Funding Wizard

The DMRDP BWMIR Award seeks to enhance combat traumatic wound care capabilities throughout the medical continuum of care, which may be complicated by combat operations, limited resources, austere conditions, and/or mass casualty events. The intent of the FY22 DMRDP BWMIR Award is to support research that will increase the understanding of complex wound physiology and infection control in order to support future application and maturation of products, technologies, and clinical practice. Research that advances and/or repurposes existing solutions and has the potential to be broadly applicable is advantageous, but not required. Additionally, submissions may present 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: carrying out a research project based on existing resources in order to amplify potential gains in knowledge or accelerate technical maturity. Research of interest may include knowledge products, i.e., “knowledge resulting from research with the potential to improve individual or public health,”3 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.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 and the American public.The FY22 DMRDP BWMIR Award has two different funding level options based on the scope of the research proposed. It is the responsibility of the applicant to select the funding level that is most appropriate for the proposed research project. The government reserves the right to fund a proposal/application at a lower funding level.Funding Level 1: Preclinical research studies supported by substantial preliminary or published data. Clinical research and clinical trials are not allowed. Anticipated total costs of Funding Level 1 will not exceed $1.2 million (M).Funding Level 2: Studies including clinical research or clinical trials supported by substantial preliminary or published data. Research proposed under Funding Level 2 may include some preclinical activities, but must include some aspect of clinical research or a clinical trial. Anticipated total costs of Funding Level 2 will not exceed $2.2M.For projects proposing a clinical trial or clinical studies: If the proposed clinical trial involves the use of a drug that has not been approved by the FDA for the proposed investigational use, then an Investigational New Drug (IND) application to the FDA 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 FDA if an IND application is not required. If an IND application is required, evidence that an IND application has been submitted or IND authorization without clinical hold status has been secured must be included in the FY22 DMRDP BWMIR Award proposal/application. The IND application should be specific for the product (i.e., the product should not represent a derivative or alternate version of the investigational agent described in the IND application) and indication to be tested in the proposed clinical trial. For more information on IND applications, the FDA has provided guidance at https://www.fda.gov/drugs/types-applications/investigational-new-drug-i…; If the investigational product is a device, then an Investigational Device Exemption (IDE) application to the FDA that meets all requirements under 21 CFR 812 may be required. It is the responsibility of the applicant to provide evidence if an IDE application is not required or the device qualifies for an abbreviated IDE application. If an IDE application is required, evidence that an IDE application submission or IDE authorization without clinical hold status has been secured must be included in the FY22 DMRDP BWMIR Award proposal/ application. The IDE application should be specific for the device (i.e., should not represent a derivative or modified version of the device described in the IDE application) and indication to be tested in the proposed clinical trial. If the proposed clinical trial of an investigational product will be conducted at international sites, evidence that an application to the relevant national regulatory agency of the host country(ies) has been submitted or approved must be included in the FY22 DMRDP BWMIR Award proposal/application. 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 a clinical trial is proposed in the DMRDP BWMIR Award proposal/application, 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 JPC-2/MIDRP and JPC-6/CCCRP expect to allot approximately $9.39M of FY22 and $7.29M of FY23 DHP RDT&E funds to support approximately 7 to 10 DMRDP BWMIR Award 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. It is anticipated that awards made from this FY22 funding opportunity will be funded with FY22 funds, which will expire for use on September 30, 2028; and FY23 funds, which will expire for use on September 30, 2029. As of the release date of this funding opportunity announcement, the FY23 Defense Appropriations Bill has not been passed and there is no guarantee that any additional funds will be made available to support this program. The funding estimated for this funding opportunity announcement is approximate and subject to realignment. Funding of applications received in response to this funding opportunity announcement is contingent upon the availability of federal funds for this program. 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.Proposals/applications received in response to both the extramural FY22 DMRDP BWMIR BAA and the intramural program announcement (W81XWH-22-DMRDP-BWMIR) 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, assistance agreements (grants and cooperative agreements), and Other Transaction Agreements (OTAs). 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.An Other Transaction (OT) will also be considered as a vehicle for award under this BAA, in accordance with 10 USC 4021 and 10 USC 4022. The OT authorities were created to give the DOD the flexibility necessary to adopt and incorporate business practices that reflect commercial industry standards and best practices into its award instruments. When leveraged appropriately, OTs provide the government with access to state-of-the-art technology solutions from traditional and non-traditional defense contractors (NDCs), through a multitude of potential teaming arrangements tailored to the particular project and the needs of the participants. OTs can help to foster new relationships and practices involving traditional and NDCs, especially those that may not be interested in entering into FAR-based contracts with the government; broaden the industrial base available to government; support dual-use projects; encourage flexible, quicker, and cheaper project design and execution; leverage commercial industry investment in technology development and partner with industry to ensure DOD requirements are incorporated into future technologies and products; and collaborate in innovative arrangements. OTs are not FAR-based procurement contracts, grants, cooperative agreements, or cooperative research and development agreements.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 Human and Animal Research Oversight (OHARO), OHARO’s Office of Human Research Oversight (OHRO), 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 OHARO OHRO regulatory review and approval processes following submission of all required and complete documents to the OHRO. 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 submit Attachment 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 DMRDP BWMIR involving new and ongoing research with animals must be reviewed and approved by the USAMRDC OHARO 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 CDMRP intends that information, data, and research resources generated under awards funded by this BAA be made available to the research community (which includes both scientific and consumer advocacy communities) and to the public at large. For additional guidance, refer to the General Submission Instructions, Appendix 2, Section L.

