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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).

The purpose of the INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Predoctoral to postdoctoral Fellow Transition award (F99/K00) is to recruit exceptional graduate students from a variety of research fields to pursue postdoctoral training focused on Down syndrome related research. Talented graduate students from disciplines including, but not limited to, genetics, biochemistry, data science, imaging, engineering and neurobiology are invited to apply to this opportunity. Prospective applicants are strongly encouraged to contact the INCLUDE Program Staff prior to initiating plans for application submission.

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.

The Center for Inherited Disease Research (CIDR) high-throughput genotyping, sequencing and supporting statistical genetics services are designed to aid the identification of genes or genetic modifications that contribute to human health and disease or to enhance existing collections of well-phenotyped specimens in biorepositories by the addition of genotype or next-generation sequence data. The laboratory specializes in genomic services that cannot be efficiently carried out in individual investigator laboratories. CIDR provides the most up-to-date platforms, services and statistical genetic support. This is an NIH-wide initiative that is managed by NHGRI. Information about current services offered can be accessed via: http://www.cidr.jhmi.edu.

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

The purpose of the notice of funding opportunity (NOFO) is to solicit applications for a Coccidioidomycosis Collaborative Research Centers (CCRC) program. This new initiative will establish highly collaborative, multi-disciplinary, research teams to conduct translational and clinical research to support the development of a Valley fever vaccine as outlined in NIAID's Strategic Plan for Research to Develop a Valley fever Vaccine.

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...

The purpose of this notice of funding opportunity (NOFO) is to support applications for the Tuberculosis (TB) Research Advancement Centers (TRACs) program. The goal of the TRACs is to develop the next generation of TB researchers and to catalyze multidisciplinary and innovative TB science by providing expertise and resources to facilitate basic and clinical TB research.

The purpose of the NIA Career Transition Award (CTA) is to facilitate the transition of mentored researchers to tenure-track faculty conducting research that advances the mission of NIA. This three-year award provides protected time through salary and research support and is targeted at applicants who plan to start a tenure-track faculty position within a year of the award.

The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The over-arching goal of this NINDS 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.

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...

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 Ill and beyond) application submitted underTEMP-26943. The DCC application must be specific to the collaborating 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 the NCCIH and considered a high priority by the Center. For additional information about the mission, strategic vision, and research priorities of the NCCIH, applicants are encouraged to consult the NCCIH website: (http://www.nccih.nih.gov). Applicants are strongly 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) aims to support new biomedical, behavioral, and social science investigators who are in the early stages of establishing independent careers in tobacco regulatory research. The R03 grant mechanism supports 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. Applicants are encouraged to conduct projects that ultimately have the potential to inform regulations on tobacco product manufacturing, distribution, and marketing. Research projects must address one or more High-Priority Research Topic(s) related to the regulatory authority of the Food and Drug Administration (FDA) Center for Tobacco Products (CTP) as mandated by the Family Smoking Prevention and Tobacco Control Act (FSPTCA), Public Law 111-31. The awards under this NOFO will be administered by NIH using funds made available through FDA CTP and the FSPTCA. Research results from this NOFO are expected to generate findings and data directly relevant to informing the FDA's regulation of the manufacture, distribution, and marketing of tobacco products to protect public health.

The purpose of this notice of funding opportunity (NOFO) is to solicit applications for pilot projects to identify new druggable targets for pain within the understudied druggable proteome. Awards will support generation of preliminary data and/or tools around eligible understudied protein(s) listed in this NOFO. This NOFO is intended to jumpstart research on understudied proteins within the context of pain and pain management and provide applicants with sufficient funding to perform basic biochemical and/or biological work to further the characterization of understudied proteins to identify new druggable targets for pain. This NOFO is part of the NIH Helping to End Addiction Long Term (HEAL) initiative to accelerate the development of novel medications to treat all aspects of the opioid addiction cycle, including progression to chronic use, withdrawal symptoms, craving, relapse, and overdose.

The National Human Genome Research Institute (NHGRI) seeks to broaden the types of knowledge, skills, expertise, experience, and perspectives brought to bear in research addressing the ethical, legal and social implications (ELSI) of advances in human genetics or genomics. This Notice of Funding Opportunity (NOFO) solicits UM1 applications from domestic organizations located in the United States and its territories that received less than $30 million per year in total NIH funding for the past three fiscal years. These organizations are underrepresented among those receiving NHGRI funding for ELSI research. The Building Partnerships and Broadening Perspectives to Advance Ethical, Legal, and Social Implications (ELSI) Research (BPAER) Program will support: 1) transdisciplinary ELSI research addressing timely, complex, and understudied topics, 2) the establishment of research teams that include representatives from relevant communities who are affected by and have an interest in the proposed research, 3) research capacity building to develop, conduct and sustain ELSI research, and 4) workforce development opportunities for early career scholars, research team members, and other research project staff. Transdisciplinary ELSI research projects require involvement from two or more fields of knowledge and use of multiple research approaches. Relevant communities must be actively and meaningfully involved on ELSI research teams across all phases of proposed research projects. Research capacity building plans must be informed by a needs assessment. Given the complex structure, a str...

This Funding Opportunity Announcement (FOA) encourages joint applications for the Global Infectious Disease (GID) Research Training programs from U.S. and low- and middle-income country (LMIC) institutions. The application should propose a collaborative training program that will strengthen the capacity of a LMIC institution to conduct infectious disease research. FIC will support research-training programs that focus on major endemic or life-threatening emerging infectious diseases, neglected tropical diseases, infections that frequently occur as co-infections in HIV infected individuals or infections associated with non-communicable disease conditions of public health importance in LMICs. Training related to prevention, treatment or public health approaches to any technical area of basic, epidemiology, clinical, behavioral or social science health research may be supported. Research Training programs should incorporate didactic, mentored research and career development skills components to prepare individuals for careers that will have significant impact on the priority health research needs of LMICs. This Funding Opportunity Announcement (FOA) allows support of [trainees] as the lead investigator of an independent clinical trial; or a separate ancillary clinical trial or proposing to gain research experience in a clinical trial led by another investigator, as part of their research and career development.

