Grants for Small businesses - Science and Technology

The FY24 Transformative Breast Cancer Consortium Award is designed to support collaborations and ideas that will transform the lives of individuals with, and/or at risk for, breast cancer and will significantly accelerate progress toward ending breast cancer. Applicants must bring together different perspectives to develop new paradigms that will solve fundamental yet overarching problems in breast cancer. This award requires a team-based approach by a consortium of exceptional researchers and advocates, whose collaborative efforts will make a transformative impact in breast cancer. The transformation intended by the consortium must be in peoples lives, and not in the healthcare or research system.This funding opportunity is a separate mechanism from the Transformative Breast Cancer Consortium Development Award, which is intended to provide successful applicants the time and resources needed to bring investigators and breast cancer advocates together to establish a consortium framework and conduct preliminary research to support application to a future, full Transformative Breast Cancer Consortium Award (pending availability of funds). For FY24, investigators may be named as Consortium Director on an application submitted to either (but not both) of these mechanisms. It is not necessary to receive a development award in order to apply for the current funding opportunity or anticipated full consortium awards in the future. Detailed information on the FY24 Transformative Breast Cancer Consortium Development Award is available under a separate program announcement (HT942524BCRPTBCCDA).For the FY24 Transformative Breast Cancer Consortium Award, the consortium should have at least four, but no more than five, project teams, each investigating different projects under a central hypothesis. No more than two project teams may be based at one institution. Each teams work must be integrated within the consortium so that every component is working toward the consortiums central hypothesis. Note: This award is not intended to replace, supplement, duplicate, or compete with other collaborative research efforts, such as the National Cancer Institute (NCI) Specialized Programs of Research Excellence (SPOREs), and it should not represent a collection of related Program Project grants or subprojects.The proposed consortiums overall work is expected to be innovative. In addition, the Transformative Breast Cancer Consortium Award will include funds for seed projects to pursue brand-new, high-risk/high-reward concepts that arise from the work, during the award period.DOD FY24 Transformative Breast Cancer Consortium Award 5The Breast Cancer Landscape describes the reality of breast cancer and identifies overarching challenges to progress the field. Research funded under this award mechanism should result in answers that will fundamentally and significantly transform and disrupt the present landscape.Applications submitted to the Transformative Breast Cancer Consortium Award must include the following: Research that includes truly innovative and brand-new, paradigm-shifting work in breast cancer that will address vital issues in a unique way. The issues may be one (or more) of the FY24 BCRP Overarching Challenges or, with justification, may be a different issue that meets the intent of the award mechanism and addresses the mission of ending breast cancer. If the application identifies a different fundamental issue, it must be coupled with at least one of the FY24 BCRP Overarching Challenges. Research that includes different disciplines that come together to address ending breast cancer with an ecologic approach. The consortiums proposed research must look at all aspects of the disease and bring together these different perspectives into one overarching plan for a deep, definitive dive into the FY24 BCRP Overarching Challenge(s) or other fundamental issue identified in the application. The plan also should include issues related to the hypothesis that have not been previously addressed or answered. A plan that describes in detail the integration across the consortium in all aspects, including administration, logistics, and substance. Applications must describe the substantive integration across and among teams that are necessary for the work. The required communication plan and administrative management plan will not suffice to show integration, nor will identifying individual team members who will cross teams. A detailed explanation of the substantive research processes that will be integrated is required.Synergistic, highly integrated, multidisciplinary, and multi-institutional research teams of leading scientists, clinicians, and consumer advocates must be assembled into a consortium to address a major problem in a way that could not be accomplished by a single investigator or group. While the project teams are made up of different groups, each with its own Principal Investigator (PI), the teams must be working on the major problem identified in the Transformative Breast Cancer Consortium Award application and under the leadership of the Consortium Director. The research proposed in Transformative Breast Cancer Consortium Award applications may include phase 1 clinical trials and collaborations with pharmaceutical or biotechnology industry scientists and/or companies, as appropriate. However, a clinical trial is not required, and the primary thrust of the application should not be a clinical trial.Although not all-inclusive, applications that propose the following as the primary effort(s) or central hypothesis of the consortium will not meet the intent of this award mechanism: NCI Program Project or SPORE grants or applications Conducting drug screens or testing a cocktail of therapeutics Targeting a single gene or protein Developing a new derivative or formulation of an old drug Conducting genomic landscape mapping analyses Seeking to improve existing technologies (e.g., mammography or magnetic resonance imaging screening)All applications submitted to the Transformative Breast Cancer Consortium Award must address the following key features:1. IMPACTDemonstrate potential to transform or improve the lives of individuals with, and/or at risk for, breast cancer. The time to the final impact may vary, but the outcomes of the effort must be transformative and significantly advance the BCRPs mission of ending breast cancer. A clear and compelling presentation of how the effort will be transformative for individuals with, and/or at risk for, breast cancer must be provided. Applications proposing research that represents an incremental advance in breast cancer do not meet the intent of this award mechanism.2. INNOVATIONPursue innovative, high-risk/high-reward research that has the potential to change existing paradigms, or develop new paradigms. Innovative research may introduce a new paradigm, look at existing problems from new perspectives, or exhibit other highly creative qualities. In addition to the requirement that the consortiums overall research be innovative, applications must describe a plan to support the pursuit of innovative concepts through seed projects, i.e., the development of new concepts that emerge during the course of the award. These seed projects should enable the research team to explore new avenues of high-risk/high-reward ideas that were not part of the original application, but that develop during the project and are within the scope of the overall vision of the research. A portion of the total direct budget costs (no more than 5%) must be reserved to support the seed projects, and these funds may not be used for equipment or travel.3. CONSORTIUMIntegrate project teams consisting of preeminent investigators and advocates from appropriate disciplines and institutions. Applications should include a robust consortium of researchers with the combined backgrounds and breast cancer-related expertise to enable successful conduct of the proposed research. Emphasis must be placed on integrating the most highly qualified investigators and advocates to focus on the research problem, regardless of their location. These investigators must include highly accomplished scientists, clinicians, and promising young investigators in the targeted areas of research who collectively represent the best team to solve the problem(s) identified. The proposed research effort should be broad enough to require a multidisciplinary approach that is reflected in the composition of the consortium team. Inclusion of scientists from nontraditional disciplines is encouraged.The award mechanism is structured with a Consortium Director and at least three, but no more than four, Project Team PIs representing at least two institutions. The Consortium Director is responsible for the day-to-day management of the consortium, as well as for leading their own project team. The Consortium Director, together with the Project Team PIs, are jointly responsible for leading and executing the proposed research projects that are integrated into a central hypothesis and will result in answers that will fundamentally and significantly transform and disrupt the present breast cancer landscape. Please see the top of this section, Section II.B, Award Information, for more details.Incorporate breast cancer consumer advocates into every aspect of the proposed consortiums activities. Applications are required to include consumer advocate involvement. The consortium team must include at least one breast cancer consumer advocate per project team. The consumer advocates are expected to represent the perspective of the patient population(s) that are most relevant to the consortiums proposed research. Breast cancer consumer advocates must have an active role in every aspect of the proposed consortiums work including consortium conception and design, ongoing discussion, decisions and oversight, program evaluation, and dissemination of information to the public. Consumer advocates must be integrated into and play an active role in the leadership and decision-making committees for the consortium at each participating institution. Examples of appropriate integration include membership on the advisory board(s) and steering committee(s), participation in each project team, and attendance at all consortium-related meetings. As lay representatives, the consumer advocates must be individuals who have been diagnosed with breast cancer, they should be part of a breast cancer advocacy organization, and their role in the project should be independent of their employment. They cannot be employees of any of the institutions participating in the application. They must have a high level of familiarity and training involving science and current issues in breast cancer research.4. INTEGRATIONProvide a plan that describes in detail the integration across the consortium in all aspects, including administration, logistics, and substance. Applications must demonstrate the substantive integration across and among teams that are necessary for the work. The integration plan must provide a detailed explanation of the substantive research processes that will be integrated.5. IMPLEMENTATIONProvide a strategy for implementation. Projects must demonstrate solid scientific rationale, and applications must include published and/or preliminary data that support the feasibility of their hypotheses and/or approaches. The application must include a detailed research management plan that identifies critical milestones, outlines the innovations and technical solutions that will be implemented to accomplish the milestones, and explains how these solutions will ultimately be translated to individuals with, and/or at risk for, breast cancer. It is expected that the proposed plan will present an exceptional level of innovation and creativity.Accelerate research progress through communication. Communication between and among consortium team members is essential to the success of the consortium. Applications must include a strategy for sharing data in real time and using information technologies to facilitate timely and effective communication and cooperation. The communication plan should specify the processes and tools to be used for regular and structured communication. The consortium should take full advantage of state-of-the-art communication and data sharing tools in addition to formal and informal meetings. The framework for the communication plan must be part of the application and the individual(s) who will maintain the data sharing and communications technologies must be identified.Provide an effective, coordinated administrative management plan that integrates and optimizes the research and collaborations. The Consortium Director is required to commit a minimum level of time and effort of 25% to direct and manage an initiative of this magnitude, as well as lead their own project team. The Consortium Director must have the scientific ability and proven administrative ability to oversee large research programs and a proven record of leadership, including experience in the effective use of communication tools and the management of multifaceted and multidisciplinary projects. The administrative management plan must explain how the consortium will be organized and managed, and specify the processes and tools to be used for project meeting scheduling, reviews of research findings, ensuring multidisciplinary authorship of all publications arising from the consortiums work, and other issues of common concern to the consortium and its investigators. The administrative management plan also must describe procedures and processes that will be used to maximize the resources (e.g., databases, animal models) and products (e.g., antibodies) generated by the consortium and how these resources and products will be made available to the scientific community. A portion of the total direct budget costs must be reserved for a program manager.Award Structure: The Transformative Breast Cancer Consortium Award is structured to accommodate up to five PIs (the Consortium Director and three or four Project Team PIs). The Consortium Director will be responsible for the majority of the administrative tasks associated with application submission and the day-to-day management of the consortium. In addition, the Consortium Director will be responsible for leading their own project team. The Consortium Director and Project Team PIs each have different submission requirements; however, all PIs should contribute significantly to the development of the proposed research project, including the Project Narrative, Statement of Work (SOW), and other required components. If recommended for funding, each PI will be named on separate awards to the recipient organizations. For individual submission requirements for the Consortium Director and Project Team PIs, refer to Section II.D.2, Content and Form of the Application Submission.The Consortium Director, Project Team PIs, and consumer advocates will be required to present an update on progress toward accomplishing research milestones and goals of the consortium and each project at an annual In-Progress Review (IPR) Meeting for the Transformative Breast Cancer Consortium Award. The intent of the IPR Meeting is to assess research progress, address problems, and define future directions. Annual IPR Meetings will be held at the conclusion of year 1 and every subsequent year in the period of performance and will be attended by members of the BCRP Programmatic Panel, CDMRP staff, and the USAMRAA Grants Officer to facilitate oversight and provide feedback to the consortium. IPR Meetings will either be held in person in the National Capital Region or virtually, at the discretion of the government. Continued funding may be contingent upon the successful completion of specific research milestones and goals. Research milestones from the approved SOW will be determined during the award negotiation process.In addition to IPR Meetings, each consortium must hold biannual workshops, which may be held at the PIs institutions or virtually, to facilitate ongoing communication and exchange of information within the consortium, as well as with advisory board(s) and/or steering committee(s).

