Complete List of Activities 2020

TitleCollaboration TypeHHS Participating AgenciesNIH Participating Institutes, Centers, and OfficesDescription
(Former) HHS Behavioral Health Coordinating Committee (BHCC) Subcommittee on Opioids and Controlled SubstancesCommittee, Work group, Advisory group, or Task ForceAHRQ, CDC, CMS, FDA, HRSA, HIS, OS, OSG, SAMHSANIDA, OD/OSPThe National Institute of Drug Abuse (NIDA) Serves as Co-Chair with the Centers for Disease Control and Prevention (CDC) on this inter-agency subcommittee addressing prescription drug abuse.
https://www.samhsa.gov/about-us/interagency
12th Annual Conference on the Science of Dissemination and ImplementationMeeting/ WorkshopAHRQNHLBI, NCCIH, NCI, NIAAA, NIAID, NIDA, NIDDK, NIMH, NINRA forum for discussing the science of dissemination and implementation, the 10th annual conference aimed to grow the research base by bridging the gap between evidence, practice, and policy in health and medicine.
http://www.academyhealth.org/events/site/10th-annual-conference-science-dissemination-and-implementation-health
2020 Surgeon General's Report on Oral HealthResource DevelopmentOASHNIDCRCommissioning of a Surgeon General's Report presenting prominent issues affecting oral health. The report will document progress in oral health in the twenty years since the 2000 Surgeon General's Report on Oral Health, identify existing knowledge gaps, and articulate a vision for the future.
https://www.nidcr.nih.gov/news-events/nidcr-news/surgeon-general-commissions-report-oral-health?_ga=2.14508791.1344579615.1549306183-947560668.1518815364
3rd National Conference on Advancing Early Psychosis Care in the United States: Addressing Inequities - Race, Culture, and COVIDMeeting/ WorkshopSAMHSANIMHWith the rapid expansion of evidence-based early psychosis care in the U.S., largely the result of the successful NIMH-funded Recovery After an Initial Schizophrenia Episode (RAISE) initiative, additional clinician training on early psychosis is needed. The National Institute of Mental Health (NIMH), in collaboration with the Substance Abuse and Mental Health Services Administration (SAMHSA), sponsored a meeting entitled, "Advancing Early Psychosis Care in the United States: Addressing Inequities - Race, Culture, and COVID," on November 12-13, 2020. More than 3,000 clinicians and other professionals working in the early psychosis care field attended the virtual event. NIMH staff served on the planning committee and as presenters.
https://www.psychiatry.org/psychiatrists/meetings/advancing-early-psychosis-care
A nested case-control study of circulating per- and polyfluoroalkyl substances (PFAS) and renal cell carcinomaResearch InitiativeCDCNCINational Cancer Institute (NCI) and Centers for Disease Control and Prevention (CDC) are collaborating to measure serum levels of per- and polyfluoroalkyl substances (PFAS) for a nested case-control study of renal cell carcinoma (RCC) in the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial.
A nested case-control study of circulating per- and polyfluoroalkyl substances (PFAS) and uterine and ovarian cancersResearch InitiativeCDCNCINational Cancer Institute (NCI) and Centers for Disease Control and Prevention (CDC) are collaborating to measure serum levels of per- and polyfluoroalkyl substances (PFAS) for nested case-control studies of endometrial (uterine) and ovarian cancers in the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial.
A Study of Markers of Cosmic Radiation Exposure and Effect Among Flight CrewsResearch InitiativeCDCNCINational Cancer Institute (NCI) and Centers for Disease Control and Prevention (CDC) are collaborating on a cross-sectional study of 83 airline pilots and 50 university faculty to assess the relation of stable chromosome translocations with cosmic radiation exposure.
A Working Group to Consider the Question of Federal Public Health and Medical Resource AllocationCommittee, Work group, Advisory group, or Task ForceOSCCThe National Institutes of Health (NIH) Clinical Center is participating in a working group to consider the question of federal public health and medical resource allocation. The group developed a framework for allocation of federal resources during scarcity after engaging with stakeholders in ethics, disaster preparedness, and emergency management.
A5349/TBTC S31 - Rifapentine - Containing Treatment Shortening Regimens for Pulmonary Tuberculosis: A Randomized, Open-Label, Controlled Phase 3 Clinical TrialResearch InitiativeCDCNIAIDThe purpose of this research initiative is to provide scientific discovery to improve patient care and safety by reducing the duration of treatment for drug-susceptible pulmonary tuberculosis to 4 months by using new regimens, including high-dose rifapentine.
Abuse Liability Evaluation for Research, Treatment, and Training (ALERTT)Research InitiativeFDANIDAAbuse Liability Evaluation for Research, Treatment, and Training (ALERTT) is part of the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership with the US Food and Drug Administration (FDA). The mission of the (ACTTION) is to identify, prioritize, sponsor, coordinate, and promote innovative activities with a special interest in optimizing clinical trials that will expedite the discovery and development of improved analgesic, anesthetic, and addiction treatments for the benefit of public health.
http://www.acttion.org/news/3_1_12.html
Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Therapeutics Working GroupCommittee, Work group, Advisory group, or Task ForceCDC, FDA, ASPRNIAIDDevelop master protocols to support the ACTIV Research; Prioritize putative therapeutics candidates for entry into trials
Accelerating Medicines Partnership (AMP)OtherFDAOD/OSP, NIA, NIDDK, NIAMS, NINDS, NIMHPublic-private partnership between the National Institutes of Health (NIH), the Food and Drug Administration (FDA), multiple biopharmaceutical companies and multiple non-profit organizations, and managed by the Foundation for NIH (FNIH), to transform the current model for developing new diagnostics and treatments by jointly identifying and validating promising biological targets for therapeutics.
https://www.nih.gov/research-training/accelerating-medicines-partnership-amp
Accelerating Medicines Partnership Schizophrenia (AMP SCZ)Research InitiativeFDANIMHThe Foundation for the National Institutes of Health (FNIH), together with National Institute of Mental Health (NIMH) and public and private partners, has launched the Accelerating Medicines Partnership - Schizophrenia (AMP SCZ) as the first neuropsychiatric project within the AMP program. The public-private partnership will tackle the critical need for more effective treatments for people with schizophrenia.
https://fnih.org/what-we-do/programs/accelerating-medicines-partnership-schizophrenia
AccessGUDIDResource DevelopmentFDA, GDMNLMThe Global Unique Device Identification Database (GUDID) contains key device identification information submitted to the Food and Drug Administration (FDA) about medical devices that have Unique Device Identifiers (UDI). The National Library of Medicine (NLM), in collaboration with the FDA, has created the AccessGUDID portal to make device identification information in the GUDID available for everyone, including patients, caregivers, healthcare providers, hospitals, and industry.
https://accessgudid.nlm.nih.gov
ACL Advisory Council on Grandparents Raising GrandchildrenCommittee, Work group, Advisory group, or Task ForceACL, ACF, SAMHSA, CDC, HRSA, ASPE, ONCNIAThe mission of the Advisory Council to Support Grandparents Raising Grandchildren (SGRG) is to identify, promote, coordinate and disseminate information, resources, and best practices to help grandparents and older relative caregivers of children meet the health, educational, nutritional, and other needs of the children in their care, while maintaining their own physical, mental, and emotional well-being. As part of this vision, all recommendations will consider the needs of members of Native American tribes and families affected by the opioid crisis.
https://acl.gov/programs/support-caregivers/supporting-grandparents-raising-grandchildren-0
Action for Health in Diabetes Extension (Look AHEAD-E)Research InitiativeCDC, IHSNIDDK, NIAThe Action for Health in Diabetes (Look AHEAD) is a randomized trial comparing the effects of Intensive Lifestyle Intervention (ILI) focused on weight loss achieved through healthy eating and increased physical activity versus a control condition of Diabetes Support and Education (DSE) in overweight and obese individuals with type 2 diabetes. The Look AHEAD Extension (Look AHEAD-E) will examine whether ILI, provided for 10 years during mid-life, has enduring benefits that persist beyond the period of the intervention for older individuals with diabetes.
https://www.niddk.nih.gov/about-niddk/research-areas/obesity/long-term-lifestyle-change-type-2-diabetes-obesity-study
Acute Flaccid Myelitis (AFM) StudiesResearch InitiativeCDCNIAID, NICHD, NINDSThis is a joint effort to find the cause of AFM by developing research initiatives as well as working group activities.
Acute Flaccid Myelitis (AFM) Workshop Planning CommitteeMeeting/ WorkshopCDCNICHD, NIAID, NINDSThis workshop (planned for May 2020) will bring together research scientists, clinicians, patient advocacy groups, and representatives from relevant organizations to discuss the state-of-the-science for AFM and GBS. The meeting will highlight similarities between the two diseases and facilitate cross-pollination of ideas to advance research, diagnostics, and therapy development for both. Particularly for NICHD, the gaps identified for diagnosis, treatment and management of AFM and it’s consequences in children would inform potential development of future initiatives to address these.
Adjuvant Working GroupCommittee, Work group, Advisory group, or Task ForceBARDA, FDANIAID, NCIStaff from all National Institute of Allergy and Infectious Diseases (NIAID) Divisions, program staff from the Biomedical Advanced Research and Development Authority (BARDA), and regulatory staff from the Food and Drug Administration (FDA) exchange information about ongoing programs related to novel adjuvants for infectious disease vaccines, identify high priority research areas (and gap areas), and discuss ideas to accelerate progress in adjuvant research through better access to information and resources.
Adolescent Brain Cognitive Development (ABCD) StudyResearch InitiativeCDCNIDA, NCI, NIAAA, NICHD, NIMH, NIMHD, NINDS, OD/DPCPSI/OBSSRThe Adolescent Brain Cognitive Development (ABCD) project, a landmark longitudinal study of brain development and child health, will increase our understanding of how diverse experiences during adolescence interact with changing biology to influence brain, cognitive, and social/emotional development of youth. In partnership with area public and private schools, researchers at twenty-one research sites across the country will recruit 10,000 children at age 9-10 from diverse races and ethnicities, education and income levels, and living environments and follow them through their teens and into early adulthood. Throughout this period, researchers will assess each child’s physical and mental health, substance use, sleep patterns, genetics, childhood experiences, and cultural/environmental influences, as well as track brain and cognitive development with non-invasive magnetic resonance imaging scans at regular intervals. To enrich the value of the study, ABCD will release anonymized data annually to the research community in an open science model to allow scientists from all over the world to conduct analyses and pool resources to rapidly expand the types of scientific questions that can be answered. The actionable information coming out of this study will enable education, substance use prevention, and other health promotion policies to ensure the wellbeing and success of the Nation’s children.
http://abcdstudy.org/
Adolescent Health Working GroupCommittee, Work group, Advisory group, or Task ForceACF, AHRQ, CDC, CMS, FDA, HRSA, OS, SAMHSANICHD, NIAAA, NIDA, NIMHThis interagency working group, which was established in January 2010 within the Office of the Assistant Secretary for Health, provides a forum for Department of Health and Human Services (HHS) agencies and other federal agencies to learn from each other and support a full-range of evidence-based approaches to improve adolescent health, to address adolescents’ health risks, and highlight programs focused on positive youth development. This collaboration among many HHS agencies and offices serves as a forum for exchanging information relevant to improving adolescent health and well-being
Adolescent HIV Prevention and Treatment Implementation Science Alliance (AHISA)Committee, Work group, Advisory group, or Task ForceCDC, OSNICHD, FIC, NIAID, NIMH, OD/DPCPSI/OARThe Adolescent HIV Prevention and Treatment Implementation Science Alliance (AHISA) aims to enhance the effective use of evidence and help overcome implementation challenges related to prevention, screening and treatment of HIV among adolescents (ages 15 to 24) in sub-Saharan Africa by catalyzing collaboration and communication among implementation scientists, program implementers and policymakers. The Center for Global Health Studies at Fogarty is launching the initiative in collaboration with the Office of the Global AIDS Coordinator and other NIH Institutes and Centers.
https://www.fic.nih.gov/About/center-global-health-studies/Pages/adolescent-hiv-prevention-treatment-implementation-science-alliance.aspx
Advanced Anticonvulsant System Interagency Product TeamCommittee, Work group, Advisory group, or Task ForceFDA, OSNINDSThe Advanced Anticonvulsant System Interagency Product Team is a Department of Defense-led effort to facilitate activities, both research and regulatory, related to the FDA approval of midazolam for use in treating nerve agent exposure.
Advanced Viral Detection Technology IG (AVDTIG)Committee, Work group, Advisory group, or Task ForceCDC, FDANIAIDThis working group seeks to develop guidelines for best practices for Next Generation Sequencing to identify viral contaminants in biological products.
https://msphere.asm.org/content/2/5/e00307-17
Advancing American Kidney Health InitiativeResearch InitiativeCDC, CMS, FDA, ASPE, ASPR, HRSA, HIS, OCRNIDDK, NIEHSThis initiative aims to improve the lives of Americans suffering from kidney disease, expand options for American patients, and reduce healthcare costs. The initiative provides specific solutions to deliver on three goals: fewer patients developing kidney failure, fewer Americans receiving dialysis in dialysis centers, and more kidneys available for transplant.
Advancing Protection and Care for Children in Adversity: A U.S. Government Strategy for International Assistance (APCCA)Committee, Work group, Advisory group, or Task ForceCDCFIC, NICHD, NIMHInteragency working group focused on Advancing Protection and Care for Children in Adversity, with a focus on developing a coordinated US government strategy for international assistance. The National Institutes of Health (NIH) funds research and evidence-based interventions, which often inform the development and refinement of other USG programs aimed at benefiting at-risk children around the globe. Several institutes and centers within the NIH fund research to build knowledge in areas related to APCCA priorities and objectives.
https://www.childreninadversity.gov/docs/default-source/default-document-library/apcca-strategy-final-web.pdf?sfvrsn=4
Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA)Committee, Work group, Advisory group, or Task ForceCDC, FDA, OSCC, NHLBIThe Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA) is a 31-member federal advisory committee that provides advice to the Secretary of Health and Human Services through the Assistant Secretary for Health on a range of policy issues related to blood, blood products, and tissues.
https://www.hhs.gov/ohaidp/initiatives/blood-tissue-safety/advisory-committee/index.html
Advisory Committee on Heritable Disorders in Newborn and ChildrenCommittee, Work group, Advisory group, or Task ForceAHRQ, CDC, FDA, HRSANICHD, NHGRI, NHLBI, NIDDK, NLMThe Advisory Committee on Heritable Disorders in Newborns and Children was established under the Public Health Service Act, Title XI, § 1109 (42 USC 300b-10), as amended by the Newborn Screening Saves Lives Reauthorization Act of 2014 (PL 113-240). The mission of the Advisory Committee on Heritable Disorders in Newborns and Children is to reduce morbidity and mortality in newborns and children who have or are at risk for heritable disorders. The Committee recommends that every newborn screening program include a Uniform Screening Panel that screens for 32 core disorders and 26 secondary disorders. The Committee advises the Secretary, US Department of Health and Human Services on the most appropriate application of universal newborn screening tests, technologies, policies, guidelines, and standards. Specifically, the committee provides to the Secretary, the following: Advice and recommendations concerning grants and projects authorized, awarded, or funded related to screening heritable disorders in newborns and children; technical information to develop Heritable Disorders Program policies and priorities that will enhance the ability of the state and local health agencies to provide screening; counseling and health care services for newborns and children who have or are at risk for heritable disorders, and recommendations; and advice and information to enhance, expand, or improve the ability of the Secretary to reduce mortality and morbidity from heritable disorders in newborns and children. The committee was chartered on May 7, 2015.
http://www.hrsa.gov/advisorycommittees/mchbadvisory/heritabledisorders/
Advisory Committee on Organ Transplantation (ACOT)Committee, Work group, Advisory group, or Task ForceHRSANIAIDThe Advisory Committee on Organ Transplantation (ACOT) was established to assist the Department of Health and Human Services (HHS) Secretary in enhancing organ donation, ensuring that the system of organ transplantation is grounded in the best available medical science, and assuring the public that the system is as effective and equitable as possible, thereby increasing public confidence in the integrity and effectiveness of the transplantation system.
http://organdonor.gov/legislation/advisory.html
Advisory Council on Blood Stem Cell Transplantation (ACBSCT) of the U.S. Department of Health and Human Services (HHS)Committee, Work group, Advisory group, or Task ForceCDC, CMS, FDA, HRSANHLBIThe Advisory Council advises the Secretary, Department of Health and Human Services and Administrator, Health Resources and Services Administration (HRSA) on matters related to the activities of the C.W. Bill Young Cell Transplantation Program and the National Cord Blood Inventory Program. The principal purpose of these programs is to make blood stem cells from adult donors and cord blood units available for patients who need a transplant to treat life-threatening conditions such as leukemia, and who lack a suitably matched relative who can be the donor.
https://bloodcell.transplant.hrsa.gov/about/advisory_council/index.html
Aging and Disability Federal Partners Working GroupCommittee, Work group, Advisory group, or Task ForceASPENIAWG to enable/ catalyze/ promote translation, dissemination, implementation and evaluation of evidence-based findings to inform policy, improve practice, & strengthen capacity for enhancing health, well-being, & independence of older adults & people with disabilities across the life span in environments from community to clinic/hospital to long-term care.
Alaska Native Tumor RegistryResource DevelopmentCDC, IHSNCIIn collaboration with the Centers for Disease Control and Prevention (CDC), Indian Health Service (IHS), and National Cancer Institute (NCI), and with technical assistance from the Surveillance, Epidemiology, and End Results Program (SEER), the Alaska Native Tumor Registry collects cancer information on all American Indian and Alaska Native people residing in Alaska at the time of diagnosis.
http://seer.cancer.gov/registries/alaska.html; http://anthctoday.org/epicenter/antr.html;
Alzheimers.gov Collaborations with Federal AgenciesPublic Education CampaignACL, ASPA, ASPE, CDCNIA, NINDSIn the course of developing the new Alzheimers.gov website, NIA consulted with the NAPA Federal Subgroup on website content, usability, and outreach, including working with NINDS, ACL, and CDC to review website content.
https://www.alzheimers.gov
America's Children Forum on Health and Family StatisticsResource DevelopmentSAMHSANIDAAs a member of this collaboration, the National Institute on Drug Abuse (NIDA) contributes data from the, “Monitoring the Future Survey on Illicit Drugs, Alcohol and Tobacco Trends”.
http://www.childstats.gov/index.asp
American Academy of Pediatrics (AAP) Committee on DrugsCommittee, Work group, Advisory group, or Task ForceFDANICHDThe AAP Committee on Drugs reviews all aspects of pediatric pharmacology, including drug indications, contraindications, absorption rates, routes of administration, dosing, use precautions, and mode of action as they apply to children. The Committee also advises the Board of Directors in matters related to drug labeling, safety, and efficacy for both prescription and over-the-counter drugs; monitors federal legislation related to the drug approval process; and promotes the need for expanded pediatric drug trials.
https://www.aap.org/en-us/about-the-aap/Committees-Councils-Sections/pages/Committee-on-Drugs.aspx
American Academy of Pediatrics (AAP) Committee on NutritionCommittee, Work group, Advisory group, or Task ForceCDC, FDANICHDThe Committee on Nutrition (CON) studies the nutritional needs of infants, children, and adolescents and develops guidelines for the pediatrician based on sound, objective, clinical science as well as practical experience in fostering optimal health status. CON also maintains active liaisons with the Food and Drug Administration, United States Department of Agriculture (USDA), Centers for Disease Control and Prevention (CDC), National Institutes of Health (NIH), and the Canadian Paediatric Society, pursues advocacy opportunities which promote healthy dietary habits; and provides technical assistance as needed relative to the federal regulatory process.
https://crs.od.nih.gov/CRSAdmin/AddCollaborations.aspx
American Academy of Pediatrics (AAP) Committee on Pediatric AIDSCommittee, Work group, Advisory group, or Task ForceCDCNICHDThe Committee on Pediatric AIDS (COPA) provides guidelines and recommendations for the care and treatment of infants, children, and adolescents with HIV and their families through the development of AAP Policy Statements.
https://www.aap.org/en-us/about-the-aap/Committees-Councils-Sections/Pages/Committee-On-Pediatric-AIDS.aspx
American Academy of Pediatrics (AAP) Council on GeneticsCommittee, Work group, Advisory group, or Task ForceCDC, HRSANICHDThe AAP Council on Genetics (COG) studies and makes recommendations to the AAP Board of Directors on recent advances in genetics and provides support to chapters on state legislative issues as they relate to genetics.
https://www.aap.org/en-us/about-the-aap/Councils/Genetics/Pages/COG.aspx
American Academy of Pediatrics (AAP) Council on Injury, Violence and Poison Prevention (COIVPP)Committee, Work group, Advisory group, or Task ForceACF, HRSA, IHSNICHDThe AAP Council on Injury, Violence, and Poison Prevention was formed on July 1, 2011, with the merging of the former Section and Committee on Injury, Violence, and Poison Prevention. This new leadership body addresses all facets of injury prevention policy, programs, advocacy, and education of general pediatricians, pediatric subspecialists, and families as a unified group.
https://www.aap.org/en-us/about-the-aap/Councils/Council-on-Injury-Violence-Poison-Prevention/Pages/COIVPP.aspx?
American Academy of Pediatrics (AAP) Section on ObesityCommittee, Work group, Advisory group, or Task ForceCDC, FDANICHDThe Section on Obesity's mission is to improve the health and well-being of children and families by reducing the prevalence of childhood obesity and promoting healthy active living.
https://services.aap.org/en/community/aap-sections/obesity/
American College of Obstetricians and Gynecologists (ACOG) Patient Education Review PanelCommittee, Work group, Advisory group, or Task ForceFDANICHDThe Patient Education Review Panel (PERP) reviews the College Patient Education materials for currency, accuracy, and consistency with College guidelines.
https://www.acog.org/About-ACOG/ACOG-Departments/Committees-and-Councils/Committee-Descriptions?IsMobileSet=false#Patient%20Education%20Review%20Panel
American Congress of Obstetricians and Gynecologists (ACOG) Committee on Gynecologic PracticeCommittee, Work group, Advisory group, or Task ForceCDC, FDANICHDThe National Institutes of Health (NIH) advises the American Congress of Obstetricians and Gynecologists (ACOG) Committee on Gynecologic Practice about research advances that can inform gynecologic clinical practice.
AMP Bespoke Gene Therapy Program/Bespoke Gene Therapy Consortium (BGTC)Research InitiativeFDANHLBI, NCATS, NIMH, NINDSThe Bespoke Gene Therapy Consortium (BGTC) is a developing public-private partnership dedicated to making gene therapy a reality for people with rare genetic diseases affecting populations too small to be viable from the current commercial perspective.
https://fnih.org/what-we-do/programs/bespoke-gene-therapy-consortium#:~:text=The%20Bespoke%20Gene%20Therapy%20Consortium,from%20the%20current%20commercial%20perspective.
Analgesic Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION)Research InitiativeFDANINDS, NCATS, NCI, NIAAA, NIDAThe mission of the Analgesic Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership funded by the US Food and Drug Administration (FDA) is to identify, prioritize, sponsor, coordinate, and promote innovative activities — with a special interest in optimizing clinical trials — that will expedite the discovery and development of improved analgesic treatments for the benefit of the public health.
http://www.acttion.org/
Animal Care Radiation Models MeetingMeeting/ WorkshopASPRNIAIDThe purpose of this meeting is to work with stakeholders to examine and discuss currently accepted animal care protocols and how they translate to human care in an emergency setting. The meeting will also explore how euthanasia criteria impact drug efficacy studies. A meeting report will be published as an open source of information for other researchers.
Annual Conference on the Science of Dissemination and ImplementationMeeting/ WorkshopAHRQNCI, FIC, NHGRI, NHLBI, NIAAA, NIAID, NIDA, NIDDK, NIMH, NIMHD, NINR, OD/DPCPSI/OBSSR, ODPThe Annual Conference on the Science of Dissemination and Implementation is a forum for discussing the science of dissemination and implementation and aims to grow the research base by bridging the gap between evidence, practice, and policy in health and medicine. Researchers, evaluators, and implementers who are interested in identifying opportunities, challenges, and strategies for disseminating the findings and implementation of research to key stakeholders are encouraged to attend. Discuss, debate, and explore in-depth approaches to advance dissemination and implementation science.
https://www.academyhealth.org/events/site/12th-annual-conference-science-dissemination-and-implementation-health
Antibody Interest Group (ABIG)Committee, Work group, Advisory group, or Task ForceFDANCI, NHLBI, NIAID, NIDCR, NIDDKThe NIH Antibody Interest Group (ABIG) promotes information exchange and interaction among NIH scientists who work on various aspects of antibody engineering and therapy. The success of antibody therapy requires a thorough understanding of biological systems in relation to molecular and cell biology, immunology, biochemistry, and microbiology, as well as diseases such as cancer, autoimmunity, and infectious diseases. Interest in antibody therapy crosses traditional biomedical disciplinary boundaries. ABIG provides an open forum for multidisciplinary discussion among colleagues who otherwise may have limited interaction. The principal ABIG activities are monthly meetings on current topics as well as an annual symposium on the NIH campus. The monthly ABIG meetings are open to everyone interested. These meetings are devoted to research seminars on numerous aspects of antibody engineering and therapy presented by both NIH scientists and outside speakers.
https://oir.nih.gov/sigs/antibody-interest-group
Antimicrobial Drugs Advisory CommitteeCommittee, Work group, Advisory group, or Task ForceFDANIAIDThe Committee reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of infectious diseases and disorders and makes appropriate recommendations to the Food and Drug Administration (FDA) Commissioner.
https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Anti-InfectiveDrugsAdvisoryCommittee/default.htm
Antiretroviral Pregnancy RegistryResource DevelopmentCDCNICHDThis is a registry of use of antiretroviral drugs in pregnancy that is sponsored by various pharmaceutical companies and has a committee of external experts and government staff from the National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), and Food and Drug Administration (FDA). The registry provides a resource for clinicians and researchers to improve the healthcare quality and patient safety for HIV infected mothers and their infants.
http://www.apregistry.com/
Arthritis Advisory CommitteeCommittee, Work group, Advisory group, or Task ForceFDANIAIDThis Committee provides expertise in the evaluation of evidence submitted by pharmaceutical companies to the Food and Drug Administration (FDA) for drug approval.
https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/default.htm
Asia-Pacific Economic Cooperation (APEC) Cervical Cancer InitiativeMeeting/ WorkshopOGANCIIn November and December 2020, following the launch of the Global Strategy to Accelerate the Elimination of Cervical Cancer, the US National Cancer Institute together with the APEC Health Working Group and the APEC Life Sciences Innovation Forum, organized the APEC Policy Dialogue (Day 1 and Day2) and the APEC Technical Webinar. These meetings brought together multisectoral stakeholders from APEC economies to discuss and to highlight the importance of the Global Strategy to Accelerate Cervical Cancer Elimination, HPV Vaccination and Screening in APEC during the COVID-19 Pandemic, Strengthening Health Systems and Research Priorities to Deliver on the Promise of Cervical Cancer Elimination, and Control of HPV Disease in HIV+ Women. These meetings were also supported by the University of Malaya of Malaysia and VCS Foundation Ltd of Australia.
Assessment of Inhalation Exposures to Indoor and Occupational AerosolsResearch InitiativeCDCNIEHSThe primary goal of this collaboration is to study inhalation exposures to indoor and occupational aerosols, with a current focus on characterizing the health hazards associated with exposure to common fungal contaminants. NIOSH uses a specially developed exposure system to conduct subchronic toxicology studies following repeated exposure to molds identified by the NTP as a public health concern. Subprojects under this IAA are examining the association of exposure to mycotoxins and health by analyzing indoor air samples, developing biomarkers of exposure and response, and using genomic sequencing methodologies to assess fungal diversity associated with the built environment.
Assisted Outpatient Treatment for Individuals with Serious Mental IllnessResearch InitiativeHRSA, SAMHSA, ASPENIMHThis collaboration supports the development and implementation of a rigorous and objective cross-site impact evaluation of an Assisted Outpatient Treatment Grant Program for Individuals with Serious Mental Illness. The Department of Health and Human Services, Assistant Secretary for Planning and Evaluation (ASPE) has primary responsibility for the solicitation, management, and implementation of the evaluation contract in consultation with the Substance Abuse and Mental Health Services Administration (SAMHSA) and the National Institute of Mental Health (NIMH). The Center for Behavioral Health Statistics and Quality (CBHSQ), an entity within SAMHSA that serves as a focal point for data collection, analysis, and the dissemination of critical public health data, provides consultation on the cross-site evaluation of the Assisted Outpatient Treatment grant program. ASPE, in consultation with the NIMH, brings expertise in evaluation design and implementation that benefits SAMHSA in its priority of having a rigorous multi-site evaluation. The initial Phase I Implementation Evaluation was completed in FY 2017. Results of the Implementation Evaluation were used to inform the design and data collection plan for the Phase II Outcome Evaluation, which began in FY 2019.
Autoimmune Diseases Coordinating CommitteeCommittee, Work group, Advisory group, or Task ForceCDC, FDA, HRSANIAID, CSR, FIC, NCATS, NCCIH, NCI, NEI, NHGRI, NHLBI, NIA, NIAAA, NIBIB, NICHD, NIDA, NIDCD, NIDCR, NIDDK, NIEHS, NIGMS, NIMH, NINDS, NINRThe purpose of the Autoimmune Diseases Coordinating Committee (ADCC) is to provide a forum for the coordination of research efforts in autoimmunity and autoimmune diseases among various stakeholders including the National Institutes of Health (NIH), other federal agencies such as the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), and private organizations with an interest in autoimmune diseases. The ADCC meets twice yearly to discuss a broad range of basic, preclinical, and clinical endeavors.
https://www.niaid.nih.gov/about/autoimmune-diseases-committee
Bacteriophage Interest Group (Monthly Meeting)Meeting/ WorkshopBARDA, FDANIAIDThe purpose of this monthly meeting is to allow the National Institute of Allergy and Infectious Diseases (NIAID), the Biomedical Advanced Research and Development Authority (BARDA) and the Food and Drug Administration (FDA) staff to hear seminars on bacteriophage therapy and discuss progress in this area.
Bacteriophage Therapy: Intraagency meetingMeeting/ WorkshopFDANIAIDThe purpose of this meeting is to exchange information regarding phage therapy with other United States Government (USG) stakeholders. The meeting is planned for summer 2021.
Bench to Bedside: Integrating Sex and Gender to Improve Human HealthResource DevelopmentFDAOD/DPCPSI/ORWHBench to Bedside: Integrating Sex and Gender to Improve Human Health was developed in partnership with the Food and Drug Administration (FDA) Office of Women’s Health (OWH). This online course gives users a thorough and up-to-date understanding of sex and gender influences on health and disease so users can apply this knowledge when conducting research and interpreting evidence for clinical practice. Course material showcases examples from basic science through clinical trials and translation into practice to ensure participants understand the importance of considering the influence of sex and gender throughout the research spectrum and beyond. Through its six modules, the course focuses on key health conditions on which sex and gender have an impact. The six modules that compose the course are Immunology, Cardiovascular disease, Pulmonary disease, Neurology, Endocrinology, and Mental Health.
https://orwh.od.nih.gov/career-development-education/e-learning/bench-bedside
Best Pharmaceuticals for Children Act (BPCA) Data Monitoring CommitteeCommittee, Work group, Advisory group, or Task ForceFDANICHD, NCI, NHLBIThis group provides safety oversight for all studies conducted under BPCA.
https://www.nichd.nih.gov/research/supported/bpca
Bi-Weekly Assay subgroup for SARS-CoV-2Committee, Work group, Advisory group, or Task ForceCDC, FDA, BARDA, FDANIAIDThe objective is to share assay development activities within the government Labs
BioCompute Object ProjectCommittee, Work group, Advisory group, or Task ForceFDANCIThe BioCompute Object (BCO) Project is a community-driven initiative to build a framework for standardizing and sharing computations and analyses generated from High-throughput sequencing (HTS -- also referred to as next-generation sequencing or massively parallel sequencing). The project has since been standardized as IEEE 2791-2020, and the project files are maintained in an open source repository. [1] The July 22nd, 2020 edition of the Federal Register announced that the FDA now supports the use of BioCompute (officially known as IEEE 2791-2020) in regulatory submissions, and the inclusion of the standard in the Data Standards Catalog for the submission of HTS data in NDAs, ANDAs, BLAs, and INDs to CBER, CDER, and CFSAN. Originally started as a collaborative contract between the George Washington University and the Food and Drug Administration, the project has grown to include over 20 universities, biotechnology companies, public-private partnerships and pharmaceutical companies including Seven Bridges and Harvard Medical School.[2] The BCO aims to ease the exchange of HTS workflows between various organizations, such as the FDA, pharmaceutical companies, contract research organizations, bioinformatic platform providers, and academic researchers. Due to the sensitive nature of regulatory filings, few direct references to material can be published. However, the project is currently funded to train FDA Reviewers and administrators to read and interpret BCOs, and currently has 4 publications either submitted or nearly submitted.
https://www.biocomputeobject.org
Biodefense Coordination Team (BCT)Committee, Work group, Advisory group, or Task ForceCDC, FDA, OSOD/OSPCoordinates implementation of the U.S. National Biodefense Strategy and Presidential Memorandum on the Support for Biodefense towards an integrated, comprehensive approach to manage biodefense activities in support of the broader biodefense enterprise.
Bioeconomy Interagency Working GroupCommittee, Work group, Advisory group, or Task ForceFDA, OSOD/OSPDiscusses and coordinates policy options related to promoting and protecting the bioeconomy.
Biological Select Agents and Toxins Interagency Policy Committee (BSAT PPC)Committee, Work group, Advisory group, or Task ForceCDC, FDA, OSOD/OSP, NIAIDDiscusses appropriate oversight of Select Agents and Toxins.
Biological Select Agents and Toxins sub-Interagency Policy Committee (BSAT Sub-PPC)Committee, Work group, Advisory group, or Task ForceCDC, FDA, OSOD/OSP, NIAIDDiscusses the appropriate oversight of Select Agents and Toxins; Subcommittee of the Biological Select Agents and Toxins Policy Coordination Committee (BSAT PPC).
Biomarkers of Exposure and Effect in Agriculture (BEEA)Research InitiativeCDCNCINational Cancer Institute (NCI) and the Centers for Disease Control and Prevention (CDC) are collaborating to characterize exposure to permethrin and other pesticides by measuring urinary metabolites among participants in the Biomarkers of Exposure and Effect in Agriculture (BEEA) study.
Biomarkers of Radiation injury MeetingMeeting/ WorkshopASPR, FDANIAIDMeeting held on June 1st, 2020 provided an overview on biomarkers in general and the state of the research specific to radiation countermeasures and biodosimetry and to understand the developmental challenges unique to their role in these areas. Participants identified gaps, challenges and needs for translational application with regard to special populations. Subject matter experts and researchers in the field of biomarkers, radiobiology, and biodosimetry discussed complexity of identifying and utilizing biomarkers for triage, biodosimetry, and radiation countermeasures.
Biomarkers, EndpointS, and other Tools (BEST) Resource GlossaryResource DevelopmentFDANCIBEST comprises a glossary that clarifies important definitions of terms used in translational science and medical product development with a focus on terms related to study endpoints and biomarkers. The BEST glossary aims to capture distinctions between biomarkers and clinical assessments and to describe their distinct roles in biomedical research, clinical practice, medical product development, and in the regulation of products by FDA.
https://www.ncbi.nlm.nih.gov/books/NBK338448/
Blood Products Advisory CommitteeCommittee, Work group, Advisory group, or Task ForceCDC, FDACC, NHLBIThe Food and Drug Administration (FDA) Blood Products Advisory Committee (BPAC) reviews and evaluates available data concerning the safety, effectiveness, and appropriate use of blood, products derived from blood and serum or biotechnology which are intended for use in the diagnosis, prevention, or treatment of human diseases, and, as required, any other product for which the Food and Drug Administration has regulatory responsibility. The committee also advises the Commissioner of Food and Drugs of its findings.
https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/BloodProductsAdvisoryCommittee/
Blood, Organ, and Tissue Safety Committee (BOTSEC)Committee, Work group, Advisory group, or Task ForceCDC, CMS, FDA, OSCC, NHLBIThe Blood, Organ, and Tissue Senior Executive Council (BOTSEC) is an advisory forum for senior leadership from the Department of Health and Human Services (HHS) organizational components, as well as liaison representatives from Department of Defense and Veterans’ Health Administration, that are involved in blood, organ, and tissue safety and availability. The Department of Health and Human Services (HHS) Assistant Secretary for Health serves as the Council Chair, and the Office of the Assistant Secretary of Health (OASH) Senior Advisor for Blood and Tissue Policy serves as the BOTSEC Executive Director.
https://www.hhs.gov/ohaidp/initiatives/blood-tissue-safety/blood-organ-and-tissue-senior-executive-council/index.html
Blood, Organ, and Tissue Senior Executive Council (BOTSEC)Committee, Work group, Advisory group, or Task ForceAHRQ, CDC, CMS, FDA, HRSA, OSNIAID, CCThe Blood, Organ, and Tissue Senior Executive Council (BOTSEC) is an advisory forum for senior leadership from the Department of Health and Human Services (HHS) organizational components, as well as liaison representatives from Department of Defense and Veterans’ Health Administration, that are involved in blood, organ, and tissue safety and availability. The HHS Assistant Secretary for Health serves as the Council Chair, and the Office of the Assistant Secretary for Health (OASH) Senior Advisor for Blood and Tissue Policy serves as the BOTSEC Executive Director.
https://www.hhs.gov/oidp/topics/blood-tissue-safety/blood-organ-and-tissue-senior-executive-council/charter/index.html
Board of Scientific Counselors (BSC) of the CDC's National Center for Injury Prevention and ControlCommittee, Work group, Advisory group, or Task ForceACF, ACL, AHRQ, CDC, HRSA, IHS, SAMHSANICHD, NIA, NIDA, NIMHThe BSC advises the Secretary, Department of Health and Human Services; the Director, Centers for Disease Control and Prevention (CDC); and the Director, National Center for Injury Prevention and Control (NCIPC) regarding surveillance, basic epidemiologic research, intervention research, and implementation, dissemination, and evaluation of promising and evidence-based strategies for the prevention of injury and violence. The Board makes recommendations regarding policies, strategies, objectives, projects, and priorities, and reviews progress toward injury and violence prevention.
https://www.cdc.gov/injury/bsc/index.html
Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC)Committee, Work group, Advisory group, or Task ForceFDANICHDThe Committee reviews and evaluates data on the safety and effectiveness of marketed and investigational human drug products for use in the practice of osteoporosis and metabolic bone disease, obstetrics, gynecology, urology and related specialties, and makes appropriate recommendations to the Commissioner of Food and Drugs.
https://www.fda.gov/advisory-committees/human-drug-advisory-committees/bone-reproductive-and-urologic-drugs-advisory-committee-formerly-reproductive-health-drugs-advisory
Botanical Safety ConsortiumResearch InitiativeFDANIEHS, NCCIH, NEIHSPublic-private partnership aimed at developing an in vitro toolkit for evaluating botanical safety
https://botanicalsafetyconsortium.org/
Botulism Guidelines Working GroupCommittee, Work group, Advisory group, or Task ForceCDCCCThe National Institutes of Health (NIH) Clinical Center is participating in a working group with the Centers for Disease Control and Prevention (CDC) to develop clinical guidelines for treatment of botulism and use of botulism antitoxin.
Brain Attack Coalition (BAC)Committee, Work group, Advisory group, or Task ForceCDCNINDSThe Brain Attack Coalition (BAC) is a group of public and private entities representing medical, scientific, advocacy, and government professionals from across the stroke continuum. The BAC is dedicated to setting direction, advancing knowledge, and communicating best practices to improve our ability to prevent and combat stroke.
http://www.brainattackcoalition.org
Brain Research through Advancing Innovative Neurotechnologies (BRAIN) InitiativeResearch InitiativeFDANINDS, NCCIH, NEI, NIA, NIAAA, NIBIB, NICHD, NIDA, NIDCD, NIMH, OD/DPCPSI/OBSSRThe Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative is revolutionizing our understanding of the brain by developing and applying innovative technologies to study brain circuits and, ultimately, to develop new ways to treat brain disorders. Circuits of brain cells enable us to think, perceive our world, and act upon it, and disruption of these circuits underlies neurological, psychiatric, and substance misuse disorders.
http://braininitiative.nih.gov/
Canadian - U.S. Dietary Reference Intakes Working GroupCommittee, Work group, Advisory group, or Task ForceAHRQ, CDC, FDA, OASHOD/DPCPSI/ONR, NIDDK, OD/DPCPSIThe US and Canadian governments have each established Federal DRI Committees that work collaboratively to identify DRI needs and to coordinate government sponsorship of DRI reviews and related activities. The DRIs — which reflect nutrient reference values essential to national nutrition policies and to professionals working in the field of nutrition and health — have been developed under the auspices of the Institute of Medicine with funding from the US and Canadian governments.
https://health.gov/our-work/food-nutrition/dietary-reference-intakes-dris/nutrient-assessment-dri-review
Cancer Control Plan, Link, Act, Network with Evidence-Based Tools (P.L.A.N.E.T)Resource DevelopmentAHRQ, CDCNCICancer control planners, program staff, and researchers have the same goals: to reduce cancer risk, the number of new cancer cases, and the number of deaths from cancer, as well as enhance the quality of life for cancer survivors. While many share the same goals, all do not have easy access to resources that can facilitate the transfer of evidence-based research findings into practice. This Cancer Control Plan, Link, Act, Network with Evidence-based Tools (PLANET) portal provides access to data and resources that can help planners, program staff, and researchers to design, implement and evaluate evidence-based cancer control programs.
https://cancercontrolplanet.cancer.gov/planet/index.html
Cancer Moonshot AwardResearch InitiativeOSNIDCD, NCICancer Moonshot Award to discover a panel of TCRs with various HLA restrictions for cancer and otolaryngic infectious disorders
https://www.cancer.gov/research/key-initiatives/moonshot-cancer-initiative
CDC Acute Flaccid Myelitis Task ForceCommittee, Work group, Advisory group, or Task ForceCDCNINDS, NIAIDThe AFM Task Force was established to aid in the ongoing investigation to define the cause of, and improve treatment and outcomes for, patients with AFM. The Task Force functions as a work group of the CDC Board of Scientific Counselors, Deputy Director for Infectious Diseases.
https://www.cdc.gov/ddid/bsc/afm-task-force.html
CDC Chronic Kidney Disease SurveillanceHealth SurveyCDCNIDDKThe National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) assists the Centers for Disease Control and Prevention (CDC) in its surveillance program of chronic kidney disease.
http://nccd.cdc.gov/ckd/
CDC Integration with GrantSolutionsResource DevelopmentACF, CDCOD/OERCollaboration with GrantSolutions to allow the Centers for Disease Control and Prevention (CDC) Research programs to seamlessly use electronic Research Administration (eRA) research grant support services, including the eRA Commons grantee portal and the eRA Peer Review suite while having grants management staff process awards within GrantSolutions.
CDC Office of Public Health GenomicsPublic Education CampaignCDCNHLBIThis collaboration seeks to define and implement a translational trajectory for scientific discoveries in genomics and related fields to population health benefits in health areas relevant to National Heart, Lung, and Blood Institute (NHLBI) including, heart, lung, blood, and sleep disorders.
CDC-NIH Lyme Disease Serum Sample RepositoryResource DevelopmentCDC, OSNIAIDInitiated in 2008, this resource was made available to the scientific community on a broad basis in late 2011. Lyme disease and related serum samples are available upon request for testing and comparison of new and current diagnostic tests with a common serum sample set for standardization. Samples are distributed by the Centers for Disease Control and Prevention (CDC). CDC and National Institutes of Health (NIH) both provided support to acquire the samples and continue to work together to ensure the scientific community has access to samples needed for Lyme disease diagnostic test development.
CDC/RAND Technical Expert Panel on Behavioral Health Surveillance in DisastersCommittee, Work group, Advisory group, or Task ForceCDCNIMHThe Centers for Disease Control and Prevention has contracted with the RAND Corporation to develop guidance for public health and mental health departments on how to use existing data and resources to strengthen behavioral health monitoring and surveillance during public health emergencies. The three research questions guiding this work are: 1) what strategies are currently in use at state, tribal, local, and territorial levels to monitor behavioral health during public health emergencies? 2) what data sources, indicators, and methodologic approaches could public health and mental health departments use to strengthen behavioral health surveillance during public health emergencies? 3) what are recommendations for the interpretation and use of behavioral health surveillance information during public health emergencies?
Cervical screening guidelinesResource DevelopmentCDC, HRSA, FDANCIThe National Cancer Institute (NCI) is generating risk estimates that inform cervical screening and management guidelines. NCI is working with CDC, HRSA, and FDA to collect study populations, conduct risk estimation, and disseminate guidelines.
Characterize Emerging HIV Strains from Blood Donors and PatientsResource DevelopmentFDANIAIDThis initiative will characterize emerging HIV strains from blood donors and patients to determine viral tropism based on co-receptor usage strains. It will update the global viral panels to analyze multiple, diverse isolates from different parts of the world. This activity is part of the National Institute of Allergy and Infectious Diseases (NIAID) ongoing efforts to develop a well-characterized repository for diagnostics, and drug and vaccine studies.
https://eqapol.dhvi.duke.edu/
CHEMM (Chemical Hazards Emergency Medical Management)Resource DevelopmentATSDR, CDC, IOSNLM, NICHDThis activity is to develop and maintain a comprehensive web resource and mobile app (in conjunction with the Wireless Information System for Emergency Responders [WISER]). Chemical Hazards Emergency Medical Management (CHEMM) is a tool designed to provide access to comprehensive sets of information about chemical hazards and emergency medical management via a user-friendly interface.
https://chemm.nlm.nih.gov
Cherokee Cancer Registry (CNCR)Resource DevelopmentIHSNCIThe Cherokee Nation Cancer Registry (CNCR) was established in 1997. Since its creation the registry has successfully conducted population-based cancer surveillance for the Cherokee Nation services population living within the 14 county Tribal Jurisdictional service area, in accordance with prevailing standards required by the Surveillance, Epidemiology, and End Results (SEER) Program. All data is abstracted and coded according to SEER standards. We submit data to SEER twice a year, through the New Mexico Tumor Registry in the prescribed format.
https://surveillance.cancer.gov/disparities/native/cherokee.html
Childhood Cancer Data Initiative (CCDI), National Childhood Cancer Registry (NCCR)Resource DevelopmentCDCNCIThe NCCR has been established by relying on a core of registry data from 1995 forward for all cancers diagnosed in children aged 0-19. NCI SEER and CDC NPCR registries are submitting population-based registry data and this is linked with a variety of other data sources (e.g., claims, molecular characterization, pharmacy, Virtual Pooled Registry, research studies, SDoH, Cancer Center supplements) to obtain a longitudinal understanding of treatment, procedures, risk factors, and outcomes.
https://www.cancer.gov/research/areas/childhood/childhood-cancer-data-initiative
Children's HHS Interagency Leadership on Disasters (CHILD) Working GroupCommittee, Work group, Advisory group, or Task ForceACF, CDC, HRSA, OS, SAMHSANICHD, NIAID, NIDA, NIGMS, NIMHThe U.S. Department of Health and Human Services (HHS) established the Children's HHS Interagency Leadership on Disasters (CHILD) Working Group in 2010 to identify and comprehensively integrate the activities related to the needs of children across all HHS inter- and intra-governmental disaster planning activities and operations. Co-led by the Administration for Children and Families and the Assistant Secretary for Preparedness and Response, the group then developed recommendations for how HHS can improve the delivery of care to children who are impacted by disasters.
https://www.phe.gov/Preparedness/planning/abc/Documents/child-2014-2015.pdf
Circulating Estrogens, Androgens, and Progestogens and Risk of Breast Cancer in the PLCO CohortResearch InitiativeCDCNCIIn a stratified cohort study of breast cancer in the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial (PLCO), restricted to postmenopausal women not on menopausal hormone therapy, researchers are using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) assay recently developed by the Centers for Disease Control and Prevention (CDC) to assess pre-diagnostic circulating levels of the endogenous steroid hormones believed to be involved in breast cancer etiology. Although it is known that endogenous hormones play a critical role in the etiology of breast cancer, the interrelationships among estrogens, androgens, and progesterone in determining risk are not well understood.
