Funding Wizard

The LRP Idea Award supports innovative, high-risk/high-reward research that could ultimately lead to a critical discovery or major advancement relevant to lupus. This award mechanism supports studies that have the potential to reveal entirely new avenues for investigation. The application must describe how the new idea will enhance the existing knowledge of lupus or develop a hypothesis(es) or an innovative and novel course of investigation. The Idea Award is not intended to support an incremental progression of an already established research project. Research completed through an Idea Award may generate sufficient preliminary data to enable the Principal Investigator (PI) to prepare an application for future research. Inclusion of preliminary data is not required.The following are important aspects of the Idea Award:• Innovation: Innovative research may introduce a new paradigm, look at existing problems from new perspectives, or exhibit other highly creative qualities. It is the responsibility of the PI to clearly and explicitly describe how the proposed research is innovative and will lead to novel avenues of investigation in lupus research.• Impact: The proposed research, if successful, should impact an area of paramount importance in lupus disease. Applications should clearly and explicitly describe the potential impact(s) of the proposed study for individuals living with lupus and to convey its level of significance. Research that represents an incremental advancement on previously published work is not considered impactful.• Research Strategy: The scientific rationale and experimental methodology should demonstrate critical understanding and in-depth analysis of lupus. Experimental strategies may be novel or may be based on strong rationale derived from a literature review.• Focus Areas: The proposed research must address at least one of the FY22 LRP Focus Areas.• Clinical trials are not allowed under this program announcement.The types of awards made under the program announcement will be assistance agreements. An assistance agreement is appropriate when the federal government transfers a “thing of value” to a “state, local government,” or “other recipient” to carry out a public purpose of support or by a law of the United States instead of acquiring property or service for the direct benefit and use of the U.S. government. An assistance agreement can take the form of a grant or cooperative agreement. The level of involvement on the part of the Department of Defense (DOD) during project performance is the key factor in determining whether to award a grant or cooperative agreement. If “no substantial involvement” on the part of the funding agency is anticipated, a grant award will be made (31 USC 6304). Conversely, if substantial involvement on the part of the funding agency is anticipated, a cooperative agreement will be made (31 USC 6305), and the award will identify the specific substantial involvement. Substantial involvement may include, but is not limited to, collaboration, participation, or intervention in the research to be performed under the award. The award type, along with the start date, will be determined during the negotiation process.The anticipated total costs budgeted for the entire period of performance for an FY22 Idea Award will not exceed $300,000. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.Awards will be made no later than September 30, 2023. For additional information refer to Section II.F.1, Federal Award Notices.The CDMRP expects to allot approximately $1.2M to fund approximately four Idea Award applications. Funding of applications received is contingent upon the availability of federal funds for this program as well as the number of applications received, the quality and merit of the applications as evaluated by scientific 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 FY22 funding opportunity will be funded with FY22funds, which will expire for use on September 30, 2023.

The PRP SIA supports new ideas that represent synergistic approaches to PD research involving two to four Principal Investigators (PIs) at the Assistant Professor (or equivalent) level or above. These investigators should utilize their complementary and synergistic perspectives to address a central problem or question in Parkinson’s research. This award is designed to support both new and pre-existing partnerships and encourages participation of PIs from other research fields. The PRP Synergistic Idea Award seeks applications from investigators working in a wide spectrum of disciplines including, but not limited to, basic science, engineering, bioinformatics, population science, translational research, and clinical research.

