Grants for Unrestricted - Federal

The "DoD Multiple Sclerosis, Investigator-Initiated Research Award" is a grant that supports high-quality research projects aimed at improving understanding, patient care, and quality of life for those with Multiple Sclerosis, and encourages applications from both established and early-career investigators, with a focus on projects that can provide relevant preliminary or published data.

This grant provides funding for organizations to develop solutions addressing the root causes of irregular migration from Central America to the United States, targeting countries like Guatemala, Honduras, and Costa Rica.

Maturing research ideas into clinical practice and patient benefit is at the heart of all CDMRP research programs. Despite significant investment, the gap between what is possible and what is achieved remains. Even after information, tools, and interventions have been successfully evaluated in their intended populations, the development of knowledge to support their broader dissemination and implementation has often remained outside the scope of previous clinically focused award mechanisms.The FY24 MBRP PCRA intends to bridge the gap between research, practice, and policy by building a knowledge base that provides clinically useful findings about how interventions, clinical practices/guidelines, tools, and policies can be deployed to targeted populations at the appropriate time at the point of need. Funding from this award mechanism must support clinical research or clinical trials but cannot be used for preclinical or animal research. Applications may propose prospective or retrospective research involving human subjects, human subject data/records, and human anatomical substances.The FY24 PCRA may support studies focusing on the following (not all inclusive): Research that accelerates the uptake and implementation of evidence-based research into clinical practice Comparative effectiveness research comparing the benefits and harms of emerging or established interventions and strategies to prevent, diagnose, treat, and monitor health conditions in real-world settings Development and evaluation of strategies to overcome barriers to the adoption, adaptation, integration, scale-up, and sustainability of evidence-based interventions, tools, policies, and guidelines Analysis of existing clinical data or clinical data resources to inform clinical practice Modification of established clinical tools for their intended population or environment Analysis of existing clinical tools to maximize patient-relevant outcomes Identification and analysis of the circumstances that create a need to stop or reduce (de-implement) the use of interventions, tools, policies, and guidelines that are ineffective, unproven, low-value, or harmful Analysis of burn outcomes associated with the implementation of clinical practice guidelines, evidence-based practices, and process improvements The following are important aspects of the FY24 MBRP PCRA: Precision Medicine Approaches: When appropriate, the MBRP encourages the use of precision medicine approaches. These tailored treatments deliver the right treatment at the right time while considering an individuals unique characteristics. Preliminary data are required: Inclusion of preliminary data relevant to the proposed clinical research/trial is required. Study Population: The application should demonstrate the availability of and access to a suitable patient population that will support a meaningful outcome for the study. The application should include a discussion of how accrual goals will be achieved, as well as the strategy for inclusion of women and minorities in the clinical trial appropriate to the objectives of the study. Studies utilizing human biospecimens or datasets that cannot be linked to a specific individual, gender, ethnicity, or race (typically classified as exempt from Institutional Review Board [IRB] review) are exempt from this requirement. Clinical Trial Start Date: If applicable, the proposed clinical trial is expected to begin no later than 6 months after the award date. Intervention Availability: If applicable, the application should demonstrate the documented availability of and access to the drug/compound, device, and/or other materials needed, as appropriate, for the proposed duration of the study.Rigor of Experimental Design: All projects should adhere to a core set of standards for rigorous study design and reporting to maximize the reproducibility and translational potential of clinical and preclinical research. The standards are described in SC Landis et al., 2012, A call for transparent reporting to optimize the predictive value of preclinical research, Nature 490:187-191 (http://www.nature.com/nature/journal/v490/n7419/full/nature11556.html). While these standards are written for preclinical studies, the basic principles of randomization, blinding, sample-size estimation, and data handling derive from well-established best practices in clinical studies.Applications involving multidisciplinary collaborations among academia, industry, the military Services, the U.S. Department of Veterans Affairs (VA), and other federal government agencies are highly encouraged. These relationships can leverage knowledge, infrastructure, and access to unique clinical populations that the collaborators bring to the research effort, ultimately advancing research that is of significance to Service Members, Veterans, and/or their Families. If the proposed research relies on access to unique resources or databases, the application must describe the access at the time of submission and include a plan for maintaining access as needed throughout the proposed research.A clinical trial is defined in the Code of Federal Regulations, Title 45, Part 46.102 (45 CFR 46.102) as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include a placebo or another control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.Studies that do not seek to measure safety, effectiveness, and/or efficacy outcome(s) of an intervention are not considered clinical trials.For the purposes of this funding opportunity, research that meets the definition of a clinical trial is distinct from clinical research. Clinical research encompasses research with human data, human specimens, and/or interaction with human subjects. Clinical research is observational in nature and includes:(1) Research conducted with human subjects and/or material of human origin such as data, specimens, and cognitive phenomena for which an investigator (or co-investigator) does not seek to assess the safety, effectiveness, and/or efficacy outcomes of an intervention. Research meeting this definition may include but is not limited to: (a) mechanisms of human disease, (b) diagnostic or detection studies (e.g., biomarker or imaging), (c) health disparity studies, and (d) development of new technologies.(2) Epidemiologic and behavioral studies that do not seek to assess the safety, effectiveness, and/or efficacy outcomes of an intervention.(3) Outcomes research and health services research that do not fit under the definition of clinical trial.Excluded from the definition of clinical research are in vitro studies that utilize human data or specimens that cannot be linked to a living individual and meet the requirements for exemption under 46.104(d)(4) of the Common Rule.Impact: The overall impact of the proposed research is a key component of this award mechanism. High-impact research will, if successful, lead to the clinical implementation of therapeutics, technologies, or clinical practice guidelines that advance the care of burn-injured casualties.Relevance to Military Health: Relevance to the health care needs of burn-injured military Service Members is a key feature of this award.Use of DOD or VA Resources: If the proposed research involves access to active-duty military and/or VA patient populations and/or DOD or VA resources or databases, the application must describe the access at the time of submission and include a plan for maintaining access as needed throughout the proposed research. Refer to Section II.D.2.b.ii, Full Application Submission Components, for detailed information. Refer to the General Application Instructions, Appendix 1, for additional information.Applicants are encouraged to integrate and/or align their research projects with DOD and/or VA research laboratories and programs. Collaboration with DOD or VA investigators is also encouraged. A list of websites that may be useful in identifying additional information about ongoing DOD and VA areas of research interest or potential opportunities for collaboration can be found in Appendix 2.Research Involving Human Anatomical Substances, Human Subjects, or Human Cadavers: All DOD-funded research involving new and ongoing research with human data,human anatomical substances, human subjects, or human cadavers must be reviewed and approved by the USAMRDC Office of Human and Animal Research Oversight (OHARO), Office of Human Research Oversight (OHRO), prior to research implementation. This administrative review requirement is in addition to the local IRB or Ethics Committee (EC) review. Local IRB/EC approval at the time of application submission is not required; however, local IRB/EC approval is necessary prior to OHRO review. Allow up to 3 months to complete the OHRO regulatory review and approval process following submission of all required and complete documents to the OHRO. Refer to the General Application Instructions, Appendix 1, and the OHARO web pagehttps://mrdc.health.mil/index.cfm/collaborate/research_protections for additional information.If the proposed research involves more than one institution, a written plan for single IRB review arrangements must be provided at the time of application submission or award negotiation. The lead institution responsible for developing the master protocol and master consent form should be identified and should be the single point of contact for regulatory submissions and requirements.The types of awards made under the program announcement will be assistance agreements. An assistance agreement can take the form of a grant or cooperative agreement. The level of government involvement during the projects period of performance is the key factor in determining whether to award a grant or cooperative agreement. If no substantial government involvement is anticipated, a grant will be made (31 USC 6304). Conversely, if substantial government involvement is anticipated, a cooperative agreement will be made (31 USC 6305). Substantial involvement means that members of the U.S. government will assist, guide, coordinate, or participate in project activities.The award type, along with the start date, will be determined during the negotiation process.The anticipated total costs budgeted for the entire period of performance for an FY24 MBRP Patient-Centered Research Award should not exceed $2.2M. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.Awards supported with FY24 funds will be made no later than September 30, 2025.The CDMRP expects to allot approximately $4.4M to fund approximately two Patient-Centered Research Award applications. Funding of applications received is contingent upon the availability of federal funds for this program, the number of applications received, the quality and merit of the applications as evaluated by peer and programmatic review, and the requirements of the government. Funds to be obligated on any award resulting from this funding opportunity will be available for use for a limited time period based on the fiscal year of the funds. It is anticipated that awards made from this FY24 funding opportunity will be funded with FY24 funds, which will expire for use on September 30, 2030.

