Grants for Small Businesses

The FY24 PRMRP Lifestyle and Behavioral Health Interventions Research Award (LBIRA) supports clinical research and/or clinical trials using a combination of scientific disciplines including behavioral health, psychology, psychometrics, biostatistics and epidemiology, surveillance, and public health. Applications are required to address and provide a solution to one of the congressionally directed FY24 PRMRP Topic Areas and FY24 PRMRP Strategic Goals.The overall intent of the FY24 PRMRP LBIRA mechanism is to promote evidence-based and patient-centered approaches to improve health and/or disease-related outcomes and enhance the patient experience in defined populations. Research ideas may include, but are not limited to: Development and testing for efficacy of lifestyle interventions and symptom management approaches to minimize disease risk and maximize quality of life. Studies to investigate the impact of prevention, diagnostics, treatment, or health care delivery approaches on health outcomes. Studies to assess the relationship(s) between behavioral, cognitive, and/or social functioning in relation to disease or condition initiation, progression, detection, treatment, and rehabilitation. Studies to examine and improve quality of life or decision-making. Population-focused studies to identify behavioral and lifestyle predictors of disease and/or disease progression.Pre-Application (Letter of Intent) Submission Deadline: 5:00 p.m. Eastern time (ET), May 13, 2024

The Regional Alliances and Multistakeholder Partnerships to Stimulate (RAMPS) Cybersecurity Education and Workforce Development (RAMPS) Program seeks to build multistakeholder workforce partnerships of employers, schools and institutions of higher education, and other community organizations. Effective multistakeholder workforce partnerships will organize multiple employers with skill shortages in specific occupations to focus on developing the skilled workforce to meet industry needs within the local or regional economy.

The FY24 LCRP Career Development Award supports early-career, independent investigators to conduct impactful research under the mentorship of an experienced lung cancer researcher as an opportunity to obtain the funding, mentoring, and experience necessary for productive, independent careers at the forefront of lung cancer research. Research applications only in the area of mesothelioma will not be accepted. This award is intended to support impactful research projects with an emphasis on discovery.Preliminary data are not required. However, logical reasoning and a sound scientific rationale for the proposed research must be demonstrated.Key elements of this award are as follows:Principal Investigator (PI): PIs must be research- or physician-scientists at an early stage of their independent research careers. PIs must be within 5 years of their first faculty appointment (or equivalent) and exhibit a strong desire to pursue a career in lung cancer research.Mentorship: The Mentor(s) must be an experienced lung cancer researcher(s) as demonstrated by a strong record of funding and publications in lung cancer research. In addition, the Mentor(s) must demonstrate a commitment to developing the PIs career in lung cancer research.Career Development: A Career Development Plan is required and should be prepared with appropriate guidance from the Mentor(s). A clearly articulated strategy for acquiring the necessary skills, competence, and expertise to have a career at the forefront of lung cancer research should be included. The plan should outline how the PI will gain experience in lung cancer research. Because career development is the focus of this award, the PI must commit a minimum of a 25% level of time and effort during the period of performance to conduct lung cancer research under this award.Impact: Research that has high potential impact may lead to major advancements and significantly accelerate progress toward eradicating deaths and suffering from lung cancer.Relevance to Military Health System (MHS) Beneficiaries: The application should clearly articulate how the proposed research is relevant to Service Members, Veterans, and their Families.The PI is required to attend a Department of Defense (DOD) one day in progress review meeting prior to the end of the second year of the award.

The ERP seeks to solicit Faculty members to join the Virtual Post-Traumatic Epilepsy Research Center (P-TERC) in order to advance PTE research through development of early-career investigators and investigators new to the PTE field. The ERP Virtual P-TERC is a unique, interactive virtual research center providing intensive mentoring, national networking, collaborations, and a peer group for new PTE investigators. The overarching goal of the Virtual P-TERC is to develop successful, highly productive PTE researchers in a collaborative research and career development environment to enhance quality and expand quantity of the PTE research field. The Virtual P-TERC is a multi-institutional career development and research training platform that consists of Faculty and their Career Guides (primary mentors) and is managed by a Director and Deputy Director. The Virtual P-TERC Leadership (the Director and the Deputy Director) serve as a resource for the Faculty and Career Guides, assessing the progress of Faculty and facilitating communication and collaboration among all of the Faculty and Career Guides, as well as with national research societies and representatives from the community with lived PTE experience. In addition to fostering scientific development, the Virtual P-TERC, through its Leadership, provides for professional and leadership development of the Faculty to include skills and competencies needed to fund and manage a productive PTE research laboratory.

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 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 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 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 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 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 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 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 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 Transformative Breast Cancer Consortium Development Award 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). This is a development award and is a separate mechanism from the full consortium award. Recipients of the FY24 Transformative Breast Cancer Consortium Development Award are expected to submit an application to compete for the full Transformative Breast Cancer Consortium Award anticipated to be offered in a future fiscal year(s). However, it is not necessary to receive a development award in order to apply for a full consortium award in the future. For FY24, investigators may be named as Consortium Director on an application submitted to either (but not both) of these mechanisms. Detailed information on the FY24 Transformative Breast Cancer Consortium Award is available under a separate program announcement (HT942524BCRPTBCCA).The FY24 Transformative Breast Cancer Consortium Development Award provides support to: Develop the infrastructure of a multi-institutional research team inclusive of scientists, clinicians, and breast cancer advocates (e.g., building appropriate collaborations, outlining integration, research management, administrative management, and communication plans, and devising an intellectual property plan) Generate necessary preliminary data to serve as proof of concept or for project integration Acquire research resources Develop a framework of necessary statistical analysesBreast cancer consumer advocates must be active participants in the development and execution of the Transformative Breast Cancer Consortium Development Award.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.Research involving human subjects and research involving human anatomical substances and data is permitted; however, clinical trials are not allowed under this funding opportunity.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 Transformative Breast Cancer Consortium Development Award should not exceed $100,000. 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 $0.16M to fund approximately one Transformative Breast Cancer Consortium Development 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 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.

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 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 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.