Grants for For profit organizations other than small businesses - Federal

This grant provides funding for innovative research proposals that aim to advance microsystems technology, targeting a wide range of eligible entities including universities, businesses, and research organizations focused on groundbreaking developments in microelectronics, photonics, and advanced devices.

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 CTRA is intended to support high-impact and/or emerging clinical research that may not be ready for a full-scale randomized controlled clinical trial. Projects should demonstrate potential to impact the standard of care, both immediate and long-term, as well as contribute to evidence-based guidelines for the evaluation and care of military, Veterans, and all patients with orthopaedic injuries. One goal of the FY24 PRORP CTRA is to translate current and emerging techniques and interventions into the clinical space to better serve military and non-military patients. A holistic approach that takes into account the health, functional abilities, and quality of life of individuals who have sustained an orthopaedic injury should be considered. Another goal is to identify the most effective diagnosis, treatment, rehabilitation, and prevention options available to support critical decision-making for patients, clinicians, other caregivers, and policymakers.The FY24 PRORP CTRA differs from the FY24 PRORP Clinical Trial Award (CTA) 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 clinical research and may not be used for animal research.Clinical research encompasses research with patient samples, data, and interaction with patients that may or may not be considered a clinical trial. Clinical research is observational in nature and includes: (1) Research that does not seek to evaluate the effects of interventions. Research conducted with human subjects (or on material of human origin such as data, tissues, specimens, and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects but does not seek to assess the effects of an intervention, qualifies as clinical research. Patient-oriented research 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 study 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 tissues that cannot be linked to a living individual. Note: Studies that meet the requirements for exemption under 46.104(d)(4) of the Common Rule are not considered clinical research as defined by the CDMRP. Exemption category 4 refers to secondary research for which consent is not required.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.Proposed studies submitted to the CTRA may be interventional and may involve some retrospective data analysis. Note that purely retrospective or database-related research is not allowed under this funding opportunity. Small pilot clinical trials with human subjects are allowable.Key aspects of the PRORP CTRA mechanism: Preliminary Data Are Required: Inclusion of preliminary data relevant to the proposed clinical research 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 research 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. 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 proposing a clinical trial that requires oversight by a Regulatory Agency, the trial must use a 21 CFR 11-compliant database and appropriate data standards.For the purposes of this funding opportunity, Regulatory Agency refers to the U.S. Food and Drug Administration (FDA) or any relevant international regulatory agency unless otherwise noted.If the proposed clinical research 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 Investigational New Drug (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 12 months of the CTRA 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 Investigational Device Exemption (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 12 months of the CTRA award start date. The IDE, or equivalent, should be specific for the device and indication to be tested in the proposed clinical trial.Womens Health: 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. Applications proposing research that solely address womens health may also consider the FY24 PRORP WHRA mechanism, Funding Opportunity Number HT942524PRORPWHRA.Use of Department of Defense (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.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 CTRA 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 $6.0M to fund approximately four CTRA 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.

With this solicitation, OJJDP seeks to fund a training and technical assistance (TTA) provider to build capability and capacity of diversion programs serving justice-involved youth populations with substance use disorder and co-occurring mental health and substance use disorder needs. The successful applicant will lead a national TTA program and administer a subaward program providing subawards to local demonstration sites to improve responses and outcomes for youth with substance use disorders and co-occurring mental health and substance use disorders who come into contact with the juvenile justice system, or who are at high risk of contact, by diverting these youth toward community-based treatment to address their unique mental and behavioral health needs to prevent them from entering the formal justice system.

