[Federal Register Volume 84, Number 101 (Friday, May 24, 2019)]
[Notices]
[Pages 24162-24165]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-10911]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Immediate Office of the Secretary; ReImagine HHS Accelerate
Clinical Innovation Initiative; Public Hearing, June 20-21, 2019
AGENCY: Transformation Management Office, Immediate Office of the
Secretary, HHS.
ACTION: Notice of meeting and request for comments.
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SUMMARY: The Department of Health and Human Services (HHS) is
announcing a public meeting to seek public input and comment on
opportunities to leverage departmental resources, increase
collaboration, and to partner with private stakeholders in the service
of accelerating the process for clinical innovation in the United
States. HHS is specifically interested in how to decrease the overall
time for a new medical product (drug, medical device, biologic) to go
from discovery to widespread patient access and use while maintaining
the critical public health standards of the Department.
HHS is seeking participation in the meeting and written comments
from all interested parties, including, but not limited to, patients,
physicians, researchers, medical product developers, commercial health
insurance plan sponsors and carriers, private investors, and the
community at large. This meeting and the written comments are intended
to assist HHS, in developing programs and procedures for assessing and
accelerating the pace of the clinical innovation enterprise throughout
the United States. HHS is seeking input on specific questions
identified below but is interested in any other pertinent information
participants in the public meeting would like to share. This meeting is
open to the public.
DATES:
Meeting Date: Thursday, June 20 8:30 a.m. to 4:00 p.m. eastern
standard time (EST and Friday, June 21, 8:30 a.m. to 4:00 p.m. EST.
Deadline for Meeting Registration, Presentations, Special
Accommodations and Comments: Wednesday, June 12, 5:00 p.m., EST.
ADDRESSES: Meeting Location: U.S. Department of Health & Human
Services, Hubert H. Humphrey Building, 200 Independence Avenue SW,
Great Hall, Washington, DC 20201.
Presentations and Written Comments: Presentations and written
comments should be submitted to: Benjamin Eloff, Associate Director for
Innovation Policy and Processes, Accelerate Clinical Innovation, U.S.
Department of Health & Human Services, Hubert H. Humphrey Building, 200
Independence Avenue SW, Room 749D, Washington, DC 20201 or via email at
[email protected].
FOR FURTHER INFORMATION CONTACT: Benjamin Eloff, Associate Director for
Innovation Policy and Processes, Accelerate Clinical Innovation, U.S.
Department of Health & Human Services, Hubert H. Humphrey Building, 200
Independence Avenue SW, Room 749D, Washington, DC 20201, phone: (240)
328-8717 email: [email protected]. Press inquiries are handled
through Carla Daniels, Public Affairs Specialist, Office of the
Assistant Secretary for Public Affairs; phone: (202) 690-4595 email:
[email protected].
SUPPLEMENTARY INFORMATION: Registration: The meeting is open to the
public, but attendance is limited to the space available. Persons
wishing to attend this meeting must register at the website https://www.eventbrite.com/e/reimagine-hhs-accelerate-clinical-innovation-initiative-public-hearing-tickets-61875011826 or by contacting the
individual(s) listed in the FOR FURTHER INFORMATION CONTACT section of
this notice, by the date listed in the DATES section of this notice.
Individuals requiring sign language interpretation or other special
accommodations should contact the individual(s) listed in the FOR
FURTHER INFORMATION CONTACT section of this notice at the address
listed in the ADDRESSES section of this notice by the date listed in
the DATES section of this notice.
Registration to attend the public meeting will be accepted on a
first-come, first-served basis. If seating capacity has been reached,
you will be notified that the meeting has reached capacity.
Registration to present at the public meeting will be accepted on a
first-come, first-served basis. To ensure a variety of viewpoints, HHS
has specifically reserved portions of time to receive feedback from
patients, medical product developers, investors, and private insurers.
HHS has included questions for comment in section III of this document.
Please identify by
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number each question you wish to address in your presentation and the
approximate time requested. HHS will do its best to accommodate
requests to speak. HHS will determine the amount of time allotted to
each presenter and the approximate time that each oral presentation is
scheduled to begin. Once HHS notifies registered presenters of their
scheduled times, presenters should submit a copy of each presentation,
identified with docket number HHS-OS-2019-0006, to http://www.regulations.gov.
