National Advisory Committee on Rural Health and Human Services, 40773-40774 [2018-17623]
Download as PDF
<![CDATA[
Federal Register / Vol. 83, No. 159 / Thursday, August 16, 2018 / Notices
The Food and Drug
Administration (FDA or Agency)
announces a forthcoming public
advisory committee meeting of the
Vaccines and Related Biological
Products Advisory Committee
(VRBPAC). The general function of the
committee is to provide advice and
recommendations to the Agency on
FDA’s regulatory issues. Members will
participate via teleconference.
DATES: The meeting will be held on
October 3, 2018, from 11 a.m. to 3:30
p.m.
SUMMARY:
FDA White Oak Campus,
10903 New Hampshire Avenue, Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
For those unable to attend in person, the
meeting will also be webcast and will be
available at the following link: https://
collaboration.fda.gov/vrbpac1018.
Answers to commonly asked questions
including information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/AboutAdvisory
Committees/ucm408555.htm.
FOR FURTHER INFORMATION CONTACT:
Serina Hunter-Thomas, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Silver Spring, MD
20993–0002, 240–402–5771,
serina.hunter-thomas@fda.hhs.gov, or
FDA Advisory Committee Information
Line, 1–800–741–8138 (301–443–0572
in the Washington, DC area). A notice in
the Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s website at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
ADDRESSES:
sradovich on DSK3GMQ082PROD with NOTICES
SUPPLEMENTARY INFORMATION:
Agenda: On October 3, 2018, the
VRBPAC will meet in an open session
to discuss and make recommendations
on the selection of strains to be included
in an influenza virus vaccine for the
2019 southern hemisphere influenza
season.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its website prior to the
meeting, the background material will
VerDate Sep<11>2014
17:15 Aug 15, 2018
Jkt 244001
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s website after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before September 26, 2018.
Oral presentations from the public will
be scheduled between approximately
1:30 p.m. and 2:30 p.m. Those
individuals interested in making formal
oral presentations should notify the
contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before September 18, 2018. Time
allotted for each presentation may be
limited. If the number of registrants
requesting to speak is greater than can
be reasonably accommodated during the
scheduled open public hearing session,
FDA may conduct a lottery to determine
the speakers for the scheduled open
public hearing session. The contact
person will notify interested persons
regarding their request to speak by
September 19, 2018.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact Serina HunterThomas at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our website at:
https://www.fda.gov/Advisory
Committees/AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: August 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–17702 Filed 8–15–18; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
40773
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Advisory Committee on Rural
Health and Human Services
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice of meeting.
AGENCY:
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
shirsch@hrsa.gov.
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.
SUMMARY:
E:\FR\FM\16AUN1.SGM
16AUN1
40774
Federal Register / Vol. 83, No. 159 / Thursday, August 16, 2018 / Notices
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]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Opportunity to Co-Sponsor Office of
Research Integrity Workshops
Office of the Secretary, HHS.
ACTION: Notice.
AGENCY:
The Office of Research
Integrity (ORI) announces the
opportunity for non-federal public and
private sector entities to co-sponsor ORI
conferences or workshops (ORI
Workshops). Potential co-sponsors must
have a demonstrated interest and
experience in the responsible conduct of
research (RCR) or the handling of
research misconduct allegations.
Potential co-sponsors must be willing to
participate substantively in the cosponsored activity.
Expressions of interest for cosponsorships of ORI Workshops are
received throughout the year at the
email address below. ORI co-sponsors a
limited number of workshops with other
entities each year. Expressions of
interest are being received for ORI
Workshops that will take place in the
next fiscal year (October 2018 through
September 2019) or beyond.
Expressions of interest for cosponsorships should be sent by email to
AskORI@HHS.GOV with ‘‘Cosponsorship for ORI Workshops’’ in the
subject field or by mail to ORI at 1101
Wootton Parkway, Suite 750, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Tracey Randolph, Program Analyst,
Office of Research Integrity, 1101
Wootton Parkway, Suite 750, Rockville,
MD 20852, (240) 453–8200.