The FY22 TBIPHRP TRA is intended to support translational research that will accelerate the movement of promising ideas in psychological health conditions and/or TBI research into clinical applications, including healthcare products, technologies, and/or clinical practice guidelines.Applicants should not view translational research as a one-way continuum from bench to bedside. The research plan is encouraged to involve a reciprocal flow of ideas and information between basic and clinical science. As such, applications must include preliminary and/or published data to support the proposed research project.Applications to the FY22 TBIPHRP TRA may include preclinical and/or clinical research involving human subjects and human anatomical substances. The FY22 TBIPHRP TRA may also support ancillary studies that are associated with an ongoing or completed clinical trial and projects that optimize the design of future clinical trials.If animal models are proposed, consider the following:• Pairing clinical populations to animal models in order to validate the clinical relevance and development of prevention, assessment, and treatment solutions is encouraged.• Proposed animal models should be well justified, supported within the literature, and clearly align with clinical relevance to the human condition.The FY22 TBIPHRP TRA also allows funding for a pilot/exploratory clinical trial as PART of the funded research project where limited clinical testing of a novel knowledge product,3 intervention, or device is necessary to inform the next step in the continuum of translational research. Such pilot/exploratory clinical trial studies should be small, make up only a portion of the research proposed in the Statement of Work (SOW), and be utilized to establish the feasibility of a potential approach or to aid in device or intervention refinement. Applications that include large-scale clinical trials do not meet the intent of the mechanism. Applications that consist entirely of a pilot/exploratory clinical trial or multiple pilot/exploratory clinical trials may be administratively withdrawn.Alternative trial designs to traditional randomized clinical trials are allowed, but should be appropriate to the objective of the trial. Applications that include a pilot/exploratory clinical trial as part of the proposed research will have additional submission requirements and review criteria. Funded trials are required to post a copy of the Institutional Review Board (IRB)- approved informed consent form used to enroll subjects on a publicly available federal website in accordance with federal requirements described in the Code of Federal Regulations, Title 32, Part 219 (32 CFR 219). This award may not be used to support studies requiring an exception from informed consent (EFIC).Applications that consist entirely of multiple pilot/exploratory clinical trials or solely of a pilot/exploratory clinical trial are not permitted under this funding mechanism and should consider submitting to the following FY22 TBIPHRP funding opportunities:• Clinical Trial Award (Funding Opportunity Number: W81XWH-22-S-TBIPH1)• Focused Program Award (Funding Opportunity Number: W81XWH-22-S-TBIPH2)

The FY22 TBIPHRP IIRA is intended to support studies that will make an important contribution toward understanding, preventing, assessing, and treating psychological health conditions and/or TBI. Research projects may focus on any phase of research from basic laboratory research through translational research, including preclinical studies in animal models and human subjects, as well as correlative studies associated with an existing clinical trial.Applications should clearly demonstrate the project’s potential near-term and long-term outcome(s)/product(s) (knowledge and/or materiel) and how they will impact a critical problem or question in the field of research and/or patient care in the FY22 TBIPHRP IIRA Focus Areas(s) addressed. Research involving human subjects and human anatomical substances is permitted; however, this FY22 TBIPHRP IIRA may not be used to conduct clinical trials.A clinical trial is defined 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. This award may not be used to conduct clinical trials or studies requiring an exception from informed consent (EFIC).Applications proposing clinical trials may be submitted to the following FY22 TBIPHRP funding opportunities:• Clinical Trial Award (Funding Opportunity Number: W81XWH-22-S-TBIPH1)• Focused Program Award (Funding Opportunity Number: W81XWH-22-S-TBIPH2)• Translational Research Award (Funding Opportunity Number: W81XWH-22-TBIPHRP- TRA)• Patient-Centered Research Award (Funding Opportunity Number: W81XWH-22-TBIPHRP- PCRA)Clinical research is defined as: (1) Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens, and cognitive phenomena)tigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a livingindividual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies. (2) Epidemiologic and behavioral studies. (3) Outcomes research and health services research. Note: Studies that meet the requirements for Institutional Review Board (IRB) Exemption 4 are not considered CDMRP-defined clinical research. IRB Exemption 4 refers to research involving the collection or study of existing de-identified specimens or data, if these sources are publicly available.For more information on how to distinguish clinical research from clinical trials, see the Human Subject Resource Document.If animal models are proposed, consider the following:• Pairing clinical populations to animal models in order to validate the clinical relevance and development of prevention, assessment, and treatment solutions is encouraged.• Proposed animal models should be well-justified, supported within the literature, and clearly align with clinical relevance.Preliminary data are required. The rationale for a research idea may be derived from a laboratory discovery, population-based studies, a clinician’s firsthand knowledge of patients, or anecdotal data. Applications must include relevant data that support the rationale and feasibly for the proposed study. These data may be unpublished or from published literature. Any unpublished, preliminary data provided should originate from the laboratory of the Principalor (PI) or members of the research team.

