Health grants for Students

NIOSH is encouraging the submission of an application from qualified organizations for a National Center for Construction Safety and Health Research and Translation. Applicants are encouraged to propose multidisciplinary approaches and coordination for impactful applied and intervention research, hazard identification, and controls; develop partnerships for implementing prevention and intervention activities; and serve as a leader in research translation and research-to-practice for the protection of construction workers in the U.S. The Center will accomplish these goals by integrating and advancing research, research translation, best practices, policy and guidance, and capacity building. Center work should consider the NIOSH strategic plan and NORA construction research objectives. Center structure should take advantage of diverse scientific resources and focus on national worker safety and health issues. Centers should emphasize the creation and implementation of evidence-based solutions that address important construction industry safety and health problems. Collaborations with other academic institutions, nonprofit organizations, and other occupational safety and health-focused groups are expected. Applicants must concisely describe the occupational health burden of important safety and health issues in the construction industry and discuss how focused research and outreach activities will help alleviate the burden and reduce numbers. Applicants should also clearly articulate the anticipated impacts of the Center’s proposed work, both during the project period and beyond.

The focus of this notice of funding opportunity (NOFO) is to produce insights into disease detection and prevention strategies, burden, severity, diagnostics, treatment, and outcomes of infectious diseases in international travelers. Timely surveillance and sentinel detection are essential for collecting actionable data. The research should:Address public health questions that improve the speed of outbreak detection.Help develop guidelines and recommendations to improve patient care.Enhance understanding of the natural history of disease.Optimize genomic surveillance as well as diagnostic and treatment strategies.Advance the global health security of the United States.This NOFO will have two components:Component A – Clinic-based sentinel network.Component B – Sentinel detection in international transportation hubs.You may apply for Component A, B, or both. If your application for both Component A and B is ranked top, Component B will be awarded.

The Genomics Research to Elucidate the Genetics of Rare Diseases:innovation (GREGoRi) initiative seeks to accelerate a paradigm shift in rare disease diagnosis by reimagining the tools, molecular technologies and analytical approaches used to identify the causal gene(s) and/or variant(s) underlying rare genetic disorders. The purpose of this Notice of Funding Opportunity is to establish the GREGoRi Technology Integration Center, which will enable the development of standards and best practices for applying new and emerging molecular methods in rare disease diagnosis. A major deliverable of the Center will be a multidimensional dataset that can be used for the development and benchmarking of novel tools and strategies that facilitate rare disease diagnosis.

This Notice of Funding Opportunity (NOFO) encourages applications for investigator-initiated, early phase, clinical trials of natural products (i.e., botanicals, dietary supplements, and probiotics), which have a strong scientific premise to justify further clinical testing. For this NOFO, natural products include promising nutritional regimens that standardize the amount of a specific naturally occurring nutritional compound (e.g., omega-3 fatty acids, anthocyanidins, or polyphenols) and have compelling preliminary evidence. Under this NOFO, trials must be designed so that results, whether positive or negative, will provide information of high scientific utility and will support decisions about further development or testing of the natural product. This NOFO will provide up to 3 years support for studies to replicate the impact of the natural product on target engagement when used by humans, and assess whether there is an association between the degree of the impact on target engagement and functional or clinical outcomes in a patient population. Applications are encouraged to design studies to determine how to optimize the impact of the natural product on target engagement by optimizing the delivery of the natural product through examination of different doses or formulations. In addition, applications can be designed to combine the natural product with another treatment approach that is known to engage the same target; or study the impact of the natural product in a target population that is more responsive. Clinical trials submitted under this NOFO are expected to be hypothesis based, milestone-driven, and directly related to the research priorities and mission of NCCIH. This R33 funding mechanism is intended to accelerate the translation of emerging basic science findings about natural products into early-stage clinical testing to determine whether continued clinical research is warranted. This NOFO will not support efficacy or effectiveness trials, nor will

The objective of this funding opportunity is to support investigator-initiated, phase I clinical trials for diagnostic and therapeutic interventions for heart, lung, blood, and sleep (HLBS) disorders in adults and children. The proposed trial can be single or multisite. Applicants applying for funding under this NOFO should be ready to initiate the clinical trial within the first quarter of the project period. Discussion, submission, and attainment of applicable regulatory (FDA, DSMB, IRB) approvals, and establishment of drug (and placebo, if applicable) supplies, and any necessary third-party agreements should be established by the time of award. If time and support for these and other pre-clinical and/or trial readiness activities are desired, applicants should consider the companion NOFO which utilizes an R61/R33 phased approach.

The Genomics Research to Elucidate the Genetics of Rare Diseases:innovation (GREGoRi) initiative seeks to accelerate a paradigm shift in rare disease diagnosis by reimagining the tools, molecular technologies and analytical approaches used to identify the causal gene(s) and/or variant(s) underlying rare genetic disorders. The purpose of this Notice of Funding Opportunity is to establish the GREGoRi Data Coordination and Outreach Center. The Data Coordination and Outreach Center will act as the central point of coordination for the GREGoRi Research Program, and will be responsible for ensuring that the protocols, data, metadata, computational tools and other resources developed as part of GREGoRi are made available to the broader research community.

The purpose of this initiative is to: (1) support the efforts by R15-eligible Principal Investigators (PIs) to conduct rigorous basic and/or mechanistic pain research projects; (2) promote integrated, interdisciplinary research partnerships between R15-eligible PIs and additional investigators from U.S. domestic institutions, and (3) enhance the pain research environment at the R15-eligible institution for health professional trainees or undergraduate and/or graduate students by actively engaging them in the proposed pain research projects.

This notice of funding opportunity (NOFO) invites applications for investigator-initiated clinical trials of complementary and integrative health approaches with physical and/or psychological therapeutic inputs (often called mind and body interventions) in NCCIH-designated areas of high research priority. Applications submitted under this NOFO are expected to propose a multisite feasibility clinical trial that will provide new information that is scientifically necessary for the planning and conduct of a subsequent clinical efficacy or effectiveness study, pragmatic trial, or dissemination and implementation trial within NCCIHs mission. NCCIH expects that applications to this NOFO will describe the planned future clinical trial and in so doing demonstrate that the proposed (R01) research is scientifically necessary to design or plan the subsequent fully powered, full-scale clinical trial. Under this R01, the data collected should be used to fill gaps in scientific knowledge, including, but not limited to the following: assessing whether the intervention can be delivered with fidelity across sites; demonstrating feasibility of recruitment, accrual, and randomization of participants across sites; demonstrating participant adherence to the intervention, as well as retention of participants throughout the study across sites; refining and assessing the feasibility of protocolized multimodal interventions, and/or demonstrating feasibility of data collection across sites in preparation for a future fully powered, multisite efficacy or effectiveness trial. The need for multisite feasibility trials is expected to be justified by sufficient preliminary data from previous single site feasibility or acceptability trial(s) or the published literature. The data collected should be used to fill gaps in scientific knowledge and be necessary to develop a competitive fully powered multisite clinical trial that has the potential to make a significant impact on public health.

The Genomics Research to Elucidate the Genetics of Rare Diseases:innovation (GREGoRi) initiative seeks to accelerate a paradigm shift in rare disease diagnosis by reimagining the tools, molecular technologies and analytical approaches used to identify the causal gene(s) and/or variant(s) underlying rare genetic disorders. This Notice of Funding Opportunity is intended to stimulate the development and testing of highly innovative experimental or computational approaches for rare disease diagnosis, that have the potential to make transformative improvements to the current state of the art.

This Notice of Funding Opportunity (NOFO) invites applications for Diabetes Research Centers (DRCs) that are designed to support and enhance the national research effort in diabetes, its complications, and related endocrine and metabolic diseases. The purpose of this Centers program is to bring together basic and clinical investigators to enhance communication, multidisciplinary collaboration, and effectiveness of ongoing research in Diabetes Research Center topic areas. By providing shared access to specialized technical resources (research cores) and supporting a Pilot and Feasibility Program (P&F), DRCs are intended to create an environment that provides the capability for accomplishments greater than those that would be possible by individual research project grant support alone. New Center programs that bring in diverse perspectives, propose unique scientific themes, or provide innovative resources are encouraged. Emphasis will be placed on Center programs that propose enhanced synergies with other NIDDK-funded programs as well as providing a rich mentoring environment for future diabetes researchers.

Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) invites grant applications proposing exploratory research projects focused on further development and technical validation of emerging technologies offering novel capabilities for the molecular or cellular characterization of cancer or for improved handling and quality control of biospecimens used for basic, clinical, or epidemiological cancer research. This NOFO solicits R33 applications where major feasibility gaps for the technology or methodology have been overcome, as demonstrated with supportive preliminary data, but still require further development and rigorous technical validation to encourage adoption by the research community. Well-suited applications must propose the development of technologies that offer the potential to accelerate and/or enhance research in the areas of cancer biology, early detection and screening, clinical diagnosis, treatment, cancer control, epidemiology. Technologies proposed for development may have potential for widespread applicability but must be focused in this proposal on cancer-relevant use cases. Projects proposing to apply or use existing technologies for hypothesis-driven research where the novelty resides in the biological or clinical target/question being pursued are not responsive to this solicitation and will not be reviewed.This funding opportunity is part of a broader NCI-sponsored Innovative Molecular Analysis Technologies (IMAT) Program.

This Notice of Funding Opportunity (NOFO) encourages applications for investigator-initiated, early phase, clinical trials of natural products (i.e., botanicals, probiotics, and products marketed as dietary supplements), which have a strong scientific premise to justify further clinical testing. For this NOFO, natural products include promising nutritional regimens that standardize the amount of a specific naturally occurring nutritional compound (e.g., omega-3 fatty acids, anthocyanidins, or polyphenols) and have compelling preliminary evidence. Under this NOFO, trials must be designed so that results, whether positive or negative, will provide information of high scientific utility and will support decisions about further development or testing of the natural product. This NOFO will provide up to three years (R61 phase) of support for milestone-driven testing of pharmacokinetics, bioavailability, and assessment of the natural products effect (i.e., measure of mechanism of action) when used by humans on a specified target measure. If milestones in the R61 phase are achieved, up to 3 years of additional support (R33 phase) may be awarded to replicate the impact of the natural product on target engagement(s) when used by humans and assess whether there is an association between the degree of the impact on the target engagement and clinical outcomes in a participant population. Applications are encouraged to design R33 studies to determine how to optimize the impact of the natural product on the target engagement by optimizing the delivery of the natural product through examination of different doses or formulations. In addition, applications can be designed to combine the natural product with another treatment approach that is known to impact the same target engagement measure; or study the impact of the natural product in a population that is more responsive,

This Notice of Funding Opportunity (NOFO) invites applications for advanced development and enhancement of emerging informatics technologies to improve the acquisition, analysis, visualization, and interpretation of data across the cancer research continuum including cancer biology, cancer treatment and diagnosis, early cancer detection, risk assessment and prevention, cancer control and epidemiology. As a component of the NCI's Informatics Technology for Cancer Research (ITCR) Program, this NOFO is focused on advancing emerging informatics technology, defined as one that has passed the initial prototyping and pilot development stage, has demonstrated potential to have a significant and broader impact, has compelling reasons for further improvement and enhancement, and has not been widely adopted in the cancer research field. To be successful, proposed development plans must have a clear rationale for why the proposed technology is needed and how it will benefit the cancer research field. In addition, mechanisms to solicit feedback from driving cancer research projects as well as the broader user community throughout the development process must be included.This NOFO invites applications for the enhancement and dissemination of emerging, user-friendly informatics technologies that support a wide range of cancer research, including discovery biology, population studies, as well as clinical and translational research. The emphasis is on uniqueness and potential impact on cancer research. In addition, all projects proposed in response to this NOFO must involve the following general attributes:Potential to advance driving cancer research projects and the cancer research field in general;Offers clear advantages over competing technologies in the targeted cancer research domain;Provides compelling plans and processes for supporting and engaging end users to evaluate and apply the tool or resource;Provides plans for advancing use of the tool or resource by the targeted community through collaboration, outreach, and training;Provides a realistic timeline and milestones for technology development.

Invasive surgical procedures in humans offer the unique opportunity to intracranially record and stimulate neuronal activity within precisely localized brain structures, enabling high-impact human neuroscience investigations. This NOFO seeks exploratory research projects, from newly formed or established multi-disciplinary teams, to understand how dynamic activity of single cells and ensembles of neurons in spatially organized networks gives rise to the internal states we experience as sensations, perceptions, emotions, thoughts, and memories, and to observable motor and social behaviors. The research should be proposed as exploratory research and planning activities to establish feasibility and early-stage development that, if successful, would support, enable, and/or lay the groundwork for a potential, subsequent research project grant applications using invasive neural recording and stimulation technologies in the human brain. Projects should maximize opportunities to conduct innovative in vivo human neuroscience research made available by direct access to the brain from invasive surgical procedures. Projects should employ approaches guided by specified theoretical constructs and by quantitative, mechanistic models where appropriate. Recipients will join a consortium working group, coordinated by the NIH, to identify consensus standards of practice, including neuroethical considerations, to collect and provide data for ancillary studies, and to aggregate and standardize data for dissemination among the wider scientific community.

This Notice of Funding Opportunity (NOFO) invites applications for Silvio O. Conte Digestive Diseases Research Core Centers (DDRCCs). The DDRCCs are part of an integrated program of digestive and liver diseases research support provided by the NIDDK. The purpose of this Centers program is to bring together basic and clinical investigators to enhance communication, collaboration, and effectiveness of ongoing research related to digestive and/or liver diseases within the NIDDK's mission. DDRCCs are based on the core concept, whereby shared resources aimed at fostering productivity, synergy, and new research ideas among the funded investigators are supported in a cost-effective manner. Each proposed DDRCC must be organized around a central theme that reflects the focus of the digestive or liver diseases research of the Center members. The central theme must be within the primary mission of the NIDDK, and not thematic areas for which other NIH Institutes or Centers are considered the primary source of NIH funding.

The National Library of Medicine (NLM) invites applications for innovative predoctoral and postdoctoral training programs that prepare the next generation of researchers in biomedical informatics, data science, and artificial intelligence/machine learning (AI/ML). NLM emphasizes cutting-edge, forward-looking training experiences that equip trainees to address complex health and biomedical challenges through advanced computational approaches. Applications may propose the creation of new training programs or the renewal of existing NLM-supported programs. These programs are designed to meet the growing demand for researchers with deep expertise in biomedical computing, data science, and AI/ML, with clear relevance to health and biomedical research. Recognizing the inherently interdisciplinary nature of these fields, NLM seeks programs that integrate methods and perspectives across disciplines to advance biomedical informatics, data science, and AI/ML.

Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) solicits grant applications proposing to develop innovative technologies offering new capabilities for the molecular or cellular characterization of cancer or for improved handling and quality control of biospecimens for basic, clinical, or epidemiological cancer research. The NOFO solicits R61 applications for early-stage projects proposing proof-of-concept/pilot studies to test the technical feasibility of the proposed method, tool, assay, platform, or instrument. Technologies proposed for development may have potential for widespread applicability but must be focused for this program on cancer-relevant use cases. Projects proposing to apply or use existing technologies for hypothesis-driven research where the novelty resides in the biological or clinical target/question being pursued are not responsive to this solicitation and will not be reviewed.This funding opportunity is part of a broader NCI-sponsored Innovative Molecular Analysis Technologies (IMAT) Program.

The NIH Cardiovascular Repository for Type 1 Diabetes (CaRe-T1D) was created to improve research on type 1 diabetes (T1D) and cardiovascular disease (CVD). Cardiovascular complications remain the top cause of death among people with T1D and greatly shorten lifespan. The mechanisms underlying atherosclerosis, cardiomyopathy, endothelial dysfunction, and cardiac autonomic neuropathy in T1D remain poorly understood. While managing traditional risk factors—such as high blood glucose, high blood pressure, and elevated cholesterol lower cardiovascular risk, a significant residual risk remains even with optimal control. In addition to atherosclerosis, both diastolic and systolic diabetic cardiomyopathy play a major role in morbidity and mortality among these patients. Currently, no therapies are specifically approved to prevent or treat these common and severe cardiovascular issues in T1D. The purpose of this NOFO is to promote collaborative and interdisciplinary research aimed at enhancing the understanding of the development of CVD in individuals with T1D and the differences with CVD in T1D by continuing the efforts of the CaRe-T1D consortium.This NOFO is associated with the Special Diabetes Program (https://www.niddk.nih.gov/about-niddk/research-areas/diabetes/type-1-diabetes-special-statutory-funding-program/about-special-diabetes-program) which funds research on the prevention, treatment, and cure of type 1 diabetes and its complications, including unique, innovative, and collaborative research consortia and clinical trials networks.

The goal of this program is to support collaborative translational research projects aligned with NIH efforts to enhance the translation of basic biological discoveries into clinical applications that improve health. It encourages high quality science demonstrating the potential to result in understanding an important disease process or lead to new therapeutic interventions, diagnostics, or prevention strategies within the research interests and priorities of the participating NIH Institutes/Centers (ICs).Specifically, the program seeks to broaden and strengthen translational research collaborations between basic and clinical researchers both within and outside NIH to accelerate and enhance translational science by promoting partnerships between NIH intramural investigators (e.g., those conducting research within the labs and clinics of the NIH) and extramural investigators (e.g., those conducting research in labs outside the NIH), and by providing support for extramural investigators to take advantage of the unique research opportunities available at the NIH Clinical Center by conducting clinical research projects in collaboration with NIH intramural investigators.