Individuals who need special accommodations should contact staff
listed in the FOR FURTHER INFORMATION CONTACT section of this notice.
Submission of Comments for the Public Meeting
Submit electronic comments, identified with docket number HHS-OS-
2019-0006, to http://www.regulations.gov.
Submit written comments to Comments for HHS Public Meeting,
Transformation Management Office, U.S. Department of Health & Human
Services, Hubert H. Humphrey Building, 200 Independence Avenue SW, Room
749D, Washington, DC 20201.
I. Background
The HHS 2018-2022 strategic plan identifies ReImagine HHS as the
approach to meet the strategic goals of the department. The Accelerate
Clinical Innovation (ACI) initiative is one of ten initiatives under
ReImagine HHS and is focused on identifying and facilitating ways to
shorten the time needed for safe and effective medical products to go
from discovery to patient use. ACI is seeking public comment regarding
the entire medical innovation process at an enterprise level to ensure
that patients have timely access to new medical products that meet the
high public health standards expected and deserved by the American
public and ensured by HHS.
HHS as a department is involved in all stages of the clinical
innovation enterprise, including performing and funding basic
laboratory research, clinical trials, small business grants, protecting
patient rights and welfare, evaluating scientific data, approving
products for use, establishing criteria and payment rates for their
inclusion in the Medicare program, and monitoring products in the
marketplace. These different functions of HHS are performed across
separate divisions. When an innovation completes development and
becomes available to patients, it is uncommon for the Department to
perform a retrospective review of lessons learned about the processes
involving coordination between multiple divisions that could promote
future reforms to improve the service delivery model and make the
process more efficient or effective.
HHS is seeking public comment from key stakeholders involved in the
biomedical innovation process. Specifically, HHS would like to receive
public comment regarding:
1. The appropriate federal role, if any, in connecting medical
product developers with payers, commercial plan carriers, and/or
Medicaid managed care plans for purposes of making the coverage
decision process more efficient;
2. Enhanced knowledge sharing to assist in the innovation
enterprise stakeholder's decision-making processes;
3. Metrics for the overall innovation system to assess the
viability of the system and measure the impact of procedural and policy
changes; and,
4. Procedures, methods, and data for the identification and
prioritization of diseases or conditions that would benefit from
enhanced focus.
Coverage Decision Process Facilitation
HHS is seeking more information about an appropriate federal role,
if any, in connecting medical product developers with payers,
commercial plan carriers and/or Medicaid managed care plans for
purposes of making the coverage decision process more efficient. We
have heard from certain stakeholders, especially medical product
developers from smaller companies, that they have experienced
inefficiency and expense associated with educating payers, carriers,
and plans on new medical products after they have been cleared or
approved for use by the Food and Drug Administration. Similarly, we
have heard from representatives of payers, carriers, and plans that
they find the process of learning about new medical products to be
inefficient.
HHS is seeking comments from members of the public regarding the
coverage decision process in the commercial market. We are particularly
interested in hearing from plan sponsors/administrators, carriers, and
medical product developers about whether there may be an appropriate
role for the federal government in helping to more efficiently promote
information sharing between product developers and payers, carriers and
plans; the kind of information needed to make a coverage determination;
and what mechanisms could be used to promote information sharing to
make the process more efficient for all stakeholders.
Knowledge Sharing
HHS is interested in knowledge sharing in several domains. First,
HHS collectively holds massive data resources from clinical trials,
epidemiological data, grants, and many other sources that can inform a
host of decisions beyond the specific purpose of any individual data
set. HHS is interested to receive comments regarding how the biomedical
innovation stakeholder community can use data in making decisions, and
what data would be useful to investors and non-CMS payers to build
business cases and to make coverage and reimbursement decisions. HHS is
also interested in knowledge sharing related to experiences bringing an
innovation through the development process, and what opportunities
exist for enhanced communication and collaboration among HHS components
or with other federal and non-federal stakeholders to reduce
inefficiency and increase predictability, without altering scientific
standards and while appropriately protecting research participant
privacy and security. The data from these resources are a mix of
publicly-available and confidential information, therefore, any use or
sharing of data would require the appropriate consent and procedures to
remove identifying characteristics.