The intent of the Breakthrough Award is to support promising research that has high potential to lead to or make breakthroughs in breast cancer. The critical components of this award mechanism are:Impact: Research supported by the Breakthrough Award will have the potential for a major impact and accelerate progress toward ending breast cancer. The impact may be near-term or long-term, but must move beyond a minor advancement and have the potential to lead to a fundamentally new approach that is significantly more effective than interventions already approved or in clinical development. Applications are expected to identify the breast cancer patients or at-risk individuals who would ultimately benefit from the proposed research.Research Scope: The Breakthrough Award is structured with four different funding levels. The levels are designed to support major (but not all) stages of research that will lead to clinical application. Each level has a defined research scope. It is the responsibility of the Principal Investigator (PI) to select the level that aligns with the scope of the proposed research. The funding level should be selected based on the research scope defined in the program announcement, and not on the amount of the budget.The current program announcement discusses the Breakthrough Award Level 4. Funding Levels 1, 2, and 3 are available under other program announcements (HT942524BCRPBTA12 for Levels 1 and 2 and HT942524BCRPBTA3 for Level 3). The PI is strongly encouraged to review the research scope defined under each funding level as described in the corresponding Breakthrough Award program announcements before submitting the pre-application. An application that does not meet the intent of Funding Level 4 will not be recommended for funding, even if it might meet the intent of a different funding level.The following is a general description, although not all-inclusive, of the scope of research projects that would be appropriate to propose under the current program announcement:Funding Level 4: Large-scale projects that will transform and revolutionize the clinical management and/or prevention of breast cancer. Human clinical trials are required. Large-scale trials, such as comparative effectiveness clinical trials, that will transform and revolutionize the clinical management and/or prevention of breast cancer and lead to unprecedented impact on patients lives, may fall under this mechanism. PIs are expected to have experience in successfully leading large-scale projects and demonstrated ability (through personal experience or via a commitment from a collaborating clinical investigator) to implement a clinical trial successfully. Where relevant, applications must demonstrate availability of and access to necessary data, human samples, cohort(s), and/or critical reagents. For proposed research that will require U.S. Food and Drug Administration (FDA) involvement, project readiness requirements at the time of application submission include: proof of availability of and access to clinical reagents (e.g., therapeutics) that meet regulatory compliance guidelines, proof of availability of and access to appropriate subject population(s), validated projections for patient recruitment, and submission of an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application to the FDA, if applicable.Funding from this award mechanism must support a clinical trial. 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 more information, a Human Subject Resource Document is provided at https://cdmrp.health.mil/pubs/pdf/Human%20Subjects%20Resource%20Document_DEC2022.pdf.Note: An invited oral presentation is a requirement for application review of Funding Level 4 projects, as described in Section II.D.2.b, Full Application Submission Content.Partnering PI Option: The Breakthrough Award encourages applications that include meaningful and productive partnerships between investigators. The Partnering PI Option is structured to accommodate two PIs. One PI will be identified as the Initiating PI and will be responsible for the majority of the administrative tasks associated with application submission. The other PI will be identified as a Partnering PI. Both PIs should contribute significantly to the development of the proposed research project including the Project Narrative, Statement of Work (SOW), and other required components. The PIs may have expertise in similar or disparate scientific disciplines, but each PI is expected to bring distinct contributions to the application. The application should clearly demonstrate that both PIs have equal intellectual input into the design of the project and will devote similar and appropriate levels of effort to the conduct of the project. It is expected that funding will be balanced between both PIs unless appropriately justified. New partnerships are encouraged, but not required. The application is expected to describe how the PIs unique expertise combined as a partnership will better address the research question, how the unique expertise that each individual brings to the application is critical for the research strategy and completion of the SOW, and why the work should be done together rather than through separate efforts. To meet the intent of the Partnering PI Option, applicants are discouraged from being named as a Partnering PI on multiple Breakthrough Award Level 4 applications unless they are clearly addressing distinct research questions. Applications where one PI is providing samples or investigational agents while the other PI is performing most or all of the research and analyses do not meet the intent of the Partnering PI Option. If recommended for funding, each PI will be named on separate awards to the recipient organization(s). Each award will be subject to separate reporting, regulatory, and administrative requirements. For individual submission requirements for the Initiating and Partnering PIs, refer to Section II.D.2, Content and Form of the Application Submission.Personnel: Applications are expected to include an appropriate and robust research team with the combined backgrounds and breast cancer-related expertise to enable successful conduct of the project.Consumer Advocates: Applications are required to include consumer advocate involvement. The research team must include two or more breast cancer consumer advocates, who will be integral throughout the planning and implementation of the research project. Consumer advocates should be involved in the development of the research question, project design, oversight, recruitment, and evaluation, as well as other significant aspects of the proposed project. Interactions with other team members should be well integrated and ongoing, not limited to attending seminars and semi-annual meetings. As lay representatives, the consumer advocates must be individuals who have been diagnosed with breast cancer, and they should be active in a breast cancer advocacy organization. Their role in the project should be independent of their employment, and they cannot be employees of any of the organizations participating in the application. Their role should be focused on providing objective input on the research and its potential impact for individuals with, or at risk for, breast cancer. The consumer advocates should have a high level of knowledge of current breast cancer issues and the appropriate background and/or training in breast cancer research to contribute to the project.Key Aspects of the BCRP Breakthrough Award Level 4 Mechanism: Preliminary data are required: Inclusion of preliminary data relevant to the proposed clinical 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. Intervention Availability: 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. 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 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 projections 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 required by a Regulatory Agency, the trial must use a 21 CFR 11-compliant database and appropriate data standards.A congressionally mandated Metastatic Cancer Task Force was formed with the purpose of identifying ways to help accelerate clinical and translational research aimed at extending the lives of advanced state and recurrent patients. As a member of the Metastatic Cancer Task Force, the CDMRP encourages applicants to review the recommendations (https://health.mil/Reference-Center/Congressional-Testimonies/2018/05/03/Metastatic-Cancer-Research) and submit research ideas to address these recommendations provided they are within the limitations of this funding opportunity and fit within the FY24 BCRP priorities.Innovative research involving nuclear medicine and related techniques to support early diagnosis, more effective treatment, and improved health outcomes of active-duty Service Members and their Families is encouraged. Such research could improve diagnostic and targeted treatment capabilities through noninvasive techniques and may drive the development of precision imaging and advanced targeted therapies.The proposed research must be relevant to active-duty Service Members, Veterans, military beneficiaries, and/or the American public. Collaborations between researchers at military or Veteran institutions and non-military institutions are strongly encouraged. These relationships can leverage knowledge, infrastructure, and access to unique clinical populations that the partners bring to the research effort, ultimately advancing cancer research that is of significance to the Warfighter, military Families, and the American public.For the purposes of this funding opportunity, Regulatory Agency refers to the FDA or any relevant international regulatory agency unless otherwise noted.If the proposed clinical trial involves the use of a drug that has not been approved by the relevant Regulatory Agency for the country where the research will be conducted, then submission of an IND application, or equivalent, that meets all requirements under 21 CFR 312 may be required. It is the responsibility of the applicant to provide evidence from the IRB of record or the relevant Regulatory Agency if an IND, or equivalent, is not required. If an IND, or equivalent, is required, the regulatory application must be submitted to the relevant regulatory agency by the Breakthrough Award Level 4 application submission deadline. The IND, or equivalent, should be specific for the product and indication to be tested in the proposed clinical trial. For more information on IND applications specifically, the FDA has provided guidance at https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application.If the investigational product is a device, then submission of an IDE, or equivalent, application that meets all requirements under 21 CFR 812 may be required. It is the responsibility of the applicant to provide evidence if an IDE, or equivalent, is not required. If an IDE, or equivalent, is required, the IDE application, or equivalent, must be submitted to the relevant Regulatory Agency by the Breakthrough Award Level 4 application submission deadline. The IDE, or equivalent, should be specific for the device and indication to be tested in the proposed clinical trial.The types of awards made under the program announcement will be cooperative agreements (31 USC 6305) based on anticipated substantial involvement on the part of CDMRP. Substantial involvement includes assistance, guidance, coordination, and/or participation by CDMRP staff in project activities, including but not limited to, Milestone Meetings wherein recommendations for continued funding will be made based on overall study progress.The anticipated direct costs budgeted for the entire period of performance for an FY24 BCRP BTA4 should not exceed $15M. 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 $23.3M to fund approximately one Breakthrough Award Level 4 application. 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.