The National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC), invites grant applications for Education and Research Centers (ERCs) that are focused on occupational safety and health training. NIOSH is mandated to provide an adequate supply of qualified personnel to carry out the purposes of the Occupational Safety and Health Act, and the ERCs are one of the primary means for meeting this mandate. ERCs are academic institutions that provide high-quality interdisciplinary graduate and post-graduate training, research training, continuing education, and outreach in the core occupational safety and health disciplines of industrial hygiene, occupational health nursing, occupational medicine, and occupational safety, as well as allied disciplines. Research and research training are integral components of ERCs, with ERC faculty and NIOSH trainees conducting research on issues related to the NIOSH National Occupational Research Agenda (NORA) and emerging issues to advance the field of occupational safety and health. NIOSH ERCs have regional presence to further diversify the occupational safety and health profession through their core values, mission statements, and outputs. ERCs serve as resources for our nation's workforce through continuing education, outreach and strong collaboration with professional associations, worker advocacy groups, businesses, industries, and public health agencies. ERCs work with other institutions and organizations, including Minority Serving Institutions and other NIOSH supported training programs to have a positive impact on worker health, safety, and well-being.

This Notice of Funding Opportunity (NOFO) solicits applications to develop shared-use research facilities or research-supporting facilities that enable collaborative research and benefit broad research communities at large. The NOFO supports two existing construction programs: the Biomedical Research Facilities (BRF) program and the HIV/AIDS Research Facilities (HRF) program.The BRF program supports the construction or modernization of biomedical research facilities that advance basic, translational, clinical, or behavioral science research in all areas. Intended facilities include shared research spaces, core facilities, biorepositories, or other shared-use resource facilities that serve a broad scientific community with a significant, long-term impact on biomedical research.The HRF program funds the development of HIV/AIDS research or research-supporting resources that the empowered research activities must align with the NIH Office of AIDS Research (OAR) priorities, as outlined at OAR HIV/AIDS Research Priorities, including research focusing on the long-term health consequences of HIV infection.NIH encourages applications from institutions across all geographic regions of the country, including Institutions of Emerging Excellence (IEE) in biomedical research, to strengthen the nation"s research capacity.

The purpose of this NOFO is to enhance the capability of NCATS CTSA Program KL2 scholars and recipients of re-entry supplements supported by the CTSA Program to conduct research as they complete the transition to fully independent academic translational scientists. These R03 grants will support different clinical and translational science research projects, including pilot and feasibility studies; secondary data analysis of existing data; small, self-contained research projects; development of research methodology; and development of new research technology. Research proposed in the R03 application may or may not include patient-oriented research. The R03 is, therefore, intended to support research projects that can be carried out in a short period of time with limited resources and that provide preliminary data to support submission of a subsequent R01, or equivalent, application.

The purpose of this Notice of Funding Opportunity (NOFO) is to leverage NICHD clinical research Network infrastructure relevant to infants, children, women, pregnant and lactating women, and persons with disabilities to conduct innovative, multisite, investigator-initiated clinical trials and observational studies. This NOFO will utilize a bi-phasic (UG3/UH3), milestone-driven mechanism consisting of a start-up phase (UG3) and a full enrollment and clinical trial implementation phase (UH3). Applications submitted in response to this NOFO must address specific aims and milestones for both the UG3 and UH3 phases. A UG3 project (phase I) that meets its milestones will be administratively considered by NICHD and prioritized for transition to the UH3 award (phase II). This NOFO provides an opportunity to leverage NICHD clinical research Network infrastructure as a platform for investigator-initiated innovative hypotheses by any investigator in the extramural community. Applications must be submitted as investigator-initiated, multi-Project Director/Principal Investigator (PD/PI) grant applications in conjunction with the respective NICHD-supported Network Data Coordinating Center (DCC), or equivalent as determined by the NICHD.

Responding to the needs of the scientific community to bolster a vibrant and sustainable research workforce, the Division of Kidney, Urologic, and Hematologic Diseases (KUH) at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has incorporated additional flexibilities for institutional training programs serving the mission interests of non-malignant kidney, urologic, and hematologic diseases, encompassing both adult and pediatric conditions. The purpose of this notice of funding opportunity is to invite applications for Institutional Network Awards (U2C-TL1) to recruit, train, and retain the next generation of researchers and provide them with the coordinated support, resources, and networks they need to succeed and lead. To maximize integration and promote a highly connected trainee community, institutions are invited to submit a single, unified U2C-TL1 application. Representation across all kidney, urologic, and hematologic disciplines is not expected or required. If feasible, applications may include multiple departments within and across institutions. It is expected that each U2C-TL1 award will actively participate in the Kidney, Urology and Hematology Research-Training Network (KUHR-TN), a nationwide coalition of individual U2C-TL1 awards.

The National Institute of Environmental Health Sciences (NIEHS) is announcing the continuation of the Superfund Hazardous Substance Research and Training Program, referred to as Superfund Research Program (SRP) Centers. SRP Center grants will support problem-based, solution-oriented research Centers that consist of multiple, integrated projects representing both the biomedical and environmental science and engineering disciplines; as well as cores tasked with administrative (which includes Center leadership, data management, and training); translational research and engagement; and research support functions. The scope of the SRP Centers is taken directly from the Superfund Amendments and Reauthorization Act of 1986, which limits competition for this program to accredited institutes of higher education.Please see Section III. Eligibility for additional information. In accordance with NIH standard peer-review processes, the application(s) will be peer-reviewed, and only meritorious application(s) will be considered for funding.

The goal of this Notice of Funding Opportunity (NOFO) is to provide funding support for the pre-clinical and early stage clinical (Phase I) development of novel small-molecule and biologic drug candidates that prevent Alzheimer's disease (AD), slow its progression, or treat its cognitive and behavioral symptoms. Participants in this program will receive funding for therapy development activities such as medicinal chemistry; pharmacokinetics (PK); Absorption, Distribution, Metabolism, Excretion, Toxicology (ADMET); efficacy in animal models; development of biomarkers for target engagement; formulation development; chemical synthesis under Good Manufacturing Practices (GMP); Investigational New Drug (IND) enabling studies; and initial Phase I clinical testing. Applications not responsive to this NOFO include research on basic mechanisms of disease or mechanisms of drug action; development ofrisk, diagnostic, prognostic, predictive, and preventionbiomarkers, devices, non-pharmacological interventions (e.g., exercise, diet, cognitive training), repurposed drugs and combination therapies; discovery activities such as high-throughput screening and hit optimization; and stand-alone clinical trials.

The goal of the training grant program is to enhance the quality and availability of safety training for United States commercial fishermen. Availability includes the frequency, geographic considerations, channels or partners of dissemination, culturally and/or educational appropriate training material, and other characteristics of a successful training program. As a result, the Coast Guard and NIOSH invite applications to support the development and implementation of training and education programs that: develop and deliver training which addresses the needs of commercial fishermen in the United States provide qualified marine safety instructors, or otherwise accepted by the National Maritime Center instructors and faculty to conduct the training evaluate the effectiveness and impact of the training program on reducing injuries among fishermen coordinate with existing training programs and partnerships with industry fishermen, and agencies conform to 46 U.S.C. § 4502 (i) Safety Standards for commercial fishing safety training In order to support and administer the grant program, the Coast Guard and NIOSH signed a Memorandum of Understanding on May 17, 2018. While the Coast Guard, along with the Occupational Safety and Health Administration (OSHA), provides regulatory oversight for safety and health matters within the commercial fishing industry, NIOSH is an agency operating under the Centers for Disease Control and Prevention (CDC) with the mission of generating new knowledge in occupational safety and health and transferring that knowledge into practice to prevent worker injury, illness and death. NIOSH conducts and funds scientific research, develops methods to prevent occupational hazards, develops guidance and authoritative recommendations, translates scientific knowledge into products and services, disseminates information, identifies factors underlying work-related disease and injury and responds to requests for workplace health hazard evaluations.

This Notice of Funding Opportunity (NOFO) invites applications that propose to use mouse models to conduct rigorous preclinical testing of drugs or drug combinations currently used for other conditions, as well as investigational drugs at various stages of clinical development, predicted to be efficacious in AD/ADRD. This initiative will also support preclinical testing of repurposable or investigational drug candidates in combination with non-pharmacologic interventions leading to robust translational outcomes. The central goal is to establish robust proof of concept that will enable rational drug repurposing and combination therapy development for the treatment and prevention of AD/ADRD.

The Fishing Safety Research Grant Program established by The Coast Guard Authorization Act of 2010 (P.L. 111-281), as amended by the Howard Coble Coast Guard and Maritime Transportation Act of 2014 (P.L. 113-281), is intended to provide funding to individuals in academia, members of non-profit organizations and businesses involved in fishing and maritime matters, and other persons with expertise in commercial fishing safety. The funding will be used to support research on improving the occupational safety of workers in the commercial fishing industry. This includes: improving vessel design; developing and improving emergency and survival equipment; enhancing vessel monitoring systems; improving communication devices, de-icing technology, and severe weather detection. In order to support and administer the grant program, the Coast Guard and NIOSH signed a Memorandum of Understanding on May 17, 2018. While the Coast Guard, along with the Occupational Safety and Health Administration (OSHA), provides regulatory oversight for safety and health matters within the commercial fishing industry, NIOSH is an agency operating under the Centers for Disease Control and Prevention (CDC) with the mission of generating new knowledge in occupational safety and health and transferring that knowledge into practice to prevent worker injury, illness and death. NIOSH conducts and funds scientific research, develops methods to prevent occupational hazards, develops guidance and authoritative recommendations, translates scientific knowledge into products and services, disseminates information, identifies factors underlying work-related disease and injury and responds to requests for workplace health hazard evaluations. NIOSH has an extensive history of conducting research to understand and to reduce hazards in the commercial fishing industry. This research has largely been conducted in close collaboration with crews, industry and the US Coast Guard. To learn more about NIOSH’s work in commercial fishing safety and health, visit https://www.cdc.gov/niosh/topics/fishing/default.html. Research objectives supported by NIOSH include, but are not limited to, the following: identification and investigation of the relationships between hazardous working conditions and associated occupational injuries and fatalities; development of more sensitive means of evaluating hazards at work sites; development of methods for measuring early markers of injuries and fatalities; development of new protective equipment and engineering control technology to reduce work-related injuries and fatalities; development of work practices that reduce the risks of occupational hazards; and evaluation of the technical feasibility or application of a new or improved occupational safety procedure, method, technique, or system, including assessment of economic and other factors that influence their diffusion and successful adoption in workplaces.

This funding opportunity announcement (FOA) encourages research grant applications to develop in vitro and/or ex vivo assays and conduct iterative screening efforts to identify and characterize potential therapeutic agents for neurological or neuromuscular disorders. This FOA is part of a suite of Innovation Grants to Nurture Initial Translational Efforts (IGNITE) to advance projects to the point where they can meet the entry criteria for the Blueprint Neurotherapeutics Network (BPN) or other translational programs.

The CTSA Collaborative and Innovative Acceleration Award (CCIA) aims to accelerate the pace of translational research by supporting the collaborative development, dissemination, and sustainable implementation of innovative solutions across the CTSA Program Consortium and beyond. This Notice of Funding Opportunity (NOFO) invites investigator-initiated applications to develop, demonstrate, and disseminate innovative new approaches, technologies, resources, or models that increase the impact of research across diseases, transform the field of translational science, and bring more treatments for all people more quickly.

This funding opportunity announcement (FOA) encourages the development and validation of animal models and human/animal tissue ex vivo systems that recapitulate the phenotypic and physiologic characteristics of a defined neurological or neuromuscular disorder. The goal of this FOA is to promote a significant improvement in the translational relevance of animal models or ex vivo systems that will be utilized to facilitate future development of neurotherapeutics. Ideally, models proposed for this FOA would have the potential to provide feasible and meaningful assessments of efficacy following therapeutic intervention that would be applicable in both preclinical and clinical settings. This FOA is part of a suite of Innovation Grants to Nurture Initial Translational Efforts (IGNITE) Program focused on enabling the exploratory and early stages of drug discovery.

The purpose of this Notice of Funding Opportunity (NOFO) is to encourage UG3/UH3 phased cooperative agreement research applications to plan and implement behavioral and social intervention clinical trials. Studies appropriate for this announcement include clinical trials to develop and test behavior change interventions related to dental, oral, or craniofacial conditions. Awards made under this FOA will initially support a milestone-driven planning phase (UG3) for up to 2 years, with possible transition to a clinical trial implementation phase (UH3) of up to five years. Only UG3 projects that have met the scientific milestones and feasibility requirements may transition to the UH3 phase. The UG3/UH3 application must be submitted as a single application, following the instructions described in this FOA. The UG3 phase will permit both scientific and operational planning activities. Scientific planning activities include small-scale data collection to assess the feasibility and/or acceptability of a planned behavioral or social intervention and associated study procedures (e.g., acceptability of study content or mode of delivery; feasibility of proposed data collection procedures; preliminary testing of intervention training and fidelity monitoring procedures). Operational planning activities include, at a minimum, development of: the final clinical protocol; the intervention manual or equivalent; the data management system and other tools for data and quality management, safety and operational oversight plans; recruitment and retention strategies; and other essential documents. The UH3 phase will support the conduct of investigator-initiated intervention research at all stages, from early mechanistic research and intervention development (e.g., Stages 0/ I) through implementation and cost-effectiveness research (Stages IV/V).

This Funding Opportunity Announcement (FOA) is intended to provide an avenue for basic scientists, clinicians and clinical scientists to jointly initiate and conduct translational research projects which translate basic research findings into clinical tools for better human health. The scope of this FOA includes a range of activities to encourage translation of basic research findings which will impact the diagnosis, treatment and prevention of communication disorders. Connection to the clinical condition must be clearly established and the outcomes of the grant must have practical clinical impact.

This Notice of Funding Opportunity Announcement (NOFO) invites R25 applications to support the development and implementation of research education programs for recent baccalaureates from all backgrounds, including those from groups underrepresented in the biomedical and behavioral sciences. It is essential to expand and broaden the skilled Alzheimers Disease (AD) and Alzheimers Disease and Related Dementias (ADRD) research workforce and provide exposure to AD/ADRD research to individuals early in their careers. The proposed research education programs will support intensive research experiences in the AD/ADRD field with the goal of preparing recent baccalaureates to transition into strong, research-focused advanced degree programs or competitive private sector research careers in AD-related disciplines.

The NIH INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Project seeks to improve health and quality-of-life for individuals with Down syndrome. The purpose of this Notice of Funding Opportunity (NOFO) is to solicit Transformative Research Award applications to support individual scientists or groups of scientists proposing groundbreaking, exceptionally innovative, original, and/or unconventional research that has the potential to create new scientific paradigms, establish entirely new and improved clinical approaches, or develop transformative technologies related to Down syndrome. Applications are welcome in all topics relevant to Down syndrome-related research or its co-occurring conditions. No preliminary data are required. Projects must clearly demonstrate, based on the strength of the logic, a compelling potential to produce a major impact in research related to Down syndrome.

This Notice of Funding Opportunity (NOFO) invites applications for innovative research on the factors that cause human behaviors and the oral-systemic health impacts of those behaviors to enhance health, lengthen life, and reduce illness and disability among people with chronic conditions. Causal hypotheses may include biological, biopsychosocial, congenital, environmental, interpersonal, neurological, psychological, and comorbidity factors that individually, sequentially, or in combination trigger human behaviors and oral-systemic health outcomes, with impacts that may be direct or traceably distal. Applications that propose projects to develop or refine causal hypotheses also are encouraged.

This Notice of Funding Opportunity (NOFO) will support, through the cooperative agreement mechanism, investigator-initiated observational studies or biomarker validation studies that require prospective collection of data/biospecimens or continued analysis of data/biospecimens.

The National Institute on Deafness and Other Communication Disorders (NIDCD), with the National Institute of Biomedical Imaging and Bioengineering (NIBIB) aims to support the development and/or adaptation of transformative in vivo high-resolution/high specificity imaging of the human olfactory system. Currently, there are limited non-invasive/minimally invasive technologies available for imaging the living human peripheral and central olfactory system with high spatial and temporal resolution. Imaging the olfactory system in the laboratory and in the clinic is essential to understanding underlying biological mechanisms as well as the etiology of an olfactory disorder. Such imaging has proven challenging due to the olfactory system"s unique anatomical and functional characteristics such as restricted accessibility, multiple cell types, and low signal resolution. Addressing these challenges requires multimodal approaches including leveraging existing advanced tools and technologies and developing new tools tailored for the olfactory system. Recent advances in minimally invasive and non-invasive imaging technologies, such as cell specific biomarkers, fluorescence imaging, specialized endoscopes, optical and acoustic imaging, molecular imaging, and hemodynamic and diffusion imaging have the potential to transform our ability to image and investigate the peripheral and central olfactory system in the living human with superior temporal and spatial resolution and eventually improve diagnostic accuracy of olfactory disorders. Applications must leverage advanced non-invasive/minimally invasive imaging technologies to visualize peripheral (e.g., olfactory- and non-olfactory epithelium) and central olfactory (e.g., olfactory bulb) targets at a level previously unattainable. In addition, projects should engage multidisciplinary teams combining expertise in olfaction, biomedical imaging, biochemistry, bioengineering, and biophysics, as appropriate.

The National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC), invites grant applications for Training Project Grants (TPGs) that are focused on occupational safety and health training. NIOSH is mandated to provide an adequate supply of qualified personnel to carry out the purposes of the Occupational Safety and Health Act, and the TPGs are one of the principal means for meeting this mandate. The majority of TPGs are in academic institutions that provide high quality undergraduate, graduate, and post graduate academic training in a variety of occupational safety and health (OSH) and allied disciplines. NIOSH also funds a limited number of non-academic TPGs to provide specialized training for target audiences and build or strengthen the Nation's OSH workforce capacity.

The National Cancer Institute's (NCI) Metastasis Research Network (MetNet) is a collection of U54 Research Centers that support using systems-level approaches to understand pressing questions in metastasis. The overall goal of the MetNet is to advance our understanding of metastasis as a whole body, systems-level problem to develop a comprehensive and cohesive picture of the processes involved. Through this Notice of Funding Opportunity (NOFO), the NCI invites applications for MetNet Research Projects. These Research Projects should be defined as discrete entities that use systems-level approaches to address gaps and opportunities in metastasis research to integrate into the MetNet and complement ongoing research across the Network.

