Notice2022-12833
Request for Information: Inviting Comments and Suggestions From Stakeholders on Pediatric Medical Devices Public-Private Partnership
Primary source
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Published
June 15, 2022
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
The National Institute of Child Health and Human Development (NICHD), in collaboration with the National Institute of Biomedical Imaging and Bioengineering (NIBIB), seek comments and input focusing on challenges, gaps, clinical needs, and research opportunities related to Pediatric Medical Devices (PMD) to inform priorities for a Public Private Partnership (PPP) to catalyze the national ecosystem. Such ecosystem will focus on optimizing the translation of technological advancements into medical devices designed, evaluated, and approved for pediatric populations to improve quality of life in this population. These comments are requested from public and private stakeholders such as, but not limited to, innovators, researchers, academic and medical centers, small- and large-scale industries, non-profit organizations, patients, providers, advocacy groups, payors, and federal agencies.
Full Text
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<title>Federal Register, Volume 87 Issue 115 (Wednesday, June 15, 2022)</title>
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[Federal Register Volume 87, Number 115 (Wednesday, June 15, 2022)]
[Notices]
[Pages 36138-36140]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-12833]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Request for Information: Inviting Comments and Suggestions From
Stakeholders on Pediatric Medical Devices Public-Private Partnership
AGENCY: National Institutes of Health, HHS.
ACTION: Request for Information.
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SUMMARY: The National Institute of Child Health and Human Development
(NICHD), in collaboration with the National Institute of Biomedical
Imaging and Bioengineering (NIBIB), seek
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comments and input focusing on challenges, gaps, clinical needs, and
research opportunities related to Pediatric Medical Devices (PMD) to
inform priorities for a Public Private Partnership (PPP) to catalyze
the national ecosystem. Such ecosystem will focus on optimizing the
translation of technological advancements into medical devices
designed, evaluated, and approved for pediatric populations to improve
quality of life in this population. These comments are requested from
public and private stakeholders such as, but not limited to,
innovators, researchers, academic and medical centers, small- and
large-scale industries, non-profit organizations, patients, providers,
advocacy groups, payors, and federal agencies.
DATES: The Request for Information is open for public comment and will
be accepted through Sept 21, 2022, to ensure consideration.
ADDRESSES: Responses should be limited to one to two page(s) and marked
with this RFI identifier ``NOT-EB-22-008'' in the email subject line as
well as in the title of the response. Responses should be directly
submitted to <a href="/cdn-cgi/l/email-protection#e9998c8d9ac7848c8d9d8c8a81a9878081c78e869f"><span class="__cf_email__" data-cfemail="a6d6c3c2d588cbc3c2d2c3c5cee6c8cfce88c1c9d0">[email protected]</span></a>.
FOR FURTHER INFORMATION CONTACT: Questions about this request for
information should be directed to, Afrouz Anderson, Ph.D., National
Institute of Biomedical Imaging and Bioengineering (NIBIB), National
Institutes of Health, 6707 Democracy Boulevard, Suite 200, Bethesda, MD
20892, <a href="/cdn-cgi/l/email-protection#85f5e0e1f6abe8e0e1f1e0e6edc5ebecedabe2eaf3"><span class="__cf_email__" data-cfemail="4d3d28293e6320282939282e250d232425632a223b">[email protected]</span></a>, 301-496-4558.
SUPPLEMENTARY INFORMATION: This RFI is in accordance with the NIH
Reform Act of 2006, 42 U.S.C. Sec. 282, as amended. Catalyzing and
unifying the national ecosystem around pediatric medical devices will
necessitate leveraging collective opportunities, such as through the
formation of a multi-stakeholder Public Private Partnership (PPP) to
address the existing challenges in development, optimization, and
translation of pediatric medical devices.
Despite numerous legislative, regulatory, and scientific efforts of
the recent past, there has been little change in the number of devices
being developed, reviewed, and/or approved for use in the pediatric
population in the United States. The cause of this public health
problem is multifold:
<bullet> Real and perceived ethical considerations of carrying out
trials in pediatric patients.
<bullet> The heterogeneous developmental range of children, from
birth to 21 years.
<bullet> Lack of access to disease- and age-specific patient sets,
and experienced clinical-trial infrastructure.
<bullet> Unclear regulatory pathways and financial environment
(i.e., unpredictable reimbursement).
<bullet> A lack of technical innovation for approaches to meet
pediatric-specific needs.
<bullet> Lack of clear value proposition to device manufacturers
and industry partners.
Such problems have caused difficulties such as off-label use of
devices in children, often without clear instructions or with non-
standard modifications that create further complications and risks.
Additionally, many conditions for children that could be treated via a
device are not pursued. Pediatric patients with serious or life-
threatening diseases that are often in greatest need might only have
access to an investigational medical device without an appropriate
level of evidence.
