Immediate Office of the Secretary; ReImagine HHS Accelerate Clinical Innovation Initiative; Public Hearing, June 20-21, 2019, 24162-24165 [2019-10911]
Download as PDF
<![CDATA[
khammond on DSKBBV9HB2PROD with NOTICES
24162
Federal Register / Vol. 84, No. 101 / Friday, May 24, 2019 / Notices
84. Michael Brent Klusman, Olathe,
Kansas, Court of Federal Claims No:
19–0604V
85. Siddharth Mehta on behalf of Amrit
Mehta, Deceased, Mount Kisco,
New York, Court of Federal Claims
No: 19–0606V
86. Kenneth Barber, Lake City, Florida,
Court of Federal Claims No: 19–
0607V
87. Sophia Simm-Bankston, Riverdale,
Georgia, Court of Federal Claims
No: 19–0608V
88. Carl Felts, Lancaster, Ohio, Court of
Federal Claims No: 19–0609V
89. Carmen Teufel, Woodbridge,
Virginia, Court of Federal Claims
No: 19–0610V
90. Roberta Decker, Cockeysville,
Maryland, Court of Federal Claims
No: 19–0620V
91. Beverly Hicks, Great Falls, Montana,
Court of Federal Claims No: 19–
0621V
92. Robert Yuodelis, Bellevue,
Washington, Court of Federal
Claims No: 19–0622V
93. Lafonda Collier, High Point, North
Carolina, Court of Federal Claims
No: 19–0623V
94. Priscilla Johansen, Portland, Oregon,
Court of Federal Claims No: 19–
0626V
95. Tyler Anthony Thacker, Cincinnati,
Ohio, Court of Federal Claims No:
19–0627V
96. Suzanne Allmart and Husayn
Allmart on behalf of A. A.,
Evanston, Illinois, Court of Federal
Claims No: 19–0628V
97. Nicole White, Apple Valley,
Minnesota, Court of Federal Claims
No: 19–0630V
98. Amy Thompson, Spotsylvania
Courthouse, Virginia, Court of
Federal Claims No: 19–0631V
99. Marissa Sheppard, Atlanta, Georgia,
Court of Federal Claims No: 19–
0632V
100. Tammy Ernst, Northfield, New
Jersey, Court of Federal Claims No:
19–0633V
101. Heather Nelson, Rockport,
Massachusetts, Court of Federal
Claims No: 19–0634V
102. Patricia Slugo, Beaver,
Pennsylvania, Court of Federal
Claims No: 19–0635V
103. Peggy Stager, Aberdeen, South
Dakota, Court of Federal Claims No:
19–0636V
104. Julie A. Fullerton, Missoula,
Montana, Court of Federal Claims
No: 19–0637V
105. Herman Haji, Rancho Cucamonga,
California, Court of Federal Claims
No: 19–0639V
106. Laura Mariani, Midland Park, New
Jersey, Court of Federal Claims No:
19–0640V
VerDate Sep<11>2014
18:10 May 23, 2019
Jkt 247001
107. Steinar Lee, Laguna Niguel,
California, Court of Federal Claims
No: 19–0641V
108. Erica Urech, Santa Barbara,
California, Court of Federal Claims
No: 19–0642V
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
[FR Doc. 2019–10828 Filed 5–23–19; 8:45 am]
should be submitted to: Benjamin Eloff,
BILLING CODE 4165–15–P
Associate Director for Innovation Policy
and Processes, Accelerate Clinical
Innovation, U.S. Department of Health &
DEPARTMENT OF HEALTH AND
Human Services, Hubert H. Humphrey
HUMAN SERVICES
Building, 200 Independence Avenue
SW, Room 749D, Washington, DC 20201
Immediate Office of the Secretary;
or via email at Benjamin.Eloff@
ReImagine HHS Accelerate Clinical
fda.hhs.gov.
Innovation Initiative; Public Hearing,
June 20–21, 2019
FOR FURTHER INFORMATION CONTACT:
Benjamin Eloff, Associate Director for
AGENCY: Transformation Management
Innovation Policy and Processes,
Office, Immediate Office of the
Accelerate Clinical Innovation, U.S.
Secretary, HHS.
Department of Health & Human
ACTION: Notice of meeting and request
Services, Hubert H. Humphrey Building,
for comments.