The goal of the NHLBI Catalyze Program is to provide a comprehensive suite of support and services to facilitate the transition of basic science discoveries into viable diagnostic and therapeutic candidates that have been cleared for human testing, and to develop translational researchers fluent in product development and entrepreneurship. This specific Catalyze Enabling Technologies and Transformative Platforms initiative will support needed to rigorously validate transformative, multi-use platforms or technologies that can enable. Well-suited applications must offer the potential to significantly accelerate and/or transform the areas of early detection and screening, model development, clinical diagnosis, treatment, control, behavior, prevention or epidemiology. Proposed platforms and technologies may have widespread applicability but must be able to improve the outlook for HLBS-related diseases and disorders.

The purpose of this Notice of Funding Opportunity (NOFO) is tofurther elucidate the mechanisms of early immune development in utero, during the early post-natal period and during early childhood in neonates, infants, and children and adolescents with or without in-utero exposure to HIV or Anti-Retroviral Therapeutics (ART).This initiative aims to understand intricate mechanisms of immune cells at the maternal-fetal interface, T and B cell development and maturation in offspring, and local immune responses and the role of systemic immunity.

The purpose of the Research Enhancement Award Program (REAP) for Health Professional Schools and Graduate Schools is to support small scale research grants at institutions that do not receive substantial funding from the NIH, with an emphasis on providing biomedical research experiences primarily for health professional, undergraduate and graduate students and enhancing the research environment at applicant institutions.Eligible institutions must award baccalaureate or advanced science degrees and have received no more than $6 million dollars per year of NIH support (in both direct and F&A/indirect costs) in 4 of the last 7 fiscal years. For institutions composed of multiple schools and colleges, the $6 million funding limit is based on the amount of NIH funding received by all the schools and colleges within the institution as a whole.Help determining the Organization Funding Level can be found here or https://grants.nih.gov/grants/funding/r15.htmThis REAP Notice of Funding Opportunity (NOFO) supports investigator-initiated mechanistic and/or minimal risk clinical trials addressing the mission and research interests of the participating NIH institutes. For purposes of this NOFO, minimal risk clinical trials are defined as those that do not require FDA oversight, do not intend to formally establish efficacy, and have low risks to potentially cause physical or psychological harm.

The purpose of this Notice of Funding Opportunity (NOFO) is to solicit basic research applications to investigate the pathological mechanisms of skin injuries caused by toxic Chemicals of Concern (CoC) identified as public health threats by the United States Government. This NOFO supports the goal of the trans-NIH Chemical Countermeasures Research Program (CCRP) and is intended to spur the discovery and early development of broad-spectrum medical countermeasures (MCMs) to advance the nation's medical and public health preparedness for, response to, and recovery from high consequence chemical disasters and emergencies.

The National Library of Medicine (NLM) seeks applications for innovative research in clinical informatics. The overarching goal of this forthcoming program is to catalyze the development and advancement of novel informatics methodologies that empower clinicians, patients, and the broader public to better understand, manage, and improve health and health care delivery. This NOFO will support research focused on the design, implementation, and evaluation of clinical informatics tools and methods that enable data-driven discovery, promote evidence-based decision-making, and support personalized and precision health care. Emphasis will be placed on domain-independent, scalable, and reusable/reproducible approaches for the discovery, analysis, organization, and management of health-related digital objects—including electronic health records (EHRs), clinical notes, imaging data, and patient-generated data. The aim is to transform raw and heterogeneous health data into actionable knowledge, to develop innovative tools, and to implement practical applications that can be generalized across multiple clinical settings and populations. Projects should demonstrate the potential to accelerate scientific insights, improve clinical workflows, and ultimately lead to improved health outcomes.

The National Library of Medicine (NLM) seeks applications for research projects that drive groundbreaking innovation and advanced development in the fields of bioinformatics, translational bioinformatics, and computational biology. The primary goal of this initiative is to support the creation and implementation of cutting-edge methods, tools, and approaches that can transform the landscape of biomedical data science. This NOFO aims to address the growing need to leverage transformative technologies — such as artificial intelligence (AI), machine learning, and large-scale computational platforms — to extract actionable knowledge from vast, diverse, and complex biological datasets. By enabling more effective interpretation and integration of multi-dimensional biological and biomedical data, this research will ultimately contribute to improving individual and population health outcomes.

This Notice of Funding Opportunity (NOFO) solicits applications for the development of enabling informatics technologies to improve the acquisition, management, analysis, and dissemination of data and knowledge across the cancer research continuum including cancer biology, cancer treatment and diagnosis, early cancer detection, risk assessment and prevention, cancer control and epidemiology. As a component of the NCI's Informatics Technology for Cancer Research (ITCR) Program, this NOFO is focused on early-stage development from prototyping to initial dissemination. Early-stage development is defined for the purpose of this NOFO as initial tool development or the significant modification of existing tools for new applications. The central mission of ITCR is to promote research-driven informatics technology across the development lifecycle to address priority needs in cancer research. In order to be successful, proposed development plans must have a clear rationale for why the proposed technology is needed and how it will benefit the cancer research field. In addition, mechanisms to solicit feedback from driving research projects and other users throughout the development process must be included.This NOFO encourages applications that involve the development of new, user-friendly informatics technologies that support a wide range of cancer research, including discovery biology, population studies, as well as clinical and translational research. The emphasis is on uniqueness and potential impact on cancer research. In addition, all projects proposed in response to this NOFO must involve the following general attributes:Potential to advance driving cancer research projects and the cancer research field in generalNovel informatics capabilities for the targeted cancer research domainCompelling plans and processes for engaging end users to evaluate and apply the tool or resourceA realistic timeline and milestones for technology development

The purpose of this Notice of Funding Opportunity (NOFO) is to solicit UG3/UH3 phased, cooperative agreement research applications to evaluate, implement, and/or test population-based interventions to policies, programs, and/or practices for promoting integration of services, systems, and/or values by leveraging cross-sector partnerships in communities. Such interventions must address social and chronic disease common risk factors and/or barriers driving oral disease burden in communities. Projects funded through this funding opportunity and a separately funded Community Engagement Evaluation and Data Coordination hub (CEED) will form a Community-Based Participatory Research (CBPR) consortium: Advancing Data and Practice Transformation (ADAPT), which will receive consultative services from the NIH Community Engagement Alliance Consultative Resource (CEACR) and join in the Science Collaborative for Health and Artificial Intelligence Reduction of Errors (SCHARE) platform for the overarching goal of promoting data use and transformational community engagement to optimize oral health for all people across the lifespan.

The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The overarching goal of this R25 program is to support educational activities that help recruit individuals with specific specialty or disciplinary backgrounds to research careers in biomedical, behavioral and clinical sciences.

The Instrumentation Grant Program for Resource-Limited Institutions supports the purchase of state-of-the-art scientific instruments to enhance the research and educational missions of resource-limited institutions. Requested instruments may support biomedical research and education in basic, translational, biomedically-related behavioral or clinical fields. This is a Notice of Funding Opportunity (NOFO) for a Limited Competition that will invite application(s) from eligible organization(s) to apply. Please see Section III. Eligibility for additional information. In accordance with NIH standard peer-review processes, the application(s) will be peer-reviewed, and only meritorious application(s) will be considered.

The purpose of this Notice of Funding Announcement (NOFO) is to encourage pilot research that is not an immediate precursor to testing a service intervention but is consistent with NIMH priorities for services research. While NIMH now requires use of an experimental therapeutics model for all intervention studies, there is recognition that some mission-relevant areas of services research do not involve clinical trials.

Reissue of RFA-20-351.The purpose of this Notice of Funding Opportunity (NOFO) is to encourage applications to pursue invasive neural recording studies focused on mental health-relevant questions. Invasive neural recordings provide an unparalleled window into the human brain to explore the neural circuitry and neural dynamics underlying complex moods, emotions, cognitive functions, and behaviors with high spatial and temporal resolution. Additionally, the ability to stimulate, via the same electrodes, allows for direct causal tests by modulating network dynamics. This funding opportunity aims to target a gap in the scientific knowledge of neural circuit function related to mental health disorders. Researchers should target specific questions suited to invasive recording modalities that have high translational potential. Development of new technologies and therapies are outside the scope of this NOFO.

The purpose of this Funding Opportunity is to address the needs of the maternal and pediatric HIV scientific community for research data translation and sharing.This initiative will support secondary data analyses using archived HIV/AIDS data and specimens. The goal of this initiative is to encourage the scientific community to utilize HIV/AIDS archived data sets and specimen collections to answer important questions about the epidemiology, pathogenesis, treatment, clinical manifestations, and HIV-associated co-infections and co-morbidities in maternal, pediatric and adolescent populations.

The NIH INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Project seeks to improve health and quality-of-life for individuals with Down syndrome. This Notice of Funding Opportunity (NOFO) invites researchers to submit applications for support of new exploratory and developmental research projects that address critical needs for Down syndrome projects, as articulated in the INCLUDE Project objectives. For example, such projects could assess the feasibility of a novel area of investigation or a new experimental system that has the potential to enhance health-related research. Another example could include the unique and innovative use of an existing methodology to explore a new scientific area. These studies may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel techniques, agents, methodologies, models, or applications that could have a major impact on a field of biomedical, behavioral, or clinical research.

This FOA encourages research relevant to the development of novel screening approaches and/or therapeutic interventions for potentially fatal or disabling conditions that have been identified through newborn screening, as well as for "high priority" genetic conditions where screening may be possible in the near future.Having an accurate screening test, as well as demonstrating the benefits of early intervention or treatment, are important criteria for including a condition on a newborn screening panel. This FOA defines a "high priority" condition as one where screening is not currently recommended, but infants with the condition would significantly benefit from early identification and treatment.

This Notice of Funding Opportunity (NOFO) invites R25 applications to support the development and implementation of summer research education programs for high school students, undergraduates, or science teachers from all backgrounds, including those from groups underrepresented in the biomedical and behavioral sciences. It is essential to expand and broaden the skilled Alzheimer's Disease (AD) and Alzheimers Disease Related Dementias (ADRD) research workforce and provide exposure to AD/ADRD research to individuals early in their careers. The proposed research education programs will support intensive summer research experiences in the AD/ADRD field with the goal of exposing participants to AD/ADRD research and encourage further study or participation in biomedical and behavioral research. This NOFO does not allow participants to lead an independent clinical trial, but does allow them to obtain research experience in a clinical trial led by a mentor or co-mentor.

This notice of funding opportunity (NOFO) encourages innovative research to develop, improve, characterize, and preserve animal models as well as animal model related biological materials, technologies, and new approach methodologies (NAMs) for studies relevant to human health and disease. This NOFO also seeks projects aimed at improving the diagnosis and control of diseases that could confound or interfere with animal use in biomedical research. The proposed project must have broad applicability to multiple NIH Institutes or Centers (ICs) to align with the NIH-wide mission of the Office of Research Infrastructure Programs (ORIP). The proposed studies must include animal models and explore multiple body systems or multiple categories of diseases. Applications that develop models focused on a specific disease or area of research, or only propose studies primarily relevant to a single NIH IC, will be considered not acceptable to this NOFO and will be withdrawn.

The NEI supports large-scale clinical vision research projects, including randomized clinical trials and epidemiologic studies on eye/vision conditions. At the time of submission, applications requesting support for these activities are expected to provide detailed information regarding the study rationale, design, analytic methods, protocols and procedures, facilities and environment, organizational structure, and collaborative arrangements. This information is best conveyed in a study protocol and Manual of Procedures (MOP), the development of which represents a costly and time-consuming activity. This clinical research planning grant funding opportunity supports applicants in their planning efforts to conduct collaborative clinical research. The grant may be used to support the development of a study protocol and MOP, as well as to conduct preliminary studies to refine study procedures or document recruitment potential. The grant must not be used to generate data on the effects of a proposed intervention. This NEI NOFO is applicable to both epidemiologic and clinical trial research studies.

The purpose of the NIAID Career Transition Award program is to assist postdoctoral fellows' transition to positions of assistant professor or equivalent and initiate a successful biomedical career as an independent research scientist.

The purpose of this notice of funding opportunity (NOFO) is to solicit applications for pilot projects to elucidate a role for understudied proteins in rare disease. Awards will support generation of preliminary data and/or tools around eligible understudied protein(s). A list of eligible proteins is provided and are members of druggable protein families that have a known association with a rare disease. This NOFO is intended to jumpstart research on understudied proteins that are associated with rare diseases and provide applicants with sufficient funding to perform basic biochemical and/or biological work to further the characterization of understudied proteins within the context of rare disease.

The NICHD Small Research Grant Program (Clinical Trial Required) supports clinical trials that fall within the NICHD mission.

This NOFO seeks to advance research and training in high-priority areas of child health by stimulating the use of Environmental Influences on Child Health Outcomes (ECHO) Cohort data by postdoctoral fellows from relevant scientific disciplines. This RFA will provide opportunities for fellows to study child health outcomes through the analysis of ECHO's large longitudinal data sets within the NICHD Data and Specimen Hub (DASH) repository. ECHO's DASH dataset integrates de-identified longitudinal data from more than 71,000 participants across the U.S. Prenatal and child exposure data include physical, chemical, social, behavioral, and biological factors. ECHO's five primary pediatric outcome areas are pre-, peri-, and postnatal outcomes, upper and lower airway, obesity, neurodevelopment, and positive health.

This NOFO encourages applications for multi-site exploratory and confirmatory clinical trials focused on promising interventions; biomarker or outcome measure validation studies that are immediately preparatory to trials in stroke prevention, treatment, and recovery; and ancillary studies designed to add scientific aims to active studies being conducted within StrokeNet. Successful applicants will collaborate and conduct the study within the NIH StrokeNet. Following peer review, NINDS will prioritize studies among the highest scoring to be conducted in the NIH StrokeNet infrastructure. The NIH StrokeNet National Coordinating Center (NCC) will work with the successful applicant to implement the proposed study efficiently and the National Data Management Center (NDMC) will provide statistical and data management support. The NIH StrokeNet Regional Coordinating Centers (RCCs) and their affiliated clinical sites will provide recruitment/retention support as well as on-site implementation of the clinical protocol.

The purpose of this Notice of Funding Opportunity (NOFO) is to invite applications that bundle independent protocols for phase 1 clinical trials with phase 1b/phase 2a clinical trials to streamline the early-stage evaluation of promising pharmacological interventions for Alzheimer's disease (AD) and Alzheimer's disease-related Dementias (ADRD). Candidate interventions evaluated through this program, which can include small molecules or biologics for example, must engage non-amyloid/non-tau mechanisms and aim to address cognitive and/or neuropsychiatric symptoms in individuals across the spectrum from pre-symptomatic to more severe stages of disease. This NOFO uses the UG3/UH3 phased award mechanism and proposals must include prespecified, go/no-go safety and tolerability milestones that gate the advance from phase 1 to latter stages of clinical development.

The goal of this notice of funding opportunity (NOFO) is to support feasibility trials of complementary and integrative health approaches with physical and/or psychological therapeutic inputs (often called mind and body interventions) for conditions that have been identified by NCCIH as high-priority research topics. This funding opportunity is intended to support feasibility clinical trials that provide new information that are scientifically necessary for the planning and conduct of a subsequent clinical efficacy or effectiveness study, pragmatic trial, or dissemination and implementation trial within NCCIHs mission. NCCIH expects that applications to this NOFO will describe the planned future clinical trial and in so doing demonstrate that the proposed (R34) research is scientifically necessary to design or plan the subsequent competitive full-scale clinical trial. Under this R34, the data collected should be used to fill gaps in scientific knowledge necessary to develop a competitive full-scale clinical trial, including, but not limited to the following: examining feasibility and acceptability of interventions lacking published data; tailoring or adapting the content or structure of an intervention to a specific population, modality, or setting; refining the intervention to determine the most appropriate frequency or duration; determining feasibility of recruitment, retention, and data collection procedures; refining and assessing the feasibility of protocolized multi-component interventions; or examining acceptability and adherence of control conditions. The subsequent full-scale clinical trial should have the potential to make a significant impact on public health. Prior to submitting to this NOFO, applicants are encouraged to contact the appropriate NCCIH Scientific/Research contact person for the science area of the planned application.

The purpose of this Notice of Funding Opportunity (NOFO) is to solicit applications for the conduct of scientific research utilizing data from expanded access (EA) for investigational drugs or biological products as described in section 561 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb). These applications will target intermediate size populations of patients living with amyotrophic lateral sclerosis (ALS) who are not eligible for ongoing clinical trials for the prevention, diagnosis, mitigation, treatment, or cure of ALS.

