| FNIH Advanced Medicines Partnership® - Bespoke Gene Therapy Consortium (FNIH AMP BGTC) |
Research Initiative |
FDA |
NCATS, NEI, NIAMS |
The BGTC is a public–private partnership, where NIH is working with the Food and Drug Administration (FDA), industry and nonprofit partners with experience in designing, developing and manufacturing AAV-based gene therapies. It was formed to address the challenge of developing adeno-associated virus (AAV) gene therapies for rare monogenic diseases. The BGTC’s objectives are to streamline and accelerate clinical development, support first-in-human clinical trials for several rare diseases, and to increase knowledge about AAV transduction, production and gene expression through grants that support research. By reducing the cost and challenges for the development of AAV gene therapies, BGTC’s efforts may change what diseases are of commercial interest, with rare diseases becoming more mainstream for investment by the pharmaceutical industry and other stakeholders. The goal of the BGTC is to optimize and streamline the gene therapy development process to help fill the unmet medical needs of people with rare diseases, in particular those diseases that are too rare to be of commercial interest. The BGTC aims to advance the understanding of adeno‑associated virus (AAV) biology, improve and accelerate gene and vector manufacturing and production processes, standardize and streamline clinical and regulatory processes for gene therapies. |
| FNIH Biomarkers Consortium |
Research Initiative |
CMS, FDA |
NCI, NHLBI, NIA, NIAMS, NIBIB, NICHD, NIDCD, NIDDK, NIEHS, NIMH, NINDS |
The Biomarkers Consortium is a major public-private biomedical research partnership managed by the Foundation for the National Institutes of Health (FNIH) with broad participation from members of government, industry, patients and patient advocacy groups, and not-for-profit organizations. In addition to the FNIH, founding members include the National Institutes of Health (NIH), Food and Drug Administration (FDA), and the Pharmaceutical Research and Manufacturers of America. The Biomarkers Consortium brings together the expertise and resources of various partners to rapidly identify, develop, and qualify potential high-impact biomarkers to enable improvements in drug development, clinical care, and regulatory decision-making. |
| FNIH Biomarkers Consortium Neuroscience Steering Committee |
Research Initiative |
CMS, FDA |
NIA, NIAAA, NIMH, NINDS |
The Biomarkers Consortium is a major public-private biomedical research partnership managed by the Foundation for the National Institutes of Health (FNIH) with broad participation from members of government, industry, academia, patients and patient advocacy groups , and not-for-profit organizations. In addition to the FNIH, founding members include the National Institutes of Health (NIH), Food and Drug Administration (FDA), and the Pharmaceutical Research and Manufacturers of America. The Biomarkers Consortium brings together the expertise and resources of various partners to rapidly identify, develop, and qualify potential high-impact biomarkers to enable improvements in drug development, clinical care, and regulatory decision-making. The Neuroscience Steering Committee is responsible for identifying and moving forward promising pre-competitive biomarkers projects for implementation by the Biomarkers Consortium, as well as overseeing each individual project under its purview. The members of the Steering Committee represent a variety of sectors, including academia, government, industry and not-for-profit/advocacy organizations, and are led by two co-chairs representing two of the following three sectors: academia, government or industry. |
| FNIH Partnership for Accelerating Cancer Therapies (RFA-CA-22-038) |
Committee, Work group, Advisory group, or Task Force |
FDA |
NCI |
The Partnership for Accelerating Cancer Therapies (PACT) is a five-year public-private research collaboration totaling $215 million launched by the National Institutes of Health, the FNIH (Foundation for the NIH) and 11 leading pharmaceutical companies as part of the Cancer Moonshot. PACT is initially focused on efforts to identify, develop and validate robust biomarkers — standardized biological markers of disease and treatment response — to advance new immunotherapy treatments that harness the immune system to attack cancer. The partnership is managed by the FNIH, with the Food and Drug Administration serving in an advisory role. |
| Focus on Aging: Federal Partners Webinar Series |
Meeting/ Workshop |
ACL, AHRQ, ASPE, CDC, CMS, HRSA, IHS |
NIA |
The Focus on Aging: Federal Partners Webinar Sereies addresses important topics for public health and health care professionals, aging services organizations, the research community, and other stakeholders in aging. The series is a joint project of nine of the federal agencies that support the health and wellness of older adults in the U.S.: the Administration for Community Living, the Agency for Healthcare Research and Quality, the Office of the Assistant Secretary for Planning and Evaluation, the Centers for Disease Control and Prevention, the Centers for Medicare and Medicaid Services, the Health Resources and Services Administration, the Indian Health Service, the National Institute on Aging, and the Department of Veterans Affairs. In addition to general topics of interest for older adults and those who work with them, each webinar includes information specific to individuals living with Alzheimer’s disease and other types of dementia, as well as their caregivers. |