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, etc.) 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 FY24 PRORP ARA seeks applied research applications focused on advancing optimal treatment and restoration of function for individuals with orthopaedic injuries sustained during combat and service-related activities. Applicants are encouraged to address how the proposed research will support patient care and allow patients to more quickly return to duty/work. It is expected that any research findings would also provide benefit to the general population. To meet the intent of the award mechanism, applications must specifically address an FY24 PRORP ARA Focus Area, listed in Section II.A.1, above.The FY24 PRORP ARA is focused on applied research, defined as work that refines concepts and ideas into potential solutions with a view toward evaluating technical feasibility of promising new knowledge products, pharmacologic agents, behavioral and rehabilitation interventions, diagnostic and therapeutic techniques, clinical guidance, and/or emerging approaches and technologies.Awards may not be used to support fundamental basic research. Basic research is defined as research directed toward greater knowledge or understanding of the fundamental aspects of phenomena and of observable facts without specific applications toward process or products in mind.Research Scope: Research proposed under the FY24 PRORP ARA may include small- to large-scale projects. Upon successful completion, the proposed research is expected to yield knowledge products, approaches, or technologies that have the potential to advance toward clinical translation. Strong transition plans are expected.Inclusion of preliminary and/or published data relevant to the proposed research is required. Applicants must demonstrate logical reasoning for the proposed work. To be competitive, the application must include a sound scientific rationale and a well-formulated, testable hypothesis established through a critical review and analysis of the literature.Studies allowed under the FY24 PRORP ARA may include, but are not limited to: Refinement of concepts and ideas into potential solutions, or research tools, with a view toward evaluating technical feasibility of emerging approaches, technologies, and promising new knowledge products. Evaluation, maturation, and/or down-selection of potential product candidates (drugs, biologic constructs, or devices/systems) in vitro and/or in vivo. Preparation activities needed to support a future clinical trial or regulatory submission.Applications to the FY24 PRORP ARA mechanism must support preclinical applied research and may not be used for clinical research studies. Applicants seeking support for clinical research projects should consider the FY24 PRORP Clinical Translational Research Award (Funding Opportunity Number HT942524PRORPCTRA), Clinical Trial Award (Funding Opportunity Number HT942524PRORPCTA), or Womens Health Research Award (Funding Opportunity Number HT942524PRORPWHRA) mechanisms.The funding instrument for awards made under the program announcement will be grants (31 USC 6304).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 8, 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.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. Applications proposing research that solely address womens health may also consider the FY24 PRORP WHRA mechanism, Funding Opportunity Number HT942524PRORPWHRA.Encouraged Department of Defense (DOD) and/or VA Collaboration: Military relevance is a key feature of this award. Principal Investigators (PIs) are encouraged, but not required, to collaborate with DOD or VA researchers and clinicians.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.The anticipated total costs budgeted for the entire period of performance for an FY24 PRORP Applied Research Award should not exceed $750,000. 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 $3.75M to fund approximately five ARA 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.

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.

The U.S. Department of State, Bureau of Democracy, Human Rights, and Labor (DRL) announces an open competition for organizations interested in submitting applications for a project that strengthens the resilience of independent media and advances the protection and inclusion of marginalized populations in Lebanon.

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.

Key aspects of the MASA: Principal Investigator: The PI (i.e., Scholar) must be an early-career researcher or physician-scientist no more than 7 years from obtaining their first faculty-level appointment. Postdoctoral fellows (and equivalent) are not eligible for this award mechanism. The PIs record of accomplishments and the proposed research will be evaluated regarding their potential for contributing to the FY24 MRP Focus Area(s) in Section II.A.1. Not all of the PIs accomplishments need to be in the field of melanoma. The PIs organization must demonstrate a commitment to the PI through confirmation of independent laboratory space. Impact: The impact of the proposed research must relate to at least one of the FY24 MRP Focus Areas in Section II.A.1. Impactful research, including basic research, should expedite the advancement of promising ideas towards clinical and/or public utility. The application must articulate the short- and long-term impact the proposed research will have on melanoma research and/or patient care. Career Development: A Career Development and Sustainment Plan (Attachment 7) is required and should be prepared with appropriate guidance from the Career Guide. The Career Development and Sustainment Plan should include a clearly articulated strategy for establishing collaborations and acquiring the necessary skills, competencies, and expertise to advance and sustain an independent career at the forefront of the melanoma field. The Scholar must show milestones and career pathways toward achieving the milestones. The Scholar must articulate commitment to interactions with the MA. Career Guide: The Scholar must designate a Career Guide. The Career Guide must be an experienced melanoma researcher, as demonstrated by a strong record of funding and publications in melanoma. In addition, the Career Guide must demonstrate a commitment to advancing the Scholars career in the melanoma field. The Career Guide must also be committed to fully participating in the MA throughout the award period of performance, including interacting with other MA Scholars and Career Guides and participating in MA activities (e.g., serving on the MA Advisory Board) as requested by MA Leadership. The Career Guide must not be the named Career Guide on any previously funded (FY21-FY23) MASA applications, nor may a Career Guide be named on more than ONE FY24 MASA application. Preliminary Data NOT Required: Preliminary data are not required. However, any unpublished, preliminary data presented should originate from the laboratory of the PI or a member of the research team.