The intent of the Breakthrough Award is to support promising research that has high potential to lead to or make breakthroughs in breast cancer. The critical components of this award mechanism are:Impact: Research supported by the Breakthrough Award will have the potential for a major impact and accelerate progress toward ending breast cancer. The impact may be near-term or long-term but must move beyond a minor advancement and have the potential to lead to a fundamentally new approach that is significantly more effective than interventions already approved or in clinical development. Applications are expected to identify the breast cancer patients or at-risk individuals who would ultimately benefit from the proposed research.Research Scope: The Breakthrough Award is structured with four different funding levels. The levels are designed to support major (but not all) stages of research that will lead to clinical application. Each level has a defined research scope. It is the responsibility of the Principal Investigator (PI) to select the level that aligns with the scope of the proposed research. The funding level should be selected based on the research scope defined in the program announcement, and not on the amount of the budget.The current program announcement discusses the Breakthrough Award Levels 1 and 2. Funding Levels 3 and 4 are available under other program announcements (HT942524BCRPBTA3 and HT942524BCRPBTA4, respectively). The PI is strongly encouraged to review the research scope defined under each funding level as described in the corresponding Breakthrough Award program announcement before submitting the pre-application. An application that does not meet the intent of the funding level selected will not be recommended for funding, even if it might meet the intent of a different funding level.The following are general descriptions, although not all-inclusive, of the scope of research projects that would be appropriate to propose under the current program announcement: Funding Level 1: Innovative, high-risk/high-reward research that is in the earliest stages of idea development or is an untested theory that addresses an important problem. To foster research that yields new avenues of investigation, preliminary data are not required. Proof of concept is the anticipated outcome. Funding Level 2: Research that is already supported by substantial preliminary or published data and strongly validates clinical translation in a well-defined context within thebreast cancer landscape. Funding Level 2: Population Science and Prevention Studies: Population Science and Prevention Studies should involve investigations into why certain human patient populations differ in cancer risk or clinical prognosis. The studies should focus on the analysis of human data and biospecimens. Research should be already supported by substantial preliminary or published data and strongly validate clinical translation in a well-defined context within the breast cancer landscape. With compelling justification, population science and prevention studies may request higher levels of funding and an additional year in the period of performance.Partnering PI Option: The Breakthrough Award encourages applications that include meaningful and productive partnerships between investigators. The Partnering PI Option is structured to accommodate two PIs. One PI will be identified as the Initiating PI and will be responsible for the majority of the administrative tasks associated with application submission. The other PI will be identified as a Partnering PI. Both PIs should contribute significantly to the development of the proposed research project, including the Project Narrative, Statement of Work (SOW), and other required components. The PIs may have expertise in similar or disparate scientific disciplines, but each PI is expected to bring distinct contributions to the application. The application should clearly demonstrate that both PIs have equal intellectual input into the design of the project and will devote similar and appropriate levels of effort to the conduct of the project. It is expected that funding will be balanced between both PIs unless appropriately justified. New partnerships are encouraged, but not required. The application is expected to describe how the PIs unique expertise combined as a partnership will better address the research question, how the unique expertise that each individual brings to the application is critical for the research strategy and completion of the SOW, and why the work should be done together rather than through separate efforts. To meet the intent of the Partnering PI Option, applicants are discouraged from being named as a Partnering PI on multiple Breakthrough Award Levels 1 and 2 applications unless they are clearly unique, meaningful partnerships addressing distinct research questions. Applications in which a mentor and their current postdoctoral fellow or junior investigator are named as Initiating and Partnering PIs do not meet the intent of the Partnering PI Option. Applications where one PI is providing samples, animal models, or investigational agents while the other PI is conducting most, or all of the experiments and analyses, do not meet the intent of the Partnering PI Option. If recommended for funding, each PI will be named on separate awards to the recipient organization(s). Each award will be subject to separate reporting, regulatory, and administrative requirements. For individual submission requirements for the Initiating and Partnering PIs, refer to Section II.D.2, Content and Form of the Application Submission.Personnel: Applications are expected to include an appropriate and robust research team with the combined backgrounds and breast cancer-related expertise to enable successful conduct of the project.Research involving human subjects and research involving human anatomical substances and data is permitted; however, clinical trials are not allowed under this funding opportunity.Applications seeking support for a clinical trial may be submitted to the FY24 BCRP Breakthrough Award Level 3 and Level 4 program announcements (HT942524BCRPBTA3 and HT942524BCRPBTA4, respectively).A congressionally mandated Metastatic Cancer Task Force was formed with the purpose of identifying ways to help accelerate clinical and translational research aimed at extending the lives of advanced state and recurrent patients. As a member of the Metastatic Cancer Task Force, CDMRP encourages applicants to review the recommendations (https://health.mil/Reference-Center/Congressional-Testimonies/2018/05/03/Metastatic-Cancer-Research) and submit research ideas to address these recommendations provided they are within the limitations of this funding opportunity and fit within the FY24 BCRP priorities.Innovative research involving nuclear medicine and related techniques to support early diagnosis, more effective treatment, and improved health outcomes of active-duty Service Members and their Families is encouraged. Such research could improve diagnostic and targeted treatment capabilities through noninvasive techniques and may drive the development of precision imaging and advanced targeted therapies.The proposed research must be relevant to active-duty Service Members, Veterans, military beneficiaries, and/or the American public. Collaborations between researchers at military or Veteran institutions and non-military institutions are strongly encouraged. These relationships can leverage knowledge, infrastructure, and access to unique clinical populations that the partners bring to the research effort, ultimately advancing cancer research that is of significance to the Warfighter, military Families, and the American public.Clinical trials are not allowed. 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.The funding instrument for awards made under the program announcement will be grants (31 USC 6304).The anticipated direct costs budgeted for the entire period of performance for an FY24 BCRP Breakthrough Award Funding Level 1 should not exceed $450,000 for applications with a single PI or $750,000 if applying under the Partnering PI Option.The anticipated direct costs budgeted for the entire period of performance for an FY24 BCRP Breakthrough Award Level 2 should not exceed $1.0M for applications with a single PI or $1.5M if applying under the Partnering PI Option.The anticipated direct costs budgeted for the entire period of performance for an FY24 BCRP Breakthrough Award Funding Level 2, Population Science and Prevention Studies, should not exceed $1.5M for applications with a single PI or $2.0M if applying under the Partnering PI Option. 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 $20.9M to fund approximately 14 Breakthrough Award Levels 1 and 2 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.

