[Federal Register Volume 87, Number 115 (Wednesday, June 15, 2022)]
[Notices]
[Pages 36138-36140]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 [email protected].

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, [email protected], 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:
     Real and perceived ethical considerations of carrying out 
trials in pediatric patients.
     The heterogeneous developmental range of children, from 
birth to 21 years.
     Lack of access to disease- and age-specific patient sets, 
and experienced clinical-trial infrastructure.
     Unclear regulatory pathways and financial environment 
(i.e., unpredictable reimbursement).
     A lack of technical innovation for approaches to meet 
pediatric-specific needs.
     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 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-031.html.)
    (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