This Notice of Funding Opportunity (NOFO) encourages applications for investigator-initiated mid-phase clinical trials of natural products(i.e., botanicals, dietary supplements, and probiotics), which have a strong scientific premise to justify further clinical testing. For this NOFO, natural products include promising nutritional regimens that standardize the amount of a specific naturally occurring nutritional compound (e.g., omega-3 fatty acids, anthocyanidins, or polyphenols) and have compelling preliminary evidence. All applications submitted under this NOFO must be supported by sufficient preliminary data demonstrating bioavailability (if applicable) and documentation that the natural product produces a reproducible and measurable impact on target engagement (i.e., measure of the mechanism of action). Only in cases when it is not possible/practical to measure target engagement in the patient population of interest or when there is a fundamental understanding of the products mechanism of action will this preliminary data requirement be waived. Applications submitted to this NOFO should propose a mid-phase clinical trial to do the following: determine the optimal dose or formulation of a given natural product for use in a future multi-site efficacy trial; or determine which patient phenotypes will be responders versus non-responders to the natural product to inform inclusion/exclusion criteria of a future efficacy trial. Clinical trials submitted under this NOFO are expected to be hypothesis based, milestone-driven, and directly related to the research priorities and mission of NCCIH. This NOFO will not support single-site or multi-site efficacy or effectiveness trials, nor will it support trials to test natural products for the treatment or prevention of cancer. Applicants are encouraged to contact the appropriate NCCIH Scientific/Research contact for the area of science for which they are planning to develop an application prior to submitting to this NO

This Notice of Funding Opportunity (NOFO) encourages applications for investigator-initiated fully remotely delivered and conducted clinical trials to assess the efficacy or effectiveness of complementary and integrative health interventions in NCCIH- designated areas of high research priority. Applications submitted under this NOFO are expected to propose a remotely delivered and conducted fully powered clinical trial with no in-person contact between research staff and study participants and may utilize mHealth tools or technologies. Applicants must provide justification for the remotely delivered approach and provide preliminary data on the feasibility and safety of the approach, along with evidence that the intervention has promise of clinical benefit. Applicants are encouraged to contact the appropriate NCCIH Scientific/Research contact for the area of science for which they are planning to develop an application prior to submitting to this NOFO.

This Notice of Funding Opportunity (NOFO) focuses on prevention and intervention strategies for fetal alcohol spectrum disorders (FASD) throughout the lifespan. The intent of this NOFO is to support research that advances (1) prevention approaches to reduce prenatal alcohol exposure and the incidence of FASD and that (2) interventions for FASD. These objectives will be accomplished with the Exploratory/Developmental Phased Award (R61/R33) mechanism, clinical trial optional. The R61 phase will support pilot studies or secondary data analysis for hypothesis development and feasibility, and research testing the hypotheses can be expanded in the R33 phase. The transition to the R33 phase will be determined by NIAAA program staff after evaluation of the achievement of specific milestones set for the R61 phase. Highest priority will be given to applications with clinical trials. Applicants interested in planning clinical trials or adding to current projects may also consider NOFO (TEMP-23832, the R34 option).

This Notice of Funding Opportunity (NOFO) announces the renewal of the NIH Research Evaluation and Commercialization Hub (REACH) program, established to facilitate and accelerate the translation of academic biomedical discoveries into products that improve patient care and public health. Through this program, NIH will provide the qualifying institutions with the funds to seed the creation of academic entrepreneurship Hubs. Hubs will be responsible for providing innovators with both the initial investment and resources to support the proof-of-concept work and the mentorship in product development and commercialization needed to develop high priority technologies within the NIH's mission. Funded Hubs are intended to work as a consortium to enable: (1) the infrastructure for identifying the most promising technologies, (2) funding for product definition studies (e.g. feasibility studies, prototype development, proof-of-concept studies) provided to individual researchers, (3) access to resources and expertise in areas required for early stage technology development (including scientific, regulatory, reimbursement, business, legal, and project management), and (4) skills development and hands-on experience in entrepreneurship. Establishing public-private partnerships and providing additional non-federal funds will be critical for success. This is a Notice of Funding Opportunity (NOFO) for a Limited Competition that will invite applications from eligible organizations to apply. Please see Section III. Eligibility for additional information. In accordance with NIH standard peer-review processes, the application(s) will be peer-reviewed, and only meritorious application(s) will be considered for funding.

This Clinical Observational (CO) Studies in Musculoskeletal, Rheumatic, and Skin Diseases (R01 Clinical Trial Not Allowed) PAR, was re-issued as a result of the Simplifying Review of Research Project Grant Applications [link: https://grants.nih.gov/policy-and-compliance/policy-topics/peer-review/simplifying-review]. The Simplified Review changes in Section V are the only changes that have been made. All other aspects of this funding opportunity remain the same.

This Exploratory Clinical Trial Grants in Arthritis and Musculoskeletal and Skin Diseases (R61 Clinical Trial Required) PAR, a re-issue of PAR-24-035, was re-issued as a result of the Simplifying Review of Research Project Grant Applications [link: https://grants.nih.gov/policy-and-compliance/policy-topics/peer-review/simplifying-review]. The Simplify Review changes in Section V are the only changes that have been made. All other aspects of this funding opportunity remain the same.

As part of the Gabriella Miller Kids First Pediatric Research Program (Kids First Program), the NIH invites applications to submit samples from pediatric cohorts for whole genome sequencing at a Kids First Program supported genomic data generating centers. Applicants are encouraged to propose sequencing of existing pediatric cancer or congenital anomaly cohorts to elucidate the genetic contribution (somatic and/or germline) to childhood cancers, to investigate the genetic etiology of congenital anomalies, to study the molecular basis of the associations between congenital anomalies and increased cancer risk, or to expand the range of pediatric disorders included within the Kids First Data Resource. The program will accept applications that propose whole genome, exome, and transcriptome sequencing, as well as clinical-grade sequencing, long-read sequencing, proteomics, and epigenomic assays of tumor or affected tissue, when justified. Applicants are encouraged to propose cohorts to increase representation of existing Kids First Program projects. These data, and associated clinical and phenotypic data, will become part of the Kids First Data Resource Center for sharing with the research community.

The objective of this funding opportunity is to support investigator-initiated, Phase I clinical trials for diagnostic and therapeutic interventions for heart, lung, blood, and sleep (HLBS) disorders in adults and children. In addition to supporting clinical trial start-up and implementation activities, this FOA will provide support for final stage preclinical activities needed for the implementation of the proposed trial. All the activities proposed in the R61 phase must be directly related to the therapeutic/diagnostic in preparation for the clinical trial. The proposed trial can be single or multisite. This NOFO will utilize a bi-phasic, milestone-driven mechanism of award where the first phase can be used to finalize required pre-trial activities such as stability, shipping studies, and site training.

This Notice of Funding Opportunity (NOFO) for R34 planning grant applications focuses on prevention and intervention strategies for fetal alcohol spectrum disorders (FASD) throughout the lifespan. The intent of this NOFO is to support research that advances (1) prevention approaches to reduce prenatal alcohol exposure and incidence of FASD and (2) interventions for FASD. It is expected that research conducted via this mechanism will consist of studies that are a pre-requisite for preparing and submitting subsequent applications for larger scale FASD prevention or intervention studies. Applicants interested in exploratory phased projects may consider NOFO (TEMP-23833, the R61/R33 option).

This Notice of Funding Opportunity Announcement (NOFO) intends to supports studies that are both necessary and sufficient to inform the planning of a Phase II-IV clinical trial within NHLBI's mission. The NHLBI expects that applications to this NOFO will describe the planned clinical trial and in so doing demonstrate that the proposed (R34) research is scientifically necessary to design or plan the subsequent trial. Furthermore, this NOFO will support research projects that are designed to provide results that will be sufficient to inform the future trial without further studies. The planned Phase II, III, or IV trial must be primarily intended to test the efficacy, safety, clinical management, or implementation of intervention(s) in the prevention and/or treatment of heart, lung, blood, and sleep disorders. In contrast to the study start up or preparation phase of NHLBI funding opportunities for clinical trials (as described at https://www.nhlbi.nih.gov/grants-and-training/funding-opportunities-and-contacts/clinical-trials-optimization), the R34 mechanism is intended to provide new information that answers a scientific or operational question(s) which may be pragmatic in nature and, therefore, informs the final development of a Phase II-IV clinical trial. Regardless of the results of the R34, support of the proposed future clinical trial will require a new application.

This NOFO is a call to action in response to the mental health crisis in the United States. We seek applications that will study methods to increase access to evidence-based interventions and services for youth mental health, including those living in rural areas, inner cities, and other under-resourced areas, and youth experiencing housing and food insecurities and out-right homelessness. Applications should address research related to optimizing assessment, intervention and service strategies, overcoming challenges related to the workforce shortage, wait lists for treatment, integration of treatment and preventive interventions into settings where people are most likely to be best identified as needing care (eg: schools, social service, pediatric medicine and justice), and service interventions that address systemic barriers to access and quality of mental health care (structural, policy, organizational, value (cost/financing), management).

NIMH seeks applications for pilot research to adapt, optimize, and test behavioral interventions that address common sleep problems in adolescents and young adults with or at risk for a mental health disorder. This notice of funding opportunity (NOFO) supports pilot clinical trials designed to evaluate the feasibility, tolerability, acceptability, safety, and potential effectiveness of the approach in real world settings. Applications should aim to conduct a preliminary test of the intervention's impact on sleep and mental health outcomes, as well as an examination of the mechanisms that underlie the intervention's effectiveness, and to obtain preliminary data needed as a prerequisite for larger-scale effectiveness trials. In addition, interdisciplinary, collaborative teams of investigators from the fields of mental health, sleep medicine, developmental science, clinical trials research methods, behavioral economics, implementation science, data science, and human computer interaction are encouraged.

The purpose of this Notice of Funding Opportunity (NOFO) is to seek applications for a Community Engagement Evaluation and Data coordination hub (CEED) for the Community-Based Participatory Research (CBPR) consortium: Advancing Data and Practice Transformation (ADAPT) for Optimizing Oral Health for All. In addition to CEED, the ADAPT consortium will include separately funded CBPR projects, which will receive consultative services from the NIH Community Engagement Alliance Consultative Resource (CEACR) and join in the Science Collaborative for Health and Artificial Intelligence Reduction of Errors (SCHARE) platform for the overarching goal of promoting data use and transformational community engagement to optimize oral health for all people. The CEED hub will coordinate communications and various activities in support of CBPR projects and consortium functions in three domains:1) Data Planning, Consultation, and Technical Assistance for Research Methodology and Analytics; 2) Community Engagement Evaluation; and 3) ADAPT Infrastructure and Operational Support.

This Notice of Funding Opportunity (NOFO) is for support of National Centers for Cryoelectron Tomography (CryoET) to provide nationwide access to advanced cryoET instrumentation and technical support, and to assist investigators in acquiring the skills needed to perform cryoET studies.

The goal of the Medical Scientist Training Program (MSTP) is to develop a broad pool of highly trained physician-scientist leaders available to meet the needs of the Nations biomedical research agenda. Specifically, this Notice of Funding Opportunity (NOFO) provides support to eligible domestic institutions to develop and implement effective, evidence-based approaches to integrated dual-degree training leading to the award of both professional medical doctorate degrees and research doctorate degrees (Ph.D. or equivalent). With the dual qualification of rigorous scientific research and clinical practice, graduates will be equipped with the skills to develop research programs that accelerate the translation of research advances to the understanding, detection, treatment and prevention of human disease, and to lead the advancement of biomedical research. Areas of particular importance to NIGMS are the iterative optimization of MSTP training efficacy and efficiency, and fostering the persistence of MSTP alumni in research careers. NIGMS expects that the proposed research training programs will incorporate didactic, research, mentoring and career development elements to prepare trainees for careers that will have a significant impact on the health-related research needs of the Nation.

The purpose of this Notice of Funding Opportunity (NOFO) 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 or Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) 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 NOFO 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 the Tribal Undergraduate to Graduate Research Training and Leadership Experiences (TURTLE) program is to fund federally recognized American Indian/Alaska Native (AI/AN) Tribes, tribal colleges or universities, Tribal health programs, or Tribal organizations (collectively termed, eligible Tribal Entities) to identify and develop a pool of scientists to conduct research on AI/AN health and health disparities. Through this Notice of Funding Opportunity (NOFO), NIGMS will provide support for a phased award to eligible AI/AN Tribal Entities to develop (UE5) and implement (T34) effective training and mentoring activities for research-oriented individuals earning a bachelor's degree in a biomedically-relevant field at a variety of institutions across the United States and territories. The overall purpose is to support the development of individuals who have the technical, operational, and professional skills required to conduct AI/AN health research in a culturally appropriate, ethically responsible and rigorous manner, to complete a bachelor's degree in a biomedical field, and ultimately to transition into careers in the biomedical research workforce.

Since 1990, CDC's Division of Cancer Prevention and Control (DCPC) has been working with national organizations, state, territory, freely associated state, and tribal health agencies, and other key groups to develop, implement, and promote effective strategies for preventing and controlling cancer. DCPC's overall mission is to work toward having all people free of cancer while improving health outcomes through prevention, screening, and ongoing care for cancer survivors. DCPC supports comprehensive cancer control, a philosophical approach that brings together partners and other organizations to collectively address a community's cancer burden in a much more impactful way than any one organization could accomplish alone. This NOFO will fund eligible applicants to facilitate collaborative planning and implementation of evidence-based cancer surveillance, prevention, and control strategies in communities that improve the provision of clinical preventive services, and cancer survivorship. Ultimately, a successful implementation of the work described in this NOFO will demonstrate that by the three programs working together through partnerships, coordination of resources and efforts, consistent communication, and community involvement, we will come that much closer to the division's mission of "All People Free of Cancer." This program takes a comprehensive, coordinated approach to achieve these goals. It supports breast and cervical cancer screening and diagnostic services, cancer control plan implementation by coalitions, and surveillance programs to monitor and report cancer burden. These goals will be accomplished by funding three national programs: Program 1: National Breast and Cervical Cancer Early Detection Program (NBCCEDP) supports clinical services for women with low incomes who do not have adequate insurance and implementation of evidence-based interventions in the clinics that serve them. Component A: Supports breast and cervical cancer screening and diagnostic follow-up for women with low incomes who do not have adequate insurance. Component B: (Optional) Supports implementation of evidence-based interventions (EBIs) shown to increase breast and cervical cancer screening. Program 2: National Comprehensive Cancer Control Program (NCCCP) supports cancer coalition efforts that use their individual and collective resources to plan and implement evidence-based strategies as described in jurisdiction-wide cancer plans. Program 3: National Program of Cancer Registries (NPCR) supports the implementation of a population-based central cancer registry program.

The purpose of the Tribal Undergraduate to Graduate Research Training and Leadership Experiences (TURTLE) program is to fund federally recognized American Indian/Alaska Native (AI/AN) Tribes, tribal colleges or universities, Tribal health programs, or Tribal organizations (collectively termed, eligible Tribal Entities) to identify and develop a pool of scientists to conduct research on AI/AN health and health disparities. Through this Notice of Funding Opportunity (NOFO), NIGMS will provide support for a phased award to eligible AI/AN Tribal Entities to develop (UE5) and implement (T32) effective training and mentoring activities for research-oriented individuals earning a doctoral degree in a biomedical research field at a variety of institutions across the United States and territories. The overall purpose is to support the development of individuals who have the technical, operational, and professional skills required to conduct AI/AN health research in a culturally appropriate, ethically responsible and rigorous manner, to complete Ph.D.s in a biomedical field, and to transition into careers in the biomedical research workforce.

This NIAMS Clinical Trial Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required) PAR, a re-issue of PAR-24-208, was re-issued as a result of the Simplifying Review of Research Project Grant Applications [link: https://grants.nih.gov/policy-and-compliance/policy-topics/peer-review/simplifying-review]. The Simplified Review changes in Section V. Application Review Information of the funding opportunity are the only changes that have been made. All other aspects of this funding opportunity remain the same.

The purpose of this Notice of Funding Opportunity (NOFO) is to support investigators who have the interest and capability to join efforts for the discovery of in vivo chemical probes for novel brain targets. It is expected that applicants will have, in hand, the starting compounds (validated hits) for chemical optimization and bioassays for testing new analog compounds.Through this NOFO, NIH wishes to stimulate research in:Discovery and development of novel, small molecules for their potential use in understanding biological processes relevant to the missions of National Institute of Mental Health (NIMH), National Institute on Drug Abuse (NIDA), National Eye Institute (NEI), and/or National Institute on Aging (NIA) andDiscovery and/or validation of novel, biological targets that will inform studies of brain disease mechanisms.Emphasis will be placed on projects that provide new insight into important disease-related biological targets and biological processes.

This Funding Opportunity Announcement is intended to identify and support research projects by exceptionally promising Early Stage Investigators with a long-term career interest in pursuing innovative research in genomics. This opportunity is open to research in all areas relevant to the mission of NHGRI, including genomic sciences, genomic medicine, genomic data science, and ethical, legal, and social implications of genomics.

The purpose of this Program Announcement with Special Receipt, Referral, and/or Review Considerations (PAR) is to solicit applications to access stored blood plasma, blood serum, and extracted DNA from the All of Us Research Program supported Biobank to advance the program's mission of accelerating health research and medical breakthroughs, enabling individualized prevention, treatment, and care for all of us.All of Us partnered research studies are collaborative initiatives funded by a study sponsor external to All of Us to collect and add new data to the All of Us Researcher Workbench in accordance with All of Us" best practices. All of Us partnered research studies are open to the broad scientific community and require investigators to apply for and receive an X01 award under this announcement.This will enable longitudinal follow‐up and repeat sampling, and provide multiomic data (genomics, proteomics, metabolomics, and other high‐dimensional molecular profiles), integrated clinical, environmental, and life‐course data, infrastructure designed to support future clinical‐trial recruitment, and public‐private partnership pathways.This opportunity will enable researchers to conduct assays to evaluate associations between newly collected and existing All of Us data and add new data to the All of Us dataset for broad use by the research community. High-priority areas for biospecimen analyses may include, but are not limited to, large scale projects that propose integrated multiomics analyses, early disease detection, biomarker discovery or validation, novel risk models for incident disease, and/or novel disease stratification for chronic disease risk, diagnosis, and prognosis, in support of advancing precision medicine. For more information, please visit the All of Us X01 Partnered Research Studies Resource webpage.