200 Independence Avenue SW, Room
SUMMARY: The Department of Health and 749D, Washington, DC 20201, phone:
(240) 328–8717 email: Benjamin.eloff@
Human Services (HHS) is announcing a
public meeting to seek public input and fda.hhs.gov. Press inquiries are handled
through Carla Daniels, Public Affairs
comment on opportunities to leverage
Specialist, Office of the Assistant
departmental resources, increase
Secretary for Public Affairs; phone:
collaboration, and to partner with
(202) 690–4595 email: Carla.Daniels@
private stakeholders in the service of
hhs.gov.
accelerating the process for clinical
innovation in the United States. HHS is
SUPPLEMENTARY INFORMATION:
specifically interested in how to
Registration: The meeting is open to the
decrease the overall time for a new
public, but attendance is limited to the
medical product (drug, medical device,
space available. Persons wishing to
biologic) to go from discovery to
attend this meeting must register at the
widespread patient access and use
website https://www.eventbrite.com/e/
while maintaining the critical public
reimagine-hhs-accelerate-clinicalhealth standards of the Department.
innovation-initiative-public-hearingHHS is seeking participation in the
tickets-61875011826 or by contacting
meeting and written comments from all
the individual(s) listed in the FOR
interested parties, including, but not
FURTHER INFORMATION CONTACT section of
limited to, patients, physicians,
this notice, by the date listed in the
researchers, medical product
DATES section of this notice. Individuals
developers, commercial health
requiring sign language interpretation or
insurance plan sponsors and carriers,
other special accommodations should
private investors, and the community at contact the individual(s) listed in the
large. This meeting and the written
FOR FURTHER INFORMATION CONTACT
comments are intended to assist HHS, in section of this notice at the address
developing programs and procedures for listed in the ADDRESSES section of this
assessing and accelerating the pace of
notice by the date listed in the DATES
the clinical innovation enterprise
section of this notice.
throughout the United States. HHS is
Registration to attend the public
seeking input on specific questions
meeting will be accepted on a firstidentified below but is interested in any come, first-served basis. If seating
other pertinent information participants capacity has been reached, you will be
in the public meeting would like to
notified that the meeting has reached
share. This meeting is open to the
capacity.
public.
Registration to present at the public
meeting will be accepted on a firstDATES:
Meeting Date: Thursday, June 20 8:30 come, first-served basis. To ensure a
variety of viewpoints, HHS has
a.m. to 4:00 p.m. eastern standard time
specifically reserved portions of time to
(EST and Friday, June 21, 8:30 a.m. to
receive feedback from patients, medical
4:00 p.m. EST.
product developers, investors, and
Deadline for Meeting Registration,
Presentations, Special Accommodations private insurers. HHS has included
questions for comment in section III of
and Comments: Wednesday, June 12,
this document. Please identify by
5:00 p.m., EST.
PO 00000
Frm 00088
Fmt 4703
Sfmt 4703
ADDRESSES:
E:\FR\FM\24MYN1.SGM
24MYN1
Federal Register / Vol. 84, No. 101 / Friday, May 24, 2019 / Notices
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 https://
www.regulations.gov.
Individuals who need special
accommodations should contact staff
listed in the FOR FURTHER INFORMATION
CONTACT section of this notice.
khammond on DSKBBV9HB2PROD with NOTICES
Submission of Comments for the Public
Meeting
Submit electronic comments,
identified with docket number HHS–
OS–2019–0006, to https://
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
VerDate Sep<11>2014
18:10 May 23, 2019
Jkt 247001
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
PO 00000
Frm 00089
Fmt 4703
Sfmt 4703
24163
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,
E:\FR\FM\24MYN1.SGM
24MYN1
24164
Federal Register / Vol. 84, No. 101 / Friday, May 24, 2019 / Notices
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.
khammond on DSKBBV9HB2PROD with NOTICES
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.
VerDate Sep<11>2014
18:10 May 23, 2019
Jkt 247001
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?
PO 00000
Frm 00090
Fmt 4703
Sfmt 4703
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 https://www.dhs.gov/
real-id-enforcement-brief.
We recommend that confirmed
registrants arrive reasonably early, but
no earlier than 45 minutes prior to the
E:\FR\FM\24MYN1.SGM
24MYN1
Federal Register / Vol. 84, No. 101 / Friday, May 24, 2019 / Notices
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:
FOIARequest@psc.hhs.gov.
khammond on DSKBBV9HB2PROD with NOTICES
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
VerDate Sep<11>2014
18:10 May 23, 2019
Jkt 247001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Findings of Research Misconduct
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
Findings of research
misconduct have been made against
William W. Cruikshank, Ph.D.
(Respondent), former Professor of
Medicine, Pulmonary Center, Boston
University (BU) School of Medicine. Dr.