The key aspects of this award are: Impact: The SRA is intended to support research designed to have a major impact on the health and well-being of melanoma survivors, their families, and/or caregivers. Impactful research will accelerate the movement of promising ideas into clinical applications or other real-world applications and advance the field of melanoma-specific quality of life and survivorship. Study Design: Applications should clearly articulate and justify the chosen study design. Studies proposing retrospective analyses or prospective enrollment should clearly describe the architecture of the study (e.g., descriptive, correlational, field experimental, meta-analyses) and the study population(s). The study population(s) should be representative of the people who are anticipated to benefit from the research. If applicable, questionnaires should be described in sufficient detail to justify interpretation of potential results. Melanoma Consumer Collaboration: For the purposes of the SRA, a melanoma consumer is defined as a melanoma survivor, family member, and/or caregiver who can provide lived experience expertise to the research project team. Applicants to the SRA are required to establish a collaborative research approach with the melanoma consumer community to maximize the impact and translatability of the research for the benefit of the intended melanoma community(ies). The research team must include at least one melanoma consumer or a melanoma-community supporting organization who will be integral to the planning, execution, and implementation of the proposed research. The role of the melanoma consumer collaborator(s) should include providing objective input on the research question being addressed; the study design, execution, and evaluation; and the potential impact of the research outcomes on the health and well-being of melanoma survivors, their families, and/or their caregivers. The melanoma consumer collaborator(s) should be active participants and integrated into the research team; their participation should not be limited only to passive activities (e.g., attending seminars or quarterly team meetings). Additional information and resources for establishing a collaborative research approach with the melanoma consumer community is provided below.Other Important Considerations:Collaborative Research Approaches: Collaborative research approaches create partnerships between scientific researchers and, for the purposes of the SRA, melanoma consumers to create knowledge useable by both sets of stakeholders. Recognizing the strengths of each partner, scientific researchers and melanoma consumers collaborate and contribute equitably on all aspects of the project, which may include needs assessment, planning, research intervention design, implementation, evaluation, and dissemination. Collaborative research approaches feature shared responsibility and ownership for the research project to ensure non-tokenistic involvement of the melanoma consumers within the research team. Research results are jointly interpreted, disseminated, and fed back to affected communities and in some instances may be translated into interventions or policy.Collaborative relationships with the melanoma consumer community may be established through integrating melanoma consumers and/or melanoma-community supporting organizations into research teams as co-researchers, advisors, and/or consultants. Examples for implementing collaborative research approaches are listed below, but each research team may pursue other options as appropriate for the proposed research: The research team includes at least one melanoma consumer who will provide advice and consultation throughout the planning and implementation of the research project. The consumer(s) should be able to speak to the needs of the melanoma consumer community, not just speak to their own personal experiences. The research team establishes partnerships with at least one community-supporting organization that provides advice and consultation throughout the planning and implementation of the research project. Community-supporting organizations may include advocacy groups or other formal organizational stakeholders that can speak to the needs of the melanoma consumer community. The research team assembles a melanoma consumer community advisory board. The advisory board may include melanoma consumers, a coalition of community-supporting organizations, or any combination thereof that provides advice and consultation throughout the planning and implementation of the overall program and/or individual research projects.

