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This announcement (NOFO) encourages applications for multi-center clinical trials focused on neurological emergencies. Successful applicants will collaborate and conduct the trial within the NIH SIREN Network. The NIH SIREN Clinical Coordinating Center (CCC) will work with the successful applicants to implement the proposed trial efficiently and the SIREN Data Coordinating Center (DCC) will provide statistical and data management support. The NIH SIREN hubs and their affiliated clinical sites will provide on-site implementation of the clinical protocols. The NIH SIREN Network will also be uniquely poised to collaborate with other US and international consortia necessary to conduct larger, definitive trials of promising interventions for neurological emergencies. Multi-center clinical trials in stroke treatment, recovery, or prevention supported by NINDS will be conducted in the NIH StrokeNet, and not within SIREN. Applicants do not need to be part of the existing SIREN infrastructure to apply under this FOA.

The purpose of this announcement is to encourage investigators to pursue translational activities and small clinical studies to advance the development of therapeutic, and diagnostic devices for disorders that affect the nervous or neuromuscular systems. Activities supported in this program include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities, obtaining an Investigational Device Exemption (IDE) for a Significant Risk (SR) study, as well as a subsequent small clinical study. The clinical study is expected to provide information about the device function or final design that cannot be practically obtained through additional non-clinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. This FOA is a milestone-driven cooperative agreement program and will involve participation of NIH program staff in negotiating the final project plan before award and monitoring of research progress.

The purpose of this announcement is to encourage investigators to pursue a small clinical trial to obtain critical information necessary to advance recording and/or stimulating devices to treat central nervous system disorders and better understand the human brain (e.g., Early Feasibility Study). Clinical studies supported may consist of acute or short-term procedures that are deemed Non-Significant Risk (NSR) by an Institutional Review Board (IRB), or Significant Risk (SR) studies that require an Investigational Device Exemption (IDE) from the FDA, such as chronic implants. The clinical trial should provide data to answer key questions about the function or final design of a device. This final device design may require most, if not all, of the non-clinical testing on the path to more advanced clinical trials and market approval. The clinical trial is expected to provide information that cannot be practically obtained through additional non-clinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. Activities supported by this Funding Opportunity include a small clinical trial to answer key questions about the function or final design of a device. As part of the BRAIN Initiative, NIH has initiated a Public-Private Partnership Program (BRAIN PPP) that includes agreements (Memoranda of Understanding, MOU) with a number of device manufacturers willing to make such devices available, including devices and capabilities not yet market approved but appropriate for clinical research. In general it is expected that the devices' existing safety and utility data will be sufficient to enable new IRB NSR or FDA IDE approval without need for significant additional non-clinical data. For more information on the BRAIN PPP, see http://braininitiative.nih.gov/BRAIN_PPP/index.htm

This Notice of Funding Opportunity (NOFO) aims to support the establishment of programs to enhance research rigor and transparency practices within academic and research institutions to promote a culture of high-quality neuroscience research. Attention to principles of rigorous study design and transparent reporting are essential to enable the neuroscientific community, as well as the biomedical community at large, to design and perform valid experiments and to assess the value of scientific findings. Awards are intended to support the implementation of innovative programs, strategies, and approaches at the departmental, inter-departmental, or equivalent intra-institutional entity level.

Through this I-Corps at NIH program Notice of Funding Opportunity (NOFO), NIH and CDC provide administrative supplement awards to active SBIR (NIH and CDC) and STTR Phase I (NIH only) grantees/awardees. The I-Corps at NIH mission is to empower entrepreneurs in developing and validating a strategic business model through diverse customer discovery in order to meet unmet clinical needs. I-Corps enables and accelerates the transformation of invention to impact SBIR and STTR Phase I awardees in a no-cost extension are eligible as long as, if selected, their no cost extension covers the entire duration of I-Corps at NIH cohort. The program provides three-member project teams with access to instruction and mentoring to accelerate the translation of technologies currently being developed with NIH and CDC SBIR and 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. Prospective applicants are strongly encouraged to contact Scientific/Research staff for more information about the program before applying.

The National Institutes of Health (NIH) participating Institutes and Centers (ICs), in collaboration with the Global Alliance for Chronic Diseases (GACD), intends to publish Funding Opportunity Announcements (FOAs) to invite applications forimplementation research on noncommunicable diseases (NCDs) in World Bank-defined low- and middle-income countries (LMICs) and American Indian/Alaskan Native (AI/AN) Tribal Nation populations in the United States.

The NIH Office of Science Policy (OSP) within the Office of the Director (OD) announces the availability of administrative supplements to support: 1) research on bioethical issues to develop or support the development of an evidence base that may inform future policy directions, and/or 2) certain efforts to develop or augment bioethics research capacity.

This Notice of Funding Opportunity (NOFO) supports translational exploratory/developmental research that directly advances the discovery of novel treatment strategies, i.e., medical countermeasures (MCMs), that address serious morbidity and mortality after acute exposure to highly toxic chemical threats. Chemical threats are toxic compounds that could be used in a terrorist attack or accidentally released from industrial production, storage, or shipping. They include traditional chemical warfare agents, toxic industrial chemicals, pesticides, and ultra-potent synthetic (UPS) opioids. This NOFO supports translational research that includes, but is not limited to, preliminary efficacy and/or early preclinical development studies towards discovery and validation of novel molecular entities or biologics as candidate MCMs. In addition to novel agents, new treatment strategies may involve repurposing already FDA-approved products or combinations of interventions based on established mechanisms of action. Projects supported by this NOFO are expected to generate preliminary data that would facilitate the development of competitive applications for more extensive support from the NIH CounterACT Cooperative Agreement program and/or other related initiatives.

To develop a national, interdisciplinary, patient-centered research consortium to advance Temporomandibular Disorders (TMDs) basic and clinical research, research training, and translation to evidence-based treatments and improved clinical care.

The purpose of this Notice of Funding Opportunity (NOFO) is to solicit applications focused on the neurological and/or mental health-related manifestations of infection-associated chronic illnesses, including the post-acute sequelae of COVID-19 (Neuro-PASC) as well as other chronic illnesses with a potential infectious trigger (post-treatment Lyme Disease, myalgic encephalomyelitis/chronic fatigue syndrome [ME/CFS], postural orthostatic tachycardia syndrome [POTS], post-viral fatigue syndromes, etc.). Projects that investigate common neurological and/or mental health-related mechanisms across multiple infection-associated chronic illnesses would be of particular interest, although this is not a requirement (i.e., applications can focus on a single condition). Neurologically focused clinical research investigating scientifically compelling pathways that contribute to the development of infection-associated chronic illnesses - including basic experimental studies in humans (BESH) or mechanistic clinical trials that will accelerate the development of effective treatments - are within the scope of this initiative. Preclinical studies utilizing animal, cell culture, and/or human tissue models are also encouraged. All applications must propose such studies in the context of a post-infectious etiology.