The FY24 BCRP Clinical Research Extension Award aims to extend or expand the data collection, follow-up, and analysis of breast cancer clinical studies. The intent of this mechanism is to increase the clinically relevant impact of breast cancer patient participation in clinical research by addressing the knowledge lost due to early trial termination, limited patient follow-up, or suboptimal sample and/or data collection and analysis. Patients contributions of tissue, serum, and other biologic specimens and their data are invaluable to saving lives. The BCRP has created this mechanism to help ensure that science values those contributions with research that maximizes their impact.The critical components of this award mechanism are:Impact: Research supported by the FY24 BCRP Clinical Research Extension Award will have the potential to extend or affect the impact of the previously funded clinical trial or study or will result in new impact and accelerate progress toward ending breast cancer.Research Scope: Although not all-inclusive, research proposed under the FY24 BCRP Clinical Research Extension Award may entail a deeper molecular analysis of clinical samples, initiation of new correlative studies, biomarker validation, or continuing clinical follow-up of patients enrolled in an open/ongoing or completed clinical trial. The proposed research may be hypothesis-testing or -generating or may be designed to generate clinically annotated and molecularly characterized experimental platforms, including patient-derived models or tissue arrays. Innovation is not a criterion for this award mechanism. Projects proposing to conduct clinical trials will not be supported.Feasibility: Preliminary data to support the scientific rationale and feasibility of the research approaches are required. The applicant must demonstrate availability of, and accessibility to, the necessary resources or populations to accomplish the proposed research.Data Evaluation and Sharing: Proposed research should be based on a study sample size that will ensure that the results support valid conclusions or will generate a meaningful hypothesis. It is the applicants responsibility to provide sufficient evidence that the sample size is appropriate to meet the studys objectives and outline the statistical methods and considerations they will employ in their data analysis. The applicant must outline a data-sharing plan for the scientific community to have access to the experimental platforms and molecular and other data generated from the proposed research.applications that include meaningful and productive partnerships between investigators. The Partnering PI Option is structured to accommodate two Principal Investigators (PIs). One PI will be identified as the Initiating PI, who will be responsible for the majority of the administrative tasks associated with application submission. The other PI will be identified as a Partnering PI. The PIs may have expertise in similar or disparate scientific disciplines, but each PI is expected to bring a distinct contribution to the application. Both PIs should contribute significantly to the development of the proposed research project, including the Project Narrative, Statement of Work (SOW), and other required components. The application should clearly demonstrate that both PIs have equal intellectual input into the design of the project and will devote similar and appropriate levels of effort to the conduct of the project. It is expected that funding will be balanced between both PIs unless appropriately justified. The application is expected to describe how the PIs unique expertise combined as a partnership will better address the research question, how the unique expertise that each individual brings to the application is critical for the research strategy and completion of the SOW, and why the work should be done together rather than through separate efforts. Applicants are discouraged from being named as a PI, Initiating PI, or Partnering PI on multiple Clinical Research Extension Award applications unless they are clearly addressing distinct research questions. If recommended for funding, each PI will be named on separate awards to the recipient organization(s). Each award will be subject to separate reporting, regulatory, and administrative requirements. For individual submission requirements for the Initiating and Partnering PIs, refer to Section II.D.2, Content and Form of the Application Submission.Personnel: Applications are expected to include an appropriate and robust research team with the combined backgrounds and breast cancer-related expertise to enable successful conduct of the project.Consumer Advocates: Applications are required to include consumer advocate involvement. The research team must include two or more breast cancer consumer advocates, and it is the applicants responsibility to outline the advocates role in the design and execution of the study. As lay representatives, the consumer advocates must be individuals who have been diagnosed with breast cancer and are actively involved in a breast cancer advocacy organization. Their role should be independent of their employment, and they may not be employees of any organizations participating in the application. The consumer advocates should have a high level of knowledge of current breast cancer issues and the appropriate background and/or training in breast cancer research to contribute to the project. Their role should be focused on providing objective input throughout the research effort and its potential impact for individuals with, or at risk for, breast cancer.A congressionally mandated Metastatic Cancer Task Force was formed with the purpose of identifying ways to help accelerate clinical and translational research aimed at extending the lives of advanced state and recurrent patients. As a member of the Metastatic Cancer Task Force, CDMRP encourages applicants to review the recommendations (https://health.mil/Reference-Center/Congressional-Testimonies/2018/05/03/Metastatic-Cancer-Research) and submit research ideas to address these recommendations provided they are within the limitations of this funding opportunity and fit within the FY24 BCRP priorities.Innovative research involving nuclear medicine and related techniques to support early diagnosis, more effective treatment, and improved health outcomes of active-duty Service Members and their Families is encouraged. Such research could improve diagnostic and targeted treatment capabilities through noninvasive techniques and may drive the development of precision imaging and advanced targeted therapies.The proposed research must be relevant to active-duty Service Members, Veterans, military beneficiaries, and/or the American public. Collaborations between researchers at military or Veteran institutions and non-military institutions are strongly encouraged. These relationships can leverage knowledge, infrastructure, and access to unique clinical populations that the partners bring to the research effort, ultimately advancing cancer research that is of significance to the Warfighter, military Families, and the American public.Clinical research encompasses research with human data, human specimens, and/or interaction with human subjects that may or may not be considered a clinical trial. For this funding opportunity, research involving human subjects, human specimens, and data, including extended or expanded clinical follow-up of patients, is permitted; however, this award cannot be used to conduct clinical trials.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.The funding instrument for awards made under the program announcement will be grants (31 USC 6304).The anticipated direct costs budgeted for the entire period of performance for an FY24 BCRP Clinical Research Extension Award should not exceed $5M for applications with a single PI or $6M if applying under the Partnering PI Option. 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 $18.6M to fund approximately two Clinical Research Extension 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.

The SCIRP CTA supports the rapid implementation of clinical trials with the potential to have a significant impact on the treatment or management of SCI. Applications should articulate both the short- and long-term impact of the proposed research on individuals with SCI and/or their care partners. The proposed intervention(s) to be tested should offer significant potential impact for individuals affected by SCI within the context of one or more of the FY24 SCIRP Focus Areas. The U.S. Army Medical Research Acquisition Activity (USAMRAA) is soliciting applications to the Fiscal Year 2024 (FY24) Spinal Cord Injury Research Program (SCIRP) using delegated authority provided by United States Code, Title 10, Section 4001 (10 USC 4001). The Congressionally Directed Medical Research Programs (CDMRP) at the U.S. Army Medical Research and Development Command (USAMRDC) is the program management agent for this funding opportunity. Congress initiated the SCIRP in 2009 to provide support for traumatic spinal cord injury (SCI)-related research of exceptional scientific merit that has the potential to make a significant impact on improving the health and well-being of military Service Members, Veterans, and other individuals living with SCI. Appropriations for the SCIRP from FY09 through FY23 totaled $437.85 million (M). The FY24 Defense Appropriations Act provides $40M to the SCIRP through the appropriation for peer-reviewed spinal cord research. The vision of the SCIRP is to advance the treatment and management of SCI and ameliorate its consequences. The FY24 SCIRP challenges the scientific community to design research that will advance the development or translation of health care solutions for people living with SCI. Innovative research that fosters new directions or addresses neglected issues in the field of traumatic SCI is also supported, although studies focused exclusively on target identification are discouraged. The SCIRP encourages impactful research across the continuum of care from time of injury and across the life span that is well reasoned and scientifically supported. Applications from investigators within the military services and 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, their Families and/or care partners.

