| NIH-CMS Opioid Working Group |
Committee, Work group, Advisory group, or Task Force |
CMS |
NIDA |
The NIH-CMS Opioid Working Group is a collaborative effort between the National Institutes of Health (NIH) and the Centers for Medicare & Medicaid Services (CMS) to address the opioid crisis |
| NIH-FDA Biomarkers Working Group |
Committee, Work group, Advisory group, or Task Force |
FDA |
CC, CIT, CSR, FIC, NCATS, NCCIH, NCI, NEI, NHGRI, NHLBI, NIA, NIAAA, NIAMS, NIBIB, NICHD, NIDA, NIDCD, NIDDK, NIEHS, NIGMS, NIMH, NIMHD, NINDS, NINR, NLM |
The mission of the NIH-FDA Biomarker Working Group is to: promote communication across NIH and FDA on scientific issues related to biomarker development and regulatory acceptance; identify process and policy enhancements that may help address challenges; and coordinate activities and leverage resources that have an impact on NIH-FDA ICs. |
| NIH-FDA Medical Device Research Interest Group |
Committee, Work group, Advisory group, or Task Force |
FDA, CMS |
NCATS, NCCIH, NCI, NEI, NHGRI, NHLBI, NIA, NIAAA, NIAID, NIAMS, NIBIB, NICHD, NIDCD, NIDDK, NIEHS, NIGMS, NINR, NLM, OD/DPCPSI/ORIP |
MDRIG meets quarterly to share information and ideas on supporting research throughout the device development pipeline. Recent topics of interest included clinical innovation and translation efforts, artificial intelligence and machine learning in imaging, digital twins, and early feasibility supplements for the Small Business Innovation Research (SBIR) grantees that would facilitate grantee Food and Drug Administration (FDA) meetings and communication in the formative years to increase appropriate planning during the development of their technologies toward eventual FDA approval. Recently, a successful pilot program was launched through collaboration between the NCI and FDA. Scalability to other institutes was discussed. Supported by NIBIB, MDRIG continues to meet four times per year. In 2018, NIBIB hosted a trans-NIH workshop on gadolinium retention in patients after magnetic resonance imaging. Collaborators included the extramural medical imaging community. A subsequent widely referenced white paper identified gaps in knowledge and future areas for research. This workshop included FDA participation. |
| NIH/BARDA Antimicrobial Resistance (AMR) Diagnostic Challenge Working Group |
Research Initiative |
ASPR, CDC, FDA |
NIAID |
The Working Group designed, launched, and managed the largest USG Challenge competition of $20M through each of the three stages during the 5 years of the competition. The goal was to support the development of novel, innovative, rapid, point-of-need diagnostic in vitro assays to improve antibiotic stewardship and decrease the rapidly expanding AMR pandemic. |
| NIMH Ask Suicide-Screening Questions (ASQ) Research Team Collaboration with Indian Health Service |
Research Initiative |
IHS |
NIMH |
The NIMH ASQ research team has been helping the Indian Health Service implement suicide risk screening since 2017, piloting ASQ as their suicide risk screening tool, helping with training, and devising local clinical pathways. |
| NIMH-SAMHSA Collaboration to Support the Delivery of Evidence-Based Practices in Certified Community Behavior Health Clinic-Expansion (CCBHC-E) Awardees |
Research Initiative |
SAMHSA |
NIDA, NIMH |
The goal of this collaboration is to identify mutual National Institute of Mental Health (NIHMH) and Substance Abuse and Mental Health Services Administration (SAMHSA) priority areas of interest and to develop relevant funding initiatives that will invest in mental health services and implementation science research to support the adoption and sustained fidelity of evidence-based practices in Certified Community Behavioral Health Clinic-Expansion awardees. |
| NINDS Common Data Elements Program |
Resource Development |
CDC, FDA |
CIT, NCATS, NEI, NHGRI, NHLBI, NIA, NIBIB, NIDDK, NIEHS, NIGMS, NIMH, NINDS, NINR |
NINDS works closely with the research community (academia and industry), patient advocates, and other federal agencies to develop and maintain data standards called common data elements (CDEs). Data standards facilitate data collection and data sharing in clinical research. Through the efforts of several working groups, CDEs have been developed for use in adult and pediatric research studies of many neurological disorders, including ALS, cerebral palsy, Chiari I malformation, epilepsy, Friedreich’s ataxia, headache, Huntington’s disease, mitochondrial disease, multiple sclerosis, ME/CFS, several neuromuscular diseases, Parkinson’s, spinal cord injury, stroke, and TBI. |
| Nipah viral replicon particle vaccine safety & efficacy evaluation in NHP model |
Research Initiative |
CDC |
NIAID |
Testing in nonhuman primates of a newly developed vaccine for protection against Nipah virus infection. |
| NITRD Digital Twins Fast-Track Action Committee (FTAC) |
Committee, Work group, Advisory group, or Task Force |
ACL, AHRQ, AoA, ASA, ASFR, ASPA, ASPE, ASPR, ATSDR, BARDA, CFBNP, CDC, CMS, CTO, FDA, GDM, HRSA, IEA, IHS, IOS, IOS/ODPHP, OASH, OCIIO, OCR, OGC, OGA, OIDP, OIG, ONC, ONS, OPHS, ORAC, OS, OSG, OSTP, PHSSEF, PSC, SAMHSA, USPHS |
NCI, NIDCR |
Digital Twins was an area of interest for OSTP, and there was a foundational need for a Strategic Plan. The duration of this FTAC is 1 year with the exception of developing into an interagency working group (WG). The purpose of the DT FTAC is to develop a cohesive strategic plan to advance the foundational research gaps, development, and future directions for Digital Twins based on the 2024 NASEM Digital Twin Report. |
| NOFO 22-049 'Integrating Biospecimen Science Approaches into Clinical Assay Development' Steering Committee Collaboration |
Research Initiative |
FDA |
NCI |
As part of a U01 grants program/network, the Steering Committee provides an opportunity to improve the quality of funded research and potentially amplify the impact of the grants program through collaborative activities. The Steering Committee reviews research progress and develops collaborative activities that may include, among other activities, specific working groups and joint research projects. The Steering Committee also advocates for the sharing of data and biospecimens within the network and promotes best practices in biospecimen handling in related research areas. |