| Food is Medicine Federal Agencies Working Group |
Committee, Work group, Advisory group, or Task Force |
IOS/ODPHP, ACF, ACL, AHRQ, CDC, CMS, FDA, HRSA, IHS, IOS, OASH |
OD/DPCPSI/ONR |
The White House Conference on Hunger, Nutrition, and Health — held in September 2022 — renewed national attention and issued a call to action to end hunger and reduce the prevalence of chronic disease in the United States by 2030. Food is Medicine approaches that focus on integrating consistent access to diet- and nutrition- related resources are a critical component to achieve this goal. The approaches are increasingly present across many communities and systems. There’s also increasing federal investment and action to support Food is Medicine approaches in a variety of settings. Building on this collective energy, the Department of Health and Human Services (HHS) developed a Food is Medicine initiative in response to a congressionally funded initiative. This link is external to health.gov. in fiscal year 2023. This congressional action directed the Secretary of HHS, in consultation with other federal agencies, to develop and implement a federal strategy to reduce nutrition-related chronic diseases and food insecurity to improve health and racial equity in the United States. This includes diet-related research and programmatic efforts that will increase access to Food is Medicine initiatives. Access to nutritious food is critical to health and resilience. Food is Medicine is a concept that reaffirms this connection, recognizing that access to high-quality nourishment is essential for well-being. By supporting the production of and facilitating access to nutritious food across a health continuum and range of settings, approaches to Food is Medicine support immediate and long-term resources for people, communities, and systems. This HHS Office of Disease Prevention and Health Promotion (ODPHP)-led working group is focused on working collaboratively with federal partners and external organizations and communities to develop resources that can be used to advance Food is Medicine approaches across the country. |
| FoodData Central (FDC) Meeting |
Committee, Work group, Advisory group, or Task Force |
FDA, CDC, IHS |
NCI, NEI, NHLBI, NIA, NIDCR, NIDDK, OD/DPCPSI/ODS |
The National Food and Nutrient Analysis Program (NFNAP), now known as FoodData Central (FDC) Meeting, is a dynamic research program that aims to achieve long-sought improvements in the nutrient values for foods in the National Nutrient Databank System (NDBS) as well as support initiatives in development of dietary supplement databases. NFNAP is a collaboration between the US Department of Agriculture (USDA) and multiple groups including the Department of Health and Human Services (HHS) and other federal agencies. Analytical data generated through the NFNAP are compiled and released in annual updates of the USDA National Nutrient Database for Standard Reference (SR). They are also used to calculate estimates for related foods not analyzed, to assess nutrient variability, and to evaluate methods for estimating the nutrient content of multi-ingredient foods. |
| Foundations for Digital Twins programmatic working group |
Committee, Work group, Advisory group, or Task Force |
FDA |
OD/DPCPSI/ODSS |
Programmatic oversight and collaboration to support research on Foundations for Digital Twins as Catalyzers of Biomedical Technological Innovation (FDT-BioTech) https://new.nsf.gov/funding/opportunities/foundations-digital-twins-cat… |
| Framework for a Federated Linked Federal Data Ecosystem Work Group |
Committee, Work group, Advisory group, or Task Force |
CDC, CMS, FDA, IOS |
NCI |
This PCOR Trust Fund supported project seeks to develop a federated linked data system governance framework that will enable secure linkage of data across agencies and care settings and therefore improve researchers’ access to comprehensive and longitudinal patient-level data. Specifically, the framework will address data access/use governance, security/privacy controls, and a sustainable operating model for a federated linked data system to facilitate the linking of administrative and clinical data for cancer patients while preserving PII/PHI. An Executive Steering Committee has been established and is led by the HHS Office of the Chief Information Officer (OCIO) with representation from ARPA-H, NIH/NCI, CDC, FDA, CMS, Office of General Counsel (OGC), Assistant Secretary of Planning and Evaluation (ASPE), and HHS Immediate Office of the Secretary (IOS). Expected products include a landscape analysis, a final report, and an interactive dashboard for navigating project documents. |
| Full-text health-related documents at NLM (includes HSTAT) Bookshelf |
Resource Development |
AHRQ, ASPE, ATSDR, CDC, CMS, FDA, HRSA, IHS, ONC, OPHS, SAMHSA |
NLM |
NLM manages and maintains Bookshelf, a free web-based resource of full-text documents that provide evidence-based information related to health-care decision making. Content in Bookshelf is made available through NLM Literature Archive agreements and clauses in Interagency Public Access agreements to make the full text of various federal government grey literature—such as systematic reviews, clinical guidelines, assessments, and technical reports—publicly available. Bookshelf also manages the Health Services/Technology Assessment Texts (HSTAT) collection of health services research documents and serves as the point of contact for federal agencies to make their new and updated documents publicly accessible. https://www.ncbi.nlm.nih.gov/books/?term=(%22Agency+for+Health+Care+Pol… |