CLARITY - Mammary Gland effortsResearch InitiativeATSDRNIEHSCollaboration between Fenton lab at NIEHS and Soto lab at Tufts University to study BPA effects on mammary gland
Clinical and Translational Research Course for PhD StudentsTraining InitiativeFDACC, NCATS, NCI, NHLBI, NIAID, NIDA, NIDCR, NIDDK, NIGMS, NIMH, NINDSThe Clinical and Translational Research Course for PhD Students is a two-week intensive introductory course for graduate students in the basic biomedical sciences who have at least one year of graduate study. The purpose of the course is to demonstrate and highlight the roles of PhD scientists in clinical and translational research, to provide an overview and examples of how basic science and clinical observations lead to translational research, and to increase awareness and access to PhD role models, research resources, and potential career opportunities at the National Institutes of Health (NIH).
http://www.cc.nih.gov/training/phdcourse
Clinical Investigator Interagency Working Group for the Development of Antiviral Influenza TherapeuticsCommittee, Work group, Advisory group, or Task ForceCDC, FDANIAIDThis working group discusses a range of issues relevant to the development of antiviral drugs for the treatment of influenza.
Clinical Research Using Medicare Data from the Virtual Research Data Center (VRDC)Research InitiativeCMSNLMThe National Library of Medicine (NLM) is working with the Centers for Medicare and Medicaid Services (CMS) and other National Institutes of Health (NIH) institutes and centers (ICs) to demonstrate the value of the CMS Virtual Research Data Center (VRDC) as a source of Big Data.
https://www.resdac.org/cms-data/request/cms-virtual-research-data-center
Clinical Utilization Plan for Anthrax Medical Countermeasure Use in a Mass Casualty Event (CUPAC) Medical Countermeasures WorkgroupCommittee, Work group, Advisory group, or Task ForceCDCCCThe National Institutes of Health (NIH) Clinical Center is participating as a member of the Medical Countermeasures Work Group to provide clinical algorithms that will assist clinicians to evaluate, triage, diagnose and treat large numbers of patients presenting with symptoms of anthrax. It will also provide a clinical prioritization schema for the use of medical countermeasures specific to anthrax and outline unique critical care issues that may require special consideration.
Clinical Vocabulary and Standards Development for Meaningful Use of Electronic Medical RecordsCommittee, Work group, Advisory group, or Task ForceAHRQ, CDC, CMS, IOSNLMThe National Library of Medicine (NLM) collaborates with the Office of the Secretary OS and the Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) and other parts of HHS on developing and disseminating regulatory language related to health information technology, meaningful use, and standards and certification criteria related to electronic health records and messaging.
http://www.nlm.nih.gov/healthit.html
ClinicalTrials.govResource DevelopmentFDANLM, CC, NCATS, NCCIH, NCI, NCMHD, NEI, NHGRI, NHLBI, NIA, NIAAA, NIAID, NIAMS, NIBIB, NICHD, NIDA, NIDCD, NIDCR, NIDDK, NIEHS, NIGMS, NIMH, NIMHD, NINDS, NINR, OD/DPCPSI/OBSSR, OD/OER, OD/OLPA, OD/OSPClinicalTrials.gov is a National Library of Medicine (NLM) operated database containing summary protocol and results information from publicly and privately funded clinical research studies. As of September 2019, the database included summary protocol information on nearly 370,000 clinical studies conducted in 219 countries, with approximately 47,000 of these records displaying summary results. NLM originally collaborated with the Food and Drug Administration (FDA) on implementing Section 113 of the Food and Drug Administration Modernization Act of 1997. It subsequently collaborated with FDA, the Department of Health and Human Services (HHS) Office of the General Counsel (OGC), and the National Institutes of Health (NIH) Office of the Director (OD) to implement the statutory requirements of Section 801 of the Food and Drug Administration Amendments Act of 2007 through rulemaking. Regulations (42 CFR Part 11) were promulgated in September 2016. NLM continues its collaboration with FDA, OD/OSP, OGC, and other parts of NIH to implement the requirements under 42 CFR Part 11, provide educational information, conduct outreach activities, and develop compliance workflows and reporting tools. NLM is also continuing its collaborating with NIH OD and other parts of NIH to implement the 2016 NIH Policy on the Dissemination of NIH-funded Clinical Trial Information and other NIH policies (e.g., reporting results of valid analyses by sex/gender and race/ethnicity for NIH-funded trials to ClinicalTrials.gov as required by the 21st Century Cures Act). Additionally, NLM worked closely with OD/OSP to assist OHRP in implementing the Posting of Clinical Trial Consent Form provision of the revised Common Rule at 45 CFR 46.116(h). NLM has also been working with OD/OBSSR to develop resource materials specific to researchers in the field of behavioral and social science to better support submission of their research to ClinicalTrials.gov. Finally, NLM has been collaborating with OD/OSP, OER, OLPA, and OCPL on analyzing approaches for reporting NIH-funded basic experimental studies with humans.
https://www.clinicaltrials.gov/
CMS End-stage Renal Disease (ESRD) Affinity GroupCommittee, Work group, Advisory group, or Task ForceCMSNIDDKThe Centers for Medicare and Medicaid Services (CMS) has established a number of affinity groups to focus groups of individuals interested in and working on particular topics -- in this case, end-stage renal disease (ESRD). The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Program staff have participated in meetings, bringing domain expertise and perspectives on current research findings.
CMS-NIH Leadership CouncilCommittee, Work group, Advisory group, or Task ForceCMSOD/OSP, NCCIH, NCI, NHGRI, NHLBI, NIA, NIDA, NIDDK, NIMHD, OD/IMOD, OD/OERFacilitates leadership-level development of mutual priorities between both Department of Health and Human Services (HHS) operating divisions.
Coccidioidomycosis (Valley Fever): Considerations for Development of Antifungal DrugsMeeting/ WorkshopFDANIAIDA virtual public workshop sponsored by FDA for coccidioidomycosis (Valley Fever) pertaining to landscape and considerations for developing antifungal drugs. Discussions will focus on the current state and clinical trial design considerations related to coccidioidomycosis.
https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/coccidioidomycosis-valley-fever-considerations-development-antifungal-drugs-08052020-08052020
Collaborative Acute Toxicity Modeling Suite (CATMoS)Committee, Work group, Advisory group, or Task ForceATSDR, CDCNIEHS, NCATSWith the increasing number of chemicals to assess for acute oral systemic toxicity potential (LD50) and the lack of in vitro approaches, NICEATM and the ICCVAM Acute Toxicity Workgroup organized an international collaborative project to develop in silico models as alternatives to predict LD50 and bridge data gaps. Participants from 35 groups submitted a total of 139 predictive models built using a dataset of 11,992 chemicals split into training (75%) and evaluation sets (25%). Crowdsourced models were developed for five endpoints: LD50 value, EPA hazard categories, GHS hazard categories, very toxic (LD50 50 mg/kg), and non-toxic (LD50 > 2000 mg/kg). Predictions within the applicability domains of the submitted models were evaluated, then combined into consensus predictions based on a weight-of-evidence approach. The resulting consensus model, forming the Collaborative Acute Toxicity Modeling Suite (CATMoS), leverages the strengths and overcomes the limitations of individual modeling approaches. The consensus predictions are fully reproduceable and performed at least as well as independent replicate in vivo acute oral toxicity assays. The CATMoS consensus model is available via the free and open-source tool OPERA (Open Structure-activity/property Relationship App).
https://ntp.niehs.nih.gov/go/tox-models
Collaborative on Healthy Parenting in Primary CarePublic Education CampaignCDC, HRSA, SAMHSANICHDThe Collaborative on Healthy Parenting in Primary Care recognizes the accumulated evidence of the effectiveness of family-focused prevention programs that promote the physical and behavioral health and emotional well-being of children from before their birth through adolescence. Members of the Collaborative have united around an initiative to support the integration of effective programs that promote healthy parenting into primary care settings in order to achieve optimal health for children.
Collaborative Use Repurposing Engine ID (CURE ID)Research InitiativeFDANCATSCURE ID is an internet-based repository that lets the clinical community report novel uses of existing drugs for difficult-to-treat infectious diseases through a website, a smartphone or other mobile device. The platform enables the crowdsourcing of medical information from health care providers to facilitate the development of new treatments for neglected diseases. CURE ID is a collaboration between the FDA and the National Center for Advancing Translational Sciences (NCATS), part of the National Institutes of Health (NIH). FDA and NIH are also collaborating with the World Health Organization and the Infectious Disease Society of America to assess the global utility of the CURE ID.
https://www.fda.gov/drugs/science-and-research-drugs/cure-id-app-lets-clinicians-report-novel-uses-existing-drugs
Combating Antibiotic Resistant Bacteria (CARB)Resource DevelopmentCDC, FDANLM, NHGRI, NIAIDThe National Action Plan for Combating Antibiotic-resistant Bacteria is a multi-agency initiative to deal with the threat of increasing antibiotic resistance. The National Center for Biotechnology Information (NCBI) has a part in Sub-Objective 2.1.4: Develop and maintain a national sequence database of resistant bacteria.
https://obamawhitehouse.archives.gov/sites/default/files/docs/national_action_plan_for_combating_antibotic-resistant_bacteria.pdf
Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) Joint Oversight CommitteeCommittee, Work group, Advisory group, or Task ForceBARDA, CDCNIAIDCARB-X is a global non-profit partnership dedicated to accelerating antibacterial research to tackle the global rising threat of drug-resistant bacteria. CarbX is led by Boston University with funding from BARDA, NIAID, and other global funding agencies (Wellcome Trust, Germany’s BMBF, UK GAMRIF and the Gates Foundation). The Joint Oversight Committee oversees operational, financial and strategic activities. NIAID and BARDA staff also monitor progress for projects in the CarbX portfolio, as well as act as reviewers for new proposals to the program.
Community Engagement Alliance Against COVID-19 Disparities (CEAL) InitiativeResearch InitiativeAoAOD/DPCPSI/ORWH, NICHDORWH supported NIMHD's CEAL initiative by promoting the CEAL webpage via an ORWH blog, and utilizing its promotional toolkit.
https://covid19community.nih.gov/about
Community Guide Cardiovascular Coordination TeamCommittee, Work group, Advisory group, or Task ForceCDCNHLBIThe purpose of the workgroup is to assess the feasibility of and conducting an evidence-based review to assess the effectiveness of interventions using community health workers for cardiovascular disease prevention and other relevant topics. The completed reviews will be included in, “The Community Guide sponsored by the Community Preventive Services Task Force”.
https://www.thecommunityguide.org/
Community Preventive Services Task Force (CPSTF)Committee, Work group, Advisory group, or Task ForceCDCODP, OD/DPCPSIThe Community Preventive Services Task Force (CPSTF) is an independent, non-federal panel of prevention experts that uses information from rigorously conducted systematic evidence reviews to make public health recommendations for preventive services that are delivered in community settings. These recommendations are intended to inform public health decision-making about policy, practice, and research priorities for community preventive services. Recommendations from the CPSTF are published in The Guide to Community Preventive Services. The Office of Disease Prevention (ODP) represents NIH as an official liaison member and works with the CDC and CPSTF members to ensure that recommendations represent the views, concerns, and needs of the NIH and our constituents. ODP staff also serve on, or recommend NIH scientists to serve on systematic evidence review teams, and help translate CPSTF recommendations and insufficient evidence findings into actions.
http://www.thecommunityguide.org
Computational Toxicology for NIH Medications DiscoveryResearch InitiativeFDANIDAThrough an inter-agency agreement, the Food and Drug Administration (FDA) provides structure-activity, relationship-based toxicity predictions for compounds that are under evaluation in the National Institute on Drug Abuse (NIDA) Addiction Treatment Discovery Program. On a limited basis, other National Institutes of Health (NIH) ICs may utilize this resource by working through NIDA.
Computer-aided Diagnosis for Radiology ImagesResearch InitiativeFDACCThis collaboration focuses on the improvement of computer-aided diagnosis for radiology images. Specific applications include computer-aided polyp detection for computed tomography (CT )colonography, improvements in the conduct and analysis of observer performance experiments using radiology images, and the use and development of advanced machine learning and receiver operating characteristics methods with application to computer-aided diagnosis.
Congenital Heart Public Health ConsortiumResource DevelopmentAHRQ, CDCNHLBIThe Congenital Heart Public Health Consortium (CHPHC) is a group of organizations uniting resources and efforts in public health activities. The mission of the CHPHC is to prevent congenital heart defects and improve outcomes for affected children and adults. The consortium achieves its mission by providing leadership and a unified voice for public health priorities, expanding opportunities for surveillance and public health research, and informing public policy priorities that benefit public health and affected persons. The CHPHC represents various federal, state, and community organizations, including those representing patient/family, clinical, and research interests. It is pooling expertise and experience and using a public health model to address Congenital Heart Disease (CHD) issues across the lifespan.
https://www.aap.org/en-us/advocacy-and-policy/aap-health-initiatives/chphc/Pages/default.aspx
CONSUMER PRODUCT CHEMICAL EXPOSURES IN PREGNANCY AND THEIR CUMULATIVE IMPACT ON DISORDERS OF FETAL GROWTHResearch InitiativeCDCNIEHSThe purpose of this collaboration is to characterize exposure to organophosphate (OP) flame retardants and pesticides among pregnant women by measuring OP flame retardants and dialkyl phosphate metabolites (DAPs) in urine samples from 3 visits in pregnancy. We will examine associations between these markers and fetal growth as well as inflammation biomarkers.
Contract to fund Congressional mandated National Academies of Sciences, Engineering, and Medicine (NASEM) study on Organ Donation and TransplantationCommittee, Work group, Advisory group, or Task ForceHRSANIAID, NHLBI, NIDDKContract for a NASEM study to examine and recommend improvements to research, policies, and activities related to organ donation and transplantation. The report shall include: ( 1) identification of current challenges involved in modeling proposed organ allocation policy changes and recommendations to improve modeling; (2) recommendations about how costs should be factored into the modeling of organ allocation policy changes; (3) a review of scoring systems (e.g., CPRA, EPTS, KDPI, LAS, MELD, etc.) or other factors that determine organ allocation and patient prioritization and recommendations to assure fair and equitable practices are established, including reducing inequities affecting socioeconomically disadvantaged patient populations; ( 4) recommendations to update the OPTN's policies and processes to ensure that organ allocation decisions take into account the viewpoints of expert OPTN committees; and (5) such other issues as may be identified.
COPD National Action PlanMeeting/ WorkshopAHRQ, CDC, CMS, HRSA, IHSNHLBI, NCI, NIA, NIEHS, NINRThe Chronic Obstructive Pulmonary Disease (COPD) National Action Plan is the first-ever blueprint for a multi-faceted, unified fight against the disease. Developed at the request of Congress with input from the broad COPD community, it provides a comprehensive framework for action by those affected by the disease and those who care about reducing its burden.
https://www.nhlbi.nih.gov/health-topics/education-and-awareness/COPD-national-action-plan
Council on Emergency Medical Care (CEMC)Committee, Work group, Advisory group, or Task ForceAHRQ, CDC, CMS, HRSA, OS, SAMHSANIMH, NCATS, NHLBI, NICHD, NIGMS, NINDS, NLMThe Council on Emergency Medical Care (CEMC) is a coalition comprised of subject-matter experts and policymakers in emergency medical care from organizations across the Federal Government. The CEMC contributes to the development, advancement, and coordination of federal strategies, policies, and priorities relating to emergency medical care to improve the nation’s emergency care system.
Countering Biothreats PCC on Promoting and Protecting the BioeconomyCommittee, Work group, Advisory group, or Task ForceFDA, OSOD/OSPDiscusses and coordinates policy options related to promoting and protecting the bioeconomy.
Countering Biothreats sub-PCC on Promoting and Protecting the BioeconomyCommittee, Work group, Advisory group, or Task ForceFDA, OSOD/OSPDiscusses and coordinates policy options related to promoting and protecting the bioeconomy; Sub-Committee of the Countering Biothreats PCC on Promoting and Protecting the Bioeconomy.
Countermeasures Against Chemical Threats (CounterACT) Research NetworkResearch InitiativeCDC, FDA, OSNINDS, NEI, NIAID, NIAMS, NICHD, NIEHS, NIGMS, NLMThe CounterACT program is a translational research program supporting basic, translational, and clinical research aimed at the discovery and identification of better therapeutic medical countermeasures and diagnostic technologies against chemical threat agents, which facilitates their movement through the regulatory process in collaboration with other federal departments and agencies, such as the Biomedical Advanced Research and Development Authority (HHS BARDA). The program includes a comprehensive network of Research Centers of Excellence, individual co-operative research projects, small business innovation research grants, contracts, and interagency agreements with the Department of Defense. Among other activities, the National Institute of Neurological Disorders and Stroke (NINDS) organizes an annual meeting of investigators supported by the program allowing researchers to share information, encourage collaboration, and enable the National Institutes of Health (NIH) staff to evaluate the group’s progress on themes such as nerve agents, seizure detection technology, cyanide, and sulfur mustard.
https://www.ninds.nih.gov/Current-Research/Trans-Agency-Activities/CounterACT
Country Work in Cancer Research and Cancer Control Planning Strengthening; KenyaResearch InitiativeCDCNCI, FIC, NIAIDKenya has an estimated population of over 42 million. Cancer ranks third as a cause of death after infectious and cardiovascular diseases. It estimated that over 18,000 Kenyans die of cancer annually. The most common types of cancer in Kenya are cancers of the cervix, breast, esophagus, and prostate. The Ministry of Health released a National Cancer Control Strategy (2010-2015) and a National Cervical Cancer Prevention Program Strategic Plan (2012-2015). NCI looks to build upon those efforts in coordination with the many US government and non-governmental partners (NGOs) working in the country. US government agencies, including the National Cancer Institute (NCI), the National Institute of Allergy and Infectious Disease (NIAID), the Fogarty International Center (FIC), the Centers for Disease Control (CDC), and the US Agency for International Development (USAID) have a significant presence in Kenya. Between FY2010 and FY2012, there were 121 NIH or CDC awards totaling $160.1M, and USAID invested $700 million in Kenya in FY2011. At least six NCI-designated cancer centers have activities in Kenya ranging from capacity building for cancer screening and treatment to studies of cancers associated with chronic infection, including HPV. Notably, Moi University has hosted the Academic Model Providing Access to Healthcare (AMPATH) partnership, along with Indiana University (IU), since 2001. The AMPATH-Moi-IU partnership has created the largest clinical research data enterprises in the developing world and includes 18 HIV clinics in western Kenya with 2,000 new patients enrolling per month as of 2012.
COVID CDEs (caDSR)Committee, Work group, Advisory group, or Task ForceFDANCI, CC, CIT, CSR, FIC, NCATS, NCCIH, NCMHD, NCRR, NEI, NHGRI, NHLBI, NIA, NIAAA, NIAID, NIAMS, NIBIB, NICHD, NIDA, NIDCD, NIMHD, NIMH, NIGMS, NIDDK, NIDCR, NIEHS, NINDS, NINR, NLM, OD/OER, OD/DPCPSI/ODSS, OD/DPCPSI/OBSSR, ODHelp develop COVID CDE metadata for submission to NIH governance and NIH/NLM CDE Repository
https://cadsr.nci.nih.gov
COVID-19 Scientific Interest GroupCommittee, Work group, Advisory group, or Task ForceCDC, FDANCI, NCATS, CC, CIT, NHGRI, NEI, NHLBI, NIA, NIAAA, NIAID, NIAMS, NIBIB, NICHD, NIDA, NIDCD, NIDCR, NIDDK, NIEHS, NIMH, NIMHD, NINDS, NLM, ODThe COVID-19 Scientific Interest Group was created in March 2020 in response to the COVID-19 pandemic. This interest group aims to promote collaboration and facilitate the exchange of information and resources among NIH intramural scientists and their HHS colleagues concerning research on COVID-19 and SARS-CoV-2.
https://oir.nih.gov/sigs/covid-19-scientific-interest-group
COVID-19 Therapeutics Interagency Working GroupCommittee, Work group, Advisory group, or Task ForceFDA, CDCNIAIDTo share updates on the wide range of COVID therapeutics efforts that are progressing across the agencies
Critical Crossroads Federal Steering CommitteeCommittee, Work group, Advisory group, or Task ForceACF, CDC, HRSA, OS, SAMHSANICHD, NIMH, NINDSThe Critical Crossroads initiative, initiated by the Health Resources and Services Administration (HRSA) Emergency Medical Services for Children (EMSC) Program, seeks to collaborate across federal agencies to improve the identification of and care coordination for children experiencing mental health crises in rural emergency care settings. The project will identify resources and best practice tools that can be disseminated to states and rural communities. The goals of the project are to improve the coordination of care of children in emergency mental health crisis and post-crisis in rural regions and to provide training and policy resources to the Emergency Medical Services (EMS) and ED practitioners.
Cytokine Interest GroupCommittee, Work group, Advisory group, or Task ForceFDANCI, NEI, NHGRI, NIA, NIAID, NIAMS, NICHD, NIDCRThe Cytokine Interest Group brings together the National Institutes of Health (NIH) and Food and Drug Administration (FDA) scientists from many different areas working with cytokines as mediators of immune processes. It provides a platform for establishing networks for the exchange of ideas and reagents. Its activities comprise multiple minisymposia throughout the year and an award for the best paper in cytokine research for postdoctoral fellows working at the NIH or FDA.
https://oir.nih.gov/sigs/cytokine-interest-group
DailyMedResource DevelopmentFDANLMDailyMed provides high-quality information about marketed drugs, including FDA labels (package inserts). The website provides health information providers and the public with a standard, comprehensive, up-to-date, look-up and download resource of medication content and labeling as found in medication package inserts. NLM provides this DailyMed as a public service, free of advertising.
http://www.dailymed.nlm.nih.gov
Data Access for GranteesResource DevelopmentCMSNIANational Institute on Aging (NIA) has an Inter-Agency Agreement (IAA) to assist grantees with accessing Centers for Medicare & Medicaid Services (CMS) data. It is anticipated that this initiative will create a more user-friendly and more cost-efficient means for grantees to access CMS data, especially the need to access Part D data. Specifically, this agreement gives CMS's Privacy Board justification to release Part D data to NIA grantees with Data Use Agreements. Researchers pay for data use. This includes activities for remote access data enclave.
Demand Reduction Interagency Working GroupsCommittee, Work group, Advisory group, or Task ForceCDC, FDA, HRSA, OS, SAMHSANIAAA, NIDAThese working groups aim to prevent substance abuse and related negative consequences by implementing a prevention framework to serve as a foundation for collaboration among Federal agencies in the development of joint initiatives that serve States and communities across the Nation.
Department of Defense Resuscitation and Transfusion Steering CommitteeCommittee, Work group, Advisory group, or Task ForceCDCCC, NHLBIThis committee oversees the Department of Defense (DoD) research in resuscitation and transfusion.
Department of Health and Human Services (DHHS) Health Care Personnel Influenza Vaccination Interagency Working GroupCommittee, Work group, Advisory group, or Task ForceOSCCThis committee is charged with developing strategies to increase the number of healthcare professionals who are vaccinated with the influenza vaccine.
http://www.hhs.gov/ash/initiatives/hai/hcpflu.html
Department of Health and Human Services (DHHS) Healthcare Infection Control Practices Advisory Committee (HICPAC)Committee, Work group, Advisory group, or Task ForceOSCCThis committee serves as the major policy advisory committee in the nation for healthcare epidemiology.
Department of Health and Human Services (DHHS) Medical Claims Review PanelCommittee, Work group, Advisory group, or Task ForceAHRQ, CDC, CMS, FDA, HRSA, IHS, OS, SAMHSACCThe Medical Claims Review Panel (MCRP) assists the Department of Health and Human Services (DHHS) in meeting its responsibility to provide quality health care in its facilities and by its practitioners. The MCRP reviews paid claims against DHHS facilities and providers to determine if the care provided met the standard of care and makes quality improvement recommendations to health care facilities and individual providers. The Panel meets monthly and includes two National Institutes Health (NIH) representatives; the current Chair of the Panel is an NIH physician.
Department of Health and Human Services (DHHS) Steering Committee for the Prevention of Healthcare-Associated InfectionsCommittee, Work group, Advisory group, or Task ForceOSCCThis steering committee is charged with developing a national action plan for addressing the important problem of healthcare-associated infections.
https://health.gov/hcq/prevent-hai-action-plan.asp
Department of Health and Human Services (HHS) Biovigilance CommitteeCommittee, Work group, Advisory group, or Task ForceCDCCC, NHLBIThis committee develops systems for reporting adverse events resulting from blood transfusion or donation.
Developing Clinical Vocabulary Standards for Public Health ReportingResource DevelopmentCDCNLMThis collaboration between the National Library Medicine (NLM) and the Centers for Disease Control and Prevention (CDC) is to develop Logical Observation Identifiers Names and Codes (LOINC) for use in public health reporting, including tumor registry reporting and reportable disease reporting.
https://phinvads.cdc.gov/vads/SearchVocab.action
Development and Use of a Non-human Primate Model of Pertussis Disease and TransmissionOtherFDANIAIDThe National Institutes of Health (NIH) has been working with the Food and Drug Administration (FDA) towards the development and use of a non-human primate model of pertussis disease and transmission. The unique model helps to test novel vaccines and to understand host immunity.
Development of New Approach Methodologies to Reduce Animal Use in Toxicity Testing -SBIR/STTR Town Hall MeetingMeeting/ WorkshopFDANIEHSThis webinar-based town hall meeting was presented to facilitate improved communication between New Approach Methodologies (NAMs) method developers, including small business (SBIR/STTR) applicants, developing assays to reduce animal use in toxicity testing, and end-users and regulatory agency staff, providing an opportunity for the assay developers to hear from ICCVAM, agency and industry stakeholders on the desired characteristics and requirements for NAM to meet testing requirements.
https://www.niehs.nih.gov/research/supported/translational/sbir/townhall/index.cfm
Developmental Considerations of Antifungal Drugs to Address Unmet Medical NeedMeeting/ WorkshopFDANIAIDA virtual public workshop sponsored by FDA regarding the development of new therapies to address unmet medical need for the treatment of infections due to invasive molds and Candida auris. Discussions will focus on the current state and clinical trial design considerations for developing new therapies for these infections.
https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/development-considerations-antifungal-drugs-address-unmet-medical-need-08042020-08042020
Diabetes Mellitus Interagency Coordinating Committee (DMICC)Committee, Work group, Advisory group, or Task ForceAHRQ, CDC, CMS, FDA, HRSA, IHS, OS, OASHNIDDKThe DMICC facilitates cooperation, communication, and collaboration on diabetes among the participating government entities. DMICC meetings, held several times a year, help members identify emerging issues and opportunities and develop ways in which different government components can work together and build upon each other’s expertise and resources. This approach helps ensure that federal diabetes activities are coordinated and not duplicated, as well as stimulates collaborations where appropriate.
https://www.niddk.nih.gov/about-niddk/advisory-coordinating-committees/diabetes-mellitus-interagency-coordinating-committee-dmicc
Diabetes Prevention Program Outcomes Study (DPP/DPPOS)Research InitiativeCDCNIDDK, NCI, NHLBI, NIAThe Diabetes Prevention Program (DPP) showed that lifestyle change or the drug metformin delay the development of type 2 diabetes. The Diabetes Prevention Program Outcomes Study is studying the long-term effect of diet and exercise and the diabetes medication, metformin, on the delay of type 2 diabetes in participants of the DPP.
https://dppos.bsc.gwu.edu/web/dppos/about
Diabetic Eye Disease Information DisseminationPublic Education CampaignCDCNEIThe Centers for Disease Control and Prevention (CDC's) National Diabetes Education Program is part of the National Eye Health Education Program Partnership. The National Eye Institute (NEI) continues to collaborate with CDC and other stakeholders to share information about diabetic eye disease with various communities.
Diabetic Retinopathy Clinical Research NetworkResearch InitiativeOSNEI, NIDDKThe Diabetic Retinopathy Clinical Research Network (DRCR.net) is a collaborative network dedicated to facilitating multicenter clinical research of diabetic retinopathy, diabetic macular edema, and associated conditions. The DRCR.net supports the identification, design, and implementation of multicenter clinical research initiatives focused on diabetes-induced retinal disorders. Principal emphasis is placed on clinical trials, but epidemiologic outcomes and other research may be supported as well. The network is funded by the National Eye Institute (NEI), and co-funded by the Office of the Secretary (OS), through National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), with the Special Funding Program for Type 1 Diabetes Research.
https://public.jaeb.org/drcrnet
Diagnosis, Treatment, and Medical Service Utilization in Medicare and Medicaid PopulationResearch InitiativeCMSCCCenters for Medicare and Medicaid Services (CMS) and the National Institutes of Health (NIH) Clinical Center (CC) Rehabilitation Medicine (RMD) agreed to collaborate in data-sharing for research, the results of which may be helpful to improve medical-service quality, utilization, and effectiveness for Medicare and Medicaid beneficiaries. CMS will provide electronic data to the NIH Clinical Center, which will perform analyses that are agreed to by both parties.
Diet-induced Hypomethylation in Preneoplastic Liver/Genetics & Epigenetics of Susceptibility to Non-Alcoholic Fatty Liver DiseaseResearch InitiativeFDANCIThe Food and Drug Administration (FDA), the National Center for Toxicological Research, and the National Cancer Institute (NCI) Division of Cancer Prevention, Nutritional Sciences Research Group are collaborating on an Interagency Agreement in which NCI will provide funds to examine the role of epigenetic mechanisms as factors that determine susceptibility to the development of hepatocellular carcinoma and to examine epigenetic alterations which may be used as markers of susceptibility to disease development, and whether correction of those epigenetic abnormalities during hepatocarcinogenesis may be a crucial decisive factor in cancer prevention strategies.
Digital Quantitation of Plasma Cells in Marrow BiopsiesResearch InitiativeFDACCThis project is a collaboration between the National Institutes of Health (NIH )Clinical Center and the Food and Drug Administration (FDA)that consists of developing software and establishing validations for the automated determination of marrow cellularity and enumeration of plasma cells identified by immunohistochemistry (IHC) using a CD138 antibody. This initial effort should serve as proof of principle for a broader plan to utilize IHC-based automated quantitation of different types of cells in bone marrow core biopsies for diagnosis, prognosis, and therapy monitoring of marrow disorders.
Disaster Research Response Project (DR2)Research InitiativeATSDR, CDC, FDA, IOSNLM, NIEHS, OD/DPCPSIThe NIH Disaster Research Response (DR2) Project is a pilot project aimed at creating an environmental health disaster research system through platforms of ready-to-go research data collection tools and a network of specially trained research responders. This project was developed and will be administered by the NIEHS and NLM. Elements of the system include epidemiologic questionnaires and clinical protocols, specially trained disaster researchers, environmental health disaster research networks, a reach-back roster of subject matter experts, and a support infrastructure that can be activated and deployed during public health emergencies and declared disasters. This effort will not only serve as a model for enhancing environmental health research responses, but will also provide invaluable lessons and platforms for others interested in advancing timely post-disaster research activities.
Drug Development Interest GroupCommittee, Work group, Advisory group, or Task ForceBARDA, CDCNIAID, FIC, NCI, NHLBIShare information about state of the art and challenges in drug development for infectious diseases
Drug Induced Liver Injury Network (DILIN)Resource DevelopmentFDANIDDK, NCIBoth a prospective and retrospective database containing cases of drug-induced liver disease, the Drug-Induced Liver Injury Network (DILIN) is funded by a cooperative agreement and includes eight clinical centers and a central data coordinating center. One of the goals of the DILIN is to establish a database of well-characterized cases of drug-induced liver injury along with serum, DNA, and tissue samples that will facilitate research on the mechanisms of hepatic injury due to drugs. Cases of liver injury due to herbal medications are also included. The DILIN will develop standardized definitions of drug-induced liver disease and standardization of scoring systems for causality. Three employees of the Food and Drug Administration (FDA) serve as ad hoc members on the committee overseeing the network activities.
http://www.dilin.org/
E-Cigarette or Vaping Product Use-Associated Lung Injury (EVALI): Developing a Research AgendaMeeting/ WorkshopCDC, FDANHLBI, NCI, NIDAThe purpose of this workshop was to develop a research agenda to understand the causes, biology, and long-term health effects of EVALI. National Heart, Lung, and Blood Institute (NHLBI) led the workshop, and National Institute on Drug Abuse (NIDA), National Cancer Institute (NCI), National Institutes of Health (NIH) Office of the Director (OD), Centers for Disease Control and Prevention (CDC), and Food and Drug Administration (FDA).
https://www.nhlbi.nih.gov/events/2019/nih-workshop-e-cigarette-or-vaping-product-use-associated-lung-injury-evali-developing
Early Hearing Detection and InterventionMeeting/ WorkshopCDC, HRSANIDCDThis is Federal collaboration program involving the National Institute on Deafness and Other Communication Disorders (NIDCD), the Centers for Disease Control and Prevention (CDC), and the Health Resources and Services Administration (HRSA). NIDCD collaborates on early identification and diagnosis of hearing loss and intervention services for newborns and infants. HRSA funds awards to states and healthcare providers to screen newborns and young children for hearing loss. CDC funds states to develop data systems to track hearing loss. NIDCD also funds research grants to scientists throughout the US to study early hearing detection and intervention services.
http://www.cdc.gov/ncbddd/hearingloss/index.html
Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH) Multisite with Coordinating CenterResearch InitiativeHRSANHLBI, NICHD, NIDDK, OD/DPCPSI/OBSSR, ODPTo test the effectiveness of an implementation-ready intervention designed to promote cardiovascular health (CVH) and address CVH disparities in both mothers and children (0-5 yr.) who are of low socio-economic status (SES), or live in low-income underserved rural or urban communities, or in diverse geographic regions with high burden of cardiovascular disease (CVD) risk factors (obesity, hypertension, diabetes).
Ebola Clinical Research Response in Democratic Republic of the CongoResearch InitiativeCDCNIAIDMulti-lateral collaborative partnerships including, but not limited to National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), and host countries Ministeries of Health. Research focus includes Ebola and other emerging and re-emerging infectious diseases. These programs are capable of rapidly mounting a clinical research response.
Ebola Clinical Research Response in West Africa (Guinea, Liberia)Research InitiativeCDC, FDANIAIDMulti-lateral collaborative partnerships including, but not limited to National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), and host countries MoH. Research focus includes Ebola and other emerging and re-emerging infectious diseases. These programs are capable of rapidly mounting a clinical research response.
Ebola Vaccines Advisory Committee on Immunization Practises (ACIP) Working GroupCommittee, Work group, Advisory group, or Task ForceCDCNIAIDDevelop recomendations on Ebola Vaccines for Advisory Committee on Immunization Practises (ACIP)
eCare Plan for People with Multiple Chronic Conditions ProjectCommittee, Work group, Advisory group, or Task ForceAHRQ, CMS, FDA, HRSA, ASPE, ACLNIA, NCI, NIDDK, NLMTo develop and test: 1) a clinician-facing SMART on FHIR e-care plan application to enable clinicians to view and share comprehensive e-care plan data for people with multiple chronic conditions and 2) an HL7 Implementation Guide (IG) to specify data standards and help healthcare institutions implement the e-care plan.
https://ecareplan.ahrq.gov/
Emergency Preparedness, Medical CountermeasuresResource DevelopmentOSNCIThe National Cancer Institute (NCI) provides expertise in radiation biology and radiation oncology to help guide the research and development of medical countermeasures for radiation injury and for biomarkers for assessing injury, dose, and who needs treatment.
http://www.phe.gov/about/barda/Pages/default.aspx
End-stage Renal Disease CollaborationCommittee, Work group, Advisory group, or Task ForceCMS, FDANIDDK, NIBIBParticipating agencies and patient and physician groups are collaborating to help the medical product development community to understand the challenges and milestones needed to achieve the goal of a successful alternative to dialysis. Research, regulatory, and reimbursement needs for such a product are discussed in phone calls and structured meetings.
Endocrinologic and Metabolic Drugs Advisory CommitteeCommittee, Work group, Advisory group, or Task ForceFDANICHDThe Endocrinologic and Metabolic Drugs Advisory Committee (the Committee) advises the Commissioner or designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs for human use and, as required, any other product for which the Food and Drug Administration (FDA) has regulatory responsibility.
https://www.fda.gov/advisory-committees/endocrinologic-and-metabolic-drugs-advisory-committee/endocrinologic-and-metabolic-drugs-advisory-committee-charter
Environmental Phthalate Exposures in Pregnancy in Relation to Fetal and Placental DevelopmentResearch InitiativeCDCNIEHSThe purpose of this collaboration is to characterize exposure to phthalates and phthalate alternatives in pregnant women by measuring phthalate and phthalate alternative metabolites in urine samples from 8 visits in pregnancy. We will examine associations between these markers and fetal growth as well as ultrasound measures of placental development.
Evidence-Based Cancer Control ProgramsResource DevelopmentCDCNCIThe EBCCP (formerly RTIPs) website is a searchable database of evidence-based cancer control programs and is designed to provide program planners and public health practitioners easy and immediate access to program materials.
https://ebccp.cancercontrol.cancer.gov/index.do
Exploratory/Developmental Grants Related to the World Trade Center Health Program (R21)Research InitiativeCDCNIAThis collaboration between NIA and NIOSH supports exploratory and developmental research projects (R21) that address/mitigate/improve issues related to diagnostic or treatment uncertainty with respect to individuals, including enrolled World Trade Center (WTC) responders and certified-eligible WTC survivors, receiving monitoring and/or treatment under subtitle B, of the James Zadroga 9/11 health and Compensation Act (Public Law 111-347). A suitable mix of exploratory and developmental research projects are sought to help advance treatment and diagnostic effectiveness and the understanding of the health and well-being of the WTC Health Program members related to the September 2001 terrorist attacks.
https://grants.nih.gov/grants/guide/rfa-files/RFA-OH-21-004.html
Extracellular Ribonucleic Acid (RNA) CommunicationResearch InitiativeFDAOD/DPCPSI/OSC, NCATSRecent advances have indicated that ribonucleic acids (RNAs) can play a role in a variety of complex cellular functions, including newly discovered mechanisms of cell-to-cell communication. RNA can be exported from cells in extracellular vesicles or bound to lipids or proteins, to circulate through the body and affect cells at a distance. However, the actual impact of the extracellular RNAs, or exRNAs, is currently unknown. NIH and FDA have coordinated efforts on the preclinical and clinical use of exRNAs to address human health and disease. To date, several PIs have had pre-pre-IND meetings with FDA/CBER. They have been provided information necessary to submit applications, for example, a biomarkers device.
http://commonfund.nih.gov/Exrna/index
Extracting Adverse Reactions and Indexing the Content of Structured Product Labels (SPLs)Resource DevelopmentFDANLMThe objective of this initiative is for the National Library of Medicine (NLM) to assist the US Food and Drug Administration (FDA) in indexing the content of structured product labels (SPL) for drugs. Natural language processing technology is used to extract drug-drug interaction information from SPLs which will be validated by FDA subject matter experts. Transforming the narrative text to structured information encoded in national standard terminologies is a prerequisite to the effective deployment of drug safety information in drug labels for clinical decision support. Starting in FY16, the Labeling and Health Communication (LHC) and the FDA's Center for Drug Evaluation and Research (CDER) collaborate on advancing automated extraction of Adverse Reactions (ARs) from drug listing information companies have submitted to FDA in the form of Structured Product Labels (SPLs). The goals of the initial agreement were to develop optimal MetaMap settings for extracting ARs from SPLs and provide FDA with the software necessary to replicate the results. To evaluate the extraction quality, LHC and FDA needed to develop a test collection of SPLs annotated with ARs. Working together, LHC and FDA have developed annotation guidelines. LHC have annotated 200 SPLs and coded the results to MedDRA, the official controlled vocabulary used by FDA to normalize the labeled ARs. In FY18, the collaboration continues with the goals to conduct a community-wide evaluation of the available AR extraction tools. The evaluation venue is NIST Text Analysis Conference (TAC). Over 130 new labels have been annotated with DDIs in FY18.
http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
Extraction of adverse drug events from MEDLINE indexing to support a multimodal model for pharmacovigilance.Resource DevelopmentFDANLMRenewal (2019) of an IAA between Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA) and the Lister Hill National Center for Biomedical Communications (LHNCBC) at the National Library of Medicine (NLM). The collaboration delivers monthly MEDLINE dataset files derived from the Medical Subject Heading (MeSH) indexing (resulting from a 2012 FDA/CDER – NIH/NLM/LHNCBC IAA research collaboration) to harness MEDLINE as a source to support prospective detection of drug-adverse event safety signals from published scientific literature. CDER is responsible for protecting the public health by regulating over-the-counter and prescription drugs, biological therapeutics, and generic drugs. CDER is developing novel, integrative, validated analytic informatics tools to access and analyze new data sources for drug-adverse event signal detection. PEARL (an acronym for ‘Prospective Detection of Emerging Drug-Adverse Event Safety Signals from Relevant Scientific Literature through Quantitative Data Mining of MEDLINE Indexing Terms’) is a prototype, automated, web-based data mining and visual analytics tool that supports the detection of drug-adverse event (ADE) safety signals from published literature reports in MEDLINE through quantitative data mining of Medical Subject Heading (MeSH) indexing terms. MEDLINE dataset file refreshes are needed on a regular monthly basis so that the data mining and safety signal detection outputs from PEARL reflect the most current subset of MeSH-indexed citations in PubMed.
Extramural Interagency Filovirus TeamCommittee, Work group, Advisory group, or Task ForceBARDANIAIDCoordination across USG agencies of filovirus MCM activities
Eye Research CollaborationResearch InitiativeFDANEIThe National Eye Institute (NEI) is collaborating with the Food and Drug Administration (FDA) on uveitis research and on the ocular manifestations of Zika virus and Ebola virus. Uveitis is an autoimmune disease that targets the eye. If left untreated the disease can cause permanent vision loss. Current treatments consist of steroids to suppress the immune system. However, chronic use of these drugs has many side-effects and complications. Recent outbreaks of Ebola virus and Zika virus have highlighted the unique immunological responses to these infections in the “immune privileged” eye. The virus persists in ocular fluids, even after virus is cleared from other parts of the body.
Factor VIII Inhibitors: Generating a National Blueprint for Future ResearchMeeting/ WorkshopCDCNHLBI, NCI, NICHD, NLMA State of the Science meeting was planned and executed on May 15-16, 2018 in collaboration with the national and international hemophilia community. The national and international hemophilia community. The details of the planning effort, the proceedings and work of 4 working groups, and the synthesized research blueprint have been submitted to the journal Haemophilia blueprint have been submitted to the journal Haemophilia as a series of 6 papers that are currently under review. Once published they will dissiminate the consensus research hemophilia community. In so doing, the strategic priorities for future National Heart, Lung, and Blood Institute (NHLBI) funding in this field were better defined.
Fast Track Action Committee on Biosafety and Biosecurity (FTAC)Committee, Work group, Advisory group, or Task ForceCDC, FDA, OSOD/OSP, NIAIDExamines relevant biosafety regulations and further explores options for enhancing biosafety oversight.
FDA Acute Radiation Syndrome (ARS) Action TeamCommittee, Work group, Advisory group, or Task ForceFDA, OSNIAIDThis working group is collaborating on non-human primate (NHP) control animal data and meta analysis. Collaboration includes exchange of study data, study reports, development of a NHP control database and statistical analysis plan and report. The objective is to provide a data package to the Food and Drug Administration (FDA) to support vaccine product development and licensure.
FDA Cancer Imaging Program (CIP) Bi-annual MeetingMeeting/ WorkshopFDANCIThis collaboration is a bi-annual meeting to enhance communication between the Cancer Imaging Program (CIP) and the Division of Medical Imaging Products of the Center for Drug Evaluation and Research (CDER) in the Food and Drug Administration (FDA). This allows for a two-way exchange of information and discussion of issues that are important for each side. Topics that have been discussed include CIP's standardization efforts of medical imaging scanners in the National Cancer Institute's (NCI) Cancer Centers, presentation and discussion of specific new molecular imaging modalities, and discussion of recent FDA decisions regarding new medical imaging innovations.
FDA Collaboration - Psilocybin ResearchResearch InitiativeFDACCThe group is working on research that might gauge the effectiveness of psilocybin for pain management and use in other facets of palliative care.
FDA Microbiology Devices Panel of the Medical Devices Advisory CommitteeCommittee, Work group, Advisory group, or Task ForceFDANIAIDThis Committee provides expertise in the evaluation of evidence submitted by pharmaceutical companies to the Food and Drug Administration (FDA) for drug approval.
https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/MicrobiologyDevicesPanel/default.htm
FDA Risk Evaluations and Midigation workshop (FDA REMS)Meeting/ WorkshopFDAOD/DPCPSI/ORWHParticipated as panelist in the Risk Evaluation and Mitigation Strategy (REMS) workshop in December. REMS is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. This workshop was on opioids and pain.
https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems
FDA Substance Registry System Public InterfaceResource DevelopmentFDANLMThe National Library of Medicine (NLM) and the Food and Drug Administration (FDA) established a collaborative effort to provide an interface for public access to the FDA’s Substance Registration System (SRS). The FDA SRS utilizes an existing NLM database backend architecture to provide public search capability for FDA substances and medicinal products.
https://fdasis.nlm.nih.gov/srs/srs.jsp
FDA Uterine Fibroids Working GroupCommittee, Work group, Advisory group, or Task ForceFDANICHD, OD/DPCPSI/ORWHThe Uterine Fibroids Working Group is one working group of the Women’s Health Clinical Research Network (WH-CRN) that focuses specifically on the treatment of fibroids. The WH-CRN seeks to meet the growing demand for evidence that better reflects the patient experience during routine care by creating a coordinated registry network (CRN) that uses structured data capture and HL7 FHIR to efficiently extract, standardize, and exchange data from electronic health records and link registries and other data sources to cover a number of technologies in clinical areas unique to women.
http://mdepinet.org/womens-health-crn/
FDA-NIH Joint Leadership CouncilCommittee, Work group, Advisory group, or Task ForceFDAOD/OSP, NCI, NHLBI, NIAID, NIDA, NIDDK, NINDS, OD/IMOD, OD/OERFacilitates leadership-level development of mutual priorities between both Department of Health and Human Services (HHS) operating divisions.
http://www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/ucm201654.htm
FDA/NIMH Points of Contact Working Group Meeting - DrugsCommittee, Work group, Advisory group, or Task ForceFDANIMHFood and Drug Administration (FDA) and National Institute of Mental Health (NIMH) representatives meet quarterly to discuss issues of mutual interest related to the development and clinical trials of pharmacologic therapeutic interventions.
Federal Consortium on the Substance Abusing OffenderCommittee, Work group, Advisory group, or Task ForceSAMHSANIDACoordination of approximately a dozen agencies that work with substance abusing offenders. Staff meet by phone quarterly to provide updates on projects and initiatives at their agencies at the intersection of substance use and justice.
Federal Dietary Reference Intakes Steering CommitteeCommittee, Work group, Advisory group, or Task ForceAHRQ, CDC, FDA, OASHOD/DPCPSI/ONR, NHLBI, NIDDK, OD/DPCPSIThis Dietary Reference Intakes subcommittee reports to the Interagency Committee on Human Nutrition Research (ICHRN) to provide oversight on the process used to establish the Dietary Reference Intakes. These values serve as a basis for many federal nutrition programs and policies.
https://health.gov/our-work/food-nutrition/dietary-reference-intakes-dris/nutrient-assessment-dri-review
Federal Experts Security Advisory Panel (FESAP)Committee, Work group, Advisory group, or Task ForceCDC, FDA, OSOD/OSP, NIAIDProvides recommendations related to the security of biological select agents and toxins (BSAT) to the Secretaries of Health and Human Services and Agriculture and the Attorney General.
https://www.phe.gov/Preparedness/legal/boards/fesap/Pages/default.aspx
Federal Health IT Coordinating CouncilCommittee, Work group, Advisory group, or Task ForceCMS, ONCNLMONC promotes improved federal coordination through the Federal Health IT Coordinating Council, a voluntary group of 25 agencies that are actively involved in implementing the national health IT agenda. Among the topics addressed at coordination meetings were: 21st Century Cures Act implementation (ONC and CMS): MyHealthEData Initiative (CMS), Digital Health (FDA), and HIPAA Audits and HIPAA Access Right (OCR). Priority collaborations between ONC and CMS through the Council helped create increased attention to interoperability within the Administration and in specific CMS policies and programs.
