Funding Wizard

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findings into prevention strategies and/or a cure for BMF diseases.• Preliminary Data: Preliminary data, such as unpublished results from the laboratory of the Principal Investigator (PI) or collaborators named on the application and/or data from the published literature relevant to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 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 RTRP Investigator-Initiated Research Award (IIRA) is intended to support studies that have the potential to make an important contribution to reconstructive transplant research, patient care, and/or quality of life. Though the RTRP IIRA mechanism supports groundbreaking research, all projects must demonstrate solid scientific rationale with military-relevant utility. Important aspects of this award mechanism include: - Study Design and Feasibility: The proposed study design should be clearly described, rigorous, and support maximal reproducibility and translational feasibility. A statistical plan with appropriate power analysis should be included, as applicable. - Impact: The short- and long-term impact of the proposed research should be clearly articulated. Projects must address at least one of the FY22 RTRP Investigator-Initiated Research Award Focus Areas. - Military Relevance: All projects must be responsive to the healthcare needs of military Service Members and/or Veterans recovering from traumatic injury, and/or their family members, caregivers or clinicians, as well as the general public. Collaboration with military researchers and clinicians is encouraged, but not required. - 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. Preliminary and/or published data that are relevant to reconstructive transplantation and that support the rationale for the proposed research must be included. Investigator-Initiated Research Award applications may focus on any phase of research from basic through translational, including preclinical studies in animal models, human subjects, human anatomical substances, as well as correlative studies associated with an existing clinical trial.

The USAMRDC’s mission is to provide solutions to medical problems of importance to the American Service Member at home and abroad, as well as to the general public at large. The scope of this effort and the priorities attached to specific projects are influenced by changes in military and civilian medical science and technology (S&T), operational requirements, military threat assessments, and national defense strategies. Extramural research and development programs play a vital role in the fulfillment of the objectives established by the USAMRDC. General information on the USAMRDC can be obtained at https://mrdc.health.mil/.This BAA is intended to solicit extramural research and development ideas using the authority provided by 10 USC 4001. The BAA is issued under the provisions of the Competition in Contracting Act of 1984 (Public Law 98-369), as implemented in FAR 6.102(d)(2) and 35.016 and in Department of Defense Grant and Agreement Regulations (DoDGARs) 22.315. In accordance with FAR 35.016, projects funded under this BAA must be for basic and applied research to support scientific study and experimentation directed toward advancing the state-of-the-art or increasing knowledge or understanding rather than focusing on development of a specific system or hardware solution. Research and development funded through this BAA are intended and expected to benefit and inform both military and civilian medical practice and knowledge. This BAA utilizes competitive procedures in accordance with 10 USC 2302(2)(B) for the selection for award of S&T proposals/applications. For the purposes of this BAA, S&T includes activities involving basic research, applied research, advanced technology development, and, under certain conditions, may include activities involving advanced component development and prototypes.The selection process is highly competitive, and the quantity of meaningful submissions (both pre-proposals/pre-applications and full proposals/applications) received typically exceeds the number of awards that available funding can support.This BAA provides a general description of USAMRDC’s research and development programs, including Research Areas of Interest, evaluation and selection criteria, pre-proposal/ pre-application and full proposal/application preparation instructions, and general administrative information. Specific submission information and additional administrative requirements can be found in the document titled, “General Submission Instructions,” which is available on Grants.gov along with this BAA.The FY23-FY27 USAMRDC BAA is continuously open for a 5-year period, from October 1, 2022 through September 30, 2027, at 11:59 p.m. Eastern Time. Submission of a pre-proposal/pre-application is required and must be submitted through the electronic Biomedical Research Application Portal (eBRAP) (https://eBRAP.org/). Pre-proposals/pre-applications may be submitted at any time throughout the 5-year period. If the USAMRDC is interested in receiving a full proposal/application, the Principal Investigator will be sent an invitation to submit via eBRAP. A full proposal/application must be submitted through Grants.gov (http://www.grants.gov/). Invited full proposals/applications can be submitted under this FY23-FY27 BAA through September 30, 2027.

