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The NEI uses UG1 cooperative agreement awards to support investigator-initiated large-scale clinical trials, human gene-transfer, stem cell therapy trials, and other complex or high resource- or safety-risk clinical trials. These projects are multifaceted and of high public health significance requiring clear delineation of study organization including roles and responsibilities and require careful performance oversight and monitoring. For purposes of this Notice of Funding Opportunity (NOFO), the proposed study must be intended to evaluate interventions aimed at screening, diagnosing, preventing, or treating vision disorders, or to compare the effectiveness of two or more established interventions. The NEI UG1-supported studies are typically funded as a group of single-component companion grant awards including the Chairs Grant, the Coordinating Center, and Resource Centers, when appropriate. Specifically, this NOFO encourages applications for the Resource Center grant which provides imaging, laboratory, or other requisite services for a multi-center clinical trial or other complex or high-risk clinical trial.

The NEI uses UG1 cooperative agreement awards to support investigator-initiated large-scale clinical trials, human gene-transfer, stem cell therapy trials, and other complex or high resource- or safety-risk clinical trials. These projects are multifaceted and of high public health significance requiring clear delineation of study organization including roles and responsibilities and require careful performance oversight and monitoring. For purposes of this Notice of Funding Opportunity (NOFO), the proposed study must be intended to evaluate interventions aimed at screening, diagnosing, preventing, or treating vision disorders, or to compare the effectiveness of two or more established interventions. The NEI UG1-supported studies are typically funded as a group of single-component companion grant awards including the Chairs Grant, the Coordinating Center, and Resource Centers, when appropriate. Specifically, this NOFO encourages applications for the Coordinating Center grant, which provides details of the Coordinating Center's responsibilities and operations.

The NEI uses UG1 cooperative agreement awards to support investigator-initiated large-scale clinical trials, human gene-transfer, stem cell therapy trials, and other complex or high resource- or safety-risk clinical trials. These projects are multifaceted and of high public health significance requiring clear delineation of study organization including roles and responsibilities and require careful performance oversight and monitoring. For purposes of this Notice of Funding Opportunity (NOFO), the proposed study must be intended to evaluate interventions aimed at screening, diagnosing, preventing, or treating vision disorders, or to compare the effectiveness of two or more established interventions. The NEI UG1-supported studies are typically funded as a group of single-component companion grant awards including the Chairs Grant, the Coordinating Center, and Resource Centers, when appropriate. Specifically, this NOFO encourages applications for the Chair's grant, which includes the scientific rationale, study aims and significance of the research project.

The Housing Policy Research Grant Notice of Funding Opportunity provides competitive awards to eligible applicants, including institutions of higher education, nonprofit, and for-profit institutions. Awards made through this NOFO will fund quality research projects that: (1) contribute to knowledge about housing policy in the United States; and (2) generate actionable insights and evidence that can applied by policymakers and communities in the short-term.

This NOFO seeks proposals for rigorous applied research and evaluative studies on the forensic science system. The field of forensic science is changing, particularly as technological advancements improve the criminal justice system’s ability to use forensic evidence more effectively and efficiently. Research is needed to better understand the impact of forensic science on the criminal justice system and law enforcement operations. With this NOFO, NIJ requests applications in three topic areas: • The impact of forensic science on the criminal justice system and law enforcement operations, such as improving investigative clearance rates, increasing law enforcement effectiveness, and reducing crime lab backlogs. • Evaluations of the implementation of new and innovative forensic science methods and their impact on strengthening courtroom admissibility and evidentiary reliability. • Developing the forensic science workforce.

The purpose of this notice of funding opportunity (NOFO) is to support the establishment or continuation of longitudinal infant cohorts to determine and compare how initial and repeated natural influenza infections and/or influenza vaccinations shape infant and childhood immunity to future influenza exposures. The goal of this research is to understand how these exposures influence immune responses to subsequent influenza infections and/or vaccines and provide key information to facilitate design of durable, broadly protective influenza vaccines.