The intent of the Breakthrough Award is to support promising research that has high potential to lead to or make breakthroughs in breast cancer. The critical components of this award mechanism are:Impact: Research supported by the Breakthrough Award will have the potential for a major impact and accelerate progress toward ending breast cancer. The impact may be near-term or long-term, but must move beyond a minor advancement and have the potential to lead to a fundamentally new approach that is significantly more effective than interventions already approved or in clinical development. Applications are expected to identify the breast cancer patients or at-risk individuals who would ultimately benefit from the proposed research.Research Scope: The Breakthrough Award is structured with four different funding levels. The levels are designed to support major (but not all) stages of research that will lead to clinical application. Each level has a defined research scope. It is the responsibility of the Principal Investigator (PI) to select the level that aligns with the scope of the proposed research. The funding level should be selected based on the research scope defined in the program announcement, and not on the amount of the budget.The current program announcement discusses the Breakthrough Award Level 3. Funding Levels 1, 2, and 4 are available under other program announcements (HT942524BCRPBTA12 for Levels 1 and 2 and HT942524BCRPBTA4 for Level 4). The PI is strongly encouraged to review the research scope defined under each funding level as described in the corresponding Breakthrough Award program announcements before submitting the pre-application. An application that does not meet the intent of the funding level selected will not be recommended for funding, even if it might meet the intent of a different funding level.The following is a general description, although not all-inclusive, of the scope of research projects that would be appropriate to propose under the current program announcement:Funding Level 3: Advanced translational studies with a high degree of project readiness. Where relevant, proof of availability of and access to necessary data, human samples, cohort(s), and/or critical reagents must be provided. If the proposed research would ultimately require U.S. Food and Drug Administration (FDA) involvement, applications must demonstrate availability of, and access to, clinical reagents (e.g., therapeutic molecules) and patient population(s). Applications must state a realistic timeline for near-term clinical investigation. Small-scale clinical trials (e.g., first in human, phase 1/1b) may be appropriate.Partnering PI Option: The Breakthrough Award encourages applications that include meaningful and productive partnerships between investigators. The Partnering PI Option is structured to accommodate two PIs. One PI will be identified as the Initiating PI and will be responsible for the majority of the administrative tasks associated with application submission. The other PI will be identified as a Partnering PI. Both PIs should contribute significantly to the development of the proposed research project, including the Project Narrative, Statement of Work (SOW), and other required components. The PIs may have expertise in similar or disparate scientific disciplines, but each PI is expected to bring distinct contributions to the application. The application should clearly demonstrate that both PIs have equal intellectual input into the design of the project and will devote similar and appropriate levels of effort to the conduct of the project. It is expected that funding will be balanced between both PIs unless appropriately justified. New partnerships are encouraged, but not required. The application is expected to describe how the PIs unique expertise combined as a partnership will better address the research question, how the unique expertise that each individual brings to the application is critical for the research strategy and completion of the SOW, and why the work should be done together rather than through separate efforts. To meet the intent of the Partnering PI Option, applicants are discouraged from being named as a Partnering PI on multiple Breakthrough Award Level 3 applications unless they are clearly addressing distinct research questions. Applications where one PI is providing samples, animal models, or investigational agents while the other PI is conducting most or all of the experiments and analyses do not meet the intent of the Partnering PI Option. If recommended for funding, each PI will be named on separate awards to the recipient organization(s). Each award will be subject to separate reporting, regulatory, and administrative requirements. For individual submission requirements for the Initiating and Partnering PIs, refer to Section II.D.2, Content and Form of the Application Submission.Personnel: Applications are expected to include an appropriate and robust research team with the combined backgrounds and breast cancer-related expertise to enable successful conduct of the project.Consumer Advocates: Applications are required to include consumer advocate involvement. The research team must include two or more breast cancer consumer advocates, who will be integral throughout the planning and implementation of the research project. Consumer advocates should be involved in the development of the research question, project design, oversight, recruitment, and evaluation, as well as other significant aspects of the proposed project. Interactions with other team members should be well integrated and ongoing, not limited to attending seminars and semi-annual meetings. As lay representatives, the consumer advocates must be individuals who have been diagnosed with breast cancer, and they should be active in a breast cancer advocacy organization. Their role in the project should be independent of their employment, and they cannot be employees of any of the organizations participating in the application. Their role should be focused on providing objective input on the research and its potential impact for individuals with, or at risk for, breast cancer. The consumer advocates should have a high level of knowledge of current breast cancer issues and the appropriate background and/or training in breast cancer research to contribute to the project.A congressionally mandated Metastatic Cancer Task Force was formed with the purpose of identifying ways to help accelerate clinical and translational research aimed at extending the lives of advanced state and recurrent patients. As a member of the Metastatic Cancer Task Force, CDMRP encourages applicants to review the recommendations (https://health.mil/Reference-Center/Congressional-Testimonies/2018/05/03/Metastatic-Cancer-Research) and submit research ideas to address these recommendations provided they are within the limitations of this funding opportunity and fit within the FY24 BCRP priorities.Innovative research involving nuclear medicine and related techniques to support early diagnosis, more effective treatment, and improved health outcomes of active-duty Service Members and their Families is encouraged. Such research could improve diagnostic and targeted treatment capabilities through noninvasive techniques and may drive the development of precision imaging and advanced targeted therapies.The proposed research must be relevant to active-duty Service Members, Veterans, military beneficiaries, and/or the American public. Collaborations between researchers at military or Veteran institutions and non-military institutions are strongly encouraged. These relationships can leverage knowledge, infrastructure, and access to unique clinical populations that the partners bring to the research effort, ultimately advancing cancer research that is of significance to the Warfighter, military Families, and the American public.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.The funding instrument for awards made under the program announcement will be grants (31 USC 6304).The anticipated direct costs budgeted for the entire period of performance for an FY24 BCRP Breakthrough Award Level 3 should not exceed $4M for applications with a single PI or $5M if applying under the Partnering PI Option. 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 $13.95M to fund approximately two BCRP Breakthrough Award Level 3 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.

The SCIRP TRA is intended to support translational research that will accelerate the movement of promising ideas in SCI research into clinical applications. Although not all-inclusive, some examples include demonstration studies of pharmaceuticals and medical devices in preclinical systems and/or clinical research on therapeutics, devices, or practice using human tissues or resources.The ultimate goal of translational research is to move an observation forward into clinical application and accelerate the clinical introduction of health care products, technologies, or practice guidelines. Observations that drive a research idea may be derived from a laboratory discovery, population-based studies, or a clinicians first-hand knowledge of patients and anecdotal data. However, applicants should not view translational research as a one-way continuum from bench to bedside. The research plan is encouraged to involve a reciprocal flow of ideas and information between basic and clinical science.