The purpose of the NHLBI Outstanding Investigator Award (OIA) is to promote scientific productivity and innovation by providing long-term support and increased flexibility to experienced Program Directors/Principal Investigators (PDs/PIs) who are currently PDs/PIs on at least two NHLBI R01-equivalent awards and whose outstanding record of research demonstrates their ability to make major contributions to heart, lung, blood and sleep (HLBS) research. The OIA is intended to support a research program, rather than a research project, by providing the primary and most likely sole source of NHLBI funding on individual grant awards. The OIA will support the research program of NHLBI-funded investigators for up to seven years. The OIA will provide investigators increased freedom to conduct research that breaks new ground or extends previous discoveries in new directions. It will also allow PDs/PIs to take greater risks and to pursue research that requires a longer timeframe. Research supported by the OIA must be within the scope of the NHLBI mission (https://www.nhlbi.nih.gov/about/mission-statement). It is anticipated that the OIA will: Provide a stable funding environment, thereby improving productivity and facilitating nimble, ambitious, creative research; Accelerate scientific innovation by enabling flexibility in pursuing new research directions as they arise, since PDs/PIs will not be bound to specific aims proposed in advance of the studies; Reduce the time researchers spend writing grant applications and managing multiple grant awards, thereby allowing more time to be devoted to conducting research; Facilitate commitment of PDs/PIs to research through increased stability of funding; and Enable PDs/PIs to devote more time and energy to mentoring students and junior scientists and providing scientific service.

The purpose of the NHLBI Emerging Investigator Award (EIA) is to promote scientific productivity and innovation by providing long-term support and increased flexibility to experienced Program Directors/Principal Investigators (PDs/PIs) who are currently PDs/PIs on at least two NHLBI R01-equivalent awards and whose outstanding record of research demonstrates their ability to make major contributions to heart, lung, blood and sleep (HLBS) research. The EIA is intended to support a research program, rather than a research project, by providing the primary and most likely sole source of NHLBI funding on individual grant awards. The EIA will support the research program of NHLBI-funded investigators for up to seven years. The EIA will provide investigators increased freedom to conduct research that breaks new ground or extends previous discoveries in new directions. It will also allow PDs/PIs to take greater risks and to pursue research that requires a longer timeframe. Research supported by the EIA must be within the scope of the NHLBI mission (http://www.nhlbi.nih.gov/about/org/mission).

The purpose of the NIDCD Research Career Enhancement Award for Established Investigators (K18) program is to enable established, proven investigators to augment or redirect their research programs through the acquisition of new research skills to answer questions relevant to the hearing, balance, smell, taste, voice, speech and language sciences.

The purpose of the NIDCD Mentored Career Development Award for Postdoctorate Au.D./Ph.D. Audiologists (K01) is to support comprehensive and rigorous postdoctoral research and career development experiences in the biomedical, behavioral, or clinical sciences of promising Au.D./Ph.D. audiologists who have the potential to become productive, independent investigators in scientific health-related research fields relevant to NIDCD's mission.

The purpose of the NIDCD Mentored Career Development Award for Postdoctorate Au.D./Ph.D. Audiologists (K01) is to support comprehensive and rigorous postdoctoral research and career development experiences in the biomedical, behavioral, or clinical sciences of promising Au.D./Ph.D. audiologists who have the potential to become productive, independent investigators in scientific health-related research fields relevant to NIDCD's mission.

The purpose of the NIDCD Research Career Enhancement Award for Established Investigators (K18) program is to enable established, proven investigators to augment or redirect their research programs through the acquisition of new research skills to answer questions relevant to the hearing, balance, smell, taste, voice, speech and language sciences.

The Maximizing Investigators' Research Award (MIRA) for Early Stage Investigators (ESIs) provides support for ESIs with a program of research that aligns with the NIGMS mission.MIRA distributes funding among promising investigators across the country. The goal is to boost scientific productivity and the chances for important breakthroughs.Through this program, investigators can:Receive independent research funding early to start and sustain strong research careers.Explore new, unique research areas in the NIGMS mission.Take on ambitious, creative projects.Shift focus to include emerging techniques and technologies as needed.Devote more time to mentoring trainees in a stable research environment.

The NIH INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Project seeks to improve health and quality-of-life for individuals with Down syndrome. The purpose of this Notice of Funding Opportunity (NOFO) encourages Exploratory/Developmental Phased Innovation (R61/R33) grant applications to support development of clinical trials to treat critical and co-occurring health conditions in individuals with Down syndrome. The proposed research aims should be milestone-driven. The total project period for an application submitted in response to this NOFO may not exceed five years. This NOFO provides support for up to two years (R61 phase) for preliminary/developmental/planning studies, followed by possible transition to clinical trial support (R33) of up to three years, although the total duration of the award may not exceed five years. This NOFO requires measurable R61 milestones.

The Institutional Development Award (IDeA) program supports biomedical research capacity building in states that have historically received low levels of NIH funding. The Centers of Biomedical Research Excellence: Expansion/Sustainability Phases (COBRE-E/S) Notice of Funding Opportunity (NOFO) supports the expansion and sustainability of biomedical research centers in IDeA-eligible institutions. These centers will focus on building research capacity in broad scientific areas of strategic importance for the institutions. The goal of COBRE-E is to expand research capacity by growing the institutional faculty base and supporting research projects and core facilities in the new area. The objective of COBRE-S is to sustain the infrastructure by continuing the growth of the faculty base and consolidating research cores. This is a Notice of Funding Opportunity (NOFO) for a Limited Competition that will invite application(s) from eligible organization(s) to apply. Please see Section III. Eligibility for additional information. In accordance with NIH standard peer-review processes, the application(s) will be peer-reviewed, and only meritorious application(s) will be considered.

The purpose of this Notice of Funding Opportunity (NOFO) is to support the preclinical optimization and development of safe, effective, and non-addictive small molecule and biologic therapeutics for the treatment of pain. The goal of the program is to accelerate the advancement of promising early-stage therapeutic candidates and facilitate their readiness for Phase II clinical trials. Applicants must have a promising small molecule or biologic lead candidate for optimization, a strong biological rationale for the proposed approach, and established assays to guide the optimization process. The scope of the program includes lead optimization, early-stage development activities, IND-enabling studies, development of pharmacodynamic and/or target engagement biomarkers, preparation and submission of an Investigational New Drug (IND) application, and Phase I clinical testing. This is a milestone-driven, phased cooperative agreement program that involves active participation by NIH program staff in project planning and ongoing monitoring of research progress.

The purpose of this award is to support promising graduate students as they complete their doctoral research training and transition into mentored postdoctoral career development opportunities in research areas relevant to the missions of participating NIH Institutes and Centers.This Notice of Funding Opportunity (NOFO) does not allow candidates to propose to lead an independent clinical trial, but does allow candidates to propose research experience in a clinical trial led by a sponsor or co-sponsor.

The goal of the Paul Calabresi Career Development Award for Clinical Oncology (PCACO) is to increase the number of clinician-scientists trained in clinical and translational cancer research, and to promote their career development as cancer researchers. This Notice of Funding Opportunity (NOFO) does not allow Scholars to propose to lead an independent clinical trial, but does allow Scholars to propose research experience in a clinical trial led by a mentor or co-mentor.

Reissue PAR-21-122. This NOFO provides funding to conduct pharmacodynamic, pharmacokinetic, and in vivo efficacy studies to demonstrate that proposed therapeutic agent(s) have sufficient biological activity to warrant further development to treat neurological or neuromuscular disorders that fall under the NINDS mission. Therapeutic agents include small molecules, biologics or biotechnology-derived products. This FOA is part of a suite of Innovation Grants to Nurture Initial Translational Efforts (IGNITE) to advance projects to the point where they can meet the entry criteria for the Blueprint Neurotherapeutics Network or other translational programs.

The goal of the NHLBI Catalyze Program is to provide a comprehensive suite of support and services to facilitate the transition of basic science discoveries into viable diagnostic and therapeutic candidates that have been cleared for human testing, and to develop translational researchers fluent in product development and entrepreneurship. This specific Catalyze Product Definition initiative will provide the early stage translational support needed for the activities required to develop and test device prototypes, identify diagnostic disease targets and develop associated assays, and develop research tools to treat HLBS diseases and disorders. This is a phased initiative for early stage projects. The R61 phase provides support to identify and test initial prototype designs, to identify a disease target and generate experimental design, and to identify, test and pilot research tools. The R33 phase provides support for continued prototype development and testing, in addition to modifying design features and user feedback, diagnostic product generation, exploration of assay components, and characterization of a load design, and research tool improvement, large trial testing and data integration. Following successful completion of the program, it is expected that the potential products will be poised to move forward for in vivo testing (optimization, safety, efficacy) with additional support from NIH and/or other federal and private programs. This initiative has a companion initiative that supports development of therapeutics and combination products and is also part of a suite of innovation grants to advance projects to the point where they can meet the entry criteria for the NHLBI Catalyze Preclinical Program.

Reissue of PAR-20-119. This FOA encourages applications to advance the discovery, preclinical development, and proof of concept (PoC) testing of new, rationally based candidate agents and neurostimulation approaches to treat mental disorders, substance use disorders (SUDs) or alcohol use disorder (AUD), and to develop novel ligands and circuit-engagement devices as tools to further characterize existing or to validate new drug/device targets. Partnerships between academia and industry are strongly encouraged. This FOA supports a research program of multiple projects directed toward a specific major objective, basic theme or program goal, requiring a broadly based, multidisciplinary and often long-term approach. Projects seeking support for a discrete, specified, circumscribed project to be performed by the named investigator(s) in an area representing his or her specific interest and competencies should consider the companion U01 FOA.

The purpose of this Notice of Funding Opportunity (NOFO) is to advance translational research to better understand the emergence and worsening of mood and psychotic disorders (e.g., perimenopausal depression (PMD), generalized anxiety disorder, bipolar disorder and schizophrenia) during the menopause transition (MT) in an effort to identity targets for future development of novel treatment interventions. This funding opportunity aims to advance novel and innovative translational research to better comprehend the underlying neurobiological and behavioral mechanisms of mood and psychosis disorders and related symptoms during MT. This funding opportunity also encourages interdisciplinary researchers to collaborate on studies of mood and psychosis during the MT. Aspects of mood and psychosis disorders that are of interest include: classic depressive symptoms in combination with menopause symptoms (e.g., hot flashes, night sweats, sleep disturbance) and psychological challenges, the role of reproductive steroids in the regulation of mood and behavior during the MT, diagnosis of mood and psychosis symptoms at menopausal stage, investigation of co-occurring psychiatric and menopause symptoms, appreciation of psychosocial factors common in midlife, and differential diagnoses. Review criteria will focus on the comprehensiveness of the neurobiology and mechanisms of action underlying mood and psychosis symptoms and hypothesis-driven work.

NIMH seeks applications for innovative research projects to test strategies to increase the reach, efficiency, effectiveness, and quality of digital mental health interventions. This NOFO is intended to support the development of digital health test beds that leverage well-established digital mental health platforms,to rapidly refine and optimize existing evidence-based digital health interventions and conduct clinical trials testing digital mental health interventions that are statistically powered to provide a definitive answer regarding the intervention's effectiveness.

NIMH seeks applications for pilot effectiveness projects to evaluate the preliminary effectiveness of therapeutic and service delivery interventions for the post-acute management of mental health conditions that are matched to the stage of illness in terms of both their focus (e.g., consolidating and maintaining gains from initial treatment, managing residual symptoms/impairment, preventing relapse, promoting adherence and appropriate service use) and intensity/burden. In this pilot phase of effectiveness research, the trial should be designed to evaluate the feasibility, tolerability, acceptability, safety, and potential effectiveness of the approach; to address whether the intervention engages the target(s)/mechanisms(s) that is/are presumed to underlie the intervention effects; and to obtain preliminary data needed as a pre-requisite to a larger-scale effectiveness trial (e.g., comparative effectiveness study, practical trial) designed to definitely test the effectiveness of interventions to improve post-acute outcomes. This Notice of Funding Opportunity (NOFO) supports pilot effectiveness research to evaluate the feasibility, tolerability, acceptability, safety and preliminary indications of effectiveness of post-acute phase intervention approaches and inform the design of definitive effectiveness trials. Support for fully-powered, definitive effectiveness studies focused on post-acute phase interventions is provided via the R01 currently TEMP-24813.

The National Institute on Deafness and other Communication Disorders (NIDCD) intends to re-issue a Notice of Funding Opportunity (NOFO, prior funding opportunity RFA-DC-24-008 to solicit applications for research on early-stage dissemination and implementation (D&I) in the NIDCD mission areas of hearing, balance, taste, smell, voice, speech, and language. Much research is devoted to developing evidence-based innovations (EBIs) that improve a person"s health and quality of life. To impact people"s lives, EBIs need to be adopted in clinical practice and everyday life. Unfortunately, wide-scale adoption of EBIs is lengthy and rare. Dissemination and implementation (D&I) science is the field of research that seeks to close the gap between research and practice. Dissemination research is defined as the scientific study of the targeted distribution of information and materials about EBI to a specific audience (e.g., practitioners, patients, policymakers). The intent is to understand how best to communicate and integrate knowledge associated with a given EBI. Implementation Science refers to a broader array of active and planned efforts to integrate evidence into practice. Implementation research focuses on understanding why clinical and community settings are not adopting and sustaining a particular EBI. In turn, implementation research uses this understanding of barriers and facilitators to develop and evaluate different strategies (or collections of strategies) to increase adoption and integration of an EBI into practice. Many fields have applied D&I research theories, approaches, and outcome measures to improve adoption and sustainment of EBIs. This funding opportunity aims to support early-stage D&I research in NIDCD mission areas of hearing, balance, taste, smell, voice, speech, and language. Resulting findings should set a sufficient foundation for a high-quality, D&I focused R01 in NIDCD mission areas. Applications are not being solicited at this time. Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. This NOFO will utilize the R21 activity code. Investigators with expertise and insights into D&I research in NIDCD mission areas are encouraged to begin to consider applying for this new NOFO. In addition, collaborative investigations combining expertise in D&I and NIDCD mission areas will be encouraged and these investigators should also begin considering applying for this application.

The National Institutes of Health (NIH) seeks to advance its mission by maintaining strong, productive, and secure international research collaborations in support of the NIH mission. The NIH Collaborative International Research Project (Parent Announcement) supports international research collaborations. This opportunity specifically implements an award structure of prime domestic awards with independent foreign awards that are linked to the prime. This structure provides NIH with oversight capacity for international collaborations, and allows NIH to track international funding, as identified in NOT-OD-25-104. This funding opportunity is specifically designed for NIH to support funded international collaborations between a domestic prime organization and foreign organizations. This NOFO should not be used for foreign consultants, purchasing unique equipment or supplies from foreign vendors, foreign collaborations that do not involve NIH funding or any other foreign component that would not result in a foreign subaward. All collaborative international research project applications must include at least 1 international subproject. The proposed project must be related to the programmatic interests of one or more of the participating NIH Institutes, Centers and Offices (ICOs) based on their scientific missions. The application will be evaluated as a whole, and the international subproject(s) will be evaluated on whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing United States resources, and whether the proposed project has specific relevance to the mission and objectives of the ICO and has the potential for significantly advancing the health sciences in the United States.

This Notice of Funding Opportunity (NOFO) supports applications for a collaborating Data Coordinating Center (DCC) for investigator-initiated multi-site clinical trials including efficacy, comparative effectiveness, pragmatic and/or implementation research clinical trials. Trials using innovative designs such as platform trials, adaptive, and Bayesian designs are encouraged. These trials may include ones that test different therapeutic, behavioral, and/or prevention strategies. Trials for which this NOFO applies must be relevant to the research mission of the NHLBI and meet the NIH definition of a clinical trial (see NOT-OD-15-015). For additional information about the mission, strategic vision, and research priorities of the NHLBI, applicants are encouraged to consult the NHLBI website.This NOFO will utilize a milestone-driven cooperative agreement mechanism of award and runs in parallel with a companion NOFO (PAR-27-012) for a collaborating Clinical Coordinating Center (CCC). The objective of the DCC application is to present a comprehensive plan to provide overall project coordination, administration, data management, and biostatistical support for the clinical trial proposed in the collaborating CCC application. The application should also describe its approaches to collaborate with the CCC on implementation of the clinical trial community engagement plan. Both a DCC application and a collaborating CCC application must be submitted on the same application due date for consideration by NHLBI. Applicants are strongly encouraged to contact the appropriate Scientific/Research contact prior to submitting an application.

This Notice of Funding Opportunity (NOFO) supports applications to develop and conduct a Clinical Coordinating Center (CCC) for investigator-initiated multi-site clinical trials including efficacy, comparative effectiveness, pragmatic and/or dissemination and implementation science clinical trials. Trials using innovative designs such as platform trials, adaptive, and Bayesian designs are encouraged. These trials may include ones that test different therapeutic, behavioral, dissemination and implementation science clinical trials and/or prevention strategies.Trials for which this NOFO applies must be relevant to the research mission of the NHLBI and meet the NIH definition of a clinical trial (see NOT-OD-15-015). For additional information about the mission, strategic vision, and research priorities of the NHLBI, applicants are encouraged to consult the NHLBI website.This NOFO will utilize a bi-phasic, milestone-driven cooperative agreement mechanism of award and runs in parallel with a companion NOFO for a collaborating Data Coordinating Center (PAR-27-013). The objective of the CCC application is to present the scientific rationale for the clinical trial and a comprehensive scientific and operational plan that describes it. The application should address project management, subject recruitment and retention, performance milestones, scientific conduct of the trial, and dissemination of results. The application should also describe its approaches to increasing community engagement from conceptual design of the intervention through implementation and sustainability and close gaps in health outcomes within the US population and increase health for all.Both a CCC application and a collaborating Data Coordinating Center (DCC) application must be submitted on the same application due date for consideration by NHLBI. Applicants are strongly encouraged to contact the appropriate Scientific/Research contact prior to submitting an application.