Enterprise-Level Biomedical Innovation Metrics
Each individual working unit within HHS measures performance based
on metrics necessary to achieve the specific functions of that unit.
Likewise, private businesses (developers, payers, providers, investors)
have fiduciary responsibilities to measure progress, increase
efficiency, and deliver results. However, there are no universally
agreed-upon metrics for the performance of the clinical innovation
enterprise as a whole, and therefore, no objective way to assess the
effects of process or procedural changes within HHS intended to
accelerate innovation. ACI is working to identify metrics and is
seeking specific public comment regarding measures that would
accurately reflect the pace of clinical innovation in the United
States.
Identification and Prioritization of Areas of Focus
The ACI initiative has identified some strengths and opportunities
for HHS to leverage that will move the department to a more proactive
stance for clinical innovation. HHS has a strong workforce with a broad
array of expertise,
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unparalleled by any other organization in the world this is motivated
by--and believe strongly in--the public health mission of the
Department. HHS also holds vast amounts of scientific and clinical data
that can provide insights into opportunities for innovation. When
focused on specific issues, HHS has a strong track record of achieving
meaningful results by working together in the Department, across the
Federal government, with private partners, and with patients. These
assets are the foundation upon which an innovation accelerator can be
built. However, HHS resources are limited, necessitating prioritization
of diseases or conditions that would benefit from enhanced department-
wide focus to accelerate biomedical innovation and present the greatest
possible impact on public health.
HHS is seeking specific input regarding the factors, types of data
and analysis methods, and other aspects of the process for focus area
identification and prioritization. It is not the intent of this public
hearing to identify or address specific diseases or conditions at this
time, but rather to develop an objective process for doing so.
II. Public meeting
A. Purpose and Scope of the Meeting
The public meeting is intended to provide an opportunity for broad
public participation and comment concerning the process for biomedical
innovation in the United States and how HHS can act by itself or in
partnership to accelerate the pace of bringing new safe, effective
medical products to patients who need them. HHS specifically is
requesting input regarding opportunities to assess and improve the
overall innovation process across HHS through information sharing and
collaboration among federal agencies and through public-private
partnership. This meeting and the written comments are intended to
assist HHS in developing programs and processes at the HHS enterprise
level to accelerate the pace of clinical innovation while maintaining
critical public health standards for safety and effectiveness.
While HHS is considering opportunities for accelerating clinical
innovation in the United States, including data sharing, outreach,
collaborations, and partnerships, this meeting is not intended to
specifically address changes to policies, procedures, scientific or
regulatory standards, review processes or similar programmatic details
enacted and overseen by the constituent operating and staff divisions
of HHS.
B. Format of the Meeting
The meeting will be conducted by a panel of HHS officials. The
majority of the meeting will be reserved for presentations of comments,
recommendations, and data from registered presenters. The time for each
presenter's comments will be determined by HHS and will be based on the
number of registered presenters. Presentations will be grouped by the
sector the presenters represent, with time reserved for patients and
their representatives, payers including plan sponsors, carries, and
managed care plans, and investors. Within the groups, presenters will
be scheduled to speak in the order in which they register. Only the HHS
panel members may question any presenter during or at the conclusion of
each presentation. The meeting will be recorded and transcribed.
In addition, written comments will also be accepted and presented
at the meeting, time permitting, if they are received by the date
specified in the DATES section of this notice.
C. Live Streaming Information
For participants who cannot attend the public meeting in person
there will be an option to view the public meeting via live streaming
technology. Information on the option to view the meeting via live
streaming technology will be posted at a later time www.regulation.gov.
III. Issues for Discussion
HHS invites comment at the public meeting about how the Department
can act to accelerate the pace of clinical innovation while maintaining
critical public health standards. When providing comment, please
include a discussion of which phase of development (e.g. discovery,
preclinical, first-in-man, feasibility, pivotal clinical trial,
registration, marketing, benefit categorization, coding, coverage,
reimbursement, inclusion in standards of practice, etc.) and which
stakeholder sector(s)' (e.g. patients, physicians, researchers, medical
product developers, commercial health insurance plan sponsors and
carriers, private investors, and the community at large) experiences
you are providing. HHS is specifically interested in public input on
the following questions:
1. What existing resources can HHS leverage to provide the
biomedical innovation community with timely, meaningful information to
promote product development, while promoting competition and
maintaining commercial confidential information?