The FY24 LCRP Idea Development Award mechanism promotes new ideas that are still in the early stages of development and have the potential to yield impactful data and new avenues of investigation. This award supports conceptually innovative, high-risk/high-reward research that could lead to critical discoveries or major advancements that will accelerate progress toward eradicating deaths and suffering from lung cancer. Research applications only in the area of mesothelioma will not be accepted. Applications should include a well-formulated, testable hypothesis based on strong scientific rationale.New Investigators: The FY24 LCRP Idea Development Award mechanism encourages applications from independent investigators in the early stages of their careers (i.e., within 10 years of their first faculty appointment or equivalent). The New Investigator category is designed to allow applicants early in their faculty appointments to compete for funding separately from established investigators. Applications from New Investigators and Established Investigators will be peer and programmatically reviewed separately. Principal Investigators (PIs) using the New Investigator category are strongly encouraged to strengthen their applications by collaborating with investigators experienced in lung cancer research and/or possessing other relevant expertise. It is the responsibility of the applicant to describe how the included collaboration will augment the PIs expertise to best address the research question. All applicants for the New Investigator category must meet specific eligibility criteria as described in Section II.C, Eligibility Information.Preliminary data to support the feasibility of the research hypotheses and research approaches are required; however, these data do not necessarily need to be derived from studies of lung cancer.Key elements of this award are as follows:Innovation: Research deemed innovative may introduce a new paradigm, challenge current paradigms, look at existing problems from new perspectives, or exhibit other uniquely creative qualities.Impact: Research that has high potential impact may lead to major advancements and significantly accelerate progress toward eradicating deaths and suffering from lung cancer.It is the responsibility of the PI to clearly and explicitly articulate the projects innovation and its potential impact on lung cancer and its relevance to Military Health System (MHS) beneficiaries. The projects impact to both lung cancer research and to patients with lung cancer should be articulated, even if clinical impact is not an immediate outcome. Applications that demonstrate exceptional scientific merit but lack innovation and high potential impact do not meet the intent of the Idea Development Award.

The SCIRP IIRA is intended to support studies that have the potential to make an important contribution to SCI research, patient care, and/or quality of life.Important aspects of this award mechanism include: Impact: Applications should articulate the short- and long-term impact of the proposed research on both the SCI research field as well as the SCI community. Projects must address one or more of the FY24 SCIRP Focus Areas. Relevance to Military Health: Projects should be relevant to spinal cord-injured military Service Members, Veterans, and/or their Family members and care partners. Collaboration with military and VA researchers and clinicians is encouraged. Preliminary Data: Observations that drive a research idea may be derived from laboratory discovery, population-based studies, a clinicians first-hand knowledge of patients, or anecdotal data. Applications must include preliminary and/or published data that are relevant to the mission of the SCIRP and support the proposed research project.IIRA applications may focus on any phase of research from basic through translational, though studies focused exclusively on target identification are discouraged. Permitted research includes preclinical studies in animal models (except where otherwise specified), research with human subjects or human anatomical substances, as well as ancillary studies associated with an existing clinical trial.

The ARP Clinical Trial Award supports the rapid implementation of clinical trials with the potential to have a significant impact on the treatment or management of ASD. Applications are strongly encouraged to address one of the FY24 ARP Clinical Trial Award Areas of Interest. Clinical trials may be designed to evaluate promising new products, pharmacologic agents (drugs or biologics), devices, clinical guidance, and/or emerging approaches and technologies. Proposed projects may range from small proof-of-concept trials (e.g., pilot, first-in-human, phase 0) to demonstrate the feasibility or inform the design of more advanced trials through large-scale trials to determine efficacy in relevant patient populations.Research funded by the FY24 ARP should be responsive to the needs of people with ASD, their families, and/or caregivers. Researchers are therefore encouraged to establish and utilize effective collaborations and partnerships with community members to maximize the impact potential of the proposed research.CDMRP encourages research on health areas and conditions that affect women uniquely, disproportionately, or differently from men, including studies analyzing sex as a biological variable. Such research should relate anticipated project findings to improvements in womens health outcomes and/or advancing knowledge for womens health.

demonstrated significant potential to effect meaningful change in breast cancer. These individuals should be exceptionally talented scientists who have shown that they are the best and brightest in their field(s) through extraordinary creativity, vision, innovation, and productivity. They should have demonstrated experience in forming effective partnerships and collaborations and must exhibit strong potential for future leadership in breast cancer research.As the intent of the Era of Hope Scholar Award is to recognize creative and innovative individuals rather than projects, the central features of the award are the demonstrated ability of the individual named as the Principal Investigator (PI) in the application to go beyond conventional thinking in their field and the innovative contribution that the PI can make toward ending breast cancer. The application should articulate a vision that challenges current dogma and demonstrates an ability to look beyond tradition and convention.Experience in breast cancer research is not required; however, the application must focus on breast cancer, and the PI must commit a minimum of 25% level of time and effort during the period of performance to conduct breast cancer research under this award. Individuals from other disciplines who apply novel concepts to breast cancer are encouraged to submit.The PI is encouraged to assemble a research team that will provide the necessary expertise and collaborative efforts toward accomplishing the research goals. The PIs research team must include two or more breast cancer consumer advocates. As lay representatives, the consumer advocates must be individuals who have been diagnosed with breast cancer and are actively involved in a breast cancer advocacy organization. Their role should be independent of their employment, and they may not be employees of any organizations participating in the application. The consumer advocates should have a high level of knowledge of current breast cancer issues and the appropriate background and/or training in breast cancer research to contribute to the project. Their role should be focused on providing objective input throughout the research effort and its potential impact for individuals with, or at risk for, breast cancer.A congressionally mandated Metastatic Cancer Task Force was formed with the purpose of identifying ways to help accelerate clinical and translational research aimed at extending the lives of advanced state and recurrent patients. As a member of the Metastatic Cancer Task Force, CDMRP encourages applicants to review the recommendations (https://health.mil/Reference-Center/Congressional-Testimonies/2018/05/03/Metastatic-Cancer-Research) and submit research ideas to address these recommendations provided they are within the limitations of this funding opportunity and fit within the FY24 BCRP priorities.Innovative research involving nuclear medicine and related techniques to support early diagnosis, more effective treatment, and improved health outcomes of active-duty Service Members and their Families is encouraged. Such research could improve diagnostic and targeted treatment capabilities through noninvasive techniques and may drive the development of precision imaging and advanced targeted therapies.The proposed research must be relevant to active-duty Service Members, Veterans, military beneficiaries, and/or the American public. Collaborations between researchers at military or Veteran institutions and non-military institutions are strongly encouraged. These relationships can leverage knowledge, infrastructure, and access to unique clinical populations that the partners bring to the research effort, ultimately advancing cancer research that is of significance to the Warfighter, military Families, and the American public.Clinical trials are allowed. 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.The funding instrument for awards made under the program announcement will be grants (31 USC 6304).The anticipated direct costs budgeted for the entire period of performance for an FY24 Era of Hope Scholar Award should not exceed $3.5M. 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 $5.4M to fund approximately one Era of Hope Scholar Award application. 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.

The FY24 PRARP TrRA is intended to support studies that will make transformative and advanced contributions to reduce risk of or prevent the development of AD/ADRD. Risk reduction considering TBI and/or military service is of particular interest to the program. The work should significantly accelerate efforts in AD/ADRD research and demonstrate significant impact toward improving patient care and/or quality of life. To meet the intent of the funding opportunity, applications must robustly address an important problem or a critical barrier to progress in prevention and risk reduction. The proposed research may include, but is not limited to, exploring questions in the following areas: Identification of risk factors (environmental, genetic, epigenetic, lifestyle, etc.). Identification and implementation of strategies to reduce AD/ADRD risk and prevent cognitive problems following TBI and/or military service. Understanding the role of social determinants of health in risk reduction. Informational (not descriptive) epidemiology to understand environmental and other factors that contribute to development of AD/ADRD. All applications submitted to this funding opportunity must clearly indicate how the project addresses a critical unmet need, 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 include: Research should be robust: The FY24 PRARP TrRA mechanism is geared toward supporting robust, well-designed research projects that provide significant impact on the AD/ADRD field, persons living with dementia, and their families, care-partners/caregivers. Inclusion of collaborative Community partner approaches is strongly encouraged for all projects and is required for all projects involving clinical research. Use of animal models must be fully justified for relevance to human health. Non-incremental advancement: Research projects should leverage existing knowledge to accelerate ideas, strengthen evidence, and move the field forward. Therefore, preliminary data are required. Projects proposing incremental advances that do not significantly propel the field do not meet the intent of this mechanism. Feedback to the Community: Applicants are expected to articulate a plan for relaying the results and outcomes of the research supported by this mechanism must be relayed back to the research/Community(ies) to allow for continued knowledge building. Optimizing research impact through Community collaboration: Research funded by the FY24 PRARP should be responsive to the needs of people living with AD/ADRD. Community collaboration is required for clinical research projects and encouraged for preclinical studies. Establishment and utilization of effective and equitable collaborations and partnerships with members of the AD/ADRD lived experience, family, and care partner communities, which will be referred to as Community(ies) in the remainder of the Funding Opportunity, maximizes the translational and impact potential of the proposed research. Collaborative research approaches feature shared responsibility and ownership for the research project to ensure non-tokenistic 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: 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, or others as appropriate. 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. Community Advisory Board (CAB) Utilization: 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. Career Initiation or Transition (CIT) Partnership Option: The FY24 PRARP encourages applications that include meaningful and productive collaborations between two principal investigators. To promote enhanced research capacity within the AD/ADRD field, the FY24 TrRA includes an option for a CIT Principal Investigator (PI) to partner with an experienced to jointly address a research question. The CIT PI must have nominal, if any, research support in the field and may be either one of the following: The Career Initiation PI must be an early-career researcher, at least 3 years post their terminal degree but no more than 7 years into their independent position. Both PIs may have similar or disparate expertise, but each PI is expected to bring distinct and complimentary contributions to the application. The Career Transition PI must be an investigator (at any stage) who is new to the military health, TBI, or AD/ADRD field(s). New to the field is defined as having only nominal, if any, publications in the field. The other partnering investigator must have complimentary experience (as evidenced by publications) in military health, TBI, and/or AD/ADRD field(s). The CIT is structured to accommodate two PIs. One PI will be identified as the Initiating PI and will be responsible for most of the administrative tasks associated with application submission. The other will be identified as a Partnering PI. Either PI can be the CIT PI. Both PIs should contribute significantly to the development of the proposed research project, including the Project Narrative, Statement of Work (SOW), and other required components. Both PIs may have experience in similar or disparate scientific disciplines, but each PI is expected to bring distinct and complimentary contributions to the application. If recommended for funding, each PI will be named to an individual award within the recipient organization(s). For individual submission requirements for the Initiating and Partnering PI, refer to Section II.D.2, Content and Form of the Application Submission.

