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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 Biomarkers Working Group
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Committee, Work group, Advisory group, or Task Force
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FDA
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NICHD
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The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) Biomarkers Working Group is a peer-reviewed, open-access research platform where those engaged in biomarker research can turn for information on the latest advances in the application of biomarkers toward the discovery of new knowledge, and toward the clinical translation of that knowledge. BIOMARKERS Group has held many face-to-face scientific meetings on a wide variety of biomarker-related topics including the use of biomarkers in early clinical development and the validation and qualification of biomarkers, including for prevention, screening, diagnosis, and treatment purposes.
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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 Joint Leadership Council
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Committee, Work group, Advisory group, or Task Force
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FDA
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OD/OSP, NCATS, NCCIH, NCI, NHLBI, NIAID, NIDDK, NIMH, NINDS
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Facilitates leadership-level development of mutual priorities between both Department of Health and Human Services (HHS) operating divisions.
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NIH-FDA Medical Device Research Interest Group
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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
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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. MDRIG continues to meet several times per year.
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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 was launched by NIH and the Gates Foundation. Through this Challenge, NIBIB will offer $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. Awards are expected to be announced in August 2020. Other ICOs contributing to the million dollars in awards 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
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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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Novel Strategies toward Development of a Group A Streptococcal Vaccine
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Meeting/ Workshop
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OS
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NIAID
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The meeting aims to identify research and knowledge gaps to address novel strategies toward development of group A streptococcal vaccines.
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NSTC Subcommittee on Biological Sciences
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Committee, Work group, Advisory group, or Task Force
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CDC, FDA, OS
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OD/OSP
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Advises and assists the Committee on Science and the National Science and Technology Council (NSTC) on Federal policies, procedures and plans in the biological sciences; also explore ways in which the Federal government can increase the overall effectiveness and productivity of its investment in biological sciences research, especially regarding issues that cut across agency boundaries.
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NSTC Subcommittee on Biological Sciences -Interagency Synthetic Biology Working Group (BSSC-SBWG)
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Committee, Work group, Advisory group, or Task Force
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CDC
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OD/OSP, NIBIB
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Provides coordination and strategic planning to help ensure responsible innovation and significant advances in research in synthetic biology.
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