This NOFO seeks applications for rigorous applied research on the intersection of drug crimes and firearms to inform the development of evidence-based tools, practices, and policies for state, tribal, and local law enforcement and other criminal justice stakeholders that address drug trafficking, drug markets, and drug-related violence. With this FY25 NOFO, NIJ seeks applications in four topic areas: (1) Pattern Identification; (2) Interdiction & Disruption Strategies; (3) Prosecution; and (4) Drug Market Dynamics.

Background The FDA Oncology Center of Excellence (OCE) aims to advance the development and regulation of oncology products for patients with cancer. The Pediatric Oncology Program and Rare Cancers Program were established to facilitate and expedite drug development for pediatric and other rare cancers. OCE’s Project Catalyst connects scientific knowledge, creative insight, and medical professionals to foster early-stage product innovation, which is particularly important to address the challenges related to product development for ultra-rare cancers. In collaboration with the National Institutes of Health (NIH) and the OCE, the Foundation for the National Institutes of Health (FNIH) recently launched the design phase of the Ultra-Rare Cancer Treatment Advancement Program (ULTRA), a new public-private partnership dedicated to accelerating the development of innovative ultra-rare cancer treatments.  For the purposes of this NOFO, the FDA OCE refers to cancers with an approximate annual incidence in the U.S. of 300 to 400 people or less as ultra-rare (a more stringent criterion compared to the threshold for a rare disease specified in the Orphan Drug Act based on a U.S. prevalence of

The goal of this NOFO is to gather unique information not collected by other federal programs to gain a better understanding of the resources (e.g., services, supports) and opportunities (e.g., education, employment, housing, social participation) needed to reduce morbidity, mortality, and economic impacts and improve other long-term outcomes for people with autism or Fragile X Syndrome (FXS) across the lifespan. CDC proposes to implement three components in this NOFO.Component A: Survey to Promote Resources and Opportunities for aUtistic Teens and young adults (SPROUT) will utilize cohorts from the Study to Explore Early Development (SEED) Phases 1-3 (collected from 2007-2020), which were case-control studies of autism in children 2-5 years of age. Participants will range from about 10-25 years of age when this NOFO is awarded. SPROUT will be comprised of caregiver and self-report surveys intended to offer unique information on (1) service and support needs and the impact of co-occurring conditions on autistic people and their families and (2) the educational, transitional, social, and/or vocational needs and experiences of autistic adolescents and young adults. Information from these surveys will be used to improve the health and wellbeing of autistic people and their families. These activities are intended to provide data to inform ways to lessen individual, familial, and societal costs associated with autism, reduce morbidity and mortality, and improve health and well-being.Component B: Focus on Advancing Support and Transition with the Fragile X Online Registry With Ac...

This NOFO will support research and evaluation of emerging technology implementation and impact for law enforcement purposes. Topics include policies, trainings, operational and staffing issues; communications strategies associated with technology implementation; and impacts of technology implementation and use on public safety and agency budgets. NIJ encourages researchers and practitioners to partner or build on existing researcher-practitioner partnerships to guide the law enforcement community on the best ways to implement technology to solve contemporary problems in policing. Applying for this funding opportunity involves a two-stage process that begins with submission of a concept paper. Based on the merits of the concept paper, NIJ may request that the applicant submit a full proposal. Applicants should not submit a full proposal unless invited. For information on the concept paper format, please see the General Purpose of the Funding section of this NOFO.

This Notice of Funding Opportunity (NOFO) seeks applications to optimize instrumentation and device technologies for recording and modulation of neural cells and circuits, to address major challenges and to enable transformative understanding of dynamic signaling in the central nervous system. It is expected that the proposed technologies and approaches have previously demonstrated their transformative potential through initial proof-of-concept testing, and are ready for accelerated refinement through iterative engineering and end-user feedback, appropriate for a path towards sustainable dissemination and user-friendly incorporation into routine neuroscience research. Applications may propose development of instrumentation hardware and/or devices and associated software. Approaches may utilize any modality such as optical, electrical, magnetic, or acoustic recording/manipulation, to target neuronal electrical signals or other forms of neural activity, including intracellular signaling and engagement of non-neuronal cells in circuit function. This NOFO is a re-issue of RFA-NS-21-027, but unlike the previous NOFO the focus is narrowed to technologies associated with recording/manipulation instrumentation and devices, and excludes projects primarily focused on development of molecular reagents. Potential applicants primarily optimizing molecular constructs should consider RFA-MH-22-245 (or its reissue), BRAIN Initiative: Engineering and optimization of molecular technologies for functional dissection of neural circuits (UM1 Clinical Trial Not Allowed). For projects at an earli...