The intent of the FY24 ERP IDA is to solicit novel, innovative research that has the potential to increase our understanding of PTE to improve quality of life, especially in Service Members, Veterans, and/or their care partners. The work should innovatively challenge existing research paradigms or exhibit high levels of creativity. The FY24 ERP IDA offers two levels of funding dependent upon the level of experience of the Principal Investigator (PI). Funding Level I - Pathway to Independence Option: Early-career investigators ranging from the postdoctoral level (e.g., research associate, fellows, residents, or equivalent) to within 3 years of their first independent faculty position (or equivalent) may be named by the organization as the PI on the application (mentor required). Funding Level II - Innovative New Direction Option: Investigators at all career levels may be named by the organization as the PI on the application.

The intent of the FY24 Transforming Care Award (TrCA) is to support research that provides answers and solutions in critical areas to improve quality of life, reduce caregiver burden and stress, reduce health disparities, and increase support for the individual with a diagnosis of Alzheimers disease and related dementias (AD/ADRD), their care partner/caregiver, and/or both, as well as the impact on families and/or communities. For this mechanism, family is broadly defined as the family of choice and/or the family of origin. Additionally, the TrCA definition of care does not include medical care (such as medical interventions administered by a physician), as the care landscape extends beyond that of medical interventions to be inclusive of research into integration, education, and support. The PRARP requires projects to ensure strategies maintain the dignity of the individual living with a dementia diagnosis and their family/care/social communities. All applications submitted to this funding opportunity must clearly indicate how the project addresses a critical unmet need, 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. The TrCA targets research that includes, but is not limited to, improvements in long-term care, quality of life, psychosocial wellness, and supporting aging-in-place, belonging, and community living for individuals, care partners, and families living with a dementia diagnosis. Studies may include, but are not limited to, topics such as considerations for dementia care that are specific to military Service Members and/or Veterans and their Families, navigating the AD/ADRD diagnosis and care path, and overcoming care partner/caregiver stress. Projects may address knowledge gaps, interventions, strategies, technologies, and/or tools. Clinical research and clinical trials are allowed, however, clinical trials solely testing or evaluating pharmacological interventions do not meet the intent of this funding opportunity. Key elements of this award mechanism are: Person-centered research: All applications to the FY24 PRARP TrCA should be person- centered. This mechanism is intended to provide answers and solutions in critical areas to improve quality of life, reduce burden and stress, and increase support for individuals living with a diagnosis, their families, and their care partners (hereafter referred to as Community(ies) in this Funding Opportunity). The research should have near-immediate impact on the intended beneficiaries. To facilitate success, the TrCA requires Community collaboration for all projects. Focus on outcomes: The intent of the TrCA is to advance knowledge and capacity in the AD/ADRD care field. As such, applicants should clearly articulate outcomes, clearly demonstrate a pathway of feasibility, and identify realistic approaches to scaling and Community level implementation for widespread use. Additionally, applications should plan for and describe how the research will be manualized (i.e., compiled in a manual) and fed back into the research, lived experience, and care communities. See Attachment 6, Research Manual and Progression Plan. Representation: Awards supported by the PRARP are expected to address gaps in representative AD/ADRD data sets. Applicants must prioritize diversity and equity in clinical study populations including, but not limited to, social and structural determinants of health such as sex, gender, ethnicity, culture, socioeconomic status, geography, and health care access, are expected. Projects supported by this mechanism must represent a non-incremental advance in the care field. Preliminary data are required. For this mechanism, studies utilizing animal models do not meet the intent of the mechanism and are not allowed. Milestone meeting: The Principal Investigator (PI) will be required to present an update on progress toward accomplishing the goals of the award at a Milestone Meeting to be held in the National Capital Area during years 2-4 of the period of performance. The PI may bring up to three additional members of the research team, including their Community partner, to the meeting. The Milestone Meeting will be attended by members of the PRARP Programmatic Panel, CDMRP staff, the USAMRAA Grants/Contracts Officer, and other stakeholders. Optimizing research impact through Community collaboration: Research funded by the FY24 PRARP should be responsive to the needs of Communities in the remainder of the Funding Opportunity, maximizes the translational and impact potential of the proposed research. Establishing and utilizing effective and equitable collaborations and partnerships with members of the AD/ADRD lived experience Communities is essential to maximize the 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: Lived Experience Consultation: The research team includes at least one project advisor with AD/ADRD lived 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 an AD/ADRD diagnosis, their family members, care partners, or others as appropriate. 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. 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. Career Initiation or Transition (CIT) Partnership Option: The FY24 PRARP encourages applications that include meaningful and productive collaborations between two principal investigators. To promote enhanced research capacity within the AD/ADRD field, the FY24 TrCA includes an option for a CIT Principal Investigator (PI) to partner with an experienced investigator to jointly address a research question. The CIT PI must have nominal, if any, research support in the field and may be either one of the following: The Career Initiation PI must be an early-career researcher, at least 3 years post their terminal degree but no more than 7 years into their independent position. Both PIs may have similar or disparate expertise, but each PI is expected to bring distinct and complimentary contributions to the application. The Career Transition PI must be an investigator (at any stage) who is new to the military health, TBI, or AD/ADRD field(s). New to the field is defined as having only nominal, if any, publications in the field. The other partnering investigator must have complimentary experience (as evidenced by publications) in military health, TBI, and/or AD/ADRD field(s). The CIT is structured to accommodate two PIs. One PI will be identified as the Initiating PI and will be responsible for most of the administrative tasks associated with application submission. The other will be identified as a Partnering PI. Either PI can be the CIT PI. Both PIs should contribute significantly to the development of the proposed research project, including the Project Narrative, Statement of Work (SOW), and other required components. Both PIs may have experience in similar or disparate scientific disciplines, but each PI is expected to bring distinct and complimentary contributions to the application. If recommended for funding, each PI will be named to an individual award within the recipient organization(s). For individual submission requirements for the Initiating and Partnering PI, refer to Section II.D.2, Content and Form of the Application Submission.

