| Partnership for Research on Vaccines and Infectious Diseases in Liberia |
Research Initiative |
CDC |
NIAID |
The PREVAIL partnership was established between the governments of Liberia and the United States. The Government of Liberia is represented through the Ministry of Health (MOH) and three autonomous agencies, the United States government is represented through NIAID and the Centers for Disease Control (CDC). The purpose of this partnership is to conduct collaborative biomedical and public health research to advance science, strengthen health policy and practice, and improve the health of Liberians and people worldwide while enhancing Liberian preparedness and agility to rapidly respond during any future infectious disease outbreaks. |
| Partnership of FDA Centers of Excellence in Regulatory Science and Innovation (CERSI) and NIH Clinical and Translational Science Award (CTSA) Programs |
Research Initiative |
FDA |
NCATS |
This activity aims to collaborate and foster partnership between the CTSA Program and CERSI Program to advance regulatory science by leveraging the resources and expertise from both programs. The respective shared goals of regulatory science and translational science provide opportunities to tackle high-impact concepts across all stages of the translational science spectrum. Collaborative groups from the CTSA Program and CERSI Program eligible organizations are invited to develop multi-site research projects to address roadblocks in translational research with innovative solutions. |
| Pathogen Detection Project and Interagency Collaboration on Genomics for Food and Feed Safety (Gen-FS) |
Committee, Work group, Advisory group, or Task Force |
CDC, CDC, FDA |
NLM |
The Pathogen Detection Project is a multi-agency collaboration that combines pathogen outbreak data with other information to determine the major source of contamination. Collaborating agencies include NLM, FDA, CDC, USDA-Food Safety and Inspection Service, and Public Health England. The U.S. agencies formalized their collaboration in a charter document, Interagency Collaboration on Genomics for Food and Feed Safety (Gen-FS), which outlines their coordinated efforts on antimicrobial resistance. http://www.ncbi.nlm.nih.gov/pathogens/ |
| Pathways to Prevention on Postpartum Health |
Meeting/ Workshop |
AHRQ, CDC, CMS, HRSA, IHS, OASH, SAMHSA |
NHLBI, NICHD, NIMH, OD/DPCPSI/ODP, OD/DPCPSI/ORWH |
ORWH initiated the development and submission of a P2P proposal on postpartum health with coordinated through ODP and with NIMHD, NHLBI and NICHD. In 2022 NIH worked with the AHRQ to develop a systematic evidence review on the topic to inform the P2P, conducted a cross-government portfolio analysis and held the P2P workshop November 29th-December 1, 2022. The Federal Partner’s meeting to be held Octber 23 and 25, 2023. The final report form the P2P and also the Federal Partner's report came out in 2024. The formal collaboration on this P2P ended in October 2024. Materials are at: https://prevention.nih.gov/research-priorities/research-needs-and-gaps/… |
| Patient Safety Chart Book |
Committee, Work group, Advisory group, or Task Force |
AHRQ |
NIA, NIMH, NIMHD |
review of chart book publication |
| PCOR Advisory Committee |
Committee, Work group, Advisory group, or Task Force |
ASPE, ACF, ACL, AHRQ, ASPR, CDC, CMS, FDA, HRSA, IHS, OASH, ONC, SAMHSA |
NICHD, OD/OSP |
Guide and support efforts under the OS- Patient Centered Outcomes Reseach Trust Fund, and coordinate agency participation and interactions |
| PCORTF Frailty & Functional Disabilities Project Working Group |
Committee, Work group, Advisory group, or Task Force |
AHRQ, ASPE, CDC, CMS |
NIA |
Validate and Expand Claims-Based Algorithms, Identifying Patients with Frailty and Functional Disabilities across Payer and Patient Populations |
| Pediatric COVID-19/MIS-C Interagency Team |
Committee, Work group, Advisory group, or Task Force |
CDC, FDA, OASH |
NHLBI, NIAID |
To coordinate and plan research interests across the country involving MIS-C (Multi system Inflammatory Syndrome in Children) related to COVID-19. |
| Pediatric Medical Device Public Private Partnership |
Resource Development |
BARDA, FDA |
NCI, NIAMS, NIBIB, NICHD, NIMH, NINDS |
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. |
| Pediatric Radiation Medical Countermeasures Working Group |
Committee, Work group, Advisory group, or Task Force |
BARDA, FDA |
NIAID |
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 |