The purpose of this Program Announcement (PAR) is to enable clinical validation of strong candidate biomarkers for neurological diseases and conditions. Specifically, the goal of this PAR is to enable the rigorous validation of biomarker measurements within the clinical population of interest to establish the positive and negative predictive values of the candidate biomarker consistent with FDA guidelines. This PAR assumes that 1) a candidate biomarker has already been identified, 2) detection method technology has already been developed and analytically validated, and 3) the research and/or clinical need and potential context of use has been identified.

The purpose of this notice of funding opportunity (NOFO) is to support rigorous analytical validation of method(s) used for measuring biomarkers for neurological and neuromuscular disorders for use in clinical trials or clinical practice. Applicants must justify the unmet need for the biomarker(s) and measurement methods and specify one or two context(s) of use for the biomarker(s). Activities supported include optimizing and evaluating the accuracy, precision, reportable range, and analytical sensitivity and specificity of the detection method across multiple sites and operators and establishing reference intervals and quality control procedures. Multi-site applications are expected but not required.

The purpose of this proposed Notice of Funding Announcement (NOFO) is to support development of biomarkers or clinical outcomes derived from digital health technology (DHT) for use in clinical trials for remote monitoring as primary or secondary endpoints. To improve clinical impact, increase statistical feasibility, and promote standardization, applicants will be expected to develop and test the digitally derived assessments in populations from at least three different diseases or conditions. Partnerships with non-profit patient advocacy organizations will be required.

This notice of funding opportunity (NOFO) supports research, implementation science, and public health evaluations to inform best practices for preventing and responding to infectious disease threats in Kenya, while strengthening local research capacity.The award recipient will conduct research, implementation science, and public health evaluations through the Kenya Medical Research Institute (KEMRI) and focus on four required priority areas:Influenza and other respiratory pathogens: Activities include surveilling high-risk groups; monitoring for human and avian influenza and other pathogens; and evaluating efficacy and use of vaccines and other treatments. Outcomes include increasing understanding of disease burden and improving vaccination strategies.Vaccine-preventable diseases: Research will assess disease burden, vaccine effectiveness, and sociocultural factors influencing immunization. Outcomes include increasing vaccine uptake and strengthening immunization systems.Drug-resistant infections: Activities include monitoring antimicrobial resistance (AMR) trends, applying novel diagnostics, and identifying drivers of resistance. Outcomes include improving mitigation strategies and global AMR preparedness.Global and emerging health threats: Research will address malaria, HIV, tuberculosis, schistosomiasis, and emerging infections. Outcomes include improving understanding of disease dynamics, intervention effectiveness, and cross-border risks.The recipient will also conduct research coordination and administration activities to manage and oversee U.S. government–funded pub...

The National Institute for Occupational Safety and Health (NIOSH) supports research projects that address: (1) physical and mental health conditions related to the September 11, 2001, terrorist attacks; (2) diagnosing conditions for which there has been diagnostic uncertainty; and (3) treating conditions for which there has been treatment uncertainty. Conditions may have emerged since the treatment program began or since the WTC Health Program was established. This announcement solicits meritorious and scientifically rigorous applications that will: 1) improve diagnosis and treatment activities of the WTC Health Program; 2) expand knowledge about health effects related to the September 11, 2001, terrorist attacks; 3) answer critical questions about WTC-related physical and mental health conditions; and 4) apply lessons learned to improve response to future disasters. Potential projects may include, but are not limited to: (a) Screening research to evaluate current methods or facilitate the development of new or improved methods to detect disorders or health conditions; (b) Diagnostic research to evaluate current methods or facilitate the development of new or improved methods to identify diseases, disorders, or conditions; (c) Treatment research to evaluate or identify improved treatment interventions or methods, or to promote development of new or novel approaches; (d) Prevention research to identify or evaluate methods and interventions that prevent or mitigate the development or recurrence of diseases or disorders; (e) Quality of life research to identify, develop, or ev...

