83_FR_40932 83 FR 40773 - National Advisory Committee on Rural Health and Human Services

83 FR 40773 - National Advisory Committee on Rural Health and Human Services

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 83, Issue 159 (August 16, 2018)

Page Range40773-40774
FR Document2018-17623

The Secretary's National Advisory Committee on Rural Health and Human Services (NACRHHS) has scheduled a public meeting. Information about NACRHHS and the agenda for this meeting can be found on the NACRHHS website at https://www.hrsa.gov/advisory-committees/ rural-health/index.html.

Federal Register, Volume 83 Issue 159 (Thursday, August 16, 2018)
[Federal Register Volume 83, Number 159 (Thursday, August 16, 2018)]
[Notices]
[Pages 40773-40774]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-17623]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


National Advisory Committee on Rural Health and Human Services

AGENCY: Health Resources and Services Administration (HRSA), Department 
of Health and Human Services (HHS).

ACTION: Notice of meeting.

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

SUMMARY: The Secretary's National Advisory Committee on Rural Health 
and Human Services (NACRHHS) has scheduled a public meeting. 
Information about NACRHHS and the agenda for this meeting can be found 
on the NACRHHS website at https://www.hrsa.gov/advisory-committees/rural-health/index.html.

DATES: September 10, 2018, 8:30 a.m.-5:15 p.m. ET; September 11, 2018, 
8:30 a.m.-5:15 p.m. ET; September 12, 2018, 8:30 a.m.-11:15 a.m. ET.

ADDRESSES: On September 10, the address for the meeting is The Duke 
Endowment, 800 East Morehead Street, Charlotte, NC 28202.
    On the morning of September 11, NACRHHS will break into 
subcommittees. One subcommittee will travel to Happy Valley Medical 
Center, 1345 NC Highway 268, Lenoir, NC 28645. The other subcommittee 
will travel to Winnsboro Smiles Dental Clinic, 124 N Congress Street, 
Winnsboro, SC 29180. In the afternoon, at approximately 4:00 p.m. ET., 
NACRHHS will reconvene at the AC Hotel Charlotte City Center, 220 E 
Trade Street, Charlotte, NC 28202.
    On September 12, the address for the meeting is AC Hotel Charlotte 
City Center, 220 E Trade Street, Charlotte, NC 28202.

FOR FURTHER INFORMATION CONTACT: Steven Hirsch, Administrative 
Coordinator at the Federal Office of Rural Health Policy, HRSA, 5600 
Fishers Lane, 17W59D, Rockville, Maryland 20857; 301-443-7322; or 
[email protected].

SUPPLEMENTARY INFORMATION: NACRHHS provides advice and recommendations 
to the Secretary of HHS (Secretary) on policy, program development, and 
other matters of significance concerning both rural health and rural 
human services.
    During the September meetings, NACRHHS will discuss the issues of 
chronic obstructive pulmonary disease, one of the leading causes of 
mortality in rural areas, and the provision of oral health services in 
rural areas. Agenda items are subject to change as priorities dictate.
    Members of the public will have the opportunity to provide 
comments.

[[Page 40774]]

Public participants may submit written statements in advance of the 
scheduled meeting. Oral comments will be honored in the order they are 
requested and may be limited as time allows. Requests to submit a 
written statement or make oral comments to NACRHHS should be sent to 
Steven Hirsch, using the contact information above at least 3 business 
days prior to the meeting.
    Individuals who plan to attend and need special assistance or 
another reasonable accommodation should notify Steven Hirsch at the 
address and phone number listed above at least 10 business days prior 
to the meeting.