The key aspects of this award are: Overarching Question: FPA-RM applications must describe a unifying, overarching question that will be investigated by a set of research projects to address a critical unmet need relevant to rare melanoma research and/or patient care. The question may focus on one specific rare melanoma, or the question may be designed to address a critical unmet need that is relevant to multiple rare melanomas. Research Team: The overall effort will be led by a Principal Investigator (PI) with demonstrated success in leading large, focused projects. The PI is required to devote a minimum of 10% effort to this award. The PI will be the lead for one of the proposed research projects and is expected to create an environment that fosters and supports collaboration and innovation in a way that engages all members of the team. The research team assembled by the PI should be highly qualified and multidisciplinary, with an identified Project Leader(s) for the complementary and synergistic research project(s). The resources and expertise brought to the team by the Project Leader(s) should combine to create a robust collaboration. The PI and the Project Leader(s) do not have to be at the same organization. Research Projects: Applications should include multiple, distinct research projects that are each led by individual Project Leaders and address complementary aspects of the overarching question. Individual research projects may range from exploratory, hypothesis-developing studies through clinical trials. While individual projects should be capable of standing on their own high scientific merits, they should also be interrelated and synergistic to advance a solution beyond what would be possible through individual efforts. Each project, including hypothesis-developing studies, should propose a unique approach to addressing the overarching question and be capable of producing research findings with potential to advance the rare melanoma field and/or patient care. There should be a clear intent to progress toward translational/clinical work over the course of the effort. This award mechanism is not intended to support a series of research projects that are dependent on the success of the other project(s). All research projects must be based on a strong scientific rationale and preliminary data, as appropriate, that supports the feasibility of the proposed approach(es). Clinical trials are allowed; a research project proposing a clinical trial must include preliminary data. Implementation Plan: The research strategy to address the overarching question should be supported by an implementation plan that identifies critical milestones and outlines the knowledge, resources, and/or technical innovations that will be utilized to achieve the milestones. A plan for assessing individual project performance and progress toward addressing the overarching question should be included in the implementation plan. For multi-institutional collaborations, the application should discuss plans for communication and data transfer among the collaborating institutions, as well as how data, specimens, and/or products obtained during the study will be handled. Participating organizations should formalize an intellectual and material property plan. Milestone Meeting: The PI will be required to present an update on progress toward accomplishing the goals of the award at a Milestone Meeting to be held either virtually or in person in the National Capital Area after the conclusion of year 2 of the period of performance. The intent of the Milestone Meeting is to assess research progress, address problems, and define future directions. Research milestones to be accomplished by the end of year 2 must be clearly defined in the Statement of Work (SOW) and will be finalized during award negotiations. Up to two additional members of the research team may be invited to the meeting. If the research team includes rare melanoma consumer collaborators (see below), they should also be invited to attend the Milestone Meeting. The Milestone Meeting will be attended by members of the MRP Programmatic Panel, CDMRP staff, the USAMRAA Grants Officer, and other Department of Defense (DOD) stakeholders. Continued funding may be contingent upon the successful completion of specific research milestones and goals.

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.

The FY24 MRP Idea Award supports innovative, untested, exploratory, high-risk/potentially high-reward concepts, theories, paradigms, and/or methods that address at least one of the FY24 MRP Focus Areas in Section II.A.1. Key aspects of the Idea Award: The intent of the Idea Award is to generate novel research avenues for investigation; therefore, novelty and innovation should be key aspects of the proposed research. Research supported by the Idea Award must introduce a new paradigm, challenge existing paradigms, look at existing problems from new perspectives, or exhibit other highly creative qualities. The proposed project must be exploratory, hypothesis-driven, or hypothesis-generating research and be based on a well-developed study design and plan of analysis. Principal Investigators (PIs) new to the melanoma field are encouraged to apply. The Idea Award is NOT intended to expand or extend previously published findings or continue a line of research already established and /or funded in the PIs laboratory. Incremental advances, the next logical step, or merely switching the object or method of inquiry from one cancer to melanoma is not considered innovative. The expected outcome of research supported by this award is the generation of robust preliminary data to be used as a foundation for future melanoma-focused research projects. Inclusion of preliminary data is discouraged. PIs proposing projects already supported by significant preliminary data and/or other funding sources should consider applying to other FY24 MRP funding opportunities for which the inclusion of preliminary data is more appropriate or required. Inclusion of preliminary data other than serendipitous findings is not consistent with the exploratory/innovative nature of this award. If preliminary data are included, they should be unanticipated outcomes or results from an unrelated project or study.