The intent of the FY23 ALSRP Clinical Biomarker Development Award is to support the development of biomarkers to enrich clinical trials in Amyotrophic Lateral Sclerosis (ALS). Biomarker development projects can be relevant to a specific therapy, a class of therapeutics, or to a specific ALS subtype (such as a particular genetic mutation) and do not have to broadly apply to all patients. A description of the biomarker category and intended context of use (COU) in ALS therapeutic development, including regulatory considerations for use in ALS clinical trials or clinical practice, is an important component.Examples of studies appropriate for submission to the FY23 ALSRP Clinical Biomarker Development Award include, but are not limited to:Using patient-based resources to link biosamples to rigorous molecular data.Collecting and analyzing biospecimens as a companion to an anticipated/ongoing clinical trial.Correlation of clinical trial-related data (e.g., biosample analysis, imaging, or epidemiological data) with clinical outcomes or responses to therapies.Strategies to better measure disease progression, including the development or use of digital biomarkers.

The FY23 ALSRP Pilot Clinical Trial Award supports the rapid implementation of clinical trials with the potential to have a significant impact on the treatment or management of Amyotrophic Lateral Sclerosis (ALS). Projects may range from phase 1 to small-scale phase 2 trials and should aim to de-risk and inform the design of more advanced trials by investigating safety, feasibility, biomarker application, and therapeutic efficacy in relevant patient populations. Clinical trials may be designed to evaluate promising drugs, biologics, or devices with anticipated therapeutic impact that is supported by strong scientific rationale and existing preliminary studies and/or preclinical data. Potential impact is not whether a therapy is ready at the conclusion of the trial, but rather if the outcomes will improve and accelerate future larger trials. Applications submitted to this award can have outcomes that focus on specific subpopulations of ALS patients or potentially even individual patients.Applicants not investigating a therapeutic but proposing a clinical trial to optimize established ALS clinical care must submit under a lower total direct cost Clinical Care Tier. Examples of efforts that will be supported under this tier include but are not limited to optimization of respiratory care strategies, improvements to approved devices and assistive technologies, specific symptom management strategies, and/or telemedicine strategies. The capacity for near-term impact on patient care is an important component of the Clinical Care Tier.

The FY23 ALSRP Therapeutic Development Award supports research ranging from preclinical validation of therapeutic leads through U.S. Food and Drug Administration (FDA) Investigational New Drug (IND)-enabling studies. The proposed studies are expected to be empirical in nature and product driven. Applicants with limited ALS experience are strongly encouraged to include collaborators with substantial experience in the relevant ALS model systems, endpoints, and pathophysiology. Examples of activities that will be supported by this award include:Confirmation of candidate therapeutics obtained from screening or by other means, including optimization of potency and pharmacological properties and testing of derivatives and sister compounds.Validation of pilot efficacy studies (such as from an ALSRP Therapeutic Idea Award), including the use of additional ALS model systems and/or replicating preliminary data with more time points or additional doses.IND-enabling studies to include: compound characterization; absorption, distribution, metabolism, and excretion (ADME) studies; studies on formulation and stability leading to Good Manufacturing Practice production methods; dose/response and toxicology studies in relevant model systems.Applications supported by this award must begin with lead compounds in hand and must include preliminary data relevant to the phase of development, such as:Proof of identity and puritySelectivity for the intended target over closely related targetsAvailability of primary and secondary in vitro bioactivity assays for optimization or structure–activity relationship studiesAvailability of clear efficacy data in at least one relevant preclinical Amyotrophic Lateral Sclerosis (ALS) model, with adequate power and methods.Applicants seeking support for basic research focused on ALS drug discovery are encouraged to apply for the FY23 ALSRP Therapeutic Idea Award (Funding Opportunity Number HT9425-23-ALSRP-TIA), which does not require preliminary data (https://cdmrp.health.mil/funding/alsrp).