The FY23 Transformative Breast Cancer Consortium Development Award is intended to provide successful applicants the time and resources needed to bring investigators and breast cancer advocates together to establish a consortium framework and conduct preliminary research to support application to a future, full Transformative Breast Cancer Consortium Award (pending availability of funds). This is a development award and is a separate mechanism from the full consortium award. Recipients of the FY23 Transformative Breast Cancer Consortium Development Award are expected to submit an application to compete for the full Transformative Breast Cancer Consortium Award anticipated to be offered in a future fiscal year(s). However, it is not necessary to receive a development award in order to apply for a full consortium award in the future. For FY23, investigators may be named as Consortium Director on an application submitted to either (but not both) of these mechanisms. Detailed information on the FY23 Transformative Breast Cancer Consortium Award is available under a separate program announcement (HT945-23-BCRP-TBCCA). The FY23 Transformative Breast Cancer Consortium Development Award provides support to: · Develop the infrastructure of a multi-institutional research team inclusive of scientists, clinicians, and breast cancer advocates (e.g., building appropriate collaborations, outlining integration, research management, administrative management, and communication plans, and devising an intellectual property plan) · Generate necessary preliminary data to serve as proof of concept or for project integration · Acquire research resources · Develop a framework of necessary statistical analyses Breast cancer consumer advocates must be active participants in the development and execution of the Transformative Breast Cancer Consortium Development Award. A congressionally mandated Metastatic Cancer Task Force was formed with the purpose of identifying ways to help accelerate clinical and translational research aimed at extending the lives of advanced state and recurrent patients. As a member of the Metastatic Cancer Task Force, the CDMRP encourages applicants to review the recommendations (https://health.mil/Reference-Center/Congressional-Testimonies/2018/05/0…- Research) and submit research ideas to address these recommendations provided they are within the limitations of this funding opportunity and fit within the FY23 BCRP priorities.

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 FY21 PCARP Translational Research Partnership Award supports partnerships between clinicians and research scientists that will accelerate the movement of promising ideas in pancreatic cancer toward clinical applications. This award supports the development of translational research collaborations between two independent investigators to address a central problem or question in pancreatic cancer in a manner that would be less readily achievable through separate efforts. One partner in the collaboration must function as a research scientist and the other partner as a clinician investigator. It should be clear that both have had equal intellectual input in the design of the research project. Multi-institutional and multi-discipline partnerships are strongly encouraged. At least one partner must have expertise either in pancreatic cancer research or pancreatic cancer patient care. Inclusion of experts from outside the pancreatic cancer field is encouraged. A proposed project in which the clinical partner merely supplies tissue samples or access to patients will not meet the intent of this award mechanism. Full support for large-scale clinical trials is not expected; retrospective tissue analysis, correlative studies, or small pilot clinical trials are permitted. Significant features of the Translational Research Partnership Award: · Partnership: The success of the project should depend on the unique skills and contributions of each partner. · Translation: The application should provide evidence for the reciprocal transfer of information between basic and clinical science, or vice versa, in developing and implementing the research plan. Translational research may include correlative studies and/or development of or use of annotated biorepositories. The application should demonstrate how the study will leverage clinical information to address knowledge gaps in resulting outcomes, validate key research findings, expand upon potentially transformative results, and/or investigate novel findings. · Impact: The proposed research should indicate the potential to have a significant impact on pancreatic cancer research and/or patient care and have the potential to accelerate the movement of promising ideas (in prevention, diagnosis, detection, prognosis, treatment, and/or survivorship) into clinical applications. · Feasibility: The application should demonstrate that the investigators have access to the necessary specimens, data, and/or intervention, as applicable. · Preliminary Data: Published and/or unpublished results from the laboratory of the PIs or collaborators named on the application that are relevant to pancreatic cancer and the proposed research project, are required. Preliminary data to support the feasibility of the research hypothesis(es) and research approaches are required; however, these data do not necessarily need to be derived from studies of pancreatic cancer. Observations that drive a research idea may be derived from a laboratory discovery, population- based studies, or a clinician’s firsthand knowledge of patients and anecdotal data. The ultimate goal of translational research is to move a concept or observation forward into clinical application that is relevant to active duty Service Members, Veterans, other military beneficiaries, and the American public. However, translational research should not be viewed as a one-way continuum from bench to bedside. The research plan must involve a reciprocal flow of ideas and information between basic and clinical science. There should be an intellectual synergistic partnership between the clinic and the laboratory. The success of the project must be supported by the unique skills and contributions of each partner. The proposed study must include clearly stated plans for interactions between the Principal Investigators (PIs) and institutions involved. The plans must include communication, coordination of research progress and results, and data transfer. Additionally, multi-institutional applications must provide an intellectual property plan to resolve potential intellectual and material property issues and to remove institutional barriers that might interfere with achieving high levels of cooperation to ensure the successful completion of this award. The Translational Research Partnership Award requires two PIs. One will be identified as the Initiating PI and will be responsible for the majority of the administrative tasks associated with application submission. The other 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 PIs, refer to Section II.D.2, Content and Form of the Application Submission. It is the responsibility of the PIs to describe how their combined expertise will better address the research question and explain why the work should be done together rather than through separate efforts.

