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NIH Osteoporosis and Related Bone Diseases—National Resource Center
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Resource Development
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OS
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NIAMS, NIA, NIDDK, OD/DPCPSI/ORWH
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Provides patients, health professionals, and the public with an important link to resources and information on metabolic bone diseases, including osteoporosis, Paget’s disease of the bone, and osteogenesis imperfecta.
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NIH Recombinant DNA Advisory Committee (RAC)
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Committee, Work group, Advisory group, or Task Force
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FDA
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OD/OSP
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Advises the National Institutes of Health (NIH) on the safe and ethical conduct of basic and clinical research involving recombinant or synthetic nucleic acid molecules; also provides biosafety guidance for emerging technologies or agents.
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NIH Translational Research Interest Group
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Committee, Work group, Advisory group, or Task Force
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FDA
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NCI, CC, CIT, CSR, NCATS, NCCIH, NCMHD, NEI, NHGRI, NHLBI, NIA, NIAAA, NIAID, NIAMS, NIBIB, NICHD, NIDA, NIDCD, NIDCR, NIDDK, NIEHS, NIGMS, NIMH, NIMHD, NINDS, NINR, NLM, OD/DPCPSI, OD/OER, OD/OIR, OD/OSP
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As Chair of the National Institutes of Health (NIH) Translational Research Interest Group (TRIG), National Cancer Institute (NCI) staff have coordinated forums, workshops, NIH Bench-to-Bedside Awardees’ Lecture Series, and the Monthly Seminar Series to help bridge the gap between laboratory research and clinical applications; suggest topics and speakers for the Annual NIH Research Festivals; and nominate speakers for the NIH Wednesday Afternoon Lecture Series and the NIH Director’s Lecture Series. NCI staff have informed TRIG members of scientific events coordinated with other NIH scientific interest groups and working groups.
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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 activites 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 Joint Leadership Council
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Committee, Work group, Advisory group, or Task Force
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CDC
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OD/OSP, NIAID
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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-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 (BIOMARKERS) 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
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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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