NOAA/NMFS is soliciting competitive proposals for grants and cooperative agreements for projects that will support NOAA’s mission for stewardship of living marine resources and the sustainable management of U.S. commercial longline fisheries. Projects will ensure data pipelines are in place to inform the sustainable management of U.S. commercial fisheries that interact with endangered species as they migrate throughout the Pacific — a problem that has led to fishery closures when annual interaction limits are reached. Through these efforts, NOAA will strengthen the competitiveness of U.S. commercial longline fisheries, creating a more level playing field for American fishermen, while reinforcing U.S. leadership in marine resource management. Projects must benefit aggregations of endangered marine turtles that have documented linkages to the Pacific Islands Region (PIR), are impacted by PIR federally managed commercial fisheries, and address NOAA’s Endangered Species Act (ESA) recovery obligations. For the Fiscal Year (FY) 2026 funding competition, we are soliciting projects that: 1) monitor and implement protection measures to conserve western Pacific leatherback sea turtles occurring in the Coral Triangle region (Indonesia, Malaysia, the Philippines, Papua New Guinea, or Solomon Islands); 2) monitor and implement protection measures to conserve North Pacific loggerhead sea turtles in Japan; and 3) progress conservation momentum and build capacity for research, monitoring and protection of endangered marine turtle populations in order to benefit U.S. trust resources that oc...

Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) solicits applications from institutions/organizations that propose to maintain or establish Lead Academic Organizations (LAOs) as part of the NCI Experimental Therapeutics Clinical Trials Network (ETCTN). ETCTN LAOs will design, develop, monitor, conduct, and analyze early phase clinical trials (e.g., phase 0, phase 1, phase 2, pilot, and other experimental therapeutic clinical trials) involving agents under regulatory sponsorship for New Investigational Drug (IND) applications held by NCI's Division of Cancer Treatment and Diagnosis (DCTD), Cancer Therapy Evaluation Program (CTEP). Each ETCTN LAO will participate in clinical trials it leads as well as clinical trials led by other LAOs in the network.

Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) solicits applications from institutions/organizations that propose to maintain or establish a Pharmacokinetics Resource Laboratory (PK Laboratory) to support the Experimental Therapeutics Clinical Trials Network (ETCTN). The PK Laboratory will organize biospecimen collections and provide subsequent analyses of pharmacokinetic endpoints, drug-drug interactions, cytochrome P450 (CYP) interactions, pharmacodynamics, and food effects in ETCTN studies of NCI Investigational New Drug (IND) agents. The overarching goal of the ETCTN PK Laboratory is to advance the clinical development of NCI IND agents by providing a comprehensive understanding of pharmacokinetic behavior of these agents under study in ETCTN trials. The ETCTN PK Laboratory will engage physicians, clinical pharmacologists, nurses, and scientists who have appropriate expertise in pharmacokinetic studies for early drug development and translational research. This NOFO seeks U24 applications from multidisciplinary institutions/organizations to conduct all pharmacokinetic studies for ETCTN early phase clinical trials filed to IND applications in the NCI Division of Cancer Treatment and Diagnosis (DCTD), Cancer Therapy Evaluation Program (CTEP).

This BRAIN Initiative Notice of Funding Opportunity (NOFO) is to support scaled reagent production and distribution facilities involving technologies to access brain cell types. Facilities for production and distribution of these reagents by a broad set of neuroscientists will be encouraged. This NOFO is part of the BRAIN Initiative Armamentarium for Brain Cell Access transformative project. Efforts will be supported to produce and distribute gene transfer, gene regulation, and genome engineering reagents for use in both genetically tractable and less tractable systems, including primates and human tissue, which are relevant for future translational efforts. Reagents to be produced and distributed are those designed and validated under other NOFOs from the Armamentarium transformative project.