30 MAY 2024: The purpose of this amendment is to provide the finalized ISO and to provide the Administrative and National Security Form. 17 MAY 2024: The purpose of this amendment is to provide an updated Draft ISO, and the cost proposal worksheets. 22 APRIL 2024: The purpose of this amendment is to extend the Full Proposal due date to August 20, 2024, at 5:00pm, ET. 10 APRIL 2024: The Advanced Research Projects Agency for Health (ARPA-H) posts this funding opportunity in support of the Personalized Regenerative Immunocompetent Nanotechnology Tissue (PRINT) Program. ARPA-H anticipates multiple awards and award types will result from this announcement. Interested parties are invited to review the attached PRINT Innovative Solutions Opening (ISO) ARPA-H-SOL-24-101. 27 MARCH 2024: The Advanced Research Projects Agency for Health (ARPA-H) posts this funding opportunity in support of the Personalized Regenerative Immunocompetent Nanotechnology Tissue (PRINT) Program. ARPA-H anticipates multiple awards and award types will result from this announcement. ARPA-H will host a Proposers Day on May 07, 2024. The event will allow for both in-person and virtual participation and is intended to facilitate teaming and foster a greater understanding of the PRINT Program. The closing date for registration is April 30, 2024, 1:00 PM ET. In-person attendance is first-come, first-served or when capacity is reached. After reviewing the attached Proposers Day information, interested parties are encouraged to register at the link below. https://arpa-h.gov/research-and-funding/programs/print Solution Summary Due Date and Time: May 28, 2024, 9:00 AM ET Proposals will be by invitation only. Proposal Due Date and Time: August 20, 2024, 9:00 AM ET For more information about ARPA-H, please visit https://arpa-h.gov

This grant seeks input from stakeholders to design a project that will enhance agricultural growth and food security in Sylhet Division, Bangladesh, addressing local challenges such as poverty, malnutrition, and climate change.