Federal Health IT Coordinating Council (FHIT CC): Fast Healthcare Interoperability Resources (FHIR®) Work GroupCommittee, Work group, Advisory group, or Task ForceONC, CMSNHGRIThe FHIR Work Group’s mission is to coordinate federal knowledge, implementation, and decision-making around the role and use of the HL7 FHIR standard in health information technology. The Work Group will focus first on sharing knowledge about FHIR activities happening at the federal level from a regulatory, procurement, and programmatic standpoint. The Work Group will solicit and promote guidance for agencies making choices in FHIR development and implementation to align around a common version of the FHIR standard. Finally, the Work Group will prepare and advance a strategy to support federal FHIR development and implementation activities.
https://www.healthit.gov/curesrule/
Federal Health IT Coordinating Council (FHIT CC): United States Core Data for Interoperability (USCDI)Committee, Work group, Advisory group, or Task ForceONCNHGRIThe USCDI Work Group’s mission is to coordinate federal knowledge and decision making around implementing and updating the USCDI. The Work Group will provide a discussion forum for members to consider their federal agency program and policy priorities to advance or support additional data classes or data elements for future versions of the USCDI.
https://www.healthit.gov/isa/united-states-core-data-interoperability-uscdi
Federal HIV Implementation Science WorkgroupCommittee, Work group, Advisory group, or Task ForceCDC, HRSA, SAMHSANIMH, NIAID, NIDA, OD/DPCPSI/OARIn 2019-2000, representatives from the Centers for Disease Control and Prevention (Division of HIV/AIDS Prevention), the Health Resources and Services Administration (HIV/AIDS Bureau), and the National Institutes of Health continued to convene a workgroup to focus on implementation science. The membership of the workgroup expanded to include the NIH’s Office of AIDS Research and National Institute on Drug Abuse, as well as the Substance Abuse and Mental Health Services Administration. The overall goal of the workgroup is to increase collaborative efforts and decrease duplication of efforts related to implementing and studying the implementation of a broad range of interventions related to the prevention and treatment of HIV. To achieve this goal, the workgroup agrees to pursue a number of broad actions, including: 1) clearly define implementation science for the purpose of the workgroup; 2) understand current implementation science activities and interests within each agency and in the HIV prevention field; 3) identify and define current implementation science successes and challenges within each agency; 4) identify shared priorities and individual priorities for each agency and how future activities could address identified challenges; 5) within the workgroup, share lessons learned and successful strategies for program implementation and how using implementation science might advance implementation efforts; 6) advance the broader dissemination and adoption of key result and evidence-based, evidence-informed, or novel implementation strategies to programmatic and research partners; 7) align technical assistance efforts to support programs to integrate evidence-based, evidence-informed, and novel implementation strategies; and 8) support the advancement of implementation science as a field.
Federal HIV Web Council (FHWC) (HIV.gov)Committee, Work group, Advisory group, or Task ForceOASH, CDC, FDA, HRSA, IHS, SAMHSA, ACFOD/DPCPSI/OAR, NIAID, NIDAHIV.gov expands the visibility of timely and relevant Federal HIV policies, programs, and resources to the American public. It strives to increase the use of new media tools by government, minority, and other community partners to extend the reach of HIV programs to communities at greatest risk, as well as increase knowledge about HIV and access to HIV services for people most at-risk for, or living with, HIV.
https://www.hiv.gov/
Federal Hypertension Control Leadership CouncilMeeting/ WorkshopAHRQ, CDC, CMS, FDA, HRSA, IHS, ASPR, ONCNHLBI, NINDSThe Federal Hypertension Control Leadership Council convenes to inspire, connect, coordinate and accelerate action to achieve and improve hypertension control. We will use our individual levers in a collective effort to achieve and improve national hypertension control. In doing so, we will save lives and dollars, eliminate disparities, and improve our nation’s health and resiliency.
Federal Interagency Breastfeeding Working GroupCommittee, Work group, Advisory group, or Task ForceACF, AHRQ, CDC, CMS, FDA, HRSA, IHS, OSNICHD, NCI, NHLBI, NIDDKThe purpose of this working group is to discuss breastfeeding-related topics relevant to Federal agencies
Federal Interagency Forum for Child and Family StatisticsResearch InitiativeACF, AHRQ, CDC, HRSA, OS, SAMHSANICHD, NIMHThe purpose of this Interagency Agreement is to provide funds to support the work of the Federal Interagency Forum on Child and Family Statistics (Forum). The purpose of the Forum is to foster collaboration among Federal agencies that produce or use statistical data on children and families. Specifically, the Forum seeks to improve both the quality and use of data on children and families by investigating questions of data quality, data measurement, and data integration; identifying information gaps and data inconsistencies; widening access to information on children and families through the annual publication American’s Children: Key National Indicators of Well-Being and other means; coordinating the development and use of statistical data bases among Federal agencies; promoting communication among data producers, researchers, and public policymakers; and addressing concerns regarding collection, access, and dissemination of data.
http://childstats.gov
Federal Interagency Forum on Aging Related StatisticsResource DevelopmentACL, AHRQ, CDC, CMS, OS, SAMHSANIAThis Interagency Forum was formed with the goal of bringing together Federal agencies that share a common interest in improving aging-related data. The specific goals of the Forum are to improve both the quality and use of data on the aging population.
https://agingstats.gov/about.html
Federal Interagency Task Force on the Arts and Human DevelopmentResearch InitiativeACF, ACL, SAMHSANIA, NCCIH, NCI, NICHD, NIMH, OD/DPCPSI/OBSSRBeginning in 2011, the National Endowment for the Arts (NEA) has convened a Federal Interagency Task Force on the Arts and Human Development to encourage more and better research on how the arts can help people reach their full potential at all stages of life. Task force members represent multiple units across the federal government, including the US Department of Health and Human Services, the National Institutes of Health, the National Science Foundation, and the US Department of Education, among others. To date, the Task Force has met quarterly to share ideas and information about research gaps and opportunities for understanding the arts' role in improving health and educational outcomes throughout the lifespan. The Task Force has conducted a series of public webinars on compelling research and practices. Additionally, the group has begun a literature review of research on the arts and human development. In November 2012, four Task Force member agencies hosted a first-ever convening at the National Academy of Sciences to review the current state of research on the arts, health, and well-being in older Americans.
https://www.arts.gov/partnerships/task-force
Federal Interagency Traumatic Brain Injury Research (FITBIR) Working GroupResource DevelopmentAHRQ, CDC, HRSA, OS, SAMHSANINDS, CIT, NCATS, NHLBI, NIA, NIAAA, NIBIB, NICHD, NIDA, NIDCD, NIGMS, NIMHThe charge of the Interagency Committee includes promoting collaboration among federal agencies. A goal of this committee is to develop a national “Roadmap” for Traumatic Brain Injury (TBI). This strategic planning effort will represent the collective expertise of providers, educators, advocates, federal/state/national organizations, and individuals with TBI and their families and will result in a consensus document outlining the critical elements of a successful system of care for TBI service delivery. Outcomes of the planning effort include the adoption of National Institute of Neurological Disorders and Stroke (NINDS) Common Data Elements for TBI research, and creation of the FITBIR Informatics System to store data from TBI patients and controls enrolled in studies funded by the Department of Defense (DoD) and National Institutes of Health (NIH). The FITBIR Informatics System was developed to share data across the entire TBI research field and to facilitate collaboration between laboratories, as well as interconnectivity with other informatics platforms.
https://fitbir.nih.gov/
Federal Interagency Workgroup on Autism Spectrum Disorders (FIWA)Committee, Work group, Advisory group, or Task ForceACL, AHRQ, CDC, CMS, HRSA, IHS, SAMHSA, ASPENIMH, NINDSThe Federal Interagency Workgroup on Autism Spectrum Disorders (FIWA) is composed of representatives from departments and agencies across the U.S. Government, who voluntarily meet to coordinate research, services, and support activities related to autism spectrum disorder (ASD). The FIWA was first convened as an interagency workgroup to address requirements of the Autism Collaboration, Accountability, Research, Education, and Support (CARES) Act of 2014 (PL 113-157). The Autism Cares Act of 2014 required that the Secretary of Health and Human Services (HHS) designate a National Autism Coordinator to oversee national ASD research, service, and support activities, and prevent unnecessary duplication of effort, in consultation with the Secretaries of Defense and Education. The Autism Cares Act of 2014 also required that this coordination of activities take into account the Strategic Plan developed by the Interagency Autism Coordinating Committee (IACC), and requested a Report to Congress concerning young adults with ASD and the challenges related to the transition from existing school-based services to those services available during adulthood.
Federal Interagency Workgroup on Child Abuse and Neglect (FEDIAWG)Committee, Work group, Advisory group, or Task ForceACFNICHD, NIAAA, NIDA, NIMH, OD/DPCPSI/OBSSRThe Federal Interagency Workgroup on Child Abuse and Neglect meets to provide a forum through which staff from relevant federal agencies can communicate and exchange ideas concerning the prevention of child maltreatment and other related issues.
http://www.acf.hhs.gov/cb/resource/fediawg
Federal Interagency Workgroup on Improving Diagnostic Safety and Quality in Health Care.Committee, Work group, Advisory group, or Task ForceAHRQ, CDC, FDA, HRSA, IHS, ONC, SAMHSANIBIB, NLM, CC, NCATS, NCIIn 2015, The National Academies of Sciences, Engineering, and Medicine published a report titled Improving Diagnosis in Health Care that identified problems with diagnostic errors and their effect on the quality and safety of healthcare. The report outlined eight goals to reduce diagnostic error and improve diagnosis of disease. AHRQ convened a cross-agency workgroup to address the lack of dedicated research into improving medical diagnosis and reducing diagnostic failures that lead to patient harm. The working group met in March, July, and November of 2020.
https://www.ahrq.gov/topics/diagnostic-safety-and-quality.html
Federal Interagency Workgroup on Teen Dating ViolenceCommittee, Work group, Advisory group, or Task ForceACF, CDCNICHDThe Federal Interagency Workgroup on Teen Dating Violence was established as a result of the 2006 Workshop on Teen Dating Violence, which was coordinated and led by the National Institute of Justice. Since its inception, the workgroup has coordinated teen dating violence programming, policy, and research activities to combat violence from a public health perspective.
https://www.nij.gov/topics/crime/intimate-partner-violence/teen-dating-violence/Pages/research-agenda.aspx
Federal Interagency Working Group on Measuring Sexual Orientation and Gender Identity (SOGI)Committee, Work group, Advisory group, or Task ForceACF, ACL, CMS, SAMHSANICHD, OD/DPCPSI/SGMROThis working group explores measurement of sexual orientation and gender identity (SOGI), considering multiple different dimensions of sex, gender, and sexuality. The Working Group examines variability in measurement by age, race, ethnicity, and cultural group. It prepares recommendations to the Office of Management and Budget (OMB) and other Federal agencies for the development, testing, and usage of SOGI measures to more accurately describe LGBT populations.
Federal Lead Action Plan WorkgroupCommittee, Work group, Advisory group, or Task ForceFDA, OSNICHDDeveloped through cross-governmental collaboration of the President’s Task Force on Environmental Health Risks and Safety Risks to Children, which includes 17 federal departments and offices, the Federal Lead Action Plan is a blueprint for reducing lead exposure and associated harms by working with a range of stakeholders, including states, tribes and local communities, along with businesses, property owners and parents.
https://www.epa.gov/lead/federal-action-plan-reduce-childhood-lead-exposure
Federal Partners in Bullying PreventionCommittee, Work group, Advisory group, or Task ForceACF, CDC, HRSA, IHS, SAMHSANICHD, NIAAA, NIDA, OD/DPCPSI/OBSSRThe mission of the Federal Partners in Bullying Prevention is to provide information from a broad array of government agencies on the identification and prevention of and ways to respond to bullying and cyberbullying, as well as individuals most at risk to experience it.
https://www.stopbullying.gov/about-us
Federal RePORTERResource DevelopmentACF, ACL, AHRQ, CDC, FDAOD/OERFederal RePORTER is a searchable public database of scientific awards from federal agencies, which allows for portfolio analysis and metrics development across scientific domains. The trans-federal agency consortium called STAR METRICS (Science and Technology for America’s Reinvestment Measuring the Effects of Research on Innovation, Competitiveness, and Science) designed, created, and maintains Federal RePORTER.
https://federalreporter.nih.gov
Federal Sudden Unexpected Infant Death/Sudden Infant Death Syndrome (SUID/SIDS) WorkgroupCommittee, Work group, Advisory group, or Task ForceACF, CDC, HRSA, IHSNICHDThe purpose of the partnership is to establish and enhance relationships among Federal agencies with responsibilities for SIDS and SUID. The partner agencies intend to work together to improve communication and coordination, and to collaborate on a range of activities designed to reduce, and, ultimately, eliminate SIDS and SUID, including the elimination of racial, ethnic and socio-economic disparities.
Federal Supply and Demand of IsotopesCommittee, Work group, Advisory group, or Task ForceFDANIBIB, NCIA workshop on Isotope Federal Supply and Demand is held annually. The workgroup that organizes this workshop consists of representatives of federal agencies with the aim of providing a forum for interaction between agencies, departments, and medical societies to communicate about potential shortages of isotopes that are of strategic importance to the nation including the availability of medical isotopes. Also, a report of isotope supply and demand and whether needs are commercially available is compiled by National Institutes of Health (NIH) and submitted to DOE annually. The report includes demand for NIH intramural research programs and NIH extramural projects (grantees). Not included in this report are NIH intramural research needs that are supplied by its cyclotron or isotope needs met by commercial suppliers. NIH collects data from ICs and submits annual report as required. On January 12, 2021, DOE, NIH, and the members of the Isotope Needs Program held the 7th Workshop on Isotope Federal Supply and Demand. The meeting reviewed the Program’s ongoing activities and reported that the newly evolving use of electron- and alpha-emitting isotopes is seeing increased need (based on FDA’s approval for medical applications); the DOE is developing a plan to meet the current and foreseen increased use of these isotopes for cancer therapy. https://web.cvent.com/event/090a6518-df28-4afc-8a3e-f972dd76c397/websit…
Federal Tuberculosis (TB) Task ForceCommittee, Work group, Advisory group, or Task ForceAHRQ, CDC, CMS, FDA, HRSA, IHS, OSNICHD, NIAIDThe Federal Tuberculosis (TB) Task Force is a coalition composed of the federal agencies involved in U.S. TB research and control efforts. Established in 1991, it facilitates coordination of activities among these federal agencies.
Federal Working Group on Bone DiseasesCommittee, Work group, Advisory group, or Task ForceCDC, CMS, FDANIAMS, CSR, NCATS, NCI, NEI, NIA, NIAID, NICHD, NIDCR, NIDDK, OD/DPCPSI, OD/DPCPSI/ORWHAn interagency committee focusing on osteoporosis and other bone disorders. It offers a forum for sharing information, learning from each other and invited speakers, and facilitating the development, early in the planning stages, of collaborative research activities based on each agency's mission.
Federal Working Group on Dietary Supplements (FWGoDS)Meeting/ WorkshopAHRQ, CDC, HRSA, IHS, FDANCATS, CC, FIC, NCCIH, NCI, NEI, NHGRI, NHLBI, NIA, NIAAA, NIAID, NIAMS, NIBIB, NICHD, NIDCR, NIDDK, NIDA, NIEHS, NIGMS, NIMH, NIMHD, NINDS, NINR, NLMThe Federal Working Group on Dietary Supplements (FWGoDS) consists of representatives from federal agencies that share information and discuss issues, initiatives, and research related to dietary supplements. The FWGoDS serves as means of communication between the Office of Dietary Supplements (ODS) and its federal partners in several ways: 1) to co-fund research investigations within the National Institutes of Health (NIH); 2) to expand opportunities for research-investigator training; and 3) to strengthen collaborative efforts involving dietary supplement research, education, and communication across the government. The FWGoDS was established in part on the basis of a Congressional law which specifies that ODS serve as an advisor to federal health agencies on issues related to dietary supplements. It also exists in response to a goal in the ODS Strategic Plan to expand and conduct outreach efforts that inform and educate about supplements. The FWGoDS has met twice a year since 2005, generally in April and October. It also maintains periodic contact via email and other means as appropriate.
https://ods.od.nih.gov/Research/federalworkinggroupondietarysupplements.aspx
federated learning across Health Information Exchanges (HIE)Committee, Work group, Advisory group, or Task ForceONCNCIIn cooperation with the Nebraska Health Information Initiative (NEHII) and the National Cancer Institute (NCI), NIH launched a pilot program earlier this year that uses a machine learning concept known as federated learning that could leverage existing HIE data while ensuring privacy. Federated learning is a machine learning technique that shares an analytical model between different groups, allowing them to analyze their own data – and share those results – without needing to share the actual raw data. The pilot aimed to expand clinical insights regarding COVID-19 using the existing ways health data are stored and protected in the US. In our pilot, each organization connected to a central cloud ecosystem known as the Multi-state Federated Architecture for Shared Analytics, better known as MuFASA.
Filovirus Animal Non-Clinical Group (FANG)Committee, Work group, Advisory group, or Task ForceCDC, FDA, OSNIAIDThe Filovirus Animal Non-Clinical Group (FANG) focuses on the advanced development of Filovirus medical countermeasures (MCM), both vaccines and therapeutics. The FANG focuses on the product development tools and other interagency product development issues relevant to FDA approval of filovirus MCM. A standing interagency working group, the Portfolio Advisory Committee, oversees the FANG. The FANG will develop strategies to address broadly applicable and interagency product development issues relevant to licensure of filovirus MCM. The FANG will develop consensus recommendations to facilitate standardization of reagents, methods, and procedures across multiple agencies and laboratories.
Filovirus Animal Non-Clinical Group (FANG) WorkshopMeeting/ WorkshopCDC, FDA, OSNIAIDThe Filovirus Animal Non-Clinical Group (FANG) focuses on the advanced development of Filovirus medical countermeasures (MCM), both vaccines and therapeutics. The primary focus of the Workshop will be on Marburg virus, although other filoviruses will also be addressed.
FNIH Advanced Medicines Partnership on Gene TherapyResearch InitiativeFDANCATSWorking with the Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) and FNIH to develop an Accelerated Medicines Partnership (AMP) on the topic of AAV gene therapy.
https://fnih.org/
FNIH Biomarkers ConsortiumResearch InitiativeCMS, FDANIMH, NCATS, NCI, NHLBI, NIA, NIAAA, NIAID, NIAMS, NICHD, NIDA, NIDCR, NIDDK, NIEHS, NINDSThe 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 stakeholders across the health field, including government, industry, academia, patient advocacy, and other not-for-profit organizations. In addition to the FNIH, founding members include the National Institutes of Health, Food and Drug Administration, 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.
https://fnih.org/what-we-do/biomarkers-consortium
Focus on Aging: Federal Partners Webinar SeriesPublic Education CampaignACL, CDC, HRSANIAThe Focus on Aging: Federal Partners' Webinar Series 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 four of the federal agencies that support the health and wellness of older adults in the U.S.: the Administration for Community Living, the Centers for Disease Control and Prevention, the Health Resources and Services Administration, and the National Institute on Aging. Each webinar includes information specific to individuals with Alzheimer’s disease and other types of dementia, as well as their caregivers.
https://www.nia.nih.gov/alzheimers/focus-aging-federal-partners-webinar-series
Foundation for the National Institutes of Health (FNIH) PACT (Partnership for Accelerating Cancer Therapies)Committee, Work group, Advisory group, or Task ForceFDANCIThe 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 will initially focus 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 will be managed by the FNIH, with the Food and Drug Administration serving in an advisory role.
https://fnih.org/what-we-do/current-research-programs/partnership-for-accelerating-cancer-therapies
Full-text health-related documents at NLM (includes HSTAT) Bookshelf/Digital RepositoryResource DevelopmentAHRQ, ATSDR, CDC, CMS, FDA, SAMHSANLMThe National Library of Medicine of the National Institutes of Health provides a free, web-based resource of full-text documents that provide information on health-care decision making.
https://www.ncbi.nlm.nih.gov/books/?term=intra_hhs_collaborations%5bfilter%5d
Funding Opportunity Announcement Module (FOAM)Resource DevelopmentACF, ACL, AHRQ, CDC, CMS, FDA#VALUE!The Funding Opportunity Announcement Module (FOAM) allows National Institutes of Health (NIH) Institutes and Centers and Department of Health and Human Services (HHS) Operating Divisions to develop content for and perform the needed approvals to publish funding opportunity announcements. The system has a flexible configuration to meet all of the needs for HHS Operating Divisions. In addition FOAM serves as a Federal Shared Service in collaboration with Grant Solutions supporting other agencies including Department of the Interior, Department of Housing and Urban Development, and Department of Homeland Security. FOAM achieves economies of scale by preventing the need for individual agencies to develop duplicate systems at a cost much greater than that of developing a unified system.
Funding Opportunity Announcement: Native American Research Centers for Health (NARCH) (S06 Clinical Trials Optional)OtherIHSOD/DPCPSI/ORWH, NCI, NIGMS, NHLBI, NHGRI, NIA, NIAID, NIAMS, NIDCR, NIDDK, NIDA, NIMHD, NCCIH, NICHD, NIEHSFOA released on March 5, 2020.
https://grants.nih.gov/grants/guide/pa-files/PAR-20-125.html
Gabriella Miller Kids First Common Fund Working GroupCommittee, Work group, Advisory group, or Task ForceCDCNICHD, NCI, NEI, NHGRI, NHLBI, NIAAA, NIAMS, NIDA, NIDCR, NIDDK, NIEHS, NINDS, OD/DPCPSI/ORIPThe National Institutes of Health (NIH) Gabriella Miller Kids First Common Fund Working Group supports the goals and initiatives of the NIH Gabriella Miller Kids First Common Fund Pediatric Research Program (Kids First). Kids First is developing a data resource for the pediatric research community of well-curated clinical and genetic sequence data that will allow scientists to identify genetic pathways that underlie specific pediatric conditions but that may also be shared between apparently disparate conditions. A representative from the Centers for Disease Control and Prevention (CDC) participates in the Kids First Working Group.
https://commonfund.nih.gov/kidsfirst/overview
Genetic Studies in the National Birth Defects Prevention Study (NBDPS)Research InitiativeCDCNHGRIThis study is a collaboration between The Centers for Disease Control and Prevention (CDC) and the National Human Genome Research Institute (NHGRI) to carry out DNA sequencing and genotyping on samples collected as part of the National Birth Defects Prevention Study.
https://www.cdc.gov/ncbddd/birthdefects/nbdps.html
Genome in a Bottle Consortium (GIAB)Resource DevelopmentCDC, FDANLM, NCI, NHGRIThe "Genome in a Bottle Consortium" was organized to develop the reference materials, reference data, and reference methods needed to assess performance of human genome sequencing. It is a public-private-academic consortium hosted by NIST to develop the technical infrastructure (reference standards, reference methods, and reference data) to enable translation of whole human genome sequencing to clinical practice and innovations in technologies. The priority of GIAB is authoritative characterization of human genomes for use in benchmarking, including analytical validation and technology development, optimization, and demonstration.
https://www.nist.gov/programs-projects/genome-bottle
Genomic Surveillance at US Swine FairsResource DevelopmentCDCFIC, NIAIDThe goal of this project is to identify zoonotic influenza A viruses (IAV) that are capable of transmitting from swine to humans, causing illness and potentially igniting a global pandemic. IAVs are collected from pigs attending US agricultural fairs and genome sequenced, either in real-time using nanopore sequencing technology or later at a CEIRS network lab. Viruses collected from humans that appear to be of swine origin are also sequenced and compared to the swine viruses. Phylogenetic analysis is performed to understand how viruses from agricultural fairs in different US states are genetically related and how the virus moves between events. Serological studies are performed in youth exhibitors attending the fair to determine exposure histories.
https://www.fic.nih.gov/About/Staff/pages/epidemiology-population.aspx
GeT-RM BrowserResource DevelopmentCDCNLMThe GeT-RM Coordination Program is a Centers for Disease Control and Prevention (CDC) project for establishing a community process to create reference materials, quality control measures, and proficiency testing for genetic testing. The GeT-RM Browser is provided by National Center for Biotechnology Information (NCBI) to facilitate access to the data generated by this project, which is intended to aid evaluation of the analytical validity of next-generation sequencing assays.
https://www.ncbi.nlm.nih.gov/variation/tools/get-rm/
Global Environmental and Occupational Health (GEOHealth)Research InitiativeCDCNIEHS, FIC, NCI, OD/DPCPSI/ORWHThe Global Environmental and Occupational Health (GEOHealth) program supports the development of institutions in low- or middle-income countries (LMICs) serving as regional hubs for collaborative research, data management, training, curriculum and outreach material development, and policy support around high-priority local, national and regional environmental and occupational health threats.
https://www.fic.nih.gov/Programs/Pages/environmental-occupational.aspx
Global Health - Household Air Pollution Investigation Network (HAPIN)Research InitiativeCDCOD/DPCPSI/OSC, FIC, NCI, NHLBI, NICHD, NIEHSThe Household Air Pollution Investigation Network (HAPIN) is a large National Institutes of Health (NIH) initiative designed to tackle the challenge of reducing the burden of disease from household air pollution (HAP). Within HAPIN, an Implementation Science Network (ISN) was formed to advance the science of uptake and scale-up of clean cooking technology in the developing world. The ISN steering committee is composed of HAP experts from across NIH and various government and non-government agencies.
https://commonfund.nih.gov/globalhealth/HAPINresources
Global Health Security Agenda (GHSA) Action Package Prevent 3 (APP3), Biosafety and Biosecurity Working GroupCommittee, Work group, Advisory group, or Task ForceCDC, OSOD/OSPPromotes awareness and implementation of comprehensive national-level biosafety and biosecurity frameworks within the Global Health Security Agenda.
https://www.ghsagenda.org/
Global Ingredient Archival System (GINAS)Research InitiativeFDANCATSThe Global Ingredient Archival System is a project that aims to provide a common identifier for all of the substances used in medicinal products, utilizing a consistent definition of substances globally, including active substances under clinical investigation, consistent with the ISO 11238 standard. The FDA is utilizing software from this project to meet their obligations under the Identification of Medicinal Products (IDMP) global regulatory scheme. In 2016, the software was deployed onto FDA internal systems and FDA’s existing data was migrated into their instance (internally called Global Substance Registration Service (GSRS)). A public version of FDA’s substance definitions for use by researchers outside the agency was made available through NCATS’ website for the project.
https://ncats.nih.gov/expertise/preclinical/ginas
Global Initiative for Cancer Registry DevelopmentResource DevelopmentCDCNCICancer incidence and mortality are rising rapidly worldwide, particularly in low- and middle-income countries. There is an overwhelming need for countries to adopt and implement cancer control actions. Yet only one in five low- and middle-income countries have the necessary data to drive policy and reduce the burden and suffering due to cancer. The Global Initiative for Cancer Registry Development (GICR) is a coordinated, multi-partner approach to deliver the required change. Its objective is to make cancer data count. NCI partners with the U.S. Centers for Disease Control and Prevention to provide technical and financial support to the Caribbean Hub of GICR.
http://gicr.iarc.fr/
Global Strategic Plan to Prevent Harms Associated with Alcohol MisuseMeeting/ WorkshopCDC, SAMHSANIAAA, NICHD, NIDA, ODPThe National Institute on Alcohol Abuse and Alcoholism (NIAAA) represented the Department of Health and Human Services (HHS) at the World Health Organization (WHO), coordinating with officials at the Centers for Disease Control and Prevention (CDC) and the Substance Abuse and Mental Health Services Administration (SAMHSA) to review Global Strategies to Prevent Harms Associated with Alcohol Misuse.
Harmonization of various Common Data Models and Open Standards for Evidence GenerationResource DevelopmentFDANCATS, NCI, NLMThe goal of this project is to build data infrastructure for conducting patient-centered outcomes research using data derived from the delivery of health care in routine clinical settings. These data are collectively referred to as observational data. The sources of these data may include, but are not limited to insurance billing claims, electronic health records (EHRs), and patient registries. The Common Data Model (CDM) organizes data into a standard structure, which may differ across networks. This project intends to harmonize several existing CDMs in order to support research and analyses across multiple data networks. The aim is to advance the utility of data and its interoperability across networks to facilitate patient-centered outcomes research. The enhanced data infrastructure created through this project will have the capacity to support evidence generation on patient-centered outcomes that can inform regulatory and clinical decision making within federal programs.
HCS Research CollaboratoryResearch InitiativeAHRQ, CDC, CMS, FDA, OSOD/DPCPSI/OSC, ODPThe Health Care Systems (HCS) Research Collaboratory program is strengthening the national capacity to implement cost-effective large-scale research studies that engage health care delivery organizations as research partners. The studies funded through this program, referred to as pragmatic clinical trials, engage medical centers across the country in addressing a wide range of pressing public health concerns. The HCS Collaboratory works with representatives from the Food and Drug Administration (FDA), Agency for Healthcare Research and Quality (AHRQ), Office for Human Research Protections (OHRP), and Centers for Disease Control and Prevention (CDC) in order to bring expertise from across HHS to bear on the implementation of these complex pragmatic clinical trials.
https://commonfund.nih.gov/hcscollaboratory
Health and Retirement Study (HRS)Research InitiativeCDC, CMSNIAThis study follows more than 20,000 men and women over 50, offering insight into the changing lives of the older US population. Launched in 1992, this multidisciplinary, longitudinal study has become known as the Nation’s leading resource for data on the combined health and economic conditions of older Americans.
http://hrsonline.isr.umich.edu/
Health Information National Trends Survey (HINTS)Health SurveyONCNCIThe Health Information National Trends Survey (HINTS) regularly collects nationally representative data about the American public’s knowledge of, attitudes toward, and use of cancer- and health-related information.
https://hints.cancer.gov/
Health Information Technology Advisory Committee (HIT)Committee, Work group, Advisory group, or Task ForceAHRQ, CDC, CMS, IOSNLM, NEI, NIAID, NIAMS, NICHD, NIEHS, NIGMS, NINDSThe Health Information Technology Advisory Committee (HITAC) was established by the 21st Century Cures Act (P.L. 114-255) and is governed by the provisions of the Federal Advisory Committee Act (FACA), P.L. 92-463, as amended, 5 U.S.C. App. 2, which sets forth standards for the formation and use of federal advisory committees. The HITAC will recommend to the National Coordinator for Health Information Technology policies, standards, implementation specifications, and certification criteria relating to the implementation of a health information technology infrastructure, nationally and locally, that advances the electronic access, exchange, and use of health information. HITAC unifies the roles of, and replaces, the Health Information Technology Policy Committee and the Health Information Technology Standards Committee that were in existence before the date of the enactment of the 21st Century Cures Act. HITAC replaced the Content Standards Workgroup of the Health Information Technology (HIT) Standards Committee, which was part of the Federal Advisory Committee that was charged with making recommendations to ONC on standards, implementation specifications, and certification criteria for the electronic exchange and use of health information.
https://www.healthit.gov/hitac/committees/health-information-technology-advisory-committee-hitac
Health Information Technology Advisory Committee (HITAC)Committee, Work group, Advisory group, or Task ForceONCNLMThe Health Information Technology Advisory Committee (HITAC) was established in the 21st Century Cures Act (P.L. 114-255) and is governed by the provisions of the Federal Advisory Committee Act (FACA), P.L. 92-463, as amended, 5 U.S.C. App. 2, which sets forth standards for the formation and use of federal advisory committees. The Health Information Technology Advisory Committee (HITAC) will recommend to the National Coordinator for Health Information Technology, policies, standards, implementation specifications, and certification criteria, relating to the implementation of a health information technology infrastructure, nationally and locally, that advances the electronic access, exchange, and use of health information. HITAC unifies the roles of, and replaces, the Health Information Technology Policy Committee and the Health Information Technology Standards Committee, as in existence before the date of the enactment of the 21st Century Cures Act.
https://www.healthit.gov/hitac/committees/health-information-technology-advisory-committee-hitac
Health-professional Education Partnership Initiative (HEPI) and African Association for Health Professionals Education and Research (AFREHealth)Training InitiativeOSFIC, NINRThe Health-professional Education Partnership Initiative (HEPI) builds human capacity for health in Africa by strengthening the medical and nursing education system in an environment that values and nurtures research in President’s Emergency Plan for AIDS Relief (PEPFAR)-funded countries. HEPI aims to advance PEPFAR's goal of increasing the number of new health care workers by 140,000; strengthen in-country medical and nursing education systems; and build clinical and research capacity in Africa as part of a retention strategy for faculty of medical and nursing schools and clinical professors. The nine HEPI awards are complemented by one award for an African Association for Health Professions Education and Research, which acts as a convening and networking entity across all medical and nursing schools in Africa. The new initiatives work in collaboration with State Department's Global AIDS Coordinator.
https://www.fic.nih.gov/Programs/Pages/african-association-health-professions.aspx
HealthMap: Knowledge Management for Emerging Infectious Disease IntelligenceResearch InitiativeIOSNLMLeveraging previous National Library of Medicine (NLM) funded work under the HealthMap project, the HHS Assistant Secretary for Preparedness and Respone (ASPR) and OPEO co-funded an administrative supplement to an NLM/NIH grant to provide funding to Harvard University for a pilot project in which Harvard will develop real-time applications to collect, parse, analyze, and display open source data in order to address the national needs of emergency preparedness and response for hurricanes.
Healthy People 2020/2030 Heart Disease and Stroke Federal Work GroupCommittee, Work group, Advisory group, or Task ForceCDC, OSNINDS, NHLBIThe Healthy People Initiative sets science-based, national objectives with 10-year targets to improve the health of the nation. The HP2030 HDS Federal Work Group is responsible for creation, refinement, and tracking of HP2030 goals related to heart disease and stroke related prevention and health promotion.
https://www.healthypeople.gov/
Healthy People 2030 - Cancer WorkgroupCommittee, Work group, Advisory group, or Task ForceCDC, AHRQ, OASHNCIHealthy People provides 10-year, measurable public health objectives — and tools to help track progress toward achieving them. The Cancer Workgroup has developed Healthy People national objectives and collaborated to track and achieve progress related to cancer prevention and control.
https://health.gov/healthypeople/about/workgroups/cancer-workgroup
Healthy People 2030 - Heart Disease and Stroke WorkgroupCommittee, Work group, Advisory group, or Task ForceAHRQ, CDC, OSNHLBI, NINDSHealthy People provides science-based, 10-year national objectives for improving the health of all Americans.
https://www.healthypeople.gov/
Healthy People 2030 - Kidney DiseaseCommittee, Work group, Advisory group, or Task ForceCDC, CMS, FDA, HRSA, OSNIDDKThe Office of the Secretary of Department of Health and Human Services (HHS) leads the Healthy People 2030 initiative. The lead agency for most data activities is the Centers for Disease Control and Prevention (CDC). However, for the kidney area, most of the information is provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) through the US Renal Data System.
https://health.gov/healthypeople
Healthy People 2030 - Nutrition and Weight Status WorkgroupCommittee, Work group, Advisory group, or Task ForceCDC, FDA, OASHOD/DPCPSI/ONR, NIDDKThe Nutrition and Weight Status group develops goals based on strong science supporting the health benefits of eating a healthful diet and maintaining a healthy body weight. The objectives also emphasize that efforts to change diet and weight should address individual behaviors, as well as the policies and environments that support these behaviors in settings such as schools, worksites, health care organizations, and communities.
https://health.gov/healthypeople/about/workgroups/nutrition-and-weight-status-workgroup
Healthy People 2030 - Respiratory DiseasesHealth SurveyCDCNHLBI, NIA, NICHD, NIDA, NIDDK, NIMHD, NINDS, NINR, OD/DPCPSI/OBSSR, OD/DPCPSI/ODSThe purpose of the collaborative activity is to support the identification of nationally representative measures that could be used to assess progress towards achieving Healthy People respiratory disease objectives. The National Heart, Lung and Blood Institute leads this activity.
https://www.healthypeople.gov/2020/About-Healthy-People/Development-Healthy-People-2030
Healthy People 2030 - Sleep HealthHealth SurveyCDCNHLBI, NIA, NICHD, NIDA, NIDDK, NIMHD, NINDS, NINR, OD/DPCPSI/OBSSR, OD/DPCPSI/ODSThe purpose of the collaborative activity is to support the identification of nationally representative measures that could be used to assess progress towards achieving Healthy People sleep health objectives. The National Heart, Lung and Blood Institute leads this activity.
https://health.gov/healthypeople/objectives-and-data/browse-objectives/sleep
Healthy People 2030 - Social Determinants Working GroupCommittee, Work group, Advisory group, or Task ForceACF, CDC, HRSA, OASH, SAMHSA, PSC, FDANIMHD, NIA, NCI, NIAAAThe overarching goals for Healthy People 2020 incorporate a focus on social determinants of health as well as on health outcomes and risk factors. The Working Group intends to develop objectives for the social determinants and methods to ensure their integration across all Healthy People 2020 objectives.
https://www.healthypeople.gov/2020/about/history-development/Federal-Interagency-Workgroup
Healthy People 2030 Disability and Health Work GroupCommittee, Work group, Advisory group, or Task ForceACL, CDCNICHDHealthy People is a national effort that sets goals and objectives to improve the health and well-being of people in the United States. Every decade, the Healthy People initiative develops a new set of science-based, 10-year national objectives with the goal of improving the health of all Americans. Healthy People 2030 is the fifth edition of Healthy People. It aims at new challenges and builds on lessons learned from its first 4 decades. The development of Healthy People 2030 includes establishing a framework for the initiative—the vision, mission, foundational principles, plan of action, and overarching goals—and identifying new objectives. The development of Healthy People 2030 is a multiyear process with input from a diverse group of subject matter experts, organizations, and members of the public. The framework explains the central ideas and function of the Healthy People 2030 initiative and it will guide the selection and prioritization of 2030 objectives.
https://www.healthypeople.gov/2020/About-Healthy-People/Development-Healthy-People-2030
Healthy People InitiativeCommittee, Work group, Advisory group, or Task ForceACL, AHRQ, CDC, FDA, HRSA, IHS, OS, SAMHSAODP, NCI, NEI, NHLBI, NIA, NIAID, NIAMS, NICHD, NIDA, NIDCR, NIDCD, NIDDK, NIEHS, NIMH, NINDSHealthy People provides science-based national goals and objectives with 10-year targets designed to guide national health promotion and disease prevention efforts to improve the health of all Americans. As part of its mission, Healthy People has established benchmarks and monitored progress over three decades in order to (1) engage multiple sectors to strengthen policies and improve practices that are driven by the best available evidence and (2) to increase public awareness of the determinants of health, disease, and disability and the opportunities for progress. Healthy People published a mid-course review in 2017 and can be found here: https://archive.cdc.gov/#/details?url=https://www.cdc.gov/nchs/healthy_people/hp2020.htm Office of Disease Prevention (ODP) serves as the official National Institutes of Health (NIH) liaison to the Healthy People program. ODP and NIH staff have been engaged in the HHS-wide effort to develop the objectives, targets, and evidence base for Healthy People 2030.
https://www.healthypeople.gov/
Healthy People Initiative - Visual HealthHealth SurveyAHRQ, CDCNEI, ODPHealthy People Initiative is a collaboration with the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the Agency for Healthcare Research and Quality (AHRQ) to survey and measure public health outcomes for a variety of common diseases over the current decade. The National Eye Institute's (NEI) goal for this program is to Improve the visual health of the Nation through prevention, early detection, timely treatment, and rehabilitation.
https://www.healthypeople.gov/
Healthy Vision MonthPublic Education CampaignCDCNEIEach May the National Eye Institute (NEI) sponsors Healthy Vision Month (HVM), which is a national observance designed to elevate eye health as a priority for Americans. The National Institutes of Health (NIH) has worked with the Centers for Disease Control and Prevention (CDC) and recently with the Office of the Surgeon General to spotlight on the connection between eye health and overall health.
http://www.nei.nih.gov/hvm/
Helicobacter pylori Genome Project (HpGP)Research InitiativeCDCNCI, NLMInvestigators in the Infections and Immunoepidemiology Branch and the Metabolic Epidemiology Branch of DCEG are undertaking a joint effort to catalog comprehensively bacterial genetic and epigenetic variation potentially related to long-term outcomes of infection. Isolates from patients with gastric cancer or advanced premalignant lesions are compared to controls with benign infection (superficial gastritis) from the same geographic area. The study goal is to sequence 1000 strains representing both high and low gastric cancer risk populations worldwide, with over 750 isolates from 50 different countries completed to date. An international team of experts is collaborating on analyses of these complex data to identify associations with the gastric carcinogenesis cascade.
https://dceg.cancer.gov/research/how-we-study/genomic-studies/h-pylori-genome-project
Hepatitis B Research NetworkResearch InitiativeCDCNIDDK, NCIThe Hepatitis B Research Network (HBRN) was established in 2008 to advance understanding of disease processes and natural history of chronic hepatitis B, as well as to develop effective approaches to treatment with currently available therapies. The Network brings together clinical centers from throughout the US and Canada. This multi-center Network is enrolling patients in multiple clinical trials in both adults and children with hepatitis B.
http://www.hepbnet.org/
HHS Action Plan for the Prevention, Care, and Treatment of Viral Hepatitis Interagency Implementation Group (VHIG)Research InitiativeAHRQ, CDC, CMS, FDA, HRSA, IHS, SAMHSANIDA, NIAID, NIDDK, NIMHDThe Department of Health and Human Services (HHS) agencies review the Institute of Medicine (IOM) recommendations and develop a comprehensive strategic viral hepatitis action plan that would: address IOM recommendations for viral hepatitis prevention, care, and treatment; set forth actions to improve viral hepatitis prevention and ensure that infected persons are identified and provided care and treatment; and improve coordination of all activities related to viral hepatitis across HHS and promote collaborations with other government agencies and nongovernmental organizations.
https://www.hhs.gov/hepatitis/viral-hepatitis-action-plan/index.html
HHS Adult Maltreatment Prevention Working GroupCommittee, Work group, Advisory group, or Task ForceACF, ACL, AHRQ, CDC, CMS, HRSA, IHS, OS, SAMHSANIATo discuss department-wide interests and priorities.
HHS Antiretroviral Treatment Guidelines Panel for Adults and Adolescents with HIVCommittee, Work group, Advisory group, or Task ForceHRSA, CDC, FDANIAIDThe Panel was formed in 1996, to provide guidelines for clinicians for adult and adolescents with HIV. The Panel is a working group of the NIH Office of AIDS Research Council. One of the co-chairs of the Panel is Dr. Cliff Lane of NIAID, the executive secretary is Alice Pau of NIAID. The Panel updates the guidelines annually, and more frequently if needed.
https://clinicalinfo.hiv.gov/en/guidelines/adult-and-adolescent-arv/whats-new-guidelines
HHS Biannual Dual Use Research of Concern (DURC) InventoryResource DevelopmentCDC, FDA, OSOD/OSP, CC, FIC, NCATS, NCCIH, NCI, NEI, NHGRI, NHLBI, NIA, NIAAA, NIAID, NIAMS, NIBIB, NICHD, NIDA, NIDCD, NIDCR, NIDDK, NIEHS, NIGMS, NIMH, NIMHD, NINDS, NINR, NLM, OD/DPCPSIDevelops the Department of Health and Human Services (HHS) Biannual Dual Use Research of Concern (DURC) inventory reports, as required by the United States Government (USG) Policy for Oversight of Dual Use Research of Concern.
HHS Biosafety and Biosecurity Coordinating Council (HHS BBCC)Committee, Work group, Advisory group, or Task ForceCDC, FDA, OSOD/OSP, OD/ORSHigh-level and formal mechanism for coordinating and collaborating on biosafety and biosecurity issues across the Department of Health and Human Services.
HHS Border Health Intra-agency Working GroupCommittee, Work group, Advisory group, or Task ForceACF, AHRQ, CDC, FDA, HRSA, OSNICHD, NIA, NIAID, NIDDK, NIMH, NIMHDThis intra-agency workgroup allows for the exchange of information and cooperation among the Department of Health and Human Services (HHS) agencies on issues related to border health. The purpose of this group is to convene HHS components that have a vested interest in US-Mexico border health issues to provide a platform for discussion, coordinate efforts, and potentially identify mutual areas of collaboration to improve the health and quality of life for border residents.
HHS Cessation WorkgroupCommittee, Work group, Advisory group, or Task ForceAHRQ, CDC, HRSA, CMS, FDA, SAMHSA, IOSNCI, NIDA, NHLBI, NICHDDiscussion of current HHS initiatives on efforts to support smoking cessation.
HHS DATA Act ComplianceCommittee, Work group, Advisory group, or Task ForceASFROD/OER, OD/OM/NBSThe HHS Assistant Secretary for Financial Resources (ASFR) coordinates OPDIV activities including communications, implementation, and compliance with the DATA Act.
HHS Data CouncilCommittee, Work group, Advisory group, or Task ForceACF, ACL, AHRQ, ASA, ASFR, ASPA, ASPE, ASPR, ATSDR, CDC, CMS, FDA, GDM, HRSA, IHS, ONC, OMHAOD/OER, NLM, OD/DPCPSI/OBSSR, OD/DPCPSI/ODSSThe HHS Data Council is the principal internal advisory body to the Secretary on health and human services data policy. The Council coordinates data collection and analysis activities in HHS, including an integrated data collection strategy as well as coordination of health data standards and privacy policy. The Council consists of senior level officials designated by their agency and staff office heads, the director of the national center for health statistics, and the HHS privacy advocate. It is co-chaired by the Assistant Secretary for Planning and Evaluation on a permanent basis and the head of an operating division on a rotating basis. A subcommittee of the HHS Data Council, the Data-Oriented Workforce Subcommittee, is composed of staff from 10 HHS agencies, including the NIH. This subcommittee is charged with developing a high-level work plan to enhance the data science capacity of HHS’ workforce by identifying training opportunities for existing staff, recruitment strategies and tools to hire new staff, and retention and succession planning strategies to sustain the data science workforce.
https://aspe.hhs.gov/health-and-human-services-hhs-data-council
HHS Data Council Data-Oriented Workforce SubcommitteeCommittee, Work group, Advisory group, or Task ForceAHRQ, CDC, CMS, FDANCATS, NLM, OD/IMOD, OD/OIRDevelop a high-level work plan, for year 1, to enhance the data science capacity of the Department of Health and Human Services (HHS) workforce by identifying training opportunities for existing staff, recruitment strategies and tools to hire new staff, and retention and succession planning strategies to sustain the data science workforce.
https://www.cdc.gov/maso/facm/pdfs/ACDCDC/ACD_CDC_October-20-2016_MeetingMinutes508c.pdf
HHS Dietary Guidance Review CommitteeCommittee, Work group, Advisory group, or Task ForceACF, CDC, FDA, HRSA, IHS, OASHOD/DPCPSI/ONR, NIDDKThis committee reviews draft nutrition materials developed by all federal agencies and fulfills the legislative mandate (1990 NNMRRA) to ensure that Federal dietary guidance is consistent with the Dietary Guidelines for Americans and is scientifically accurate.
HHS Disability CollaborativeCommittee, Work group, Advisory group, or Task ForceACL, AHRQ, ASPA, ASPE, ASFR, ASA, ASPR, ACF, CDC, CMS, OASH, OCR, ONC, OIG, OGA, HRSA, SAMHSA, FDA, IHSNIA, NICHDThe HHS Collaborative is for OpDivs and StaffDivs to work in partnership on issues that impact person with disabilities. This group will address emerging issues, funding announcements, research and evaluation, pre-clearance conversations, special events, announcements, and rollouts. Anticipated results includes enhanced communication across agencies, elevated focus on key disability issues, improved awareness and coordinated messaging, alignments of budgets and policy proposal, and enhanced knowledge transfer across HHS. This is not a governing body. The lead organizations are ACL and ASPE.
HHS Environmental Justice and Natural Disasters Working Group (EJ)Committee, Work group, Advisory group, or Task ForceASPR, OASH, CDC, HRSANIEHSEnvironmental Justice is “the fair treatment and meaningful involvement of all people regardless of race, color, national origin, or income with respect to the development, implementation, and enforcement of environmental laws, regulations, and policies”. Executive Order 12898, Federal Actions to Address Environmental Justice in Minority Populations and Low-income Populations requires each Federal agency to “make achieving environmental justice part of its mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of its programs, policies, and activities on minority populations and low-income populations.” The Executive Order also states that “each Federal agency responsibility set forth under this order shall apply equally to Native American programs.”
https://www.hhs.gov/environmental-justice/index.html
HHS Global Health CollaborativeCommittee, Work group, Advisory group, or Task ForceACF, ACL, AHRQ, ATSDR, CDC, CMS, FDA, HRSA, IHS, OS, OSG, SAMHSANIMHThis interagency working group meets to provide a forum within the Department of Health and Human Services (HHS) that identifies Global Health issues relevant to the HHS Global mental health agenda.
HHS Health Disparities CouncilCommittee, Work group, Advisory group, or Task ForceAHRQ, CDC, CMS, FDA, HRSA, OS, SAMHSANIMHDThe Department of Health and Human Services (HHS) Health Disparities Council serves as the venue to share information, leverage HHS investments, coordinate HHS activities, reduce program duplication, and track progress on the strategies and actions of the HHS Disparities Action Plan.
HHS HIV Bidirectional Meeting Planning CommitteeCommittee, Work group, Advisory group, or Task ForceCDC, FDA, HRSA, OS, SAMHSANIAID, NIMHPlanning committee for June 26, 2019 meeting for the Department of Health and Human Services (HHS) global and domestic policy and program leaders to share successful strategies and lessons learned, and to discuss potential adaptations to enable the transfer/implementation of proven strategies among new environments.
HHS Kidney Care Work GroupCommittee, Work group, Advisory group, or Task ForceCDC, FDA, OSNIAIDThe goals of the Department of Health and Human Services (HHS) Kidney Care Work Group are to 1) reduce the number of new patients needing organ transplants by 25% by 2030; 2) provide healthier options for those on life-saving protocols so that 80 % of dialysis patients can be treated by alternatives to current dialysis by 2025; and 3) expand the supply of organs 3 fold by 2025.