Maturing research ideas into clinical practice and patient benefit is at the heart of all CDMRPresearch programs. Despite significant investment, the gap between what is possible and what is achieved remains. Even after information, tools, and interventions have been successfully evaluated in their intended populations, the development of knowledge to support their broader dissemination and implementation has often remained outside the scope.The FY22 TBIPHRP PCRA intends to bridge the gap between research, practice, and policy by building a knowledge base on how interventions, clinical practices/guidelines, tools, and policies can be deployed to targeted populations at the appropriate time at the point of need. Funding from this award mechanism must support clinical research or clinical trials but cannot be used for preclinical or animal research. Applications may propose prospective or retrospective research involving human subjects, human subject data/records, and human anatomical substances. This award may not be used to support studies requiring an exception from informed consent (EFIC).The FY22 PCRA may support (not all inclusive):• Comparative effectiveness research comparing the benefits and harms of emerging or established interventions and strategies to prevent, diagnose, treat and monitor health conditions in “real world” settings.• Development and evaluation of strategies to overcome barriers to the adoption, adaptation, integration, scale-up and sustainability of evidence-based interventions, tools, policies, and guidelines.• Analysis of existing data or resources to inform clinical practice• Modification of established clinical tools for their intended population or environment• Analysis of existing clinical tools to maximize patient-relevant outcomes• Identification and analysis of the circumstances that create a need to stop or reduce (“de- implement”) the use of interventions, tools, policies, and guidelines that are ineffective, unproven, low-value, or harmful is within scope.The following are important aspects of the FY22 TBIPHRP PCRA:• The application must include Community-Based Participatory Research (CBPR) approaches in the development and execution of the clinical research/trial. CBPR approaches should be documented in Attachments 11 and 12.• Inclusion of preliminary data relevant to the proposed clinical research/trial is required.• As applicable, the application should demonstrate availability of and access to a suitable patient population that will support a meaningful outcome for the study.• If applicable, the proposed clinical trial is expected to begin no later than 6 months after the award date.• If applicable, the application should demonstrate documented availability of and access to the drug/compound, device, and/or other materials needed, as appropriate, for the proposed duration of the study/trial.• Funded trials are required to post a copy of the Institutional Review Board (IRB)-approved informed consent form used to enroll subjects on a publicly available federal website in accordance with federal requirements described in the Code of Federal Regulations, Title 32, Part 219 (32 CFR 219).

The CRRP seeks to enhance medical capabilities and Force readiness at the point of greatest need in order to save the most lives in trauma care scenarios, which may be complicated by combat operations, limited resources, austere conditions, and/or mass casualty events. The intent of the FY22 CRRP RDTRA is to support research that will accelerate the movement of promising ideas into clinical applications, including healthcare products, technologies, and/or practice guidelines. Research under this award mechanism should represent a rapid advancement or innovative “leap ahead” and have the potential for broadly applicable, cross-cutting advances benefiting military health and medicine as well as the general public. Applicants may leverage existing resources in translational research to address high-impact research ideas or unmet needs to enable the delivery of life-saving care to the Warfighter during prolonged and en route care in austere and combat environments. For this award mechanism, the definition of “leveraging” is as follows: An investigator basing a research project on existing resources in order to amplify potential gains in knowledge or accelerate technical maturity. Research of interest may include knowledge products, “knowledge resulting from research with the potential to improve individual or public health and solutions that can accelerate the introduction of military-relevant health products or technologies into clinical and/or operational use. Projects should take into consideration the varied expertise levels of targeted medical providers, available resources, and the possible diverse environmental conditions in combat situations. Proposal/application submissions are encouraged to include characteristics relevant to military use in the pre-hospital, combat operational setting. Submissions that propose solutions to advance civilian trauma care are not precluded, since civilian trauma and trauma care in the military are mutually influential, and may be co-occurring in certain situations.Impact is a key component of this award mechanism. The potential impact of the research, both short-term and long-term, in addressing the FY22 CRRP Focus Area(s) should be clearly described. High-impact research will, if successful, lead to the rapid development and translation of applicable advances for improving medical readiness, mitigating