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

This Notice of Funding Opportunity (NOFO) solicits cooperative agreement research applications to support a multidisciplinary program titled "Accelerating Product Excellence in Innovation and for Clinical Adoption" (APEx), that will facilitate advancement of promising strategies and products for tissue engineering and regenerative medicine (TE/RM). APEx will be composed of Resource Centers (RCs) and associated Interdisciplinary Translational Projects (ITPs) in the area of therapeutics (including adult stem cell-based treatments), sensors, and diagnostics. RCs will capitalize on their available clinical, scientific, industrial, regulatory and commercialization expertise, to deliver technical support, research capacity, administrative infrastructure and regulatory and commercialization support to the ITPs and guide them to complete pre-clinical studies toward initiation of clinical trials. During this funding cycle, APEx will complete validation, manufacturing, and preclinical testing of the most promising products, which may include, but are not limited to products for detecting or treating tissue damage caused by congenital defect, traumatic injury, or chronic disease. Products that support early detection of chronic pathologies, monitoring of validated biomarkers of health or disease, as well as approaches to reduce or prevent resulting damage, are especially encouraged. The outcome of APEx will be TE/RM products with their regulatory approvals in place for first-in-human studies, along with associated clinical study protocols, and synthesis and manufacturing protocols rea...

This notice of funding opportunity (NOFO) encourages applications for investigator-initiated multi site clinical trials (e.g., efficacy, effectiveness, or pragmatic trials) to study the effects of complementary and integrative health approaches with physical and/or psychological therapeutic inputs (often called mind and body interventions), and/or multicomponent interventions that include physical, psychological, and/or nutritional approaches in NCCIH- designated areas of high research priority. Clinical Coordinating Centers (CCC) should develop and implement the proposed fully powered multi-site clinical trial (Phase III and beyond). The objective of a CCC application is to present the scientific rationale and a comprehensive scientific and operational plan for the clinical trial. CCC applications are expected to describe plans for project management, participant recruitment and retention strategies, performance milestones, scientific conduct, and dissemination of results. CCC applications submitted under this NOFO will utilize a two-phase, milestone-driven cooperative agreement (UG3/UH3) funding mechanism. In addition, an accompanying Data Coordinating Center (DCC) application (U24), submitted under PAR-24-087 proposing a data analysis and data management plan for the clinical project is required. Both a CCC application and a corresponding DCC application need to be submitted simultaneously for consideration by NCCIH. For additional information about the mission, strategic vision, and research priorities of NCCIH, applicants are encouraged to consult the NCCIH website: (h...

This notice of funding opportunity (NOFO), utilizing the U24 grant funding mechanism, encourages applications for a collaborating Data Coordinating Center (DCC) application that accompanies an investigator-initiated multi site clinical trial (Phase III and beyond) application submitted under companion PAR-21-243. The DCC application must be specific to the companion Clinical Coordinating Center (CCC) application. The objective of the DCC application is to propose a comprehensive plan that provides overall project coordination, and administrative, data management, and biostatistical support for the proposed clinical trial. Both a DCC application and a corresponding CCC application need to be submitted simultaneously for consideration by NCCIH. Trials for which this NOFO applies must be relevant to the research mission of NCCIH and considered a high priority by the Center. For additional information about the mission, strategic vision, and research priorities of NCCIH, applicants are encouraged to consult the NCCIH website (http://www.nccih.nih.gov). Applicants are encouraged to contact the appropriate 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) encourages cooperative agreement applications for investigator-initiated, multi-site, clinical trials (Phase III and beyond) to study the effects of natural products (i.e. botanicals, probiotics, and products marketed as dietary supplements) in NCCIH designated areas of high research priority. 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. Applicants should describe plans for a Clinical Coordinating Center to develop and implement the proposed multi-site clinical trial. The objective of the Clinical Coordinating Center application is to provide the scientific rationale and a comprehensive scientific and operational plan for the clinical trial. Clinical Coordinating Center applications are expected to describe plans for project management, participant recruitment and retention strategies, performance milestones, scientific conduct, and dissemination of results. Clinical Coordinating Center applications submitted under this NOFO will utilize a two-phase, milestone-driven, cooperative agreement (UG3/UH3) funding mechanism. In addition, an accompanying Data Coordinating Center application, submitted under PAR-24-125, proposing a data analysis and data management plan for the clinical project is required. Both a Clinical Coordinating Center application and a corresponding Data Coordinating Center (DCC) application need to be submitt...