                                                        You may submit comments as                          https://www.regulations.gov or at the
                                              Bone, Reproductive and Urologic                         follows:                                              Dockets Management Staff between 9
                                              Drugs Advisory Committee; Notice of                     Electronic Submissions                                a.m. and 4 p.m., Monday through
                                              Meeting; Establishment of a Public                                                                            Friday.
                                                                                                        Submit electronic comments in the
                                              Docket; Request for Comments                                                                                     • Confidential Submissions—To
                                                                                                      following way:
                                                                                                                                                            submit a comment with confidential
                                              AGENCY:    Food and Drug Administration,                  • Federal eRulemaking Portal:
                                                                                                                                                            information that you do not wish to be
                                              HHS.                                                    https://www.regulations.gov. Follow the
                                                                                                                                                            made publicly available, submit your
                                              ACTION: Notice; establishment of a                      instructions for submitting comments.
                                                                                                                                                            comments only as a written/paper
                                              public docket; request for comments.                    Comments submitted electronically,
                                                                                                                                                            submission. You should submit two
                                                                                                      including attachments, to https://
                                                                                                                                                            copies total. One copy will include the
                                              SUMMARY:   The Food and Drug                            www.regulations.gov will be posted to
                                                                                                                                                            information you claim to be confidential
                                              Administration (FDA) announces a                        the docket unchanged. Because your
                                                                                                                                                            with a heading or cover note that states
                                              forthcoming public advisory committee                   comment will be made public, you are
                                                                                                                                                            ‘‘THIS DOCUMENT CONTAINS
                                              meeting of the Bone, Reproductive and                   solely responsible for ensuring that your
                                                                                                                                                            CONFIDENTIAL INFORMATION.’’ FDA
                                              Urologic Drugs Advisory Committee.                      comment does not include any
                                                                                                                                                            will review this copy, including the
                                              The general function of the committee is                confidential information that you or a
                                                                                                                                                            claimed confidential information, in its
                                              to provide advice and recommendations                   third party may not wish to be posted,
                                                                                                                                                            consideration of comments. The second
                                              to FDA on regulatory issues. The                        such as medical information, your or
                                                                                                                                                            copy, which will have the claimed
                                              meeting will be open to the public. FDA                 anyone else’s Social Security number, or
                                                                                                                                                            confidential information redacted/
                                              is establishing a docket for public                     confidential business information, such
                                                                                                                                                            blacked out, will be available for public
                                              comment on this document.                               as a manufacturing process. Please note
                                                                                                                                                            viewing and posted on https://
                                              DATES: The meeting will be held on                      that if you include your name, contact
                                                                                                                                                            www.regulations.gov. Submit both
                                              January 16, 2019, from 8:15 a.m. to 5                   information, or other information that
                                                                                                                                                            copies to the Dockets Management Staff.
                                              p.m.                                                    identifies you in the body of your
                                                                                                                                                            If you do not wish your name and
                                                                                                      comments, that information will be
                                              ADDRESSES:   FDA White Oak Campus,                                                                            contact information be made publicly
                                                                                                      posted on https://www.regulations.gov.
                                              10903 New Hampshire Ave., Bldg. 31                        • If you want to submit a comment                   available, you can provide this
                                              Conference Center, the Great Room (Rm.                  with confidential information that you                information on the cover sheet and not
                                              1503), Silver Spring, MD 20993–0002.                    do not wish to be made available to the               in the body of your comments and you
                                              Answers to commonly asked questions                     public, submit the comment as a                       must identify the information as
                                              including information regarding special                 written/paper submission and in the                   ‘‘confidential.’’ Any information marked
                                              accommodations due to a disability,                     manner detailed (see ‘‘Written/Paper                  as ‘‘confidential’’ will not be disclosed
                                              visitor parking, and transportation may                 Submissions’’ and ‘‘Instructions’’).                  except in accordance with 21 CFR 10.20
                                              be accessed at: https://www.fda.gov/                                                                          and other applicable disclosure law. For
                                              AdvisoryCommittees/AboutAdvisory                        Written/Paper Submissions                             more information about FDA’s posting
                                              Committees/ucm408555.htm.                                 Submit written/paper submissions as                 of comments to public dockets, see 80
                                                FDA is establishing a docket for                      follows:                                              FR 56469, September 18, 2015, or access
                                              public comment on this meeting. The                       • Mail/Hand delivery/Courier (for                   the information at: https://www.gpo.gov/
                                              docket number is FDA–2018–N–4116.                       written/paper submissions): Dockets                   fdsys/pkg/FR-2015-09-18/pdf/2015-
                                              The docket will close on January 14,                    Management Staff (HFA–305), Food and                  23389.pdf.
                                              2019. Submit either electronic or                       Drug Administration, 5630 Fishers                        Docket: For access to the docket to
                                              written comments on this public                         Lane, Rm. 1061, Rockville, MD 20852.                  read background documents or the
amozie on DSK3GDR082PROD with NOTICES1




                                              meeting by January 14, 2019. Please                       • For written/paper comments                        electronic and written/paper comments
                                              note that late, untimely filed comments                 submitted to the Dockets Management                   received, go to https://
                                              will not be considered. Electronic                      Staff, FDA will post your comment, as                 www.regulations.gov and insert the
                                              comments must be submitted on or                        well as any attachments, except for                   docket number, found in brackets in the
                                              before January 14, 2019. The https://                   information submitted, marked and                     heading of this document, into the
                                              www.regulations.gov electronic filing                   identified, as confidential, if submitted             ‘‘Search’’ box and follow the prompts
                                              system will accept comments until                       as detailed in ‘‘Instructions.’’                      and/or go to the Dockets Management


                                         VerDate Sep<11>2014   17:00 Nov 29, 2018   Jkt 247001   PO 00000   Frm 00052   Fmt 4703   Sfmt 4703   E:\FR\FM\30NON1.SGM   30NON1



Document Created: 2018-11-30 04:35:19
Document Modified: 2018-11-30 04:35:19
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of availability.
DatesSubmit either electronic or written comments on the draft guidance by February 28, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
ContactLeslie Landree, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4623, Silver Spring, MD 20993-0002, 301-796-6147.
FR Citation83 FR 61648 

2024 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR