Grants for For profit organizations other than small businesses - Science and Technology

Key aspects of the TSA: Multidisciplinary Collaboration: The success of the project should depend on the unique skills and perspectives of each partner. The application must clearly define the synergistic components that will facilitate and accelerate progress in melanoma in a way that could not be accomplished through independent efforts. The plans for interactions among all PIs and institutions involved must be clearly articulated. Collectively, the members of the research team should represent the appropriate diversity of expertise necessary for addressing the proposed research question. Participating institutions must be willing to resolve potential intellectual and material property issues and remove institutional barriers to achieving high levels of cooperation. The following components of the proposed multidisciplinary collaboration are encouraged but not required: It is strongly encouraged that the research team has a least one investigator, key personnel, or consultant who can provide input on the ultimate utility/applicability (short- or long-term) of the anticipated outcome(s) to the melanoma field and/or patient care. The inclusion of an early-career investigator is encouraged. An early-career investigator is defined as an independent, early-career researcher or physician-scientist within 7 years of receiving their first faculty appointment by the time of the full application deadline. Investigators in mentored positions, (e.g., postdoctoral fellows) are not eligible to be named as a PI on a TSA application. The inclusion of a military and/or U.S. Department of Veterans Affairs (VA) investigator is encouraged. A military or VA investigator is defined as an investigator who is active-duty, active reserve, active duty detailed to agencies outside of the Department of Defense (DOD), civilian DOD investigators, or an investigator at a VA research facility. If included as PI on the research team, the military/VA investigator should have a substantial role in the research and should not be included only for access to active-duty military and/or VA populations. Impact: The application must articulate the impact the proposed work, including basic research, will have on melanoma research and/or patient care. Outcomes from this award are expected to expedite the advancement of promising ideas toward clinical applications and/or improve the current state of the science/technology in the melanoma field. The proposed research must relate to at least one of the FY24 MRP Focus Areas in Section II.A.1. Preliminary Data Required: Applications must include preliminary data to support feasibility of the study. However, these data do not necessarily need to be derived from melanoma studies. Any unpublished, preliminary data presented should originate from the laboratory of at least one of the PIs or other member(s) of the research team.

This program provides funding to a variety of organizations to create experiential learning opportunities in emerging technology fields, helping individuals from diverse backgrounds gain skills and transition into STEM careers.

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.

This funding opportunity provides financial support for projects that develop and demonstrate innovative carbon capture technologies at existing industrial and power facilities, aiming to reduce greenhouse gas emissions and promote clean energy solutions.

This funding opportunity provides financial assistance to bioscience start-ups, early-stage businesses, and academic institutions in Connecticut to help accelerate the commercialization of innovative bioscience breakthroughs.

