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NIH-BARDA Working Group
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Committee, Work group, Advisory group, or Task Force
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BARDA
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NIAID
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Working Group was created to better communicate influenza vaccine activities that each Agency is working on so there are no duplicate effects, and ways the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority(BARDA) can collaborate including co-sponsoring projects.
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NIH-CDC-IDSA Guidelines for Treatment of HIV Related Opportunistic Infections Among Adults and Adolescents
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Committee, Work group, Advisory group, or Task Force
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CDC
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CC, OD/DPCPSI/OAR
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The National Institutes of Health, the HIV Medicine Association of the Infectious Diseases Society of America, and the Centers for Disease Control and Prevention (CDC) have developed guidelines for treatment of opportunistic infections (OIs) among adults and adolescents infected with human immunodeficiency virus (HIV). These guidelines are intended for clinicians and other health-care providers who care for HIV-infected adults and adolescents, including pregnant women; they complement companion guidelines for treatment of OIs among HIV-infected children and previously published guidelines for prevention of OIs in these populations.
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NIH-FDA Interagency Clinical Outcome Assessments (ICOA) Working Group
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Committee, Work group, Advisory group, or Task Force
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FDA
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NICHD, CC, NCCIH, NCI, NHLBI, NIA, NIAMS, NIDA, NIDDK, NIMH, NINDS, OD/DPCPSI
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The Interagency Clinical Outcome Assessments Working Group (ICOA WG) works to foster the development, evaluation, and qualification of Clinical Outcomes Assessments (COAs) for use in both medical product development and clinical research. Leveraging the unique strengths, knowledge, and resources at both the US Food and Drug Administration (FDA) and the National Institutes of Health (NIH), the objectives of the ICOA WG are: (1) To increase communication between the relevant groups at FDA and the many separate efforts at NIH to advance measurement science by exchanging information about specific COA projects of common interest, thereby improving the knowledge base for COA development; (2) To clarify and disseminate information about the regulatory processes for evaluation of medical product development tools; (3) To foster appropriate interagency scientific efforts to generate evidence toward the development and potential qualification of novel COAs; and (4) To leverage public and private efforts toward consensus and standards development in this area. The ICOA WG is composed of representatives and selected senior staff of each agency
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NIH-FDA Medical Device Research Interest Group (MDRIG)
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Committee, Work group, Advisory group, or Task Force
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CMS, FDA
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NIBIB, NCATS, NCI, NEI, NHLBI, NIA, NIAID, NICHD, NIDDK, NINR, OD/DPCPSI/ORIP, FIC, NIAMS, NIDA
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The Medical Device Research Interest Group (MDRIG) meets quarterly to share information and ideas on supporting research throughout the development pipeline. Recent topics of interest include an early feasibility supplement for the Small Business Innovation Research (SBIR) grantees that would facilitate grantee Food and Drug Administration (FDA) meetings and communication in the formative years in order to increase appropriate planning during the development of their technologies toward FDA approval. The National Heart, Lung, and Blood Institute (NHLBI) is supporting a pilot of this concept and the group will incorporate feedback from this pilot into their planning. NIBIB hosted two large workshops on AI in Medical Imaging that included the FDA and CMS – one in August 2018 and another in November 2019. These were funded through the NIBIB. In 2018, we also had a workshop on post-MRI Gadolinium Retention in patients. Funded by NIBIB.MDRIG continues to meet several times per year. In August 2020, NIBIB contracted the Medical Imaging & Data Resource Center (MIDRC), which includes FDA participation in a collaborative project.
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NIH/BARDA Antimicrobial Resistance (AMR) Diagnostic Challenge Working Group
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Committee, Work group, Advisory group, or Task Force
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ASPR, FDA, CDC
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NIAID
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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.
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NIH/BMGF Collaboration - Point of Care Testing Working Group
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Committee, Work group, Advisory group, or Task Force
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CMS, FDA
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NIBIB, NCI, NIAID, NICHD
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The National Institute of Biomedical Imaging and Bioengineering (NIBIB) co-chairs the National Institutes of Health (NIH) Bill and Melinda Gates Foundation Working Group on Point of Care (POC) Diagnostics. This group of government and private partners is working to identify and collaborate on projects to develop diagnostic tests for low resource areas. One area of focus is to leverage resources for the development of a rapid POC diagnostic test for viral infections such as HIV or influenza. NIBIB hosted a working group session on March 30, 2017, that focused on patient access to health diagnostics. Ideas from this session were presented at the larger NIH-Gates Foundation meeting on June 30, 2017, hosted by NIH. In March 2020 the Tech Accelerator Challenge for Global Health (NTAC) was launched by NIH and the Gates Foundation. Through this Challenge, NIBIB offered $1,000,000 in prizes to reward and spur the development of platform concepts and prototypes of non-invasive, multiplexed diagnostic technologies for sickle cell disease, malaria, and anemia, diseases with high global and public health impact. NIBIB awarded six winners (https://www.nibib.nih.gov/ntac-challenge-winners) a total of $1,000,000 in prizes in 2020. Other ICOs partnered with the NIBIB to include NIH Office of the Director; National Institute of Allergy and Infectious Disease; National Heart, Lung and Blood Institute; National Institute of Diabetes and Digestive and Kidney Diseases; and the Fogarty International Center (https://www.nibib.nih.gov/NIH-Technology-Accelerator-Challenge). On October 30, 2020, the outcomes of NTAC were presented at the POC Diagnostics Working Group meeting that informed a Report which was presented at the 7th Annual Bill and Melinda Gates Consultative Workshop held on November 9 and 10, 2020.
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NINDS Common Data Elements Program
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Resource Development
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CDC, FDA
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NINDS, CIT, NICHD, NEI, NHGRI, NCATS, NIA, NIMH, NIEHS, NIGMS, NIBIB, NIDDK, NIDCR, NINR, NHLBI
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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.
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Non-animal approaches to assess cardiotoxicity hazard
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Research Initiative
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FDA
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NIEHS
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This project aims to identify and develop human cell- and protein-based assays, as well as in silico QSAR models, to more efficiently screen drugs and chemicals for their potential to be toxic to the heart or circulatory system
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Northwest Portland Tribal Registry Project
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Resource Development
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IHS
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NCI
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Over the past 10 years, health care delivery for Northwest American Indians and Alaska Natives (AI/AN) has evolved from a centralized system maintained by the Indian Health Service (IHS) to a diverse and complex environment. The Northwest Tribal Registry Project was developed in January 1999 by the Northwest Tribal Epidemiology Center, a tribally operated program located at the Northwest Portland Area Indian Health Board (NPAIHB) in Portland, Oregon. The Project works with state health organizations to correct racial misclassification for AI/AN in disease registries, obtain accurate estimates of the cancer burden, and to generate health status information for tribes and health programs. NCI contributes funding to the IHS for this project through the Native American Research Centers for Health (NARCH) program.
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NSTC Subcommittee on Biological Defense Research and Development - Interagency Bioconvergence Working Group
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Committee, Work group, Advisory group, or Task Force
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OS
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OD/OSP
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Provides information exchange, coordination, and strategic planning to help understand the convergence of technologies, especially regarding biology and biotechnologies, and enhance responsible innovation, national security, and biodefense
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