This Notice of Funding Opportunity (NOFO) expands national-to-subnational coordination to detect outbreaks and manage responses earlier, advance the National Public Health Institute of Liberias (NPHIL) broad vision for Liberias emergency response framework (ERF), and develop a national emergency management training program to support counties response capacity.

The purpose of Amendment 000002 is to revise the Funding Opportunity Announcement to revise Section I.B. Area of Interest 1 - General Requirements Item 11. - Definition of Project Progress Cells (PPCs) and Project Completion Cells (PCCs).

The grant titled "Notice Of Intent (NOI) To Issue Funding Opportunity Announcement De-Foa-0003183: Bipartisan Infrastructure Law (BIL) Section 41007(B)(1): Aerodynamics For Extreme-Scale Offshore Wind Performance And Survival (AESOPS)" aims to provide up to $5.1 million in funding to develop and validate aerodynamic design tools for large-scale offshore wind turbines, collect data on wind turbine airfoil behavior, and create reliable models to reduce the risk and cost of developing and deploying these turbines.

Invasive species pose a significant threat to the ecological, economic, and cultural integrity of Americas lands and waters and the communities they support. Once invasive species are established, it is often challenging and costly to control or eradicate those infestations. In some cases, however, eradication the removal or destruction of an entire population of invasive species from a defined area is both possible and feasible, resulting in substantial ecological and economic benefits. This can include eradication of a founding population of invasive species (e.g., a newly introduced species to a specific area) or eradicating a well-established population. Eradication, while it represents the ideal outcome in most cases, requires consideration of the available eradication techniques, cost, likelihood of success, likelihood of re-invasion, public support, complexity of environmental compliance, and availability of resources. This latter consideration is frequently a barrier to implementing eradication measures that can lead to restoring ecosystem health.Furthermore, successful eradication efforts are often dependent on the use of integrated pest management (IPM) strategies, making well informed decisions, and applying a collaborative approach. IPM is defined as an approach to managing pests that uses biological, cultural, physical, and chemical tools in a way that minimizes health, environmental, and economic risks. Collaboration with relevant parties, such as state, federal, local, tribal, territory, private, and other land managers, is often essential for successful eradication projects.For eradication to be an option, resource managers must have access to effective tools. Therefore, it is important to support both on-the-ground eradication efforts and also the research into and development of tools where they do not exist. DOI encourages leveraging science and technology to increase the likelihood of eradication of invasive species and increase the likelihood of long-term success. As such, proposals will be considered for on-the-ground projects that eradicate an invasive species or those projects that advance research that increases the effectiveness and near-term availability of eradication tools. For example, studies that lead to the development of genetic interventions and physical, mechanical, chemical, and biological eradication tools would be eligible.Examples of the type of work being targeted for this Invasive Species Eradication Funding Opportunity include:Eradication of the invasive annual grass Cenchrus spp. A Weed Risk Assessment for the invasive annual grass Cenchrus spp. in Hawaii identified the species as high risk for many reasons. It thrives and spreads in tropical climates. It is an invasive plant that affects native coastal vegetation and seabird habitat. It has spiny burs that disperse easily via clothing or feathers, reproduces by prolific seed production, and is easily spread by high winds and storms. It reaches maturity in less than one year and persists in the seedbank for one to five years. Cenchrus spp. was introduced to the remote island of Nihoa, a volcanic remnant in the Hawaiian Archipelago with many geographically distinct species including two endemic and endangered passerines and three endemic and endangered plants. Early detection and monitoring indicated that the Cenchrus spp. infestation on Nihoa dramatically increased from just seven plants observed in 2017 to over 600 plants in 2018. This expansion indicated that it was initiating its ascent of the exponential growth curve common in invasive species. Eradication efforts are underway to eradicate Cenchrus spp. from Nihoa via an integrated pest management process (e.g., physical and chemical treatments) coupled with rigorous biosecurity measures to prevent reinvasion.Research on the use of YY technology for invasive fish eradication. The Western Association of Fish and Wildlife Agencies initiated, in 2018, the YY Male Consortium (Consortium) with funding from 13 western states. The Consortium is building upon the work initiated by the State of Idaho to develop YY male broodstock for invasive brook trout. They are developing research broodstock for five additional regionally invasive species, including the common carp, walleye, lake trout, brown trout and Northern pike. Ongoing field evaluations of eradication programs using YY male brook trout in several western states indicate suppression is happening as modeled. In addition, populations in smaller systems are on the verge of documenting total eradication. This work combines multiple control tools using the principles of integrated pest management by suppressing invasive brook trout populations annually through mechanical and/or chemical control, and then stocking the equivalent number of YY males to replace those removed. YY males breed with the wild females, producing only YY males, leading ultimately to an all YY male population and population eradication. Note: This Invasive Species Eradication Funding Opportunity is separate from the Rapid Response Fund for Aquatic Invasive Species Notice of Funding Opportunity (grants.gov announcement number F24AS00175). The Rapid Response Fund for Aquatic Invasive Species is intended to support the planning and deployment of responses to newly detected populations of aquatic invasive species in pursuit of eradicating the population before it becomes established and spreads. This Invasive Species Eradication Funding Opportunity, however, is open to all taxa (see Eligible Taxa section) and can be used for eradication of newly detected populations of terrestrial invasive species, eradication of well-established populations of aquatic or terrestrial invasive species, or for research that advances tools for effective eradication of aquatic or terrestrial invasive species. Bipartisan Infrastructure Law (BIL) Ecosystem Restoration Program and DOI PrioritiesThe Bipartisan Infrastructure Law (also referred to as BIL, or the Infrastructure Investment and Jobs Act (IIJA)), Section 40804 (Ecosystem Restoration) provided funding to DOI for invasive species detection, prevention, and eradication, including conducting research and providing resources to facilitate detection of invasive species at points of entry and awarding grants for eradication of invasive species on non-Federal land and on Federal land. This Invasive Species Eradication Funding Opportunity aims to meet BILs direction to offer grants for eradication of invasive species.This funding opportunity also advances DOIs policy regarding invasive species management (524 DM 1) which identifies eradication undertaken in a cost-effective and environmentally sound manner as one objective of an integrated pest management approach. Additionally, it advances Goal 4 of the DOIs Invasive Species Strategic Plan for 2021-2025 to cost-effectively control or eradicate established invasive species populations to reduce impacts and help restore ecosystems.For this funding opportunity, collaboration with one of DOIs Keystone Initiatives is encouraged, as appropriate. DOI prioritized these Keystone Initiatives as focal areas for transformational conservation efforts across the nation. The Keystone Initiatives advance the Restoration and Resiliency Framework and include:Gravel to GravelGrasslandsHawaiian Forest BirdsKlamath BasinSagebrush EcosystemSaltmarsh, andAppalachiaPurpose and Program Grant Requirements:In Fiscal Year 2024, DOI prioritized BIL funds to establish this Invasive Species Eradication Funding Opportunity within the existing authorities of DOI, to be administered by the USFWS in collaboration with DOI bureaus. Accordingly, the DOI bureaus, through the USFWS, invite proposals to support the eradication of a newly introduced or established species in terrestrial or aquatic habitats of the United States, including the U.S. territories (aquatic habitats include freshwater, wetland, riparian, estuarian, and marine). While preference will be given to proposals that result in eradication of invasive species, research proposals that advance research that increases the effectiveness and availability of eradication tools will be considered. Eradication is defined as the removal or destruction of an entire population of invasive species. For the purposes of this funding opportunity, this means the elimination of all individuals of a distinct population in a geographically defined area that is not contiguous or connected (via natural dispersal) with other populations and that is surrounded by naturally occurring or human-made barriers sufficiently effective to prevent reinvasion as verified using monitoring and inventories. Projects targeted at eradicating a founding population of a terrestrial invasive species or those eradicating established populations of aquatic or terrestrial invasive species will be considered. Eradication can be a key resource management step that then allows other resource management objectives to be achieved, such as habitat restoration or the recovery of Threatened and Endangered Species. This funding opportunity recognizes that eradication of a widespread established invasive species is possible and can be successful late in the invasion stages, but it requires strategic approaches (such as by using IPM) and targeted investments. The intent of this funding opportunity is to promote and invest in those projects with a high likelihood of achieving eradication success and in those that have existing partnerships and plans in place. NOTE: Projects responding to founding populations of aquatic invasive species within the early detection and rapid response context should instead apply for funding through the Rapid Response Fund for Aquatic Invasive Species. Projects addressing established aquatic invasive species infestations with a high likelihood of eradication can apply for this Eradication Funding Opportunity. Proposals submitted for this opportunity should address how the proposed project supports DOIs mission, especially helping to protect vulnerable, high priority, or protected species or areas. Proposals that service underserved, or historically disadvantaged communities are also encouraged. These will be considered among the grant review criteria listed under the Application Review Information section later in this document.