It is the policy of my Administration to advance womens health research, close health disparities, and ensure that the gains we make in research laboratories are translated into real-world clinical benefits for women. It is also the policy of my Administration to ensure that women have access to high-quality, evidence-based health care and to improve health outcomes for women across their lifespans and throughout the country. President Joseph R. Biden, Jr., Executive Order 14120 on Advancing Womens Health Research and Innovation, 18 March 2024.In support of the Presidents Executive Order to advance womens health research, the PRORP is releasing this WHRA funding opportunity. The intent of the FY24 PRORP WHRA is to support research focused on orthopaedic issues faced by women serving in military settings, such as infantry and other physically demanding roles, who have sustained orthopaedic injuries. The overall goal of the WHRA is to address factors that contribute to the health and retention of women in military service. Although use of military populations, datasets, or samples are not required, the application should demonstrate how the proposed research relates to issues faced by women serving in military settings. The proposed research project should also include a well-formulated, testable hypothesis based on sound scientific rationale and logical reasoning.Although the PRORP is interested in supporting military-focused research, research supported by the PRORP is expected to also apply to all individuals who have sustained a major orthopaedic injury.The PRORP encourages applications from a spectrum of research areas, including but not limited to translational and clinical research. The PRORP also welcomes qualitative research, population science, and health care services research specifically designed to understand the impact of orthopaedic injuries on female Service Members.With the initiation of the Arthritis Research Program, the FY24 PRORP may not fund arthritis research; however, research that addresses conditions or health abnormalities related to arthritis is permitted provided the proposed research addresses the PRORP WHRAs focus on orthopaedic injuries in women.A key feature of the PRORP WHRA is the relevance to female military and/or Veteran populations following orthopaedic injury. Inclusion of female military and/or Veteran populations is highly encouraged for applications proposing clinical research. Applicants proposing clinical studies in non-military and/or non-Veteran populations must justify the relevance of the proposed research to the military and/or Veteran communities. All applicants should clearly describe how their study design, including recruitment strategies and access to appropriate populations, as applicable, will enable them to meet this intent.Research involving human subjects, human datasets, and human anatomical substances is permitted; however, the WHRA may not be used to conduct clinical trials. Applicants seeking support for a clinical trial should consider the FY24 PRORP Clinical Trial Award (Funding Opportunity Number HT942524PRORPCTA).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.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.Rigor of Experimental Design: All projects should adhere to a core set of standards for rigorous study design and reporting to maximize the reproducibility and translational potential of preclinical research. The standards are described in SC Landis et al., 2012, A call for transparent reporting to optimize the predictive value of preclinical research, Nature 490:187-191 (www.nature.com/nature/journal/v490/n7419/full/nature11556.html). While these standards are written for preclinical studies, the basic principles of randomization, blinding, sample-size estimation, and data handling derive from well-established best practices in clinical studies. Projects that include research on animal models are required to submit Attachment 7, Animal Research Plan, as part of the application package to describe how these standards will be addressed. Applicants should consult the ARRIVE guidelines 2.0 (Animal Research: Reporting In Vivo Experiments) to ensure relevant aspects of rigorous animal research are adequately planned for and, ultimately, reported. The ARRIVE guidelines 2.0 can be found at https://arriveguidelines.org/arrive-guidelines.Encouraged Department of Defense (DOD) and/or VA Collaboration: 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 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 funding instrument for awards made under the program announcement will be grants (31 USC 6304).The anticipated total costs budgeted for the entire period of performance for an FY24 PRORP WHRA should not exceed $1.5M. 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 $3.0M to fund approximately two WHRA 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.

This grant provides funding to researchers and organizations developing innovative medical solutions to improve the treatment and outcomes of burn injuries for military personnel in challenging environments.

This grant caters to unique and innovative projects that do not fit the conventional frameworks of the other sub-grants but still demonstrate significant economic development merit. Eligible projects may include feasibility studies, engineered drawings, architecture plans, and planning studies. These projects should aim to significantly impact the economic landscape of Goshen County. Deadlines: Applications due first Friday of November, February, May, August

This funding opportunity supports research and development of advanced transportation technologies, prioritizing projects that improve vehicle efficiency and battery technology while benefiting underserved communities across the U.S.

The Implementation Science for Strengthening Family Health (IS4FH) grant aims to fund organizations in implementing and evaluating interventions that enhance family health through partnerships and capacity building, with a total funding ceiling of $35 million available for innovative proposals.

This funding opportunity provides financial support to a wide range of organizations working to counter unmanned aerial system and weapons of mass destruction threats in Iraq, enhancing national security and regional stability.

This funding opportunity supports innovative breast cancer research projects that aim to address critical challenges in prevention, diagnosis, and treatment, benefiting military personnel, veterans, and the general public.

This program provides $20 million in funding to support the development of innovative recycling technologies and processes for materials used in wind turbines, targeting universities, businesses, nonprofits, and government entities.

This grant provides funding to U.S.-based nonprofit organizations and for-profit businesses to help foreign governments adopt secure American digital technologies, enhancing their cybersecurity and infrastructure capabilities.

NASA Established Program to Stimulate Competitive Research (EPSCoR) Basic Research aims to enhance research capabilities in underfunded regions by supporting innovative research initiatives that align with NASA's mission and priorities.