Amy P. McNulty,
Acting Director, Division of the Executive Secretariat.
[FR Doc. 2018-17623 Filed 8-15-18; 8:45 am]
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                                                                            Federal Register / Vol. 83, No. 159 / Thursday, August 16, 2018 / Notices                                          40773

                                                SUMMARY:   The Food and Drug                            be made publicly available at the                     DEPARTMENT OF HEALTH AND
                                                Administration (FDA or Agency)                          location of the advisory committee                    HUMAN SERVICES
                                                announces a forthcoming public                          meeting, and the background material
                                                advisory committee meeting of the                       will be posted on FDA’s website after                 National Advisory Committee on Rural
                                                Vaccines and Related Biological                         the meeting. Background material is                   Health and Human Services
                                                Products Advisory Committee                             available at https://www.fda.gov/                     AGENCY: Health Resources and Services
                                                (VRBPAC). The general function of the                   AdvisoryCommittees/Calendar/                          Administration (HRSA), Department of
                                                committee is to provide advice and                      default.htm. Scroll down to the                       Health and Human Services (HHS).
                                                recommendations to the Agency on                        appropriate advisory committee meeting
                                                                                                                                                              ACTION: Notice of meeting.
                                                FDA’s regulatory issues. Members will                   link.
                                                participate via teleconference.                            Procedure: Interested persons may                  SUMMARY:   The Secretary’s National
                                                DATES: The meeting will be held on                      present data, information, or views,                  Advisory Committee on Rural Health
                                                October 3, 2018, from 11 a.m. to 3:30                   orally or in writing, on issues pending               and Human Services (NACRHHS) has
                                                p.m.                                                    before the committee. Written                         scheduled a public meeting. Information
                                                                                                        submissions may be made to the contact                about NACRHHS and the agenda for this
                                                ADDRESSES:    FDA White Oak Campus,                     person on or before September 26, 2018.               meeting can be found on the NACRHHS
                                                10903 New Hampshire Avenue, Bldg. 31                    Oral presentations from the public will               website at https://www.hrsa.gov/
                                                Conference Center, the Great Room (Rm.                  be scheduled between approximately                    advisory-committees/rural-health/
                                                1503), Silver Spring, MD 20993–0002.                    1:30 p.m. and 2:30 p.m. Those                         index.html.
                                                For those unable to attend in person, the               individuals interested in making formal
                                                meeting will also be webcast and will be                                                                      DATES: September 10, 2018, 8:30 a.m.–
                                                                                                        oral presentations should notify the                  5:15 p.m. ET; September 11, 2018, 8:30
                                                available at the following link: https://               contact person and submit a brief
                                                collaboration.fda.gov/vrbpac1018.                                                                             a.m.–5:15 p.m. ET; September 12, 2018,
                                                                                                        statement of the general nature of the                8:30 a.m.–11:15 a.m. ET.
                                                Answers to commonly asked questions                     evidence or arguments they wish to
                                                including information regarding special                                                                       ADDRESSES: On September 10, the
                                                                                                        present, the names and addresses of
                                                accommodations due to a disability,                                                                           address for the meeting is The Duke
                                                                                                        proposed participants, and an
                                                visitor parking, and transportation may                                                                       Endowment, 800 East Morehead Street,
                                                                                                        indication of the approximate time
                                                be accessed at: https://www.fda.gov/                                                                          Charlotte, NC 28202.
                                                                                                        requested to make their presentation on                  On the morning of September 11,
                                                AdvisoryCommittees/AboutAdvisory                        or before September 18, 2018. Time
                                                Committees/ucm408555.htm.                                                                                     NACRHHS will break into
                                                                                                        allotted for each presentation may be                 subcommittees. One subcommittee will
                                                FOR FURTHER INFORMATION CONTACT:                        limited. If the number of registrants                 travel to Happy Valley Medical Center,
                                                Serina Hunter-Thomas, Center for                        requesting to speak is greater than can               1345 NC Highway 268, Lenoir, NC
                                                Biologics Evaluation and Research,                      be reasonably accommodated during the                 28645. The other subcommittee will
                                                Food and Drug Administration, 10903                     scheduled open public hearing session,                travel to Winnsboro Smiles Dental
                                                New Hampshire Ave., Silver Spring, MD                   FDA may conduct a lottery to determine                Clinic, 124 N Congress Street,
                                                20993–0002, 240–402–5771,                               the speakers for the scheduled open                   Winnsboro, SC 29180. In the afternoon,