HHS LGBT Policies Coordinating CommitteeCommittee, Work group, Advisory group, or Task ForceACF, ACL, AHRQ, ATSDR, CDC, CMS, FDA, HRSA, IHS, OS, OSG, SAMHSAOD/DPCPSI/SGMRO, NIMHThe Department of Health and Human Services (HHS) Lesbian, Gay, Bisexual and Transgender (LGBT) Policy Coordinating Committee is comprised of senior representatives from each division of HHS. This committee coordinates the exchange of information about LGBT-related policies across the department, and provides a mechanism for both collecting and disseminating this information across operating divisions.
https://www.hhs.gov/programs/topic-sites/lgbt/reports/index.html
HHS Maternal Health Working GroupCommittee, Work group, Advisory group, or Task ForceACF, ACL, AHRQ, ASPE, ASFR, CDC, CMS, FDA, HRSA, IHS, ONC, IOS, ATSDR, SAMHSANHLBI, NICHD, OD/DPCPSI/ORWHLed by the Deputy Assistant Secretary for Women's Health and Director of the Office on Women’s Health in the Office of the Assistant Secretary for Health (OASH). This working group stimulates and coordinates within and cross-Agency efforts to mitigate the rising rate of U.S. maternal morbidity and mortality
HHS Noise-Induced Hearing Loss Federal Partner Working GroupCommittee, Work group, Advisory group, or Task ForceCDCNIDCDWork group to coordinate and collaborate the Department of Health and Human Services (HHS) activities and messages related to noise-induced hearing loss. Federal partners include the National Institutes of Health (NIH) National Institute on Deafness and Other Communication Disorders and the Centers for Disease Control and Prevention (CDC) National Center for Environmental Health and National Institute for Occupational Safety and Health.
HHS Office on Women's Health, Section on Pregnancy and Newborn CareCommittee, Work group, Advisory group, or Task ForceOS, SAMHSANICHD, NIMHThe National Institutes of Health (NIH) scientists work together with other Department of Health and Human Services (HHS) experts to develop and review content for HHS public-facing websites, including the womenshealth.gov website.
http://www.womenshealth.gov
HHS Panel for the Prevention and Treatment of Opportunistic Infections in HIV-Exposed and HIV-Infected ChildrenCommittee, Work group, Advisory group, or Task ForceCDCNICHD, OD/DPCPSI/OARThis committee has the purpose of updating the U.S. Pediatric opportunistic infection prevention and treatment guidelines for HIV-Exposed and HIV-Infected Children and serves as executive secretary. These guidelines are developed by a panel of specialists in pediatric HIV infection and infectious diseases (the Panel on Opportunistic Infections in HIV-Exposed and HIV-Infected Children) from the U.S. government and academic institutions. The Panel is a working group of the Office of AIDS Research Advisory Council. For each OI, one or more pediatric specialists with subject-matter expertise reviews the literature for new information since the last guidelines were published, and then proposes revised recommendations for review by the full Panel. After these reviews and discussions, the guidelines undergo further revision, with review and approval by the Panel, and final review and endorsement by the National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), the HIV Medicine Association (HIVMA) of the Infectious Diseases Society of America (IDSA), and the Pediatric Infectious Disease Society (PIDS). The Panel also received input from the American Academy of Pediatrics (AAP).
https://aidsinfo.nih.gov/contentfiles/lvguidelines/adult_oi.pdf
HHS Panel on Antiretroviral Guidelines for Adults and AdolescentsCommittee, Work group, Advisory group, or Task ForceCDC, FDA, HRSANICHD, NIAID, OD/DPCPSI/OARThe Department of Health and Human Services (HHS) Panel on Antiretroviral Guidelines for Adults and Adolescents (the Panel) is a working group of the Office of AIDS Research Advisory Council (OARAC). The primary goal of the Panel is to provide HIV care practitioners with recommendations based on current knowledge of antiretroviral drugs (ARVs) used to treat adults and adolescents with HIV in the United States. The Panel reviews new evidence and updates recommendations when needed. These guidelines include recommendations on baseline laboratory evaluations, treatment goals, benefits of ART and considerations when initiating therapy, choice of the initial regimen for ART-naive patients, ARV drugs or combinations to avoid, management of treatment failure, management of adverse effects and drug interactions, and special ART-related considerations in specific patient populations.
https://aidsinfo.nih.gov/contentfiles/lvguidelines/adultandadolescentgl.pdf
HHS Panel on Antiretroviral Therapy and Medical Management of Children Living with HIVCommittee, Work group, Advisory group, or Task ForceCDC, FDA, HRSANICHD, NIAID, OD/DPCPSI/OARThis committee has the purpose of updating the U.S. Pediatric HIV treatment guidelines and serves as executive secretary. The Department's Panel on Antiretroviral Therapy and Medical Management of HIV-Infected Children (the Panel), a working group of the Office of AIDS Research Advisory Council, reviews new data on an ongoing basis, and provides regular updates to the guidelines. The guidelines are available on the AIDSinfo website. These updated guidelines address the use of combination antiretroviral therapy for HIV-infected infants, children, and adolescents. Guidance on management of adverse events associated with use of antiretroviral drugs in children and a detailed review of information about safety, efficacy, and pharmacokinetics of antiretroviral agents in children is also included.
https://aidsinfo.nih.gov/guidelines
HHS Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal TransmissionCommittee, Work group, Advisory group, or Task ForceCDC, FDA, HRSANICHD, NIAID, OD/DPCPSI/OARAlso called 'Recommendations for the Use of Antiretroviral Drugs in Pregnant Women with HIV Infection and Interventions to Reduce Perinatal HIV Transmission in the United States'. These Guidelines update the October 2016 Perinatal Guidelines. The Department of Health and Human Services Panel on Treatment of Pregnant Women Living with HIV and Prevention of Perinatal Transmission (the Panel), a working group of the Office of AIDS Research Advisory Council, develops these guidelines. The guidelines provide health care providers with information for discussion with pregnant women living with HIV infection to enable collaborative, informed decision-making regarding the use of ARV drugs during pregnancy, use of scheduled cesarean delivery to reduce perinatal transmission of HIV, and decision-making around the use of ARV drugs for prophylaxis of infants exposed to HIV. The recommendations in these Guidelines are accompanied by a discussion of various circumstances that commonly occur in clinical practice and the factors that influence treatment considerations. The Panel recognizes that strategies to prevent perinatal transmission and concepts related to management of HIV in pregnant women are rapidly evolving and will consider new evidence and adjust recommendations accordingly. The updated guidelines are available from the AIDSinfo website http://aidsinfo.nih.gov.
https://aidsinfo.nih.gov/contentfiles/lvguidelines/perinatalgl.pdf
HHS Potential Pandemic Pathogens Care and Oversight Review GroupCommittee, Work group, Advisory group, or Task ForceCDC, FDA, OSOD/OSP, NIAIDEvaluates proposed research being considered for Department of Health and Human Services (HHS) funding that is anticipated to create, transfer, or use enhanced potential pandemic pathogen (enhanced PPP)--as defined in the Department of Health and Human Services Framework for Guiding Funding Decisions about Proposed Research Involving Enhanced Potential Pandemic Pathogens (HHS P3CO Framework)--to inform agency funding decisions.
HHS SARS-CoV-2 Assay Development Task ordersResource DevelopmentBARDANIAIDAssays are being developed, qualified and validated to be shared across government studies
HHS SARS-CoV-2 Immune Assay Testing of Ph3 clinical samples- Task OrderResource DevelopmentBARDANIAIDCoordination of testing of Phase 3 clinical samples from Operation War Speed (OWS) peformers in OWS Assays (Microneutralization assay)
HHS Tick-Borne Diseases Working GroupCommittee, Work group, Advisory group, or Task ForceCDC, CMS, FDA, OSNIAIDThe Tick-Borne Disease Working Group was established by Congress in 2016 as part of the 21st Century Cures Act to provide subject matter expertise and to review federal efforts related to all tick-borne diseases, to help ensure interagency coordination and minimize overlap, and to examine research priorities. The focus of this effort is the development of a report to the Secretary of Health and Human Services and Congress on the findings and any recommendations of the Working Group for the federal response to tick-borne disease prevention, treatment, and research, as well as how to address gaps in these areas.
https://www.hhs.gov/ash/advisory-committees/tickbornedisease/index.html
HHS Viral Hepatitis Interagency Working GroupCommittee, Work group, Advisory group, or Task ForceAHRQ, CDC, CMS, FDA, HRSA, IHS, OS, SAMHSANIDDK, NIDA, NIAID, OD/DPCPSI/OARThe Department of Health and Human Services (HHS) Viral Hepatitis Interagency Working Group was created by the Office of the Assistant Secretary for Health to address a report sponsored by the Institute of Medicine entitled Hepatitis and Liver Cancer: A National Strategy for Prevention and Control of Hepatitis B and C. The group meets to discuss collaborations and activities directed at achieving the goals for viral hepatitis research and control highlighted in the IOM report. (Although the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the National Institute on Drug Abuse (NIDA) represent the National Institutes of Health (NIH) as Working Group members, other NIH Institutes/Centers/Offices also provide input to the VHIG through their participation in the Trans-NIH Committee on Viral Hepatitis.) The working group helped develop the 2021-2025 Viral Hepatitis National Strategic Plan.
https://www.hhs.gov/hepatitis/viral-hepatitis-national-strategic-plan/national-viral-hepatitis-action-plan-overview/index.html
HHS Zika Vaccine Testing Task Orders CoordinationResource DevelopmentBARDANIAIDZika vaccine testing contract efforts are being coordinated through this Department of Health and Human Services (HHS) partner meeting.
HHS-NASA Scientific Potential/Actual Collaborative Efforts (SPACE) groupCommittee, Work group, Advisory group, or Task ForceACL, CDC, FDANCATS, FIC, NCI, NEI, NHLBI, NIA, NIAID, NIAMS, NIBIB, NICHD, NIDCR, NIDDK, NIEHS, NIMH, NIMHD, NINDS, OD/IMODScientific interest group joint with the National Aeronautics and Space Administration (NASA) and other Department of Health and Human Services (HHS) OpDivs convened to explore areas of potential joint collaborative interest.
https://sites.google.com/ncats.nih.gov/nihnasa/home
HHS-wide Stigma Scientific Interest Group (Stigma SIG)Committee, Work group, Advisory group, or Task ForceCDC, HRSA, FDA, SAMHSA, IHSFIC, NIMH, NCI, NIDA, NIAAA, NINDS, NICHD, OD/DPCPSI/OBSSR, NIMHD, NINR, NIAID, NIDCRInteragency working group focused on coordinating activities and sharing information related to health-related stigma research. The group meets monthly to update one another on related grant programs, upcoming conference opportunities, discuss emerging research on stigma reduction methods and interventions, and listen to/discuss presentations from invited stigma research experts.
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HHS-Wide Stigma WorkgroupResource DevelopmentCDC, FDA, HRSA, IHS, SAMHSANIMHBuilding on the momentum of the 2019 BMC Medicine Stigma Collection and the 2019 NIMH Global Mental Health Webinar, representatives from the National Institutes of Health (NIH) formed a Stigma Planning Workgroup to harness the momentum of the 2019 BMC Medicine Stigma Collection and the 2019 NIMH Global Mental Health Webinar and to coordinate and chart a course forward for research related to stigma. The overall goal was to provide leadership, vision, and support to stigma research funded by the NIH. As the NIH-focused workgroup started to meet and gain traction, other federal partners expressed interest in joining. For example, staff from the Centers for Disease Control and Prevention (CDC), Health Resources and Services and Administration (HRSA), Indian Health Services (IHS), Food and Drug Administration (FDA), and Substance Abuse and Mental Health Services Administration (SAMHSA) joined as well. Thus, moving forward this workgroup consists of Health and Human Services (HHS) partners aiming to promote cross-cutting stigma research and related activities and to enhance opportunities for knowledge transfer and collaborative learning in the field of stigma and discrimination research. To achieve this goal, the workgroup agrees to pursue several broad actions, including: (1) Clearly defining stigma and discrimination for the purpose of the workgroup; (2) Organizing a speaker’s series to understand current stigma research findings, and interests within each federal agency; (3) Identifying and defining current stigma and discrimination research successes and challenges within each agency; (4) Identifying shared and individual priorities for each agency and how future activities could address identified challenges; (5) See enclosed list of HHS partner interests; (6) Advancing stigma and discrimination research training to build knowledge and skills among stigma-focused researchers and among other researchers seeking to increase capacity to conduct high-quality stigma and discrimination research; (7) Advancing the broader dissemination of stigma-related research; (8) Aligning technical assistance efforts to support one another; and (9) Supporting cross-cutting stigma and discrimination research as a field.
HHS/Office of the Secretary, Office of the Assistant Secretary for Planning and Evaluation (OS-ASPE) - Reentry/Criminal Justice Working |Group.Committee, Work group, Advisory group, or Task ForceCDC, CMS, HRSA, SAMHSANHLBI, NIDA, NIMHThrough the Federal Interagency Reentry Council, federal agencies are working together to enhance community safety and well-being, assist those returning from prison and jail in becoming productive citizens, and save taxpayer dollars by lowering the direct and collateral costs of incarceration. Because reintegration to the community after incarceration intersects with issues of health, housing, education, employment, family, faith, and community well-being, the U.S Department of Health and Human Services (HHS) and other federal agencies are focusing on the reentry population with activities that aim to improve outcomes in these areas.
https://aspe.hhs.gov/incarceration-reentry
HIV Implementation Science Summit for Ending the HIV Epidemic (EHE) Supplement ProjectsMeeting/ WorkshopCDC, HRSANIAID, NICHD, NIDA, NIMH, OD/DPCPSI/OARThis HIV Implementation Science Summit brought together investigators, implementation partners, and federal agencies to identify approaches for using implementation science to end the HIV epidemic in the United States. Attendees learned about (1) the projects responding to the EHE initiative through science–practice partnerships, (2) key implementation science concepts and methods and examples of how these are applied in HIV research, and (3) capacity-building services provided by the Implementation Science Coordination, Consultation, and Collaboration Initiative (ISC3I) coordinating center.
HIV Pre-exposure Prophylaxis (PrEP) Implementation Science in HRSA Primary Health Care SettingsResearch InitiativeHRSANIMHThe National Institute of Mental Health (NIMH) Division of AIDS Research (DAR) collaborated with the Health Resources and Services Administration (HRSA) HIV/AIDS Bureau and Bureau of Primary Health Care to develop a research funding opportunity (NOT-MH-020-050) which aims to support implementation science on the scale-up of HIV prevention services within selected HRSA-funded health centers under the federal Ending the HIV Epidemic initiative. The funding opportunity provides one-year administrative supplements to NIH research awards that would work collaboratively with personnel at a partnering HRSA-funded health center(s) to understand and enhance their delivery of HIV testing and/or HIV pre-exposure prophylaxis (PrEP) by concurrently answering key research questions of import to the clinics as well as the wider HIV prevention community. Three applications were funded from this opportunity, and NIMH/DAR will continue to inform the HRSA Bureau of Primary Health Care on progress and outcomes, and plan for future collaboration.
HIV/AIDS Cancer Match Study (HACM)Research InitiativeCDCNCIA study linking HIV and cancer registries in multiple US regions to evaluate the spectrum of cancer risk in people living with HIV
https://hivmatch.cancer.gov
Hospice to Palliative Care: Maximizing Patient Preferences and Cost SavingsResearch InitiativeAHRQCCThe goal of the study is to provide rational, patient-defined, evidence-based recommendations to inform the redesign of the Medicare hospice benefit, transitioning policy from the current hospice benefit to a more patient-centered palliative care model.
http://grantome.com/grant/NIH/R01-HS018360-01
HRSA Advancing Precision Medicine (HRSA APM)Committee, Work group, Advisory group, or Task ForceHRSAOD/AoUIn 2018, HRSA awarded $456K to 40 HRSA FQHCs to work on engagment activites and EHR sharing for AoU. The period of performance ran through SEptember 2020 with some FQHCs operating on a No Cost Extension through December 2020. NIH continues to meet with HRSA monthly to discuss the potential for future opportunities to add FQHCs to the All of Us Research Program.
HRSA Maternal and Child Health Bureau Grand Challenges: Promoting Pediatric Primary Prevention ("P4 Challenge") Federal JudgeMeeting/ WorkshopCDC, CMS, HRSANICHDThis challenge supports innovative innovative approaches to increase well-child visits and immunizations within primary care settings. This is a HRSA/MCHB-led initiative
https://www.challenge.gov/challenge/promoting-pediatric-primary-prevention/
HRSA Maternal and Child Health Bureau Grand Challenges: remote pregnancy monitoring panelistResearch InitiativeCDC, CMS, HRSANICHDThis challenge supports innovative technology-based solutions that help providers remotely monitor the health of pregnant women, and empower women to make informed decisions about their own care. The goal of this challenge is to use technology to allow women facing various barriers to care to experience the benefits of an ongoing relationship with a health-care provider to keep them and their children healthy.
https://mchbgrandchallenges.hrsa.gov/challenges/remote-pregnancy-monitoring
HSS Maternal Mortality Working groupCommittee, Work group, Advisory group, or Task ForceHRSA, CDCOD/DPCPSI/ORWH, NICHDServes as an ORWH representative on the HHS Office of Women's Health Working Group
Human Papillomavirus (HPV) Working Group for the Advisory Committee on Immunization Practices (ACIP)Committee, Work group, Advisory group, or Task ForceCDCNCIThe Human Papillomavirus (HPV) Working Group for the Advisory Committee on Immunization Practices (ACIP) Work Groups (WGs) serves in a key scientific role in support of vaccine policy development by the ACIP. ACIP WGs conduct extensive background reviews of relevant research data to develop options for recommendations for use of vaccines in the civilian population of the United States. WGs are convened solely to gather scientific information related to vaccines and the diseases they prevent, to analyze relevant issues and data, and to draft policies or options for review, deliberation, and vote by the ACIP.
Human skin sensitization data setResearch InitiativeFDANIEHSNICEATM and collaborators collected data for over 2,300 human predictive patch tests from more than 1,700 publications.
I-Corps @ NIHTraining InitiativeCDCNCI, NCATS, NCCIH, NHGRI, NHLBI, NIA, NIAAA, NIAID, NICHD, NIDA, NIDCD, NIDCR, NIEHS, NIMH, NINDSThe I-Corps™ at the National Institutes of Health (NIH) program is focused on educating researchers and technologists on how to translate technologies from the lab into the marketplace. The program is designed to provide three-member project teams with access to instruction and mentoring in order to accelerate the translation of technologies currently being developed with NIH and the Centers for Disease Control and Prevention (CDC) Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) funding. It is anticipated that outcomes for the I-Corps™ teams participating in this program will include significantly refined commercialization plans and well-informed pivots in their overall commercialization strategies.
https://sbir.cancer.gov/programseducation/icorps
IAA with FDA - Using big data to compare SARS-CoV-2 infection and therapeutic efficacy between human lung on a chip and animal model testingResource DevelopmentFDANIAIDThis collaboration will allow the development of in vitro organ on a chip technology for modeling of SARS-CoV-2 infection, identification of biomarkers and transcriptomic and tissue expression imaging by MIBI/CODEX. The data collected from the organ on a chip systems will then be compared to ongoing analysis of human clinical samples and parallel testing in animal models of COVID.
ICCVAM Ecotoxicology Workgroup (EcoWG)Committee, Work group, Advisory group, or Task ForceFDANIEHSICCVAM workgroup that provides expertise in identifying and evaluating in vitro and in silico methods to identify ecological and environmental hazards.
https://ntp.niehs.nih.gov/go/iccvam-wg
ICCVAM In Vitro to In Vivo Extrapolation Workgroup (IVIVE-WG)Committee, Work group, Advisory group, or Task ForceATSDR, FDANIEHS, NLMICCVAM workgroup established to catalog and evaluate currently available IVIVE approaches, to determine their suitability for specific research or regulatory purposes, and to assess whether additional tools or models are needed.
https://ntp.niehs.nih.gov/go/iccvam-wg
ICCVAM Metrics Workgroup (MWG)Committee, Work group, Advisory group, or Task ForceFDANIEHS, ODICCVAM workgroup established to develop objectives and determine how agencies can best address the recommendations in the 2019 GAO report, "Animal Use in Research"
https://ntp.niehs.nih.gov/go/903258
ICCVAM Nanomaterials Workgroup (NanoWG)Committee, Work group, Advisory group, or Task ForceFDA, CDCNIEHSICCVAM workgroup established to evaluate the suitability of alternative methods to assess potential toxicity of nanomaterials.
https://ntp.niehs.nih.gov/go/iccvam-wg
ICCVAM Public ForumMeeting/ WorkshopFDANIEHS, NCATSICCVAM holds annual public forums to promote national and international partnerships between governmental and nongovernmental groups, including academia, industry, advocacy groups, and other key stakeholders. The 2020 Public Forum was held on May 21.
https://ntp.niehs.nih.gov/go/iccvamforum-2020
ICCVAM Read Across Workgroup (RAWG)Committee, Work group, Advisory group, or Task ForceATSDR, FDANIEHS, NLMICCVAM workgroup established to build read-across capacity within member agencies, raise awareness of the state of the science, and work towards harmonization of read-across approaches.
https://ntp.niehs.nih.gov/go/iccvam-wg
Image-guided Interventional TherapeuticsResearch InitiativeFDACC, NCIThis collaboration will lead to safer and more effective treatment planning and performance of image-guided interventions and therapeutic drug delivery. The results of all of these studies of image-guided interventions and related technologies and the models used to study them will have a direct impact on the effectiveness and consistency of the Food and Drug Administration (FDA) Center for Devices and Radiological Health's preclinical review of device applications while meeting the primary research goal of optimizing image-guided interventions and pre-clinical modeling of those interventions. Regulatory science and translational therapeutics have overlapping goals when it comes to drugs and devices combination therapies.
Immunology Interest GroupMeeting/ WorkshopFDANCI, NIDDK, NHLBI, NIAID, NINDS, NIEHS, CC, NIAMS, NEI, NIDCR, NICHD, NIAAA, NIMH, NHGRIThe National Institute of Health (NIH) Immunology Interest Group (IIG) brings together immunologists from across all NIH institutes as well as the Food and Drug Administration (FDA). The two major activities of the IIG are a Wednesday afternoon lecture series highlighting world-class immunologists and intramural immunologists and an annual workshop where up to 350 NIH/FDA immunologists get together to present their work to the community.
https://ecollab.niaid.nih.gov/sites/IIG/_layouts/15/start.aspx#/SitePages/Welcome%20to%20the%20NIH%20Immunology%20Interest%20Group.aspx
Implementation Research in HRSA Ryan White Sites: Screening and Treatment for Mental and Substance Use Disorders to Further the National “Ending the HIV Epidemic” (EHE) GoalsResearch InitiativeHRSANIMH, NIDAThe National Institute of Mental Health (NIMH) and National Institute on Drug Abuse (NIDA) collaborated with the Health Resources and Services Administration (HRSA) HIV/AIDS Bureau to develop a research funding opportunity (RFA-MH-20-520 and RFA-MH-20-521) on methods to enhance screening and treatment for mental and substance use disorders in HRSA Ryan White HIV/AIDS Program funded sites through implementation research, in order to advance the goals of the Federal End the HIV Epidemic initiative. The research initiative seeks to strengthen the research/service delivery collaboration between NIH grantees and HRSA-funded HIV care sites, with the goal of increasing retention in HIV care and viral suppression through implementation of evidence-based mental disorder and substance use screening, prevention, and treatment. The research initiative was published in 2020. Eight grants were funded through this initiative (6 NIMH grants and 2 NIDA grants). The NIMH maintains ongoing communication with HRSA to discuss progress and outcomes.
Implementing Early Intervention Services for Clinical High Risk for Psychosis in U.S. Community Settings: What Do We Know and What Do We Need to Know?Meeting/ WorkshopSAMHSANIMHThe National Institute of Mental Health (NIMH) collaborated with the Substance Abuse and Mental Health Services Administration (SAMHSA) in sponsoring a research meeting on July 27-28, 2017 in Bethesda, MD. The purpose of this meeting was to lay the groundwork for developing a national strategy to expand services for early psychosis to include evidence-based interventions for individuals at clinical high-risk. Leading researchers in this field presented findings on the effectiveness of clinical high-risk interventions, and directors of clinical programs presented on the challenges and opportunities in implementing these services in communities. NIMH subsequently provided SAMHSA technical expertise in developing their Funding Opportunity Announcement, "Community Programs for Outreach and Intervention with Youth and Young Adults at Clinical High Risk for Psychosis” (SM-18-02), published April 10, 2018. The funding opportunity currently supports 21 service grants to community mental health providers for services for individuals at clinical high-risk for psychosis. NIMH subsequently released a Notice, "NIMH Priorities for Research to Inform Stepped-Care Interventions for Persons at Clinical High Risk for Psychosis" (NOT-MH-19-003), on December 11, 2018. The Notice highlights NIMIH interest in receiving grant applications for clinical research that will advance diagnosis, risk assessment, and indicated prevention methods for persons at Clinical High Risk (CHR) for psychosis.
https://www.samhsa.gov/grants/grant-announcements/sm-18-012
Improving Genomics/Omics Technical Standards and Molecular Tools for Prebiotic Probiotic Research and Development Working GroupResearch InitiativeCDC, FDA, OSNCCIH, NCI, NHGRI, NIDA, NLMThe overarching workgroup effort is to enhance research initiatives/resource development as an Interagency Agreement ( IAA) workgroup members committed to sustain and accelerate translatability of validation analytics and reference datasets using omics and other multi-omics substitutable [SMART] tools, devices, and HL-7 Fast Healthcare Interoperability Resources (FHIR) technologies to support rapid and efficient interoperability with electronic health records and clinical decision support systems. A second goal is to coordinate and plan trans-NIH and Inter-agency meetings, workshops and initiatives with greater efficiency of Institute and Center Operations (ICO) resources and expertise between agencies. Innovative technologies like HL-7 SMART on FHIR have been demonstrated to enhance health information exchange, affordably and accurately. Novel device monitoring using reference standards including, Food and Drug Administration (FDA) Precision and National Institute of Standards and Technology (NIST) nanofabrication, multi-omics and modeling strategies can be integrated to improve validation and standards biosafety, risk monitoring of adverse drug events, food safety, overuse and resistance to antibiotics, and emerging infection. The intent originated in April 2016 with an Initiative planning meeting that is now ongoing for IAA partnered with the Patient-Centered Outcomes Research Institute (PCORI); other IAA collaboratives in progress.
Improving Steps in the Development and Assessment of Live Microbiome-Based Products: Fecal Microbiota for Transplantation (FMT) and Live Biotherapeutic Products (LBPs)Resource DevelopmentFDANIAIDThis project seeks to support the development and assessment of live microbiome-base products for the treatment and prevention of infection. Fecal microbiota for transplantation (FMT) utilizes stool from healthy donors to reestablish the gut microbiota of individuals with recurrent C. difficile infection. Whereas live biotherapeutic products (LBPs) are drugs that consist of purified bacteria developed for the prevention, treatment or cure of bacterial vaginosis in women. In the context of this IAA, FMT and LBPs are being developed to prevent disease (or reinfection) after antibiotic treatment by interacting with the human microbiome.
In Vitro Assessment of Dermal Hypersensitivity: Using Alternative Methods to Predict Skin SensitizationResearch InitiativeFDANIEHSThe primary goal of these efforts is to assess the untility of non-animal test methods for prediciting human skin sensitization hazard in an expanded chemical space
Inclusion Across the LifespanMeeting/ WorkshopFDANIA, NCI, NHLBI, NICHD, NIDCR, NIMHD, OD/DPCPSI/OBSSR, OD/DPCPSI/ORWH, OD/OERIn response to scientific need and a congressional mandate in the 21st Century Cures Act (P.L. 114-255), the National Institutes of Health (NIH) convened a workshop of experts on the appropriate inclusion of pediatric and older populations in research studies involving human subjects. The workshop brought together experts in clinical research to discuss barriers and opportunities for participation of these populations in clinical studies, including those supported by NIH.
https://obssr.od.nih.gov/event/inclusion-across-the-lifespan-workshop/
Incorporating a Sex-and Gender Lens from Bench to Bedside: NeurologyMeeting/ WorkshopFDAOD/DPCPSI/ORWHThis event had one presenter and it took place on September 1, 2020. Dr. Clayton also spoke at the event
https://orwh.od.nih.gov/about/newsroom/events/incorporating-sex-and-gender-lens-bench-bedside-neurology
Industrywide exposure assessment study of workers exposed to graphene and other two-dimensional nanomaterialsResearch InitiativeCDCNIEHSThere have been relatively few studies evaluating the toxicity of 2D nanomaterials and even fewer data are available regarding workplace exposures in the United States. This project will provide real-world exposure data along with important material characteristic information for the interpretation of current and future toxicity and risk assessment studies.
Influenza Diagnostics Risk Management Meeting (FRMM) Strategy Working GroupCommittee, Work group, Advisory group, or Task ForceBARDA, CDC, FDANIAIDReviewing a draft strategic plan for senior leadership
Influenza Risk Management MeetingCommittee, Work group, Advisory group, or Task ForceCDC, FDA, OSNIAIDThe Influenza Risk Management Meetings provide members including the Office of the Assistant Secretary for Preparedness and Response (ASPR) Biomedical Advanced Research and Development Authority(BARDA), the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and the National Institutes of Health (NIH)) with a venue to discuss issues relating to the US Department of Health and Human Services (HHS) response to pandemic influenza. Subjects for discussion include but are not limited to considerations of vaccine and antiviral stockpiles and clinical trial response to influenza outbreaks such as H7N9 and H3N2v.
Inter-Agency Working Group on the National Healthcare Quality and Disparities ReportCommittee, Work group, Advisory group, or Task ForceACF, AHRQ, CDC, CMS, HRSA, IHS, OSNIMHD, NCI, NHLBI, OD/DPCPSIThis working group provides expert scientific guidance for the National Healthcare Quality and Disparities Report. These annual reports measure trends in effectiveness of care, patient safety, timeliness of care, patient centeredness, and efficiency of care. The reports present, in chart form, the latest available findings on quality of and access to health care.
https://www.ahrq.gov/research/findings/nhqrdr/index.html
Inter-Society Coordinating Committee for Practitioner Education in Genomics (ISCC-PEG)Committee, Work group, Advisory group, or Task ForceCDC, HRSANHGRI, CC, NCATS, NCI, NEI, NHLBI, NIAAA, NICHD, NLMThis education collaborative facilitates sharing interactions among professional societies, agencies, and health systems. It intends to enhance the accrual of knowledge and skill among practitioners applying genomic results to clinical care. In its start-up phase, the ISCC-PEG focused primarily on physicians and dentists. It has since expanded to engage and collaborate with allied practitioner groups such as nurse practitioners, physician assistants, pharmacists, genetic counselors, and nurses comprising integrated health care teams. It will continue to add other relevant professions and add to the reviewed and searchable educational resources on its website.
https://www.genome.gov/For-Health-Professionals/Inter-Society-Coordinating-Committee-for-Practitioner-Education-in-Genomics
Interagency Adult Literacy Research GroupCommittee, Work group, Advisory group, or Task ForceACFNICHDThis is an intra-government, trans-agency group shares updates on research relevant to adults with lower literacy skills (i.e., reading and writing) as well as practices and programs that are being implemented to assist these learners in various agencies. The goal is for staff and corresponding agencies to be informed of broader efforts occurring around adult literacy within the federal government and to keep abreast of research and promising programs that might inform their work.
Interagency Agreement NTP/NIEHS and NCTR/FDA (IAA)OtherFDANIEHSCollaborative working relationship between NTP/NIEHS and NCTR/FDA
Interagency Artificial Pancreas Working GroupCommittee, Work group, Advisory group, or Task ForceFDANIDDK, NIBIB, NICHDThe Interagency Artificial Pancreas Working Group is a group of multi-disciplined scientists and clinicians from the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) to support the Artificial Pancreas Initiative. The goals of this initiative are to provide infrastructure for narrowing the gap between basic biomedical knowledge and clinical application of novel technologies, and to cross-fertilize and partner with stakeholders in order to identify and overcome the clinical and scientific challenges to the development of an artificial pancreas. Through collaborative efforts, such as workshops, the group strives to develop innovative strategies to achieve their goals.
Interagency Autism Coordinating Committee (IACC)Committee, Work group, Advisory group, or Task ForceACF, ACL, AHRQ, CDC, CMS, FDA, HRSA, IHS, SAMHSANIMH, NICHD, NIEHS, NINDSThe Interagency Autism Coordinating Committee (IACC) is a federal advisory committee charged with coordinating federal activities concerning autism spectrum disorder (ASD) and providing advice to the Secretary of Health and Human Services on issues related to autism. Membership of the Committee includes a wide array of federal departments and agencies involved in ASD research and services, as well as public stakeholders, including self-advocates, family members of children and adults with ASD, advocates, service providers, and researchers, who represent a variety of perspectives from within the autism community. The Committee members myriad expertise and experience aim to equip the IACC to address the wide range of issues and challenges faced by individuals and families affected by autism. The IACC was reauthorized under the Autism Collaboration, Accountability, Research, Education, and Support (CARES) Act of 2019. The IACC is being reconstituted under the most recent authorization and will resume meeting in 2021.
http://iacc.hhs.gov
Interagency Biodefense Working GroupCommittee, Work group, Advisory group, or Task ForceCDC, FDA, OSOD/OSP, FIC, NIAID, NIEHS, NLM, OD/OM/OB, OD/ORSCoordinates implementation of the U.S. National Biodefense Strategy and Presidential Memorandum on the Support for Biodefense towards an integrated, comprehensive approach to manage biodefense activities in support of the broader biodefense enterprise.
InterAgency Board (IAB)Committee, Work group, Advisory group, or Task ForceCDC, FDA, ATSDRNIEHSSanctioned by the Attorney General of the United States, the InterAgency Board for Equipment Standardization and Interoperability (IAB) was founded by the Department of Defense's Consequence Management Program Integration Office and the Department of Justice's Federal Bureau of Investigation Weapons of Mass Destruction Countermeasures on October 13, 1998. The IAB is a voluntary collaborative panel of emergency preparedness and response practitioners from a wide array of professional disciplines that represent all levels of government and the voluntary sector. The IAB provides a structured forum for the exchange of ideas among operational, technical, and support organizations to improve national preparedness and promote interoperability and compatibility among local, state, and federal response communities. Based on direct field experience, IAB members advocate for and assist the development and implementation of performance criteria, standards, test protocols, and technical, operating, and training requirements for all-hazards incident response equipment with a special emphasis on Chemical, Biological, Radiological, Nuclear, and Explosive issues. The IAB also informs broader emergency preparedness and response policy, doctrine, and practice.
https://www.interagencyboard.org/
Interagency Chemical Risk Assessment Working GroupCommittee, Work group, Advisory group, or Task ForceOSNINDS, NIAIDThis working group is a Department of Homeland Security led effort to determine chemical hazards and develop Chemical Risk Threat Assessment list of priority chemicals.
Interagency Collaborative Animal Research Education (ICARE) Training ProjectTraining InitiativeBARDA, CDC, FDAOD/OERThe Interagency Collaborative Animal Research Education (ICARE) Academies and Train the Trainer Institutes use active learning to train participants to meet their responsibilities for animal welfare oversight. The program empowers accountability for facts and conceptual understanding of Federal standards through the study of realistic problems encountered in animal care and use programs. Faculty includes subject matter experts from biomedical research institutions and federal agencies, including National Institutes of Health (NIH) and United States Department of Agriculture (USDA). Institutional Animal Care and Use Committee members, staff, institutional officials, veterinarians, animal facility personnel, administrators, consultants, as well as compliance and regulatory personnel involved in the humane use of animals in research all may participate in the ICARE program.
https://olaw.nih.gov/education/icare-interagency
Interagency Collaborative to Advance Research in Epilepsy (ICARE)Committee, Work group, Advisory group, or Task ForceAHRQ, CDC, FDA, HRSA, OSNINDS, FIC, NCATS, NHGRI, NHLBI, NIA, NIAAA, NIAMS, NICHD, NIDA, NIMHThe Interagency Collaborative to Advance Research in Epilepsy (ICARE) is an interagency epilepsy working group that includes broad representation across the National Institutes of Health (NIH) institutes and centers (ICs) involved in epilepsy-related research, as well as across the Department of Health and Human Services other Federal agencies multiple epilepsy research organizations, and patient advocacy groups with a primary focus on biomedical research. The purpose of this group, which is led by the National Institute of Neurological Disorders and Stroke, is to increase communication among institutes and agencies sponsoring epilepsy-related research and to explore opportunities for increased coordination. The group’s annual meetings provide a forum for sharing information about ongoing and planned epilepsy research activities, highlighting advances, discussing needs and opportunities, and promoting increased collaboration toward common research goals.
https://www.ninds.nih.gov/Current-Research/Focus-Research/Focus-Epilepsy/ICARE
Interagency Committee on Disability Research (ICDR)Committee, Work group, Advisory group, or Task ForceACF, ACL, AHRQ, ATSDR, CDC, CMS, FDA, HRSA, IHS, OS, OSG, SAMHSANICHD, NIDCD, NIMH, NINDSThe ICDR's mission is to promote coordination and cooperation among federal departments and agencies conducting disability, independent living, and rehabilitation research programs including programs relating to assistive technology research and research that incorporates the principles of universal design.
https://icdr.acl.gov/
Interagency Committee on Human Nutrition Research (ICHNR)Committee, Work group, Advisory group, or Task ForceCDC, FDA, HRSAOD/DPCPSI/ONR, NIDDK, NCI, OD/DPCPSIThe Interagency Committee on Human Nutrition Research (ICHRN) is charged with improving the planning, coordination, and communication among federal agencies engaged in nutrition research and with facilitating the development and updating of plans for federal research programs to meet current and future domestic and international needs for nutrition.
https://www.nal.usda.gov/fnic/interagency-committee-human-nutrition-research
Interagency Committee on Smoking and HealthCommittee, Work group, Advisory group, or Task ForceCDC, CMS, FDA, HRSA, SAMHSANIDA, NCIThe Committee was chartered in 1985 and advises the Secretary, Department of Health and Human Services (DHHS), the Assistant Secretary for Health, and the Centers for Disease Control and Prevention on coordination of research, educational programs, and other activities within the Department that relate to the effect of smoking on human health, and on coordination of these activities with other Federal, State, local, and private agencies. The Committee established and maintains a liaison with appropriate private entities, other Federal agencies, and State and local public agencies respecting activities relating to the effect of cigarette smoking on human health.
https://www.cdc.gov/tobacco/about/icsh/index.htm
Interagency Committee on the American Community Survey (ACS)Committee, Work group, Advisory group, or Task ForceACF, AHRQ, CDC, CMS, HRSA, OSNICHDThe American Community Survey (ACS) is an ongoing survey that provides vital information on a yearly basis about our nation and its people. Information from the survey generates data that help determine how more than $400 billion in federal and state funds are distributed each year. Public officials, planners, and entrepreneurs use this information to assess the past and plan the future.
https://www.census.gov/programs-surveys/acs/about.html
Interagency Coordinating Committee for Newborn ScreeningCommittee, Work group, Advisory group, or Task ForceAHRQ, CDC, FDA, HRSANICHDThis committee makes recommendations for screening certain disorders, developing a system to adjudicate newborn screening expansion, and assist states in implementing programs to test for the recommended conditions.
Interagency Coordinating Committee on Fetal Alcohol Spectrum Disorders (ICCFASD)Committee, Work group, Advisory group, or Task ForceACF, ACL, AHRQ, ASA, ASPE, ASPR, ATSDR, CDC, CMS, FDA, GDM, HRSA, IHS, IOS, OASH, OCIIO, OCR, OGA, OIG, OMHA, ONC, ORAC, PHSSEF, PSC, SAMHSA, AoA, OPHSNIAAA, NIMH, NIDA, NICHDThe Interagency Coordinating Committee on Fetal Alcohol Spectrum Disorders (ICCFASD) was created in October 1996 in response to recommendations of an expert committee of the Institute of Medicine that the National Institute on Alcohol Abuse and Alcoholism (NIAAA) chair an effort to coordinate Federal activities on Fetal Alcohol Syndrome (FAS) and other disorders associated with prenatal alcohol exposure. ICCFASD works to improve communication, cooperation, and collaboration among disciplines and federal agencies that address issues of health, education, developmental disability, research, justice, and social services relevant to FASD and related disorders caused by prenatal alcohol exposure. The ICCFASD meets twice a year and arranges special panels and working groups.
http://www.niaaa.nih.gov/ICCFASD
Interagency Coordinating Committee on Human Growth Hormone and Creutzfeldt - Jakob diseaseCommittee, Work group, Advisory group, or Task ForceCDC, FDANIDDK, NICHD, NINDSThe Public Health Service Interagency Coordinating Committee on Human Growth Hormone (hGH) and Creutzfeldt-Jakob Disease (CJD) was established in 1985 by the Assistant Secretary for Health, the Department of Health and Human Services (HHS) to review information relevant to patients who received pituitary-derived hGH that was distributed through the NIH-funded National Hormone and Pituitary Program (NHPP). The Committee analyzes this information to determine the extent of the problem of transmission of CJD (a rare, incurable brain disease) through contaminated pituitary hGH, and to inform physicians and patients who received pituitary hGH about the health risks associated with pituitary hGH. Although NHPP’s distribution of hGH ceased when its potential to transmit CJD was discovered in 1985—and today, recombinant growth hormone that is not susceptible to CJD contamination is exclusively used for treatment—the Committee continues to maintain oversight of this issue because CJD may take years or decades to develop. The Committee includes representatives from the National Institutes of Health (NIH), the Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention (CDC), and is chaired by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Director.
https://www.niddk.nih.gov/about-niddk/advisory-coordinating-committees/interagency-coordinating-committee-human-growth-hormone-creutzfeldt-jacob
Interagency Coordinating Committee on the Prevention of Underage Drinking (ICCPUD)Committee, Work group, Advisory group, or Task ForceACF, CDC, IHS, OS, OSG, SAMHSANIDA, NIAAAThe Consolidated Appropriations Act of 2004 directed the Secretary of Health and Human Services (HHS) to establish the Interagency Coordinating Committee on the Prevention of Underage Drinking (ICCPUD) and to issue an annual report summarizing all Federal agency activities related to preventing underage alcohol use. HHS made ICCPUD a standing committee to provide ongoing, high-level leadership on this issue and to serve as a mechanism for coordinating Federal efforts aimed at preventing and reducing underage drinking. The Substance Abuse and Mental Health Services Administration (SAMHSA) serves as the lead ICCPUD agency.
https://www.stopalcoholabuse.gov/default.aspx
Interagency Coordinating Committee on the Validation of Alternative Toxicological Methods (ICCVAM)Committee, Work group, Advisory group, or Task ForceATSDR, FDA, CDCNIEHS, NCI, NLM, ODInteragency committee of the federal government with representatives from 17 research and regulatory agencies that require, use, generate, or disseminate toxicological and safety testing information.
https://ntp.niehs.nih.gov/go/iccvam
Interagency Elder Justice Working Group (EJWG)Committee, Work group, Advisory group, or Task ForceACLNIAThe Elder Justice Interagency Working Group brings together federal officials responsible for carrying out elder justice activities, including elder abuse prevention, research, grant and program funding, and prosecution. Since 2001, members have met informally and on a regular basis to discuss emerging issues, promising practices, and ways to coordinate their efforts. Guest speakers have addressed a range of topics, including adult protective services, guardianship, and predatory lending.
Interagency Group for Development of Lung Infection Models for P. aeruginosa and A.baumanniiCommittee, Work group, Advisory group, or Task ForceBARDA, CDC, FDANIAIDThis interagency working group meets quarterly to discuss the development of various lung infection animal models.
Interagency Group on Alzheimer's Disease and Related Dementias for implementation of the National Alzheimer's Project ActCommittee, Work group, Advisory group, or Task ForceAHRQ, CDC, CMS, FDA, HRSANIAThis interagency group was established by Department of Health and Human Services (HHS) in response to the Congressional directive to address Alzheimer disease. Under the National Alzheimer’s Project Act, HHS created three sub-groups on Research, Long Term Services, and Clinical Services. The Veteran’s Administration, National Science Foundation, and Department of Defense are also involved in this effort.
http://aspe.hhs.gov/daltcp/napa/
Interagency Modeling and Analysis Group (IMAG)Committee, Work group, Advisory group, or Task ForceAHRQ, CDC, FDANIBIB, CSR, NCCIH, NCI, NEI, NHGRI, NHLBI, NIA, NIAAA, NIAID, NIAMS, NICHD, NIDA, NIDCD, NIDCR, NIDDK, NIEHS, NIGMS, NIMH, NIMHD, NINDS, NLM, OD/DPCPSI, OD/DPCPSI/OBSSR: IMAG is comprised of program directors from over 10 government agencies including the National Institutes of Health (NIH), the National Science Foundation (NSF), Department of Energy (DOE), Department of Defense (DOD), the Department of Agriculture (USDA), the National Aeronautics and Space Administration (NASA), the Department of Veterans Administration (VA), the Food and Drug Administration (FDA), and the Intelligence Advanced Research Projects Activity (IARPA). The purpose of IMAG is to bring together program officers who have a shared interest in supporting modeling and analysis methods in biomedical, biological, and behavioral systems. IMAG has promoted and supported a wide variety of modeling, notably multi-scale modeling (MSM) through agency-specific funding opportunity announcements. IMAG also holds consortium meetings annually. The IMAG/MSM hosted a special meeting, Integrating Machine Learning with Multisscale Modeling (ML-MSM) on October 24-25, 2019. The annual MSM Consortium meeting, IMAG-AND Futures, was held virtually on March 17, 2020, that featured Multiscale Modeling Trainees that presented their MSM research in poster and podium presentations. The following two reports were published as a result of the 2019 ML-MSM Meeting, https://www.imagwiki.nibib.nih.gov/resources/meeting-reports/publicatio….
http://www.nibib.nih.gov/research/featured-programs/interagency-modeling-and-analysis-group-imag
Interagency Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) Working GroupCommittee, Work group, Advisory group, or Task ForceCDCNINDS, NIAIDThe Interagency ME/CFS Working Group consists of multiple government agencies and patient ME/CFS patient advocacy organizations interested in research and care issues related to ME/CFS. The working group was established to help coordinate ME/CFS-related efforts across the federal agencies to enhance research efforts, improve treatment options and patient outcomes, promote public outreach, and strengthen workforce development. The working group, which is co-led by NINDS and CDC, met for the first time in August 2020, and will continue to meet regularly to provide updates, discuss issues relevant to ME/CFS research, and identify and foster communication and collaboration across the federal agencies and with ME/CFS stakeholders.
Interagency Pain Research Coordinating Committee (IPRCC)Committee, Work group, Advisory group, or Task ForceAHRQ, CDC, FDANINDS, NCCIH, NIDA, NIDCR, NINRThe Interagency Pain Research Coordinating Committee is an Affordable Care Act-mandated committee to coordinate pain research activities across the government.
http://iprcc.nih.gov/
Interagency Select Agent Review Group (ISARG)Committee, Work group, Advisory group, or Task ForceCDC, OSNIAID, OD/OM/OB, OD/OSPThe Interagency Select Agent Review Group (ISARG), composed of members from the Centers for Disease Control and Prevention (CDC), the Department of Justice, the Department of State, the National Institutes of Health Office of the Director (NIH-OD) and the Biomedical Advanced Research and Development Authority (BARDA), advises the National Institute of Allergy and Infectious Diseases (NIAID) on whether facilities and procedures at NIAID-funded foreign research sites are comparable to those required by the Select Agent Regulations for domestic institutions before Select Agent work at the foreign site may proceed.
Interagency Serological Working GroupCommittee, Work group, Advisory group, or Task ForceBARDA, CDC, FDANIAIDCoordinating influenza serological studies and capabilities across agencies.
Interagency Task Force on Military and Veterans Mental Health (ITF)Committee, Work group, Advisory group, or Task ForceACL, OS, SAMHSANIMHExecutive Order 13625, Improving Access to Mental Health Services for Veterans, Service Members, and Military Families, was released on August 31, 2012, and directed the Departments of Defense (DoD), Veterans Affairs (VA), and Health and Human Services (HHS) to ensure that Veterans, Service Members, and their families have access to needed mental health services and support. The Executive Order also established the Interagency Task Force on Military and Veterans Mental Health (ITF) and directed it to provide an annual review of agency actions, to define specific goals and metrics to aid in measuring progress, and make additional recommendations as appropriate to the President to improve mental health and substance use disorder treatment services for Veterans, Service Members, and their families. The ITF, co-chaired by the DoD Assistant Secretary for Health Affairs, the VA Under Secretary for Health, and the HHS Administrator for the Substance Abuse and Mental Health Services Administration, tracks and reports progress in executing all activities resulting from recommendations made pursuant to the Executive Order.
