Facilitation of Public-Private Dialogue to Increase Innovation and Investment in the Healthcare Sector, 26485-26486 [2018-12234]
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Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices
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Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–12226 Filed 6–6–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Facilitation of Public-Private Dialogue
to Increase Innovation and Investment
in the Healthcare Sector
Immediate Office of the
Secretary, HHS.
ACTION: Request for information.
AGENCY:
This request for information
solicits public comment on a planned
initiative of the Office of the Deputy
Secretary of HHS to develop a
workgroup to facilitate constructive,
high-level dialogue between HHS
leadership and those focused on
innovating and investing in the
healthcare industry. HHS seeks
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:19 Jun 06, 2018
Jkt 244001
comment on how to structure a
workgroup, or other form of interaction
between the Department and such
participants in the healthcare industry,
in order to best support communication
and understanding between these
parties that will spur investment,
increase competition, accelerate
innovation, and allow capital
investment in the healthcare sector to
have a more significant impact on the
health and wellbeing of Americans.
HHS also seeks comment more broadly
on opportunities for increased
engagement and dialogue between HHS
and those focused on innovating and
investing in the healthcare industry.
DATES: Comments must be submitted
within 30 days after the date of
publication in the Federal Register.
ADDRESSES: You may submit comments
in one of three ways (please choose only
one of the ways listed):
1. Electronically. You may submit
electronic comments through https://
www.regulations.gov.
2. By regular mail. You may mail
written comments to the following
address ONLY: Immediate Office of the
Secretary, Office of the Deputy
Secretary, U.S. Department of Health
and Human Services, Attention: RFI
Regarding Healthcare Sector Innovation
and Investment Workgroup, 200
Independence Avenue SW, Washington,
DC 20201.
Please allow sufficient time for mailed
comments to be received before the
close of the comment period.
3. By express or overnight mail. You
may mail written comments to the
following address ONLY: Immediate
Office of the Secretary, Office of the
Deputy Secretary, U.S. Department of
Health and Human Services, Attention:
RFI Regarding Healthcare Sector
Innovation and Investment Workgroup,
200 Independence Avenue SW,
Washington, DC 20201.
FOR FURTHER INFORMATION CONTACT:
William Brady, (202) 690–6133.
SUPPLEMENTARY INFORMATION:
I. Background
The healthcare industry is a complex
and highly regulated industry, and
although significant investment occurs
within the industry, innovation and
investment in the healthcare industry
must increase to produce more
significant impact on the health and
wellbeing of the American people.
Through this effort, the Department
intends to provide a forum for HHS
leadership to engage in a dialogue with
those focused on innovating and
investing in the healthcare industry,
such as healthcare innovation-focused
PO 00000
Frm 00076
Fmt 4703
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26485
companies, healthcare startup
incubators and accelerators, healthcare
investment professionals, healthcarefocused private equity firms, healthcarefocused venture capital firms, and
lenders to healthcare investors and
innovators. While HHS seeks comment
on the structure and focus of the
workgroup, as well as other
opportunities for engagement, the
Department envisions the workgroup as
a forum to hear the individual
perspectives of attendees and foster new
and innovative approaches to tackle the
complicated challenges facing the
healthcare industry. The Department
intends for non-HHS attendees to be
diverse across the subsectors of the
healthcare industry and the investment
and innovation lifecycles, and for HHS
attendees to be diverse across the
Department in senior leadership
positions. Workgroup members will not
be asked to provide any reports or
collaborative work product. No travel
expenses, per diem, or compensation of
any type will be provided to attendees.
II. Solicitation of Comments
HHS seeks comment on how to
structure the workgroup in order to best
support communication and
understanding between these parties
that will spur investment in the
healthcare industry, increase
competition, improve innovation, and
allow capital investment in the
healthcare sector to have a more
significant impact on the health and
wellbeing of Americans. HHS also seeks
comment more broadly on opportunities
for increased engagement and dialogue
between HHS and those focused on
innovating and investing in the
healthcare industry. Specifically, HHS
seeks comments addressing the
following topics:
1. Specific areas of inquiry or focus
for the workgroup. Should the
workgroup review recent developments
in health innovation and investing?
Should the workgroup examine
perceived barriers to innovation and
competition in the healthcare industry?