                                                serina.hunter-thomas@fda.hhs.gov, or                    public hearing session. The contact                   at approximately 4:00 p.m. ET.,
                                                FDA Advisory Committee Information                      person will notify interested persons                 NACRHHS will reconvene at the AC
                                                Line, 1–800–741–8138 (301–443–0572                      regarding their request to speak by                   Hotel Charlotte City Center, 220 E Trade
                                                in the Washington, DC area). A notice in                September 19, 2018.                                   Street, Charlotte, NC 28202.
                                                the Federal Register about last minute                     Persons attending FDA’s advisory                      On September 12, the address for the
                                                modifications that impact a previously                  committee meetings are advised that the               meeting is AC Hotel Charlotte City
                                                announced advisory committee meeting                    Agency is not responsible for providing               Center, 220 E Trade Street, Charlotte,
                                                cannot always be published quickly                      access to electrical outlets.                         NC 28202.
                                                enough to provide timely notice.                           FDA welcomes the attendance of the
                                                                                                                                                              FOR FURTHER INFORMATION CONTACT:
                                                Therefore, you should always check the                  public at its advisory committee
                                                                                                                                                              Steven Hirsch, Administrative
                                                Agency’s website at https://                            meetings and will make every effort to
                                                                                                                                                              Coordinator at the Federal Office of
                                                www.fda.gov/AdvisoryCommittees/                         accommodate persons with disabilities.
                                                                                                                                                              Rural Health Policy, HRSA, 5600
                                                default.htm and scroll down to the                      If you require accommodations due to a
                                                                                                                                                              Fishers Lane, 17W59D, Rockville,
                                                appropriate advisory committee meeting                  disability, please contact Serina Hunter-
                                                                                                                                                              Maryland 20857; 301–443–7322; or
                                                link, or call the advisory committee                    Thomas at least 7 days in advance of the
                                                                                                                                                              shirsch@hrsa.gov.
                                                information line to learn about possible                meeting.
                                                                                                           FDA is committed to the orderly                    SUPPLEMENTARY INFORMATION:
                                                modifications before coming to the
                                                meeting.                                                conduct of its advisory committee                     NACRHHS provides advice and
                                                                                                        meetings. Please visit our website at:                recommendations to the Secretary of
                                                SUPPLEMENTARY INFORMATION:                                                                                    HHS (Secretary) on policy, program
                                                                                                        https://www.fda.gov/Advisory
                                                   Agenda: On October 3, 2018, the                                                                            development, and other matters of
                                                                                                        Committees/AboutAdvisoryCommittees/
                                                VRBPAC will meet in an open session                                                                           significance concerning both rural
                                                                                                        ucm111462.htm for procedures on
                                                to discuss and make recommendations                                                                           health and rural human services.
                                                                                                        public conduct during advisory
                                                on the selection of strains to be included                                                                       During the September meetings,
                                                                                                        committee meetings.
                                                in an influenza virus vaccine for the                      Notice of this meeting is given under              NACRHHS will discuss the issues of
                                                2019 southern hemisphere influenza
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                                                                                                        the Federal Advisory Committee Act (5                 chronic obstructive pulmonary disease,
                                                season.                                                 U.S.C. app. 2).                                       one of the leading causes of mortality in
                                                   FDA intends to make background                                                                             rural areas, and the provision of oral
                                                material available to the public no later                 Dated: August 13, 2018.
                                                                                                                                                              health services in rural areas. Agenda
                                                than 2 business days before the meeting.                Leslie Kux,                                           items are subject to change as priorities
                                                If FDA is unable to post the background                 Associate Commissioner for Policy.                    dictate.
                                                material on its website prior to the                    [FR Doc. 2018–17702 Filed 8–15–18; 8:45 am]              Members of the public will have the
                                                meeting, the background material will                   BILLING CODE 4164–01–P                                opportunity to provide comments.