Interagency Task Force on the Arts and Human DevelopmentCommittee, Work group, Advisory group, or Task ForceACF, CDC, SAMHSANICHD, NCCIH, NCI, NIA, NIMH, OD/DPCPSI/OBSSRBeginning in 2011, the National Endowment for the Arts (NEA) has convened a Federal Interagency Task Force on the Arts and Human Development to encourage more and better research on how the arts can help people reach their full potential at all stages of life.
https://www.arts.gov/national-initiatives/task-force/members
Interagency Task Force on Trauma-Informed CareCommittee, Work group, Advisory group, or Task ForceAHRQ, CMS, CDC, IHS, FDA, HRSA, OMHA, ACF, ASPE, OCR, SAMHSANICHDCMHS leads the Interagency Task to develop best practices for trauma-informed identification, referral, and support. The Interagency Task Force on Trauma-Informed Care (TIC Task Force) was established on October 13th, 2018 of the Public Law 115-271, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act of 2018 under Subtitle N, Section 7132. Duties include: To identify, evaluate, and make recommendations regarding: (1) best practices with respect to children and youth, and their families as appropriate, who have experienced or are at risk of experiencing trauma; and (2) ways in which Federal agencies can better coordinate to improve the Federal response to families impacted by substance use disorders and other forms of trauma
https://www.samhsa.gov/trauma-informed-care
Interagency Workgroup on Coordinating Opportunities for Evaluating Dolutegravir and Neural Tube Defects AssociationCommittee, Work group, Advisory group, or Task ForceCDC, FDANICHD, NIAIDThis is a group addressing the potential association of dolutegravir and neural tube defects and associated research and policy issues.
Interagency Workgroup on Technology to Facilitate Aging in PlaceResearch InitiativeACL, CMS, FDANIA, NCI, NHLBI, NIBIB, NINDS, NINRThe purpose of this Trans-National Institutes of Health (NIH) Inter-Agency group is to develop new platforms for everyday life technology that will enhance the common goals of multiple NIH institutes and other federal government agencies by improving the capability to rapidly conduct peer-reviewed technology research to facilitate aging in place, with a special emphasis on people from underrepresented groups. A platform is a group of technologies that are used as a base upon which other applications, processes or technologies are developed.
https://grants.nih.gov/grants/guide/rfa-files/RFA-AG-16-021.html
Interagency Working Group in the GlycosciencesCommittee, Work group, Advisory group, or Task ForceFDANIGMS, NCI, NICHD, NIDCR, NIDDKThis group meets annually to identify synergies, discuss progress on the development of national standards for carbohydrates, and exchange information on the glycosciences being pursued at each agency
Interagency working group on Biological Data SharingCommittee, Work group, Advisory group, or Task ForceFDANIGMS, NCIThe working group will identify the diverse types of biological and clinical data, define specific needs and best practices for storing, managing, curating, archiving, and maintaining the confidentiality and integrity of these data, and define agency roles and responsibilities for addressing research and policy (exclusive of regulatory) priority gaps to enable data sharing. The working group will develop a road map to enable robust sharing and maximize reuse of data, identifying opportunities for interagency coordination, and academic, industrial, and international partnerships.
Interagency Working Group on Harmful Algal Bloom and Hypoxia Research and Control Act (IWG-HABHRCA)Committee, Work group, Advisory group, or Task ForceFDA, CDCNIEHSHarmful algal bloom (HAB) and hypoxia (severe oxygen depletion) events are scientifically complex and economically damaging. They challenge our ability to safeguard the health of our nation’s coastal, Great Lakes, and freshwater ecosystems. Nearly every state experiences some type of hypoxia or HAB event. Federal agencies are working together to advance the understanding of HAB and hypoxia events, and respond to, detect, predict, control, and mitigate these events to the greatest extent possible, as mandated by the Harmful Algal Bloom and Hypoxia Research and Control Amendments Act of 2014 (HABHRCA).
Interagency Working Group on Open ScienceCommittee, Work group, Advisory group, or Task ForceACL, AHRQ, CDC, FDA, OSOD/OSP, NLM, OD/OERAdvance Federal efforts to support open science by increasing access to and use of the results of Federally funded research and development.
http://www.hhs.gov/open/publicaccess/index.html
Interdepartmental Health Equity Collaborative (formerly FIHET)Committee, Work group, Advisory group, or Task ForceACF, ACL, AHRQ, CDC, CMS, FDA, HRSA, IHS, OS, OSG, SAMHSANIMHD, NCATS, NCI, NHLBI, NIA, NIAAA, NIAID, NICHD, NIDA, NIDCR, NIDDK, NIEHS, NIMH, NINR, ODPFederal leadership for the National Partnership for Action to End Health Disparities (NPA) is provided by the Interdepartmental Health Equity Collaborative (IHEC). The IHEC was established to foster communications and activities of the NPA within federal agencies and their partners; and to increase the efficiencies and effectiveness of related policies and programs at the national, state, tribal, and local levels.
http://www.minorityhealth.hhs.gov/npa/
Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC)Committee, Work group, Advisory group, or Task ForceCMS, SAMHSANIMHIn December 2016, the 21st Century Cures Act was signed into law (Public Law 114-255). Through this Act, the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC) was established to address the needs of adults with serious mental illness (SMI) and children and youth with serious emotional disturbance (SED) and their families so that Americans with SMI and SED are able to improve their lives and receive the highest possible standard of care—care that is deeply informed by knowledge of science and medicine. The ISMICC includes representatives from eight federal departments that support programs that address the needs of people with SMI and SED, and is informed and strengthened by the participation of non-federal members, including national experts on health care research, mental health providers, advocates, people with living with mental health conditions, and their families and caregivers. This cross-sector, public-private partnership provides a unique opportunity to share and generate solutions to the problems facing the mental health system. The ISMICC seeks to support a system where individuals with SMI or SED are able to engage effectively with a range of treatment and recovery support services that promote opportunities for people to live well in their communities. A central charge of this committee is to submit two reports to Congress, the first no later than one year after the enactment of the Act, and the second five years following enactment. The ISMICC has five priority areas and corresponding workgroups for these priority areas. Representatives from National Institute of Mental Health sit on each of these workgroups.
https://www.samhsa.gov/ismicc
Interdepartmental Substance Use Disorders Coordinating Committee (ISUDCC)Committee, Work group, Advisory group, or Task ForceSAMHSANIDAThe Secretary of Health and Human Services, in coordination with the Director of the Office of National Drug Control Policy, is required by the SUPPORT for Patients and Communities Act Public Law 115-271 (PDF | 679 KB) to establish an Interdepartmental Substance Use Disorders Coordinating Committee composed of federal and non-federal members to accomplish the following duties: 1. Identify areas for improved coordination of activities, if any, related to substance use disorders, including research, services, supports, and prevention activities across all relevant federal agencies; 2. Identify and provide to the Secretary recommendations for improving federal programs for the prevention and treatment of, and recovery from, substance use disorders, including by expanding access to prevention, treatment, and recovery services; 3. Analyze substance use disorder prevention and treatment strategies in different regions of and populations in the United States and evaluate the extent to which federal substance use disorder prevention and treatment strategies are aligned with State and local substance use disorder prevention and treatment strategies; 4. Make recommendations to the Secretary regarding any appropriate changes with respect to the activities and strategies described in items (1) through (3) above; 5. Make recommendations to the Secretary regarding public participation in decisions relating to substance use disorders and the process by which public feedback can be better integrated into such decisions; and 6. Make recommendations to ensure that substance use disorder research, services, supports, and prevention activities of the Department of Health and Human Services and other federal agencies are not unnecessarily duplicative.
https://www.samhsa.gov/about-us/advisory-councils/isudcc
International Cancer Control Partnership (ICCP)OtherCDCNCIThe National Cancer Institute and the Union for International Cancer Control convened global partners including the Centers for Disease Control and Prevention (CDC) to cooperate in assisting countries to develop and implement quality cancer plans linked to Non-communicable Disease (NCD) control. This International Cancer Control Partnership, ICCP, believes that prioritizing cancer is critical to reaching the “25x25” goal. ICCP partners assist countries by: (1) Creating and maintaining a searchable database of current cancer control plans from around the globe; (2) Performing analysis of gaps and highlighting priority areas for inclusion in plans; (3) Providing technical assistance to countries working to develop plans with targets and evaluation strategies; (4) Providing planners with relevant existing materials and tools; and (5) Coordinating an online community of practice (through partnership with the University of New Mexico's Project ECHO) for dissemination and utilization of scientific knowledge for National Cancer Control Plan implementation. ICCP partners will use their collective state, country, and regional-level planning experience to guide plan development and implementation and will ensure planners utilize effective, evidence-based strategies to help meet the global NCD targets.
http://www.iccp-portal.org/
International Cancer Screening Network (ICSN)Committee, Work group, Advisory group, or Task ForceCDCNCIThe International Cancer Screening Network (ICSN) is a voluntary consortium of screening practitioners who work in countries that are planning for or implemented population-based cancer screening programs with the mission of reducing the burden of cancer by promoting dialogue and collaborative cancer screening research, evaluation and dialogue regarding the effectiveness of context-specific evidence-based cancer screening programs, including promotion, recruitment and follow-up among other relevant topics. ICSN goals include: 1. To provide global leadership in cancer screening research and evaluation by organizing scientific studies, biennial conferences, consultations, mentorship, training, and by publishing collaborative papers. 2. To create a community of screening practitioners (researchers, evaluators, implementers and screening program staff) to exchange data, evidence, ideas and experiences that advance the field of cancer screening. 3. To assist in the design of studies to evaluate the process and effectiveness of cancer screening programs; to evaluate and promote innovation in cancer screening through new technologies; to enhance the screening process for treatment of screen-detected lesions, among other topics. 4. To be a source of education and dialogue about basic aspects of cancer screening as well as advanced and emerging concepts and technology. 5. To include membership who conducts cancer screening research, develop infrastructure for cancer screening, and establish programs whose goal is to deliver the highest quality health care while producing the maximum benefit to the population and minimizing its harms.
https://www.cancer.gov/about-nci/organization/cgh/research/icsn
International Neonatal ConsortiumMeeting/ WorkshopFDANICHDLaunched on May 19, 2015, INC is C-Path’s ninth consortium – a global collaboration formed to forge a predictable regulatory path for evaluating the safety and effectiveness of therapies for neonates. “By uniting stakeholders from research institutions, drug developers, regulatory agencies, patient advocacy and other organizations,” said Janet Woodcock, Director of the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (FDA/CDER), “INC can develop practical tools that can be incorporated into clinical trials for neonates, which will then lead to more successful, efficient trials and provide this population with better treatments.”
https://c-path.org/programs/inc/
International Rare Diseases Research Consortium (IRDiRC) Funders' CommitteeCommittee, Work group, Advisory group, or Task ForceFDANICHD, NCATS, NCI, NEI, NHGRI, NIAMS, NINDSThe International Rare Diseases Research Consortium (IRDiRC) teams up researchers and organizations investing in rare diseases research in order to achieve two main objectives by the year 2020, namely to deliver 200 new therapies for rare diseases and means to diagnose most rare diseases. A number of grand challenges are being addressed through collaborative actions to reach these 2020 goals such as establishing and providing access to harmonized data and samples, performing the molecular and clinical characterization of rare diseases, boosting translational, preclinical and clinical research, and streamlining ethical and regulatory procedures.
http://www.irdirc.org/about-us/
International TB Working GroupCommittee, Work group, Advisory group, or Task ForceCDCNIAIDThis is a working group of the Federal Tuberculosis (TB) Task Force. The International TB Working Group is chaired and organized by the US Agency for International Development (USAID). It meets monthly to coordinate international TB support.
Interoperability Standards Advisory Task Force of the Health Information Technology (HIT) Standards CommitteeCommittee, Work group, Advisory group, or Task ForceIOSNLMThe Interoperability Standards Advisory Task Force of the Health Information Technology (HIT) Standards Committee is part of the Federal Advisory Committee that is charged with making recommendations to the Office of the National Coordinator for Health Information Technology (ONC) on standards and implementation specifications to promote interoperability of computer systems and health information.
https://www.healthit.gov/facas/calendar/2017/01/17/standards-2017-interoperability-standards-advisory-task-force
Intragovernmental Select Agents and Toxins Technical Advisory Committee (ISATTAC)Committee, Work group, Advisory group, or Task ForceCDC, FDA, OSOD/OSP, NCI, NIAID, OD/ORSMakes technically-based recommendations to the APHIS/CDC Select Agent and Toxin Program on restricted experiments with Select Agents and Toxins and the exclusion and exemption of attenuated strains. The Committee also conducts a biennial review of the Select Agents and Toxins list for HHS and overlap agents and toxins.
It’s a Noisy Planet. Protect Their Hearing® Public Education campaignPublic Education CampaignCDCNIDCDThe National Institute on Deafness and Other Communication Disorders (NIDCD) sponsors It’s a Noisy Planet Protect Their Hearing®, a national public education campaign to increase awareness among parents of children ages 8 to 12 about noise-induced hearing loss (NIHL) and how to prevent it. The campaign disseminates messages through print and digital materials, social media, community events, school presentations, and other methods. The CDC’s National Center for Environmental Health and National Institute for Occupational Safety and Health (NIOSH) have actively collaborated with the NIDCD for this campaign.
https://www.noisyplanet.nidcd.nih.gov
Joint Agency Nutrition Working Group (JAN)Committee, Work group, Advisory group, or Task ForceFDAOD/DPCPSI/ONR, NICHD, NIDDK, OD/DPCPSIThe Joint Agency Nutrition (JAN) was established to address gaps and opportunities in the areas of dietary supplements and nutrition research related to pregnant women and children and chronic diseases. The Working Group reports to the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) Joint Leadership Council.
Joint External Evaluation Working Group (JEEWG)Committee, Work group, Advisory group, or Task ForceCDC, FDA, OSOD/OSP, NCI, NIEHS, NINDS, OD/ORSSupports the Global Health Security Agenda activities related to International Health Regulations implementation to include internal and external joint evaluations, draft a National Action Plan (NAP) to address recommendations, and periodically review and report the status of the NAP.
https://www.ghsagenda.org/
Journal of Women's Health Special Issue on Maternal Morbidity and MortalityResearch InitiativeACF, HRSA, IHS, OASHOD/DPCPSI/ORWH, NCATS, NCCIH, NHLBI, NIA, NIAID, NICHD, NIDDK, NIEHS, NINR, NIMH, NIMHD, ODP, NIBIB, OD/DPCPSIIn an effort to advance the conversation and research on maternal morbidity and mortality (MMM), scientists across NIH Institutes, Centers, and Offices, other Health and Human Services agencies, and academic institutions and other organizations collaborated to address aspects of this critical public health issue from multiple vantage points. Over 80 authors from these partnering entities contributed to the development of 21 articles on MMM.
https://home.liebertpub.com/publications/journal-of-womens-health/42
Kaposi Sarcoma and HHV8 in Sickle Cell and Other Ugandan PopulationsResearch InitiativeCDCNCIEpidemiological studies are being conducted to assess small-area variation of Kaposi's sarcoma-associated herpesvirus (HHV8) and to learn about socio-demographical and environmental risk factors for HHV8 and Kaposi sarcoma in Uganda.
Kidney Innovation Accelerator (KidneyX)Research InitiativeCMS, FDANIDDKKidneyX, also called the Kidney Innovation Accelerator, is a public-private partnership between the U.S. Department of Health and Human Services (HHS) and the American Society of Nephrology (ASN). Established in April 2018, KidneyX aims to use prize competitions to accelerate the development of innovative solutions that can prevent, diagnose, and/or treat kidney diseases. KidneyX aims to promote collaboration between patients, health professionals, innovators, industry, and government with the ultimate goal of improving quality of life for people living with kidney diseases.
http://www.kidneyx.org
Kidney, Urologic, and Hematologic Diseases Interagency Coordinating Committee (KUHICC)Committee, Work group, Advisory group, or Task ForceAHRQ, CDC, CMS, FDA, HRSA, IHSNIDDK, NCCIH, NCI, NHLBI, NIA, NICHD, NINDSThe Kidney, Urologic, and Hematologic Diseases Interagency Coordinating Committee (KUHICC) encourages cooperation, communication, and collaboration among all Federal agencies involved in kidney, urology, and hematology research and other activities. Section 429 of Public Law 99-158 created the KUHICC in 1987. The committee met for the first time in 1988, and has the following subcommittees: Kidney Interagency Coordinating Committee, Urology Subcommittee, and Hematology Subcommittee. Meetings focus on interagency collaboration to elicit ideas from meeting participants to enhance current research directions within the National Institutes of Health and to form partnerships among agencies.
https://www.niddk.nih.gov/about-niddk/advisory-coordinating-committees/kuh-icc
Leprosy Research Support in Armadillos (Dasypus Novemcinctus)Resource DevelopmentHRSANIAIDThe Leprosy Research Support and Maintenance of an Armadillo Colony – Post Genome Era interagency agreement provides standardized research reagents to investigators worldwide to assist in the development of skin test antigens used to detect leprosy. This agreement supports collaborative research to continuously improve biochemical, microbiological, and immunological models for leprosy research in an effort to provide the most up-to-date resource and expertise for mycobacterial researchers.
Leveraging Novel Technologies for Chronic Disease Management for Aging Underserved PopulationsResearch InitiativeOASHNHLBIHHS Office of the Assistant Secretary for Health (OASH), in partnership with other federal agencies, has issued a Request for Information (RFI) to gain a more comprehensive understanding from our stakeholders regarding innovative solutions to chronic disease management. The RFI is focused on how to leverage novel technologies to optimize compliance with evidence-based standards of care in disease states that cause significant morbidity and mortality in aging populations in underserved areas. The RFI also seeks to identify opportunities to strengthen the U.S. healthcare system through public-private partnerships in data sharing, comprehensive analytics including AI, and other potential mechanisms.
https://www.federalregister.gov/documents/2020/11/17/2020-25328/request-for-information-landscape-analysis-to-leverage-novel-technologies-for-chronic-disease
LGBT Healthy People 2030 Working Group (LGBT HP 2030)Committee, Work group, Advisory group, or Task ForceACF, ACL, AHRQ, ATSDR, BARDA, CDC, CMS, FDA, HRSA, IHS, OS, OSG, SAMHSAOD/DPCPSI/SGMRO, NCI, NEI, NHLBI, NIA, NIAID, NIAMS, NICHD, NIDA, NIDCD, NIDCR, NIDDK, NIEHS, NIMH, NINDS, ODPHealthy People provides science-based national goals and objectives with 10-year targets designed to guide national health promotion and disease prevention efforts to improve the health of all Americans. As part of its mission, Healthy People has established benchmarks and monitored progress over three decades in order to (1) engage multiple sectors to strengthen policies and improve practices that are driven by the best available evidence and (2) to increase public awareness of the determinants of health, disease, and disability and the opportunities for progress.
https://www.healthypeople.gov/2020/topics-objectives/topic/lesbian-gay-bisexual-and-transgender-health
Linkage of Surveillance, Epidemiology, End Results data to Centers for Medicare and Medicaid dataResource DevelopmentCMSNCIThe Surveillance, Epidemiology, End Results (SEER) registry data (e.g., cancer diagnosis date, site, histology) are individually linked to Centers for Medicare and Medicaid Services (CMS) data (e.g., enrollment, claims, assessments and surveys) using personally identifiable information. The data on the matching cancer cases are pulled together with CMS data on non-cancer controls (e.g., individuals not known to have a cancer diagnosis who reside in a SEER area) to create four research data resources: SEER-Medicare, SEER-Medicare Health Outcomes Survey (SEER-MHOS), SEER-Consumer Assessment of Healthcare Providers and Systems (SEER-CAHPS) and SEER-Medicaid.
https://healthservices.cancer.gov/seermedicare/
Logical Observation Identifiers Names and Codes (LOINC)Resource DevelopmentAHRQ, CDC, CMS, HRSA, IHS, IOSNLMThis activity supports the maintenance, distribution, and continued development of LOINC®, a set of universal codes and names to identify laboratory and other clinical observations which facilitates the exchange and pooling of clinical results for clinical care, outcomes management, public health, and research. The Regenstrief Institute, Inc., an internationally renowned healthcare and informatics research organization, maintains the LOINC database and supporting documentation, and the RELMA mapping program.
http://www.nlm.nih.gov/research/umls/loinc_main.html
Lower Limb Prosthetics Research Standards Working GroupCommittee, Work group, Advisory group, or Task ForceACL, AHRQ, CMS, FDANICHD, NIDDK, ODThis working group helps to determine research standards for lower limb prosthetics.
Lung Scoring SystemCommittee, Work group, Advisory group, or Task ForceASPR, CDCNIAIDTo determine best practices for a systematic scoring of pathology for various pathogens of interest.
Lupus Federal Working GroupCommittee, Work group, Advisory group, or Task ForceAHRQ, CDC, FDA, HRSA, OSNIAMS, NCCIH, NEI, NHLBI, NIAID, NICHD, NIDCR, NIDDK, NIEHS, NIMHD, NINDS, OD/DPCPSI/OBSSR, OD/DPCPSI/ORWHThe Lupus Federal Working Group, established on behalf of the Department of Health and Human Services (HHS) Secretary by the National Institutes of Health (NIH), facilitates collaboration among NIH components, other Federal agencies, voluntary and professional organizations, and industry groups with an interest in lupus.
https://www.niams.nih.gov/about/working-groups/lupus-federal
Lyme and Tick-borne Diseases Work GroupCommittee, Work group, Advisory group, or Task ForceCDC, FDA, OSNIAIDThis workgroup involves members from agencies including the Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), and the National Institutes of Health (NIH) with the purpose of continued coordination and communication of activities, policy updates, events, agency highlights, and other shared interests relating to Lyme disease and other tick-borne diseases.
Machine learning methods for literature data extractionResearch InitiativeFDANIEHSThis project is applying natural language processing and machine learning methods to identify specific data elements in the full text of scientific publications
Mapping of the Systematized Nomenclature of Medicine-Clinical Terms (SNOMED CT) and International Classification of Disease (ICD) Clinical TerminologyResource DevelopmentCDC, IOSNLMThe US Department of Health and Human Services (HHS) has set a goal for the nationwide implementation of an interoperable health information technology infrastructure to improve the quality and efficiency of healthcare. Achieving this goal will require that key clinical data elements are captured or recorded in detailed, standardized form (using standard vocabularies, codes, and formats) as close to their original sources (patients, healthcare providers, laboratories, diagnostic devices, etc.) as possible. If these standardized clinical data can also be used to generate HIPAA- compliant billing transactions automatically, this will provide another incentive for adoption of clinical data standards. For the automated generation of bills from clinical data to become a reality, robust mappings from standard clinical terminologies to the HIPAA code sets must be created. To support the transition to ICD-10-CM in 2015, a map from SNOMED CT to ICD-10-CM is being created.
https://www.nlm.nih.gov/research/umls/mapping_projects/snomedct_to_icd10cm.html
Materials Genome Initiative (MGI)Committee, Work group, Advisory group, or Task ForceFDANIBIBThe Office of Science and Technology Policy(OSTP) chartered this committee to create a new era of policy, resources, and infrastructure that support U.S. institutions in the effort to discover, manufacture, and deploy advanced materials twice as fast, at a fraction of the cost. Led by the National Institute of Standards and Technology(NIST), the National Science Foundation (NSF), and the Department of Defense (DoD) as co-leads it also includes the Food and Drug Administration (FDA), the National Aeronautics and Space Administration (NASA), and the Department of Energy (DoE). 2020 meeting was cancelled due to the COVID-19 pandemic.
https://www.mgi.gov/
Maternal Health Working GroupCommittee, Work group, Advisory group, or Task ForceACF, ACL, AHRQ, CDC, CMS, FDA, HRSA, IHS, OS, SAMHSANICHD, NHLBI, NIMHD, OD/DPCPSI/ORWHThis internal Department of Health and Human Services (HHS) group was formed in June 2019, with the goal of developing a trans-HHS Action Plan aimed at making the U.S. the safest place in the world to give birth.
Medical Expenditure Panel Survey (MEPS): Experiences with Cancer Survivorship SupplementCommittee, Work group, Advisory group, or Task ForceAHRQ, CDCNCIThe National Cancer Institute (NCI) has collaborated with Centers for Disease Control and Prevention (CDC), Agency for Healthcare Research and Quality (AHRQ), and other organizations to provide supplemental funding for the Medical Expenditure Panel Survey (MEPS) to improve the quality of data for estimating the cancer survivorship burden in the United States. Using responses to the National Health Interview Survey (NHIS) question about ever receiving a cancer diagnoses, households with cancer survivors were oversampled for selection in this MEPS supplement. The increased sample of cancer survivors will improve national estimates of the burden of cancer.
https://healthcaredelivery.cancer.gov/meps/
Memorandum of Understanding (MOU) between the FDA Center for Devices and Radiological Health and NIH/NINDSOtherFDANINDSThis MOU provides a mechanism for addressing cross-cutting issues related to the development of devices for neurological disorders, from bench science to clinical studies and the Food and Drug Administration (FDA) approval.
http://www.fda.gov/AboutFDA/PartnershipsCollaborations/MemorandaofUnderstandingMOUs/DomesticMOUs/ucm446756.htm
Memorandum of Understanding (MOU) between the FDA/Center for Biologics Evaluation and Research (FDA/CBER) and NIH/NINDSOtherFDANINDSThis Memorandum of Understanding (MOU) provides a mechanism for addressing cross-cutting issues related to therapy development for neurological disorders, from bench science to clinical trials and the Food and Drug Administration (FDA) approval and licensure.
http://www.fda.gov/aboutfda/partnershipscollaborations/memorandaofunderstandingmous/domesticmous/ucm397727.htm
Meta-Analysis Interagency Group (MATIG)Committee, Work group, Advisory group, or Task ForceFDANCATS, NHLBIThe Meta-Analytical Interagency Group is an academic research collaboration between NHLBI, FDA and 2 other NIH institutions. This research collaboration is built among physician scientists, clinical trialists and data scientists from those agencies. MATIG's goal is to use data mining and machine learning tools and techniques for secondary analyses of clinical trials in order to maximize the use of data generated through clinical studies and highlight their public health value. Other goals are to use publicly available patient-level data in BioLINCC for secondary- and meta-analyses to: 1) Assess hard outcomes in atherosclerotic and cardiometabolic disorders like diabetes, coronary artery disease and heart failure. 2) Determine gender, racial, and age group differences in efficacy, outcome, and utility of the interventions tested in the trials. 3) Promote the value of combining patient-level clinical trial data in meta-analysis. 4) Establish access to other publicly available datasets like EHR/EMR. 5) Foster hypothesis generation by novel analyses through a multidisciplinary collaboration. 6) Provide mentorship and training for students, scientists, and clinicians in today’s data science.
Microphysiological Systems for COVID Research (MPSCoRe): a joint working group to support global COVID-19 tissue chip activitiesResource DevelopmentFDANIAID, NIEHS, NCATSMPSCore connects researchers, methods developers, therapeutic/vaccine manufacturers, and regulators to maximize the scientific and public health usefulness of tissue-chips in understanding and treating COVID-19, as well as other diseases with epidemic potential.
Microphysiological Systems for Drug Efficacy and Toxicity TestingResearch InitiativeFDANCATS, NCI, NEI, NHLBI, NIAID, NIAMS, NIBIB, NICHD, NIDA, NIDCR, NIDDK, NIEHS, NIGMS, NINDS, NINR, OD/DPCPSI/ORWH, OD/DPCPSI/OSCThe Microphysiological systems initiative aims to develop 3-D human tissue chips that accurately model the structure and function of human organs, such as the lung, liver, and heart. Once developed, researchers can use these models to predict whether a candidate drug, vaccine, or biologic agent is safe or toxic in humans in a faster and more cost-effective way than current methods. More than 30 percent of promising medications have failed in human clinical trials because they are determined to be toxic despite promising pre-clinical studies in animal models. These organs-on-chips will enable scientists to predict more accurately how effective a therapeutic candidate would be in clinical studies. To help streamline the therapeutic development pipeline, NIH, in collaboration with the Defense Advanced Research Projects Agency (DARPA) and the US Food and Drug Administration (FDA), is leading this initiative to improve the process for predicting whether drugs will be safe in humans.
https://ncats.nih.gov/tissuechip
Mind Your RisksPublic Education CampaignCDC, CMSNINDSThe Mind Your Risks campaign is designed to create awareness and action about the fact that risk factors for stroke, particularly hypertension, may be linked to cognitive impairment and dementia.
http://www.mindyourrisks.nih.gov/
Models of Infectious Disease Agent Study (MIDAS)Research InitiativeCDCNIGMS, FIC, NIAIDModels of Infectious Disease Agent Study (MIDAS) is a collaboration of research and informatics groups to develop computational models of the interactions between infectious agents and their hosts, disease spread, prediction systems, and response strategies. The models will be useful to public health workers and researchers who want to better understand and respond to emerging infectious diseases. If a disease outbreak occurs, the MIDAS network may be called upon to develop specific models to aid in our understanding of the disease and its spread.
http://www.nigms.nih.gov/Research/SpecificAreas/MIDAS/Pages/default.aspx
Monthly Zika Vaccine Development MeetingResource DevelopmentBARDA, FDANIAIDThis working group is collaborating on development of assays and animal models for zika vaccines. Collaboration includes exchange of study data, study reports, and regulatory strategy for assay and model development and development of a regulatory package to support licensure of products through alternative pathways.
Multinational Influenza Seasonal Mortality Study (MISMS) ResearchResearch InitiativeFDA, OSFIC, NHLBI, NIAID, NLMThe Multinational Influenza Seasonal Mortality Study (MISMS) was originally initiated to analyze national and global mortality patterns associated with influenza virus circulation. The focus of MISMS has since expanded to evaluate the interaction between the epidemiology, ecology, and evolutionary dynamics of influenza and other rapidly transmissible respiratory viruses, on natural selection, reassortment, migration, and antigenic change. Multinational and bilateral collaborations developed through MISMS collect, analyze, and disseminate research findings through scientific publications, training workshops, and communication tools for investigators and decision-makers. These research findings inform numerous national governments, multilateral organizations, and research stakeholders on interventions for both pandemic and seasonal influenza. To date, data have been acquired from more than 40 countries (representing ~3.2 billion people), resulting in over 220 publications.
http://misms.net
Multiple Chronic Conditions eCare Plan ProjectResource DevelopmentAHRQ, ASPENIDDKThe goal of this initiative is to build data capacity for conducting pragmatic, patient-centered outcomes research (PCOR) by developing an interoperable electronic care (eCare) plan to facilitate aggregation and sharing of critical patient-centered data across home, community, clinic and research-based settings by extracting data from point-of-care health systems and allowing transfer of that data cross settings. This is a joint initiative between the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the Agency for Healthcare Research and Quality (AHRQ), and the Assistant Secretary for Planning and Evaluation (ASPE).
https://ecareplan.ahrq.gov/
Muscular Dystrophy Coordinating Committee (MDCC)Committee, Work group, Advisory group, or Task ForceACL, CDC, FDA, HRSANINDS, NHLBI, NIAMS, NICHDThis Federal Advisory Committee coordinates activities relevant to the various forms of muscular dystrophy across the National Institutes of Health (NIH) and other federal agencies. The committee also includes members from patient organizations. Strategic planning efforts by the coordinating committee led to the development of an Action Plan for the Muscular Dystrophies, which contains specific research objectives appropriate to the missions of all committee member agencies and organizations, and thus serves as a central focus for research coordination. The plan is available at the MDCC web site.
https://mdcc.nih.gov/
My Family Health Portrait (MFHP)Resource DevelopmentCDCNHGRI, NCIMy Family Health Portrait (MFHP) is a web-based tool from the National Human Genome Research Institute (NHGRI) and the US Surgeon General’s Family History Initiative that helps individuals track their family health history. Using any computer, an Internet connection, and an up-to-date Web browser, individuals add health information to build a drawing of their family tree and a chart of their family health history while exploring disease calculators. The tool is designed to keep all data on the client side to maximize privacy using HTML, CSS, and client-side JavaScript as its principal platforms. Users interact with the tool in a browser to build family health history generating an XML data file (HL7v3 standard) that users store locally or in the cloud. Both the family tree and the chart can be printed and shared with family members and an individual’s doctor.
https://phgkb.cdc.gov/FHH/html/index.html
MyHealthfinder Steering CommitteeCommittee, Work group, Advisory group, or Task ForceIOS/ODPHPNLMThe MyHealthfinder Steering Committee comprises federal partners to help provide insight into the ways MyHealthfinder (an online health resource from HHS/ODPHP) more useful for public health professionals and the clients they serve. This group was formed in December 2020 and will meet quarterly.
Nanotechnology Characterization LaboratoryResearch InitiativeFDANCI, NIEHSThe Nanotechnology Characterization Laboratory (NCL) performs and standardizes the preclinical characterization of nanomaterials intended for cancer therapeutics and diagnostics developed by researchers from academia, government, and industry. The NCL serves as a national resource and knowledge base for cancer researchers and facilitates the development and translation of nanoscale particles and devices for clinical applications.
http://ncl.cancer.gov/
NAPA Federal Research SubgroupCommittee, Work group, Advisory group, or Task ForceAHRQ, ASPE, ACL, CDC, CMS, FDA, HRSA, IHSNIA, NINDSThis informal group of federal staff meets quarterly, in advance of the meetings of the Alzheimer’s Council for Alzheimer’s Research, Care, and Services, to exchange information on federal activities in the Alzheimer’s disease space and foster collaborations across agencies.
NASEM Aging Disability and Independence ForumCommittee, Work group, Advisory group, or Task ForceACLNIAThe National Academies of Sciences, Engineering, and Medicine have formed the Forum on Aging, Disability, and Independence to foster dialogue and address issues of mutual interest and concern related to aging and disability.
https://www.nationalacademies.org/our-work/forum-on-aging-disability-and-independence
National Academies Addressing Evidence Gaps in Clinical Prevention (NAM Evidence Gaps project)Committee, Work group, Advisory group, or Task ForceAHRQODPA consensus committee will examine issues in identifying and filling evidence gaps in clinical prevention recommendations made by the U.S. Preventive Services Task Force. The committee will catalog evidence gaps identified in the recommendations; summarize the types of evidence gaps to communicate with funders and researchers; identify potential research strategies that could help close evidence gaps; and suggest approaches for AHRQ and NIH to optimize announcements and requests for applications to accelerate research to close evidence gaps. This initiative is being funded through an NIH contract and co-funded by ODP and AHRQ.
https://www.nationalacademies.org/our-work/addressing-evidence-gaps-in-clinical-prevention
National Academy of Medicine Committee on Emerging Science, Technology, and Innovation in Health and MedicineCommittee, Work group, Advisory group, or Task ForceFDANIMHThe National Academy of Medicine has recently launched a new Committee on Emerging Science, Technology, and Innovation in health and medicine. The Committee will bring together experts in diverse fields to assess the landscape of emerging scientific advances and technologies in health and medicine and address the potential societal, ethical, legal, and workforce implications of such technologies. The goal of the Committee is to develop a multi-sectoral governance policy framework. The Committee plans to examine examples of emerging technologies and their implications for society, through a multi-sectoral lens. The first point of focus will be on neurotechnology, specifically transcranial direct current stimulation.
https://nam.edu/programs/committee-on-emerging-science-technology-and-innovation-in-health-and-medicine/
National Action Alliance for Suicide Prevention (NAASP)Committee, Work group, Advisory group, or Task ForceACL, CDC, HRSA, IHS, OS, OSG, SAMHSANIMH, NIAAA, NIDA, OD/DPCPSI/OBSSR, ODPFounded in September 2010, the National Action Alliance for Suicide Prevention (NAASP) is a public-private partnership designed to advance the National Strategy for Suicide Prevention in the United States. The NAASP's Research Prioritization Task Force (RPTF) was charged with developing a process to prioritize suicide prevention research efforts and consider ways to integrate science and service to ensure that suicide deaths decrease significantly within the next decade. The RPTF released the Nation's first suicide research agenda, A Prioritized Research Agenda for Suicide Prevention: An Action Plan to Save Lives. The research agenda includes an overarching goal to advance suicide prevention research more rapidly, seeking ways to reduce suicide deaths and attempts by 20 percent in five years and by 40 percent or greater in ten years. In 2015, the RPTF produced the "U.S. National Suicide Prevention Research Efforts: 2008-2013 Portfolio Analyses." The analyses revealed that investments in suicide research are severely lagging, but there is a growing knowledge base of intervention research. The National Institute of Mental Health (NIMH) Director serves as an ex-officio member of the Executive Committee of the NAASP. NIMH participates in a number of NAASP activities related to identifying research needs for improving risk identification and suicide preventive care within healthcare systems, justice, and school settings.
http://actionallianceforsuicideprevention.org/
National Action Plan for Combating Antoibiotic-Resistant Bacteria (CARB) 2020-2025Committee, Work group, Advisory group, or Task ForceAHRQ, BARDA, CDC, CMS, FDA, HRSA, OSNIAIDThe National Action Plan for Combating Antibiotic-resistant Bacteria, 2020-2025, in development through the CARB Task Force, will outline coordinated, strategic actions that the U.S. government will take in the next five years to reduce the impact of antibiotic and antimicrobial resistance on the nation.
National Action Plan for the Elimination of multi-drug resistant Tuberculosis (MDR TB)OtherCDCNIAID, CC, FIC, NCATS, NCI, NHLBI, NIA, NIAAA, NICHD, NIDAFederal agencies involved in the National Action Plan for the Elimination of Multidrug-Resistant Tuberculosis (MDR-TB) coordinate reporting across agencies. Annual reporting and regular updates on opportunities for cross-agency collaboration and information sharing are provided.
https://www.usaid.gov/what-we-do/global-health/tuberculosis/resources/news-and-updates/national-action-plan-combating-mdr
National Advisory Board for Medical Rehabilitation ResearchCommittee, Work group, Advisory group, or Task ForceACL, CDCNICHD, NHLBI, NIA, NIAMS, NIDCD, NINDS, OD/DPCPSIThe Director of the National Institutes of Health (NIH) was mandated in P.L. 101-613 to establish the National Advisory Board on Medical Rehabilitation Research. The Board advises the directors of the NIH, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), and NICHD's National Center for Medical Rehabilitation Research (NCMRR) on matters and policies relating to the NCMRR's programs. The Board is comprised of 12 members representing health and scientific disciplines related to medical rehabilitation and six members representing persons with disabilities.
http://www.nichd.nih.gov/about/advisory/nabmrr/pages/index.aspx
National Advisory Committee on Children and Disasters (NAACD)Committee, Work group, Advisory group, or Task ForceCDC, FDA, HRSA, ASPRNICHD, NIEHSThe Secretary of the U.S. Department of Health and Human Service (HHS) is responsible for a wide range of activities that include monitoring for emerging issues and concerns as they relate to medical and public health preparedness and response; developing, overseeing, and providing guidance for implementation of national preparedness goals for disasters of all types at the federal, state and local levels; identifying, conducting responses to, and recovery from public health and medical emergencies; assisting other federal agencies responsible for aspects of planning for, responding to, and recovering from public health emergencies; and taking into account the special physical, psychological, emotional, and behavioral needs of children. On behalf of HHS, the Assistant Secretary for Preparedness and Response (ASPR) leads public health and medical planning for, response to, and recovery from disasters and public health emergencies in accordance with the National Response Framework Emergency Support Function (ESF) #8 (Public Health and Medical Services). Additionally, the federal responsibilities and partnerships described in ESF #6 (Mass Care, Emergency Assistance, Housing, and Human Services) and the Health and Social Services Recovery Support Function are critical to comprehensive consideration of issues related to children and disasters. The NACCD shall provide advice and consultation to the Secretary of HHS to assist him in carrying out these and related activities as they pertain to the unique needs of children in preparation for, responses to, and recovery from disasters.The NACCD shall evaluate issues and programs and provide findings, advice, and recommendations to the Secretary of HHS in accordance with FACA to support and enhance all-hazards public health and medical preparedness, response activities, and recovery aimed at meeting the unique needs of children, in a developmentally and socially appropriate manner, across the entire spectrum of their physical, mental, emotional, and behavioral wellbeing.
https://www.phe.gov/Preparedness/legal/boards/naccd/Pages/default.aspx
National Amyotrophic Lateral Sclerosis RegistryResource DevelopmentATSDR, CDCNINDSThe National ALS Registry is a congressionally mandated registry for persons in the US with ALS. It is the only population-based registry in the US that collects information to help scientists learn more about who gets ALS and its causes.
http://wwwn.cdc.gov/als/
National Cancer Institute and HRSA Office of Women’s Health Cervical Cancer Moonshot Roundtable Series: Creating Capacity to Reduce Systems Barriers in Rural and Underserved SettingsCommittee, Work group, Advisory group, or Task ForceOASH, HRSANCIStaff in the Healthcare Delivery Research program supports the HRSA Office of Women’s Health (OWH) and the HHS Office of the Assistant Secretary of Health, Office of Population Affairs (OASH OPA) to co-sponsor an HPV and Cervical Cancer Roundtable series of meetings to support cervical cancer guideline adoption and accelerate cervical cancer control. This multi-agency approach to increasing cervical cancer screening will fund: 1) a literature review to inform written materials for a three-meeting Roundtable series, which will define current practices and needs in cervical cancer prevention and screening and treatment at HRSA-supported health care settings and other safety-net settings of care; 2) information dissemination training webinars to highlight prevention and treatment clinical recommendations for safety-net settings of care; 3) a survey of cancer center directors to understand cancer centers' ongoing collaboration with HRSA-funded clinics, and 4) provider-facing technical assistance resources (i.e., web-based toolkit). This project is consistent with high-priority areas in the recommendations of the 2016 NCI Cervical Cancer Moonshot Team of experts that advise the NCI’s National Cancer Advisory Board.
National Center for Advancing Translational Sciences (NCATS) Patient-focused Therapeutics Development ToolkitResource DevelopmentFDANCATSNCATS is dedicated to engaging the patient community throughout the translational science process. The NCATS Toolkit for Patient-Focused Therapy Development (Toolkit) was created to provide a collection of online resources that can help patient groups advance through the process of therapy development and provide them with the tools they need to advance medical research.
https://ncats.nih.gov/toolkit
National Clinical Care Commission (NCCC)Committee, Work group, Advisory group, or Task ForceAHRQ, CDC, CMS, FDA, HRSA, IHSNIDDKThe National Clinical Care Commission (NCCC) evaluates and provides recommendations on the coordination and leveraging of federal programs related to complex metabolic or autoimmune diseases that result from insulin-related issues and represent a significant disease burden in the United States, including complications due to such diseases. The Assistant Secretary for Health (ASH) provides guidance and oversight for the Commission’s function and activities. The Office of Disease Prevention and Health Promotion (ODPHP) will provide management and support services for the Commission’s activities. The NCCC will conduct activities until October 2021.
https://health.gov/hcq/national-clinical-care-commission.asp
National Coalition for Oversite of Assisted Reproductive Technologies (NCOART)Committee, Work group, Advisory group, or Task ForceCDC, FDANICHDThe National Coalition for Oversight of Assisted Reproductive Technologies (NCOART) has become a successful forum for discussion of issues by organizations involved in the assisted reproductive technologies (ART) in the United States.
National Collaborative on Childhood Obesity Research (NCCOR)Research InitiativeCDCNICHD, NCI, NHLBI, NIDDK, OD/DPCPSI/OBSSR, ODPThe mission of the National Collaborative on Childhood Obesity Research is to improve the efficiency, effectiveness, and application of childhood obesity research, and to halt -- and reverse -- childhood obesity through enhanced coordination and collaboration.
https://www.nccor.org/
National Database for Antibiotic Resistant Organisms (NDARO)Resource DevelopmentCDC, FDANIAID, CC, FIC, NCATS, NCI, NHLBI, NIA, NIAAA, NIDAThe objective of this collaboration is to produce a collection of high-quality genome sequences from antibiotic-resistant strains and to create and maintain a publicly accessible database -- National Database for antibiotic resistance (AR), developed and housed at the National Center for Biotechnology Information of the National Library of Medicine (NLM).
National Death Index Linkage Collaboration (NIH-NDI Agreement)Resource DevelopmentCDCOD/DPCPSI/OBSSR, OD/IMODBeginning January 1, 2020, through an agreement between the National Institutes of Health (NIH) and the Centers for Disease Control (CDC) National Center for Health Statistics, (NCHS), NIH began reimbursing the NCHS National Death Index (NDI) for the costs of NIH-supported investigators to link their research databases with the NDI for the research aims supported by the NIH. "NIH-supported investigators" refers to extramural investigators actively funded by the NIH, contract investigators working under an active contract with the NIH, and intramural researchers employed by the NIH. These NIH-supported investigators can link their research data to the National Death Index (NDI) at no cost to the NIH supported investigator. NIH-supported investigators will continue to submit applications for NDI linkage as per current NDI procedures, including NDI review and approval. This agreement applies only to NIH-supported investigators who are actively funded by the NIH to conduct research that requires NDI linkage. To be covered under this agreement, the NIH-supported investigator must be the owner or steward of the research data to be linked to the NDI datafile, and subject to limitations in linkages as identified in the agreement. As a part of the NIH/NCHS agreement, NCHS will be implementing an enhanced online application and will increase the frequency of NDI releases to quarterly. NDI allows fully deidentified (public access) research datasets with NDI-linked data to be shared without further NDI approval. Potentially re-identifiable datasets also may be shared without further NDI approval provided the research dataset is not transferred from one investigator to another but instead shared via a data enclave provided that the investigator obtained approval in the original NDI application to share the data via an enclave. An investigator also may share potentially re-identifiable NDI-linked research datasets with a data repository without further NDI approval provided the data repository shares the dataset on behalf of the investigator bound to the same constraints as the investigator (i.e., shared only if the dataset is fully-deidentified or shared only via a data enclave if potentially re-identifiable). During the period of this agreement, NDI will attempt to negotiate with the 57 vital registration jurisdictions to allow further data sharing flexibility without NDI approval.
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-057.html
National Death Index Working GroupCommittee, Work group, Advisory group, or Task ForceCDCNICHD, CC, NCATS, NCI, NHLBI, NIA, NIAID, NIDA, NIMH, OD/DPCPSI/OBSSRThe National Death Index (NDI) is a centralized database of death record information on file in state vital statistics offices. Working with these state offices, the National Center for Health Statistics (NCHS) established the NDI as a resource to aid epidemiologists and other health and medical investigators with their mortality ascertainment activities. The National Death Index Working Group brings together federal and non-federal demographic experts to improve the quality, comprehensiveness, and utility of the National Death Index.