The PRP IIRA supports highly rigorous, multidisciplinary, high-impact research projects that have the potential to make an important contribution to Parkinsons research. This award mechanism supports the full spectrum of research from basic science through clinical research.

The FY24 PCRP Implementation Science Award supports studies that are expected to bridge the gap between research, practice, and policy through establishment of a knowledge base of interventions, clinical practices/guidelines, tools, and policies that can be deployed to targeted populations at the appropriate time and point of need. For the purposes of this funding opportunity, an implementation science study accesses strategies used and develops tools to enhance the systematic uptake of evidence-based health interventions into clinical and/or community settings in order to improve patient outreach, patient outcomes, and/or the effectiveness of health care.Impact: Research supported by the Implementation Science Award is expected to have the potential for major, near-term impact that will accelerate the widespread adoption of evidence-based practices in prostate cancer care, prevention, and survivorship. Applications are expected to identify the prostate cancer patients or at-risk individuals who would ultimately benefit from the proposed research. Applications must also include a detailed research transition plan that articulates the pathway to moving the projects findings to the next phase for widespread clinical impact after successful completion of the award. Research transition plans are encouraged to consider future strategies targeting the patient, physician/provider, community, and/or healthcare system levels as applicable.Community Engagement: Applications are required to include members of the targeted population and/or community in the development and execution of the research project where appropriate. The research team must include one or more prostate cancer consumer advocate(s) or member(s) of the community, who will be integral throughout the planning and performance of the research project. Consumer advocates and/or community-based members should be involved in the development of the research question, project design, oversight, recruitment, and evaluation and dissemination of outcomes, 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; communication between the research team and the community should be frequent and bidirectional. The consumer advocates can be individuals who have been diagnosed with prostate cancer, a direct caregiver for someone who has been diagnosed with prostate cancer, or other representatives from the targeted community who are positioned to effect change. The consumer advocates and/or community-based members should have a high level of knowledge of current prostate cancer issues and the appropriate background in prostate cancer research and/or clinical care to contribute to the project or be otherwise positioned within the target community to effect changes in behavior based on projected outcomes. A list of implementation science resources and community or advocacy organizations is provided at the end of the Implementation Science Award Information section.Health Equity and Disproportionately Affected Populations: Regardless of the FY24 PCRP Overarching Challenge(s) being addressed, all research projects are strongly encouraged to consider health equity (e.g., access to evidence-based care) and/or have a focus on addressing the needs of disproportionately affected populations in the application.Research Scope: The Implementation Science Award mechanism is intended to fund studies including, but not limited to, the following: Small-scale clinical trials (up to phase 2) that contain clear reporting and implementation strategies to narrow the research-to-practice timeline and improve care for prostate cancer survivors, particularly within disproportionately affected populations Interventions that focus on behavioral or lifestyle changes at the patient, provider, community, and/or policy level Comparative effectiveness research establishing the benefits and harms of emerging or standard-of-care interventions and strategies to prevent, diagnose, treat, and monitor health conditions in real-world settings Development and evaluation of strategies to overcome barriers to health care access across the cancer care continuum Altering the adoption, adaptation, integration, scale-up, and sustainability of evidence-based interventions, tools, policies, and guidelines.Preliminary data to support the scientific rationale and feasibility of the research approaches are required. These preliminary data do not need to have been generated solely in prostate cancer. The inclusion of additional preliminary data to support the clinical relevance of the idea is strongly encouraged.Investigators proposing a clinical trial are highly encouraged to consider leveraging the PCRP Prostate Cancer Clinical Trials Consortium (https://pcctc.org) to facilitate the rapid initiation and completion of the trial.Correlative studies that are associated with ongoing clinical trials, and preclinical studies involving the use of animals do not meet the intent of the FY24 PCRP Implementation Science Award.Partnering Principal Investigator (PI) Option: The FY24 PCRP Implementation Science Award encourages applications that include meaningful and productive collaborations between two investigators. The PIs may have expertise in similar or disparate scientific and/or clinical disciplines, but each PI is expected to bring distinct contributions to the application. 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 and execution of the proposed research project. 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.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 PCRP prioritiesInnovative 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.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, 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.All projects should adhere to a core set of standards for rigorous study design and reporting to maximize the reproducibility and translational potential of clinical and preclinical research. The standards are described in SC Landis et al., 2012, A call for transparent reporting to optimize the predictive value of preclinical research, Nature 490:187-191 (https://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.A Clinical Trial Option allows for studies proposing small-scale clinical trials with a focus on implementation science. 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. Applications proposing a clinical trial are expected to provide detailed plans for initiating the clinical study within the first year, including U.S. Food and Drug Administration (FDA) Investigational New Drug/Investigational Device Exemption application submission plans, within 60 days of the award.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.Implementation Sciences Resources: Potential applicants for this award are encouraged to seek collaborations and access to appropriate study populations through the following (or similar) resources: CDMRP: Search the CDMRP awards database at https://cdmrp.health.mil. The North Carolina Louisiana Prostate Cancer Project (PCaP): The PCaP was supported by the PCRP to conduct prostate cancer health disparity studies and developed a large biorepository of health disparity-related epidemiological data and biospecimens that may be requested for use by the research community. Information on PCaP investigators, data, and specimens is available at https://pcap.bioinf.unc.edu. National Cancer Institute Center to Reduce Cancer Health Disparities: Search for health disparity research and researchers at https://crchd.cancer.gov/index.html. National Institute on Minority Health and Health Disparities (NIMHD), National Institutes of Health (NIH), Community-Based Participatory Research (CBPR) Initiative: Contact the NIMHD at https://www.nimhd.nih.gov/programs/extramural/community-based-participatory.html for information on current CBPR programs and scientists and communities engaged in health disparity research. Cancer Prevention and Control Research Network (CPCRN): Contact the CPCRN at https://cpcrn.org/ for information on community participatory research to reduce cancer in disproportionately affected populations. Health Resources and Services Administration, Office of Minority Health: Search for health disparity programs and funded investigators at https://www.hrsa.gov/index.html. NIH Research Portfolio Online Reporting Tool (NIH RePORTER): Search for NIH awards at https://projectreporter.nih.gov/reporter.cfm. Defense Technical Information Center (DTIC): Search for Department of Defense (DOD) and other government-funded investigators through DTIC Technical Reports at https://discover.dtic.mil/. National Library of Medicine, NIH, PubMed: Search for investigators publishing studies on prostate cancer health disparities at https://www.ncbi.nlm.nih.gov/pubmed. U.S. Department of Education: Search for institutions that may have increased access to disproportionately affected populations at https://www2.ed.gov/about/offices/list/ocr/edlite-minorityinst.html. International Cancer Research Partnership: Search for investigators and studies relevant to health disparity that are supported by cancer research funders from several countries including the United States, European Union, United Kingdom, and Canada at https://www.icrpartnership.org. National Coalition for LGBT Health: For more information on programs focused on Lesbian, Gay, Bisexual, and Transgender (LGBT) research, policy, education, and training, search https://www.healthlgbt.org. National LGBT Cancer Network: To obtain more information, search https://www.cancer-network.org.In addition, the following is a list of potential community and/or advocacy organizations that applicants may find helpful to satisfy the requirement for community engagement within their proposed studies: the American Indian Health Care Association, National African American Outreach Program of the Patient Advocate Foundation, National Alliance for Hispanic Health, National Medical Association, National Rural Health Association, and Prostate Health Education Network, as well as international organizations such as the African-Caribbean Cancer Consortium, African Organization for Research and Training in Cancer, Europa Uomo, European Cancer Patient Coalition, Global Prostate Cancer Alliance, Malecare, Men of African Descent and Carcinoma of the Prostate Consortium, Prostate Cancer Transatlantic Consortium, Urban League, and The Prostate Net.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 PCRP Implementation Science Award should not exceed $2.0M. 