The City of Shreveport, through its Department of Community Development, has announced a Notice of Funding Availability (NOFA) for Affordable Rental Housing Proposals. This initiative is primarily funded by the HOME Investment Partnerships Program American Rescue Plan (HOME ARP). The core mission of this grant program is to address the critical need for affordable housing within the community by soliciting proposals from experienced agencies dedicated to developing and managing such properties. This aligns with a broader strategic priority to enhance housing stability and accessibility for vulnerable populations. The primary beneficiaries of this program are individuals and families from specific qualifying populations. These include people experiencing homelessness, those at risk of homelessness, individuals fleeing or attempting to flee domestic violence, dating violence, sexual assault, stalking, or human trafficking, and other populations where supportive services would prevent homelessness or serve those with the greatest risk of housing instability. The impact goal is to provide safe, stable, and affordable rental housing, thereby reducing homelessness and housing insecurity for these vulnerable groups. The program's priorities and focuses revolve around the production or preservation of affordable housing through new construction, rehabilitation, and property acquisition, including vacant land, specifically for HOME-ARP rental housing projects. These projects must commit to providing affordable rental housing for a minimum of 15 years. The City of Shreveport aims to fund up to three qualified entities that demonstrate extensive experience in affordable housing development, non-congregate or transitional housing operations, supportive service programs, and federal policy compliance. Expected outcomes include an increase in the number of available affordable rental housing units in Shreveport, directly benefiting the identified qualifying populations. Measurable results will likely include the number of new units constructed or rehabilitated, the number of individuals and families housed, and the duration of their housing stability. The City's strategic priority is to leverage federal funding to create a sustainable impact on housing affordability, with a theory of change that posits that by investing in experienced developers to create and preserve affordable housing, they can directly mitigate the effects of housing instability and homelessness in the community.

The CHIPS Research and Development Program (CHIPS R) aims to advance the development of semiconductor technologies and to enhance the competitiveness of the U.S. semiconductor industry. This is the first Notice of Funding Opportunity under this program. It seeks applications for new research and development (R) activities to establish and accelerate domestic capacity for advanced packaging substrates and substrate materials, a key technology for producing microelectronics systems. This NOFO seeks applications for research and development activities that will establish and accelerate domestic capacity for advanced packaging substrates and substrate materials. Through this NOFO, the NAPMP program seeks to achieve the following objectives: (1) Accelerate domestic R&D and innovation in advanced packaging materials and substrates; (2) Translate domestic materials and substrate innovation into U.S. manufacturing, such that these technologies are available to U.S. manufacturers and customers, including to significantly benefit U.S. economic and national security; (3) Support the establishment of a robust, sustainable, domestic capacity for advanced packaging materials and substrate R&D, prototyping, commercialization, and manufacturing; and (4) Promote a skilled and diverse pipeline of workers for a sustainable domestic advanced packaging industry. NAPMP plans to release subsequent NOFOs relevant to other research areas and for an Advanced Packaging Piloting Facility (APPF), where successful development efforts will be transitioned and validated for scaled transition to U.S. manufacturing. The APPF is expected to be a key facility for technology transfer to high-volume manufacturing.

This grant provides funding and technical assistance to organizations that help state, local, and Tribal governments improve their planning and permitting processes for large-scale renewable energy projects.