The U.S. Department of Agriculture (USDA), Rural Development (RD) Rural Business‐Cooperative Service (RBCS or Agency), requests applications for the Meat and Poultry Processing Expansion Program - Phase 4 (the Program or MPPEP-4) - Fortifying the American Beef Industry. MPPEP-4 is authorized under Section 1001(b)(4) of the American Rescue Plan Act of 2021 (ARPA), which provides funding to make “loans and grants and provide other assistance to maintain and improve food and agricultural supply chain resiliency.” Pursuant to this authority, USDA is making competitive grant funding available to Very Small Processors and Small Processors, and to Intermediate Processors to maximize the value and utilization of their existing capacity, with a focus on promoting local supply chains.   Grant funding in the amount of $60 million is available under this Program. Funding will be divided equally into two separate competitions: one for Very Small Processors and Small Processors, and one for Intermediate Processors. Each competition will have its own ranking and award process. Cost share is required. Applicants will be required to identify sources and amounts that will make up the required cost share in the application and will need to verify cost share funding prior to final award approval. Two types of applications for each of the funding competitions will be accepted:1.      Processing Expansion Projects. Awards will range from $50,000 to $2 million to support a range of activities to increase and diversify processing capacity of American Meat and Poultry, including Equipment-only purc...

The Blueprint Neurotherapeutics Network (BPN) invites applications from neuroscience investigators seeking support to advance their small molecule drug discovery and development projects into the clinic. Participants in the BPN are responsible for conducting all studies that involve disease- or target-specific assays, models, and other research tools and receive funding for all activities to be conducted in their own laboratories. In addition, applicants will collaborate with NIH-funded consultants and can augment their project with NIH contract research organizations (CROs) that specialize in medicinal chemistry, pharmacokinetics, toxicology, formulations development, chemical synthesis including under Good Manufacturing Practices (GMP), and Phase I clinical testing. Projects can enter either at the Discovery stage, to optimize promising hit compounds through medicinal chemistry to the Development stage, to advance a single development candidate through Investigational New Drug (IND)-enabling toxicology studies and phase I clinical testing. Alternatively, projects can enter at the Development stage and progress in a shorter period to IND enabling toxicology studies and phase I clinical testing. BPN awardee Institutions retain their assignment of IP rights and gain assignment of IP rights from the BPN contractors (and thereby control the patent prosecution and licensing negotiations) for drug candidates developed in this program.

This Funding Opportunity Announcement (FOA) encourages grant applications for Biomedical Technology Resource Centers (BTRCs). BTRCs are national resource centers for conducting research and development on new technologies that are driven by the needs of basic, translational, and/or clinical researchers. BTRCs also make their technologies available to other investigators, train members of the research community in the use of the technologies, and disseminate the technologies broadly.

This initiative seeks to solicit applications for research projects that address the link between social disconnection including both objective social isolation as well as perceived social isolation (otherwise known as loneliness) and suicide in late-life. Emphasis is placed on research that identifies neurobiological and environmental mechanisms associated with social isolation and loneliness that increase risk for suicidal thoughts and behavior in late-life, that uses an experimental therapeutics approach to identify targets and develop and test interventions to prevent late-life suicide, and that develops new and modifies existing service delivery models to enhance social connection in late-life to prevent suicide.

The goal of this Funding Opportunity Announcement (FOA) is to encourage applications for studies that will enhance knowledge of mechanisms associated with neuropsychiatric symptoms (NPS) in persons with Alzheimer's disease (AD) or Alzheimer's disease-related dementias (ADRD). The findings are expected to advanceadavnce mechanistic understanding of both biobehavioral and neurobiologfical pathways leading to NPS. Findings may also provide insight into novel therapeutic targets that can be advanced into interventions to treat and prevent the development of NPS in AD and/or ADRD.

Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) along with other participating Institutes encourages submission of applications proposing to conduct secondary data analysis and integration of existing datasets and database resources, with the ultimate aim to elucidate cancer risk and related outcomes (e.g., risk prediction or reduction, survival, or response to treatment, etc.). The goal of this initiative is to address key scientific questions relevant to cancer by supporting the analysis of existing clinical, environmental, surveillance, health services, vital statistics, behavioral, lifestyle, genomic, and molecular profiles data. Applicants are encouraged to leverage and perform innovative analyses of the existing data. Applications may include new research aims that are being addressed with existing data, new or advanced methods of analyses, or novel combinations and integration of datasets that allow the exploration of important scientific questions in cancer research.

Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) invites applications for projects to expand, improve, or transform the utility of mammalian cancer and tumor models for translational research. With this NOFO, the NCI intends to encourage submission of projects devoted to demonstrating that mammalian models or their derivatives used for translational research are robust representations of human biology, are appropriate to test questions of clinical importance, and provide reliable information for patients' benefit. These practical goals contrast with the goals of many mechanistic, NCI-supported R01 projects that employ mammals, or develop and use mammalian cancer models, transplantation tumor models, or models derived from mammalian or human tissues or cells for hypothesis-testing, non-clinical research. Among many other possible endeavors, applicants in response to this FOA could propose demonstrations of how to overcome translational deficiencies of mammalian oncology models, define new uses of mammalian models or their genetics for unexplored translational challenges, advance standard practices for use of translational models, test approaches to validate and credential models, or challenge current practices for how models are used translationally