This Notice of Funding Opportunity (NOFO) supports applications to develop and conduct investigator-initiated single site clinical trials including efficacy, comparative effectiveness, pragmatic and/or dissemination and implementation science clinical trials. Trials using innovative designs such as platform trials, adaptive, and Bayesian designs are encouraged. These trials may include ones that test different therapeutic, behavioral, dissemination and implementation science clinical trials and/or prevention strategies. Trials for which this NOFO applies must be relevant to the research mission of the NHLBI and meet the NIH definition of a clinical trial (see NOT-OD-15-015). For additional information about the mission, strategic vision, and research priorities of the NHLBI, applicants are encouraged to consult the NHLBI website.This NOFO will utilize a bi-phasic, milestone-driven mechanism of award. The objective of the application is to present the scientific rationale for the clinical trial and a comprehensive scientific and operational plan that describes it. The application should address project management, participant recruitment and retention, performance milestones, scientific conduct of the trial, and dissemination of results. The multiple PD/PI model is strongly encouraged but not required. Applicants are encouraged to include a PD/PI with expertise in biostatistics, clinical trial design, and coordination. The application should also describe its approaches to increase community engagement from conceptual design of the intervention through implementation and sustainability, close gaps in health outcomes within the US population, and increase health for all.

This notice of funding opportunity (NOFO) invites submission of investigator-initiated Program Project (P01) applications. The proposed Programs should address scientific areas relevant to the NIAID mission including: biology and pathogenesis of infectious microbes, including HIV; host-microbe interactions; mechanisms regulating immune system development and function across the lifespan, and in response to infectious pathogens; immune dysfunction resulting in allergy, asthma, autoimmunity, immunodeficiency, or transplant rejection; and translational research to develop vaccines, therapeutics, and diagnostics to prevent and treat infectious and immune-mediated diseases. Each application submitted to this NOFO must include at least two related, synergistic Research Projects that share a common central theme, focus, and/or overall objective; and an Administrative Core. An application may include Scientific Core(s), if needed for the proposed research.

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) announces a program that provides NIAMS-supported K01, K08, K23, and K25 recipients the opportunity to apply for the Small Grant (R03) during the second to fourth year of their K award, as well as to provide support to recipients of significant career development awards from federal or non-federal organizations that are focused on the NIAMS' mission areas. Through this mechanism, which allows up to $50,000 direct costs per year for up to two years, the NIAMS is seeking to enhance the capability of scientists to conduct research as they transition to fully independent investigator. The R03 grant mechanism allows support of different types of projects, including pilot and feasibility studies; secondary analysis of existing data; small, self-contained research projects; development of research methodology; and development of new research technology. In addition to the existing career development awards, the R03 is intended to support short term research projects to enable opportunities for a subsequent R01, or equivalent, application. Clinical trials of any phase will not be supported by this NOFO.This is a Notice of Funding Opportunity (NOFO) for a Limited Competition that will invite application(s) from eligible organization(s) to apply. Please see Section III. Eligibility for additional information. In accordance with NIH standard peer-review processes, the application(s) will be peer-reviewed, and only meritorious application(s) will be considered for funding.

Current recipients of specific types of NIH research grants may apply for administrative supplements, using this Notice of Funding Opportunity (NOFO), to provide additional funding to a currently funded grant to meet increased costs that are within the scope of the peer-reviewed and approved project, but that were unforeseen when the new or competing renewal application was awarded. Applications for administrative supplements are considered prior approval requests (as described in Section 8.1.2.11 of the NIH Grants Policy Statement) and will be routed directly to the Grants Management Officer of the parent award. There is no guarantee that funds are available from the awarding IC or for any specific grant. Therefore, prior to submission, applicants must discuss potential requests with the awarding ICO grants and program officials.

Rapid advances in genotyping and next generation sequencing technologies have led to the identification of genetic variants that are associated with a wide variety of congenital defects including human congenital anomalies (HCAs), intellectual developmental disabilities (IDDs) and inborn errors of metabolism (IEMs). Large quantities of genomic data collected from pediatric congenital anomalies cohorts are available to the research community through several databases such as the Database of Genotypes and Phenotypes (dbGaP), the Gabriella Miller Kids First Data Resource Portal, the European Genome-Phenome Archive and Clinical Genome Resource (ClinGen). The purpose of this initiative is to promote the screening, functional validation and characterization of congenital anomaly-associated genetic variants identified through public facing databases and individual efforts using in-silico tools, appropriate animal models, in vitro systems or multi-pronged approaches. This initiative addresses a challenging gap between identifying sequence variations of potential interest and recognizing which of those variations have functional effects on the phenotype of interest.

NIMH requires an experimental therapeutics approach for the development and testing of therapeutic interventions, in which studies both evaluate the clinical effect of an intervention and generate information about the mechanisms underlying a disorder or an intervention response. As part of NIMHs Clinical Trial Pipeline, this NOFO encourages early stage testing of pharmacologic interventions with novel mechanisms of actions or device-based interventions. More specifically, this NOFO is intended to support early stage testing of pharmacologic or device-based interventions using a protocol design where the presumed mechanism of action of the intervention is adequately tested, to provide meaningful information where target modulation yields a dose-dependent neurophysiological/clinical/behavioral effect.

This notice of funding opportunity (NOFO) encourages applications for implementation of investigator-initiated, milestone driven clinical trials that need enhanced oversight, and as applicable, include mechanistic studies. Mechanistic work in clinical trials may be of great value because it promotes the understanding of human diseases and the development of future therapeutic modalities. Support is available for clinical trials up to 5 years, as well as for extended clinical trials of 6- or 7-years.Investigators are encouraged to visit this NIH website for additional information about the overall mission and research areas of NIAID.Only one clinical trial may be proposed in each NIAID Clinical Trial Implementation Cooperative Agreement (U01) application. In accordance with NIH standard peer-review processes, the applications will be peer-reviewed, and only meritorious applications will be considered.

The goal of the Institutional Biomedical Undergraduate Research Training (BURT) program is to strengthen research training environments and develop a pool of well-trained students who:Complete their baccalaureate degrees in biomedically-related fields, andTransition into and complete biomedical, research-focused higher degree programs (such as Ph.D. or M.D./Ph.D.).Specifically, this funding announcement provides support to eligible, domestic organizations to develop and implement effective, evidence-informed approaches to biomedical undergraduate training and mentoring to help build a strong biomedical research workforce for the nation.Applicant organizations must enroll undergraduate students and have received NIH Research Project Grant (RPG) funding averaging less than $50 million in total costs (direct and F&A/indirect) per year over the last three fiscal years (FY). To promote undergraduate research training opportunities across a range of eligible organizations, the program will accept applications in two tracks:Single Site: To support trainees from a single baccalaureate-degree granting organization.Community College Partnerships: To support community college trainee development through strong collaborations between at least one associate-degree granting organization (that is, a community college) and at least one baccalaureate-degree granting organization.The proposed research training programs will incorporate didactic, research, and career development elements to prepare trainees for careers that will have a significant impact on the health-related research needs of the nation.

The purpose of the NIDCD Research Dissertation Fellowship for Au.D. Audiologists (F32) program is to support a comprehensive, rigorous biomedical research training, and dissertation research leading to a research doctorate (i.e., Ph.D.) in the biomedical, behavioral, or clinical sciences.

This notice of funding opportunity (NOFO) supports efforts to disseminate resources for integration into neuroscience research practice. The resource(s) should be relevant to the goals of the BRAIN Initiative as outlined in the "BRAIN 2025: A Scientific Vision" and "The BRAIN Initiative 2.0: From Cells to Circuits, Toward Cures" and shared broadly to the neuroscience community. The resource(s) should address compelling needs of neuroscience researchers that are otherwise unavailable or impractical in their current form. Activities must include dissemination of an existing resource, and may include one or more of the following activities: distribution of tools and reagents; user training on the usage of new technologies or techniques; providing access to existing technology platforms and/or specialized facilities; minor improvements to increase the scale/efficiency of resource production and delivery; minor adaptations to meet the needs of a user community.

This funding announcement, issued by the Brain Research through Advancing Innovative Neurotechnologies® (BRAIN) Initiative, seeks transformative, cutting-edge, and innovative research that embraces new technologies, ideas, and approaches to understand brain circuit function and contributions to behavior. It is a component of the BRAIN Initiative Connectivity Across Scales (BRAIN CONNECTS) Program, which aims to lay the scientific foundation for the next generation of neural circuit-based approaches for preventing and treating devastating brain disorders.This Notice of Funding Opportunity (NOFO) supports Specialized Projects to develop current or emerging technologies to generate comprehensive atlases of brain connectivity, with an emphasis on human, non-human primate (NHP), and mouse. Projects using other species are also permitted, if their use is well justified and the goal is to test and validate approaches that can be generalized across species. Applications may address any aspect(s) of brain connectivity and associated data pipelines, including data collection, reconstruction, analysis, integration, dissemination, and interpretation, to enable faster, more precise, and more cost-effective generation and interpretation of brain-wide wiring diagrams. Funded projects will be integrated into the BRAIN CONNECTS Network consisting of projects funded under this and preceding BRAIN CONNECTS NOFOs, as a coordinated effort aimed at developing the capabilities to generate wiring diagrams that can span entire brains across multiple scales.

Reissue of PAR-20-118. This Notice of Funding Opportunity (NOFO) encourages applications to advance the discovery, preclinical development, and proof of concept (PoC) testing of new, rationally based candidate agents and neurostimulation approaches to treat mental disorders, substance use disorders (SUDs) or alcohol use disorder (AUD), and to develop novel ligands and circuit-engagement devices as tools to further characterize existing or to validate new drug/device targets. Partnerships between academia and industry are strongly encouraged. This NOFO using the U01 mechanism supports a discrete, specified, circumscribed project to be performed by the named investigator(s) in an area representing his or her specific interest and competencies Projects seeking support for a research program of multiple projects directed toward a specific major objective, basic theme or program goal, requiring a broadly based, multidisciplinary and often long-term approach should consider the companion U19 FOA.

Clinical Trials to Test the Effectiveness of Treatment, Preventive, and Services Interventions (R01 Clinical Trial Required). This NOFO is a key element of NIMHs set of NOFOs to support clinical trials research across the intervention development and testing pipeline. The NOFO supports (1) clinical trials to test the effectiveness of optimized therapeutic and preventive interventions for use in community and practice settings; and (2) clinical trials to evaluate the effectiveness of patient-, provider-, organizational-, or systems-level services interventions to improve access, continuity, quality, equity, and/or value of mental health services. This NOFO is intended to support trials that: address a significant problem, such that the findings have potential to inform practice; are adequately powered to definitively answer the primary research question(s), with well-justified hypotheses supported by pilot data; and are designed to examine questions regarding mediators and moderators of effects. Consistent with the NIMH experimental therapeutics approach, this NOFO is intended to support effectiveness trials that explicitly address whether the intervention engages the target(s)/mechanism(s) presumed to underlie the intervention effects (i.e., the mechanism(s) that accounts for changes in clinical/functional outcomes, changes in provider behavior, improved access or continuity of services, etc.). The collaborative R01 mechanism provides support for multisite trials when two or more sites are necessary for completion of the trial (e.g., to increase sample size, accelerate recruitment, or increase sample diversity and representation).

This Notice of Funding Opportunity (NOFO) invites researchers to submit applications for support of clinical projects that address critical needs for clinical trial readiness in rare diseases. The initiative seeks applications that are intended to facilitate rare diseases research by enabling efficient and effective movement of candidate therapeutics or diagnostics toward clinical trials, and to increase their likelihood of success. This could be through the development and testing of rigorous biomarkers and clinical outcome assessment measures, or by defining the presentation and course of a rare disease to enable the design of upcoming clinical trials.

The purpose of this Notice of Funding Opportunity (NOFO) is to encourage applications to pursue invasive neural recording studies focused on mental health-relevant questions. Invasive neural recordings provide an unparalleled window into the human brain to explore the neural circuitry and neural dynamics underlying complex moods, emotions, cognitive functions, and behaviors with high spatial and temporal resolution. Additionally, the ability to stimulate, via the same electrodes, allows for direct causal tests by modulating network dynamics. This funding opportunity aims to target a gap in the scientific knowledge of neural circuit function related to mental health disorders. Researchers should target specific questions suited to invasive recording modalities that have high translational potential. Development of new technologies and therapies are outside the scope of this NOFO.

The National Center for Complementary and Integrative Health (NCCIH) announces this Notice of Funding Opportunity (NOFO) to solicit applications for research on how mind and body interventions through psychological and/or physical inputs (e.g., mindfulness meditation, yoga, acupuncture, massage, and other brain and/or body based interventions) impact mechanisms of emotional well-being (EWB) and their associations with whole person health (WPH), consistent with the NIH priority to address the health needs of the American people and improve their well-being. The NOFO will support rigorous and well-powered mechanistic research studies that are supported by strong preliminary data. The studies should examine the effects of mind and body interventions on innovative mechanisms of EWB (as the primary outcome), as well as the associated relationship with the Whole Person Health Index (WPHI, as a secondary outcome). To enhance research safety, rigor, and efficiency of NIH-funded mechanistic clinical trials, this initiative will use a two-phased award funding mechanism (R61/R33). The funding will support an initial phase (R61) to establish feasibility benchmarks for the proposed mechanistic clinical trial(s), followed by a second phase (R33) to complete the full-scale trials, which will be contingent upon successful completion of R61 milestones. Applications should provide preliminary data that are comparable in quality and quantity to those expected for an R01 proposal.

This Notice of Funding Opportunity (NOFO) invites applications to use NHLBI-funded TransOmics for Precision Medicine (TOPMed) program to generate a large volume of integrated genetic and multi-omics data to facilitate discovery of the molecular mechanisms of Heart, Lung, Blood, and Sleep (HLBS) disorders. No funding will be provided under this NOFO. The genomic data and related phenotypic data will be deposited in a public NIH-designated controlled-access database such as the database for Genotypes and Phenotypes (dbGaP) and NHLBIs BioData Catalyst (BDC). The overall goal is to move from simply cataloguing genetic associations to understanding how genetic factors contribute to HLBS diseases at the molecular and cellular levels. This transformation will help move TOPMed from genetic Map to Mechanism with potential applications of AI and ML tool sets where possible, enabling functional genomics research that will accelerate mechanistic personalized medicine

This NOFO solicits applications for next generation sensor and bioelectronic device development that will synchronize with brain recordings. The sensor and neural recording data will be used to generate new computational models of behavior in human and animal models. There has been a lack of quantitative approaches and models to understand the complexity of human and animal behavior in naturalistic settings. This NOFO focuses on the development of next generation sensors to acquire data and synchronize it with simultaneous brain recordings to build computational models.

Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) encourages grant applications to support research in cancer epidemiology cohort studies that address specific knowledge gaps in cancer etiology and survivorship. Applications should include hypothesis-based research, support for cohort infrastructure and/or maintenance, continued follow-up, and sharing of data and biospecimen resources as appropriate.

The purpose of this Notice of Funding Opportunity (NOFO) is to encourage applications seeking to develop the next generation of brain stimulation devices for treating mental health disorders. Applications are sought that will either 1) develop novel brain stimulation devices or 2) significantly enhance, by means of hardware/software improvements, the effectiveness of brain stimulation devices that are currently U.S. Food and Drug Administration (FDA)-approved or cleared. Novel devices should move beyond existing electrical/magnetic stimulation and develop new stimulation techniques capable of increased spatiotemporal precision as well as multi-focal, closed-loop approaches. Applications seeking to develop new capabilities should focus on significant enhancement of the spatial resolution, depth of delivery, and/or precision of the device. Incremental changes to existing devices (e.g., software updates) are not withinthe scope of this announcement.

This Notice of Funding Opportunity (NOFO) encourages grant applications for Animal and Biological Material Resource Centers. These Centers provide support for special colonies of laboratory animals and associated services, as well as other resources such as informatics tools, reagents, cultures (cells, tissues, and organs) and genetic stocks that serve the biomedical research community in a variety of research areas on a local, regional, and national basis. The goal of projects supported by this NOFO is to provide research resources that facilitate optimization and enhancement of scientific rigor, transparency, and experimental reproducibility of biomedical research. Proposed Animal and Biological Material Resource Centers must have broad application to multiple NIH Institutes or Centers (ICs) to align with the ORIP"s NIH-wide mission (https://orip.nih.gov/about-orip). This funding opportunity is designed to support both continuation of existing resources and to develop new ones when appropriate. Of special interest of the announcement is a requirement of the Center"s close coordination with efforts to develop new approach methodologies (NAMs) that complement traditional animal-based research. These include cell culture, organoids, computational models, and microphysiological systems. Applied Research Component should include studies to generate comparative data to increase applicability of NAMs and promote integration of the most predictive human disease models. Prior to preparing an application, all applicants are strongly encouraged to consult with Scientific/Research staff to be advised on appropriateness of the intended resource plans for this program, competitiveness of a potential application, and ORIP's program priorities.

The purpose of this Notice of Funding Announcement (NOFO) is to encourage innovative research that will inform and support the delivery of high-quality, continuously improving mental health services to benefit the greatest number of individuals with, or at risk for developing, a mental illness. This announcement invites applications for non-clinical trial R01-level projects that address NIMH strategic priorities for mental health services research.

Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders (R33 Clinical Trial Required). As part of NIMH's clinical trials pipeline, this NOFO encourages pilot research developing and testing novel psychosocial interventions and/or targets. Consistent with NIMH's emphasis on the experimental therapeutics approach to intervention development, it intends to speed the translation of emergent research in basic, behavioral, cognitive, affect, and neuropsychological science into preventative or therapeutic interventions. This RFA will provide up to three years of support to replicate target engagement from prior studies and to test the association between target engagement and change in clinical outcome(s).