National Emerging Contaminant Research InitiativeResearch InitiativeCDC, ATSDR, FDANIEHSCongressional Mandate
National Family Health History GroupPublic Education CampaignCDCNHGRI, CC, OD/OSPFederal, state, and other stakeholders focus on increasing awareness of the value of family health history in managing health risks. National Family History Day is designated by the Surgeon General for increasing awareness of the above. Members of this group coordinate public communications and resource development.
https://www.genome.gov/health/Family-Health-History
National Health Interview Survey (NHIS) Cancer Control SupplementHealth SurveyCDCNCIThe National Health Interview Survey (NHIS) - started in 1957 - is a continuous, nationwide in-person survey of approximately 27,000 sample adult and 9,000 sample child interviews annually, in the civilian non-institutionalized population. The NHIS oversamples African-American and Hispanic respondents. The National Cancer Institute (NCI) periodically sponsors a Cancer Control Supplement (CCS) which is administered to a randomly selected sample of 39,000 adults.
http://www.cdc.gov/nchs/nhis.htm
National Healthcare Quality and Disparities (NHQDR) Inter-Agency WorkgroupCommittee, Work group, Advisory group, or Task ForceAHRQ, CDC, CMS, HRSANCI, NIAID, NIEHS, NIMHDFor the 16th year in a row, the Agency for Healthcare Research and Quality (AHRQ) has reported on progress and opportunities for improving healthcare quality and reducing healthcare disparities. As mandated by the U.S. Congress, the report focuses on “national trends in the quality of health care provided to the American people” (42 U.S.C. 299b-2(b)(2)) and “prevailing disparities in health care delivery as it relates to racial factors and socioeconomic factors in priority populations” (42 U.S.C. 299a-1(a)(6)). The report is produced with the support of an HHS Interagency Work Group (IWG) and guided by input from AHRQ’s National Advisory Council and the Institute of Medicine (IOM), now known as the Health and Medicine Division of the National Academies of Sciences, Medicine, and Engineering. The National Cancer Institute (NCI) Surveillance, Epidemiology, and End Results (SEER) Data and data from Tumor Registries are among the data for monitoring cancer related care. NCI currently Chairs the Cancer Care Sub-Committee which defines the measures/ indicators and data sources in the reports for access to and quality of cancer care received by population groups at various phases of the Cancer Care Continuum.
https://www.ahrq.gov/research/findings/nhqrdr/index.html
National Hispanic Science Network (NHSN)Meeting/ WorkshopAHRQ, CDC, SAMHSANIDA, NIAAA, NIMHThe National Hispanic Science Network is dedicated to improving the health equity of Hispanics. It has broad representation from academic and government agencies, including several National Institutes of Health Institutes and Centers, the Centers for Disease Control and Prevention, the Substance Abuse and Mental Health Services Administration, and the Agency for Healthcare Research and Quality.
http://nhsn.med.miami.edu/
National Institute on Deafness and Other Communication Disorders (NIDCD) Directory of OrganizationsResource DevelopmentAHRQ, CDC, CMSNIDCDThe National Institute on Deafness and Other Communication Disorders (NIDCD) Directory of Organizations is designed to help patients, health consumers, providers, and others find agencies and organizations with an interest in the diseases and disorders of human communication. The directory is maintained as an online database accessible to the public from the NIDCD website. Several US Department of Health and Human Services agencies are included.
https://www.nidcd.nih.gov/directory/
National Institutes of Health (NIH) Flow Cytometry Interest GroupCommittee, Work group, Advisory group, or Task ForceFDANCI, CC, NEI, NHLBI, NIAID, NIAMS, NIDCRThe NIH Flow Cytometry Interest Group, an NIH-affiliated scientific interest group supported by the NIH Office of the Director, provides central information for basic and clinical investigators doing flow and image cytometry at NIH. The group sponsors two meetings a year on the science and technology of cytometry, and is a central clearinghouse for cytometry resources at NIH.
https://oir.nih.gov/sigs/flow-cytometry-interest-group
National Institutes of Health (NIH) Metabolomics Scientific Interest GroupCommittee, Work group, Advisory group, or Task ForceFDANCI, NHLBI, NIA, NIAAA, NIAID, NIDCR, NIDDK, NIEHS, NIMH, NLM, OD/DPCPSI/ODSThe Metabolomics Scientific Interest Group was created to help stimulate more interest in the field and aims to bring interested NIH program officials, intramural investigators and others together. The group will have periodic webinars and seminars that highlight recent work in the field. Additionally, the listserv will be used to communicate information on upcoming metabolomics-related seminars, funding opportunities, and other NIH activities and initiatives.
https://metabolomics-sig.nih.gov/
National Interagency Confederation for Biological ResearchCommittee, Work group, Advisory group, or Task ForceCDC, FDA#VALUE!The National Interagency Confederation for Biological Research (NICBR) is a consortium of eight agencies with a common vision of Federal research partners working in synergy to achieve a healthier and more secure nation. It serves as a framework for facilitating and encouraging interaction among the NICBR member organizations where there are areas of mutual interest. Members collaborate and share technical expertise and scientific services. This multiagency confederation operates by consensus to ensure a balanced direction and focus. The eight members include elements of the Department of Defense, Health and Human Services, Agriculture, and Homeland Security. The mission of NICBR is to develop unique knowledge, tools, and products by leveraging advanced technologies and innovative discoveries to secure and defend the health of the American people.
https://www.nicbr.mil/
National Neurological Conditions Surveillance System (NNCSS)Research InitiativeCDCNINDSThe NNCSS is a congressionally mandated program of the Centers for Disease Control and Prevention (CDC). The authorizing legislation requires CDC to "enhance and expand infrastructure and activities to track the epidemiology of neurological diseases and incorporate information obtained through such activities into an integrated surveillance system, which may consist of or include a registry, to be known as the National Neurological Conditions Surveillance System."
https://www.cdc.gov/surveillance/neurology/index.html
National Pain Strategy. Provider Eduction Committee (NPS)Meeting/ WorkshopCDC, HRSA, FDA, OASHOD/DPCPSI/ORWH, NINDSDr. Thomas Co-chairs monthly meeting
https://www.iprcc.nih.gov/national-pain-strategy-overview
National Response Team (NRT)Resource DevelopmentASPR, ATSDR, CDCNIEHSThe U.S. National Response Team (NRT) provides technical assistance, resources and coordination on preparedness, planning, response and recovery activities for emergencies involving hazardous substances, pollutants and contaminants, oil, and weapons of mass destruction in natural and technological disasters and other environmental incidents of national significance.
https://www.nrt.org/
National Robotics Initiative (NRI)Research InitiativeCDCNIBIB, NCATS, NEI, NIA, NINRThe National Robotics Initiative 3.0: Innovations in Integration of Robotics (NRI-3.0) program was launched by NSF in February of 2021. It builds upon the preceding National Robotics Initiative (NRI) programs to support fundamental research in the United States that will advance the science of robot integration. The program supports research that promotes integration of robots to the benefit of humans including human safety and human independence. The National Institute of Health (NIH) has joined NRI 3.0 to promote robotics to address health needs. The first round of funding will occur in FY2022.
http://www.nsf.gov/funding/pgm_summ.jsp?pims_id=503641&org=CISE
National Science Advisory Board for BiosecurityCommittee, Work group, Advisory group, or Task ForceCDC, FDA, OSOD/OSP, NIAIDThe NSABB is a federal advisory committee that addresses issues related to biosecurity and dual use research at the request of the United States Government.
http://osp.od.nih.gov/office-biotechnology-activities/biosecurity/nsabb
National Science and Technology Council Subcommittee on Open Science (NSTC SOS)Committee, Work group, Advisory group, or Task ForceACL, AHRQ, ASPR, CDC, FDANLM, OD/OSP, OD/OERThe Subcommittee on Open Science (SOS) advances Federal efforts to support open science by increasing access to, and use of, the results of federally funded research and development, including, but not limited to, scholarly publications and digital data. Among its responsibilities, the SOS aims to improve implementation of policies to increase access to the results of federally funded scientific research and to identify additional steps that Federal Departments and Agencies can take to enhance the preservation, discoverability, accessibility, quality, and utility of research outputs. Meets monthly to advance government-wide efforts to advance open science by coordinating agency efforts to improve access to publications, data, and other outputs of Federally funded research
https://www.whitehouse.gov/ostp/nstc/%20
National Security Staff Dual Use Research of Concern Interagency Policy Committee (NSS DURC PCC)Committee, Work group, Advisory group, or Task ForceCDC, OSOD/OSP, NIAIDDevelops policy options for US government oversight of dual-use research of concern (DURC).
National Security Staff Dual Use Research of Concern Sub-Interagency Policy Committee (NSS DURC Sub-PCC)Committee, Work group, Advisory group, or Task ForceCDC, OSOD/OSP, NIAIDDevelops policy options for US government oversight of dual-use research of concern (DURC); supports the NSS DURC PCC.
National Sexually Transmitted Infections (STI) Strategic PlanCommittee, Work group, Advisory group, or Task ForceOASH, ACF, ACL, CDC, CMS, FDA, HRSA, IHS, SAMHSANIAIDPlan sets national goals, objectives, and strategies to respond to the STI epidemic. The plan will serve as a roadmap to help federal and non-federal stakeholders at all levels and in all sectors reverse the sharp upward trends in STI rates
https://www.hhs.gov/programs/topic-sites/sexually-transmitted-infections/plan-overview/index.html
National Survey of Family GrowthHealth SurveyACF, CDCNICHDThe National Survey of Family Growth (NSFG) gathers information on family life, marriage and divorce, pregnancy, infertility, use of contraception, and men’s and women’s health. The survey results are used by the US Department of Health and Human Services and others to plan health services and health education programs and to do statistical studies of families, fertility, and health. The NSFG is used by: scholars in the behavioral sciences (e.g., sociology, demography, and economics) to study marriage, divorce, fertility, and family life; scholars in public health to study reproductive, maternal and infant health topics; agencies of the US Department of Health and Human Services to brief senior officials and to inform program decision-making; in research programs and in health and social service programs; state and local governments to plan health and social service programs; and the press, to prepare articles on a number of topics related to health and family life.
https://www.cdc.gov/nchs/nsfg/index.htm
National Toxicology Board of Scientific Counselors (NTP BSC)Meeting/ WorkshopCDC, FDANIEHSA federally chartered external advisory committee whose members are appointed by the Secretary of Health and Human Services
https://ntp.niehs.nih.gov/events/bsc/index.cfm
National Toxicology Program Executive Committee (NTP EC)Meeting/ WorkshopATSDR, CDC, FDA, OASHNIEHSAn internal government group comprised of heads (or designees) of HHS (NCEH/ATSDR, FDA, NCI, NIEHS, NIOSH) and non-HHS (CPSC, DoD, EPA, OSHA) agencies
https://ntp.niehs.nih.gov/go/advisory
National Toxicology Program Steering Committee (NTP SC)Meeting/ WorkshopCDC, FDANIEHSAn internal government group comprised of the principal agencies of the National Toxicology Program
Native American Research Center for Health (NARCH)Research InitiativeIHSNIGMS, CSR, NCI, NIA, NIAAA, NIAID, NIAMS, NICHD, NIDA, NIDCR, NIDDK, NIEHS, NIMH, NIMHD, OD/DPCPSI/OBSSR, OD/DPCPSI/ORWHThe Native American Research for Health (NARCH) program is a trans-NIH collaboration with the Indian Health Service (IHS) that supports collaborations between federally-recognized American Indian/Alaska Native (AI/AN) Tribes or Tribal organizations and research-intensive academic institutions that support health research projects prioritized by the Tribal communities. NARCH supports competitive research linked to the health priorities of AI/AN organizations and health disparities; increasing the capacity of both AI/AN organizations and research-intensive institutions to reduce distrust by AI/AN communities and people toward research; and developing a cadre of AI/AN scientists and health professionals engaged in biomedical, clinical, behavioral, and health services research who will be competitive in securing the National Institutes of Health (NIH) funding.
https://www.nigms.nih.gov/Research/CRCB/NARCH/Pages/default.aspx
Natural Compounds to Reduce Nitrate in Meat Products: PhytomeResearch InitiativeCDCNCIThe National Cancer Institute (NCI) and the Centers for Disease Control and Prevention (CDC) are collaborating on a longitudinal human feeding study of processed meats and drinking water nitrate conducted by Maastricht University. CDC researchers are measuring volatile nitrosamines (NOCs) and nitrate concentrations in urine samples taken before and after consumption different types of processed meats with and without the intake of nitrate in drinking water. NCI will also evaluate nitrate and nitrosamine excretion levels in relation to the oral microbiome. Results from this study will characterize NOC formed from water nitrate and processed meat ingestion.
Natural Experiments and Effectiveness Studies in the Prevention and Control of DiabetesResearch InitiativeCDCNIDDKThis project will focus on population-targeted interventions that health systems, communities, and governments can undertake to reduce the incidence of diabetes and its complications. This project will also strengthen the capacity of the Centers for Disease Control and Prevention (CDC) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to conduct vital health services and health policy research related to diabetes prevention and care.
NCHS-CDC-NHANES, Audiometry, Balance, and Words in Noise ComponentHealth SurveyCDCNIDCDTo provide support to the National Center for Health Statistics (NCHS), CDC for balance/vestibular testing and related questions on balance and dizziness problems in the U.S. population aged 40+ years.in the National Health and Nutrition Examination Survey (NHANES Epidemiology Survey), 2018 (pilot testing) and 2019-2020 (implementation). In addition the Audiometry Component of NHANES 2019-2020 will be augmented with a Word in Noise test administered to older adults, 70+ years of age. The prevalence of balance disorders in the US is high and increases with age. Data from NHANES 2000-2004 epidemiological survey indicate that 35.4% (69 million) US adults aged 40 or older have some balance dysfunction; prevalence jumps to 69% among those aged 70-79 years and 85% among those aged 80+ years. The higher risk of balance impairments among the elderly is due to functional changes associated with aging. The control of balance becomes increasingly dependent on visual and proprioceptive cues as we age, making the elderly more vulnerable to falls when those orientation cues are degraded. Individuals with balance trouble have a six-fold increase in the risk of falling; fall risk increases even further among individuals who report symptoms of dizziness. Falls are the leading cause of both fatal and nonfatal injuries among older adults (aged 65 years and older). In 2014, approximately 3 million older adults sought treatment in emergency rooms for fall-related injuries; 800,000 of these patients required hospitalization and 27,000 patients died. Direct medical costs of falls in the US in 2000 were more than $19 billion. Many people who fall develop a fear of falling, even if they are not injured. This fear may cause them to limit their activities leading to reduced mobility and loss of physical fitness, which in turn increases their actual risk of falling. In addition to the elderly, several other groups are at increased risk for balance disorders. Race other than white, lower educational status, diabetes, and hearing loss is associated with poorer balance function. In addition, individuals who have sustained head injuries are likely to suffer from problems with balance and dizziness.
http://www.cdc.gov/nchs/nhanes.htm
NCI Cancer Data Standards Repository and Registry (caDSR)Committee, Work group, Advisory group, or Task ForceFDANCI, CIT, NEI, NHLBI, NIAMS, NIBIB, NICHD, NIMH, NINDS, NLM, NCATSThe National Cancer Institute (NCI) is collaborating with other NIH institutes to develop and harmonize data standards across NCI and others NIH institutes for basic, translational and clinical research, clinical care, epidemiology, public health, administration, and public information. NCI caDSR provides services to meet NCI needs, and works with other NIH institutes to reuse/share existing content.
https://cadsr.nci.nih.gov
NCI Clinical Trials and Translational Research Advisory Committee (CTAC)Committee, Work group, Advisory group, or Task ForceCMS, FDANCIThe Clinical Trials and Translational Research Advisory Committee makes recommendations on the National Cancer Institute-supported national clinical trials enterprise to build a strong scientific infrastructure by bringing together a broadly developed and engaged coalition of stakeholders involved in the clinical trial process. The Committee will provide advice on matters related to the conduct, oversight, and implementation of clinical trials and translational research across the Institute.
http://deainfo.nci.nih.gov/advisory/ctac/ctac.htm
NCI Convenes Workshop on Reproducibility of Fecal Microbiota Transplants in Cancer TherapeuticsMeeting/ WorkshopFDANCI, NIAIDTo explore the potential role that fecal microbiota transplants (FMT) and pre/probiotics may play in cancer therapeutics and to address reproducibility and safety to inform translational human studies and clinical trials, NCI convened a “Strategic Workshop on Rigor and Reproducibility: Precision Fecal Microbiota Transplant and Microbiome Cancer Therapeutics” on September 5, 2019. This timely meeting brought together scientists and FDA regulatory staff in the fields of FMT, pre/probiotics, nutrition, microbiome, synthetic biology, biomarkers, computation, immunology, gastroenterology, oncology, and infection. Workshop Goals Assess the current state of clinical research and clinical trials involving FMT and microbiome-based cancer therapeutics; Discuss the knowledge gaps and future opportunities in the field; Provide feedback to National Cancer Institute (NCI) and National Institutes of Health (NIH) regarding future priority areas to enhance precision- and mechanism-based rigor and reproducibility of defined microbiome-based therapeutic clinical research for cancer and other diseases Workshop Focus Areas Standardization (material manufacture and quality control), FMT donor selection, microbiome measurement, clinical protocols, procedures, and trial design; Microbiome composition and function as biomarkers associated with cancer therapy, such as reproducibility, safety, and efficacy; Confounding variables — host genetic and disease state, environment, antibiotics, diet and other lifestyle factors; Clinical efficacy and safety of FMT and microbiome-based cancer therapy; Clinically relevant models and human translational studies; Data sharing; FDA regulatory issues
https://dctd.cancer.gov/NewsEvents/20191031_reproducibility_of_fecal_microbiota_transplants.htm
NCI Scientific Steering Committees (SSCs)Research InitiativeFDANCIFDA engages with the NCI Scientific Steering Committees on their monthly calls, in person meetings, and Clinical Trials Planning Meetings (CTPMs).
https://www.cancer.gov/about-nci/organization/ccct/steering-committees
NCI's Surveillance, Epidemiology and End Results (SEER) cancer registry data and the Centers for Medicare & Medicaid Services' (CMS) Medicare Consumer Assessment of Healthcare Providers and Systems (CAHPS®) patient surveys.Committee, Work group, Advisory group, or Task ForceCMSNCIThe SEER-CAHPS data set is a resource for quality of cancer care research based on a linkage between the NCI's Surveillance, Epidemiology and End Results (SEER) cancer registry data and the Centers for Medicare & Medicaid Services' (CMS) Medicare Consumer Assessment of Healthcare Providers and Systems (CAHPS®) patient surveys.
https://healthcaredelivery.cancer.gov/seer-cahps/
NCI/CCR-FDA Clinical Investigator ProgramResearch InitiativeFDANCIMultilateral Benefit in a Joint Program to Recruit Combined Food and Drug Administration (FDA) and the National Cancer Institute's (NCI) Center for Cancer Research (CCR) Clinical Investigators: the FDA gains an academic oncologist with disease-specific expertise who is actively involved and understands critical nuances of the field; NCI gains a clinical investigator and leader who understands regulatory considerations in drug development; and the oncologic community gains a regulator/academic who will provide a leadership voice to help design trials with regulatory endpoints in mind
https://deainfo.nci.nih.gov/advisory/joint/0615/03%20Pazdur.pdf
NCI/FDA Memorandum of Understanding for ProteomicsResearch InitiativeFDANCIThis Memorandum of Understanding (MOU), signed in 2007 and renewed in 2012, establishes an official relationship in clinical proteomic regulatory science between the National Cancer Institute's (NCI) Office of Cancer Clinical Proteomics Research and the Food and Drug Administration (FDA). Active areas of research collaboration include sample collection, preparation, storage and processing; bioinformatics and data analysis; discovery and validation of biomarkers; and surrogate biomarkers of cancer development and drug response, including standardization among technology platforms and assay standards development.
https://proteomics.cancer.gov/news_and_announcements/nci-and-fda-study-cancer-proteogenomics-together
NCI/FDA/HRSA/CMS Task Force on Cancer Diagnostic Devices (CD2) for Near-Patient UseCommittee, Work group, Advisory group, or Task ForceCMS, FDA, HRSANCIThe primary goal of this initiative is to develop opportunities that accelerate the pace by which point of care diagnostic devices get to patients for the earlier detection and screening of cancer. The Task Force and Initiative will address cancer types for geographically isolated, medically underserved, and otherwise vulnerable communities, with emphasis to: 1) Cancer types with clear, existing need and highly prevalent, for example cervical cancer; and 2) Cancer types that have evidence of future need from emerging at-risk populations, for example liver cancers derived from nonalcoholic steatohepatitis (NASH).
Networking and Information Technology Research and Development (NITRD)Research InitiativeAHRQNIGMSThe Networking and Information Technology Research and Development (NITRD) Program provides a framework in which many Federal agencies come together to coordinate their networking and information technology (IT) research and development (R&D) efforts.
https://www.nitrd.gov/Index.aspx
Neutron Radiobiology and Dosimetry Workshop Meeting ReportMeeting/ WorkshopASPRNIAIDThe purpose of this meeting was to work with stakeholders to discuss the current state of dosimetery used in research involving neutrons and mixed field radiation. The discussion examined gaps in knowledge and discuss strategies to plan studies to better inform the research community on the impact neutrons on drug efficacy studies. A meeting report is now being drafted for submission in 2020, as an open source of information for other researchers.
Newborn Screening Coding and Terminology GuideResource DevelopmentCDC, FDA, HRSA, IOSNLM, NHGRI, NHLBI, NICHDThis ongoing collaboration develops, supplements, and publicizes a free online resource with guidance to help promote the efficient electronic exchange of standardized newborn screening data. Related efforts include studying the screening process for diseases including severe combined immunodeficiency (SCID), lysosomal storage disorders (LSDs), and critical congenital heart disease (CCHD), and developing standard codes for ordering and reporting the results of newborn screening for SCID, CCHD, and other conditions added to the Uniform Recommended Screening Panel by the Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children.
https://newbornscreeningcodes.nlm.nih.gov/
Newborn Screening Federal Partners CommitteeCommittee, Work group, Advisory group, or Task ForceAHRQ, CDC, FDA, HRSANICHD, NHGRI, NLMThe federal members of the Advisory Committee on Heritable Disorders in Newborns and Children meet monthly to share information about newborn screening activities.
NGSP (formerly the National Glycohemoglobin Standardization Program)Resource DevelopmentCDCNIDDKThe purpose of the NGSP (formerly the National Glycohemoglobin Standardization Program) is to standardize Hemoglobin A1c test results to those of the Diabetes Control and Complications Trial (DCCT) and the United Kingdom Prospective Diabetes Study (UKPDS), which established the direct relationships between HbA1c levels and outcome risks in patients with diabetes.
http://www.ngsp.org/
NHANES 2011-14 Accelerometer DataHealth SurveyCDCNCI, NIA, NIDDK, NHLBI, OD/DPCPSI/OBSSR, ODP, OD/DPCPSI/ORWHLed by NCI, NIH supported inclusion of accelerometer-based devices in NHANES 2011-14. NCI supported data preparation for release and quality control checking pre-release. Summary data will be publicly available at day/hour/minute levels, as well as 80Hz "raw" data for select users. Data are released. Analyses are ongoing.
https://epi.grants.cancer.gov/physical/research-resources.html#data
NIA IMPACT Collaboratory Transforming Dementia CareResearch InitiativeCDCNIAThe mission of the IMbedded Pragmatic Alzheimers disease (AD) and AD Related Dementias (AD/ADRD) Clinical Trials (IMPACT) Collaboratory is to build the nation’s capacity to conduct pragmatic clinical trials of interventions embedded within health care systems for people living with dementia and their care partners. The IMPACT Collaboratory accomplishes this mission by: developing and disseminating best practice research methods; supporting the design and conduct of pragmatic trials, including pilot studies; building investigator capacity through training and knowledge generation; catalyzing collaboration among stakeholders, healthcare providers, and investigators; and ensuring the research includes culturally-tailored interventions and people from diverse and under-represented backgrounds.
https://impactcollaboratory.org/overview/
NIAID-CDC Joint US Partnership Implementing TB Elimination Research (JUPITER)Committee, Work group, Advisory group, or Task ForceCDCNIAIDThrough bi-weekly teleconferences, the Joint US Partnership Implementing TB Elimination Research (JUPITER) facilitates cooperation, communication, and collaboration on tuberculosis between the National Institute of Allergy and Infectious Diseases (NIAID) and the Centers for Disease Control and Prevention (CDC). This approach helps ensure that Federal activities are coordinated and not duplicated, and stimulates collaborations where appropriate.
NIAID/Armed Forces Radiobiology Research Institute (AFRRI) Research Coordination Team (RCT)Committee, Work group, Advisory group, or Task ForceASPRNIAIDThe Research Coordinating Team (RCT) has been successfully reestablished and will continue to meet quarterly in 2021. The purpose of the RCT is to discuss progress, resolve any concerns and to explore new areas of research to be conducted under the IAA.
NIAID/CDC Dual Use Research of Concern (DURC) Risk Mitigation ReviewsCommittee, Work group, Advisory group, or Task ForceCDCNIAIDThe Centers for Disease Control and Prevention (CDC) Division of Select Agents and Toxins Division will provide technical assistance in evaluating the sufficiency of the biosecurity and/or biosafety measures incorporated into risk mitigation plans received from institutions, and cross-check risk mitigation plans and research conducted using select agents and toxins against information in the Federal Select Agent Program (FSAP) database.
NIAID/FDA/BARDA Meeting on Cutaneous Radiation InjuriesMeeting/ WorkshopBARDA, FDANIAID, NIGMSA meeting was held May 6-7, 2019. The purpose of this meeting was to bring together medical countermeasures stakeholders such as academicians, industry, and funding and regulatory agencies to consider animal models and endpoints for radiation injuries to the skin
NIAID/FDA/BARDA Meeting on Radiation-Induced Lung InjuriesMeeting/ WorkshopFDA, ASPRNIAIDA meeting was held March 20-21, 2019. The purpose of this meeting was to bring together medical countermeasures stakeholders such as academicians, industry, and funding and regulatory agencies to consider animal models and endpoints for radiation injuries to the lung.
NIAID/NASA Medical Countermeasures Working GroupCommittee, Work group, Advisory group, or Task ForceBARDA, FDANIAID, NCI, NHLBIThe purpose of this Working Group (WG) is to bring together experts in radiation countermeasures to look for complementary areas of research across agencies in the following areas: medical countermeasure selection, repurposing, research strategies, and animal models for select endpoints.
Nicotine Research Cigarettes (SPECTRUM)Committee, Work group, Advisory group, or Task ForceFDANIDAThis partnership with the Food and Drug Administration (FDA) is for the production of research cigarettes.
NIEHS SBIR PHASE IIB Awards for Validation and Commericialization of Approaches to Reduce Animal Use in Toxicology Testing (U44)Committee, Work group, Advisory group, or Task ForceFDANIEHSThis SBIR program uses a cooperative agreeement mechanism, including regular consulation with a Steering Committee (SC), to conduct formal validation of alternative test methods. The SCs consist of ICCVAM NICEATM members.
https://grants.nih.gov/grants/guide/rfa-files/RFA-ES-15-016.html
NIH American Indian and Alaska Native Health Communications and Information Work GroupCommittee, Work group, Advisory group, or Task ForceACL, IHSNIAMS, NCCIH, NCI, NHGRI, NHLBI, NIA, NIAAA, NIAID, NICHD, NIDA, NIDDK, NIGMS, NIMH, NIMHD, NINDS, NINR, NLM, OD/DPCPSI/THROThe National Institutes of Health (NIH) American Indian and Alaska Native (AI/AN) Health Communications and Information Work Group provides a forum for health education and communications staff from National Institutes of Health (NIH) Institutes, Centers, and Offices to share strategies and effective communication approaches to develop and disseminate health information to American Indian and Alaska Native communities. In collaboration with the Indian Health Service (IHS) and the Administration on Aging/Administration for Community Living (AoA/ACL), the Work Group conducts outreach to approximately 1600 IHS Community Health Representatives (CHRs) and 270 AoA/ACL Title VI grantees nationwide through the e-newsletter, Honoring Health: Resources for American Indians and Alaska Natives. The e-newsletter features a wide range of NIH resources and is distributed to IHS CHRs, AoA/ACL grantees, and other subscribed individuals that provide services to Native communities. The purpose of the project is to increase awareness among CHRs and Title VI grantees about the availability of free or low-cost, science-based health information for patients and the general public.
NIH Autoimmune Diseases Coordinating Committee (ADCC)Committee, Work group, Advisory group, or Task ForceFDA, HRSANIEHS, NIAID, OD, NCI, NCATS, NCCIH, NEI, NHLBI, NHGRI, NIAMS, NIBIBThe purpose of the ADCC is to facilitate coordination of research across the National Institutes of Health (NIH), federal agencies, professional societies, and patient and advocacy organizations with an interest in autoimmune diseases. The ADCC meets once or twice yearly.
https://www.niaid.nih.gov/about/autoimmune-diseases-committee
NIH Common Data Elements Task Force (CDETF)Committee, Work group, Advisory group, or Task ForceAHRQ, FDA, CMSNLM, CC, CIT, CSR, FIC, NCATS, NCCIH, NCI, NCMHD, NCRR, NEI, NHGRI, NHLBI, NIA, NIAAA, NIAID, NIAMS, NIBIB, NICHD, NIDA, NIDCD, NIDCR, NIDDK, NIEHS, NINDS, NINR, OD/DPCPSI/OBSSR, OD/DPCPSI/ODSS, OD/OERThe NIH CDE Task Force as a whole provides a trans-NIH communications forum – including COVID-related activities. Through its subgroups, such as the COVID CDE Coordinating Committee and the NIH CDE Governance Committee, the Task Force addresses specific trans-NIH issues like coordination across COVID efforts, NIH CDE governance, etc.
NIH COVID-19 Treatment Guidelines PanelCommittee, Work group, Advisory group, or Task ForceCDC, FDANIAIDThe Panel was formed in March 2020, at the beginning of the COVID-19 pandemic in the US, to provide clinicians with rapidly updated guidance on how to care for patients with COVID-19. Coordinated by NIH, the Panel includes members from academia and professional societies and federal agencies, including BARDA, CDC, DoD, FDA, and VA. Working groups that address different areas of the guidelines are charged with identifying relevant information and published scientific literature then conducting a systematic, comprehensive review of that information to determine recommendations.
https://www.covid19treatmentguidelines.nih.gov
NIH Guide for Grants and ContractsResource DevelopmentAHRQ, CDC, FDAOD/OER, CC, CIT, CSR, FIC, NCATS, NCCIH, NCI, NEI, NHGRI, NHLBI, NIA, NIAAA, NIAID, NIAMS, NIBIB, NICHD, NIDA, NIDCD, NIDCR, NIDDK, NIEHS, NIGMS, NIMH, NIMHD, NINDS, NINR, NLM, OD/DPCPSIThe National Institutes of Health (NIH) Guide for Grants and Contracts is the official publication for NIH medical and behavioral grant policies, guidelines, and funding opportunities. Other US Department of Health and Human Services agencies also use the Guide to disseminate Funding Opportunity Announcements to its 60,000 subscribers.
http://grants.nih.gov/grants/guide/index.html
NIH Medical Rehabilitation Coordinating CommitteeCommittee, Work group, Advisory group, or Task ForceCDC, HRSA, SAMHSANICHD, CC, CSR, NCCIH, NCI, NEI, NHLBI, NIA, NIAMS, NIBIB, NIDCD, NIDDK, NIMH, NINDS, NINRPursuant to Public Law 101-613, the National Institutes of Health (NIH) Director established the Medical Rehabilitation Coordinating Committee. The Coordinating Committee makes recommendations to the National Institute of Child Health and Human Development (NICHD) Director and the Director of the National Center for Medical Rehabilitation Research with respect to the content of the research plan and activities that are carried out in conjunction with other components of NIH and with other Federal Government agencies.
https://www.nichd.nih.gov/sites/default/files/publications/pubs/Documents/NIH_ResearchPlan_Rehabilitation.pdf#search=NIH_ResearchPlan_Rehabilitation
NIH Scientific Data Council for the Common Data Elements (CDE) Task ForceCommittee, Work group, Advisory group, or Task ForceAHRQOD/DPCPSI/SGMRO, CC, CIT, NCATS, NCCIH, NCI, NEI, NHGRI, NHLBI, NIA, NIAAA, NIAID, NIAMS, NIBIB, NICHD, NIDA, NIDCD, NIDCR, NIDDK, NIEHS, NIGMS, NIMH, NIMHD, NINDS, NINR, NLM, OD/DPCPSI, OD/DPCPSI/OBSSR, OD/DPCPSI/ORWH, OD/OER, OD/OSPThe Common Data Elements (CDE) Task Force is charged by the National Institutes of Health (NIH) Scientific Data Council to advise it concerning how to improve the communication and coordination of NIH efforts to identify, develop, and promote the use of CDEs in NIH-supported research. Previously, as a working group under the aegis of the Trans-NIH BioMedical Informatics Coordinating Committee (BMIC), the group provided advice to the development of a CDE Repository that serves as a platform for searching, harmonizing, developing, and disseminating CDEs used by NIH Institutes and Centers; Task Force members continue to work with the National Library of Medicine (NLM) to improve this publicly available platform. The Task Force also maintains a web portal with information about NIH-supported CDE initiatives that are intended for use by NIH-funded researchers. The Task Force continues to take steps to encourage the use of CDEs by NIH-funded researchers, minimize overlap and redundancy in CDE initiatives, improve interoperability and compatibility between and among CDE initiatives and with other standards development activities (e.g., related to electronic health records), and assist NIH Institute and Center staff and researchers in identifying and using CDEs that are relevant to their projects.
https://www.nlm.nih.gov/cde/
NIH, HUD, CDC Housing and Health GroupCommittee, Work group, Advisory group, or Task ForceCDCODP, NCI, NICHD, NIDDKThe collaboration between National Institutes Health (NIH), Centers for Disease Control and Prevention (CDC) and Department of Housing and Urban Development (HUD) is focused on identifying housing and health-related research resources, current activities and investments on this topic by each agency, and opportunities for collaboration to advance housing and health research. In 2020, a porfolio analysis was conducted of NIH and CDC applications and funded research pertaining to housing and health.
NIH-BARDA Working GroupCommittee, Work group, Advisory group, or Task ForceBARDANIAIDWorking 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.
NIH-CDC-IDSA Guidelines for Treatment of HIV Related Opportunistic Infections Among Adults and AdolescentsCommittee, Work group, Advisory group, or Task ForceCDCCC, OD/DPCPSI/OARThe 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.
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5315a1.htm
NIH-FDA Interagency Clinical Outcome Assessments (ICOA) Working GroupCommittee, Work group, Advisory group, or Task ForceFDANICHD, CC, NCCIH, NCI, NHLBI, NIA, NIAMS, NIDA, NIDDK, NIMH, NINDS, OD/DPCPSIThe 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
NIH-FDA Medical Device Research Interest Group (MDRIG)Committee, Work group, Advisory group, or Task ForceCMS, FDANIBIB, NCATS, NCI, NEI, NHLBI, NIA, NIAID, NICHD, NIDDK, NINR, OD/DPCPSI/ORIP, FIC, NIAMS, NIDAThe 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.
NIH/BARDA Antimicrobial Resistance (AMR) Diagnostic Challenge Working GroupCommittee, Work group, Advisory group, or Task ForceASPR, FDA, CDCNIAIDThe 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.
NIH/BMGF Collaboration - Point of Care Testing Working GroupCommittee, Work group, Advisory group, or Task ForceCMS, FDANIBIB, NCI, NIAID, NICHDThe 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.
NINDS Common Data Elements ProgramResource DevelopmentCDC, FDANINDS, CIT, NICHD, NEI, NHGRI, NCATS, NIA, NIMH, NIEHS, NIGMS, NIBIB, NIDDK, NIDCR, NINR, NHLBININDS 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.
https://www.commondataelements.ninds.nih.gov/
Non-animal approaches to assess cardiotoxicity hazardResearch InitiativeFDANIEHSThis 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
https://ntp.niehs.nih.gov/go/cardio
Northwest Portland Tribal Registry ProjectResource DevelopmentIHSNCIOver 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.
http://surveillance.cancer.gov/disparities/native/portland.html
NSTC Subcommittee on Biological Defense Research and Development - Interagency Bioconvergence Working GroupCommittee, Work group, Advisory group, or Task ForceOSOD/OSPProvides 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
NSTC Subcommittee on Biological SciencesCommittee, Work group, Advisory group, or Task ForceCDC, FDA, OSOD/OSPAdvises 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.
NSTC Subcommittee on Biological Sciences -Interagency Synthetic Biology Working Group (BSSC-SBWG)Committee, Work group, Advisory group, or Task ForceCDCOD/OSP, NIBIBProvides coordination and strategic planning to help ensure responsible innovation and significant advances in research in synthetic biology.
Nutrition Research Coordinating Committee (NRCC)Committee, Work group, Advisory group, or Task ForceACL, AHRQ, ASPE, CDC, FDA, HRSA, OASHOD/DPCPSI/ONRThe Nutrition Research Coordinating Committee (NRCC) was established by the National Institutes of Health (NIH) Office of the Director in 1975 to improve communication and research coordination of nutrition activities within the NIH and across the federal government. Today it provides an open forum for members to discuss current and future nutrition research challenges and opportunities. The NRCC has broad representation from the NIH institutes and centers. In addition, liaisons from other federal offices and agencies also participate. The NRCC meets monthly, alternating between intra-NIH and interagency meetings. NRCC membership is open to any federal staff member interested in carrying out any trans-NIH or trans-agency nutrition research efforts.
https://dpcpsi.nih.gov/onr/nrcc
Obesity Prevention and Control: Combined School-Based Interventions to Increase Healthier Food and Beverage Consumption and Physical ActivityMeeting/ WorkshopCDCNHLBIOngoing participation on monthly calls by the Community Guide Coordinating Team.
https://www.thecommunityguide.org/
Observational Cohort to Assess Therapeutic Efficacy and Emergence of HIV Drug Resistance following Initiation of Tenofovir-Lamivudine-Dolutegravir (TLD)Research InitiativeCDCNIAIDThis is a study of the safety, adherence, and efficacy of a fixed-dose combination of drug tenofovir/lamivudine/dolutegravir (TLD) among HIV patients, including those co-infected with tuberculosis, receiving care at PEPFAR (President’s Emergency Plan for AIDS Relief) funded sites in resource limited countries.
https://actgnetwork.org/
Occupational Exposure Assessment of Emerging Per- and Polyfluoroalkyl Substances (PFAS)Research InitiativeCDCNIEHSThe primary objectives of this study are to identify PFAS compounds currently in use in commerce or industry and the companies, industries, and worker populations who are manufacturing, processing, or using PFAS products and to conduct targeted occupational exposure assessments in high- and moderate-PFAS volume industries. Based on the results of the exposure assessment, secondary objectives of this study are to assess health effects associated with PFAS exposure. To meet the objectives of this study, we propose four specific aims.
Office for Human Research Protections/Office of Extramural Research Training InitiativeMeeting/ WorkshopOSOD/OERThe National Institutes of Health (NIH) collaborated with the OER"s Division of Human Subjects Research to provide comprehensive human subjects protection training at the fall NIH Virtual Meeting for the extramural community.
https://grants.nih.gov/news/contact-in-person/seminars.htm
Office of AIDS Research Advisory Council (OARAC)Committee, Work group, Advisory group, or Task ForceCDCOD/DPCPSI/OAR, OD, NIAID, OD/DPCPSIThe Office of AIDS Research Advisory Council (OARAC) provides advice to the Office of AIDS Research (OAR) Director on the planning, coordination, and evaluation of research and other HIV/AIDS activities conducted or supported by the National Institutes of Health (NIH). The OARAC advises the Secretary of Health and Human Services, the Assistant Secretary for Health, the Director of NIH, and the Director of OAR on HIV/AIDS research programs and the development and annual review of the comprehensive NIH Strategic Plan for HIV and HIV-Related Research.
https://www.oar.nih.gov/about/oarac
Office of Justice Programs/HHS Medicolegal Death Investigation Working GroupCommittee, Work group, Advisory group, or Task ForceCDCNIAID, CC, NICHDIdentify short and long term goals to develop and implement programmatic activities that support the Medicolegal Death Investigation system.
https://obamawhitehouse.archives.gov/sites/default/files/microsites/ostp/NSTC/strengthening_the_medicolegal_death_investigation_system_final.pdf
Office of Science and Technology Mo99 Stakeholders Working GroupCommittee, Work group, Advisory group, or Task ForceCMS, FDA, OSGNIBIB, NCIThe purpose of this working group is to coordinate the efforts of multiple stakeholders (Department of State, Department of Energy, Department of Homeland Security, Department of Health and Human Services, private sector) to establish a stable, long-term domestic supply of Mo99 (molybdenum-99) for medical purposes. Such a supply needs to be consistent with current international goals (to which the US is an active participant) of reduction in the use of high-enriched uranium in all reactors, including Mo99 production facilities, as well as full cost recovery solutions. The National Institutes of Health (NIH) staff attend stakeholders workshops, the last was held in the Spring of 2018. A symposium was scheduled in 2020 but was postponed due to COVID-19.
Office of Secretary, Patient-Centered Outcomes Research Trust Fund (OS-PCORTF) PCORTF Projects titled, “Data Capacity for PCOR through eCare Planning for People with Multiple Chronic Conditions & Disability.”Resource DevelopmentACL, AHRQ, IHSNHLBI, NCI, NIA, NIDDK, NLMThis project aims to improve the accessibility of patient-centered data for research and care by developing an accessible, interoperable, person-centered electronic (e)care plan.
Operation War Speed - Model Assessment TeamCommittee, Work group, Advisory group, or Task ForceASPRNIAIDAssess models for MCM evaluation as it relates to SARS-CoV-2
Operation War Speed - Preclinical Vaccine TeamCommittee, Work group, Advisory group, or Task ForceBARDANIAIDConduct and coordinate preclinical activities to help facilitate the development of OWS vaccine candidates (etc., animal models, testing, and correlates of protection studies)
Operation War Speed - Preclinical Vaccine Team - Product Assessment subteamCommittee, Work group, Advisory group, or Task ForceBARDANIAIDDiscussion of SARS-CoV-2 vaccine candidates, nonclinical support coordination.
Operation Warp Speed (OWS)Research InitiativeCDC, FDA, ASPRNIAIDA program designed to coordinate and respond to the public health emergency by expediting the development of vaccines, treatments, testing and other measures as needed.
https://www.defense.gov/Explore/Spotlight/Coronavirus/Operation-Warp-Speed/
Operation Warp Speed - Vaccine Development TeamCommittee, Work group, Advisory group, or Task ForceBARDANIAIDSupport pre-clinical and clinical development of COVID-19 vaccines.
Operation Warp Speed - Vaccine Development Team - Immune Assays Working GroupCommittee, Work group, Advisory group, or Task ForceBARDANIAIDCoordinate the various testing assays and direct the application of immune assays to the COVID-19 vaccine trials in order to establish correlates of protection.
Operation Warp Speed COVID-19 Research Group (now the USG COVID-19)Committee, Work group, Advisory group, or Task ForceCDC, FDA, ASPRNIAIDDiscussion of trial data, Prioritization of agents
Oral Health & Aging: Information for CaregiversPublic Education CampaignACL, HRSA, IOSNIDCR, NIAFact sheets designed to provide caregivers with information they need to assist older adults with oral hygiene. There are four fact sheets in the series: Brushing, Flossing, Dry Mouth, and Finding Low-Cost Dental Care.
https://catalog.nidcr.nih.gov/OrderPublications/#101
ORWH E-learning coursesTraining InitiativeFDAOD/DPCPSI/ORWH, NIGMSNIGMS promotes the ORWH E-learning courses Bench to Bedside: Integrating Sex and Gender to Improve Human Health and the SABV Primer on its Clearinghouse for Training Modules to Enhance Data Reproducibility website.
https://www.nigms.nih.gov/training/pages/clearinghouse-for-training-modules-to-enhance-data-reproducibility.aspx
P63, P13K and RAS oncogenes in tumorigenesis, immune deregulation and therapy of squamous cell carcinomaResearch InitiativeFDANIDCDAt the Food and Drug Administration (FDA), Dr. Weinberg is transducing murine keratinocytes with combinations of oncogenes found in human squamous cell carcinomas to determine if they generate transformation and tumors in laboratory conditions. Dr. Van Waes’ laboratory at the National Institute on Deafness and Other Communication Disorders (NIDCD) will study how these oncogene-driven tumors in mice deregulate keratinocytes and host immune responses, as well as response to various standard, molecular, and immune therapies.
Pathogen Detection Project and Interagency Collaboration on Genomics for Food and Feed Safety (Gen-FS)Resource DevelopmentCDC, FDANLMThe Pathogen Detection Project is a multi-agency collaboration that is combining data from pathogen outbreaks with other information to determine the major source of contamination. The project is conducted via a centralized system that integrates sequence data for bacterial pathogens obtained from food, the environment, and human patients. A number of public health agencies in the US and internationally are collecting samples from these sources to facilitate active, real-time surveillance of pathogens and foodborne disease. The agencies sequence the samples and submit the data to the National Center for Biotechnology Information (NCBI), a division of the National Library of Medicine (NLM) at the National Institutes of Health (NIH), which analyzes the sequences against others in its database to identify closely related sequences. The aim is to uncover potential sources of contamination by linking isolates from food or the environment to human illness and to quickly report the sequence relationships to public health scientists in order to aid traceback investigations and outbreak response. Collaborating agencies include the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), USDA-Food Safety and Inspection Service, and Public Health England. The US agencies formalized their collaboration in a charter document (Interagency Collaboration on Genomics for Food and Feed Safety (Gen-FS)) that includes coordinating activities on antimicrobial resistance.
http://www.ncbi.nlm.nih.gov/pathogens/
Pathways to Prevention (P2P) Workshop ProgramMeeting/ WorkshopAHRQODPThe Pathways to Prevention (P2P) program is a workshop series hosted by the Office of Disease Prevention (ODP) to identify research gaps in a selected scientific area, identify methodological and scientific weaknesses in that scientific area, suggest research needs, and move the field forward through an unbiased, evidence-based assessment of a complex public health issue. P2P workshops are designed for topics that have incomplete or underdeveloped research and for which there is a need for a systematic evidence review that synthesizes the published literature. After each workshop, ODP also organizes a meeting of all Federal Partners who have an interest in or activities related to the workshop topic to discuss ways that the Federal Partners might collaborate to implement workshop recommendations.
https://prevention.nih.gov/programs-events/pathways-to-prevention/
Patient Centered Outcomes Research Trust Fund Leadership Council (OS-PCORTF LC)Committee, Work group, Advisory group, or Task ForceASPE, CMS, AHRQ, ACF, ACL, CDC, FDA, HRSA, ONC, IHSNLM, NCCIH, OD/DPCPSI, OD/OERThis council provides for the coordination of relevant Federal health programs to build data capacity for comparative clinical effectiveness research, including the development and use of clinical registries and health outcomes research networks, in order to develop and maintain interoperable data network to collect and analyze data on outcomes and effectiveness from multiple sources.
https://aspe.hhs.gov/patient-centered-outcomes-research-trust-fund-faqs
PCC Technical Working Group on PFASCommittee, Work group, Advisory group, or Task ForceCDC, FDA, ATSDRNIEHSTechnical coordination on toxicology,exposure,analysis, mitigation of PFAS
https://www.who.int/ipcs/network/en/
PCORTF Frailty & Functional Disabilities Project Working GroupResource DevelopmentASPE, AHRQ, CDC, CMSNIAValidate and Expand Claims-Based Algorithms, Identifying Patients with Frailty and Functional Disabilities across Payer and Patient Populations
https://aspe.hhs.gov/validating-and-expanding-claims-based-algorithms-frailty-and-functional-disability-value-based-care-and-payment
Pediatric COVID-19/Multisystem Inflammatory Syndrome in Children (MIS-C) interagency teamCommittee, Work group, Advisory group, or Task ForceCDC, FDA, HRSANIAID, NHLBI, NICHDInter-agency review of current status of HHS efforts to address pediatric Sars-CoV-2 infection
Pediatric Device Consortia Grants ProgramResearch InitiativeFDANICHDThe goal of the Food and Drug Administration (FDA) Pediatric Device Consortia (PDC) Grants Program is to facilitate the development, production, and distribution of pediatric medical devices through funding of nonprofit consortia.
https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/PediatricDeviceConsortiaGrantsProgram/
Phylodynamic Monitoring of HIV Transmission Hotspots to End the HIV EpidemicMeeting/ WorkshopCDCNIAID, NLMThis workshop brought together NIAID grantees, NIH and CDC officials, and people living with HIV to discuss the use and implementation of phylogenetic tools to support the Ending the HIV Epidemic: A Plan for America (EHE) initiative. The workshop featured scientific presentations on HIV phylogenetics, bioinformatics/mathematical modeling, and HIV prevention and transmission, as well as a panel discussion to highlight community perspectives on the responsible use of phylogenetic data to identify HIV transmission hotspots.
PillboxResource DevelopmentFDANLMThe National Library of Medicine and the Food and Drug Administration have established a collaborative relationship to enhance patient safety through the linking of digital images of prescription solid dosage form medications to the Structured Product Labeling (SPL) files and the substance information of those pharmaceuticals.
Planning and Design for Post-Acute Care Assessment Instruments and Data ElementsResource DevelopmentCMSNLMThe ultimate goal of this work is to improve quality of care and interoperability of computerized data in acute hospitals and post-acute care (PAC) settings through the use of health informatics and real-time transfer of patient information. The National Library of Medicine (NLM) and Centers for Medicare & Medicaid Services (CMS) collaborate on planning and design for the Continuity Assessment Record & Evaluation (CARE) instrument and its data elements, and those of other CMS post-acute care assessment tools; develop logical data model and software applications that promote compliance and compatibility with Federal Health Architecture consolidated health informatics (CHI) standards; adopt Federal government-wide health information interoperability standards associated with Meaningful Use; and improve data and messaging for the Medicare program. This collaboration benefits from NLM's role as central US Department of Health and Human Services (HHS) coordinating body for clinical terminology standards, and provides NLM specific and usage-based feedback on the utility of such standards in this environment.
Policies and Regulatory Pathways to FDA LicensureMeeting/ WorkshopFDANIAIDThe purpose of this meeting was to understand the policies that advance radiation countermeasure agents and biodosimetry devices towards eventual FDA approval. Manuscript preparation is ongoing with input from all agencies, with anticipated submission to Radiation Research
Polyhalogenated Aromatic Hydrocarbons (PHAH) and Thyroid CancerResearch InitiativeCDCNCIPolyhalogenated aromatic hydrocarbons are being measured in banked serum/plasma samples from cohort studies to evaluate the association with thyroid cancer incidence. The National Cancer Institute (NCI) investigators are leading nested case-control studies of thyroid cancer in three cohorts to examine associations between pre-diagnostic concentrations of polychlorinated biphenyls (PCB), polybrominated diethyl ethers (PBDE), and organochlorine insecticides and thyroid cancer risk.