The TrDA is intended to improve diagnosis now. Proposed projects must build knowledge, capacity, technology, and/or research to reduce or overcome important barriers to obtaining a diagnosis, meaningful disease monitoring, and accurate prognosis. Barriers could include, but are not limited to, technologies, cost, equitable patient access, applicability, structural and social determinants of health, clinical implementation, relationship to clinical outcome measures, biomarker validation, lack of longitudinal data to inform prediction/prognosis, and more. The investigator must clearly attune their project to provide true benefit to people living with AD/ADRD diagnoses and their families. All applications submitted to this funding opportunity must clearly indicate how the project addresses an important barrier, explain how the research will be representative of the population it intends to benefit, and demonstrate cultural competence. Culturally competent research factors the cultural background and diversity of the intended beneficiaries of the research outcomes when developing research ideas, conducting research, and implementing the research findings. Cultural competency in research is critical in reducing health disparities and enhancing the quality and impact of research by ensuring inclusivity, understanding, and responsiveness to the needs of diverse populations.Key elements of this award mechanism are: Clear pathway to applicability: To meet the intent of this mechanism, applications should be focused on a clear pathway to clinical applicability. Proposed projects should identify and begin to address gaps limiting advances in equitable, accessible, and rapid diagnosis and/or prognosis. Gaps may include but are not limited to technologies, state of the science, health equity, biomarker applicability, and more. Applications that do not clearly delineate how the proposed project addresses and/or overcomes barriers to accessible and viable diagnosis and/or prognosis do not meet the intent of this mechanism. Non-incremental advance: Proposed research should demonstrate an appreciable advance on the current state of the field. As such, preliminary data are required. Person-focused research: For diagnostic/prognostic outcomes proposed by the research to be successful, those impacted by AD/ADRD diagnoses need to buy into the approach. This means researchers should design their projects to focus on the people who need the outcomes most and partner with them. For the FY24 PRARP TrDA, inclusion of Community collaboration is required for all projects.The proposed project should leverage existing resources, where possible, and must ensure the advances proposed by the project aims are representative and applicable to diverse populations, especially including women. Careful consideration of equitable, representative inclusion of the study populations is essential to ensuring AD/ADRD diagnostic or prognostic solutions are of benefit to all and that this is a high priority for the program.For this mechanism, the investigator will host a Community meeting with a facilitated discussion, to occur within the first three quarters of the period of performance, that will help inform the execution of the research. This meeting should involve the intended research population and their Community. The intent of this meeting is to gather feedback and input that will inform the execution of the research, optimize and refine research questions and execution as well as help inform the dissemination strategy of the research outcomes. Optimizing research impact through Community collaboration: Research funded by the FY24 PRARP should be responsive to the needs of persons with AD/ADRD lived experience, family, and/or care provider communities (referred to as Community/ies from hereon in the Funding Opportunity). Establishment and utilization of effective and equitable collaborations and partnerships maximizes the near-term translational and impact potential of the proposed research. Collaborative research approaches feature shared responsibility and ownership for the research project to ensure fully integrated involvement of Community members within the research team. Collaborative research approaches such as Community-based participatory research, participatory action research, and integrated knowledge transition generate partnerships between scientific researchers and Community members to create knowledge useable by both sets of stakeholders. Recognizing the strengths of each partner, scientific researchers and Community members must collaborate and contribute their expertise equitably on all aspects of the project, which may include needs assessment, planning, research intervention design, implementation, evaluation, and dissemination. Research results are jointly interpreted, disseminated, fed back to affected communities, and may be translated into interventions or policy. These methods are critically important for Community-level interventions and can also augment the potential impact of a research program on people living with dementia, their families, and/or their care partners.These collaborative relationships are often established through integrating Community members into research teams as co-researchers, advisors, and consultants. Some examples for Community collaborations include: o Lived Experience Consultation: The research team includes at least one project advisor with AD/ADRD experience who will integrate with the research team to provide consultation throughout the planning, implementation, and dissemination of the research project. Lived experience consultants (LECs) may include individuals with AD/ADRD, their family members, care partners/caregivers, or others as appropriate.o Partnership with a Community-Based Organization: The research team establishes partnerships with at least one Community-based organization that provides consultation throughout the planning, implementation, and dissemination of the research project. Community-based organizations may include advocacy groups, service providers, policymakers, or other formal organizational stakeholders.o Community Advisory Board (CAB): A CAB is composed of multiple Community stakeholders and can take many forms, from a board of LECs to a coalition of Community-based organizations or any combination thereof. As with LECs and organizational partners, the CAB provides consultation throughout the planning, implementation, and dissemination of the research project.