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 PRP IIRA supports highly rigorous, multidisciplinary, high-impact research projects that have the potential to make an important contribution to Parkinson’s research. This award mechanism supports the full spectrum of research from basic science through clinical research.The following are important aspects of the IIRA:• Research Strategy and Feasibility: The scientific rationale and experimental methodology should demonstrate critical understanding and in-depth analysis of the neurodegenerative effects of PD. Experimental strategies may be novel or may be based on strong rationale derived from previously published data, presented preliminary data, or literature review. The feasibility of the research design and methods should be well-defined, and a clear plan should be articulated as to how the proposed goals of the project can be achieved.Preliminary data to support feasibility are encouraged but not required. Any unpublished, preliminary data provided should originate from the laboratory of the Principal Investigator (PI) or member(s) of the research team. The preliminary data must support the feasibility of the study. Clinical trials may be supported by this award mechanism and require the submission of Attachment 8: Regulatory Strategy.• Impact: The proposed research should impact an area of paramount importance in PD.The application must clearly and explicitly describe the potential short-term and long-term impact of the proposed study and convey its level of significance.The research should benefit individuals with PD.• Focus Areas: The proposed research must address at least one of the two FY22 PRP Focus Areas.• Principal Investigator and Research Team: The PRP seeks applications from investigators working in a broad spectrum of disciplines including, but not limited to, basic science, engineering, bioinformatics, population science, translational research, and clinical research. The application should demonstrate that the research team’s background is appropriate to successfully achieving the proposed research and contributing to the field of PD research.• The PRP IIRA requires that the PI dedicate at least 15% of their full-time professional effort to this award during the award period.

The FY22 RTRP Advanced Technology Development Award is intended to support research critical for the translation of promising preclinical findings into products focused on reconstructive transplantation. Important aspects of this award mechanism include: - Study Design and Feasibility: The proposed study design should be clearly described, rigorous, well-integrated, and support maximal reproducibility and translational feasibility. A statistical plan with appropriate power analysis should be included, if applicable. It should be clear how the proposed study design of this project will position the product for the next phase of development as described in the post-award Transition Plan (Attachment 9). - Impact/Military Relevance: The short- and long-term impact of the proposed research should be clearly articulated. Projects must address at least one of the FY22 RTRP Advanced Technology Development Award Focus Areas listed in Section II.A.1 above. All products to be developed must be responsive to the healthcare needs of military Service Members and/or Veterans recovering from traumatic injury, and/or their family members, caregivers, or clinicians, as well as the general public. Collaboration with military and VA researchers and clinicians is encouraged but not required. - Transition Plan: The post-award Transition Plan (Attachment 9) should include potential funding and resources and show how the product will progress to the next level of development (e.g., clinical trials, delivery to the military or civilian market) after the successful completion of this award. A regulatory strategy as applicable to the proposed research/product should also be included. - Preliminary Data: Proof of concept demonstrating potential utility of the proposed product, or a prototype/preliminary version of the proposed product, must already be established. Preliminary and/or published data that are relevant to reconstructive transplantation, and that support the rationale for the proposed study, must be included (these data may be unpublished if from a member of the research team, or from the published literature). Proposed research and products to be developed may be materiel products such as drugs, biologic agents, or devices, or knowledge-based products such as technical reports and clinical practice guidelines that inform clinical/operational decisions and promote evidence-based changes in clinical practice and standard of care. Proposed research may include preclinical studies in animal models, human subjects, human anatomical substances, as well as correlative studies associated with an existing clinical trial.