Population Assessment of Tobacco and Health (PATH) StudyHealth SurveyFDANIDAThe Population Assessment of Tobacco and Health (PATH) Study is the first large-scale National Institutes of Health (NIH)/ and the US Food and Drug Administration (FDA) collaboration since Congress granted FDA the authority to regulate tobacco products in the Family Smoking Prevention and Tobacco Control Act (FSPTCA) in 2009. The PATH Study is a national longitudinal cohort study that will follow an estimated 59,000 US household residents ages 12 years and older for at least three years. Objectives are to assess initiation and use patterns; to study trends in tobacco-product use cessation and relapse; to monitor behavioral and health impacts, including in risk perceptions and other tobacco-related attitudes; and to assess differences in tobacco-related attitudes, behaviors, and health outcomes among racial/ethnic, gender, and age subgroups. The PATH Study will also collect biospecimens from adults to analyze biomarkers of tobacco use and related health outcomes. By measuring and accurately reporting on the social, behavioral, and health effects associated with tobacco-product use in the United States, the PATH Study will provide an empirical evidence base to help inform FDA’s decisions about changes in tobacco products in meeting the objectives of the 2009 FSPTCA.
http://www.PATHStudyInfo.nih.gov
Post Market Safety Study of OpioidsCommittee, Work group, Advisory group, or Task ForceFDAOD/DPCPSI/ORWH, NIDAParticipated in the oversight committee in the FDA Mandated Post-Market Opioid Safety Studies, which is a 100 million-dollar FDA mandated series of research projects related to the safety and risks associated with the long-term use of opioids for pain.
Post-Traumatic Stress Disorder (PTSD)/Trauma Brain Injury (TBI), Suicide Prevention National Research Action Plan (NRAP) WorkgroupCommittee, Work group, Advisory group, or Task ForceOSNIMH, NIAAA, NIDA, NINDSA 2012 White House Executive Order, emphasizing support of Service Members, Veterans, and their families as a top priority, called for an urgent increase in the Departments of Health and Human Services (HHS), Defense (DoD), and Veterans Affairs (VA) research coordination to address the problems of Post-Traumatic Stress Disorders (PTSD), Trauma Brain Injury (TBI), and suicide. Section 5 of this Executive Order requested a National Research Action Plan (NRAP) to develop biomarkers, define the pathophysiology, and develop new treatments for PTSD. HHS charged the National Institute of Mental Health (NIMH) to lead this effort along with a parallel effort for TBI led by National Institute of Neurological Disorders and Stroke (NINDS), with both Institutes working closely with VA and DoD. The NRAP was published in 2013. Prior investments integrating the molecular, genomic, and brain circuitry changes that give rise to PTSD in the context of environmental factors provide the requisite foundation to respond to this White House request for biomarkers for risk prediction, as well as new targets for medications, and other therapies to treat PTSD. This investment has the potential to revolutionize care for individuals at high risk for PTSD and prevent the development of chronic, complex treatment-resistant PTSD. The agencies meet weekly and produce quarterly progress reports.
http://www.whitehouse.gov/the-press-office/2012/08/31/executive-order-improving-access-mental-health-services-veterans-service
Preclinical Assessment of Phage Therapy for Pathogen DecolonizationResearch InitiativeFDANIAIDThis project addresses key regulatory considerations relevant to using bacteriophages for decolonization of the drug-resistant nosocomial pathogens, vancomycin-resistant enterococci (VRE) and methicillin-resistant Staphylococcus aureus (MRSA). These include characterizing pathogen resistance to phage, defining phage mixtures ("cocktails") to circumvent resistance, optimizing mouse models to evaluate pathogen decolonization, and identifying endpoints that support claims for clinical benefit (e.g., reduced risk of disease transmission).
Predictive Biodosimetry Guidance Planning Working GroupCommittee, Work group, Advisory group, or Task ForceASPR, FDANIAIDWorking group meets monthly with the following goals: 1) Convene a subject matter expert (SME) panel to discuss target product profile (TPP) or device/assay specifications for predictive biodosimetry in early 2021; 2) Identify key SMEs. trans-agency partners and companies; 3) Host meeting, write panel consensus report; 4) Partner with FDA to generate an addendum to the Biodosimetry Guidance; 5) Identify pathways for development and potential pitfalls; 6) Identify funding to support mid-stage to advanced development of predictive biodosimetry devices/assays.
Pregnancy and Birth to 24 Months (P/B-24) ProjectCommittee, Work group, Advisory group, or Task ForceCDC, FDA, HRSA, OSNICHD, NCI, NHLBI, NIDDKIn 2012, the US Department of Agriculture (USDA) and Department of Health and Human Services (HHS) initiated a project informally called the “B-24 project.” This multi-phase project was originally intended to conclude in 2018 with information that could help the Departments develop dietary recommendations for infants and toddlers for release separate from the Dietary Guidelines. The first phase was completed in 2012-2013. In February 2014, Congress passed the Agricultural Act of 2014, also known as the Farm Bill, mandating that the Dietary Guidelines expand to include dietary guidance for infants and toddlers (from birth to age 24 months), as well as women who are pregnant, beginning with the 2020-2025 edition. Thus, USDA and HHS adjusted the purpose, timeline, and scope of the project. Now called the “Pregnancy and Birth to 24 Months project” or “P/B-24 project” to reflect the addition of pregnant women, this project is a joint initiative led by USDA and HHS in collaboration with programmatic and scientific experts. Rather than concluding in 2018 with dietary recommendations, the goal of the current project is to begin examining topics of public health importance for women who are pregnant and infants and toddlers from birth to 24 months of age. The findings from this work will be made publicly available at the completion of the project.
https://www.fns.usda.gov/resource/pregnancy-and-birth-24-months
Pregnancy and Maternal Conditions that Increase Risk of Morbidity and Mortality Virtual WorkshopMeeting/ WorkshopOASHOD/DPCPSI/ORWH, NICHD, NHLBI, ODPThere were various speakers that presented at this event which took place on May 19-20, 2020.
https://orwh.od.nih.gov/about/newsroom/events/nichdorwh-pregnancy-and-maternal-conditions-increase-risk-morbidity-and
Pregnancy Risk Assessment Monitoring System: Addition of Disability QuestionsHealth SurveyCDCNICHDThe purpose of this collaboration is to contribute to the funding of the development, fielding, and data preparation for a survey supplement to the Pregnancy Risk Assessment Monitoring System (PRAMS) to assess disabilities among postpartum women using the PRAMS survey
https://projectreporter.nih.gov/project_info_description.cfm?icde=0&aid=10138734
PregSource® Management TeamPublic Education CampaignCDC, HRSANICHD, NCCIH, NHLBI, NIEHS, NIMHD, NINR, OD/DPCPSI/OBSSR, OD/DPCPSI/ORWHPregSource is a crowdsourcing research project that aims to learn about the pregnancy experience. Getting information directly from pregnant women about what they feel, think, do, and experience during pregnancy and after giving birth can teach us more about pregnancy and how to improve care.
https://pregsource.nih.gov/
President's Advisory Council for HIV/AIDS (PACHA)Committee, Work group, Advisory group, or Task ForceCDC, CMS, HRSA, IHS, OASHOD/DPCPSI/OARThe Presidential Advisory Council on HIV/AIDS (PACHA) provides advice, information, and recommendations to the Secretary of Health & Human Services regarding programs, policies, and research to promote effective treatment, prevention and cure of HIV disease and AIDS, including considering common co-morbidities of those infected with HIV as needed to promote effective HIV prevention and treatment and quality services to persons living with HIV disease and AIDS.
https://www.hiv.gov/federal-response/pacha/about-pacha
President's Emergency Plan for AIDS Relief (PEPFAR) Implementation Science/Combination PreventionResearch InitiativeCDCNIAID, FIC, NCI, NIAAA, NIDA, NIMH, OD/DPCPSI/OARThis President’s Emergency Plan for AIDS Relief (PEPFAR) activity focuses on testing treatment as prevention on the population level in South Africa and Zambia. This activity was initiated through the HIV Prevention Trials Network (HPTN), with support of multiple National Institutes of Health (NIH) Institutes and Centers, PEFPAR, and the Bill & Melinda Gates Foundation. The Requests for Application (RFA) was issued concurrently with a Centers for Disease Control and Prevention (CDC) RFA for combination prevention, and the agencies have worked together to ensure that the studies are complementary and do not overlap.
http://www.pepfar.gov/
President's Task Force on Environmental Health Risks and Safety Risks to Children (PTFCEH)Committee, Work group, Advisory group, or Task ForceACF, ASPR, CDC, ATSDR, FDA, OASH, SAMHSANIEHS, NICHD, NHLBI, NIMH, NIMHDThe PTFCEH is the focal point for coordinating federal government efforts to explore, understand, and act together to improve children's environmental health. The Task Force mission includes a goal of prioritizing issues of environmental justice and health disparities among children.
ptfceh.niehs.nih.gov
President's Task Force on Environmental Health Risks and Safety Risks to Children: Lead Exposures SubcommitteeCommittee, Work group, Advisory group, or Task ForceACF, CDC, FDA, HRSA, OSNICHD, NHLBI, NIEHS, ODPThe President's Task Force on Environmental Health and Safety Risks to Children is the focal point for coordinating the federal government's effort to explore, understand, and improve children's environmental health. The task force's objectives are to: 1) develop federal interagency strategies to protect children’s environmental health and safety; 2) identify priority children's environmental health and safety issues best addressed through federal interagency efforts; and 3) communicate information to federal, state, and local decision-makers to protect children from environmental health risks. The Lead Subcommittee seeks to reduce lead exposure and associated harms through collaboration among federal agencies and with a range of stakeholders, including states, tribes and local communities, along with businesses, property owners and parents. This Subcommittee will help federal agencies work strategically and collaboratively to reduce exposure to lead with the aim of ultimately improving children’s health.
https://ptfceh.niehs.nih.gov/activities/lead-exposures/index.htm
Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB)Committee, Work group, Advisory group, or Task ForceBARDANIAIDIn March 2015, the Department of Health and Human Services (HHS) announced the establishment of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB). This Federal Advisory Committee (FACA) includes public voting members, non-voting liaison representatives from organizations and/or interest groups, and non-voting federal ex-officio members. PACCARB provides advice, information, and recommendations to the Secretary regarding programs and policies intended to support and evaluate the implementation of Executive Order 13676, including the National Strategy for CARB and the National Action Plan for CARB. PACCARB has been reauthorized until Jan 18, 2019 (based on its charter), through Executive Order 13811 on Sept. 29, 2017.
https://www.hhs.gov/ash/advisory-committees/paccarb/index.html
Prevention Research Coordinating Committee (PRCC)Committee, Work group, Advisory group, or Task ForceAHRQ, CDC, OSODP, CC, FIC, NCATS, NCCIH, NCI, NEI, NHGRI, NHLBI, NIA, NIAAA, NIAID, NIAMS, NIBIB, NICHD, NIDA, NIDCD, NIDCR, NIDDK, NIEHS, NIGMS, NIMH, NIMHD, NINDS, NINR, NLM, OD/DPCPSI/OAR, OD/DPCPSI/OBSSR, OD/DPCPSI/ORWH, OD/DPCPSI/ODS, OD/OLPAThe NIH Prevention Research Coordinating Committee (PRCC) serves as a venue for exchanging information on recent scientific advances in disease prevention; examining the impact of new policies on research; planning new or discussing ongoing initiatives; and highlighting program accomplishments. As a trans-NIH, trans-agency committee, the PRCC provides a broad perspective on the current state-of-the-science and actively disseminates information about prevention-related activities sponsored by federal and non-federal organizations to the NIH Institutes and Centers.
https://prevention.nih.gov/prevention-research/prcc
Probiotic and Prebiotic Working Group [PPWG]Committee, Work group, Advisory group, or Task ForceFDANCI, NCCIH, NIAMS, NIDA, NIDCR, OD/DPCPSI/ODSThe Probiotic and Prebiotic Working Group (PPWG) is a trans-National Institutes of Health (NIH) effort formed in 2006 to identify gaps and challenges in prebiotic and probiotic research. Their goals include (1) facilitating interactions and collaborations among research scientists in the field of probiotics and prebiotics, (2) advancing prebiotic and probiotic research, and (3) understanding the role of gut microbiota and use of prebiotics and probiotics in health and disease. The working group strives to promote constructive interactions across NIH Institutes, Centers, and Offices, by disseminating real-time information and keeping PPWG members abreast of current and future activities occurring in the fields of probiotics and prebiotics. The group meets quarterly to form allied partnerships and collaborate on various pre- and probiotic activities. Two trans-NIH Program Announcements were released in 2015 and were renewed in 2018 (PA-18-902; PA-18-876 ).
https://grants.nih.gov/grants/guide/pa-files/pa-18-902.html
Project ECHO for Cancer Research and ControlResource DevelopmentCDCNCIProject Extension for Community Healthcare Outcomes (ECHO) is a collaborative medical education model that aims to build workforce and knowledge capacity, through use of online videoconferencing to allow for knowledge exchange across interdisciplinary teams on relevant medical, healthcare, and health systems related topics. The National Cancer Institute (NCI) Center for Global Health (CGH) Project Echo Cancer Control Planning Program will link participants active in cancer control planning in low- and middle-income country settings with researchers, regional colleagues, and relevant technical experts, through monthly ECHO sessions that will provide virtual didactic instruction, case study learning, and knowledge exchange on relevant evidence-based cancer control planning principles. These sessions will relay evidence-based, general cancer control principals and related to cervical cancer screening. The CGH Project ECHO program’s primary goals are to increase participant knowledge of the aforementioned topics, improve the application of knowledge, including evidence-based practices and policies, and to increase collaboration among participants and experts who are active in cancer control planning in the participating countries.
Promoting Semantic Interoperability of Laboratory Data Test ResultsResource DevelopmentCDC, FDANLMThe Centers for Disease Control and Prevention (CDC) and the National Library of Medicine (NLM) encourage considering ways that the Food and Drug Administration (FDA) could accelerate specifications of LOINC codes that apply to each test result that a lab/test instrument or kit can generate. Availability of the right LOINC codes with each instrument test kit will greatly simplify the correct assignment of codes by a laboratory for sending to clinician's medical record system.
Public Health and Emergency Medical Countermeasures Enterprise (PHEMCE)Committee, Work group, Advisory group, or Task ForceACF, CDC, FDA, OS, SAMHSANIAID, NIAMS, NICHD, NINDS, NLMThe Public Health and Emergency Medical Countermeasures Enterprise (PHEMCE) advances national preparedness for natural, accidental, and intentional threats by coordinating medical countermeasure-related efforts within HHS and in cooperation with PHEMCE interagency partners. NIAID has representatives on many groups within PHEMCE.
http://www.phe.gov/Preparedness/mcm/phemce/Pages/mission.aspx
Public Health Emergency Management Countermeasures Enterprise (PHEMCE)Committee, Work group, Advisory group, or Task ForceACF, CDC, FDA, IOS, SAMHSANLM, NIAMSThe Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) determines the various MCMs that are needed and oversees their development and procurement. The PHEMCE also advances national preparedness against chemical, biological, radiological, nuclear (CBRN) and emerging infectious disease (EID) threats, including pandemic influenza, by coordinating medical countermeasure related efforts within HHS and in cooperation with interagency PHEMCE partners. In order to accomplish this objective, the PHEMCE uses a multitier approach. Each tier comprises multiple agencies within HHS and/ or DHS that work together in a collaborative fashion to further the preparedness of the nation. The first tier includes the Biological, Chemical, Radiological/Nuclear Working Groups; the Blood/Tissue MCM Requirements Working Group; and Integrated Program Teams (IPTs). The Working Groups (WG) utilize scenario-based analyses to determine which medical countermeasures are needed for the SNS, or affiliated repositories. The IPTs provide an end-to-end vision of medical countermeasures needed for a particular threat type (e.g., anthrax, rad/nuc, etc.). The scope of their work includes setting requirements for the stockpiling of MCMs, MCM delivery and dispensing and monitoring MCM development. The IPTs also advise the Enterprise Executive Committee as to threat- or capability-specific MCM priorities for improving preparedness, to inform leadership consideration of cross-threat prioritizations and strategic goal setting. Agencies represented on the PHEMCE WGs and IPTs include; National Institute of Health(NIH), Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), Department of Defense (DOD), Assistant Secretary for Preparedness and Response ( ASPR), Biomedical Advanced Research and Development Authority (BARDA), Department of Homeland Security (DHS) and the Department of Veterans Affairs (VA). The second tier of this process is the Enterprise Executive Committee (EEC). The EEC is comprised of senior program managers across the partner agencies. It provides the critical interface and organizing capability between the strategic focus of the Enterprise Senior Council (ESC) and the tactical-level efforts conducted within the subordinate IPTs and WGs. This committee serves as a Senior Advisor-level coordination mechanism across the federal agencies involved in PHEMCE-related activities to facilitate vetting and prioritization of policy decision materials to be presented to the ESC. The third and most senior tier of the PHEMCE and the forum for cooperation and overall mission fulfillment is the Enterprise Senior Council (ESC). Structurally, the ESC is led by the Assistant Secretary for Preparedness and Response and comprised of the senior leadership of National Institute of Allergy and Infectious Disease (NIAID) within the National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), and Food and Drug Administration (FDA) with comparable senior level representatives from the Department of Defense (DoD) , the Department of Homeland Security (DHS), the Department of Veterans Affairs (VA) , and the U.S. Department of Agriculture (USDA) As the most senior level in the PHEMCE structure, this group approves major policies, product requirements, and large-scale procurement actions. It also oversees strategic reviews of the activities in each of the major threat portfolios (e.g., anthrax, smallpox, rad/nuc) and is the final reporting body for high priority actions identified as gaps in these reviews.
NIAID NIAMS NICHD NINDS
Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Pediatrics and Obstetrics Integrated Program Team (IPT)Committee, Work group, Advisory group, or Task ForceCDC, FDA, OSNICHD, NIGMSThe Public Health Emergency Medical Countermeasures Enterprise's (PHEMCE) mission is to advance national preparedness for natural, accidental, and intentional threats by coordinating medical countermeasure-related efforts within HHS and in cooperation with PHEMCE interagency partners. The Pediatrics and Obstetrics Integrated Program Team (IPT) provide a complete, end-to-end vision of medical countermeasures for pregnant women, mothers, and their children. The IPT considers requirement-analysis, development and production, stockpiling, delivery and dispensing to the end user, adverse event monitoring, communications, guidance and policy development, and evaluating medical countermeasures' effectiveness and replacement needs.
https://www.phe.gov/Preparedness/mcm/phemce/Pages/default.aspx
Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Preparedness Against Chemical Threats (PACT) Working GroupCommittee, Work group, Advisory group, or Task ForceCDC, FDA, OSNINDS, NIAIDThe US Department of Health and Human Services (HHS) Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) leads the mission to develop and acquire medical countermeasures that will improve public health emergency preparedness as well as prevent and mitigate the adverse health consequences associated with chemical, biological, radiological and nuclear (CBRN), and naturally occurring threats.
https://www.medicalcountermeasures.gov/
Quantitative Data Mining for Drug-Adverse Event Safety Signal Detection Using MEDLINEResearch InitiativeFDANLMThe objective of this initiative between the National Library of Medicine (NLM) Cognitive Science Branch and the Center for Drug Evaluation and Research at the US Food and Drug Administration (FDA) is to develop a mutually beneficial automated data mining analytical tool in which NLM’s electronic databases and resources (including MEDLINE) are utilized to support the FDA’s mission related to enhancing postmarket drug safety surveillance and safe use.
http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162057.htm
Quantum Barcoding for analysis of Ebola infectionResource DevelopmentFDANIAIDViral MIBI and Quantum barcoding: These projects are part of an Food and Drug Administration (FDA) contract with Dr. Gary Nolan's group at Stanford. The first project will develop and validate an assay for nucleic acid-based method for viral detection on the MIBI, compatible with Formalin-Fixed Paraffin-Embedded tissue, and then apply to Ebola samples. The second will use quantum barcoding to develop anti-human and anti-macaque antibody reagents, to hep develop a system that will replace multiplexing technologies such as high parameter FACS and CyTOF with a platform based on sequence tags (rather than fluorophores or mass tags) that uses decontaminated and ambient temperature-stable samples. This will be applied to BSL-3/4 samples.
Racial/Ethnic Variation of HPV Type Distribution in High-Grade Cervical Precancers and Invasive Cancers in the United StatesResearch InitiativeCDCNCIThe National Cancer Institute (NCI) and Centers for Disease Control and Prevention (CDC) are collaborating in pooled anlaysis of seven U.S. studies conducted between 1997-2015 to examine HPV genotype attribution for cervical precancer and cancer by race/ethnicity.
Radiation and Chemical Defense Working GroupCommittee, Work group, Advisory group, or Task ForceASPR, FDANIAID, NIEHS, NIAMSThis group is responsible for ensuring that any scientific or budgetary overlap between the chemical defense and radiation defense missions are identified and leveraged to advance the missions of both research areas. Goals are to understand areas of synergy in chemical and radiological insults, identify key pathways, foci of intervention, MCM development. The group includes staff from across the NIH, FDA and ASPR. Special Journal Issue and Government staff positional paper are planned.
Radiation Biodosimetry Working GroupCommittee, Work group, Advisory group, or Task ForceFDANIAIDThis working group is focused on regulatory and scientific issues regarding technologies and devices for radiation biodosimetry. The working group assisted in drafting the new Food and Drug Administration (FDA) Center for Device and Radiological Health (CDRH) guidance for industry.
Radiation Emergency Medical Management (REMM)Resource DevelopmentCDC, IOS, ASPRNLM, NCIThis activity is to develop a comprehensive web resource and mobile app. Radiation Emergency Medical Management (REMM) is a mechanism to collect, evaluate, collate, store, and make available electronically to health care professionals immediate, up-to-date, evidence-based clinical information they would use to treat civilian patients and others affected by radiation incidents.
http://www.remm.nlm.gov/
Radiation-Induced Immune Dysfunction MeetingMeeting/ WorkshopASPRNIAIDThe purpose of the workshop is to bring investigators together from the radiation biology and basic immunology fields to examine effects of radiation-induced hematopoietic injury, including natural history – early effects, recovery and residual damage.
Radiation-Induced Multi Organ Dysfunction Meeting Planning GroupMeeting/ WorkshopASPRNIAID, NCIThe objectives of the workshop are to 1) explore radiation-induced multi-organ injury, in particular, the connections and underlying mechanisms driving injury to affected organs; 2) assess how various treatments can ameliorate these injuries; and 3) publish a meeting report in a peer-review journal. Meeting will be held November 2-3, 2021.
Radiobiology Bioterrorism Research and Training Group (RABRAT)Meeting/ WorkshopFDA, OSNCI, NIAIDThis activity involves monthly meetings to discuss research initiatives, funding opportunities, training, conferences, publications, and other events and information related to preparing the US Government to respond to nuclear terrorism.
https://rrp.cancer.gov/programsResources/program_collaborations.htm
Rapid Acceleration of Diagnostics Tech Program (RADx Tech)Research InitiativeCMS, FDA, CDC, ASPRNIBIBTo help address the COVID-19 pandemic, National Institute of Biomedical Imaging and Bioengineering (NIBIB) received $500 million to support the development of new SARS-CoV-2 virus testing technologies. The funding is part of the fourth congressional supplement (PPP Act). Additional funds ($307 mil) from Biomedical Advanced Research and Development Authority (BARDA) were transferred and an additional appropriations ($100 mil) from the fifth congressional supplement. The Rapid Acceleration of Diagnostics (RADx) Tech program is leveraging NIBIB's existing Point-of-Care Technologies Research Network (POCTRN) to accelerate the development, validation, and commercialization of innovative POC and home-based tests, as well as improvements to existing clinical laboratory methods. RADx Tech is supporting the full range of product development including technology validation, clinical translation, commercialization, and product distribution. General information about the RADx Tech https://www.nih.gov/research-training/medical-research-initiatives/radx… RADx Tech dashboard - https://www.nibib.nih.gov/covid-19/radx-initiative-dashboard
https://www.poctrn.org/radx https://www.nibib.nih.gov/covid-19/radx-tech-program
Rare Disease Day at NIHMeeting/ WorkshopFDANCATS, NHLBI, NCI, NHGRI, NICHD, NINDS, CCRare Disease Day® takes place worldwide, typically on or near the last day of February each year, to raise awareness among policymakers and the public about rare diseases and their impact on patients’ lives. Each year, the National Center for Advancing Translational Sciences (NCATS) and the National Institutes of Health (NIH) Clinical Center sponsor Rare Disease Day at NIH as part of this global observance. Rare Disease Day at NIH aims to raise awareness about rare diseases, the people they affect, and NIH research collaborations underway to address scientific challenges and to advance new treatments. The goals of Rare Disease Day at NIH are to: demonstrate the NIH commitment to helping people with rare diseases through research; highlight NIH-supported rare diseases research and the development of diagnostics and treatments; initiate a mutually beneficial dialogue among public and private researchers, patients, patient advocates, and policymakers; exchange the latest rare diseases information with stakeholders to advance research and therapeutic efforts; put a face on rare diseases by sharing stories of patients, their families, and their communities.
https://ncats.nih.gov/rdd
rCR training to Grants ManagersTraining InitiativeOASHOD/OEROHRP and NIH staff will discuss the responsibilities regarding human subjects protection in NIH funded research. This session will cover the fundamentals of the Common Rule including Federalwide Assurance, IRB review, and informed consent. OHRP faculty will discuss the impact of the revised Common Rule. NIH faculty will discuss NIH policies and procedures relevant to implementation of the revised Common Rule.
https://stafftraining.intranet.od.nih.gov/events/20200708/human-subjects-research-revised-hhs-regulations-and-nih-implementation
Reciprocal Educational and Training Partnerships between FDA/CDER and the NIH Clinical CenterTraining InitiativeFDACC, NCI, NIAID, NIDCR, NIDDK, NIMH, NINDSThis activity is sponsored by the Clinical Pharmacology Program, Office of Clinical Research Training and Medical Education (OCRTME) at The National Institutes of Health (NIH) Clinical Center (CC). It consists of elective rotations at the Office of Clinical Pharmacology (OCP) and the Office of New Drugs (OND) of the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research. It is for NIH staff, with a primary focus on clinical fellows and research fellows, who expressed an interest in learning more about FDA regulatory sciences applicable to drug development research. Rotating fellows are mentored by FDA staff on the required elements of an Investigational New Drug (IND) application and the key elements of the FDA review process from a regulatory perspective. This program also established a mechanism for FDA scientific reviewers at the OCP to rotate at the NIH CC and to interact with members of a clinical research team, thus acquiring a better perspective on clinical research protocol implementation and the requirements of an Institutional Review Board (IRB) at the NIH.
Recognize, Assist, Include, Support and Engage (RAISE) Family Caregiving Advisory CouncilCommittee, Work group, Advisory group, or Task ForceACF, ACL, CDC, CMS, FDA, HRSA, IHS, SAMHSANIAFederal and non-federal advisory council is charged with providing recommendations to the Secretary of Health and Human Services on effective models of both family caregiving and support to family caregivers, as well as improving coordination across federal government programs, as mandated by the Recognize, Assist, Include, Support, and Engage (RAISE) Family Caregivers Act of 2017.
https://acl.gov/programs/support-caregivers/raise-family-caregiving-advisory-council
Reentry Research NetworkCommittee, Work group, Advisory group, or Task ForceACF, SAMHSANIDA, OD/DPCPSI/OBSSRThis is a subgroup that reports to the Federal Interagency Reentry Council. The purpose of this group is to bring together numerous federal agencies to make communities safer, assist those returning from prison and jail to becoming productive, tax-paying citizens, and save taxpayer dollars by lowering the direct and collateral costs of incarceration. The National Institute on Drug Abuse (NIDA) serves on the HHS Re-entry/CJ working group. Staff meets by phone monthly.
Regenerative Medicine Innovation Project Senior Oversight CommitteeCommittee, Work group, Advisory group, or Task ForceFDANIAID, NCATS, NEI, NHLBI, NIA, NIAMS, NIDCD, NIDCR, NIDDK, NINDSThe Regenerative Medicine Innovation Project was established by the 21st Century Cures Act to accelerate progress in the field by supporting clinical research on adult stem cells, while promoting scientific rigor and protecting patient safety. This initiative is a trans-NIH effort, in coordination with the Food and Drug Administration (FDA).
Regenerative Medicine ProjectResearch InitiativeFDANIAThe Regenerative Medicine Innovation Project (RMIP) was established by the 21st Century Cures Act to accelerate progress in the field by supporting clinical research on adult stem cells, while promoting scientific rigor and protecting patient safety. This initiative is a trans-NIH effort, in coordination with the Food and Drug Administration (FDA).
https://www.nih.gov/rmi
Registry-based studies of hematologic malignancy incidence and survivorshipResearch InitiativeFDANCINCI and FDA investigators are collaborating to utilize registry-based data to describe incidence trends of hematologic malignancies as well as second cancer risk and mortality patterns among hematologic malignancy survivors.
Report Out Session of the HIV-related Intersectional Stigma Research Advances and Opportunities WorkshopMeeting/ WorkshopOASHOD/DPCPSI/OAR, NIMHOn September 18, 2020, join the NIH Office of AIDS Research and the NIMH Division of AIDS Research for a discussion about the outcomes of recent meetings of four workgroups focused on HIV-related intersectional stigma research advances and opportunities. The goal of this virtual workshop is to advance HIV prevention and treatment science, inform the Ending the HIV Epidemic (EHE) initiative, and bolster HIV efforts worldwide.
https://www.nimh.nih.gov/news/events/announcements/report-out-session-of-the-hiv-related-intersectional-stigma-research-advances-and-opportunities-workshop.shtml
RePORT South AfricaResearch InitiativeCDC, OSNIAIDRePORT South Africa is a jointly funded project between the National Institutes of Health (NIH), the US President's Emergency Plan for AIDS Relief (PEPFAR), and the South African Medical Research Council and Department of Science and Technology to establish a consortium of Tuberculosis (TB) researchers in South Africa.
Repurposing Off-Patent Drugs: Research & Regulatory ChallengesMeeting/ WorkshopFDANCATSThe workshop mapped out the challenges to repurposing drugs that are already on the market but lack commercial and regulatory incentives for research and development.
https://reaganudall.salsalabs.org/repurposingoffpatentdrugsworkshop/index.html
Research in Diabetes Mellitus, Its Complications, and ObesityResearch InitiativeIHSNIDDKThe objectives are to identify the determinants and understand the progression of type 2 diabetes, obesity, and other chronic diseases in Native American and related populations.
Research IND Portal ( Pilot)Resource DevelopmentFDANCICDER’s Office of Business Informatics and Office of Medical Policy have partnered with NIH to build, and pilot, a cloud-based submission portal for research INDs. CDER is actively engaging with NIH to gain insight into the needs for this research IND submission portal. The portal will streamline and intuitively assist in submission of research INDs, digitize data that is currently captured in static PDFs in an electronic, structured format to alleviate the amount of PDF/paper submissions FDA receives thereby increasing FDA review efficiency, and create a dashboard interface for management of sponsor INDs
Research to Guide Practice Enhancing HIV/AIDS Platforms to Address Non- Communicable Diseases in Low Resource Settings (HIV/NCD Integration Project)Research InitiativeCDCFIC, NCI, NHLBI, NIAID, NICHD, NIDDK, NIMH, NIMHD, NINDS, NINR, OD/DPCPSI/OARResearch to guide practice: Enhancing human immunodeficiency virus(HIV) and the acquired immunodeficiency syndrome (AIDS) platforms to address non-communicable diseases (NCDs) in low-resource settings (the HIV/NCD Integration Project) aims to bring together researchers, implementers, and government representatives to articulate practical goals, approaches, and a related research agenda to incorporate prevention, care, and treatment for NCDs into HIV/AIDS platforms in sub-Saharan Africa. The HIV/NCD Integration Project focuses on people living with HIV, many of whom are being treated successfully for HIV, but who are increasingly experiencing co-morbid diseases or conditions such as cardiovascular disease, diabetes, cancer, and depression. This project has produced landscape analyses, is establishing research agendas and priorities, and supports products, including modeled data, to enhance NCD services through HIV platforms.
http://www.fic.nih.gov/About/Staff/Policy-Planning-Evaluation/Pages/pepfar-ncd-project.aspx
Review of Applications for the Biomedical Data Translator: Development PhaseCommittee, Work group, Advisory group, or Task ForceFDANCATS, NHGRI, NIDDK, NLMThe goal of the Biomedical Data Translator program is to build an online tool based on a massive network of biomedical knowledge that can be used to augment human reasoning and allow biomedical researchers to create new hypotheses, leading to innovative solutions for patient care. The review of applications for funding to create this tool is an important step on the road to creating the final Translator infrastructure.
https://ncats.nih.gov/translator
Review Policy Committee (RPC)Committee, Work group, Advisory group, or Task ForceAHRQ, CDCOD/OER, CSR, NCATS, NCCIH, NCI, NEI, NHGRI, NHLBI, NIA, NIAAA, NIAID, NIAMS, NIBIB, NICHD, NIDA, NIDCR, NIDDK, NIEHS, NIGMS, NIMH, NIMHD, NINDS, NINR, NLM, NIDCD, ODThe Review Policy Committee (RPC) is the principal forum for the development, implementation, and evaluation of review policies and procedures for all types of research, training, and development awards submitted to the NIH. RPC membership includes the NIH Review Policy Officer/RPC Executive Co-Chair in the Office of Extramural Research (OER) and one senior extramural review official from each NIH Institute and Center that has extramural review functions. The RPC has designated liaisons from other HHS agencies including Agency for Healthcare Research and Quality (AHRQ) and Centers for Disease Control and Prevention (CDC).
Revision of Centers for Disease Control and Prevention (CDC) Guidelines on Hepatitis BCommittee, Work group, Advisory group, or Task ForceCDCCCThe collaboration serves to revise guidelines for managing occupational exposures to the human immunodeficiency virus (HIV) and managing healthcare workers infected with hepatitis B.
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr6103a1.htm?s_cid=rr6103a1_e
Role of IFNL4 in immune response to infectionResearch InitiativeFDANCIAnalysis of human bronchial epithelial cells infected with various strains of flu virus. Analysis of unusual pattern of IFNL4 protein expression
Ruth L. Kirschstein National Research Service Award ProgramTraining InitiativeAHRQ, HRSAOD/OERThe National Institutes of Health (NIH) Ruth L. Kirschstein National Research Service Award program provides predoctoral and postdoctoral training to meet the nation’s need for investigators in biomedical, behavioral, and clinical research. In accordance with the Public Health Service Act and annual appropriations acts, NIH annually transfers a portion of these funds to the Agency for Healthcare Research and Quality and Health Resources and Services Administration to foster the training of health services and primary care researchers.
NIH: https://researchtraining.nih.gov/; AHRQ: https://www.ahrq.gov/funding/training-grants/index.html; HRSA: https://bhw.hrsa.gov/grants/medicine
RxNormResource DevelopmentFDANLMRxNorm provides normalized names for clinical drugs and links its names to many of the drug vocabularies commonly used in pharmacy management and drug interaction software. By providing links between these vocabularies, RxNorm can mediate messages between systems not using the same software and vocabulary.
http://www.nlm.nih.gov/research/umls/rxnorm/
Sabbatical in Clinical Research Management ProgramTraining InitiativeFDA, OSCC, FIC, NCATS, NEI, NHLBI, NIAID, NIDCR, NIDDKExperienced investigators come to the National Institutes of Health (NIH) to learn about management of a clinical research enterprise, including topics such as planning and budget development, protocol writing and tracking, and scientific review. Sabbaticals are self-directed, meaning that the participant chooses from a list of electives and helps determine how much time to spend studying each topic. The electives are offered by leaders at the NIH and other US Department of Health and Human Services agencies with the NIH Clinical Center being the most heavily involved.
http://www.cc.nih.gov/training/sabbatical/index.html
Safe to SleepPublic Education CampaignCDC, HRSANICHDThe Safe to Sleep® campaign seeks to educate parents and caregivers about ways to reduce the risk of Sudden Infant Death Syndrome (SIDS) and other sleep-related causes of infant death, such as accidental suffocation. The National Institute of Child Health and Human Development (NICHD) offers print and electronic materials, media resources, toolkits, and a continuing education program for nurses to help spread the word about safe infant sleep. The Safe to Sleep® campaign partners with organizations to help reach various audiences, including African American, and American Indian/Alaska Native communities, which have the highest SIDS rates of any racial/ethnic group in the United States.
https://safetosleep.nichd.nih.gov/
SAMHSA Recovery MonthPublic Education CampaignSAMHSANIDAThe Substance Abuse and Mental Health Services Administration (SAMHSA) holds an annual public health observance for people in recovery from substance abuse. The National Institute on Drug Abuse (NIDA) is part of SAMHSA's inter-agency planning committee and a promotional partner.
http://www.recoverymonth.gov/
SARS-CoV-2 Antiviral SummitMeeting/ WorkshopFDANCATSOrganized a summit on SARS-CoV-2 antiviral therapeutics, held Nov 2020, with summit report released Jan 2020
SARS-CoV-2 Assay Development, Training, and StandardizationResource DevelopmentFDANIAIDSARS-CoV-2 Assay Development, Training, and Standardization in BSL4 lab at Integrateed Research Facility, Fort Dietrick
SARS-CoV-2 Sequencing for Public Health Emergency Response, Epidemiology and Surveillance (SPHERES)Resource DevelopmentCDCNLMTo help accelerate the use of near-realtime pathogen genomic data throughout the pandemic response, CDC’s Advanced Molecular Detection (AMD) program (https://www.cdc.gov/amd) is establishing an open genomics consortium to spearhead and organize public health sequencing and response efforts across the United States. This consortium, SARS-CoV-2 Sequencing for Public Health Emergency Response, Epidemiology and Surveillance (SPHERES), is intended to help coordinate and support sequencing at state and local public health laboratories across the country, and to better engage clinical, academic and commercial laboratories that are sequencing – or planning to sequence -- SARS-CoV-2 at any scale. With this coalition, we hope to improve communication and knowledge-sharing between US laboratories, to develop consensus guidance on data and metadata standards, to reduce barriers to bioinformatic analysis and data sharing, and to better align sequencing requirements and resource needs with different sources of funding, technology, expertise and other means of support.
https://www.cdc.gov/coronavirus/2019-ncov/covid-data/spheres.html
SEARCH for Diabetes in YouthResearch InitiativeCDCNIDDKSEARCH is a multi-center study designed to characterize the epidemiology of both type 1 diabetes and type 2 diabetes in the population aged 20 years, along with the associated complications, quality of diabetes care, and quality of life of children and youth with diabetes. SEARCH aims also include 1) the development and validation of simple and low-cost case definitions and classifications of diabetes types in youth, 2) the establishment of a repository of biological specimens, and 3) systems to maintain contact with study participants to facilitate studies of childhood diabetes.
http://www.searchfordiabetes.org
Seasonal Influenza Vaccine Improvement GroupCommittee, Work group, Advisory group, or Task ForceCDC, FDA, OSNIAIDThe Influenza Vaccine Manufacturing Improvement Group aims to optimize donor strains, improve sterility assays, and develop alternative potency assays.
Secretary's Advisory Committee on Infant MortalityCommittee, Work group, Advisory group, or Task ForceCDC, HRSANICHDThe Secretary’s Advisory Committee on Infant Mortality (SACIM) was formed in 1991 to advise the Secretary on Department of Health and Human Services’ programs that are directed at reducing infant mortality and improving the health status of pregnant women and infants.
https://www.hrsa.gov/advisory-committees/infant-mortality/index.html
Senior Medical Advisor to Assistant Secretary for Preparedness and Response (ASPR)Committee, Work group, Advisory group, or Task ForceOSNCI, NIAIDA National Cancer Institute (NCI) staff member serves as Senior Medical Advisor to the Office of the Assistant Secretary for Preparedness and Response (ASPR). As such, NCI helps to develop plans for emergency and disaster responses and plays a role in responses operations as needed. A good number of the Operations plans and models that apply to all hazards have been developed from NCI science and knowledge.
https://www.phe.gov/about/aspr/Pages/default.aspx
Sepsis Interagency MeetingMeeting/ WorkshopAHRQ, BARDA, CDC, CMSNIGMS, CC, NHLBI, NIAID, NICHDDiscuss Sepsis Priority Areas identified in Biomedical Advanced Research and Development (BARDA) market research: Unifying definitions of Sepsis across the patient continuum, Harmonizing Data for Access and Interoperability, Optimizing Health Outcomes and Reducing Economic Burden, Improving Evaluation and Catalyzing Adoption of Critical Technologies
Sex Differences Meeting Planning CommitteeMeeting/ WorkshopBARDANIAID, OD/DPCPSI/ORWHUnderstanding sex differences within animal models is needed to develop effective biodosimeters and MCMs. Therefore, a meeting is planned to 1) explore sex differences in metabolomics and/or other biomarkers that may track with assessing acute radiation syndrome (ARS), delayed effects of acute radiation exposure (DEARE), and/or predicting the efficacy of MCMs; 2) look at effects of synchronizing estrocycle in pre-clinical studies, and pheromones when co-housing male and female animals; 3) explore regulatory challenges in clinical studies involving representation from both sexes and policies that influence inclusion of women in research, and the gaps that exist in these practices. Meeting to be held Oct 25-26, 2021.
SHIELD – Standardization of Lab Data to Enhance Outcomes Research and Value Based CareCommittee, Work group, Advisory group, or Task ForceFDANLMThis project will expand the collaborative efforts of FDA and other stakeholders involved in the SHIELD initiative to ensure laboratory information interoperability, such that the same type of device is described the same way in electronic health records (EHR) systems. To realize this goal, this project will develop code mapping manuals to consistently map the same LOINC (Logical Observations Identifiers Names and Codes) to the same type of IVD. This is important because without the specific guidance, manufacturers of IVD devices and laboratories often assign different (and frequently incorrect) LOINC codes for the same type of device. This project will also pilot implementation of SHIELD standard digital formats to update infrastructure in active healthcare provider laboratories, which will include the seamless distribution of LOINC and SNOMED-CT (Systematized Nomenclature of Medicine--Clinical Terms) coding to those provider institutions and registries.
https://aspe.hhs.gov/shield-standardization-lab-data-enhance-patient-centered-outcomes-research-and-value-based-care
Smokefree.govResource DevelopmentCDC, FDA, IHSNCI, NIMHD, OD/DPCPSI/OBSSRThe Smokefree.gov Initiative (SFGI) provides smokers who want to quit with free, evidence-based smoking cessation information and on-demand support. SFGI includes 6 mobile-optimized websites, 9 SMS text programs, 2 smartphone apps, and 6 social media platforms, available in English and Spanish. Special programs exist for women, teens, veterans, and people older than age 60.
https://smokefree.gov/
Society for Prevention Research Annual MeetingsMeeting/ WorkshopACF, CDCNIDA, NCI, NIAAA, NICHD, OD/DPCPSI/OBSSR, ODPThe Society for Prevention Research was formed in 1991 and has grown from a small group of researchers focused on drug and alcohol abuse prevention and mental health to become a leading scientific organization devoted to advancing prevention science, with 700+ members and a multidisciplinary prevention focus that emphasizes drug abuse, mental health, and HIV/AIDS prevention in addition to diverse, public health domains (e.g., obesity, violence, translational science). The annual meetings promote cross-fertilization of theory, methods, and intervention and provide an opportunity to enhance understanding of the underlying mechanisms of health-related issues with the goal of building the science of effective strategies, and for prevention and health promotion.
http://preventionscience.org
Society for Prevention Research R13 Conference Award (R13AA025540)Meeting/ WorkshopACF, CDCNIAAA, NCCIH, NCI, NIDA, OD/DPCPSI/OBSSR, ODPCoordinate cofunding of an R13 award (total of $180,00/fiscal year from NIAAA, NIDA, NCI, NCCIH, ODP, OBSSR, CDC, ACF); as well as a research and training funding information session at the annual meeting and the Friday SPR board meeting with SPR leadership and cofunders.
https://www.preventionresearch.org/
Somatic Cell Genome EditingResearch InitiativeFDAOD/DPCPSI/OSC, NCATS, NCI, NHGRI, NHLBI, NIAID, NIAMS, NIDDK, NIMH, NINDS, OD/DPCPSI/ORIPThe Somatic Cell Genome Editing (SCGE) program aims to develop quality tools to perform effective and safe genome editing in human patients. These research tools will be made widely available to the research community to reduce the time and cost required to develop new therapies. A representative from Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) plays an advisory role for the program regarding regulatory issues. The SCGE program is a member of the National Institute of Standards and Technology (NIST) Gene Editing Consortium. The SCGE program also coordinates with the DARPA Safe Genes program when appropriate.
https://commonfund.nih.gov/editing
Specificity and Quality of Influenza-Specific AntibodiesResearch InitiativeFDANIAIDThis collaboration supports the evaluation of specificity and quality of influenza-specific antibodies in human subjects that have been vaccinated or naturally infected with influenza. Specific tasks include the construction of phage display libraries, production of recombinant proteins, development of surface plasmon resonance assays and the use of these technologies to measure antibody affinity maturation.
Standardized Machine-Readable Units of MeasureCommittee, Work group, Advisory group, or Task ForceIOSNLMHistorically, the National Library of Medicine (NLM) has been at the nexus of standards needed to make clinical data flow to and from sources for clinical care, biomedical research, and epidemiologic databases. The big new research initiatives such as PCORI, Precision medicine, and the Cancer Moonshot depend heavily on efficient access to rich clinical data. A core problem of clinical data science is the prevalence of local and idiosyncratic coding systems used by individual care institutions. The major enabler of the use of big clinical Data is the standardization of the coding systems and formats (i.e. message standards) that clinical organizations use. On the coding system side, we have been developing, disseminating, and facilitating the adoption of universal standards, i.e., Unified Code for Units of Measure (UCUM) for units of measure so that clinical measures that different institutions report in different units of measure could be converted to a single unit of measure, which would simplify their use in care and research. We are working with the National Institute of Standards and Technology (NIST) to promote the use of UCUM as a replacement for ISO-8000. We have also developed a web-based open source tool to enable the conversion of units of measure to standard machine-readable format using UCUM.
http://unitsofmeasure.org/trac
Standards for Genetic Testing ReportResearch InitiativeAHRQ, CDC, IOSNLM, NHGRIThis activity aims to develop a standard reporting format for genetic variations using Logical Observation Identifiers Names and Codes (LOINC) and HL7, for electronic medical records health information exchange, and activities of the Office of the Secretary.
State Cancer ProfilesResource DevelopmentCDCNCIThe objective of the State Cancer Profiles Website is to provide a system to characterize the cancer burden in a standardized manner in order to motivate action, integrate surveillance into cancer control planning, characterize areas and demographic groups, and expose health disparities. The focus is on cancer sites for which there are evidence-based control interventions. Interactive graphics and maps provide visual support for deciding where to focus cancer control efforts.
https://statecancerprofiles.cancer.gov/
State of Illinois - Governor's ChallengeCommittee, Work group, Advisory group, or Task ForceSAMHSACCOutcome Measurements for Interventions to Decrease Veteran Suicide. This collaboration works to measure various outcomes for interventions to decrease suicide among US Veterans. Following this evaluation, the group will make recommendations based of their assessments.
Steering Committee Meeting for PAR 18-947. “Integrating Biospecimen Science Approaches into Clinical Assay Development”Committee, Work group, Advisory group, or Task ForceFDANCIFDA and NIST participate in the Steering Committee for an NCI-funded research program, “Integrating Biospecimen Science Approaches into Clinical Assay Development.” Investigators under this research program are brought together with NCI, FDA and NIST experts to review research data and progress and discuss potential collaborative activities that may include joint research projects as well as jointly prepared publications, biospecimen SOPs and best practices.