The FY24 HRRP FRA mechanism is intended to support promising research that accelerates drug discovery and therapeutic development for hearing restoration after military-relevant auditory system injury. Applicants are encouraged to leverage resources and expertise at the National Center for Advancing Translational Sciences (NCATS) to improve efficiency and accelerate the translational process. A list of NCATS programs and resources supporting preclinical innovation can be found at https://ncats.nih.gov/preclinical. Applications from investigators within the military Services and applications involving multidisciplinary collaborations among academia, industry, the military Services, the VA, and other federal government agencies are highly encouraged. These relationships can leverage knowledge, infrastructure, and access to unique clinical populations that the collaborators bring to the research effort, ultimately advancing research that is of significance to Service Members, Veterans, and/or their Families. If the proposed research relies on access to unique resources or databases, the application must describe the access at the time of submission and include a plan for maintaining access as needed throughout the proposed research.

The FY24 ALSRP Therapeutic Idea Award (TIA) supports new, innovative, high-risk, high-gain ideas aimed at Amyotrophic Lateral Sclerosis (ALS) drug or therapy discovery. The studies supported by this award mechanism are expected to be hypothesis-driven and generate preliminary data for future avenues of therapeutic investigation. Projects that focus primarily on pathophysiology of ALS without development of a therapy are outside the scope of this funding opportunity.Applications may demonstrate the ability to achieve interpretable results in the absence of preliminary data supporting the hypothesis. While the inclusion of preliminary data is not prohibited, the strength of the application should rely on the approach.The key elements of this award mechanism are:Innovation: Research deemed innovative may introduce a new paradigm, challenge current paradigms, introduce novel concepts or technologies, or exhibit other uniquely creative qualities that may lead to potential therapeutics for ALS.Impact: The FY24 TIA can be for a specific ALS subtype and does not have to broadly apply to all patients. Research should be non-incremental and pioneer transformative results that could lay the foundation for a new direction in the field of ALS therapy development. Incremental research does not meet the intent of this funding opportunity.Strong Scientific Rationale: Projects that address in the intent of the mechanism should include a well-formulated, testable hypothesis based on strong scientific rationale that holds translational potential to improve ALS treatment and/or advance a novel treatment modality.Biomarkers: Applicants are required to include consideration to biomarker(s) development in parallel with their proposed Therapeutic Idea Award research for eventual clinical trials. Efforts should be mechanism-specific and may include development of target engagement biomarkers, objective pharmacodynamic biomarkers to measure the biological effect of an investigational therapeutic, or predictive/cohort-selective biomarkers that indicate whether a specific therapy will be effective in an individual patient or patient subgroup, including pre-symptomatic gene carriers. Development of markers for the purposes of diagnosis, prognosis, or measurement of disease progression apart from consideration of the therapeutic development process will not be supported and instead investigators should consider the Clinical Outcomes and Biomarkers Award (HT942524ALSRPCOBA).