Should the workgroup encourage
outside parties to provide HHS with
information about how they are affected
by HHS programs or regulatory
requirements? Should the workgroup
provide a forum for attendees to share
their perspectives as to how the
Department may improve relevant
regulations, guidance, or other
documents? Should the workgroup
examine ways to encourage private
sector investment to help combat health
crises? What other areas of focus would
best help the Department engage with
diverse subsectors of the healthcare
E:\FR\FM\07JNN1.SGM
07JNN1
sradovich on DSK3GMQ082PROD with NOTICES
26486
Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices
industry and investment industry in
order to increase innovation and
investment in the healthcare sector?
2. How the workgroup should be
convened and structured, including
what subsectors of the healthcare
economy should be invited to
participate, and the most effective size.
How should the agency structure
meetings or other engagements in order
to best facilitate the exchange of
information and the presentation of
attendees’ individual perspectives? The
Department seeks comment on how
suitable attendees should be identified
and selected to attend and engage in an
exchange of ideas about the
Department’s goals of increasing
innovation and investment in the
healthcare sector.
3. HHS also seeks comment more
broadly on opportunities for increased
engagement and dialogue between HHS
and those focused on innovating and
investing in the healthcare industry,
including alternatives to the workgroup
structure discussed in this request for
information. The Department is
interested in comments that propose
alternatives for developing a durable
and consistent approach to increase
innovation and investment in the
healthcare sector to improve the public
health and wellbeing of Americans.
This is a request for information only.
Respondents are encouraged to provide
complete but concise responses to any
or all of the questions outlined above.
This request for information is issued
solely for information and planning
purposes; it does not constitute a notice
of proposed rulemaking or request for
proposals, applications, proposal
abstracts, or quotations, nor does it
suggest that the Department will
undertake any particular action in
response to comments. This request for
information does not commit the United
States Government (‘‘Government’’) to
contract for any supplies or services or
make a grant award. Further, HHS is not
seeking proposals through this request
for information and will not accept
unsolicited proposals. Respondents are
advised that the Government will not
pay for any information or
administrative costs incurred in
response to this request for information;
all costs associated with responding to
this request for information will be
solely at the interested party’s expense.
Not responding to this request for
information does not preclude
participation in any future rulemaking
or procurement, if conducted. It is the
responsibility of the potential
responders to monitor this request for
information announcement for
additional information pertaining to this
VerDate Sep<11>2014
17:19 Jun 06, 2018
Jkt 244001
request. We also note that HHS will not
respond to questions about the policy
issues raised in this request for
information. HHS may or may not
choose to contact individual responders.
Such communications would only serve
to further clarify written responses.
Contractor support personnel may be
used to review the responses submitted
under this request for information.
Responses to this notice are not offers
and cannot be accepted by the
Government to form a binding contract
or issue a grant. Information obtained in
response to this request for information
may be used by the Government for
program planning on a non-attribution
basis. Respondents should not include
any information that might be
considered proprietary or confidential.
This request for information should not
be construed as a commitment or
authorization to incur cost for which
reimbursement would be required or
sought. All submissions become
Government property and will not be
returned. HHS may publicly post the
comments received, or a summary
thereof. While responses to this request
for information do not bind HHS to any
further actions related to the response,
all comments may be posted online on
https://www.regulations.gov.
III. Collection of Information
This document does not impose
information collection requirements;
that is, reporting, recordkeeping or
third-party disclosure requirements.
This request for information constitutes
a general solicitation of comments. In
accordance with the implementing
regulations of the Paperwork Reduction
Act of 1995 (PRA) at 5 CFR 1320.3(h)(4),
information subject to the PRA does not
generally include ‘‘facts or opinions
submitted in response to general
solicitations of comments from the
public, published in the Federal
Register or other publications,
regardless of the form or format thereof,
provided that no person is required to
supply specific information pertaining
to the commenter, other than that
necessary for self-identification, as a
condition of the agency’s full
consideration of the comment.’’
Consequently, this document need not
be reviewed by the Office of
Management and Budget under the
authority of the PRA (44 U.S.C. 3501 et
seq.).
Authority: 42 U.S.C. 3501.
PO 00000
Frm 00077
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Dated: June 1, 2018.
Eric D. Hargan,
Deputy Secretary, Department of Health and
Human Services.
[FR Doc. 2018–12234 Filed 6–6–18; 8:45 am]
BILLING CODE 4150–03–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Arthritis and
Musculoskeletal and Skin Diseases;
Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Arthritis and
Musculoskeletal and Skin Diseases Initial
Review Group; Arthritis and Musculoskeletal
and Skin Diseases Special Grants Review
Committee.