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:15 Aug 15, 2018
Jkt 244001
ORI
oversees and directs U.S. Public Health
Service (PHS) research integrity
activities on behalf of the Secretary of
U.S. Department of Health and Human
Services (HHS), with the exception of
the regulatory research integrity
activities of the Food and Drug
Administration. ORI is a program office
within the Office of the Assistant
Secretary for Health, Office of the
Secretary, HHS.
ORI’s Division of Education and
Integrity (DEI) has among its duties the
responsibility to develop and
implement activities and programs to
teach RCR and train Research Integrity
Officers (RIOs) as well as others that are
involved in research integrity, such as
Institutional Officials (IOs) and
institutional counsel.
Consistent with ORI’s mission and the
applicable statutory authority, 42 U.S.C.
289b, ORI Workshops aim to provide
clarification and technical information
on the HHS regulations for handling
research misconduct allegations and on
education in RCR to foster integrity in
research. ORI Workshops are
moderately sized, convening over one to
three days, and typically accepting
between 20 and 50 attendees.
Co-sponsors will assist with
workshop and agenda development,
coordination, financial management,
and meeting logistics in conjunction
with ORI staff.
Co-sponsors can charge registration
fees to recover costs associated with the
events; however, co-sponsors may not
set registration fees at an amount higher
than necessary to recover related event
expenses. Further, co-sponsors are
solely responsible for collecting and
handling any registration fees collected.
Eligibility for Co-Sponsorship: The cosponsoring entity must have a
demonstrated interest and experience in
the RCR or the handling of research
misconduct allegations. The cosponsoring entity must participate
substantively in the co-sponsored
activity, not just provide funding or
logistical support.
Each co-sponsorship expression of
interest shall describe: (1) The entity’s
interest and goals in promoting research
integrity or the RCR, (2) the entity’s
prior experience and current readiness
to undertake the responsibilities
described above, (3) the type of event(s)
that the entity is interested in cosponsoring with ORI, (4) facilities
available for the event(s), and (5) any
current constraints with respect to dates
or facilities. The type of event may be
an event from ORI’s regular program of
recurring events (e.g., RCR Instructor’s
Workshop) or a special topic of mutual
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
interest to be developed jointly. The
expression of interest should be a
bulleted outline, no more than two
pages in length, single-spaced, and 11point font. An entity may submit an
expression of interest individually or
jointly with other entities describing
their relative contributions.
Evaluation Criteria: After engaging in
exploratory discussions with potential
co-sponsors that respond to this notice,
the following considerations will be
used by HHS officials, as appropriate
and relevant, to select the co-sponsor(s):
• Qualifications and capability to fulfill
co-sponsorship responsibilities
• suitability of the location of the
proposed event in terms of the overall
geographical distribution of ORI
events
• potential for reaching, generating, and
engaging adequate number of
attendees from stakeholders
• availability and description of
facilities needed to support the
workshop
• availability of administrative support
for the logistics of hosting such
workshops
The selected co-sponsoring
organization(s) shall furnish the
necessary personnel, materials, services,
and facilities to administer its
responsibility for the workshop. These
duties will be outlined in a cosponsorship agreement with ORI that
will set forth the details of the cosponsored activity, including the
requirements that any fees collected by
the co-sponsor shall be limited to the
amount necessary to cover the cosponsor’s related event expenses. This
co-sponsorship agreement does not
represent an endorsement by ORI of an
individual co-sponsor’s policies,
positions, or activities. Additionally,
this agreement will not affect any
determination concerning activities by
the co-sponsors that are regulated by
ORI.
Dated: August 9, 2018.
Scott J. Moore,
Deputy Director, Office of Research Integrity.
[FR Doc. 2018–17615 Filed 8–15–18; 8:45 am]
BILLING CODE 4150–31–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Advisory Committee on
Blood and Tissue Safety and
Availability
Department of Health and
Human Services, Office of the Secretary,
Office of the Assistant Secretary for
Health.
AGENCY:
E:\FR\FM\16AUN1.SGM
16AUN1
]]>Agencies
[Federal Register Volume 83, Number 159 (Thursday, August 16, 2018)]
[Notices]
[Pages 40773-40774]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-17623]
-----------------------------------------------------------------------
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/.
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]
BILLING CODE 4165-15-P
