83 FR 26485 - Facilitation of Public-Private Dialogue to Increase Innovation and Investment in the Healthcare Sector

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary

Federal Register Volume 83, Issue 110 (June 7, 2018)

Page Range		26485-26486
FR Document		2018-12234

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.

Federal Register, Volume 83 Issue 110 (Thursday, June 7, 2018)

[Federal Register Volume 83, Number 110 (Thursday, June 7, 2018)]
[Notices]
[Pages 26485-26486]
From the Federal Register Online  [www.thefederalregister.org]
[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 
http://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 http://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

26486 Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices

industry and investment industry in request. We also note that HHS will not Dated: June 1, 2018.
order to increase innovation and respond to questions about the policy Eric D. Hargan,
investment in the healthcare sector? issues raised in this request for Deputy Secretary, Department of Health and
2. How the workgroup should be information. HHS may or may not Human Services.
convened and structured, including choose to contact individual responders. [FR Doc. 2018–12234 Filed 6–6–18; 8:45 am]
what subsectors of the healthcare Such communications would only serve BILLING CODE 4150–03–P
economy should be invited to to further clarify written responses.
participate, and the most effective size. Contractor support personnel may be
How should the agency structure DEPARTMENT OF HEALTH AND
used to review the responses submitted
meetings or other engagements in order HUMAN SERVICES
under this request for information.
to best facilitate the exchange of
information and the presentation of Responses to this notice are not offers
National Institutes of Health
attendees’ individual perspectives? The and cannot be accepted by the
Department seeks comment on how Government to form a binding contract National Institute of Arthritis and
suitable attendees should be identified or issue a grant. Information obtained in Musculoskeletal and Skin Diseases;
and selected to attend and engage in an response to this request for information Notice of Closed Meetings
exchange of ideas about the may be used by the Government for
Department’s goals of increasing program planning on a non-attribution Pursuant to section 10(d) of the
innovation and investment in the basis. Respondents should not include Federal Advisory Committee Act, as
healthcare sector. any information that might be amended, notice is hereby given of the
3. HHS also seeks comment more considered proprietary or confidential. following meetings.
broadly on opportunities for increased This request for information should not The meetings will be closed to the
engagement and dialogue between HHS be construed as a commitment or public in accordance with the
and those focused on innovating and authorization to incur cost for which provisions set forth in sections
investing in the healthcare industry, reimbursement would be required or 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
including alternatives to the workgroup sought. All submissions become as amended. The grant applications and
structure discussed in this request for Government property and will not be the discussions could disclose
information. The Department is
returned. HHS may publicly post the confidential trade secrets or commercial
interested in comments that propose
comments received, or a summary property such as patentable material,
alternatives for developing a durable
thereof. While responses to this request and personal information concerning
and consistent approach to increase
for information do not bind HHS to any individuals associated with the grant
innovation and investment in the
further actions related to the response, applications, the disclosure of which
healthcare sector to improve the public
all comments may be posted online on would constitute a clearly unwarranted
health and wellbeing of Americans.
This is a request for information only. http://www.regulations.gov. invasion of personal privacy.
Respondents are encouraged to provide III. Collection of Information
Name of Committee: Arthritis and
complete but concise responses to any Musculoskeletal and Skin Diseases Initial
or all of the questions outlined above. This document does not impose Review Group; Arthritis and Musculoskeletal
This request for information is issued and Skin Diseases Special Grants Review
information collection requirements;
solely for information and planning Committee.
that is, reporting, recordkeeping or Date: June 13–14, 2018.
purposes; it does not constitute a notice third-party disclosure requirements. Time: 8:00 a.m. to 5:00 p.m.
of proposed rulemaking or request for This request for information constitutes Agenda: To review and evaluate grant
proposals, applications, proposal a general solicitation of comments. In applications.
abstracts, or quotations, nor does it Place: Embassy Suites, Chevy Chase
accordance with the implementing
suggest that the Department will Pavilion, 4300 Military Rd. NW, Washington,
regulations of the Paperwork Reduction
undertake any particular action in DC 20015.
response to comments. This request for Act of 1995 (PRA) at 5 CFR 1320.3(h)(4),
Contact Person: Helen Lin, Ph.D.,
information does not commit the United information subject to the PRA does not
Scientific Review Officer, NIH/NIAMS/RB,
States Government (‘‘Government’’) to generally include ‘‘facts or opinions 6701 Democracy Blvd., Suite 800, Plaza One,
contract for any supplies or services or submitted in response to general Bethesda, MD 20817, 301–594–4952, linh1@
make a grant award. Further, HHS is not solicitations of comments from the mail.nih.gov.
seeking proposals through this request public, published in the Federal Name of Committee: Arthritis and
for information and will not accept Register or other publications, Musculoskeletal and Skin Diseases Initial
unsolicited proposals. Respondents are regardless of the form or format thereof, Review Group; Arthritis and Musculoskeletal
advised that the Government will not provided that no person is required to and Skin Diseases Clinical Trials Review
pay for any information or supply specific information pertaining Committee.
administrative costs incurred in to the commenter, other than that Date: June 19, 2018.
response to this request for information; necessary for self-identification, as a Time: 8:00 a.m. to 5:00 p.m.
all costs associated with responding to Agenda: To review and evaluate grant
condition of the agency’s full applications.
this request for information will be consideration of the comment.’’ Place: Hyatt Regency Bethesda, 1 Bethesda
solely at the interested party’s expense. Consequently, this document need not Metro Center, Bethesda, MD 20814.
Not responding to this request for
sradovich on DSK3GMQ082PROD with NOTICES

be reviewed by the Office of Contact Person: Nakia C Brown, Ph.D.,
information does not preclude Management and Budget under the Scientific Review Officer, 6701 Democracy
participation in any future rulemaking authority of the PRA (44 U.S.C. 3501 et Blvd., RM 816, Bethesda, MD 20892, 301–
or procurement, if conducted. It is the seq.). 827–4905, brownnac@mail.nih.gov.
responsibility of the potential (Catalogue of Federal Domestic Assistance
responders to monitor this request for Authority: 42 U.S.C. 3501. Program Nos. 93.846, Arthritis,
information announcement for Musculoskeletal and Skin Diseases Research,
additional information pertaining to this National Institutes of Health, HHS)

VerDate Sep<11>2014 17:19 Jun 06, 2018 Jkt 244001 PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 E:\FR\FM\07JNN1.SGM 07JNN1

Document Created: 2018-06-07 00:51:01
Document Modified: 2018-06-07 00:51:01

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Request for information.
Dates		Comments must be submitted within 30 days after the date of publication in the Federal Register.
Contact		William Brady, (202) 690-6133.
FR Citation		83 FR 26485

83 FR 26485 - Facilitation of Public-Private Dialogue to Increase Innovation and Investment in the Healthcare Sector

DEPARTMENT OF HEALTH AND HUMAN SERVICESOffice of the Secretary

Federal Register Volume 83, Issue 110 (June 7, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary