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The NIH Bone Marrow Stromal Cell Transplantation Center
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Research Initiative
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FDA
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NIDCR, CC, NCI, NHLBI, NIAID, NIAMS, NIBIB, NINDS
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The mission of the NIH BMSC Transplantation is to develop clinical grade bone marrow stromal cells for use in clinical trials that utilizes the ability of these cells to exert immunomodulatory and immunosuppressive effects that are beneficial for the treatment of a number of diseases and disorders, and to provide assistance to clinical investigators in the preparation of regulator documents for IRBs and the FDA.
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The Pharmacology Research Associate (PRAT) Program
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Training Initiative
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FDA
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NIGMS
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Funding provided for the support of PRAT Associate as a second year fellow in the laboratory at the Food and Drug Administration (FDA).
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The Science of Sex and Gender in Human Health
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Other
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FDA
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OD
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This is a Web-based course that offers a basic scientific understanding of the major physiological differences between the sexes; their influence on illness and health outcomes; and their implications for policy, medical research, and health care.
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The Trans-NIH Rare Diseases Working Group
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Committee, Work group, Advisory group, or Task Force
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FDA
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NIDCR, CC, CSR, FIC, NCCAM, NCI, NCATS, NEI, NHGRI, NHLBI, NIA, NIAAA, NIAID, NIAMS, NIBIB, NICHD, NIDA, NIDCD, NIDDK, NIEHS, NIGMS, NIMH, NIMHD, NINDS, NINR, NLM, OD
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The Trans-NIH Rare Diseases Working Group was established in 2004. The working group assists ORDR to carry out its mission by working towards a set of goals that build on partnerships ORDR has developed with NIH Institutes, Centers, and Offices, HHS agencies, and other organizations that address issues in rare diseases research such as identifying research opportunities and advances in rare diseases research; promoting coordination and cooperation in joint research efforts among the NIH ICs and Offices and the research entities they support.
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The United States Renal Data System (USRDS)
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Resource Development
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CMS, HRSA
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NIDDK
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The 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 the 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.
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Therapeutics for Rare and Neglected Diseases (TRND)/FDA Working Group
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Committee, Work group, Advisory group, or Task Force
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FDA
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NHGRI, OD
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A group of Therapeutics for Rare and Neglected Diseases (TRND) staff and FDA staff from the Center for Drug Evaluation and Research (CDER) meet on a semi-monthly basis to discuss pilot projects for the TRND program. The purpose of this working group is to discuss the scientific progress on each project toward the eventual goal of an Investigational New Drug Application for each project. Results of experiments are discussed, and TRND staff takes the feedback of FDA/CDER staff into consideration when developing future project plans.
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Tobacco Control Strategic Planning Committee
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Committee, Work group, Advisory group, or Task Force
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CDC, FDA, HRSA, IHS, OS, OSG, SAMHSA
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NIDA, NCI
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This committee, led by the Department of Health and Human Services, helped to develop the HHS Tobacco Control Strategic Action Plan.
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Topic Refinement Panel for Peripheral Artery Disease (AHRQ) and Duke University Evidence-based Practice Center
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Committee, Work group, Advisory group, or Task Force
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AHRQ
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NHLBI
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The Duke University Evidence-Based Practice Center (EPC) is working with the Agency for Healthcare Research and Quality (AHRQ) to conduct a comparative effectiveness review on the topic of Treatment Strategies for Patients With Peripheral Artery Disease (PAD). The Technical Expert Panel (TEP) members provide expertise in the project research area to support the team of EPC investigators. TEP participation consists of attending 1-2 teleconferences over the course of roughly 12 months to discuss the protocol, key questions, analytical framework, literature search strategy, and other project-specific questions regarding report structure and data to be abstracted from the literature for inclusion in the report.
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Tox21 Collaboration
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Research Initiative
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FDA
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NHGRI, NIEHS
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The Toxicology in the 21st Century project, or Tox21, is a collaborative effort that began in 2006 with the NIH Chemical Genomics Center (NCGC), the National Toxicology Program (NTP) based at the National Institute of Environmental Health Sciences (NIEHS), and the Environmental Protection Agency. The ambitious initiative was designed to predict the toxicity of chemicals on human health and the environment. This is accomplished by developing in vitro assays for more predictive, mechanistically-based methods than those used with current animal testing. On July 19th, 2010, the U.S. Food and Drug Administration (FDA) joined this ground-breaking collaboration. The FDA will bring human toxicity data into the project, along with other expertise, to improve upon current chemical testing methods.
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Trans-Atlantic Task Force on Antimicrobial Resistance (TATFAR)
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Committee, Work group, Advisory group, or Task Force
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CDC, FDA, OS
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NIAID
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The 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 task force are to increase the mutual understanding of US and EU activities and programs relevant to the antimicrobial resistance issues identified in the declaration to deepen the transatlantic dialogue, to provide opportunities to learn from each other, and to promote information exchange, coordination and co-operation.
In September of 2011, the task force published a list of 17 recommended areas for future cooperation between the EU and the US.
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