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)

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, 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