fatalities, optimally treating life-threatening injuries, and promoting positive long-term outcomes for military health and medicine, as well as the general public.Applications in response to this BAA may not be used to support fundamental basic research. For this BAA, 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. Applied and preclinical research, including animal studies, that is already supported by substantial preliminary or published data, and is designed to validate clinical translation, is appropriate for this award mechanism.This BAA may be used to support preclinical research, clinical research, and small-scale clinical trials (e.g., first in human, phase 1/1b). Phase 2 and phase 3 clinical trials for U.S. Food and Drug Administration (FDA) licensure of drugs and definitive/pivotal testing for device clearance by the FDA will NOT be permitted under this BAA. This BAA may not be used to support studies requiring an exception from informed consent (EFIC).Clinical research is defined as: (1) Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens, and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies. (2) Epidemiologic and behavioral studies. (3) Outcomes research and health services research. Note: Studies that meet the requirements for Institutional Review Board (IRB) Exemption 4 are not considered CDMRP-defined clinical research. IRB Exemption 4 refers to research involving the collection or study of existing de-identified specimens or data, if these sources are publicly available.A clinical trial is defined as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. Funded trials are required to post a copy of the IRB-approved informed consent form used to enroll subjects on a publicly available federal website in accordance with federal requirements described in Code of Federal Regulations, Title 32, Part 219 (32 CFR 219).The proposed research must be relevant to active-duty Service Members, Veterans, military beneficiaries, and/or the American public.Awards funded under this mechanism may propose a base award with a potential option year (not required) to be considered for funding with a future appropriation, if available. Applicants are required to select one of the following funding options when applying:1. CRRP RDTRA: The period of performance of the CRRP RDTRA will be 2 years. The anticipated total costs budgeted for an FY22 CRRP RDTRA will not exceed $2.2M. This does not include the option for a third year.2. CRRP RDTRA with Option (if applicable): The CRRP RDTRA with Option may be funded in two phases over a 3-year period. The first phase of performance of the CRRP RDTRA will be 2 years. The second phase will be the additional Option year, for the potential of 3 years in total. Each phase must be a distinct, but related, research effort with a non-overlapping period of performance, research outcomes/milestones, and budget. The Option must clearly be a follow-on effort stemming from the work completed during the base CRRP RDTRA. Research products from the CRRP RDTRA shall be leveraged in the subsequent option phase, if planned. The anticipated total costs budgeted will not exceed $2.2M for an FY22 CRRP RDTRA and $1.0M for the Option period of performance. A virtual milestone review meeting will be conducted on or about month 18 of the CRRP RDTRA period of performance to evaluate progress against the proposed Statement of Work (SOW). Exercise of the Option is contingent on the availability of sufficient future congressional appropriations to the CRRP, alignment of the proposed research during the Option period to that fiscal year’s congressional language, acceptable performance by the recipients, and relevance to current program priorities.For projects proposing a clinical trial:• If an Investigational New Drug (IND) or Investigational Device Exemption (IDE) is required for the CRRP RDTRA or CRRP RDTRA with Option base period of performance, the IND/IDE application must be submitted to the FDA by the FY22 CRRP RDTRA proposal/ application submission deadline. It is the responsibility of the applicant to provide evidence from the IRB of record or the FDA if an IND/IDE is not required. Refer to Attachment 9, Regulatory Strategy, for further details.• If an IND or IDE is required for the Option period of performance, applicants must provide documentation of communication from the FDA indicating the IND or IDE application is active/safe to proceed prior to the conclusion of the base period of performance.• If the clinical trial of an investigational product will be conducted at international sites, evidence that an application has been submitted to the relevant national regulatory agency of the host country(ies) is required by the above deadlines.