The FY24 ALSRP Therapeutic Development Award supports research ranging from preclinical validation of therapeutic leads through Food and Drug Administration (FDA) Investigational New Drug (IND)-enabling studies. The proposed studies are expected to be empirical in nature and product-driven. Applicants with limited ALS experience are strongly encouraged to include collaborators with substantial experience in the relevant ALS model systems, endpoints, and pathophysiology.Applications supported by this award must begin with lead compounds in hand and must include proof-of-concept efficacy data in at least one preclinical model system of ALS, including whole animal and cellular model systems.Examples of activities that will be supported by this award include:Confirmation of candidate therapeutics obtained from screening or by other means, including optimization of potency and pharmacological properties and testing of derivatives and sister compounds.Validation of pilot efficacy studies (such as from an ALSRP Therapeutic Idea Award [TIA]), including the use of additional ALS model systems and/or replicating preliminary data with more time points or additional doses.ND-enabling studies to include: compound characterization; absorption, distribution, metabolism, and excretion (ADME) studies; studies on formulation and stability leading to Good Manufacturing Practice production methods; dose/response and toxicology studies in relevant model systems.Applicants seeking support for basic research focused on ALS drug discovery are encouraged to apply for the FY24 ALSRP TIA (Funding Opportunity Number HT942524 ALSRP TIA), which does not require preliminary data (https://cdmrp.health.mil/funding/alsrp).Mechanism-specific, predictive/cohort-selective, target engagement, and pharmacodynamic biomarker development, in parallel to the main therapeutic effort, is a critical component of the FY24 ALSRP Therapeutic Development Award. If biomarkers are already available or currently in development, how the existing biomarkers will improve trial design, patient selection, and efficiency or interpretation of the proposed ALS therapeutic approach must be apparent in the application. Development of biomarkers for the purposes of diagnosis, prognosis, or measurement of general disease progression without consideration of the therapeutic development process will not be supported. Applicants seeking support for biomarker development independent of therapeutic development are encouraged to apply for the FY24 ALSRP Clinical Outcomes and Biomarkers Award (Funding Opportunity Number HT942524ALSRPCOBA).