2. Which aspects of the regulatory framework for biomedical product
development marketing are the most unclear to your stakeholder
community, and how could HHS act to clarify processes?
3. What additional information or data would be helpful to your
stakeholder sector (e.g. patients, physicians, private insurance,
product developers, private investors, etc.) to improve decision-making
and efficiency of product development?
4. Are there specific metrics for the overall biomedical innovation
enterprise across public and non-public sectors that HHS could use to
track and measure results of process changes?
5. What metrics, data sources, procedures or other factors should
be considered in the identification and prioritization of diseases or
conditions that would receive the most impact from enhanced HHS-wide
focus?
IV. Security, Building, and Parking Guidelines
The meeting is open to the public, but attendance is limited to the
space available. Persons wishing to attend this meeting must register
by contacting the individual(s) at the address listed in the ADDRESSES
section of this notice or by telephone at the number listed in the FOR
FURTHER INFORMATION CONTACT section of this notice by the date
specified in the DATES section of this notice. This meeting will be
held in a federal government building, the Hubert H. Humphrey (HHH)
Building; therefore, federal security measures are applicable.
The REAL ID Act of 2005 (Pub. L. 109-13) establishes minimum
standards for the issuance of state-issued driver's licenses and
identification (ID) cards. It prohibits federal agencies from accepting
an official driver's license or ID card from a state for any official
purpose unless the Secretary of the Department of Homeland Security
determines that the state meets these standards. Beginning October
2015, photo IDs (such as a valid driver's license) issued by a state or
territory not in compliance with the Real ID Act will not be accepted
as identification to enter federal buildings. Visitors from these
states/territories will need to provide alternative proof of
identification (such as a valid passport) to gain entrance into federal
buildings. The current list of states from which a federal agency may
accept driver's licenses for an official purpose is found at http://www.dhs.gov/real-id-enforcement-brief.
We recommend that confirmed registrants arrive reasonably early,
but no earlier than 45 minutes prior to the
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start of the meeting, to allow additional time to clear security.
Security measures include the following:
Presentation of a government issued photographic
identification to the Federal Protective Service or Guard Service
personnel.
Inspection, via metal detector or other applicable means,
of all persons entering the building. We note that all items brought
into HHH Building, whether personal or for the purpose of presentation
or to support a presentation, are subject to inspection. We cannot
assume responsibility for coordinating the receipt, transfer,
transport, storage, set up, safety, or timely arrival of any personal
belongings or items used for presentation or to support a presentation.
Note: Individuals who are not registered in advance will not be
permitted to enter the building and will be unable to attend the
meeting.
V. Transcripts
As soon as a transcript of the public meeting is available, it will
be accessible on www.regulations.gov. A transcript also will be
available in either hardcopy or on CD-ROM, after submission of a
Freedom of Information request. Written requests are to be sent to the
PHS FOIA Office, 7700 Wisconsin Avenue, Suite #920, Bethesda, MD 20857;
phone: (301) 492-4800; fax: (301) 492-4848; email:
[email protected].
VI. Collection of Information
This document does not impose information collection requirements,
that is, reporting, recordkeeping or third-party disclosure
requirements. All information will be received subsequent to a general
solicitation of comments in the Federal Register or solicited at or in
connection with a public hearing or meeting, thereby making the
information collection requests in accordance with the implementing
regulations of the PRA at 5 CFR 1320.3(h)(4) and 5 CFR 1320.3(h)(8),
respectively. Consequently, there is no need for review by the Office
of Management and Budget under the authority of the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq).
Dated: May 20, 2019.
Charles N.W. Keckler,
Associate Deputy Secretary, Immediate Office of the Secretary.
[FR Doc. 2019-10911 Filed 5-23-19; 8:45 am]
BILLING CODE 4150-03-P