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Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) intends to support extramural research to investigate and mitigate challenges facing clinical assay development and subsequent analytical validation due to preanalytical variability in tumor tissue biopsies, blood biospecimens utilized as liquid biopsies", or other biospecimens as described in this NOFO. Extramural research funded under this NOFO may include investigations of preanalytical variability associated with the procurement and study of small biopsies (core biopsies, small excision samples), blood utilized for "liquid biopsies", tissue swabs, tissue secretions, pleural and esophageal aspirates, feces, or bodily fluids like sweat, urine, CSF, breast milk and saliva. Investigator-designed experiments will explore how different biospecimen preanalytical conditions affect emerging and clinically relevant biomarkers quantified by a variety of testing platforms. The results from this research program will improve the understanding of how analytical quantification of clinically relevant biomarkers is affected by variation in biospecimen collection, processing, and storage procedures. The overall goal is to expedite biomarker clinical assay development through evidence-based standardization of biopsy handling practices.

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.

This Funding Opportunity Announcement (FOA) encourages the submission of applications that propose to advance research in cancer etiology and early detection biomarkers, utilizing the advantages of the unique biorepository resources of the NCI-sponsored Prostate, Lung, Colorectal, and Ovarian Cancer (PLCO) Screening Trial. The PLCO Biorepository offers high-quality, prospectively collected, serial pre-diagnostic blood samples from the PLCO screened arm participants, and a onetime collection of buccal cells from the control arm participants. Available data associated with the biospecimens includes demographic, diet, lifestyle, smoking, screening results, and clinical data. This FOA supports a wide range of cancer research including, but not limited to, biochemical and genetic analyses of cancer risk, as well as discovery and validation of early detection biomarkers. The proposed research project must involve use of PLCO biospecimens; additionally, it should also take advantage of the unique characteristics of the PLCO biospecimens. Research projects that do not involve the use of PLCO biospecimens will not be supported under this FOA.

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 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 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.

The purpose of this NOFO is to facilitate well planned clinical trials across the cancer prevention and control spectrum aimed at improving prevention/ interception, cancer-related health behaviors, screening, early detection, healthcare delivery, management of treatment-related symptoms, supportive care, and the long-term outcomes of cancer survivors. Although the scientific literature or preliminary data may provide the rationale for conducting a clinical trial, investigators often lack critical information about the study population, accrual challenges, intervention, outcome/ endpoints, data/statistical challenges or operational risks necessary to finalize the trial protocol completely. These information gaps can result in multiple protocol changes before and after trial start-up, leading to the need for additional time and expenses that may prevent study completion. Further, the suitability and feasibility of new trial designs, which minimize infrastructure and reduce costs may need to be tested in the context of a particular intervention, at-risk group, symptom or venue. Preparatory studies may fill information gaps and address unknowns, improving trial design and knowledge of trial feasibility and thus saving NCI time and money.

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.

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.

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 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.

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)

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 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 document...

The purpose of this announcement is to encourage investigators to pursue translational activities and clinical feasibility 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 clinical feasibility study. The clinical study is expected to provide information about the device function or final design that cannot be practically obtained through additional non-clinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. This FOA is a milestone-driven cooperative agreement program and will involve participation of NIH program staff in negotiating the final project plan before award and monitoring of research progress. Participants in Blueprint MedTech receive funding for all activities to be conducted in their own laboratories. In addition, applicants will collaborate with NIH-funded consultants to receive assistance with specialty areas including regulatory, reimbursement, intellectual property, commercialization, and strategic partnerships. Participants can also augment their project with NIH contract research organizations that specialize in large animal testing, sterilizatio...

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, ide...

This announcement supports Executive Order 14276, Restoring America’s Seafood Competitiveness, by soliciting projects that support: workforce development for marine-related professions in marine science, aquaculture/mariculture, and maritime operations; enhancing seafood safety and management through training in seafood best practices, marketing, and fishery management; technological innovation in fishing practices; outreach and education for consumers on quality and sustainability of wild caught fish or products farmed through aquaculture/mariculture; enhanced regionally-specific management of fishery resources based on local knowledge; and strengthening the seafood supply chain through partnerships with industry, researchers, and community organizations to build relationships that increase the sustainability and competitiveness of the marine community in Alaska. Proposed projects must be conducted in Alaska. 

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 purpose of this Funding Opportunity (NOFO) is to solicit grant applications to support research on the discovery and development of interventions to prevent and/or treat substance use disorders (SUDs) and overdose, including medications and medical devices to treat co-morbid SUDs. This includes preclinical and clinical research studies that will have high impact and quickly yield the necessary results to advance candidate interventions closer to regulatory approval or clinical adoption. This NOFO will utilize the UG3/UH3 activity code.

The goal of this NOFO is to fund veterinary diagnostic laboratories in the Vet-LIRN network for grants associated with projects and equipment. Specific objectives include:1. Supporting the development, adaptation, or verification/validation of new methods associated with animal food issues or antimicrobial resistance.2. Short-term surveillance or monitoring efforts aligned with the CVM mission.3. Supporting equipment for testing or developing tests associated with animal food-related issues or antimicrobial resistance, including those for emerging technologies.4. Developing projects related to antimicrobial stewardship, in alignment with CVM's key initiatives in this area.5. Contributing as part of Vet-LIRN's AMR monitoring program, including sequencing isolates.6. Supporting work associated with One Health, including emerging diseases such as COVID-19, when funding is available.

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 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...

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/Resear...

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 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.