81_FR_14504 81 FR 14452 - Request for Comments on National Bioethics Advisory Bodies

81 FR 14452 - Request for Comments on National Bioethics Advisory Bodies

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 81, Issue 52 (March 17, 2016)

Page Range14452-14453
FR Document2016-06015

The Presidential Commission for the Study of Bioethical Issues is requesting public comment on the role of past, present, and future national bioethics bodies, such as this one, in the United States and elsewhere.

Federal Register, Volume 81 Issue 52 (Thursday, March 17, 2016)
[Federal Register Volume 81, Number 52 (Thursday, March 17, 2016)]
[Notices]
[Pages 14452-14453]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-06015]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Request for Comments on National Bioethics Advisory Bodies

AGENCY: Presidential Commission for the Study of Bioethical Issues, 
Office of the Secretary, Department of Health and Human Services.

ACTION: Notice.

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SUMMARY: The Presidential Commission for the Study of Bioethical Issues 
is requesting public comment on the role of past, present, and future 
national bioethics bodies, such as this one, in the United States and 
elsewhere.

[[Page 14453]]


DATES: To ensure consideration, comments must be received by July 1, 
2016. Comments received after this date will be considered as time 
permits.

ADDRESSES: Individuals, groups, and organizations interested in 
commenting on this topic may submit comments by email to 
[email protected] or by mail to the following address: Public 
Commentary, Presidential Commission for the Study of Bioethical Issues, 
1425 New York Ave. NW., Suite C-100, Washington, DC 20005.

FOR FURTHER INFORMATION CONTACT: Lisa M. Lee, Executive Director, 
Presidential Commission for the Study of Bioethical Issues. Telephone: 
202-233-3960. Email: [email protected]. Additional information may 
be obtained at http://www.bioethics.gov.

SUPPLEMENTARY INFORMATION: On November 24, 2009, the President 
established the Presidential Commission for the Study of Bioethical 
Issues (the Commission) to advise him on bioethical issues generated by 
novel and emerging research in biomedicine and related areas of science 
and technology. The Commission is charged with identifying and 
promoting policies and practices that ensure ethically responsible 
conduct of scientific research and health care delivery. Undertaking 
these duties, the Commission seeks to identify and examine specific 
bioethical, legal, and social issues related to potential scientific 
and technological advances; examine diverse perspectives and 
possibilities for international collaboration on these issues; and 
recommend legal, regulatory, or policy actions as appropriate.
    The Commission will conclude at the end of the Presidential 
administration, and in its two final meetings will reflect on the past, 
present, and future of national bioethics advisory bodies. These 
meetings will include discussion of the role of national advisory 
bodies in the developing public policy in the United States and 
elsewhere, and consideration of the future of U.S. national bioethics 
advisory bodies that might follow.
    The Commission is interested in receiving comments from 
individuals, groups, and professional communities who wish to join the 
Commission in reflecting on the past, present, and future of national 
bioethics advisory bodies in the United States and elsewhere. The 
Commission is particularly interested in receiving public commentary 
regarding:
     The advantages and disadvantages of different models for 
national bioethics advisory bodies, e.g., standing or temporary, 
narrowly or broadly focused (examining one topic or issue or a variety 
of issues);
     The lessons we can learn from national bodies in other 
countries to inform how U.S. bodies might work;
     The influence of national bioethics bodies on bioethics as 
a field; other academic fields, such as science, medicine, and 
technology; and public policy;
     The future of national bioethics advisory groups in the 
United States.
    To this end, the Commission is inviting interested parties to 
provide input and advice through written comments. Comments will be 
publicly available, including any personally identifiable or 
confidential business information that they contain. Trade secrets 
should not be submitted.