The FY24 ALSRP Pilot Clinical Trial Award supports the rapid implementation of clinical trials with the potential to have a significant impact on the treatment or management of ALS. Projects may range from phase 1 to small-scale phase 2 trials and should aim to de-risk and inform the design of more advanced trials by investigating safety, feasibility, biomarker application, and therapeutic efficacy in relevant patient populations. Clinical trials may be designed to evaluate promising drugs, biologics, or devices with anticipated therapeutic impact that is supported by strong scientific rationale and existing preliminary studies and/or preclinical data. Clinical trials aimed to improve aspects of patient care and ALS symptom management are also applicable to this award mechanism.Funding from this award mechanism must support a clinical trial. A clinical trial is defined as a research study in which one or more study participants are prospectively assigned to one or more interventions (which may include a placebo or another control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. For more information, a Human Subject Resource Document is provided at https://cdmrp.health.mil/pubs/pdf/Human%20Subjects%20Resource%20Document_DEC2022.pdf. Principal Investigators (PIs) seeking funding for a preclinical research project should consider one of the other FY24 ALSRP program announcements being offered. Studies that do not seek to measure safety, effectiveness, and/or efficacy outcome(s) of an intervention are not considered clinical trials.Projects proposing a therapeutic intervention (drug, biologic, and/or device) must incorporate biomarkers specific to the intervention into the trial design. Applicants must clearly describe a biomarker-driven approach and its potential to de-risk and improve the design of anticipated later-stage trials. For further description, see Attachment 13, Biomarker Statement. Biomarker development and characterization can include target engagement biomarkers, pharmacodynamic biomarkers to measure the biological effect of an investigational therapeutic, and/or predictive/cohort-selective biomarkers that indicate whether a specific therapy will be effective in an individual patient or patient subgroup.Key aspects of the FY24 ALSRP Pilot Clinical Trial Award mechanism include:Impact: Potential impact from a pilot clinical trial is not whether an intervention is ready at the conclusion of the trial, but rather if the outcomes will improve and accelerate future larger trials or clinical care and symptom management. Applications submitted to this award can have outcomes that focus on specific subpopulations of ALS patients or potentially even individual patients.Biomarker-Driven Interventions: Therapeutic outcomes should directly and substantially de-risk and inform the design of anticipated later-phase trials of the intervention under investigation.Clinical Care: Improving aspects of clinical care and symptom management should have near-term impact on patients. All interventions must offer significant potential impact for individuals affected by ALS; however, this may include just specific subpopulations or potentially even individual patients.Employing Community Collaborations to Optimize Research Impact Is Required. Research funded by the FY24 ALSRP Pilot Clinical Trial Award should be responsive to the needs of people with ALS, their families, and/or their care partners. Research teams are therefore required to establish and utilize effective and equitable collaborations and partnerships with Community members to maximize impact potential of the proposed research. These collaborations are expected to facilitate accessible, efficient, and humane clinical trials. Applications to the FY24 ALSRP Pilot Clinical Trial Award must name at least one Community partner (e.g., person with ALS, family member and/or caregiver, representative of a community-based organization) who will provide advice and consultation throughout the planning and implementation of the research project. Scientific researchers and Community members will collaborate and contribute equitably on all aspects of the project, which may include needs assessment, planning, research intervention design, implementation, evaluation, and dissemination. Interactions with other team members should be well integrated and ongoing, not limited to attending seminars and semi-annual meetings. Examples for implementing collaborative research approaches include:Person Living with ALS, Family Member, and/or Caregiver: The research team includes a person with ALS, their family member, or caregiver (past or present) as a project advisor who will provide advice and consultation throughout the planning and implementation of the research project.Partnership with a Community-Based Organization: The research team establishes partnerships with at least one Community-based organization that provides advice and consultation throughout the planning and implementation of the research project. Community-based organizations may include advocacy groups, service providers, policymakers, or other formal organizational stakeholders.Community Advisory Board: A Community advisory board is composed of multiple Community stakeholders and can take many forms, from a board of people with ALS, their family members, or caregivers to a coalition of Community-based organizations or any combination thereof. As with people living with ALS and organizational partners, the Community advisory board provides advice and consultation throughout planning and implementation of the research project.Clinical Trial Start Date and Intervention Availability: The proposed clinical trial is expected to begin no later than 12 months after the award date or 18 months after the award date for Food and Drug Administration (FDA)-regulated studies. The application should demonstrate the documented availability of and access to the drug/compound, device, and/or other materials needed, as appropriate, for the proposed duration of the study.Study Population: The application should demonstrate the availability of and access to a suitable patient population that will support a meaningful outcome for the study. The application should include a discussion of how accrual goals will be achieved, as well as the strategy for inclusion of women and minorities in the clinical trial appropriate to the objectives of the study.Research Personnel and Environment: The application should demonstrate the study teams expertise and experience in all aspects of conducting clinical trials, including appropriate statistical analysis, knowledge of FDA processes (if applicable), and data management. The application should include a study coordinator(s) who will guide the clinical protocol through the local Institutional Review Board (IRB) of record and other federal agency regulatory approval processes, coordinate activities from all sites participating in the trial, and coordinate participant accrual. The application should show strong institutional support and, if applicable, a commitment to serve as the FDA regulatory sponsor, ensuring all sponsor responsibilities described in the Code of Federal Regulations, Title 21, Part 312 (21 CFR 312), Subpart D, are fulfilled.Statistical Analysis and Data Management Plans: The application should include a clearly articulated statistical analysis plan, a power analysis reflecting sample size projection that will answer the objectives of the study, and a data management plan that includes use of an appropriate database to safeguard and maintain the integrity of the data. If FDA-regulated, the trial must use a 21 CFR 11-compliant database and appropriate data standards. For more on data standards, see https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/ FormsSubmissionRequirements/ElectronicSubmissions/UCM511237.pdf.Transition Plan: Applications should include a transition plan (including potential funding and resources) showing how the intervention will progress to the next clinical trial phase and/or improve current standards of care after the successful completion of the FY24 ALSRP Pilot Clinical Trial Award.Milestone meeting: The Principal Investigator (PI) will be required to present an update on progress toward accomplishing the goals of the award at annual, virtual In Progress Review meetings to be held during the period of performance. The PI should ideally include their Community collaboration partner(s) in the meeting. The In Progress Review Meeting will be attended by members of the ALSRP Programmatic Panel, CDMRP staff, the USAMRAA Grants/Contracts Officer, and other stakeholders.

The FY24 ALSRP Clinical Outcomes and Biomarkers Award (COBA) supports the development and/or validation of clinical outcomes and biomarkers to enrich clinical trials in Amyotrophic Lateral Sclerosis (ALS). Projects can be relevant to a specific therapy, a class of therapeutics, or to a specific ALS subtype (such as a particular genetic mutation) and do not have to broadly apply to all patients.Research may include, but is not limited to:Target engagement biomarkers.Objective pharmacodynamic biomarkers to measure the biological effect of an investigational therapeutic.Predictive/cohort-selective biomarkers that indicate whether a specific therapy will be effective in an individual patient or patient subgroup.Diagnostic, prognostic, or disease progressionValidate clinician-, observer-, patient-reported and/or performance outcomes to better support clinical trial success metrics.Define ALS subtypes using patient-based resources to link biosamples and/or digital data elements to rigorous molecular and clinical data.Realize improved strategies that better measure disease progression for people living with ALS.Augment biospecimens, outcome, or digital health data to an on-going clinical trial.Correlate clinical-trial related data (e.g., biosample, imaging, digital health data) with clinical outcomes or responses to therapies.Use of existing well-characterized and highly curated clinical resources is encouraged. Examples of patient-based ALS resources include ongoing or completed clinical trial datasets, biorepositories of clinical specimens, registries (e.g., Centers for Disease Control and Prevention National ALS Registry and/or Biorepository; https://www.cdc.gov/als/Default.html), large omics datasets, patient-report outcomes, digital biomarker datasets, and databases of clinical data and/or metadata. Active-duty military and/or Veteran patient populations or resources should be considered. A list of suitable resources can be found on the ALSRP web page (https://cdmrp.health.mil/alsrp/resources/ALSRPresources). Other resources may be used, provided they have an adequate description of repository parameters and mechanisms for broad access.