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 $9.6M to fund approximately three PCRP Implementation Science 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 FY24 DMDRP IDA promotes new ideas that are still in the early stages of development and have the potential to yield impactful data and new avenues of investigation. This award supports conceptually innovative, high-risk/high-reward research that could lead to critical discoveries or major advancements that will accelerate progress in improving outcomes for individuals with DMD. Applications should include a well-formulated, testable hypothesis based on strong scientific rationale.New Investigators: The FY24 DMDRP IDA mechanism encourages applications from independent investigators in the early stages of their careers (i.e., within 10 years of their first faculty appointment or equivalent) or applications from established investigators new to DMD research.The New Investigator Early Stage category is designed to allow applicants early in their faculty appointments to compete for funding separately from established investigators.The New Investigator Transitioning category is designed to allow investigators in an area other than muscular dystrophy, at or above the level of Assistant Professor, seeking to transition to a career in DMD, thereby bringing their expertise to the field.Applications from New Investigators and Established Investigators will be peer and programmatically reviewed separately. Principal Investigators (PIs) using the New Investigator Early Stage category or New Investigator Transitioning category are strongly encouraged to strengthen their applications by collaborating with investigators experienced in DMD research and/or possessing other relevant expertise. It is the responsibility of the applicant to describe how the included collaboration will augment the PIs expertise to best address the research question. All applicants for the New Investigator categories must meet the specific eligibility criteria described in Section II.C, Eligibility Information.Preliminary data relevant to DMD that supports the feasibility of the research hypotheses and research approaches are required. Preliminary data may include unpublished results from the laboratory of the PI, research team or collaborators named on the application.Key elements of this award are as follows:Innovation: Research deemed innovative may introduce a new paradigm, challenge current paradigms, look at existing problems from new perspectives, or exhibit other uniquely creative qualities.Impact: Research that has high potential impact may lead to major advancements and significantly accelerate progress toward improving outcomes for individuals with DMD.It is the responsibility of the PI to clearly and explicitly articulate the projects innovation and its potential impact on DMD. The projects impact to both DMD research and to individuals with DMD should be articulated, even if clinical impact is not an immediate outcome. Applications that demonstrate exceptional scientific merit but lack innovation and high potential impact do not meet the intent of the IDA.Clinical trials are not allowed under this funding opportunity.A clinical trial is defined in 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 FY24 DMDRP CTRA mechanism supports advanced translational research that will accelerate the movement of promising ideas in DMD research into clinical applications. Translational research may be defined as an integration of basic science and clinical observations. However, applicants should not view translational research as a one-way continuum from bench to bedside. The research plan must involve a reciprocal flow of ideas and information between applied and clinical research. As such, applications must include preliminary and/or published data relevant to DMD to support the proposed research project.This mechanism is intended to support established projects that have moved beyond the realm of basic research and proof of concept studies and have the potential to result in a near-term impact in clinical research or the clinic. Research projects investigating therapies that will be efficacious across the life span, including infants, toddlers, and non-ambulatory individuals, are strongly encouraged. Pilot, proof-of-principle clinical trials, and correlative studies to better inform development of drugs, devices, and other interventions are allowed.Early-Career Partnering PI Option: The FY24 DMDRP encourages applications that include meaningful and productive collaborations between investigators. In an effort to promote enhanced research capacity within the DMD field, the FY24 CTRA includes an option for an Early-Career Partnering Principal Investigator (PI). 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 Early-Career PI will be identified as the Partnering PI. Both PIs should contribute significantly to the development and execution of the proposed research project. 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 PI, refer to Section II.D.2, Content and Form of the Application Submission.The FY24 DMDRP CTRA offers two funding levels (refer to Section II.D.5 Funding Restrictions). Only one funding level category may be chosen per application, and the choice of application category is at the discretion of the applicant. The following are generalized descriptions of the scope of the research appropriate for each funding level:Funding Level 1: Funding Level 1 is intended to support smaller, less complex preclinical and/or clinical research. Pilot clinical trials are allowed. The proposal/applications direct costs budgeted for the entire period of performance should not exceed $650,000.Funding Level 2: Funding Level 2 is intended to support larger, more complex preclinical and/or clinical research. Pilot clinical trials are allowed. The proposal/applications direct costs budgeted for the entire period of performance should not exceed $1.35M.Additionally, both funding levels will support an Early-Career Partnering PI Option at the same maximum direct costs and periods of performance, respectively.For the purposes of this funding opportunity, research that meets the definition of a clinical trial is distinct from clinical research. Both pilot clinical trials and clinical research are permitted under this mechanism.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.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.All investigators applying to FY24 DMDRP funding opportunities and conducting clinical research are encouraged to consult the Strategies to Promote Diversity in Muscular Dystrophy Research Participation developed by the MDCC.