This Notice of Funding Opportunity (NOFO) invites applications for P30 Cancer Center Support Grants (CCSGs) to support NCI-Designated Cancer Centers. CCSGs support three types of Cancer Centers: 1) Comprehensive Cancer Centers, which demonstrate reasonable depth and breadth of research activities in each of three major areas: basic laboratory; clinical; and prevention, control and population-based research, and which have substantial transdisciplinary research that bridges these scientific areas; and 2) Clinical Cancer Centers, which are primarily focused on basic laboratory; clinical; and prevention, cancer control, and population-based research; or some combination of these areas, and 3) Basic Cancer Centers, which focus on basic laboratory research. The purpose of all types of NCI-Designated Cancer Centers is to capitalize on all institutional cancer research capabilities, integrating meritorious research into a single transdisciplinary research enterprise across all institutional boundaries. Cancer Centers supported through this NOFO are expected to serve as major sources of discovery of the nature of cancer and of development of more effective approaches to prevention, diagnosis, and therapy; to contribute significantly to the development of Shared Resources that support research; to collaborate and coordinate their research efforts with other NCI-funded programs and investigators; and to disseminate research findings for the benefit of the community.

Confirmatory Efficacy Clinical Trials of Non-Pharmacological Interventions for Mental Disorders (R01 Clinical Trial Required). As part of NIMH's clinical trials pipeline NOFOs, this announcement supports confirmatory efficacy testing of non pharmacological therapeutic and preventive interventions for mental disorders in adults and children that address unmet therapeutic needs, and are consistent with the NIMH emphasis on the experimental therapeutics approach. In this approach, clinical trials should be designed to increase knowledge of the relationship between underlying disease processes and the mechanisms of action through which any intervention produces therapeutic change.

The objective of the NIH Career Transition Award (K22) is to provide support to outstanding basic or clinical investigators to develop their independent research skills through a two phase program: an initial period involving an intramural appointment at the NIH and a final period of support at an extramural institution. This NINDS K22 is specifically designed to facilitate the transition of NINDS intramural neurologist- and neurosurgeon-scientists to independent, academic faculty positions that support clinician-scientists to engage in independently funded scientific research as well as clinical activities.

The Office of Research Infrastructure Programs (ORIP) encourages grant applications aimed at developing, characterizing, or improving research models of human health and diseases; developing biology based new approach methodologies (NAMs) applicable to human health and diseases; or improving access to information about or generated from the use of models of human disease. The models, including NAMs, and related biological materials developed must be broadly applicable to the scientific interests of two or more NIH Institutes or Centers (ICs) and must evaluate diseases and processes that impact multiple organ systems in order to align with the ORIP"s NIH-wide mission and programs. Applications must describe the need for and the potential impact of the proposed resources on the research community across a range of scientific disciplines supported by multiple NIH ICs. Applications to develop models that relate strictly to a specific disease or a select area of research or that do not have a broad impact on the NIH-wide research community will not be accepted. Projects that predominantly address the research interests of one NIH IC but are only peripherally related to the research interests of other ICs will also not be accepted, if submitted in response to this notice of funding opportunity (NOFO).

This notice of funding opportunity (NOFO) invites applications for investigator-initiated Resource-Related Research Projects (R24). The proposed resource must provide a significant benefit to currently funded high priority projects in need of further coordination and support in the areas specified. This mechanism may also be used to support development of a new resource to the broader scientific community of the National Institute of Allergy and Infectious Diseases (NIAID). It is anticipated that the request for resource support through the R24 activity code will occur on an infrequent basis and only in circumstances where other mechanisms of support from the NIAID are not appropriate.The proposed resources should be relevant to the scientific areas of the NIAID mission including the biology, pathogenesis, and host response to microbes, including HIV; the mechanisms of normal immune function and immune dysfunction resulting in autoimmunity, immunodeficiency, allergy, asthma, and transplant rejection; and translational research to develop vaccines, therapeutics, and diagnostics to prevent and treat infectious, immune-mediated, and allergic diseases.

The purpose of this notice of funding opportunity (NOFO) is to provide investigators with a mechanism to request services from the state-of-the-art Biological Testing Facility that would advance their contraceptive development or reproductive health programs. This NOFO aims to position innovative and validated methods for future regulatory submission and/or clinical development. Applicants do not need to have current NIH funding to apply, but priority may be given to programs receiving NIH support at the time of application submission.

The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The overarching goal of this R25 program is to support educational activities that complement and/or enhance the training of a workforce to meet the nations biomedical, behavioral and clinical research needs.

The goal of the NHLBI Catalyze Program is to provide a comprehensive suite of support and services to facilitate the transition of basic science discoveries into viable diagnostic and therapeutic candidates that have been cleared for human testing, and to develop translational researchers fluent in product development and entrepreneurship. This specific Catalyze Product Definition initiative will provide the early stage translational support needed for prototype testing/design modification, assay development for diagnostic disease targets, and development of research tools for use in the treatment of HLBS diseases and disorders. Following successful completion of the program, it is expected that the potential products will be poised to move forward for in vivo testing (optimization, safety, efficacy) with additional support from NIH and/or other federal and private programs. This initiative has a companion initiative that supports development of therapeutics and combination products and is also part of a suite of innovation grants to advance projects to the point where they can meet the entry criteria for the NHLBI Catalyze Preclinical Program.

To support UG3/UH3 phased, cooperative agreement research applications to plan and implement clinical trials within the mission of the National Institute of Dental and Craniofacial Research (NIDCR)

The purpose of this Notice of Funding Opportunity (NOFO) is to encourage cooperative agreement applications to support early stage clinical trials of novel mechanism of action, investigational drugs, or novel neuromodulatory devices for the treatment of psychiatric disorders in areas of unmet medical need. The NOFO will support milestone-driven early stage trials in pediatric and adult populations. First in human (FIH) and Phase II studies of novel agents must assess target engagement (brain exposure), pharmacological effects, safety, and tolerability to assess feasibility for Phase II/proof of concept (PoC) studies in psychiatric disorders. Phase II/PoC studies must evaluate the drugs impact on clinically relevant physiological systems (functional measures) and clinical indicators of effect. The NOFO also supports FIH and early feasibility studies (EFS) of novel devices to evaluate target engagement, safety, tolerability, and efficacy. The overall objective is to facilitate rapid collection of data to "de-risk" novel mechanism of action investigational drugs, novel drugs for use in pediatric populations with psychiatric disorders, and devices or combination treatments in order to attract private or other public funding for further clinical development as FDA-approved treatments. A key aspect of this NOFO is the formation of collaborative partnerships between the biomedical researchers and biotechnology or industry researchers to facilitate psychiatric drug or device development.

The purpose of the NIDCR Dual Degree Dentist Scientist Pathway to Independence Award (K99/R00) program is to develop and maintain a strong cohort of independently funded dentist scientists dedicated to improving dental, oral and craniofacial health. This program is designed to facilitate a timely transition of outstanding dual degree dentist scientists from mentored, postdoctoral research positions to independent, tenure-track or equivalent faculty positions by providing support for two years of mentored training and three to five years of independent research. An option for five years of independent (R00) support is available to accommodate clinical training in a dental specialty program at no more than 3 person-months effort (25% full-time professional effort) in any year of the R00 phase.

This Notice of Funding Opportunity (NOFO) supports projects relevant to the NIGMS mission that focus solely on the development of technologies with potential to enable acquisition of biomedical knowledge. Projects should be justified in terms of technical innovation and utility of such technical innovation for impacting future biomedical research. Outcomes or products of the proposed project should significantly advance the current state of the art and be sufficiently characterized for application in addressing a broad range of biomedical research questions.

This FOA encourages research relevant to the development of novel screening approaches and/or therapeutic interventions for potentially fatal or disabling conditions that have been identified through newborn screening, as well as for "high priority" genetic conditions where screening may be possible in the near future.Having an accurate screening test, as well as demonstrating the benefits of early intervention or treatment, are important criteria for including a condition on a newborn screening panel. This FOA defines a "high priority" condition as one where screening is not currently recommended, but infants with the condition would significantly benefit from early identification and treatment.

The purpose of this NOFO is to build research about the effectiveness, implementation, and optimization of family navigation ED diversion models for non-urgent mental health problems. Models of interest are designed to (a) utilize triage tools to identify mental health acuity, (b) facilitate engagement in mental health services and needed resources, and (c) provide support, knowledge about the mental health condition, and facilitate linkages/address barriers to help-seeking among families.

To support competing renewal or competitive revision of ongoing clinical trials supported by the National Institute of Dental and Craniofacial Research (NIDCR)

The purpose of this NOFO is to build research about the effectiveness, implementation, and optimization of family navigation ED diversion models for non-urgent mental health problems. Models of interest are designed to (a) utilize triage tools to identify mental health acuity, (b) facilitate engagement in mental health services and needed resources, and (c) provide support, knowledge about the mental health condition, and facilitate linkages/address barriers to help-seeking among families.

The National Center for Advancing Translational Sciences (NCATS) will award Ruth L. Kirschstein National Research Service Award (NRSA) Predoctoral Institutional Research Training Grants for the Clinical and Translational Science Awards (CTSA) Program (T32) to eligibleinstitutions to create, provide, and disseminate clinical and translational science training and career support programs for individuals seeking a PhD or an equivalent research health professional degree and help ensure a heterogenous pool of clinical and translational scientist trainees who are equipped with the knowledge, skills and abilities (KSAs) to advance diagnostics, therapeutics, clinical interventions, and behavioral modifications aimed at improving health and support meaningful translational science research projects that address demonstrable needs among stakeholder communities.

The NIDCD Early Career Research (ECR) Award (R21) is intended to support both basic and clinical research from scientists who are beginning to establish an independent research career. It cannot be used for thesis or dissertation research. The research must be focused on one or more of the areas within the biomedical and behavioral scientific mission of the NIDCD: hearing, balance, smell, taste, voice, speech, or language. The NIDCD ECR Award R21 grant mechanism supports different types of projects including secondary analysis of existing data; small, self-contained research projects; development of research methodology; translational research; outcomes research; and development of new research technology. Irrespective of the type of project, the intent of the NIDCD ECR Award R21 is for the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) to obtain sufficient preliminary data for a subsequent R01 application.

The National Institutes of Health (NIH) Research Education Program supports research education activities in the mission areas of the NIH. The overarching goal of the Research Education program is to:Support educational activities that complement and/or enhance training of a workforce to meet the nation's biomedical, behavioral and clinical research needs;Help recruit individuals with specific specialty or disciplinary backgrounds to research careers in biomedical, behavioral and clinical sciences; andFoster a better understanding of biomedical, behavioral and clinical research and its implications.

The National Center for Advancing Translational Sciences (NCATS) will award Ruth L. Kirschstein National Research Service Award (NRSA) Postdoctoral Institutional Research Training Grants for the Clinical and Translational Science Awards (CTSA) Program (T32) to eligible institutions to create, provide, and disseminate clinical and translational science training and career support programs that enhance postdoctoral research training of individuals with doctoral degrees (these include, but are not limited to, the following: D.M.D., DC, DO, DVM., OD, DPM, ScD, EngD, DrPH, DNSc, DPT, PharmD, ND [Doctor of Naturopathy], DSW, PsyD, as well as a doctoral degree in nursing research) and help ensure a heterogenous pool of clinical and translational scientists trainees who are equipped with the knowledge, skills and abilities to advance diagnostics, therapeutics, clinical interventions, and behavioral modifications that improve health and support meaningful translational science research projects that address demonstrable needs among stakeholder communities.

The purpose of this Notice of Funding Opportunity (NOFO) encourages applications that will expand knowledge of the natural history of disorders that currently are, or may become, part of statewide newborn screening programs. A comprehensive understanding of the natural history of a condition is necessary to facilitate appropriate interventions for infants identified by newborn screening. Characterization of the sequence and timing of symptom development provides information crucial for developing targeted, age-appropriate treatments and for establishing a baseline against which to assess novel interventions. In addition, for some conditions, establishment of genotype-phenotype correlations may facilitate prediction of the clinical course; for others, identification of modifying genetic, epigenetic, or environmental factors may enhance understanding of clinical outcomes. Comprehensive data on the natural history of a condition will facilitate the fields ability to: 1) identify the underlying biological mechanisms; 2) understand the genetic and clinical heterogeneity and phenotypic expression of the condition; 3) improve diagnostic accuracy; 4) facilitate clinical trials by providing comprehensive natural history data; 5) prevent, manage, and treat symptoms and complications of the condition; 6) furnish physicians and families with needed support and predictive information about the condition; and 7) establish data collection systems or patient registries to collect longitudinal data (e.g., child/family outcomes following newborn screening).

The objective of the NIA Academic Leadership Career Award (K07) is to provide support for established investigators who have the expertise and leadership skills to enhance aging and/or Alzheimer's Disease (AD) and Alzheimers Disease Related Dementias (ADRD)research capacity within their academic institution. Through this award, investigators will endeavor to develop research and educational infrastructure, mentorship, and career development activities in support of new or emerging areas of aging and/or AD/ADRDresearch. These may include, but are not limited to, courses, curricula, research support, pilot funding, travel awards, visiting scholars, or networks. This Notice of Funding Opportunity (NOFO) is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial. Applicants to this FOA are permitted to propose research experience in a clinical trial led by another investigator.

NIMH requires an experimental therapeutics approach for the development and testing of therapeutic interventions, in which studies both evaluate the clinical effect of an intervention and generate information about the mechanisms underlying a disorder or an intervention response. As part of NIMHs Clinical Trial Pipeline, this NOFO encourages early stage testing of pharmacologic interventions with novel mechanisms of actions or device-based interventions. More specifically, this NOFO is intended to support early stage testing of pharmacologic or device-based interventions using a protocol design where the presumed mechanism of action of the intervention is adequately tested, to provide meaningful information where target modulation yields a dose-dependent neurophysiological/clinical/behavioral effect.

This Notice of Funding Opportunity (NOFO) intends to support fundamental research that will contribute to basic understanding of skin injuries caused by chemicals that have been identified as public health threats, with an emphasis on investigating the commonalities of such injuries and identifying potential shared signaling pathways and therapeutic targets for medical countermeasure development.

The Maximizing Investigators' Research Award (MIRA) provides support for individual investigators for research within the scientific mission of NIGMS via a single grant to achieve the following:Increase the stability of funding for NIGMS-supported investigators, which could enhance their ability to take on ambitious scientific projects and approach problems more creatively;Increase flexibility for investigators to follow important new research directions within the NIGMS mission as opportunities arise, rather than being bound to specific aims proposed in advance of the studies;More widely distribute funding among the nation's highly talented and promising investigators to increase overall scientific productivity and the chances for important breakthroughs;Reduce the time spent by researchers writing and reviewing grant applications, allowing them to spend more time conducting research;Reduce the administrative burden associated with a PD/PI managing multiple NIGMS research grants; andEnable PD(s)/PI(s) to devote more time and energy to mentoring junior scientists in a more stable research environment.This NOFO invites applications from eligible NIGMS-funded investigators and from New Investigators proposing research that is aligned with NIGMS' scientific mission. The NOFO also allows renewal applications from all current MIRA grantees (including those previously funded as Early-Stage Investigators). Current Early-Stage Investigators (ESIs) should apply through the ESI MIRA NOFO, not this NOFO.

The purpose of NEI's Translational Research program (TRP) is the rapid and efficient translation of innovative laboratory research findings into therapeutics for use by clinicians to treat visual system diseases or disorders. The TRP will support the product development of biological, pharmaceutical, medical device, and/or combination therapies for any disease or disorder of the visual system.The TRP will utilize a bi-phasic, milestone-driven mechanism of award. The R61 phase can be up to two years and will support research that has demonstrated significant preliminary data but has not advanced to the level of clinical translation. The R33 phase can be up to four years and will support research that is in the final states of preclinical development with potential for near-term clinical development. The total duration of both R61 and R33 cannot exceed five years. The R33 is to focus on advancing a single therapeutic candidate through Investigational New Drug or Investigational Device Exemption (IND/IDE) enabling studies, filing an IND/IDE package with the FDA, and designing future clinical trials. R33 recipients must submit or obtain an IND/IDE application to FDA, or must transition the product to clinical practice, within the period of performance. The specific activities appropriate for the R33 phase will depend on the product under study and available preliminary data on the product. Delineation of milestones by the applicant for the R61 and R33 phases is a key characteristic of this program. A milestone is defined as a scheduled event in the project timeline that signifies the completion of a major project stage or activity. This program will support applications that propose a series of milestones including manufacturing and product development goals. Applications that address contingency plans to proactively confront potential delays in meeting the milestones are strongly encouraged. Milestones are required for both phases. Milestones must be specific, measurable, achievable, relevant, and time-bound (SMART). All projects will begin with a R61 phase regardless of therapeutic starting point.

The purpose of this Program Announcement with Special Receipt, Referral, and/or Review Considerations (PAR) is to solicit applications to access limited identifiable data or biospecimens from the ECHO Cohort to study high-priority areas of maternal and child health.

The purpose of this Notice of Funding Opportunity (NOFO) is to support the continued operation, maintenance, and dissemination of unique database bioinformatics resources that are of major importance to the research community using animal models of embryonic developmental processes. These grants will support ongoing development and enhancement of the resources, user training and services, provision of community generated data storage and curation, wide dissemination of the tools and/or resources, and expansion of interoperability with other NIH bioinformatics resources.

Pilot Effectiveness Trials for Treatment, Preventive and Services Interventions (R01 Clinical Trial Required). As part of NIMH's clinical trials pipeline NOFOs, this announcement encourages pilot effectiveness studies focused on 1) optimizing the effectiveness of preventive and therapeutic interventions with previously demonstrated efficacy, for use with broader target populations or for use in community practice settings, and 2) developing and preliminary testing innovative services interventions. Consistent with the NIMH experimental therapeutics approach, this NOFO is intended to support pilot studies of intervention effectiveness or service delivery approaches that explicitly address whether the intervention engages the target(s)/mechanism(s) presumed to underlie the intervention effects (i.e., the mechanism(s) that accounts for changes in clinical/functional outcomes, changes in provider behavior, improved access or continuity of services, etc.).

