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Racial/Ethnic Variation of HPV Type Distribution in High-Grade Cervical Precancers and Invasive Cancers in the United States
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Research Initiative
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CDC
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NCI
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The 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.
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Radiation and Chemical Defense Working Group
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Committee, Work group, Advisory group, or Task Force
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ASPR, FDA
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NIAID, NIEHS, NIAMS
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This 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.
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Radiation Biodosimetry Working Group
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Committee, Work group, Advisory group, or Task Force
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FDA
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NIAID
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This 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.
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Radiation-Induced Immune Dysfunction Meeting
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Meeting/ Workshop
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ASPR
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NIAID
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The 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.
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Radiation-Induced Multi Organ Dysfunction Meeting Planning Group
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Meeting/ Workshop
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ASPR
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NIAID, NCI
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The 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.
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Radiobiology Bioterrorism Research and Training Group (RABRAT)
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Meeting/ Workshop
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FDA, OS, ASPR
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NCI, NIAID
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This 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.
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Rapid Acceleration of Diagnostics Tech Program (RADx Tech)
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Research Initiative
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CMS, FDA, CDC, ASPR
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NIBIB
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To help address the COVID-19 pandemic, National Institute of Biomedical Imaging and Bioengineering (NIBIB) received $651 million (in FY2021) to support the development of new SARS-CoV-2 virus testing technologies. 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. ;RADx Tech also established the Independent Test Assessment Program (ITAP) in order to accelerate;regulatory review and availability of high-quality, accurate, and reliable over-the-counter COVID-19 tests to the public. ;
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Rare Disease Day at NIH
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Meeting/ Workshop
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FDA
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NCATS, NHLBI, NCI, NHGRI, CC, NIAAA
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Rare 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.
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Rare Diseases Registry Program (RaDaR)
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Resource Development
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FDA
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NCATS
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NCATS launched the Rare Diseases Registry Program (RaDaR) website to provide the rare diseases community with easily accessible guidance on how to set up and maintain high-quality registries that are based on best practices and data standards. The goal is to enable rare diseases patient organizations to better promote and support patient-focused research and the collection of patient data that can be used in developing treatments for rare diseases.
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Reciprocal Educational and Training Partnerships between FDA/CDER and the NIH Clinical Center
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Training Initiative
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FDA
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CC, NCI, NIAID, NIDCR, NIDDK, NIMH, NINDS
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This 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.
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