The PRP EIRA supports research opportunities for investigators in the early stages of their careers. The Early Investigator is considered the Principal Investigator (PI) of the application and must exhibit strong potential for, and commitment to, pursuing a career as an investigator at the forefront of PD research; however, the PI is not required to have previous PD research experience.

This program to build social cohesion between at-risk groups in northern Ghana and northern Cote dIvoire by improving equitable access to livelihoods in communities hosting refugees and asylum seekers in these regions. Impoverished host communities demonstrate resentment and hostility towards growing refugee/asylum seeker populations in this region as they compete for land, resources, and support from the state and from nongovernmental organizations. Through strengthening inclusive, equitable, and sustainable communal management of land and water resources in communities hosting refugees/asylum seekers, increasing equitable economic exchange between host communities and refugees/asylum seekers, and building conflict management skills in these communities, this program will improve equitable access to livelihoods for at-risk communities, thereby contributing to strengthened social cohesion between these groups in keeping with Objective 1 of the 10-Year Plan to implement the Strategy to Prevent Conflict and Promote Stability in Coastal West Africa.

This NOFO seeks proposals from eligible applicants for activities to establish and operate a CHIPS Manufacturing USA Institute focused on digital twins with integrated physical assets and computational capabilities (digital assets) to tackle important semiconductor-industry manufacturing challenges. The CHIPS Manufacturing USA Institute will join an existing network of seventeen Institutes designed to increase U.S. manufacturing competitiveness and promote a robust R infrastructure. The Institute will manage a portfolio of Institute-led projects and competitively funded Member-led projects, including Education and Workforce Development (EWD) activities, basic and applied research, and technology demonstrations.

With this solicitation, OVC seeks to award a 36-month cooperative agreement to one lead organization that will (1) fund (through a competitive process) subawards to communities severely affected by violence to establish trauma recovery centers , and (2) provide technical assistance to the subawardees to support operation of the centers. The trauma recovery centers funded under this demonstration project will address crime victimization and support access to victims compensation, crime victims rights enforcement, trauma recovery, and healing. Subawardees will be expected to design centers to provide services to crime victims who traditionally do not seek victims services, assistance, or counseling, or are historically underserved. This demonstration is intended to span 5 years (60 months total) via an initial 3-year budget allocation under this solicitation, with the potential for noncompetitive continuation funding as the project moves from year 3 to year 5 of its implementation.