[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