Date: June 13–14, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites, Chevy Chase
Pavilion, 4300 Military Rd. NW, Washington,
DC 20015.
Contact Person: Helen Lin, Ph.D.,
Scientific Review Officer, NIH/NIAMS/RB,
6701 Democracy Blvd., Suite 800, Plaza One,
Bethesda, MD 20817, 301–594–4952, linh1@
mail.nih.gov.
Name of Committee: Arthritis and
Musculoskeletal and Skin Diseases Initial
Review Group; Arthritis and Musculoskeletal
and Skin Diseases Clinical Trials Review
Committee.
Date: June 19, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, 1 Bethesda
Metro Center, Bethesda, MD 20814.
Contact Person: Nakia C Brown, Ph.D.,
Scientific Review Officer, 6701 Democracy
Blvd., RM 816, Bethesda, MD 20892, 301–
827–4905, brownnac@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.846, Arthritis,
Musculoskeletal and Skin Diseases Research,
National Institutes of Health, HHS)
E:\FR\FM\07JNN1.SGM
07JNN1
]]>Agencies
[Federal Register Volume 83, Number 110 (Thursday, June 7, 2018)]
[Notices]
[Pages 26485-26486]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12234]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Facilitation of Public-Private Dialogue to Increase Innovation
and Investment in the Healthcare Sector
AGENCY: Immediate Office of the Secretary, HHS.
ACTION: Request for information.
-----------------------------------------------------------------------
SUMMARY: This request for information solicits public comment on a
planned initiative of the Office of the Deputy Secretary of HHS to
develop a workgroup to facilitate constructive, high-level dialogue
between HHS leadership and those focused on innovating and investing in
the healthcare industry. HHS seeks comment on how to structure a
workgroup, or other form of interaction between the Department and such
participants in the healthcare industry, in order to best support
communication and understanding between these parties that will spur
investment, increase competition, accelerate innovation, and allow
capital investment in the healthcare sector to have a more significant
impact on the health and wellbeing of Americans. HHS also seeks comment
more broadly on opportunities for increased engagement and dialogue
between HHS and those focused on innovating and investing in the
healthcare industry.
DATES: Comments must be submitted within 30 days after the date of
publication in the Federal Register.
ADDRESSES: You may submit comments in one of three ways (please choose
only one of the ways listed):
1. Electronically. You may submit electronic comments through
https://www.regulations.gov.
2. By regular mail. You may mail written comments to the following
address ONLY: Immediate Office of the Secretary, Office of the Deputy
Secretary, U.S. Department of Health and Human Services, Attention: RFI
Regarding Healthcare Sector Innovation and Investment Workgroup, 200
Independence Avenue SW, Washington, DC 20201.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may mail written comments to
the following address ONLY: Immediate Office of the Secretary, Office
of the Deputy Secretary, U.S. Department of Health and Human Services,
Attention: RFI Regarding Healthcare Sector Innovation and Investment
Workgroup, 200 Independence Avenue SW, Washington, DC 20201.
FOR FURTHER INFORMATION CONTACT: William Brady, (202) 690-6133.
SUPPLEMENTARY INFORMATION:
I. Background
The healthcare industry is a complex and highly regulated industry,
and although significant investment occurs within the industry,
innovation and investment in the healthcare industry must increase to
produce more significant impact on the health and wellbeing of the
American people. Through this effort, the Department intends to provide
a forum for HHS leadership to engage in a dialogue with those focused
on innovating and investing in the healthcare industry, such as
healthcare innovation-focused companies, healthcare startup incubators
and accelerators, healthcare investment professionals, healthcare-
focused private equity firms, healthcare-focused venture capital firms,
and lenders to healthcare investors and innovators. While HHS seeks
comment on the structure and focus of the workgroup, as well as other
opportunities for engagement, the Department envisions the workgroup as
a forum to hear the individual perspectives of attendees and foster new
and innovative approaches to tackle the complicated challenges facing
the healthcare industry. The Department intends for non-HHS attendees
to be diverse across the subsectors of the healthcare industry and the
investment and innovation lifecycles, and for HHS attendees to be
diverse across the Department in senior leadership positions. Workgroup
members will not be asked to provide any reports or collaborative work
product. No travel expenses, per diem, or compensation of any type will
be provided to attendees.
