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President''s Commission on the Study of Bioethical Issues
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Committee, Work group, Advisory group, or Task Force
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OS
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CC
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Christine Grady participates as a Commissioner on the Presidential Commission for the Study of Bioethical Issues. The Commission advises the President on bioethical issues arising from advances in biomedicine and related areas of science and technology. The Commission seeks to identify and promote policies and practices that ensure scientific research, health care delivery, and technological innovation are conducted in a socially and ethically responsible manner. The Commission undertakes study of issues presented to them by the President and the Secretary of Health and Human Services.
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President’s Emergency Plan for AIDS Relief (PEPFAR) Implementation Science / Combination Prevention
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Research Initiative
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CDC
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NIAID, FIC, NCI, NIAAA, NIDA, NIMH, OD/DPCPSI/OAR
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This 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.
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Prevention Research Centers
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Research Initiative
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CDC
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NCI
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The Prevention Research Centers program funds community-based research projects at 37 academic research centers across the U.S.; 5 developmental and 32 comprehensive centers. These centers: Conduct research projects that promote health and prevent disease; Build research teams of multidisciplinary faculty; Seek solutions, strategies, and policies that address public health problems; Participate in research networks that address priority health issues, such as healthy aging, cancer prevention & control, and obesity prevention; Build long-term relationships for engaging communities as partners in research; Conduct research in directions guided by advisory boards of community leaders; Develop and deliver trainings that enhance the public health workforce; and Conduct additional research funded by other federal agencies, foundations, and nonprofit organizations.
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Prevention Research Coordinating Committee (PRCC)
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Committee, Work group, Advisory group, or Task Force
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AHRQ, ATSDR, CDC, OS
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OD/DPCPSI/ODP, CC, CIT, CSR, FIC, NCATS, NCCAM, 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/OLPA
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The Prevention Research Coordinating Committee promotes prevention research designed to yield results directly applicable to identifying and assessing risk, and to developing interventions for preventing or ameliorating high-risk behaviors and exposures, the occurrence of disease/disorder/injury, or the progression of detectable but asymptomatic disease. Prevention research also includes research studies to develop and evaluate disease prevention and health promotion recommendations and public health programs.
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Prevention with Positives Intervention HIV Clinics (Y01-MH-1318)
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Research Initiative
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CDC
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NIMH, NIAID
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The Prevention with Positives Intervention HIV Clinics is a contract with the CDC to conduct an HIV clinic-based comparison of a comprehensive prevention program for people living with HIV targeting multiple health behaviors (sexual risk, medication adherence, clinic attendance) and health outcomes (viral load, retention in care). In FY14, the comprehensive intervention was launched in 3 HIV clinics in the US. Clinic-based data will serve as the metric for intervention outcomes and the data will be transferred to the CDC starting in the first quarter of FY15.
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Public Health and Emergency Medical Countermeasures Enterprise (PHEMCE)
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Committee, Work group, Advisory group, or Task Force
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CDC, FDA
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NIAID, NINDS
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The PHEMCE Work Group 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.
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Public Health Emergency Management Countermeasures Enterprise
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Other
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ACF, CDC, FDA, OS, SAMHSA
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NICHD, NIAID, NIAMS, NINDS, NLM
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The 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.
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Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Chemical Integrated Product Development Team (IPT)
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Committee, Work group, Advisory group, or Task Force
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CDC, FDA, OS
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NINDS, NIAID
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The U.S. 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.
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Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Chemical Requirements Working Group
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Committee, Work group, Advisory group, or Task Force
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CDC, FDA, OS
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NINDS, NIAID, NICHD, NIEHS
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The U.S. 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.
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Quantitative Data Mining for Drug-Adverse Event Safety Signal Detection Using MEDLINE
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Research Initiative
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FDA
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NLM
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The objective of this initiative between the National Library of Medicine (NLM) Cognitive Science Branch and the Center for Drug Evaluation and Research at the U.S. 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.
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