Information Requested
NICHD and NIBIB seek information and actionable recommendations on
research gaps, needs, best practices, innovative study designs and
measurement, resources and data resources, and opportunities to inform
a PPP to enhance pediatric medical devices space.
Specifically, respondents are asked to briefly address the
following topics or categories in the context of Pediatric Medical
Devices. Comments are strongly encouraged to address unique challenges
of using pediatric medical devices on health disparity populations. NIH
defines health disparity populations as racial and ethnic minority
populations, less privileged socioeconomic status (SES) populations,
underserved rural populations, sexual and gender minorities (SGM), and
any subpopulations that can be characterized by two or more of these
descriptions. For more information, please refer to NIH definition of
Health Disparity (https://www.nimhd.nih.gov/about/strategic-plan/nih-
strategic-plan-definitions-and-
parameters.html#:~:text=NIH%20defines%20health%20disparity%20populations
,or%20more%20of%20these%20descriptions.)
(1) Potential partners to ensure success of public-private
partnership to advance the national PMD ecosystem. Some of these
challenges pertain, but are not limited to, involvement and integration
of:
(a) Philanthropic and non-profit organizations.
(b) Patient advocacy groups.
(c) Primary care providers, specialists and clinicians, clinical
trialists, and pediatric patients.
(d) Financial experts.
(e) Regulatory science experts to evaluate new and existing
regulations in PMD.
(2) Involvement of Private Industry while considering factors such
as:
(a) Small market size in pediatric medical devices being one of the
key barriers for industry participation.
(b) Identifying approaches to de-risk development and
commercialization of PMD.
(c) Federal efforts to assist further small companies.
(d) Overcoming manufacturing, clinical trials, logistical and
regulatory burdens.
(e) Engineering and manufacturing challenges for evaluation of
feasibility, validation and scale-up strategies of device prototype and
relative costs.
(3) Priorities in Pediatric Medical Device innovation, research,
and commercialization such as:
(a) Accelerating PMD Research & Development, including, but not
limited to, point of care technologies in response to Health
Emergencies.
(b) Specific preclinical and clinical research areas to enhance
innovation in pediatric medical devices.
(c) Projects focusing on development of technologies based on
specific disease, conditions, and patient population.
(d) Reduce off-label usage of adult medical devices for pediatric
patients.
(e) Resources and support for innovators, small business concerns
to enhance successful development and commercialization of PMD designed
and tested for pediatric indications.
(f) Building inclusive, diverse, and transdisciplinary workforce.
For more information on diverse workforce, please refer to the Notice
of NIH's Interest in Diversity NOT-OD-20-031 (<a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-031.html">https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-031.html</a>.)
(4) Accountability measures to evaluate the program success in
areas such as, but not limited to:
(a) Performance and accomplishment of public private partnership.
(b) Number of products and devices that obtain regulatory approval.
(c) Improvement of processes for PMD development and
commercialization.
(5) Clinical Trial infrastructure, data sharing, and protocol
standardization such as:
(a) Establishment of hospital-based and decentralized clinical
trials networks to evaluate and validate new technologies and
therapeutic devices.
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(b) Issues pertaining to number of clinical sites.
(c) Patient reported outcomes.
(d) Challenges related to patient enrollment and limited dataset.
(e) Data science expertise, such as biostatistics, to address
issues related to clinical trial database.
(f) Standardization of data and protocol integration across various
health care settings.
(6) Reimbursement Challenges for Pediatric Medical Devices:
(a) Exploring reimbursement incentive strategies for Pediatric
Medical Device innovators.
(b) Involvement of Federal agencies such as Centers for Medicare
and Medicaid (CMS).
(c) Interaction with insurance companies during commercialization
planning process.
(7) Any other topics which may be relevant for NIH to enhance the
national pediatric medical device ecosystem via public-private
partnership.
Responses to this RFI are voluntary and may be submitted
anonymously. Please do not include any personally identifiable
information or any information that you do not wish to make public. You
may voluntarily include your name and contact information with your
response. If you choose to provide NIH with this information, NIH will
not share your name and contact information outside of NIH unless
required by law. Proprietary, classified, confidential, or sensitive
information should not be included in your response. The Government
will use the information submitted in response to this RFI at its
discretion. Other than your name and contact information, the
Government reserves the right to use any submitted information on
public websites, in reports, in summaries of the state of the science,
in any possible resultant solicitation(s), grant(s), or cooperative
agreement(s), or in the development of future funding opportunity
announcements. This RFI is for informational and planning purposes only
and is not a solicitation for applications or an obligation on the part
of the Government to provide support for any ideas identified in
response to it. Please note that the Government will not pay for the
preparation of any information submitted or for use of that
information.
Afrouz A. Anderson,
Program Director, National Institute of Biomedical Imaging and
Bioengineering, National Institutes of Health.
[FR Doc. 2022-12833 Filed 6-14-22; 8:45 am]
BILLING CODE 4140-01-P
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