• If the clinical trial is proposed in the CRRP RDTRA, or during the base period of the CRRP RDTRA with Option, the trial must be initiated no later than month 9 of the initial period of performance.Refer to Section II.D.6, Funding Restrictions, for detailed funding information.Awards will be made no later than September 30, 2023. For additional information refer to Section II.F.1, Federal Award Notices.The CDMRP expects to allot approximately $8.71M to fund approximately four CRRP RDTRA proposals/applications. Funding of proposals/applications received is contingent upon the availability of federal funds for this program as well as the number of proposals/applications received, the quality and merit of the proposals/applications as evaluated by scientific 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 FY22 funding opportunity will be initially funded with FY22 funds, which will expire for use on September 30, 2028.Applications received in response to both the extramural FY22 CRRP RDTRA BAA and the intramural program announcement will be evaluated and considered for funding together. The government reserves the right to fund any combination of extramural and/or intramural proposals/applications.The USAMRDC executes its extramural research program primarily through the awarding of contracts and assistance agreements (grants and cooperative agreements). The type of instrument used to reflect the business relationship between the organization and the government is at the discretion of the government, in accordance with the Federal Grant and Cooperative Agreement Act of 1977, as amended, 31 USC 6301-6308, which provides the legal criteria to select a procurement contract or an assistance agreement. An assistance agreement (grant or cooperative agreement) is appropriate when the federal government transfers a “thing of value” to a “state, local government,” or “other recipient” to carry out a public purpose of support or stimulation authorized by a law of the United States, instead of acquiring property or service for the direct benefit and use of the U.S. government. An assistance agreement can take the form of a grant or cooperative agreement. If “no substantial involvement” on the part of the funding agency is anticipated, a grant award will be made (31 USC 6304).Conversely, if substantial involvement on the part of the funding agency is anticipated, a cooperative agreement will be made (31 USC 6305) and the award will identify the specific substantial involvement. Substantial involvement may include collaboration, participation, or intervention in the research to be performed under the award.A contract is required when the principal purpose of the instrument is to acquire property or services for the direct benefit or use of the U.S. government.The award type, along with the start date, will be determined during the negotiation process.Please see Appendix 2, Section E, of the General Submission Instructions for more information.Research Involving Human Anatomical Substances, Human Subjects, or Human Cadavers: All DOD-funded research involving new and ongoing research with human anatomical substances, human subjects, or human cadavers must be reviewed and approved by the USAMRDC Office of Research Protections (ORP), Human Research Protection Office (HRPO), prior to research implementation. This administrative review requirement is in addition to the local IRB or Ethics Committee (EC) review. Local IRB/EC approval at the time of submission is not required. Allow up to 3 months to complete the HRPO regulatory review and approval processes following submission of all required and complete documents to the HRPO. Refer to the General Submission Instructions, Appendix 1, and the Human Research Protections Office Resources and Overview document available on the eBRAP “Funding Opportunities & Forms” web page (https://ebrap.org/eBRAP/public/Program.htm) for additional information.If the proposed research involves more than one institution, a written plan for single IRB review arrangements must be provided at the time of application submission or award negotiation. The lead institution responsible for developing the master protocol and master consent form should be identified and should be the single point of contact for regulatory submissions and requirements.Rigor of Experimental Design: All projects should adhere to accepted standards for rigorous study design and reporting to maximize the reproducibility and translational potential of preclinical research. Core standards are described in Landis, S.C., et al., A call for transparent reporting to optimize the predictive value of preclinical research, Nature 2012, 490:187-191 (www.nature.com/nature/journal/v490/n7419/full/nature11556.html). While these standards were written for preclinical studies, the basic principles of randomization, blinding, sample-size estimation, and data handling derive from well-established best practices in research and should be applied consistently across translational studies. Projects that include research on animal models are required to submitAttachment 8, Animal Research Plan, as part of the proposal/ application package to describe how these standards will be addressed. Applicants should consult the Animal Research: Reporting In Vivo Experiments (ARRIVE) guidelines 2.0 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.Use of DOD or Department of Veterans Affairs (VA) Resources: If the proposed research involves access to active-duty military or Veteran patient populations and/or DOD or VA resources or databases, the proposal/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 Proposal/Application Submission Components, for detailed information. Refer to the General Submission Instructions, Appendix 1, for additional information.Research Involving Animals: All research funded by the FY22 CRRP RDTRA involving new and ongoing research with animals must be reviewed and approved by the USAMRDC ORP Animal Care and Use Review Office (ACURO), in addition to the local Institutional Animal Care and Use Committee (IACUC) of record. IACUC approval at the time of submission is not required. Allow at least 3 to 4 months for ACURO regulatory review and approval processes for animal studies. Refer to the General Submission Instructions, Appendix 1, for additional information.