    Dated: March 1, 2016.
Lisa M. Lee,
Executive Director, Presidential Commission for the Study of Bioethical 
Issues.
[FR Doc. 2016-06015 Filed 3-16-16; 8:45 am]
 BILLING CODE 4150-06-P



                                                    14452                        Federal Register / Vol. 81, No. 52 / Thursday, March 17, 2016 / Notices

                                                    presence of naltrexone, an opioid                          FDA welcomes the attendance of the                 risk of losing their hospital. The day
                                                    antagonist, in the formulation. The                     public at its advisory committee                      will conclude with a period of public
                                                    committees will be asked to discuss                     meetings and will make every effort to                comment at approximately 5:00 p.m.
                                                    whether the data submitted by the                       accommodate persons with disabilities.                   The Committee will break into
                                                    Applicant are sufficient to support                     If you require accommodations due to a                Subcommittees and depart for site visits
                                                    labeling of the product with the                        disability, please contact Stephanie L.               Tuesday morning, April 19, at
                                                    properties expected to deter abuse.                     Begansky at least 7 days in advance of                approximately 8:30 a.m. Subcommittees
                                                       FDA intends to make background                       the meeting.                                          will visit the Beaufort County
                                                    material available to the public no later                  FDA is committed to the orderly                    Department of Social Services and the
                                                    than 2 business days before the meeting.                conduct of its advisory committee                     Keyserling Cancer Center. The day will
                                                    If FDA is unable to post the background                 meetings. Please visit our Web site at                conclude at the Keyserling Cancer
                                                    material on its Web site prior to the                   http://www.fda.gov/                                   Center with a period of public comment
                                                    meeting, the background material will                   AdvisoryCommittees/                                   at approximately 5:00 p.m.
                                                    be made publicly available at the                       AboutAdvisoryCommittees/                                 The Committee will meet to
                                                    location of the advisory committee                      ucm111462.htm for procedures on                       summarize key findings and develop a
                                                    meeting, and the background material                    public conduct during advisory                        work plan for the next quarter and the
                                                    will be posted on FDA’s Web site after                  committee meetings.                                   following meeting on Wednesday
                                                    the meeting. Background material is                        Notice of this meeting is given under              morning, April 20, at 8:30 a.m. at the
                                                    available at http://www.fda.gov/                        the Federal Advisory Committee Act (5                 Keyserling Cancer Center.
                                                    AdvisoryCommittees/Calendar/                            U.S.C. app. 2).                                       FOR FURTHER INFORMATION CONTACT:
                                                    default.htm. Scroll down to the                            Dated: March 11, 2016.                             Steve Hirsch, MSLS, Administrative
                                                    appropriate advisory committee meeting                  Jill Hartzler Warner,                                 Coordinator, National Advisory
                                                    link.                                                   Associate Commissioner for Special Medical            Committee on Rural Health and Human
                                                       Procedure: On June 8, 2016, from 9:30                Programs.                                             Services, Health Resources and Services
                                                    a.m. to 4 p.m., the meeting is open to                  [FR Doc. 2016–05999 Filed 3–16–16; 8:45 am]           Administration, Parklawn Building,
                                                    the public. Interested persons may                      BILLING CODE 4164–01–P                                17W61, 5600 Fishers Lane, Rockville,
                                                    present data, information, or views,                                                                          MD 20857, Telephone (301) 443–0835,
                                                    orally or in writing, on issues pending                                                                       Fax (301) 443–2803.
                                                    before the committees. Written                          DEPARTMENT OF HEALTH AND                                 Persons interested in attending any
                                                    submissions may be made to the contact                  HUMAN SERVICES                                        portion of the meeting should contact
                                                    person on or before May 24, 2016. Oral                                                                        Pierre Joseph at the Federal Office of
                                                    presentations from the public will be                   Health Resources and Services                         Rural Health Policy (FORHP) via
                                                    scheduled between approximately 1                       Administration                                        telephone at (301) 945–0897 or by email