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                                                40774                       Federal Register / Vol. 83, No. 159 / Thursday, August 16, 2018 / Notices

                                                Public participants may submit written                  SUPPLEMENTARY INFORMATION:       ORI                  interest to be developed jointly. The
                                                statements in advance of the scheduled                  oversees and directs U.S. Public Health               expression of interest should be a
                                                meeting. Oral comments will be                          Service (PHS) research integrity                      bulleted outline, no more than two
                                                honored in the order they are requested                 activities on behalf of the Secretary of              pages in length, single-spaced, and 11-
                                                and may be limited as time allows.                      U.S. Department of Health and Human                   point font. An entity may submit an
                                                Requests to submit a written statement                  Services (HHS), with the exception of                 expression of interest individually or
                                                or make oral comments to NACRHHS                        the regulatory research integrity                     jointly with other entities describing
                                                should be sent to Steven Hirsch, using                  activities of the Food and Drug                       their relative contributions.
                                                the contact information above at least 3                Administration. ORI is a program office                 Evaluation Criteria: After engaging in
                                                business days prior to the meeting.                     within the Office of the Assistant                    exploratory discussions with potential
                                                  Individuals who plan to attend and                    Secretary for Health, Office of the                   co-sponsors that respond to this notice,
                                                need special assistance or another                      Secretary, HHS.                                       the following considerations will be
                                                reasonable accommodation should                           ORI’s Division of Education and                     used by HHS officials, as appropriate
                                                notify Steven Hirsch at the address and                 Integrity (DEI) has among its duties the              and relevant, to select the co-sponsor(s):
                                                phone number listed above at least 10                   responsibility to develop and                         • Qualifications and capability to fulfill
                                                business days prior to the meeting.                     implement activities and programs to                    co-sponsorship responsibilities
                                                                                                        teach RCR and train Research Integrity                • suitability of the location of the
                                                Amy P. McNulty,                                         Officers (RIOs) as well as others that are
                                                Acting Director, Division of the Executive
                                                                                                                                                                proposed event in terms of the overall
                                                                                                        involved in research integrity, such as                 geographical distribution of ORI
                                                Secretariat.                                            Institutional Officials (IOs) and
                                                [FR Doc. 2018–17623 Filed 8–15–18; 8:45 am]
                                                                                                                                                                events
                                                                                                        institutional counsel.                                • potential for reaching, generating, and
                                                BILLING CODE 4165–15–P                                    Consistent with ORI’s mission and the                 engaging adequate number of
                                                                                                        applicable statutory authority, 42 U.S.C.               attendees from stakeholders
                                                                                                        289b, ORI Workshops aim to provide                    • availability and description of
                                                DEPARTMENT OF HEALTH AND                                clarification and technical information
                                                HUMAN SERVICES                                                                                                  facilities needed to support the
                                                                                                        on the HHS regulations for handling                     workshop
                                                                                                        research misconduct allegations and on                • availability of administrative support
                                                Office of the Secretary                                 education in RCR to foster integrity in                 for the logistics of hosting such
                                                Opportunity to Co-Sponsor Office of                     research. ORI Workshops are                             workshops
                                                Research Integrity Workshops                            moderately sized, convening over one to
                                                                                                        three days, and typically accepting                     The selected co-sponsoring
                                                AGENCY: Office of the Secretary, HHS.                   between 20 and 50 attendees.                          organization(s) shall furnish the
                                                ACTION: Notice.                                           Co-sponsors will assist with                        necessary personnel, materials, services,
                                                                                                        workshop and agenda development,                      and facilities to administer its
                                                SUMMARY:   The Office of Research                       coordination, financial management,                   responsibility for the workshop. These
                                                Integrity (ORI) announces the                           and meeting logistics in conjunction                  duties will be outlined in a co-
                                                opportunity for non-federal public and                  with ORI staff.                                       sponsorship agreement with ORI that
                                                private sector entities to co-sponsor ORI                 Co-sponsors can charge registration                 will set forth the details of the co-
                                                conferences or workshops (ORI                           fees to recover costs associated with the             sponsored activity, including the
                                                Workshops). Potential co-sponsors must                  events; however, co-sponsors may not                  requirements that any fees collected by
                                                have a demonstrated interest and                        set registration fees at an amount higher             the co-sponsor shall be limited to the
                                                experience in the responsible conduct of                than necessary to recover related event               amount necessary to cover the co-
                                                research (RCR) or the handling of                       expenses. Further, co-sponsors are                    sponsor’s related event expenses. This
                                                research misconduct allegations.                        solely responsible for collecting and                 co-sponsorship agreement does not
                                                Potential co-sponsors must be willing to                handling any registration fees collected.             represent an endorsement by ORI of an
                                                participate substantively in the co-                      Eligibility for Co-Sponsorship: The co-             individual co-sponsor’s policies,
                                                sponsored activity.                                     sponsoring entity must have a                         positions, or activities. Additionally,
                                                  Expressions of interest for co-                       demonstrated interest and experience in               this agreement will not affect any
                                                sponsorships of ORI Workshops are                       the RCR or the handling of research                   determination concerning activities by
                                                received throughout the year at the                     misconduct allegations. The co-                       the co-sponsors that are regulated by
                                                email address below. ORI co-sponsors a                  sponsoring entity must participate                    ORI.
                                                limited number of workshops with other                  substantively in the co-sponsored                       Dated: August 9, 2018.
                                                entities each year. Expressions of                      activity, not just provide funding or                 Scott J. Moore,
                                                interest are being received for ORI                     logistical support.
                                                Workshops that will take place in the                     Each co-sponsorship expression of                   Deputy Director, Office of Research Integrity.
                                                next fiscal year (October 2018 through                  interest shall describe: (1) The entity’s             [FR Doc. 2018–17615 Filed 8–15–18; 8:45 am]
                                                September 2019) or beyond.                              interest and goals in promoting research              BILLING CODE 4150–31–P
                                                  Expressions of interest for co-                       integrity or the RCR, (2) the entity’s
                                                sponsorships should be sent by email to                 prior experience and current readiness
                                                AskORI@HHS.GOV with ‘‘Co-                               to undertake the responsibilities                     DEPARTMENT OF HEALTH AND
                                                sponsorship for ORI Workshops’’ in the                  described above, (3) the type of event(s)             HUMAN SERVICES
                                                subject field or by mail to ORI at 1101                 that the entity is interested in co-
sradovich on DSK3GMQ082PROD with NOTICES