The FY23 ALSRP Therapeutic Idea Award supports the initial exploration of innovative, high-risk, high-gain ideas aimed at Amyotrophic Lateral Sclerosis (ALS) drug or treatment discovery. The studies supported by this award mechanism are expected to be hypothesis-driven and generate preliminary data for future avenues of therapeutic investigation. All research projects should include a well-formulated, testable hypothesis based on strong scientific rationale that holds translational potential to improve ALS treatment and/or advance a novel treatment modality. Applications may demonstrate the ability to achieve interpretable results in the absence of preliminary data supporting the hypothesis. While the inclusion of preliminary data is not prohibited, the strength of the application should not rely on preliminary data, but on the innovative approach.Projects that focus primarily on investigating the pathophysiology of ALS, without consideration of therapeutic development, are not within the scope of this funding opportunity.Innovation and impact are important aspects of the Therapeutic Idea Award. Research deemed innovative may introduce a new paradigm, challenge current paradigms, introduce novel concepts or technologies, or exhibit other uniquely creative qualities that may lead to potential therapeutics for ALS. Research with high impact should pioneer transformative research that could lay the foundation for a new direction in the field of ALS therapeutic development. Projects should strive to produce the type and amount of data needed to apply for the next stage, i.e., ALSRP Therapeutic Development Award or other mechanisms for ALS therapeutic advancement.The Therapeutic Idea Award encourages applications submitted by early-career investigators as well as applications that include meaningful and productive collaborations between/among investigators. Applicants from outside the ALS research field are encouraged to include collaborators with the necessary relevant expertise, such as experience with ALS model systems, endpoints, and pathogenic findings.Biomarker Option: The FY23 ALSRP Therapeutic Idea Award Biomarker Option encourages applicants to include the development of biomarker(s) in parallel with the main proposed Therapeutic Idea Award research effort. Additional funding, as described in Section II.D.5, Funding Restrictions, is being offered for the co-development of biomarkers that will enhance the drug development process. Efforts may include development of target engagement biomarkers, objective pharmacodynamic biomarkers to measure the biological effect of an investigational therapeutic, or predictive/cohort-selective biomarkers that indicate whether a specific therapy will be effective in an individual patient or patient subgroup. Development of markers for the purposes of diagnosis, prognosis, or measurement of disease progression apart from consideration of the therapeutic development process will not be supported.To apply for this option, applicants must clearly describe the marker and its potential to improve the effectiveness of the therapeutic development process. For further description, see Section II.D.2.b.ii, Full Application Submission Components, Attachment 9, Biomarker Statement.

The FY23 ARP Career Development Award supports early-career, independent investigators and/or the transition of established investigators from other research fields to conduct innovative, DOD FY23 Autism Research Program Career Development Award 5 high-impact ideas or early-phase, proof-of-principle clinical trials with the potential to have a major impact on ASD. Applications are strongly encouraged to address one of the FY23 ARP Career Development Award Areas of Interest or provide justification that the proposed research addresses a critical problem, question, or need in ASD.This award enables such investigators to compete for funding separately from investigators with established programs of ASD research. Previous experience in ASD research is allowed, but not required. However, in FY23 Career Development Award applications that name a Principal Investigator (PI) with limited background in ASD research, the ARP strongly encourages the inclusion of collaboration with investigators who are experienced in ASD research and/or possess other relevant expertise in order to strengthen the application.

The ARP Clinical Trial Award supports the rapid implementation of clinical trials with the potential to have a significant impact on the treatment or management of ASD. Applications are strongly encouraged to address one of the FY23 ARP Clinical Trial Award Areas of Interest. If the proposed study does not address an Area of Interest, an explanation of how the study addresses an important problem with respect to individuals with ASD must be provided. Clinical trials may be designed to evaluate promising new products, pharmacologic agents (drugs or biologics), behavioral interventions, devices, clinical guidance, and/or emerging approaches and technologies. Funding from this award mechanism must support a clinical trial and may not be used for preclinical research studies.

The FY23 ARP Idea Development Award supports the development of innovative, high-risk/high-reward research that could lead to critical discoveries or major advancements that will accelerate progress in improving outcomes for individuals with ASD. Applications are strongly encouraged to address one of the FY23 ARP Idea Development Award Areas of Interest or provide justification that the proposed research addresses a critical problem, question, or need in ASD. This award mechanism is designed to support innovative ideas with the potential to yield impactful data and new avenues of investigation.

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.