Orthopaedic injuries have a profound impact on military readiness and return to work/activity/duty. In the military, extremity battle wounds comprise approximately 50% of injuries reported in the Department of Defense Trauma Registry. Additionally, orthopaedic injuries and conditions that occur outside of combat (e.g., during training, leisure activities, resultant from old injuries) present one of the greatest threats to the readiness of our Service Members and military. Early stabilization, treatment, and rehabilitation of orthopaedic injuries in both civilian and military populations have led to better outcomes, particularly in the prevention of secondary complications and in minimizing morbidity. Availability of orthopaedic care and treatment as early as possible, or as close to the point of injury as possible, also minimizes limb loss and affects military readiness.Although the PRORP is interested in supporting military-focused research, research supported by the PRORP is expected to also apply to all individuals who have sustained a major orthopaedic injury.With the initiation of the Arthritis Research Program, the FY24 PRORP may not fund arthritis research; however, research that addresses conditions or health abnormalities related to arthritis is permitted provided the proposed research addresses the selected Focus Area.The PRORP CTA supports the rapid implementation of clinical trials with the potential to have a significant impact on the treatment or management of military combat or service-related orthopaedic injuries that significantly impact unit readiness and return-to-duty/work rates. Applicants are encouraged to address how the proposed research will support patient care closer to the point of injury and/or allow patients to more quickly return to duty/work. 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.The FY24 PRORP CTA differs from the FY24 PRORP Clinical Translational Research Award (CTRA) in that the CTRA allows for clinical research projects that may or may not include a clinical trial, whereas the CTA is restricted to clinical trials only.Funding from this award mechanism must support a clinical trial and may not be used for animal or preclinical studies. 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.All applications submitted to this program announcement, regardless of the selected Focus Area, are eligible for Research Level 1.Collaborative Care Option (Research Level 2): Applications submitted to the FY24 PRORP CTA, with Focus Area Translation of Early Findings Soft Tissue Trauma, are eligible for a Collaborative Care Option (Research Level 2); refer to Section II.D.5, Funding Restrictions. The Collaborative Care Option provides additional support to encourage collaborative interdisciplinary research among physical therapists, occupational therapists, prosthetists, surgeons, and other orthopaedic care providers. The proposed research should include both surgical and rehabilitation strategies that create a cohesive project. Surgical strategies are reconstruction and repair and/or application of biologics, pharmaceuticals, and devices for the purpose of restoration of native architecture, composition, and function of traumatically injured tissues. Rehabilitative strategies are those that restore function following injury or illness, with the goal of optimal health and independence. Projects should integrate principles and approaches from surgical and rehabilitative strategies, beyond what each approach would provide by itself, with the goal of optimizing form, function, and independence for those who have sustained traumatic orthopaedic injuries. The rehabilitation strategy and the standard of care must be specified. Projects that follow patients across the continuum of care are highly encouraged. To encourage meaningful and productive multidisciplinary collaborations, projects submitted for this option must include at least one investigator with orthopaedic rehabilitation expertise and at least one clinician who specializes in orthopaedic or trauma care. A Letter of Collaboration is required from each specialist (i.e., rehabilitation expert and surgeon) who is serving as Key Personnel, excluding the Principal Investigator (PI), on the application. A clinician is defined as an individual who is credentialed (possesses the necessary degrees, licenses, and other certifications) and practicing as a care provider in a relevant capacity.If the proposed research includes a clinical trial of an investigational product to be conducted at international sites, an application to the relevant national Regulatory Agency of each host country must be submitted within 6 months of the award date.The government reserves the right to withdraw funding if an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application and/or international regulatory application is necessary but has not been submitted within 6 months of the award date.For more information, a Human Subject Resource Document is provided at https://cdmrp.health.mil/pubs/pdf/Human%20Subjects%20Resource%20Document_DEC2022.pdf.Key aspects of the PRORP CTA mechanism: Clinical Trial Start Date: The proposed clinical trial is expected to begin no later than 6 months after the award date, or 12 months after the award date for studies regulated by the Regulatory Agency. 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 U.S. Food and Drug Administration (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 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.Womens Health Research: The 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 women's health outcomes and/or advancing knowledge for women's health.Use of DOD or VA Resources: If the proposed research involves access to DOD or VA resources or databases, the application must describe the access at the time of submission and include a plan for maintaining access as needed throughout the proposed research. Refer to Section II.D.2.b.ii, Full Application Submission Components, for detailed information. Refer to the General Application Instructions, Appendix 1, for additional information.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 within 6 months of the CTA award start date. 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 within 6 months of the CTA award start date. The IDE, or equivalent, should be specific for the device and indication to be tested in the proposed clinical trial.The funding instrument for awards made under the program announcement will be grants (31 USC 6304).The anticipated total costs budgeted for the entire period of performance for an FY24 PRORP CTA should not exceed $2.5M (Research Level 1) or $3.25M (Research Level 2). 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 $13.25M to fund approximately four Research Level 1 and one Research Level 2 CTA 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 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.