                                                Wootton Parkway, Suite 750, Rockville,                                                                        Meeting of the Advisory Committee on
                                                                                                        sponsoring with ORI, (4) facilities                   Blood and Tissue Safety and
                                                MD 20852.                                               available for the event(s), and (5) any               Availability
                                                FOR FURTHER INFORMATION CONTACT:                        current constraints with respect to dates
                                                Tracey Randolph, Program Analyst,                       or facilities. The type of event may be               AGENCY:  Department of Health and
                                                Office of Research Integrity, 1101                      an event from ORI’s regular program of                Human Services, Office of the Secretary,
                                                Wootton Parkway, Suite 750, Rockville,                  recurring events (e.g., RCR Instructor’s              Office of the Assistant Secretary for
                                                MD 20852, (240) 453–8200.                               Workshop) or a special topic of mutual                Health.


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Document Created: 2018-08-16 01:01:55
Document Modified: 2018-08-16 01:01:55
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 meeting.
DatesSeptember 10, 2018, 8:30 a.m.-5:15 p.m. ET; September 11, 2018, 8:30 a.m.-5:15 p.m. ET; September 12, 2018, 8:30 a.m.-11:15 a.m. ET.
ContactSteven Hirsch, Administrative Coordinator at the Federal Office of Rural Health Policy, HRSA, 5600 Fishers Lane, 17W59D, Rockville, Maryland 20857; 301-443-7322; or [email protected]
FR Citation83 FR 40773 

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