The BMFRP IDA is intended to support innovative ideas and high-impact approaches based on scientifically sound evidence to move toward the BMFRP’s vision of understanding and curing BMF diseases. This award mechanism is designed to support new ideas. Proposed research studies should have a high probability of revealing new avenues of investigation. The research project should include a well-formulated, testable hypothesis based on strong scientific rationale and a well-developed and articulated research approach. Personnel on the proposed team should have a strong background in BMF disease research.This funding opportunity is open to Established Investigators (EIs) and Early-Career Investigators (ECIs).The following are significant features of this award mechanism:• Innovation: Innovative research may introduce a new paradigm, challenge existing paradigms, look at existing problems from new perspectives, or exhibit other creative qualities. This may include high-risk, potentially high-gain, approaches to BMF disease research, provided the application demonstrates the potential for significant impact on the field of research and/or patient care and/or quality of life. Research that is only an incremental advance is not considered innovative.• Impact: Proposed research projects should address a central critical issue or question in BMF disease research or clinical care. High-impact research, if successful, will significantly advance current methods and concepts for the prevention, detection, diagnosis, and/or treatment of BMF diseases.• Translational Potential: The translational potential of the project should be considered and described. Applications should address how the research will translate findings into prevention strategies and/or a cure for BMF diseases.• Preliminary Data: Preliminary data, such as unpublished results from the laboratory of the Principal Investigator (PI) or collaborators named on the application and/or data from the published literature relevant to BMF diseases and the proposed research project, may be included but are not required. If preliminary data are not included, the proposed research should be based on a strong rationale with sound logical support from published literature.• Personnel: Personnel are considered a crucial element of the BMFRP IDA. The application should demonstrate expertise in BMF diseases through the PI’s background, the research team, or through collaboration. Collaborations should be documented.-Established Investigator: An EI applying for the IDA is defined as an independent investigator at or above the level of Associate Professor (or equivalent) or an Assistant Professor (or equivalent) with 10 years or more from their first faculty appointment (or equivalent). The EI should have BMF disease-related expertise and background as demonstrated by funding and publication records. The EI should plan research collaborations and dedicate a level of effort appropriate for the successful conduct of the proposed work.-Early-Career Investigator: An ECI applying for the IDA should be an independent investigator at the level of Assistant Professor (or equivalent) with less than 10 years from their first faculty appointment (or equivalent). Time spent on extended family medical leave will not count against the 10 year eligibility restriction, and associated lapses in research time and appointments should be articulated in the application. Current appointment status and aggregate time from first faculty appointment (or equivalent) should be clearly articulated in the PI’s biographical sketch. Postdoctoral fellows are not eligible as ECIs. The ECI’s training should demonstrate the ECI’s ability to accomplish the proposed work. Institutional commitment beyond financial backing such as, but not limited to, independent laboratory space, dedicated research time, and potential collaborations should be demonstrated. The level of effort dedicated to the proposed work by the ECI should be appropriate for the successful conduct of the research project.

The FY22 BMFRP IIRA will offer two funding levels with different intent:Funding Level 1 (FL1): To support studies that further develop ideas, expand upon key discoveries, and have the potential to make significant advances in research, patient care, and/or quality of life in the FY22 BMFRP IIRA Focus Areas. IIRA applications may involve basic, translational, and clinically oriented research, including studies in animal models, research with human anatomical substances, and research with human subjects, as well as correlative studies associated with an existing clinical trial; however, FL1 awards may not be used to support a clinical trial. Multidisciplinary collaborations are encouraged.Funding Level 2 (FL2): To support Investigational New Drug (IND)-enabling efforts. The BMFRP recognizes the scientific and financial challenges associated with advancing promising, potentially life-changing, therapeutic agents from the laboratory to clinical evaluation. Data related to lead compound characterization; formulation and stability; absorption, distribution, metabolism and excretion; dose/response; and toxicology are required before clinical trials can commence. The proposed studies under the FL2 IND-enabling efforts are expected to be empirical in nature, product-driven, and focused on the accumulation of data for a lead therapeutic candidate(s). At least one, and no more than three, lead therapeutic candidates must be named at the time of application submission to meet the intent of the FL2 mechanism. Library screening or drug optimization studies do not meet the intent of FL2. At the end of the period of performance, the cumulative data should be sufficient to submit an IND to the Food and Drug Administration (FDA). The intent of FL2 awards is to perform the necessary evaluation of promising therapies that will lead to clinical trials; however, clinical trials themselves are not supported by this mechanism. FL2 applications must address the FY22 BMFRP Focus Area “Find effective BMF treatments and cures”.The following are significant features of this award mechanism:• Impact: Proposed research projects should address a central critical issue or question in BMF disease research or clinical care. High-impact research, if successful, will significantly advance current methods and concepts for the prevention, detection, diagnosis, and/or treatment of BMF diseases.