II. Solicitation of Comments
HHS seeks comment on how to structure the workgroup in order to
best support communication and understanding between these parties that
will spur investment in the healthcare industry, increase competition,
improve innovation, and allow capital investment in the healthcare
sector to have a more significant impact on the health and wellbeing of
Americans. HHS also seeks comment more broadly on opportunities for
increased engagement and dialogue between HHS and those focused on
innovating and investing in the healthcare industry. Specifically, HHS
seeks comments addressing the following topics:
1. Specific areas of inquiry or focus for the workgroup. Should the
workgroup review recent developments in health innovation and
investing? Should the workgroup examine perceived barriers to
innovation and competition in the healthcare industry? Should the
workgroup encourage outside parties to provide HHS with information
about how they are affected by HHS programs or regulatory requirements?
Should the workgroup provide a forum for attendees to share their
perspectives as to how the Department may improve relevant regulations,
guidance, or other documents? Should the workgroup examine ways to
encourage private sector investment to help combat health crises? What
other areas of focus would best help the Department engage with diverse
subsectors of the healthcare
[[Page 26486]]
industry and investment industry in order to increase innovation and
investment in the healthcare sector?
2. How the workgroup should be convened and structured, including
what subsectors of the healthcare economy should be invited to
participate, and the most effective size. How should the agency
structure meetings or other engagements in order to best facilitate the
exchange of information and the presentation of attendees' individual
perspectives? The Department seeks comment on how suitable attendees
should be identified and selected to attend and engage in an exchange
of ideas about the Department's goals of increasing innovation and
investment in the healthcare sector.
3. HHS also seeks comment more broadly on opportunities for
increased engagement and dialogue between HHS and those focused on
innovating and investing in the healthcare industry, including
alternatives to the workgroup structure discussed in this request for
information. The Department is interested in comments that propose
alternatives for developing a durable and consistent approach to
increase innovation and investment in the healthcare sector to improve
the public health and wellbeing of Americans.
This is a request for information only. Respondents are encouraged
to provide complete but concise responses to any or all of the
questions outlined above. This request for information is issued solely
for information and planning purposes; it does not constitute a notice
of proposed rulemaking or request for proposals, applications, proposal
abstracts, or quotations, nor does it suggest that the Department will
undertake any particular action in response to comments. This request
for information does not commit the United States Government
(``Government'') to contract for any supplies or services or make a
grant award. Further, HHS is not seeking proposals through this request
for information and will not accept unsolicited proposals. Respondents
are advised that the Government will not pay for any information or
administrative costs incurred in response to this request for
information; all costs associated with responding to this request for
information will be solely at the interested party's expense. Not
responding to this request for information does not preclude
participation in any future rulemaking or procurement, if conducted. It
is the responsibility of the potential responders to monitor this
request for information announcement for additional information
pertaining to this request. We also note that HHS will not respond to
questions about the policy issues raised in this request for
information. HHS may or may not choose to contact individual
responders. Such communications would only serve to further clarify
written responses. Contractor support personnel may be used to review
the responses submitted under this request for information. Responses
to this notice are not offers and cannot be accepted by the Government
to form a binding contract or issue a grant. Information obtained in
response to this request for information may be used by the Government
for program planning on a non-attribution basis. Respondents should not
include any information that might be considered proprietary or
confidential. This request for information should not be construed as a
commitment or authorization to incur cost for which reimbursement would
be required or sought. All submissions become Government property and
will not be returned. HHS may publicly post the comments received, or a
summary thereof. While responses to this request for information do not
bind HHS to any further actions related to the response, all comments
may be posted online on https://www.regulations.gov.
III. Collection of Information
This document does not impose information collection requirements;
that is, reporting, recordkeeping or third-party disclosure
requirements. This request for information constitutes a general
solicitation of comments. In accordance with the implementing
regulations of the Paperwork Reduction Act of 1995 (PRA) at 5 CFR
1320.3(h)(4), information subject to the PRA does not generally include
``facts or opinions submitted in response to general solicitations of
comments from the public, published in the Federal Register or other
publications, regardless of the form or format thereof, provided that
no person is required to supply specific information pertaining to the
commenter, other than that necessary for self-identification, as a
condition of the agency's full consideration of the comment.''
Consequently, this document need not be reviewed by the Office of
Management and Budget under the authority of the PRA (44 U.S.C. 3501 et
seq.).
Authority: 42 U.S.C. 3501.
Dated: June 1, 2018.
Eric D. Hargan,
Deputy Secretary, Department of Health and Human Services.
[FR Doc. 2018-12234 Filed 6-6-18; 8:45 am]
BILLING CODE 4150-03-P