                                                    p.m. and 2 p.m. Those individuals                                                                             at PJoseph@hrsa.gov. Individuals who
                                                    interested in making formal oral                        National Advisory Committee on Rural                  plan to attend and need special
                                                    presentations should notify the contact                 Health and Human Services; Notice of                  assistance, such as sign language
                                                    person and submit a brief statement of                  Meeting                                               interpretation or other reasonable
                                                    the general nature of the evidence or                     In accordance with section 10(a)(2) of              accommodations, should notify the
                                                    arguments they wish to present, the                     the Federal Advisory Committee Act                    contact person listed above at least 10
                                                    names and addresses of proposed                         (Pub. L. 92–463), notice is hereby given              days prior to the meeting. The
                                                    participants, and an indication of the                  of the following meeting:                             Committee meeting agenda will be
                                                    approximate time requested to make                        Name: National Advisory Committee                   posted on the Committee’s Web site at
                                                    their presentation on or before May 16,                 on Rural Health and Human Services.                   http://www.hrsa.gov/
                                                    2016. Time allotted for each                              Date And Time: April 18, 2016, 8:30                 advisorycommittees/rural/.
                                                    presentation may be limited. If the                     a.m.–5:00 p.m., April 19, 2016, 8:30
                                                    number of registrants requesting to                                                                           Jackie Painter,
                                                                                                            a.m.–5:15 p.m., April 20, 2016, 8:30
                                                    speak is greater than can be reasonably                                                                       Director, Division of the Executive Secretariat.
                                                                                                            a.m.–11:00 a.m.
                                                    accommodated during the scheduled                                                                             [FR Doc. 2016–05998 Filed 3–16–16; 8:45 am]
                                                                                                              Place: Keyserling Cancer Center,
                                                    open public hearing session, FDA may                    1680b Ribaut Road, Port Royal, SC                     BILLING CODE 4165–15–P
                                                    conduct a lottery to determine the                      29935, (843) 522–7800.
                                                    speakers for the scheduled open public                    Status: The meeting will be open to
                                                    hearing session. The contact person will                the public.                                           DEPARTMENT OF HEALTH AND
                                                    notify interested persons regarding their                 Purpose: The National Advisory                      HUMAN SERVICES
                                                    request to speak by May 17, 2016.                       Committee on Rural Health and Human                   Request for Comments on National
                                                       Closed Committee Deliberations: On                   Services provides counsel and                         Bioethics Advisory Bodies
                                                    June 8, 2016, from 8 a.m. to 9:30 a.m.,                 recommendations to the Secretary with
                                                    the meeting will be closed to permit                    respect to the delivery, research,                    AGENCY:  Presidential Commission for
                                                    discussion and review of trade secret                   development, and administration of                    the Study of Bioethical Issues, Office of
                                                    and/or confidential commercial                          health and human services in rural                    the Secretary, Department of Health and
                                                    information (5 U.S.C. 552b(c)(4)).                      areas.                                                Human Services.
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                                                    During this session, the committees will                  Agenda: The meeting on Monday,                      ACTION: Notice.
                                                    discuss the drug development program                    April 18, will be called to order at 8:30
                                                    of an investigational abuse-deterrent                   a.m. by the Chairperson of the                        SUMMARY:   The Presidential Commission
                                                    opioid product.                                         Committee, the Honorable Ronnie                       for the Study of Bioethical Issues is
                                                       Persons attending FDA’s advisory                     Musgrove. The Committee will examine                  requesting public comment on the role
                                                    committee meetings are advised that the                 the issue of Opioid Abuse Disorder in                 of past, present, and future national
                                                    Agency is not responsible for providing                 rural areas and alternatives for                      bioethics bodies, such as this one, in the
                                                    access to electrical outlets.                           emergency care in rural communities at                United States and elsewhere.