This grant provides funding for long-term ecological research at designated sites to enhance our understanding of ecosystems and their dynamics over time, primarily aimed at researchers and institutions in the field of ecology.

This Funding Opportunity Announcement (FOA) is jointly issued by the U.S. Department of Energy Solar Energy Technologies Office (SETO) and Wind Energy Technologies Office (WETO) as part of their Interconnection Innovation Exchange (i2X) program1 to support innovative work to enable simpler, faster, and fairer interconnection of clean energy resources while enhancing the reliability, resiliency, and security of our electrical grid. The two FOA topic areas are as follows: Topic Area 1: Improved Efficiency of EMT Simulations for Interconnection Studies of IBRs Projects in this topic area will seek to improve the efficiency of the interconnection study process for new IBRs, such as solar and wind plants and battery energy storage systems, by improving software tools to study plant dynamics to increase long-term plant reliability. Projects will achieve this both by improving the speed of advanced, high-fidelity EMT modeling and simulation tools used in power systems interconnection studies and by developing a better understanding of when such high-fidelity simulations are necessary in the interconnection process. Topic Area 2: Dynamic Stability-Enhanced Network Assessment Tools Projects in this topic area will develop tools to provide stakeholders with data on transmission system characteristics related to stability, voltage, and grid strength while securing confidential and critical energy infrastructure information. Projects will establish the type of information required by stakeholders, develop a tool or tools, and test and evaluate those tools on at least one real transmission system. Topic Area 1 is primarily focused on the improvement of software tools, methods, or processes used to conduct EMT studies, the results of which will inform the transmission system interconnection stakeholders in Topic Area 2. Projects in Topic Area 2 do not need to be focused solely on transmission system characteristics based on EMT studies.

The ADAPT Program, initiated by the Advanced Research Projects Agency for Health (ARPA-H), aims to transform cancer care through innovative research focused on developing adaptive strategies for treating the evolution of cancer. This program seeks to create a dynamic cancer treatment platform capable of detecting tumor changes, updating treatment plans accordingly, and evaluating these plans through a novel clinical trial design. The goal is to match each patient’s evolving cancer with the most effective therapy, thereby revolutionizing cancer care by integrating new science and medical approaches to improve survival rates for patients with metastatic cancer.

The aim of the PAC program is to support empirically grounded, theoretically engaged and methodologically sophisticated research in a wide range of topic areas related to human perceptual, motor, and cognitive processes and their interactions. The PAC program welcomes a wide range of perspectives and a variety of methodologies (including computational modeling if the goal is to expand explanatory theories of human perception, action, or cognition). PAC strongly encourages proposals that examine human behavior in realistic (or real-world) scenarios, with more inclusive subject populations than have been used historically. It is expected that knowledge gained from PAC-supported projects will have a clear and direct path towards benefitting society. PAC is open to co-review of proposals submitted to other programs both within the Social, Behavioral, and Economic Sciences Directorate and across other directorates. Note: Proposals may be returned without review if the primary goal of the research is to understand (1) structure/function mappings between PAC processes and neural activity; (2) clinical populations per se; or (3) behavior of non-human animals without a clear and direct impact on our understanding of human perception, action or cognition. Before submitting a proposal, investigators are encouraged to email [email protected] with a one-page summary of the proposed research (modeled after the Project Summary page of a standard proposal and including a description of both Intellectual Merit and Broader Impacts) in order to confirm appropriateness of the work for the PAC program. PIs are strongly encouraged to submit the Single Copy Document titled List of Suggested Reviewers with their full proposal. Sharing of data and other materials is an expectation for funded research. Please consult the NSFDear Colleague Letter: Effective Practices for Data for more details. Interested in talking with a program director? Send a one-page description of the proposed research to [email protected].

The Human Networks and Data Science program (HNDS) supports research that enhances understanding of human behavior by leveraging data and network science research across a broad range of topics. HNDS research will identify ways in which dynamic, distributed, or heterogeneous data can provide novel answers to fundamental questions about individual or group behavior. HNDS is especially interested in proposals that provide data-rich insights about human networks to support improved health, prosperity, and security. HNDS has two tracks: (1) Human Networks and Data Science Infrastructure (HNDS-I). Infrastructure proposals will address the development of data resources and relevant analytic techniques that support fundamental Social, Behavioral and Economic (SBE) research. Successful infrastructure proposals will construct, within the financial resources provided by the award, databases or relevant analytic techniques and produce a finished product that will enable previously impossible data-intensive research in the social sciences. The databases or techniques should have significant impacts, either across multiple fields or within broad disciplinary areas, by making possible new types of data-intensive research in the SBE sciences. (2) Human Networks and Data Science Core Research (HNDS-R). Core research proposals will advance theory in a core SBE discipline by the application of data and network science methods. This includes the leveraging of large data sets with diverse spatio-temporal scales of measurement and linked qualitative and quantitative approaches, as well as multi-scale, multi-level network data and techniques of network analysis. Supported projects are expected to yield results that will enhance, expand, and transform theory and methods, and that generate novel understandings of human behavior particularly understandings that can lead to significant societal benefits or opportunities. HNDS-R encourages core research proposals that make innovative use of NSF-supported data networks, databases, centers and other forms of scientific infrastructure including those developed by HNDS-I (formerly RIDIR) projects.