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FDA Center for Tobacco Products (CTP) funding opportunity: Development of a cingulate-striatal addiction circuit in a rodent model of nicotine dependence
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Research Initiative
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FDA
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NIDA
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This project is designed to address question #30: What novel biological and physiological markers (including genetic and epigenetic markers) are predictive of smoking related and smokeless tobacco related health outcomes? Since we also address biomarker magnitude changes, the project also overlaps with #29.
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FDA Center of Drug Evaluation and Research (CDER) Workgroup
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Other
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FDA
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CC
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The joint CC-CDER collaborative working team is aimed at developing new processes to consider exceptions to existing Center of Drug Evaluation and Research (CDER) policies and procedures for extraordinary clinical circumstances. Over the past few years, CC investigators have encountered instances in which regulatory barriers may have precluded novel pharmacological interventions for severely ill patients. Leaders at the FDA CDER became aware of the concern of some NIH intramural investigators and approached CC leadership to understand the issues.
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FDA Drug Safety Oversight Board
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Committee, Work group, Advisory group, or Task Force
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AHRQ, CDC, CMS, FDA, HRSA, IHS
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OD/OSP, NCI
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The FDA Drug Safety Oversight Board (DSB), created in 2005 and mandated by law in the FDA Amendments Act of 2007, advises the FDA''s Center for Drug Evaluation and Research (CDER) Center Director on the handling and communicating of important and often emerging drug safety issues and regulatory science.
The DSB is composed of representatives from two FDA Centers and eight other federal government agencies, the Agency for Healthcare Research and Quality (AHRQ), Centers for Disease Control and Prevention (CDC), Centers for Medicare and Medicaid Services (CMS), Department of Defense (DOD), Health Resources and Services Administration (HRSA), Indian Health Service (IHS), National Institutes of Health (NIH), and Department of Veterans Affairs (VA). An important role of the DSB is to help FDA assess the impact of their safety decisions on the healthcare systems of its Federal Partners. The Board, with its broad representation from federal healthcare organizations, can provide valuable input and allows FDA to hear other perspectives on drug safety issues.
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FDA Medical Countermeasures initiative (MCMi) Regulatory Science Steering Committee
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Meeting/ Workshop
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FDA
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NIAID
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This committee provides guidance to Medical Countermeasures initiative (MCMi) stakeholders.
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FDA Pediatric Advisory Committee
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Other
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FDA
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NICHD
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This is a committee of ad hoc pediatric clinical pharmacologists and pediatricians.
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FDA Substance Registry System Public Interface
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Resource Development
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FDA
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NLM
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The National Library of Medicine and the Food and Drug Administration established a collaborative effort to provide an interface for public access to the FDA’s Substance Registration System (SRS). The FDASRS utilizes an existing NLM database backend architecture to provide public search capability for FDA substances and medicinal products.
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FDA-NCI Monthly Meeting
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Meeting/ Workshop
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FDA
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NCI
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A monthly meeting to enhance communication between the two agencies, thereby expediting the development of new anti-cancer agents. General topics discussed include patient safety, clinical efficacy, and regulatory pathways to licensure; as well as an understanding of the operations of the sister agencies.
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Federal Breastfeeding Working Group
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Other
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CDC, FDA
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NICHD
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The purpose of this workgroup is to develop strategies to implement the Surgeon General''s call to action to support breastfeeding.
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Federal Collaboration on Rural Health
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Meeting/ Workshop
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AHRQ, HRSA, SAMHSA
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NIMH, NIA, NIDA, NINR
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On May 17, 2012, NIMH participated in a workshop entitled "Opportunities and Programs in Rural Communities" during the National Association for Rural Mental Health (NARMH) and AgriWellness Annual Meeting. The meeting brought together researchers, persons in recovery, healthcare providers, family members, advocates, and policy makers to learn about effective rural health programs and practices as well as new discoveries. In addition, participants discussed rural behavioral health policy, rural mental health research, and how best to reduce health disparities in rural populations. NIMH provided an overview of opportunities and programs supporting Rural Health at NIH.
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Federal Dietary Reference Intakes Steering Committee
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Other
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AHRQ, CDC, FDA, OS
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NIDDK
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This committee serves as an interagency forum 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.
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