• Translational Potential: The translational potential of the project should be considered and described. Applications should address how the research will translate findings into prevention strategies and/or a cure for BMF diseases.• Preliminary Data: Observations that drive a research idea may be derived from laboratory discovery, population-based studies, a clinician’s first-hand knowledge of patients, or anecdotal data. Applications must include preliminary and/or published data that are relevant to the mission of the BMFRP and support the proposed research project. Any unpublished preliminary data provided should originate from the laboratory of the Principal Investigator (PI) or a member(s) of the research team.• Multidisciplinary Collaborations: Applicants are encouraged, but not required, to form multidisciplinary teams of investigators who bring specific skills that contribute to the successful completion of the project. This can include both intellectual input and research resources (e.g., supplies, reagents, equipment, personnel, services, tissue samples, access to patients or populations).• Correlative Studies: Applications to FL1 are encouraged to propose correlative studies of open/ongoing or completed clinical trials to better characterize treatment response and provide deeper insights that can be used to develop future clinical trial endpoints or support personalized medicine approaches.Partnering PI Option: The IIRA encourages applications that include meaningful and productive collaborations between investigators and includes an option for more than one PI. Electing to submit to the partnering PI option does not influence the total direct cost limit as outlined in Section II.D.5, Funding Restrictions. 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. If recommended for funding, each PI will be named to an individual award within the recipient organization. For individual submission requirements for the Initiating and Partnering PI, refer to Section II.D.2, Content and Form of the Application Submission.

The FY22 RCRP Resource and Community Development Award supports the development of resources that advance the field of rare cancers research and ultimately improve outcomes for individuals with rare cancers. Major gaps in patient care of rare cancers include lack of communication and dissemination strategies for rare cancer research and clinical findings within communities; lack of therapeutics and mechanistic studies to inform treatment development; lack of research and clinical resources, including patient tissues, cell, and tumor models; and lack of infrastructure for sharing data and other resources. The intent of this funding opportunity is to develop platforms that can share resources and knowledge pertaining to available models, molecular pathways, and therapeutic approaches to facilitate collaboration and information sharing among stakeholders such as researchers, patients, caregivers, clinicians, and other members of the rare cancers community. Examples of platforms include, but are not limited to the following: • Building and sharing rare tumor biospecimen repository with clinical annotation • Databases/banks for centralizing and sharing data for patient registries that can be accessed globally • Centralizing and sharing research models and molecular data related to genomics/ transcriptomics/immune profiling/proteomics/metabolomics/methylomics/bioinformatics • Generating a data/reagent/model exchange program where researchers can list resources that they are willing to share and are tagged with indications that may be relevant • Platform to enable or leverage longitudinal studies of disease natural history and treatment response • Development of novel methods and systems for collection, sharing, and analysis of data or biospecimens Applicants should include a well-formulated project design based on a strong scientific rationale and clearly articulate how the proposed resource-platform or community development addresses an unmet need in rare cancer research. Applicants should explain the advantage of their approach to developing resources or community versus standard methodologies, techniques, or scopes. A clear plan for collaboration and data sharing needs to be demonstrated. It is critical to demonstrate how the outcome of the proposed project can benefit multiple rare cancers.

The FY22 RCRP Idea Development Award promotes new ideas that are still in the early stages of development and have the potential to yield impactful data and new avenues of investigation. This award supports conceptually innovative, high-risk/high-reward research that could lead to critical discoveries or major advancements that will accelerate progress toward eradicating deaths and suffering from rare cancers. Applications should include a well-formulated, testable hypothesis based on strong scientific rationale. Preliminary data with disease-specific rationale (may include correlatives studies to ongoing clinical research) to support the feasibility of the research hypotheses and research approaches are required; however, these data do not necessarily need to be derived from studies of the proposed rare cancer type(s)/subtype(s) under study. Key elements of the Idea Development 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 in the following ways: in concept or question, research methods or technologies, adaptations of existing methods or technologies, or other ways. Research that is likely to yield only an incremental advance is not considered innovative. • Impact: Research that has high potential impact may lead to major advancements and greatly improve outcomes for people with rare cancers.