Steering Committee of the Scientific Interest Group in GlycobiologyCommittee, Work group, Advisory group, or Task ForceFDANIGMS, NCI, NHGRI, NHLBI, NIAID, NICHD, NIDCR, NIDDKThe Steering Committee of the Scientific Interest Group in Glycobiology (GlycoSIG) is comprised of National Institutes of Health (NIH) intramural scientists and program staff as well researchers from the Food and Drug Administration (FDA) and the National Institute of Standards and Technology (NIST). The committee organizes a seminar series; an annual NIH/FDA Glycosciences Research Day Meeting (averaging 250 people in attendance); and a Mentoring & Networking Luncheon for graduate students and postdoctoral fellows to meet with staff from federal agencies and learn about NIH extramural programs. The Committee also offers a Special Topics in the Glycosciences Course every other year. In addition, the GlycoSIG maintains an email list serve to distribute information on meetings, jobs, funding opportunities, and seminars. The SIG cross posts with other NIH SIG’s that share interests.
https://oir.nih.gov/sigs/glycobiology-scientific-interest-group
Stimulating Peripheral Activity to Relieve ConditionsResearch InitiativeFDAOD/DPCPSI/OSC, NCATS, NCCIH, NCI, NEI, NHLBI, NIAID, NIBIB, NICHD, NIDA, NIDCD, NIDDK, NIMH, NINDSThe Stimulating Peripheral Activity to Relieve Conditions (SPARC) program seeks to accelerate development of therapeutic devices that modulate electrical activity in nerves to improve organ function. SPARC has a memorandum of understanding with Food and Drug Administration (FDA) that facilitates coordination and collaboration around common interests and goals in developing neurostimulatory devices for interrogating and elucidating peripheral autonomic and sensory control of organ function to catalyze development of more effective and minimally invasive neuromodulation therapies. SPARC is also collaborating with the FDA through an interagency agreement to support development of technologies in the CDRH/OSEL laboratories for imaging of peripheral nerves to increase understanding of nerve structure, function and neuromodulation safety.
https://commonfund.nih.gov/sparc/index
Structured Data Capture (SDC) InitiativeResource DevelopmentAHRQ, CDC, CMS, FDA, HRSA, IHS, IOSNLM, NCATS, NCIThe Structured Data Capture (SDC) Initiative was initially sponsored by the Department of Health and Human Services, Office of the National Coordinator for Health Information Technology (ONC), as part of its Standards and Interoperability Framework, a program developed to foster collaboration between the public and private sectors to promote the interoperable exchange of health data and information. The SDC mission is to develop and validate a data architecture and set of exchange standards so that a structured set of data can be accessed from electronic health record systems, merged with comparable data and made accessible for purposes other than clinical care, such as research, patient safety, and public health. The SDC Working Group on Common Data Elements and Forms, chaired by NLM/NIH with NCI/NIH participation, evaluated and selected two ISO standards to serve as the basis for definitions of Common Data Elements and electronic Case Report Forms (eCRF) under the initiative: ISO/IEC 11179 (Metadata Registries and Data Elements metamodel) and ISO/IEC 19763-13 (Forms metamodel). Current work applies and extends these standards for use with the FHIR (Fast Healthcare Interoperability Resources) Specification, a developing HL7 standard for exchanging healthcare information electronically.
https://www.nlm.nih.gov/cde/
Sudden Death in the Young (SDY) RegistryResource DevelopmentCDC, HRSANHLBI, NINDSThe Sudden Death in the Young (SDY) Registry is a surveillance system to track sudden deaths in youths less than or equal to 19 years of age in up to 10 states and to gather clinical data and a DNA sample to be used for research to explore the causes and risk factors for sudden death in the young. The SDY Registry is a collaboration between the National Heart, Lung, and Blood Institute (NHLBI), National Institute of Neurological Disorders and Stroke (NINDS), and Centers for Disease Control and Prevention (CDC).
https://www.sdyregistry.org/research/
Support for Implementation of Agency Public Access PoliciesResource DevelopmentAHRQ, CDC, FDA, IOSNLM, OD/OSPNIH Public Access Policy was created by NIH and established in statute by Congress in the Consolidated Appropriations Act 2008, P. L. 110-161, enacted on 12/26/2007. It ensures that the public can access without charge peer-reviewed journal articles arising from NIH-funded research. Since 2008, the PubMed Central (PMC) database has served as the repository for journal articles subject to the NIH Public Access Policy. The Office of Science and Technology Policy (OSTP) coordinated the development of public access policies across federal science agencies, and OSTP released a directive in February 2013 to increase public access to scientific publications and digital data. NIH is collaborating with five divisions and offices in HHS and four agencies outside HHS to use PMC and related services in support of their public access policies. Interagency agreements have been signed with AHRQ, ASPR, CDC, FDA and ACL within HHS, as well as with NASA, NIST, VA, EPA, and DHS. Researchers either employed and/or funded by all of these agencies have begun depositing manuscripts in PMC. IAAs with VA and AHRQ have also been extended to support inclusion of non-journal literature in NCBI's Bookshelf resource. NIH has also entered memorandums of understanding with NOAA and DOD to share manuscripts deposited in PMC with other federal repositories, streamlining compliance with public access requirements for authors.
https://www.ncbi.nlm.nih.gov/pmc/about/public-access-info/
Supporting Early Psychosis Research and ImplementationResearch InitiativeOSNIMHThe Assistant Secretary of Health and Human Services for Planning and Evaluation and the National Institute of Mental Health support research on the delivery of evidence-based early psychosis care, including facilitating the implementation of evidence-based coordinated specialty care (CSC) for early psychosis. The agencies meet on a regular basis to inform each other's research agenda on early psychosis care generally and CSC specifically, identify synergies in our research initiatives and formulate new research initiatives, and share related draft reports and funding opportunity announcements for comment.
Supporting the Whole Student: Mental Health and Well-Being in STEMM Undergraduate and Graduate EducationCommittee, Work group, Advisory group, or Task ForceSAMHSANIMH, NIAAA, NIDAA Committee, convened by the National Academy of Sciences, conducted a study of the ways in which colleges and universities provide treatment and support for the mental health and well-being of undergraduate and graduate students, with a focus on students enrolled in science, technology, engineering, mathematics, and medicine (STEMM) courses. The Committee reviewed data and findings and conferred with experts in the mental health field, to gain an understanding of the resources, programs, policies, and practices geared to improving mental health in colleges and universities. The Committee published a report in January 2021, detailing their findings and recommendations for improving resources, programs, policies, and practices.
https://www8.nationalacademies.org/pa/projectview.aspx?key=51350
Surveillance, Epidemiology and End Results (SEER) cancer registry and the Centers for Medicare & Medicaid Services' (CMS) Medicare Health Outcomes Survey (MHOS)Committee, Work group, Advisory group, or Task ForceCMSNCIThe SEER-MHOS is a data resource for cancer health outcomes research. It is based on a linkage between the NCI's Surveillance, Epidemiology and End Results (SEER)External Web Site Policy cancer registry data and the Centers for Medicare & Medicaid Services' (CMS) Health Outcomes Survey (HOS)
https://healthcaredelivery.cancer.gov/seer-mhos/
Surveillance, Epidemiology, and End Results (SEER) ProgramResource DevelopmentCDCNCIThe Surveillance, Epidemiology, and End Results (SEER) program is the premier source for cancer statistics in the US. It collects information on incidence, prevalence, and survival from specific geographic areas representing 26 percent of the US population. Through SEER, the National Cancer Institute (NCI) develops reports on all of these information areas plus cancer mortality for the entire country. The site is intended for anyone interested in US cancer statistics or cancer surveillance methods.
https://seer.cancer.gov/
Synthetic DNA Working GroupCommittee, Work group, Advisory group, or Task ForceCDC, OSOD/OSPRe-examining and updating (if necessary) the Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA, which was released in 2010.
System of Hospitals for Innovation in Pediatrics - Medical Devices (SHIP-MD)Meeting/ WorkshopFDANICHDAll stakeholders interested in pediatric medical device development are invited to a dynamic 3-day virtual public meeting developed and guided by a multi-stakeholder group including C-Path, the U.S. Food and Drug Administration, AdvaMed, American Academy of Pediatrics, and leaders of pediatric health systems.
https://c-path.org/ship-md-2021-virtual-workshop-save-the-date/
Systematized Nomenclature of Medicine-Clinical Terms (SNOMED CT)Resource DevelopmentAHRQ, CDC, CMS, FDA, HRSA, IHS, IOS, SAMHSANLMThis activity provides support for SNOMED CT, a systematically organized computer processable collection of medical terminology covering most areas of clinical information such as diseases, findings, procedures, microorganisms, pharmaceuticals, etc. It allows a consistent way to index, store, retrieve, and aggregate clinical data across specialties and sites of care. It also helps to organize the content of medical records, reducing the variability in the way data is captured, encoded and used for clinical care of patients and research.
http://www.nlm.nih.gov/research/umls/Snomed/snomed_main.html
Task Force for Combating Antibiotic-Resistant Bacteria (CARB)Committee, Work group, Advisory group, or Task ForceAHRQ, BARDA, CDC, CMS, FDA, HRSANIAIDEstablished by Executive Order 13676, the Task Force facilitates implementation of the CARB Action Plan and provides progress reports and quarterly updates describing key achievements. The Task Force is an internal government committee comprised of federal representatives and co-chaired by the Secretaries of Defense, Agriculture, and HHS.
https://aspe.hhs.gov/pdf-report/national-action-plan-combating-antibiotic-resistant-bacteria-progress-report-year-3
Task Force on Research Specific to Pregnant Women and Lactating WomenCommittee, Work group, Advisory group, or Task ForceAHRQ, CDC, FDA, HRSA, SAMHSANCATS, NHLBI, NIAID, NICHD, NIDDK, NIMH, OD/DPCPSI/ORWHThe 21st Century Cures Act established PRGLAC to advise the Secretary of Health and Human Services (HHS) regarding gaps in knowledge and research on safe and effective therapies for pregnant women and lactating women. PRGLAC was tasked with identifying these gaps and reporting its findings back to the Secretary.
https://www.nichd.nih.gov/about/advisory/PRGLAC
Technical and Clinical Consultation to Indian Health Service in Kidney DiseaseOtherIHSNIDDKA National Institute of Diabetes and Digestive and Kidney Diseases senior staff member serves as Chief Clinical Consultant for Nephrology for the Indian Health Service.
Technical Consultation on Viral Hepatitis (HCV) Infection in Young Injection Drug UsersMeeting/ WorkshopCDC, OS, SAMHSANIDA, NIAID, NIDDKThis collaboration brings Federal and non-Federal clinician/researchers from academia, state public health departments, and communities together to present and discuss current research and other information on an emerging epidemic of viral hepatitis (HCV) infection in the 15-30 year group of Injection Drug Users (IDUs).
Technical Expert Panel on Pharmacologic and Nonpharmacologic Treatments for Posttraumatic Stress Disorder: Groundwork for a Publicly Available Repository of Randomized Controlled TrialsCommittee, Work group, Advisory group, or Task ForceAHRQNIMHThe purpose of this project is to identify and abstract data from randomized controlled trials of posttraumatic stress disorder (PTSD) interventions, to support the development of a publicly accessible data repository by the Veterans Affairs' National Center for Posttraumatic Stress Disorder.
https://effectivehealthcare.ahrq.gov/topics/ptsd-pharm-treatment/draft-report
Technical Expert Panel on the development of Evidence-Based Practice Guide on the treatment of serious mental illness (SMI) in older adults.Meeting/ WorkshopSAMHSANIMHSubstance Abuse and Mental Health Services Administration (SAMHSA) convened a technical expert panel to provide guidance on the development of an evidence-based practice guide on the treatment of serious mental illness in older adults. The guide is an important part of the 21st Century Cures Act's charge at SAMHSA to disseminate information on evidence-based practices and will address best practices for older adults.
Technology Transfer Policy Board (TTPB)OtherFDA, CDC, OGCOD/OSP, OD/OIR, OD/OEROfficial policy board for PHS Technology Transfer (TT) operations. TT Policy Manual Chapters are approved by TTPB
https://oir.nih.gov/sourcebook/committees-advisory-ddir/phs-technology-transfer-policy-board
Terminology Standards for Medicare Assessment InstrumentsResource DevelopmentCMSNLMThe National Library of Medicine (NLM) is working with the Centers for Medicare and Medicaid Services (CMS) to develop LOINC codes for all of the CMS Medicare assessment instruments.
http://loinc.org
The APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO) Steering Committee MeetingsCommittee, Work group, Advisory group, or Task ForceHRSANIAID, NIDDK, NIMHThe APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO) aims to prospectively assess the effects of renal-risk variants (RRVs) in the apolipoprotein L1 gene (APOL1) on outcomes for kidneys from donors with recent African ancestry and the recipients of their kidneys, after deceased- and living-donor renal transplantation. For the purposes of APOLLO, recent African ancestry is defined as individuals with similar genetic make-up to those currently residing in Africa. APOLLO will also study the impact of APOL1 RRVs on the health of living kidney donors with recent African ancestry.
The Assay Guidance ManualResource DevelopmentFDANCATSThe Assay Guidance Manual (AGM) is a free, best-practices online resource devoted to the successful development of robust, early-stage drug discovery assays.
The Assistant Secretary for Preparedness and Response (ASPR)'s chemical, biological, radiological and nuclear defense teamCommittee, Work group, Advisory group, or Task ForceOSNCI, NIAIDThe National Cancer Institute (NCI) and the National Institute of Allergy and Infectious Diseases (NIAID) participate in Assistant Secretary for Preparedness and Response (ASPR)'s chemical, biological, radiological and nuclear defense team. Both NCI and NIAID provide expertise on radiation topics and for the Biomedical Advanced Research and Development Authority (BARDA), within the Office of ASPR in the U.S.
https://www.phe.gov/about/aspr/Pages/default.aspx
The Centers for Disease Control and Prevention (CDC)'s Field Epidemiology Training Program (FETP) Cancer CurriculumTraining InitiativeCDCNCIThe Centers for Disease Control and Prevention (CDC) and the National Cancer Institute NCI (Center for Global Health and Cancer Prevention Fellowship Program) are collaborating to add a cancer curriculum to CDC’s Field Epidemiology Training Program.
https://www.cdc.gov/globalhealth/healthprotection/fetp/additionalresources.htm
The Effect of Various Drugs on the RetinaResearch InitiativeFDANEIUsing powerful in vivo imaging technology, it is possible to view the retina at the cellular level. This collaboration with the Food and Drug Administration (FDA) seeks to monitor changes to the retina for drugs that are known to cross the blood/retina barrier to better understand possible toxicity.
The Environmental Determinants of Diabetes in the Young (TEDDY)Research InitiativeCDCNIDDK, NIAID, NICHD, NIEHSThis consortium is organizing international efforts to identify infectious agents, dietary factors, or other environmental factors that trigger type 1 diabetes in genetically susceptible people. The study enrolled over 8,000 newborns and is following them for 15 years to identify environmental triggers of type 1 diabetes.
http://www.teddystudy.org
The Epidemiology of Burkitt Lymphoma in East-African Children and Minors (EMBLEM)Research InitiativeCDC, FDANCI, NHGRI, NHLBIThe Epidemiology of Burkitt Lymphoma in East-African Children and Minors (EMBLEM) initiative provides a unique infrastructure to obtain valuable data and samples to study Burkitt’s lymphoma (BL) epidemiology. Study data will help characterize or investigate: (1) The association of malaria-resistance genes with endemic BL. (2) Host genetic polymorphisms associated with BL using genome-wide association methods. (3) The role of the Epstein-Barr virus (EBV) genetic variants in endemic BL. (4) The role of malaria immunology and phenotype of inflammation in BL. (5) The complexity of coinfection with different P. falciparum malaria genotypes in BL. (6) The interaction between helminthic parasites, HIV, malaria, and EBV in BL. (7) The immunohistochemistry and molecular pathology of BL. (8) The impact of malaria, helminthic parasites, and HIV on childhood BL.
https://emblem.cancer.gov/
The Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE)Research InitiativeCDCNIDDKGRADE is a randomized clinical trial of participants diagnosed with type 2 diabetes within the past 10 years who are already on metformin. Participants will be randomly assigned to 1 of 4 commonly-used glucose-lowering drugs (glimepiride, sitagliptin, liraglutide, and basal insulin glargine), plus metformin, and will be followed for up to 7 years. The goal of the GRADE Study is to determine which combination of two diabetes medications is best for achieving good glycemic control, has the fewest side effects, and is the most beneficial for overall health in long-term treatment for people with type 2 diabetes.
https://portal.bsc.gwu.edu/web/grade
The Golestan Cohort Study of Esophageal CancerResearch InitiativeCDCNCIThe National Cancer Institute (NCI) and the Centers for Disease Control and Prevention (CDC) are collaborating on a pilot study to measure nitrate in urine. The aim of the pilot is to determine if drinking water sources in high and low nitrate regions of Golestan province are associated with higher urinary nitrate concentrations (a biomarker of ingestion) after accounting for dietary intake.
The Impact of Tobacco Use on Oral Health and the Oral MicrobiomeResearch InitiativeCDC, FDANCIThe US Food and Drug Administration Intramural Center of Tobacco Regulatory Science Award Program funded a project examining how tobacco affects oral health and the oral microbiome in the National Health and Nutrition Examination Survey (NHANES) study.
https://www.fda.gov/TobaccoProducts/PublicHealthScienceResearch/Research/ucm404564.htm
The Incidence of Breast and Other Cancers Among Female Flight AttendantsResearch InitiativeCDCNCIA cohort study of approximately 10,000 Pan Am flight attendants to determine cancer incidence (primarily breast cancer) associated with cosmic radiation and circadian disruption from their work.
The MDEpiNet TMJ RoundTableMeeting/ WorkshopAHRQ, FDANIDCRThis workshop facilitated collaboration of stakeholders to address data on implant performance, surgical outcomes, and adverse events in an effort to: develop outcome and assessment and reporting tools based on patient input, the intersection of patient biology, anatomy, genetics, physiology with TMJ medical devices, and clinical patient-centered outcomes to better target therapies.
https://www.mdepinet.net/tmj
The NIH Helping to End Addiction Long Term (HEAL) InitiativeResearch InitiativeAHRQ, CDC, CMS, HRSA, OS, SAMHSANIDA, NCATS, NCCIH, NHLBI, NIAAA, NIAID, NIAMS, NIBIB, NICHD, NIDDK, NIMH, NINDS, OD/OSPIn April 2018, the National Institutes of Health (NIH) launched the HEAL (Helping to End Addiction Long-termSM) Initiative, an aggressive, trans-agency effort to speed scientific solutions to stem the national opioid public health crisis. This Initiative will build on extensive, well-established NIH research, including basic science of the complex neurological pathways involved in pain and addiction, implementation science to develop and test treatment models, and research to integrate behavioral interventions with Medication-Assisted Treatment (MAT) for opioid use disorder (OUD) The NIH HEAL Initiative? will bolster research across NIH to improve treatments for opioid misuse and addiction and enhance pain management.
https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative
The President’s Roadmap to Empower Veterans and End a National Tragedy of Suicide (PREVENTS) Task ForceCommittee, Work group, Advisory group, or Task ForceCDC, IHS, SAMHSA, AHRQNIMH, NINDS, OD/DPCPSI/OBSSRThe President's Roadmap to Empower Veterans and End a National Tragedy of Suicide (PREVENTS) will focus on a holistic public health approach to suicide prevention. PREVENTS seeks to change the culture surrounding mental health and suicide prevention through enhanced community integration, prioritized research activities, and implementation strategies that emphasize improved overall health and well-being.
https://www.va.gov/PREVENTS/index.asp
The Scientific Registry of Transplant Recipients (SRTR) Visiting CommitteeCommittee, Work group, Advisory group, or Task ForceHRSANIAIDThe SRTR Visiting Committee advises the SRTR on:(1) analytic methodologies to support the Organ Procurement and Transplantation Network policy development and evaluation; (2) objectives, study designs, and statistical methods for research projects performed by SRTR, including risk-adjusted analyses of organ procurement organization and transplant program performance; (3) methods used in simulated allocation models; (4) new areas of research and innovative advances in analytical methodologies that might improve the effectiveness of SRTR.
https://www.srtr.org/about-srtr/visiting-committee/
The United States Renal Data System (USRDS)Resource DevelopmentCMS, HRSANIDDKThe United States Renal Data System (USRDS) is a national data system that collects, analyzes, and distributes information about chronic kidney disease and end-stage renal disease (ESRD) in the United States. The missions of USRDS are: (1) To characterize the total renal patient population and describe the distribution of patients by socio-demographic variables across treatment modalities; (2) To report on the incidence, prevalence, mortality rates, and trends over time of renal disease by primary diagnosis, treatment modality and other variables; (3) To develop and analyze data on the effect of various modalities of treatment by disease and patient group categories; (4) To identify problems and opportunities for more focused special studies of renal research issues; (5) To conduct cost effectiveness studies and other economic studies of ESRD; and (6) To make the data available to investigators, and by supporting investigator-initiated projects, to conduct biomedical and economic analyses of ESRD patients.
http://www.usrds.org
The wireless sensing and artificial intelligence (AI) for smart healthcare Work GroupCommittee, Work group, Advisory group, or Task ForceFDANHLBI, NCI, NIBIBThe wireless sensing and AI for smart healthcare Working Group covers the topics related to wireless sensing and wireless in medical devices. Some of the topics include but not limited to: standards, interoperability, security, privacy, and safety.
Tissue Chip Testing CentersResearch InitiativeFDANCATSThe National Center for Advancing Translational Science (NCATS) funded Tissue Chip Testing Centers (TCTC) scientists have used a reference set of validation compounds vetted by pharmaceutical representatives through an NCATS partnership with the IQ Consortium and the Food and Drug Administration (FDA) to run tests to determine functionality, reproducibility, robustness, and reliability in these organ platforms. The TCTC scientists coordinated activities among Tissue Chip program-funded investigators and the FDA to support the progress of these chips, with the goal of getting chips to be used widely as a validated research tool and qualified for use in pre-clinical drug testing. The NextGen TCTCs funded in 2018 continued these goals, with a focus on building a self-sustaining financial business model for continuation of the TCTCs after the end of their funding periods.
https://ncats.nih.gov/tissuechip/projects/centers
Tobacco and Nicotine Research Interest Group (TANRIG)Committee, Work group, Advisory group, or Task ForceCDC, SAMHSA, FDAODP, FIC, NCI, NEI, NHGRI, NHLBI, NIAAA, NIAID, NICHD, NIDA, NIDCR, NIEHS, NIMHD, NIGMS, NLM, OD/DPCPSIThe Tobacco and Nicotine Research Interest Group (TANRIG) was formed in January 2003 with the goal of increasing collaboration, coordination, and communication of tobacco- and nicotine-related research among National Institutes of Health Institutes and Centers, as well as with other relevant US Department of Health and Human Services agencies.
https://oir.nih.gov/sigs/tobacco-nicotine-research-interest-group
Tobacco Centers of Regulatory Science (TCORS)Research InitiativeFDAODPThe Tobacco Regulatory Science Program located in the National Institutes of Health (NIH) Office of Disease Prevention coordinates the trans-NIH collaboration effort with the Food and Drug Administration (FDA) Center for Tobacco Products to conduct research that is needed to ensure that US tobacco regulatory actions and activities are based on sound and relevant scientific evidence. The U54 Tobacco Centers of Regulatory Science (TCORS) are the centerpiece of this NIH-FDA collaboration. The TCORS are expected to demonstrate research excellence and leadership in tobacco regulatory science that will contribute to the science base that FDA will use to develop meaningful product regulation, which will, in turn, reduce the toll of tobacco-related disease, disability, and death in the United States. Essential elements of the TCORS include at least three theoretically grounded, strong research projects with an integrative theme; an Administrative Core and other cores as needed; the ability to conduct developmental/pilot and time-sensitive research; and a program for career development. Nine TCORS, made up of scientists with a broad range of expertise (e.g., epidemiology, economics, toxicology, addictions, and marketing) are currently funded.
https://prevention.nih.gov/tobacco-regulatory-science-program/research-portfolio/centers
Tobacco Product Disease RisksResearch InitiativeFDANCIThe National Cancer Institute (NCI) and the Food and Drug Administration (FDA) Center for Tobacco Products, in collaboration with the US Census Bureau, co-lead this study, which harmonizes data on cigarette, cigar, and pipe use from various Tobacco Use Supplements that have been administered over the years as part of the Current Population Survey. The participants in these surveys have been followed for mortality by linkage to the National Death Index. These data are used to provide contemporary estimates of the mortality risks of daily and non-daily use of cigarettes, pipes, and cigars.
Tobacco Regulatory Science Program (TRSP)Research InitiativeFDAODP, CSR, NCI, NHLBI, NIAAA, NICHD, NIDA, NIEHS, OD/OERLocated in the National Institutes of Health (NIH) Office of Disease Prevention, the Tobacco Regulatory Science Program (TRSP) coordinates the trans-NIH collaborative effort with the US Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP) to conduct research to support its regulatory activities over tobacco products. Within the framework of the Tobacco Control Act, the NIH and FDA formed an interagency partnership to foster tobacco regulatory research. The NIH has the infrastructure for the solicitation, review, and management of research. The FDA has expertise in tobacco regulatory science and the authority and resources to support research responsive to FDA’s regulatory authority. Support from FDA was used to fund grants and to provide administrative support and oversight to manage Funding Opportunity Announcements (FOA), application review, policy implementation and oversight, and communicating and reporting to a variety of sources.
https://prevention.nih.gov/tobacco-regulatory-science-program
Tobacco Use Supplement to Current Population SurveyHealth SurveyCDC, FDANCI, NIMHDThe Tobacco Use Supplement to the Current Population Survey (TUS-CPS) is an National Cancer Institute (NCI)-sponsored survey of tobacco use that has been administered as part of the US Census Bureau's Current Population Survey approximately every 3-4 years since 1992-93.
http://cancercontrol.cancer.gov/tus-cps
Tox 21Resource DevelopmentFDANCATS, NIEHSThe Toxicology in the 21st Century (Tox21) program is a federal collaboration among National Institutes of Health(NIH) National Center for Advancing Translational Science (NCATS) and the National Toxicology Program at the National Institute of Environmental Health Sciences; the Environmental Protection Agency; and the Food and Drug Administration. Tox21 researchers aim to develop better toxicity assessment methods to quickly and efficiently test whether certain chemical compounds have the potential to disrupt processes in the human body that may lead to negative health effects.
https://ncats.nih.gov/tox21/about
Toxicology in the 21st Century Federal Consortium NTP – NCATS Interagency Agreement, ES-7020-01, Year 11 (Tox21)OtherFDANIEHS, NCATSTox21 is a US federal research collaboration focused on driving the evolution of Toxicology in the 21st Century by developing methods to rapidly and efficiently evaluate the safety of commercial chemicals, pesticides, food additives/contaminants, and medical products. This IAA is designed to explore new, effective, primarily non-animal methods and technologies to elucidate critically important questions pertaining to impacts of environmental exposures on cellular toxicity pathways that may lead to human disease. A major focus is the development of innovative approaches in toxicology assessment.
https://tox21.gov/overview/
Toxin Working Group of the Intragovernmental Select Agents and Toxins Technical Advisory Committee (ISATTAC)Committee, Work group, Advisory group, or Task ForceCDC, FDANIAIDThe workgroup holds biweekly meetings to discuss the following: point of regulation of select toxins (Botulinum neurotoxins, Staphylococcal enterotoxins, Abrin, Ricin, Conotoxins, Saxitoxin, Tetrodotoxin, Diacetoxyscirpenol, T-2 toxin), natural environment, toxin exclusion limits, space decontamination, and potential updates to the Centers for Disease Control and Prevention (CDC) manual “Biosafety in Microbiological and Biomedical Laboratories.”
http://www.cdc.gov/phpr/dsat.htm
Toxins Assessment Working GroupCommittee, Work group, Advisory group, or Task ForceASPR, CDC, FDANIAIDBiological (not engineered) toxins with specific effects on the nervous system, focusing on neurotoxins, applications in medical research and historical consideration as bioweapons
Training Advisory Committee (TAC)Committee, Work group, Advisory group, or Task ForceAHRQOD/OER, CSR, FIC, NCATS, NCCIH, NCI, NCMHD, NEI, NHGRI, NHLBI, NIA, NIAAA, NIAID, NIAMS, NIBIB, NICHD, NIDA, NIDDK, NIEHS, NIGMS, NIMH, NIMHD, NINDS, NINR, NLM, OD/DPCPSI/ORIPThe Training Advisory Committee (TAC) advises on programmatic, review, and management issues related to extramural research training, research education, career development and diversity programs and the Loan Repayment Programs (LRP), and evaluation of these programs. TAC provides a trans-NIH forum to identify and discuss issues related to these programs and recommend solutions.
Trans-Atlantic Task Force on Antimicrobial Resistance (TATFAR)Committee, Work group, Advisory group, or Task ForceBARDA, CDC, FDANIAIDThe presidential declaration issued at the 2009 EU-US summit called for the creation of “a transatlantic task force on urgent antimicrobial resistance issues focused on appropriate therapeutic use of antimicrobial drugs in the medical and veterinary communities, prevention of both healthcare- and community-associated drug-resistant infections, and strategies for improving the pipeline of new antimicrobial drugs, which could be better addressed by intensified cooperation between us.” The objectives of the Trans-Atlantic Task Force on Antimicrobial Resistance (TATFAR) are to increase the mutual understanding of US and EU activities and programs relevant to the antimicrobial resistance issues identified in the declaration in order to deepen the transatlantic dialogue, provide opportunities to learn from each other, and promote information exchange, coordination, and cooperation.
http://www.cdc.gov/drugresistance/tatfar/
Trans-National Institutes of Health (NIH) Tuberculosis (TB) Working GroupCommittee, Work group, Advisory group, or Task ForceCDCNICHD, FIC, NCATS, NCI, NHLBI, NIAAA, NIAID, NIDA, NIGMS, OD/DPCPSI/OARThe TB Working Group provides a forum for sharing information about NIH-specific TB projects, including both ongoing and proposed research, including extramural funding initiatives. In addition, the working group fosters continual open communication about TB research being conducted across NIH and maintains a consistent message about the importance of NIH intramural and extramural TB research. It also provides an avenue for the introduction of new technology programs of interest and importance for TB research (such as the "human on a chip"). The working group invites guests/speakers from outside NIH and convenes invitations for teleconference participation to other US Government agencies including the Centers for Disease Control and Prevention (CDC) and the US Agency for International Development (USAID).
Trans-NIH Structural Birth Defects Working Group (SBDWG)Committee, Work group, Advisory group, or Task ForceCDCNICHD, NCI, NEI, NHGRI, NHLBI, NIAAA, NIAMS, NIDCD, NIDCR, NIDDK, NIEHS, NINDSThe Trans-NIH SBDWG brings together extramural program officials from NIH components whose missions include research into structural birth defects, with the ultimate goal of facilitating advances in our understanding of the etiology, mechanisms, epidemiology, prevention, and treatment of structural birth defects.
https://www.nichd.nih.gov/about/org/der/branches/dbsvb/programs/trans_NIH_SBDWG
Trans-NIH Working Group for Objective Measures in CancerCommittee, Work group, Advisory group, or Task ForceFDANCI, NIBIB, NIDDKAn National Institutes of Health (NIH) working group was formed to develop and consolidate wearable, passive and continuous out-of-clinic monitoring strategies for clinical assessment and understanding of disease progression in cancer. The goal of this group and its activities is to examine how these devices and techniques can be used to assess and understand cancer progression from multi-parameter data (context, vitals, and/or chemistry). Currently, several non-HHS agencies (National Institute of Standards and Technology (NIST), Department of Defense (DoD), Department of Energy (DOE), the National Aeronautics and Space Administration (NASA) and HHS agencies (NIH and the Food and Drug Administration) are also involved in these discussions and will integrate their expertise/mission to propagate for medical purposes.
Translational Science Interagency FellowshipTraining InitiativeFDANCATSThe Translational Science Interagency Fellowship (TSIF) program is jointly sponsored by NCATS and the U.S. Food and Drug Administration (FDA) and aims to provide training in both translational science and regulatory science. The common goal of NCATS and the FDA is to bring safe and effective drugs, regimens and devices from the bench to the bedside as quickly and efficiently as possible. To that end, fellows will be trained in preclinical translational science, technology development, and regulatory research and review.
Translational Science Interagency Program flyer.
Transplant Cancer Match StudyResearch InitiativeHRSANCIA study linking databases of US transplant recipients, donors, and waitlist candidates to multiple US cancer registries to evaluate the spectrum of cancer risk in transplant recipients.
https://transplantmatch.cancer.gov/
Trial to Assess Chelation Therapy 2 (TACT2)Research InitiativeCDCNIDDK, NCCIH, NHLBI, NIEHSTACT2 is a clinical trial to determine whether intravenous (IV) Na2EDTA chelation therapy with oral (by mouth) multivitamins will reduce the risk of major cardiovascular events (such as stroke and heart attack) in patients who have already had a heart attack and who also have type 2 diabetes.
http://tact2.org/
Tribal Epidemiology Centers ProgramResearch InitiativeIHS, CDCNIMHD, OD/DPCPSI/THROThe Tribal Epidemiology Centers Program develops Epidemiology Centers and public health infrastructure for American Indian/Alaska Native communities.
http://www.ihs.gov/epi/index.cfm?module=epi_tec_tecs
Tribal Health Research Advisory Council (HRAC)Committee, Work group, Advisory group, or Task ForceACF, AHRQ, CDC, HRSA, IHS, OS, SAMHSANIMHD, OD/DPCPSI/THROThe National Institutes of Health (NIH) supports the activities of the Tribal Health Research Advisory Council (HRAC), including obtaining input from tribal leaders on health research priorities and needs, and dissemination of information.
http://minorityhealth.hhs.gov/hrac/
Tularemia Animal Model Qualification Working GroupCommittee, Work group, Advisory group, or Task ForceBARDA, FDANIAIDThis working group is collaborating on the qualification of a primate model of pneumonic tularemia under the Food and Drug Administration (FDA) Animal Model Qualification/Drug Development Tools Program. Animal model qualification is a regulatory decision and will be published on the FDA website when final. The collaboration includes the exchange of study data, study reports, and agreements on regulatory strategy for model qualification.
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugDevelopmentToolsQualificationProgram/ucm284078.htm
U.S. Burden of Health Disparities Working GroupCommittee, Work group, Advisory group, or Task ForceCDCNIMHD, NCI, NHLBI, NIA, OD/DPCPSI/OBSSR, ODP, NIAMSThrough this project, the U.S. Burden of Health Disparities Working Group at NIH aims to generate a landmark and comprehensive report and public platform with data on U.S. Burden of Health Disparities by Race/Ethnicity, Sex, Age, Socioeconomic Status and Geography. The project entails producing detailed county-level estimates of disease burden stratified by race/ethnicity, socioeconomic status (SES), age, and sex for a vast array of diseases, injuries and risk factors. The report would include a broad set of measures of the burden of disease (e.g., disability-adjusted life years and healthy life expectancy). This project would result in a platform for downloadable, publicly available data review and visualization tools for extracting information on these stratified analyses at the county-level for every U.S. county. CDC/NCVS is providing guidance on vital statistics data, algorithms and procedures used to generate life expectancy estimates, etc., by race/ethnicity.
U.S. FDA Medical Imaging Drugs Advisory CommitteeCommittee, Work group, Advisory group, or Task ForceFDACCThe Committee reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in diagnostic and therapeutic procedures using radioactive pharmaceuticals and contrast media used in diagnostic radiology and makes appropriate recommendations to the Commissioner of Food and Drugs.
https://www.fda.gov/advisory-committees/human-drug-advisory-committees/medical-imaging-drugs-advisory-committee
Understanding and Identifying the Needs for Medical DevicesCommittee, Work group, Advisory group, or Task ForceFDANCATSThe Institute of Medicine Rare Diseases and Orphan Products 2010 Report recommended that the Food and Drug Administration (FDA) and National Institutes of Health (NIH) perform an assessment of unmet devices needs, and determine the impediments, and options for overcoming these impediments. The assessment was completed and analyzed in 2017. A manuscript and report have been written and will be published soon. The assessment will document examples of compelling unmet needs across sections of medical specialties. Collaborating are the Office of Rare Diseases Research at National Center for Advancing Translational Science (NCATS), and the Office of Orphan Product Development and other parts of the FDA.
Unified Medical Language System Metathesaurus (UMLS)Resource DevelopmentAHRQ, CDC, CMS, FDANLMThe National Library of Medicine (NLM) Unified Medical Language System (UMLS®) facilitates the development of computer systems that behave as if they understand the meaning of the language of biomedicine and health. To that end, NLM produces and distributes the UMLS Knowledge Sources (databases) and associated software tools (programs) for use by system developers in building or enhancing electronic information systems that create, process, retrieve, integrate, and/or aggregate biomedical and health data and information, as well as in informatics research. By design, the UMLS Knowledge Sources are multi-purpose.
http://www.nlm.nih.gov/pubs/factsheets/umls.html
United States Government Children in Adversity Working GroupCommittee, Work group, Advisory group, or Task ForceCDC, ACFNICHD, FIC, NIEHS, NIMHThe United States Government (USG) Children in Adversity Working Group (WG) is a United States Agency for International Development (USAID)-led, USG-wide working group aimed at coordinating USG activities focused on at-risk children globally in accordance with Public Law 109-95.
https://www.childreninadversity.gov/home
United States Government Global Nutrition Coordination PlanCommittee, Work group, Advisory group, or Task ForceCDC, FDANICHDThe purpose of the US Government Global Nutrition Coordination Plan is to strengthen the impact of the many diverse nutrition investments across the US Government through better communication and collaboration and through linking research to program implementation. Through coordination mechanisms, the US Government will maximize its support to country-led programs, continue its global leadership and partnerships, and generate, share, and apply knowledge and evidence in the nutrition sector in order to accelerate progress toward shared nutrition goals. The US Government is committed to improving nutrition throughout the world in order to enhance health, productivity, and human potential.
https://www.usaid.gov/what-we-do/global-health/nutrition/usgplan
Urine biomarkers and risk of lung cancer in the Sisters StudyResearch InitiativeCDC, FDANCIThe National Cancer Institute (NCI) is using urine samples from the Sisters study cohort National Institute of Environmental Health Sciences (NIEHS) and the laboratory resources of the Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) funding to examine urine biomarkers of tobacco exposure and risk of lung cancer in a prospective study.
Urine biomarkersof tobacco and opium and risk of cancers anad heart diseaseResearch InitiativeCDC, FDANCIThe National Cancer Institute (NCI) is using urine samples from the Golestan Cohort Study and the laboratory resources of the Centers for Disease Control and Prevention (CDC) and partial Food and Drug Administration (FDA) funding to examine urine biomarkers of tobacco and opium exposure and risk of several cancers, heart disease, and lung disease.
US Government Inter agency Working Group on Nanotechnology Environmental, and Health Implications (NEHI), of the Nanoscale Science, Engineering, and Technology Subcommittee (NSET) of the National Science and Technology Council (NSTC)Committee, Work group, Advisory group, or Task ForceCDC, FDANCI, NIEHSThe Nanoscale Science, Engineering, and Technology (NSET) Subcommittee and Nanotechnology Environmental, and Health Implications (NEHI) Working Group provide leadership in establishing the national nanotechnology environmental, health, and safety research agenda and in communicating data and information related to environmental and health aspects of nanotechnology between National Nanotechnology Initiative (NNI) agencies and with the public. NNI activities support the development of new tools and methods required for the research that will enable risk analysis and assist in regulatory decision-making. NNI agencies engage and interact with regional, state, and local groups, educational institutions, industry-supported groups, and non-governmental organizations to enhance the impact and value of NNI efforts and to provide a collaborative approach.
https://www.nano.gov/nehi
US Preventive Services Task Force (USPSTF)Resource DevelopmentAHRQODP, NCIThe US Preventive Services Task Force (USPSTF) is an independent panel of non-Federal experts in prevention and evidence-based medicine. The USPSTF uses information from systematic evidence reviews to make recommendations for a broad range of clinical preventive health care services (such as screening, counseling, and preventive medications) that are delivered in or referred from primary care practice. USPSTF recommendations are developed for primary care clinicians, health systems, and policy-makers, and published in the form of "Recommendation Statements." The Agency for Healthcare Research and Quality (AHRQ) has been authorized by the US Congress to convene the Task Force and to provide ongoing scientific, administrative, and dissemination support to the Task Force. The NIH Office of Disease Prevention (ODP) works closely with AHRQ and the USPSTF to provide scientific input from NIH Institutes and Centers on draft research plans, draft evidence reviews, and draft recommendation statements. The ODP also disseminates information to NIH Institutes and Centers about high-priority evidence gaps for clinical preventive services that have been identified by the USPSTF.
http://www.uspreventiveservicestaskforce.org/
US Public Health Service (USPHS) Physicians Professional Advisory Committee (PPAC)Committee, Work group, Advisory group, or Task ForceACF, ACL, AHRQ, ATSDR, BARDA, CDC, CMS, FDA, HRSA, IHS, OS, OSG, SAMHSANIAIDThe purpose of this committee is to provide advice and consultation to the Surgeon General on issues relating to the professional practice and personnel activities, civil service, and Commissioned Corps of the Medical Category. The committee provides advisory assistance to the Chief Professional Officer and to the Agency and/or Program Heads of the USPHS and to non-PHS programs that routinely use USPHS personnel.
USDA-HHS Birth to 24 Months & Pregnant Women Project Federal Expert GroupCommittee, Work group, Advisory group, or Task ForceCDC, FDANHLBI, NCI, NICHD, NIDDK, OD/DPCPSI/OBSSR, ODPThe current work includes identifying topics of public health importance and conducting a small number of systematic reviews on diet and health for infants, toddlers, and women who are pregnant; it will not include specific dietary recommendations or advice. The scientific basis for dietary guidance for these population groups will be informed by the advisory report of the next (2020) Dietary Guidelines Advisory Committee.
https://www.cnpp.usda.gov/birthto24months
Using Real-time Prescription and Insurance Claims Data to Support the HIV Care ContinuumResearch InitiativeCDCNIMHThe Centers for Disease Control and Prevention (CDC) and the National Institute of Mental Health (NIMH) have established co-funding agreement to collaboratively advance research under a cooperative agreement titled “Using Real-time Prescription and Insurance Claims Data to Support the HIV Care Continuum (CDC RFA-PS-19-003).” The purpose of the cooperative agreement is to develop, implement and evaluate a “Data-to-Care (D2C) Rx” and “Insurance-based D2C” model. Both models will use real-time pharmacy claims data to identify persons with HIV who fail to fill antiretroviral (ARV) medications and to target these individuals for escalating adherence, retention, and re-linkage interventions. The D2C Rx model will start by identifying persons with HIV who fail to fill prescribed ARV medications while the insurance-based D2C model will start with medical (diagnosis and procedure) claims to identify persons with diagnosed HIV and then use pharmacy claims data to determine whether these individuals fill ARV prescriptions.
Vaccines and Related Blood Products Advisory Committee (VRBPAC)Committee, Work group, Advisory group, or Task ForceFDANCATSThe Committee reviews and evaluates data concerning the safety, effectiveness, and appropriate use of vaccines and related biological products which are intended for use in the prevention, treatment, or diagnosis of human diseases, and, as required, any other products for which the Food and Drug Administration has regulatory responsibility. The Committee also considers the quality and relevance of FDA's research program which provides scientific support for the regulation of these products and makes appropriate recommendations to the Commissioner of Food and Drugs. The Committee shall consist of a core of 15 voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of immunology, molecular biology, rDNA, virology; bacteriology, epidemiology or biostatistics, vaccine policy, vaccine safety science, federal immunization activities, vaccine development including translational and clinical evaluation programs, allergy, preventive medicine, infectious diseases, pediatrics, microbiology, and biochemistry.
https://www.fda.gov/advisory-committees/blood-vaccines-and-other-biologics/vaccines-and-related-biological-products-advisory-committee
Validation study of the electrophilic allergen screening assayResearch InitiativeFDANIEHSThe study is evaluating the assay's usefulness for identifying potential skin sensitizers.
https://ntp.niehs.nih.gov/go/903348
Value Set Authority Center (VSAC)Resource DevelopmentAHRQ, CDC, CMS, IOSNLMThe National Library of Medicine (NLM) provides an online repository of value sets (code sets from standardized medical vocabularies) that are used for clinical quality measurement in the CMS EHR Incentive Program (meaningful use). The Value Set Authority Center (VSAC) provides downloadable access to all official versions of vocabulary value sets contained in the 2014 Clinical Quality Measures (CQMs). Each value set consists of the numerical values (codes) and human-readable names (terms), drawn from standard vocabularies such as SNOMED CT ®, RxNorm, LOINC, and ICD-10-CM, which are used to define clinical concepts used in clinical quality measures (e.g., patients with diabetes, clinical visit).
http://vsac.nlm.nih.gov
Violence Against Women Steering Committee (DHHS VAW)Committee, Work group, Advisory group, or Task ForceCDC, HRSA, SAMHSA, ACF, ACL, AHRQ, CMS, IHS, OASHOD/DPCPSI/ORWH, NIA, NIDA, NIAAA, NICHD, NIMH, OD/DPCPSI/OAR, OD/DPCPSI/OBSSRThe DHHS Violence Against Women Act (VAWA) steering committee is chaired by the Office on Women’s Health (OWH). The VAWA committee has the responsibility for coordinating the Department of Health and Human Services (DHHS) response to issues related to violence against women and their children, and also coordinates DHHS violence-related activities with those of other Federal agencies. The members of the committee establish links with professional societies in the health and social service fields to increase attention to women’s health and violence issues. The members of the committee also serve as resource experts for the National Advisory Committee on VAW, which is chaired by the HHS Secretary and the DOJ Attorney General.
https://www.womenshealth.gov/about-us/what-we-do/working-groups-and-committees
Virology Interest GroupCommittee, Work group, Advisory group, or Task ForceFDANCI, NHLBI, NIAID, NIAMS, NICHD, NIDCR, NIDDK, NIMH, NINDSThe Virology Interest Group comprises researchers at National Institutes of Health (NIH) and in the local area who are interested in virology. The group organizes activities designed to promote interactions and exchange information.
https://ccr.cancer.gov/sig/nih-virology-scientific-interest-group-nih-vig
Vision Research CollaborativeResearch InitiativeFDANEIhe Vision Research Collaborative (VRC) is a joint initiative between the National Eye Institute (NEI) and the Congressionally Directed Medical Research Programs (CDMRP) Vision Research Program (VRP) of the Department of Defense (DOD). The goal of this partnership is to provide additional funding opportunities for VRP proposals, enhance current NEI Program portfolios, expand the scope of research supported by the NEI, and provide support for high quality projects addressing critical gaps in civilian and military vision research.
https://grants.nih.gov/grants/guide/pa-files/PAR-20-152.html
WHO Risk Assessment NetwordPublic Education CampaignCDCNIEHSInternational communication, education, collaboration. Several workgroups, workproducts, and international meetings.
Why has progress in hypertension control plateaued in the United States, and how can progress be restarted? Establishing a Research Agenda for the 2020’sMeeting/ WorkshopCDCNHLBIWorkshop to develop a research agenda for Centers for Disease Control and Prevention (CDC) and National Heart, Lung, and Blood Institute (NHLBI).
Working Groups to Develop HIV/AIDS Treatment and Prevention GuidelinesCommittee, Work group, Advisory group, or Task ForceOASHOD/DPCPSI/OAR, CC, NIAID, NICHD, NLM, OD/DPCPSIThere are five Office of AIDS Research Advisory Council (OARAC) Working Groups to maintain updated federally approved medical practice guidelines for HIV/AIDS Treatment and the Prevention of HIV Transmission from Mother to Infant. The five working groups are the 1) Panel on Antiretroviral Guidelines for Adults and Adolescents, 2) Panel on Opportunistic Infections in HIV-Infected Adults and Adolescents, 3) Panel on Antiretroviral Therapy and Medical Management of Children Living with HIV, 4) Panel on Opportunistic Infections in HIV-Exposed and HIV-Infected Children, and 5) Panel on Treatment of Pregnant Women with HIV Infection and Prevention of Perinatal Transmission. The HIV/AIDS Treatment and Prevention Guideline Panels update guidelines for HIV/AIDS care providers with the most current information on combination antiretroviral therapy, treatment and prevention of opportunistic infections for people with HIV; the prevention of HIV transmission from an infected mother to her infant; and the safety and efficacy of HIV/AIDS therapies.
https://clinicalinfo.hiv.gov/en/guidelines
World Cancer Research Day, HPVAware, and World No Tobacco Day, World Cancer Day observancesPublic Education CampaignOSNCI, FICThe National Cancer Institute (NCI) Office of Communications and Public Liaison and Center for Global Health collaborate with the Department of Health and Human Services (DHHS) Assistant Secretary for Public Affairs Digital Media Office to coordinate public education campaigns featuring digital materials that highlight prevention promotion and wellness programs. These materials are shared across all HHS Operating Divisions (OPDIVs).
https://www.cancer.gov/about-nci/organization/cgh
World Health Organization (WHO) Programme on Prevention of Deafness and Hearing LossCommittee, Work group, Advisory group, or Task ForceCDCNIDCDNIDCD is a founding member of WHO’s World Hearing Forum, a global network of stakeholders promoting ear and hearing care worldwide. Members work, in part, to facilitate implementation of the World Health Assembly resolution on Prevention of Deafness and Hearing Loss. The resolution called on WHO to develop a World Report on Hearing; NIDCD has supported the development of this report – the first of its kind – via a contract mechanism and subject matter expertise via stakeholders’ meetings.
https://www.who.int/activities/promoting-world-hearing-forum
Zoster Working Group of the CDC Advisory Committee for Immunization Practices (ACIP)Committee, Work group, Advisory group, or Task ForceCDCNIAIDThe Working Group discusses new zoster vaccines and makes recommendations to the Advisory Committee for Immunization Practices (ACIP) on how to use zoster vaccines.