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PCORTF Frailty & Functional Disabilities Project Working Group
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Committee, Work group, Advisory group, or Task Force
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AHRQ, ASPE, CDC, CMS
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NIA
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Validate and Expand Claims-Based Algorithms, Identifying Patients with Frailty and Functional Disabilities across Payer and Patient Populations
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Pediatric Medical Device Public Private Partnership
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Resource Development
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BARDA, FDA
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NCI, NIAMS, NIBIB, NICHD, NIDA, NIMH, NINDS
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Despite numerous legislative, regulatory, and scientific efforts in the recent past, innovative pediatric medical devices (PMDs) have yet to be made timely available at the same rate as adult medical devices. In many cases, the cause of this disparity is not a lack of technologies but rather a lack of incentives for the industry to become involved in PMD R&D. Furthermore, many innovative medical devices approved for adult use have not been approved for pediatric use; when used “off-label” in children, it exposes children to a benefit/risk profile that has not been evaluated by the FDA, deepening the health inequities between these two populations. Over the past 13 years, the FDA Center for Devices and Radiological Health (CDRH) developed multiple programs for accelerating the innovation of PMDs. Nevertheless, medical device development for pediatrics has remained relatively stagnant, as evidenced by premarket approvals (PMAs) and humanitarian device exemptions (HDEs) with labeling for pediatric usage. During this period, at CDRH, approvals of PMAs and HDEs labeled only for adults increased at about twice the rate of devices labeled for both adult and pediatric use and about 21 times the rate of devices labeled solely for pediatric use. These data point to the persisting lack of availability, and subsequent access, to medical device options designed and approved for the pediatric population, which is even more dramatic for the youngest patients. This is a long-standing and significant public health problem.To address this inequality in our healthcare system, from 2023-2025, the FNIH will lead the design of a full-scale public-private partnership (PPP), bringing together the resources of multiple U.S. government agencies and private sector organizations, including industry and non-profits. The Design Phase of the PMD project will assemble a governance structure incorporating and building on foundational elements developed during the System of Hospitals for Innovation in Pediatrics – Medical Devices (SHIP-MD) 2021 pre-consortium workshop and convening a series of meetings for up to six integrated workstreams (i.e., Navigation, Hospitals, Regulatory, Finance, Decentralized Health Innovation, and Reimbursement). Additionally, this phase will produce a white paper with a detailed plan to build and launch a multi-year PPP. The focus is on the critical primary processes of building the national pediatric medical device ecosystem, as proposed in the SHIP-MD framework, which would include a network of hospitals, as well as associated but decentralized elements, optimizing public and private financing and reimbursement for R&D of pediatric medical devices, and ultimately creating a self-sustaining entity that will administer and manage the partnership over the long-term to benefit pediatric patients.With the goal of launching a full-scale PMD-PPP in 2025, the project aims to consolidate a national ecosystem that optimizes the translation of technological advancements in medical device design, evaluation, and approval for pediatric populations. The project will de-risk and streamline processes enabling the translation of medical advances from bench-to-bedside for medical devices for children. The PMD-PPP project will strive to develop a sustainable infrastructure for the successful development and commercialization of pediatric medical devices. Additionally, the project will integrate existing frameworks and the expertise and resources of the public and private sectors into a strategic and actionable plan. Ultimately this PPP will address the lack of access to medical device options designed and approved for the pediatric population. The PPP also will allow new, impactful synergies with other key players in the emerging national ecosystem, shaping and contributing to the success of the ongoing and new activities.
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Pediatric Prevention of Mother-to-Child Transmission (PMTCT) PEPFAR Working Group
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Committee, Work group, Advisory group, or Task Force
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Not Reported
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NIAID, NICHD, NIMH, OD/DPCPSI/OAR
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This working group supports the objectives of the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) and prevention of mother-to-child transmission (PMTCT). Beginning with the President's Mother and Child HIV Transmission Initiative in 2002, and then expanding with the launch of the PEPFAR in 2003, PMTCT has been a central focus of U.S. Government global HIV/AIDS efforts. Congress established the Expert Panel on Prevention of Mother-to-Child Transmission of HIV in Section 309 of H.R. 5501, the Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008. Its purposes are to provide an objective review of PEPFAR's PMTCT activities, and provide recommendations to the U.S. Global AIDS Coordinator and the appropriate Congressional committees for further scale-up of services to achieve the ambitious target of reaching 80 percent of pregnant women in countries most affected by HIV/AIDS in which the United States has HIV/AIDS programs. https://www.fic.nih.gov/About/center-global-health-studies/Pages/pmtct-…
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Pediatric Radiation Medical Countermeasures Working Group
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Committee, Work group, Advisory group, or Task Force
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BARDA, FDA
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NIAID
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This group was established in an effort to harmonize efforts in the pediatric space and to push ahead pediatric radiation and multi-utility (Chem/Rad) products. The plan is to critically evaluate the status of pediatric drug development against radiation injury. Identify resources and cross-cutting efforts in this area to ensure a clear pathway is established to advance radiation products with a pediatric indication
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Pharmaceutical Interventions for Hearing Loss (PIHL)
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Committee, Work group, Advisory group, or Task Force
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Not Reported
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NIDCD
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This group has monthly conference calls in which we all regularly participate. The goal of the group is to share information and develop resources to generate therapies for hearing loss.
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Pharmacogenetics Advisory Subpanel of the Precision Care Advisory Panel of the Department of Defense
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Committee, Work group, Advisory group, or Task Force
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Not Reported
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NHGRI
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Trans-agency working group to advise on implementation of genomic testing in clinical care in the military health system.
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Physical Activity Guidelines Advisory Committee
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Committee, Work group, Advisory group, or Task Force
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OASH
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NCI, NIAMS
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The Physical Activity Guidelines is an essential resource for health professionals and policy makers. It includes recommendations for Americans ages 3 years and over — including people at increased risk of chronic disease — and provides evidence-based advice on how physical activity can help promote health and reduce the risk of chronic disease.The Guidelines serves as the primary, authoritative voice of the federal government for evidence-based guidance on physical activity, fitness, and health for Americans. ODPHP leads the development of the Guidelines in collaboration with the Centers for Disease Control and Prevention, the National Institutes of Health, and the President’s Council on Sports, Fitness & Nutrition.
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Plain Language Community
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Committee, Work group, Advisory group, or Task Force
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Not Reported
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NIA
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Community of federal employees share resources and best practices on clear communications.
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Population Assessment of Tobacco and Health (PATH) Study
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Health Survey
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FDA
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NIDA
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The PATH Study is a national longitudinal cohort study that will follow an estimated 59,000 US household residents ages 12 years and older for at least three years.
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PRAMS Interagency Workgroup
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Committee, Work group, Advisory group, or Task Force
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CDC, CMS, HRSA
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NICHD
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Support team of PRAMS users as they build their internal capacity to link MCH data sets and inform their future programming.
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