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                                                                                 Federal Register / Vol. 81, No. 52 / Thursday, March 17, 2016 / Notices                                             14453

                                                    DATES:  To ensure consideration,                        or temporary, narrowly or broadly                     SUPPLEMENTARY INFORMATION:        When
                                                    comments must be received by July 1,                    focused (examining one topic or issue or              submitting comments or requesting
                                                    2016. Comments received after this date                 a variety of issues);                                 information, please include the
                                                    will be considered as time permits.                       • The lessons we can learn from                     document identifier HHS–OS–0945–
                                                    ADDRESSES: Individuals, groups, and                     national bodies in other countries to                 0003–60D for reference.
                                                    organizations interested in commenting                  inform how U.S. bodies might work;                       Information Collection Request Title:
                                                    on this topic may submit comments by                      • The influence of national bioethics               HIPAA Privacy, Security, and Breach
                                                    email to info@bioethics.gov or by mail to               bodies on bioethics as a field; other                 Notification Rules, and Supporting
                                                    the following address: Public                           academic fields, such as science,                     Regulations Contained in 45 CFR parts
                                                    Commentary, Presidential Commission                     medicine, and technology; and public                  160 and 164.
                                                    for the Study of Bioethical Issues, 1425                policy;                                                  Abstract: This revision does not
                                                    New York Ave. NW., Suite C–100,                           • The future of national bioethics                  change any requirements of the HIPAA
                                                    Washington, DC 20005.                                   advisory groups in the United States.                 Privacy, Security, and Breach
                                                                                                              To this end, the Commission is                      Notification Rules. Among other
                                                    FOR FURTHER INFORMATION CONTACT: Lisa
                                                                                                            inviting interested parties to provide                updates summarized below, the ICR
                                                    M. Lee, Executive Director, Presidential                                                                      requests to rename the information
                                                    Commission for the Study of Bioethical                  input and advice through written
                                                                                                            comments. Comments will be publicly                   collection and incorporate into it the
                                                    Issues. Telephone: 202–233–3960.                                                                              substance of two other information
                                                    Email: Lisa.Lee@bioethics.gov.                          available, including any personally
                                                                                                            identifiable or confidential business                 collections (#0945–0004, set to expire
                                                    Additional information may be obtained                                                                        on May 31, 2016; and #0945–0001,
                                                    at http://www.bioethics.gov.                            information that they contain. Trade
                                                                                                            secrets should not be submitted.                      expiring on September 30, 2016), which
                                                    SUPPLEMENTARY INFORMATION: On                                                                                 then would be discontinued. The ICR
                                                    November 24, 2009, the President                          Dated: March 1, 2016.
                                                                                                                                                                  addresses the burden on regulated
                                                    established the Presidential Commission                 Lisa M. Lee,                                          entities for compliance with the
                                                    for the Study of Bioethical Issues (the                 Executive Director, Presidential Commission           information collection requirements of
                                                    Commission) to advise him on                            for the Study of Bioethical Issues.                   the HIPAA Privacy, Security, and
                                                    bioethical issues generated by novel and                [FR Doc. 2016–06015 Filed 3–16–16; 8:45 am]           Breach Notification Rules; the voluntary
                                                    emerging research in biomedicine and                    BILLING CODE 4150–06–P                                burden on members of the public for
                                                    related areas of science and technology.                                                                      obtaining information from covered
                                                    The Commission is charged with                                                                                entities regarding breaches of their
                                                    identifying and promoting policies and                  DEPARTMENT OF HEALTH AND                              protected health information; and the
                                                    practices that ensure ethically                         HUMAN SERVICES                                        information collection burden on the
                                                    responsible conduct of scientific                                                                             Office for Civil Rights (OCR) associated
                                                    research and health care delivery.                      Office of the Secretary                               with administering aspects of the
                                                    Undertaking these duties, the                           [Document Identifier: HHS–OS–0945–0003–               HIPAA Breach Notification program.