The SCIRP CTRA is intended to support high-impact and/or new/emerging clinical research that may not be ready for a larger-scale clinical trial and for which feasibility/pilot/optimization studies are necessary. Projects should demonstrate potential to impact the standard of care, both immediate and long term, or contribute to evidence-based guidelines for the evaluation and care of military Service Members, Veterans, and other individuals living with SCI. The U.S. Army Medical Research Acquisition Activity (USAMRAA) is soliciting applications to the fiscal year 2024 (FY24) Spinal Cord Injury Research Program (SCIRP) using delegated authority provided by United States Code, Title 10, Section 4001 (10 USC 4001). The Congressionally Directed Medical Research Programs (CDMRP) at the U.S. Army Medical Research and Development Command (USAMRDC) is the program management agent for this funding opportunity. Congress initiated the SCIRP in 2009 to provide support for traumatic spinal cord injury (SCI)-related research of exceptional scientific merit that has the potential to make a significant impact on improving the health and well-being of military Service Members, Veterans, and other individuals living with SCI. Appropriations for the SCIRP from FY09 through FY23 totaled $437.85 million (M). The FY24 Defense Appropriations Act provides $40M to the SCIRP through the appropriation for peer-reviewed spinal cord research. The vision of the SCIRP is to advance the treatment and management of SCI and ameliorate its consequences. The FY24 SCIRP challenges the scientific community to design research that will advance the development or translation of health care solutions for people living with SCI. Innovative research that fosters new directions or addresses neglected issues in the field of traumatic SCI is also supported, although studies focused exclusively on target identification are discouraged. The SCIRP encourages impactful research across the continuum of care from time of injury and across the life span that is well reasoned and scientifically supported. Applications from investigators within the military services and 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, their Families and/or care partners.

The FY24 ARP Idea Development Award supports the development of innovative, high-risk/high-reward research that could lead to critical discoveries or major advancements that will accelerate progress in improving outcomes for Autistic individuals. Applications are strongly encouraged to address one of the FY24 ARP Idea Development Award Areas of Interest or provide justification that the proposed research addresses a critical problem, question, or need in ASD. This award mechanism is designed to support innovative ideas with the potential to yield impactful data and new avenues of investigation.Research funded by the FY24 ARP should be responsive to the needs of people with ASD, their families, and/or caregivers. Researchers are therefore encouraged to establish and utilize effective collaborations and partnerships with community members to maximize the translational and impact potential of the proposed research.CDMRP encourages research on health areas and conditions that affect women uniquely, disproportionately, or differently from men, including studies analyzing sex as a biological variable. Such research should relate anticipated project findings to improvements in womens health outcomes and/or advancing knowledge for womens health.

The FY24 ARP Career Development Award supports early-career, independent investigators and/or the transition of established investigators from other research fields to conduct innovative, high-impact ideas or early-phase, proof-of-principle clinical trials with the potential to have a major impact on ASD. Applications are strongly encouraged to address one of the FY24 ARP Career Development Award Areas of Interest or provide justification that the proposed research addresses a critical problem, question, or need in ASD.This award enables such investigators to compete for funding separately from investigators with established programs of ASD research. Previous experience in ASD research is allowed, but not required. However, in FY24 Career Development Award applications that name a Principal Investigator (PI) with limited background in ASD research, the ARP strongly encourages the inclusion of collaboration with investigators who are experienced in ASD research and/or possess other relevant expertise in order to strengthen the application. PIs must meet specific eligibility criteria as described in Section II.C, Eligibility Information.Research funded by the FY24 ARP should be responsive to the needs of people with ASD, their families, and/or caregivers. Researchers are therefore encouraged to establish and utilize effective collaborations and partnerships with community members to maximize the translational and impact potential of the proposed research.CDMRP encourages research on health areas and conditions that affect women uniquely, disproportionately, or differently from men, including studies analyzing sex as a biological variable. Such research should relate anticipated project findings to improvements in womens health outcomes and/or advancing knowledge for womens health.

The intent of the FY24 ERP LRA is to leverage ongoing or completed research studies for which PTE was not an original focus and to provide support to expand the research to develop such a focus and increase our understanding of PTE. The project may include basic, translational, and/or clinical research studies. The study must be associated with an ongoing or completed research effort in which PTE is/was not a research priority and for which addition of cohorts, outcomes, assessments, or analysis specific to PTE would be scientifically justified to increase our understanding of PTE. Examples of allowable research include but are not limited to: Secondary analysis of epilepsy surveillance data to evaluate PTE risk; Addition of a chronic TBI cohort in an ongoing preclinical animal study to evaluate seizure outcomes and epileptogenesis; Recruitment/Analysis of a PTE cohort within an ongoing observational longitudinal study for a known concomitant comorbidity of PTE such as depression, cognitive deficits, sleep disorder, etc.

The intent of the FY24 LCRP Concept Award is to support innovative, non-incremental, high-risk/potentially high-reward research that will provide new insights, paradigms, technologies, or applications in lung cancer. Studies supported by this award are expected to lay the groundwork for future avenues of scientific investigation. The proposed research project should include a well-formulated, testable hypothesis based on a sound scientific rationale and study design. Research applications only in the area of mesothelioma will not be accepted.Inclusion of preliminary data is not required but is allowed. The strength of the proposed research should be based on sound scientific rationale and logical reasoning. The presentation of substantial preliminary data suggests that the proposed research project would be more appropriately submitted to a different FY24 LCRP funding opportunity. The outcome of research supported by this award should be the generation of robust preliminary data that can be used as a foundation for future research projects. Absence of preliminary data will not negatively affect scientific or programmatic review of the application.Care Delivery and Health Disparity Option: The FY24 LCRP Concept Award mechanism encourages applications that specifically address the comprehensive lung cancer care and/or health disparities FY24 LCRP Areas of Emphasis by offering a Care Delivery and Health Disparity option. Applications from the Care Delivery and Health Disparity option will be peer and programmatically reviewed separately from applications submitted to the Cancer Research Continuum option.Relevance to Military Health: The LCRP seeks to support research that is relevant to the healthcare needs of military Service Members, Veterans, and their Families. Relevance to military health will be considered in determining relevance to the mission of the Defense Health Program (DHP) and FY24 LCRP during programmatic review. Investigators are strongly encouraged to consider the following characteristics as examples of how a project may demonstrate relevance to military health:Use of military or Veteran populations, biospecimens, data/databases, or programs in the proposed research Collaboration with Department of Defense (DOD) or Department of Veterans Affairs (VA) investigatorsExplanation of how the project addresses an aspect of lung cancer that has relevance or is unique to the military, Veterans, other Military Health System (MHS) beneficiaries, or Family readiness of Service Members, including environmental exposures other than tobacco.All investigators applying to FY24 LCRP funding opportunities are encouraged to consider leveraging resources from the LCRP-funded Lung Cancer Biospecimen Resource Network (LCBRN) if retrospectively collected human anatomical substances and correlated clinical data are relevant to the proposed studies. Samples from the LCBRN are currently available through the Cooperative Human Tissue Network (CHTN). To request LCBRN samples, contact the Division Coordinator for the CHTN Mid-Atlantic division (email: [email protected]) located at the University of Virginia.A congressionally mandated Metastatic Cancer Task Force was formed with the purpose of identifying ways to help accelerate clinical and translational research aimed at extending the lives of advanced state and recurrent patients. As a member of the Metastatic Cancer Task Force, the CDMRP encourages applicants to review the recommendations (https://health.mil/Reference-Center/Congressional-Testimonies/2018/05/03/Metastatic-Cancer-Research) and submit research ideas to address these recommendations provided they are within the limitations of this funding opportunity and fit within the FY24 LCRP priorities.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 U.S. Army Medical Research Acquisition Activity (USAMRAA) is soliciting applications to the fiscal year 2024 (FY24) Epilepsy Research Program (ERP) using delegated authority provided by United States Code, Title 10, Section 4001 (10 USC 4001). The Congressionally Directed Medical Research Programs (CDMRP) at the U.S. Army Medical Research and Development Command (USAMRDC) is the program management agent for this funding opportunity. Congress initiated the ERP in 2015 to provide support for longitudinal epidemiological research to better understand the incidence of post-traumatic epilepsy (PTE) following a traumatic brain injury (TBI) and to improve patient care and outcomes. The FY24 ERP challenges the research community to (1) investigate topics related to epileptogenesis for the identification of mechanisms by which brain injury produces epilepsy, (2) study the prevention of PTE and concomitant comorbidities, and (3) develop innovative research tools or biomarkers to better detect, diagnose, or predict the development of PTE. Appropriations for the ERP from FY15 through FY24 totaled $85.5 million (M). The FY24 appropriation is $12M. The ERP encourages collaboration among PTE researchers and urges the scientific community to utilize equitable partnerships with people living with PTE to maximize the translational and impact potential of proposed research. Applications from investigators within the military Services and 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, their Families and/or care partners.