Cruikshank engaged in research
misconduct in research supported by
National Cancer Institute (NCI),
National Institutes of Health (NIH),
grant R01 CA122737–01A2. The
administrative actions, including
debarment for a period of five (5) years,
were implemented beginning on May
13, 2019, and are detailed below.
FOR FURTHER INFORMATION CONTACT:
Wanda K. Jones, Dr. P.H., Interim
Director, Office of Research Integrity,
1101 Wootton Parkway, Suite 750,
Rockville, MD 20852, (240) 453–8200.
SUPPLEMENTARY INFORMATION: Notice is
hereby given that the Office of Research
Integrity (ORI) has taken final action in
the following case:
William W. Cruikshank, Ph.D., Boston
University School of Medicine: Based on
the report of an investigation conducted
by BU and analysis conducted by ORI
in its oversight review, ORI found that
Dr. William W. Cruikshank, former
Professor of Medicine, Pulmonary
Center, BU School of Medicine, engaged
in research misconduct in research
supported by NCI, NIH, grant R01
CA122737–01A2.
ORI found that Respondent engaged
in research misconduct by knowingly,
intentionally, and/or recklessly
falsifying and/or fabricating data
included in the following published
paper, an earlier version of the
submitted manuscript, a seminar
presentation, and two grant applications
submitted to NCI, NIH:
• J. Clin. Invest. 2011;121:4838–49
(hereafter referred to as ‘‘JCI 2011’’).
Retracted in J. Clin. Invest.
2014;124(11):5085.
• Manuscript submitted to J. Clin.
Invest. (hereafter referred to as the ‘‘JCI
manuscript’’).
• Cruikshank, W. ‘‘A New Look at T
Cell Cancers: A Case Study of
Translational Research.’’ Presented at
the Clinical Research Training (CREST)
Seminar Series on 09/08/09 (hereafter
referred to as the ‘‘CREST
Presentation’’).
• R01 CA122737–01A1 and R01
CA122737–01A2.
SUMMARY:
PO 00000
Frm 00091
Fmt 4703
Sfmt 4703
24165
Respondent knowingly, intentionally,
and recklessly falsified and/or
fabricated Western blot data for protein
expression in primary CD4+ T cells
from patients with advanced T-cell
acute lymphocytic leukemia (T–ALL) or
cutaneous T-cell lymphomas (CTCL), by
copying blot band images from
unrelated sources, manipulating to
disguise their origin, and combining
multiple images to generate new figures
to falsely represent results using sixtyfour (64) such band images in the
following sixteen (16) figures and
related text included in one (1)
manuscript, one (1) published paper,
two (2) grant applications, and a
seminar presentation:
• Figures 1 and 3 in JCI 2011, also
included as Figure 3 (top and bottom
right) in R01 CA122737–01A2 and as
Figures 1 and 4 in the initial JCI
manuscript, respectively
• Figure 8B in JCI 2011, also included
as Figure 9 in R01 CA122737–01A2
• Figure 9 in JCI 2011
• Figures 14A and 14B in R01
CA122737–01A2, also included as
Figure 14B in R01 CA122737–01A1
• Figure 4 in R01 CA122737–01A2, also
included as Figure 4 in R01
CA122737–01A1
• Slides 24, 25, and 29 in the CREST
Presentation
Specifically:
• In Figure 3 in JCI 2011, also
included as Figure 4 in the JCI
manuscript and Slide 24 of the CREST
Presentation (with no white spaces
between bands) as well as Figure 3 (top
right section with the tubulin panel
flipped 180° clockwise) in R01
CA122737–01A2, the respondent reused
a single Western blot band image to
represent expression of tubulin and ProIL–16 in more than one experimental
and control subjects.
• In Figure 1 in JCI 2011, also
included as Figure 1 in the JCI
manuscript, Figure 3 (bottom panel) in
R01 CA122737–01A2, and in Slide 25 of
the CREST Presentation, the respondent
copied blot band images from
unpublished and/or previously
published unrelated experiments and
reused a single Western blot band image
to falsely represent expression of
p27Kip1 and Skp2 in more than one
CTCL Patient.
• The respondent reused and
relabeled blot band images from
unpublished and/or previously
published unrelated experiments to
falsely represent new experimental
results as follows:
➢ Four band images from the
unpublished and unrelated figure
E:\FR\FM\24MYN1.SGM
24MYN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
[[Page 24163]]
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 https://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 https://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,
[[Page 24164]]
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 https://www.dhs.gov/real-id-enforcement-brief.
We recommend that confirmed registrants arrive reasonably early,
but no earlier than 45 minutes prior to the
[[Page 24165]]
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