                                                    Commission seeks to identify and                        60D]                                                  Combining the three existing
                                                    examine specific bioethical, legal, and                                                                       information collections identified above
                                                    social issues related to potential                      Agency Information Collection                         will allow the regulated community, the
                                                    scientific and technological advances;                  Activities; Proposed Collection; Public               public, and OCR to more easily view
                                                    examine diverse perspectives and                        Comment Request                                       and track the estimated burdens
                                                    possibilities for international                         AGENCY:   Office of the Secretary, HHS.               associated with the HIPAA Rules that
                                                    collaboration on these issues; and                                                                            are administered and enforced by OCR.
                                                    recommend legal, regulatory, or policy                  ACTION:   Notice.                                     In addition to combining the ICRs, the
                                                    actions as appropriate.                                 SUMMARY:   In compliance with section                 proposed updates take into account our
                                                       The Commission will conclude at the                  3506(c)(2)(A) of the Paperwork                        experience administering the Rules to
                                                    end of the Presidential administration,                 Reduction Act of 1995, the Office of the              more accurately reflect the burdens of
                                                    and in its two final meetings will reflect              Secretary (OS), Department of Health                  compliance with the applicable
                                                    on the past, present, and future of                     and Human Services, announces plans                   regulatory requirements; remove the
                                                    national bioethics advisory bodies.                     to submit an Information Collection                   estimated burden of initial compliance
                                                    These meetings will include discussion                  Request (ICR), described below, to the                with the Omnibus HIPAA Final Rule,
                                                    of the role of national advisory bodies                 Office of Management and Budget                       because we are well past the compliance
                                                    in the developing public policy in the                  (OMB). The ICR is for revision of the                 dates; and incorporate increases in
                                                    United States and elsewhere, and                        approved information collection                       wages for the job categories that we
                                                    consideration of the future of U.S.                     assigned OMB control number #0945–                    expect to be involved in compliance
                                                    national bioethics advisory bodies that                 0003, which expires on January 1, 2017.               activities.
                                                    might follow.                                           Prior to submitting that ICR to OMB, OS                  Need and Proposed Use of the
                                                       The Commission is interested in                                                                            Information: The HIPAA Rules require
                                                                                                            seeks comments from the public
                                                    receiving comments from individuals,                                                                          covered entities, and in many respects
                                                                                                            regarding the burden estimate, below, or
                                                    groups, and professional communities                                                                          their business associates, to protect the
                                                                                                            any other aspect of the ICR.
                                                    who wish to join the Commission in                                                                            privacy and security of individually
                                                                                                            DATES: Comments on the ICR must be                    identifiable health information (called
                                                    reflecting on the past, present, and
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                                                    future of national bioethics advisory                   received on or before May 16, 2016.                   ‘‘protected health information’’ or
                                                    bodies in the United States and                         ADDRESSES: Submit your comments to                    ‘‘PHI’’); fulfill individuals’ rights under
                                                    elsewhere. The Commission is                            Information.CollectionClearance@                      HIPAA with respect to their health
                                                    particularly interested in receiving                    hhs.gov or by calling (202) 690–6162.                 information; and provide notification in
                                                    public commentary regarding:                            FOR FURTHER INFORMATION CONTACT:                      case of a breach of unsecured protected
                                                       • The advantages and disadvantages                   Information Collection Clearance staff,               health information. The information
                                                    of different models for national                        Information.CollectionClearance@                      collections associated with these
                                                    bioethics advisory bodies, e.g., standing               hhs.gov or (202) 690–6162.                            regulatory requirements include


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Document Created: 2016-03-17 00:58:19
Document Modified: 2016-03-17 00:58:19
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.
DatesTo ensure consideration, comments must be received by July 1, 2016. Comments received after this date will be considered as time permits.
ContactLisa M. Lee, Executive Director, Presidential Commission for the Study of Bioethical Issues. Telephone: 202-233-3960. Email: [email protected] Additional information may be obtained at http://www.bioethics.gov.
FR Citation81 FR 14452 

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