The purpose of this Notice of Funding Opportunity (NOFO) is to advance translational research to better understand the emergence and worsening of mood and psychotic disorders (e.g., perimenopausal depression (PMD), generalized anxiety disorder, bipolar disorder and schizophrenia) during the menopause transition (MT) in an effort to identity targets for future development of novel treatment interventions. This funding opportunity aims to advance novel and innovative translational research to better comprehend the underlying neurobiological and behavioral mechanisms of mood and psychosis disorders and related symptoms during MT. This funding opportunity also encourages interdisciplinary researchers to collaborate on studies of mood and psychosis during the MT. Aspects of mood and psychosis disorders that are of interest include: classic depressive symptoms in combination with menopause symptoms (e.g., hot flashes, night sweats, sleep disturbance) and psychological challenges, the role of reproductive steroids in the regulation of mood and behavior during the MT, diagnosis of mood and psychosis symptoms at menopausal stage, investigation of co-occurring psychiatric and menopause symptoms, appreciation of psychosocial factors common in midlife, and differential diagnoses. Review criteria will focus on the comprehensiveness of the neurobiology and mechanisms of action underlying mood and psychosis symptoms and hypothesis-driven work.

The purpose of the NHLBI Career Transition Award (K22) program is to provide highly qualified postdoctoral fellows in the NHLBI Division of Intramural Research the opportunity to transition their research programs as new investigators to extramural institutions. To achieve these objectives, the NHLBI Career Transition Award will support two phases of research: a mentored intramural phase (up to two years) and an extramural phase (three years), for a total of five years of combined support. Transition from the intramural phase of support to the extramural phase is not automatic. Approval of the transition will be based on the success of the awardee's research program during the mentored phase as determined by an NHLBI progress review, which will include an evaluation of a research plan to be carried out at the extramural institution.

The purpose of the NIDCR Dentist Scientist Career Transition Award for Intramural Investigators (K22) program is to facilitate transition of highly qualified dentists from NIH Intramural postdoctoral research positions to extramural academic tenure-track or equivalent faculty positions at eligible institutions. The award will provide support for two years of mentored postdoctoral research training in the NIH Intramural Research Program, and three years of independent research funding at the extramural institution.

To provide highly qualified postdoctoral fellows and other doctoral-level researchers currently in training in the NHLBI Division of Intramural Research with the opportunity to transition their research programs to extramural institutions as junior investigators.

The NIDCD is committed to identifying effective interventions for the treatment or prevention of communication disorders by supporting well designed and well executed clinical trials. This funding opportunity announcement (FOA) supports a cooperative agreement between an NIDCD Project Scientist and an investigator to support a clinical trial that meets ANY of the following criteria: requires FDA oversight, is intended to formally establish efficacy, or has a higher risk to potentially cause physical or psychological harm.

This NIDCR Small Grant Program for New Investigators supports basic and clinical research conducted by scientists who are in the early stages of establishing an independent research career in oral, dental and craniofacial research. This R03 program supports pilot or feasibility studies and developmental research projects with the intention of obtaining sufficient preliminary data for a subsequent investigator initiated Research Project Grant (R01) or equivalent application.

Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders (R61/R33 Clinical Trial Required). As part of NIMH's clinical trials pipeline, this NOFO encourages pilot research developing and testing novel psychosocial interventions and/or targets. Consistent with NIMH's emphasis on the experimental therapeutics approach to intervention development, it intends to speed the translation of emergent research in basic, behavioral, cognitive, affect, and neuropsychological science into preventative or therapeutic interventions. This RFA will provide up to two years of support for evaluation of target engagement and establishment of intervention parameters, and up to three years of support to replicate target engagement from prior studies and to test the association between target engagement and change in clinical outcome(s).

The goal of the NHLBI Catalyze Program is to provide a comprehensive suite of support and services to facilitate the transition of basic science discoveries into viable diagnostic and therapeutic candidates that have been cleared for human testing, and to develop translational researchers fluent in product development and entrepreneurship. This specific Catalyze Product Definition initiative will provide the early stage translational support needed for the activities required to identify and characterize potential therapeutic candidates and combination products to treat HLBS diseases and disorders. This initiative has a companion initiative that supports development of devices and diagnostics and is also part of a suite of innovation grants to advance projects to the point where they can meet the entry criteria for the NHLBI Catalyze Preclinical Program.

The National Institutes of Health (NIH) Research Education Program supports research education activities in the mission areas of the NIH. The overarching goal of the Research Education program is to:Support educational activities that complement and/or enhance training of a workforce to meet the nation's biomedical, behavioral and clinical research needs;Help recruit individuals with specific specialty or disciplinary backgrounds to research careers in biomedical, behavioral and clinical sciences; and Foster a better understanding of biomedical, behavioral and clinical research and its implications.

This Notice of Funding Opportunity (NOFO) encourages applications for NIGMS Biomedical Technology Optimization and Dissemination (BTOD) Centers to support late-stage technology optimization and sustainable dissemination of the technologies to the wider biomedical research community. A BTOD Center should be at the leading edge of its field with respect to both technology optimization and engagement with relevant research communities.BTOD projects must address biomedical research areas within the NIGMS mission. Potential applicants are strongly encouraged to consult with NIGMS staff about adherence of their proposed research strategy to the Institute's goals and mission and its responsiveness to this NOFO.

The National Institutes of Health (NIH) will award Institutional Mentored Career Development grants to eligible domestic institutions to support career development programs designed to prepare later stage postdoctoral fellows and junior faculty scholars who have made a commitment to an independent research career for their career advancement and transition to independence. Supported scholars will have "protected time" to engage in intensive, mentored research career development experiences in the fields of biomedical and behavioral research.This Notice of Funding Opportunity (NOFO) does not allow appointed scholars to lead an independent clinical trial but does allow them to obtain research experience in a clinical trial led by a mentor or co-mentor. NIH strongly supports training towards a career in clinically relevant research. As such, gaining experience in clinical trials under the guidance of a mentor or co-mentor is encouraged.

The purpose of this notice of funding opportunity (NOFO) is to encourage community-engaged research that broadens the conceptualization of qualities of the environment that can support language development in children and that focuses on the development of novel measures of childrens language development. The overall goal is to build the number of strengths-focused, culturally and linguistically responsive, and generalizable toolsto further our understanding of childrens language development and/or impairment, and predictors thereof.

The purpose of this notice of funding opportunity (NOFO) is to encourage community-engaged research that broadens the conceptualization of qualities of the environment that can support language development in children and that focuses on the development of novel measures of childrens language development. The overall goal is to build the number of strengths-focused, culturally and linguistically responsive, and generalizable toolsto further our understanding of childrens language development and/or impairment, and predictors thereof.

The objective of the NIH Career Transition Award (K22) is to provide support to outstanding basic or clinical investigators to develop their independent research skills through a two phase program: an initial period involving an intramural appointment at the NIH and a final period of support at an extramural institution. This NINDS K22 is specifically designed to facilitate the transition of NINDS intramural neurologist- and neurosurgeon-scientists to independent, academic faculty positions that support clinician-scientists to engage in independently funded scientific research as well as clinical activities.

The Ultra-Rare Gene-Based Therapy (URGenT) network supports Investigational New Drug (IND)-enabling studies and planning activities for First-in-Human (FIH) clinical testing of gene-based or transcript-directed therapeutics, such as oligonucleotides and viral-based gene therapies, for ultra-rare neurological or neuromuscular disorders. The goal of this announcement is to accelerate the development of a promising clinical candidate with robust biological rationale and demonstrated proof of concept (POC) data for the intended approach in a model system relevant to a specified patient population towards an IND filing and the initiation of a clinical trial.

The purpose of this Notice of Funding Opportunity (NOFO) is to solicit applications for exploratory and early-stage projects that focus on undruggable target classes within intractable human disease. Applicants will identify a human disease relevant undruggable target class and develop a method or agent that is selective for one or more targets within that target class. This NOFO is intended to jumpstart research that demonstrates innovative strategies to modulate targets that cannot be addressed by established therapeutic types, furthering the development of methods and/or agents selective for undruggable target classes.

The overarching purpose of this Funding Opportunity Announcement (FOA) is to promote the discovery and/or early evaluation of strong candidate biomarkers and biomarker signatures that can be used as tools to facilitate the clinical development of neurotherapeutics and their use in clinical practice. Specifically, the focus of this FOA is on the identification and initial biological, analytical and clinical evaluation of biomarkers and biomarker signatures for neurological and neuromuscular disorders. Although research supported by this FOA can include animal studies, it must also include preliminary human evaluation using carefully standardized human samples or datasets. The goal of this initiative is to deliver candidate biomarkers or biomarker signatures that are ready for definitive analytical and clinical validation studies.

The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The overarching goal of this NIH Science Education Partnership Award (SEPA) program is to support educational activities that increase understanding of biomedical research among pre-college (pre-kindergarten to grade12) individuals, and to encourage awareness of and continued interest in careers in science, technology, engineering, and mathematics (STEM).

The overall goal of the Stimulating Access to Research in Residency (StARR) program is to provide resident clinicians in training with in-depth research experiences early in their careers, in order to recruit, retain and accelerate independence of a pool of clinician-investigators with both clinical and research experience necessary to perform basic, clinical and/or translational research.

The purpose of the Academic Career Excellence (ACE) Award (K32) is to support rigorous, mentored scientific research and career development for up to three years for early-stage postdoctoral scholars. Candidates must submit their application up to one year prior to beginning their postdoctoral position or no more than two years after their postdoctoral training begins (resubmissions included). The ACE K32 will foster early, goal-directed planning and encourage innovative applications with the potential for a significant impact on scientific research and career development. Inclusion of preliminary data are not required as the ACE K32 emphasizes innovative research ideas and thoughtful plans for training and mentorship that will facilitate the development of the postdoctoral scholars who have the potential to become productive, independent investigators in research fields relevant to the missions of the participating NIH Institutes and Centers.

The goal of this notice of funding opportunity (NOFO) is to address the opioid crisis and/or overdose events by supporting action-oriented research, accelerating the translation of addiction epidemiology, prevention, treatment services, and recovery research to practice. Proposed studies may target the individual, provider, organizational, community, or system level. This initiative prioritizes replicable and scalable approaches for accelerating the routine use of effective, evidence-based prevention, treatment and recovery interventions and services. The translation of research to practice and research relevant to chronic pain comorbid with substance use is also a priority. Research may deploy a variety of methods and approaches, including but not limited to identifying and characterizing malleable factors, developing and testing interventions and implementation strategies, deploying and testing collaborative data science approaches, and/or developing and testing approaches that integrate the collaboration of researchers and decision-makers at any levels (e.g., clinical-, health system-, public health- or policy-level).

The goal of the NHLBI Catalyze Program is to provide a comprehensive suite of support and services to facilitate the transition of basic science discoveries into viable diagnostic and therapeutic candidates that have been cleared for human testing, and to develop translational researchers fluent in product development and entrepreneurship. This specific Catalyze Product Definition initiative will provide the early stage translational supportneeded for the activities required to identify and characterize potential therapeutic candidates and combination products to treat HLBS diseases and disorders. This initiative has a companion initiative that supports development of devices and diagnostics and is also part of a suite of innovation grants to advance projects to the point where they can meet the entry criteria for the NHLBI Catalyze Preclinical Program.

The purpose of this Notice of Funding Opportunity (NOFO) is to encourage applications seeking to develop the next generation of brain stimulation devices for treating mental health disorders. Applications are sought that will either 1) develop novel brain stimulation devices or 2) significantly enhance, by means of hardware/software improvements, the effectiveness of brain stimulation devices that are currently U.S. Food and Drug Administration (FDA)-approved or cleared. Novel devices should move beyond existing electrical/magnetic stimulation and develop new stimulation techniques capable of increased spatiotemporal precision as well as multi-focal, closed-loop approaches. Applications seeking to develop new capabilities should focus on significant enhancement of the spatial resolution, depth of delivery, and/or precision of the device. Incremental changes to existing devices (e.g., software updates)are not within the scope of this announcement. Applications should be submitted by multi-disciplinary teams with a variety of expertise including systems neuroscience, engineering, clinical, and regulatory affairs.

This Notice of Funding Opportunity (NOFO) encourages applications for support of resources that will provide access to state-of-the-art equipment, technologies, research tools, materials, organisms, software, and/or services to a substantial regional (multi-state) or national user base. Only those resources with technical capabilities that fall within the NIGMS-supported program areas are eligible for awards. The resources should already be established or may be formed through consolidation of existing local or regional facilities. The intent is to provide resource access to investigators without regard to the specific biomedical focus of their research, while not duplicating or replacing resources supported by sources such as other NIH Institutes and Centers (ICs) or host institutions. The resource is expected to be maintained or upgraded to current best practices, make its capabilities and availability known to the biomedical research community through a robust web presence and outreach activities, and provide user training and support.

This R61/R33 concept complements NIMHs suite of clinical trial NOFOs by supporting feasibility and infrastructure development (R61) followed by well-powered clinical trials (R33) to test the effectiveness of system interventions and strategies for improving the organization, delivery, coordination, and clinical and functional outcomes of mental health services. System interventions - which may span, for example, structural, policy, organizational, and interpersonal domains - attend to issues about the access, equity, engagement/utilization, value (cost/financing), management, or quality and safety of mental health services, with the goal of improved care processes and clinical and functional outcomes. Accordingly, the focus of system interventions may include a variety of care settings, such as health systems and organizations, mental health and community clinics, schools, and child welfare or juvenile justice systems

NIMH seeks applications for research projects to evaluate the effectiveness of therapeutic and service delivery interventions for the post-acute management of mental health conditions affecting youth, adults, and older adults. This Notice of Funding Opportunity (NOFO) encourages clinical trials to establish the effectiveness and test hypotheses regarding moderators, mediators, and mechanisms of action of post-acute phase therapeutic and services interventions that are matched to the stage of illness in terms of both their focus (e.g., consolidating and maintaining gains from initial treatment, managing residual symptoms/impairment, preventing relapse, promoting adherence and appropriate service use) and intensity/burden for promoting optimal longer-term outcomes. This NOFO is intended to support effectiveness trials testing post-acute phase interventions that are statistically powered to provide a definitive answer regarding the study intervention's effectiveness. Support for pilot effectiveness trials to evaluate the initial feasibility, tolerability, acceptability, safety and preliminary indications of effectiveness of post-acute phase intervention approaches is provided via a companion R34 (Currently TEMP-24814)

This Notice of Funding Opportunity announcement (NOFO) invites applications for the Clinical and Translational Science Award (CTSA) Program hubs that will be part of a national, collaborative consortium focused on bringing more treatments for all people more quickly through advancing clinical and translational science (CTS) by (1) developing, demonstrating, and disseminating scientific and operational innovations that improve the efficiency and effectiveness of clinical translation from identification to first-in-human studies to medical practice implementation to community health dissemination; (2) promoting partnerships and collaborations to facilitate and accelerate translational research projects locally, regionally, and nationally; (3) creating, providing, and disseminating innovative research programs and partnerships across institutions and communities to address health disparities and deliver the benefits of translational science to all; (4) creating and implementing scientific and operational innovations that increase the quality, safety, efficiency, effectiveness, and informativeness of clinical research; (5) providing a national resource for the rapid response to urgent public health needs; and (6) creating, providing, and disseminating CTS training for clinical research professionals of all disciplines on the research team.

The National Center for Advancing Translational Sciences (NCATS) will award Institutional Research Career Development (K12) programs through the Clinical and Translational Science Awards (CTSA). The purpose of this Notice of Funding Opportunity (NOFO) is to encourage institutions to propose creative and innovative institutional research career development programs designed to prepare an outstanding heterogeneous pool of promising later stage postdoctoral fellows and junior faculty scholars who have made a commitment to independent clinical and translational science research careers (i.e., tenure-track or equivalent faculty positions)to facilitate their timely career advancementand continued engagement in research (i.e., sectors including academia, industry, nonprofit and government).

The goal of this funding opportunity announcement (FOA) is to fund meritorious vision-related research projects that involve secondary data analyses using existing database resources. The development of statistical methodology necessary for improving methods to analyze vision health data using existing vision data may also be proposed.

This notice of funding opportunity (NOFO) provides funding to conduct efficacy studies in an established rare disease preclinical model to demonstrate that a proposed therapeutic agent warrants further development. In addition to preclinical efficacy, accompanying pharmacodynamic and pharmacokinetic studies would be supported. Therapeutic agents include small molecules, biologics or biotechnology-derived products. The goal of this NOFO is to spur therapeutic development for a variety of rare diseases by advancing projects to the point where they would attract subsequent investment supporting full Investigational New Drug (IND) application development or progression to clinical trials in the case of repurposing or repositioning.

The Commercialization Readiness Pilot (CRP) program helps small business concerns (SBCs) move NIH-funded SBIR or STTR projects from late-stage development to commercialization. The CRP supports later-stage research and development (R&D) and/or technical assistance that Phase II and Phase IIB Strategic Breakthrough awards do not typically support. This includes:Independent replication or confirmation of key studiesIND- or IDE-enabling studiesClinical studiesManufacturing scale-up and related quality activitiesRegulatory and other specialized technical supportSBCs may subcontract (outsource) a significant amount of the work in a CRP to meet the project goals.

The National Institutes of Health (NIH) Research Education Program supports research education activities in the mission areas of the NIH. The overarching goal of the Research Education program is to:Support educational activities that complement and/or enhance training of a workforce to meet the nation's biomedical, behavioral and clinical research needs;Help recruit individuals with specific specialty or disciplinary backgrounds to research careers in biomedical, behavioral and clinical sciences; andFoster a better understanding of biomedical, behavioral and clinical research and its implications.

The purpose of this notice of funding opportunity (NOFO) is to facilitate the entry of investigators into multiple high-priority areas of substance use research, including comorbidity with HIV. The Science Track Award for Research Transition (START) Program aims to provide investigators with the opportunity to gather preliminary data that will assist them in securing future research grants and advancing their scientific careers.