Eligible Applicants: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility"

Agency Name: Jennifer Shankle Grantor

Description:

The intent of the FY24 CRRP TRA is to support high-impact translational research that will accelerate innovative ideas into clinical applications, including health care products, technologies, and/or practice guidelines. Research funded under this award mechanism will be hypothesis-driven, high-impact applied research that is relevant to Service Members, Veterans, their Families, and the American public.

Applicants may leverage existing resources in translational research to address essential 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,”1 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 FY24 CRRP Focus Area(s) should be clearly described. Successful high-impact research should lead to the accelerated 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.

Key aspects of the CRRP TRA Mechanism:

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This BAA may be used to support applied, preclinical, clinical research, and/or small-scale clinical trials (e.g., first in human, phase 1/1b).

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Preliminary data are required: Inclusion of preliminary data relevant to the proposed study is required.

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.

Funding from this BAA may not be used to support studies requiring an exception from informed consent (EFIC).

Funding from this BAA may not be used to support larger or advanced clinical trials (e.g., phase 2/3, pivotal).

A clinical trial is defined in the Code of Federal Regulations, Title 45, Part 46.102 (45 CFR 46.102) as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include a placebo or another control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.

Studies that do not seek to measure safety, effectiveness, and/or efficacy outcome(s) of an intervention are not considered clinical trials.

For the purposes of this funding opportunity, research that meets the definition of a clinical trial is distinct from clinical research. Clinical research encompasses research with human data, human specimens, and/or interaction with human subjects. Clinical research is observational in nature and includes:

(1) Research conducted with human subjects and/or material of human origin such as data, specimens, and cognitive phenomena for which an investigator (or co-investigator) does not seek to assess the safety, effectiveness, and/or efficacy outcomes of an intervention. Research meeting this definition may include but is not limited to: (a) mechanisms of human disease, (b) diagnostic or detection studies (e.g., biomarker or imaging), (c) health disparity studies, and (d) development of new technologies.

(2) Epidemiologic and behavioral studies that do not seek to assess the safety, effectiveness, and/or efficacy outcomes of an intervention.

(3) Outcomes research and health services research that do not fit under the definition of clinical trial.

Excluded from the definition of clinical research are in vitro studies that utilize human data or specimens that cannot be linked to a living individual and meet the requirements for exemption under §46.104(d)(4) of the Common Rule. Rigor of Experimental Design: All projects should adhere to a core set of standards for rigorous study design and reporting to maximize the reproducibility and translational potential of clinical and preclinical research. The standards are described in SC Landis, et al., 2012, A call for transparent reporting to optimize the predictive value of preclinical research, Nature 490:187-191 (https://www.nature.com/nature/journal/v490/n7419/full/nature11556.html). While these standards are written for preclinical studies, the basic principles of randomization, blinding, sample-size estimation, and data handling derive from well-established best practices in clinical studies.

Women’s Health: The CDMRP encourages research on health areas and conditions that affect women uniquely, disproportionately, or differently from men, including studies analyzing sex as a biological variable. Such research should relate anticipated project findings to improvements in women's health outcomes and/or advancing knowledge for women’s health.

Relevance to Military Health: Relevance to the health care needs the Warfighter ahead of deployment and in operational environments is a key feature of this award. Use of DOD or Department of VA Resources: Applications engaging investigators within the military Services and applications involving multidisciplinary collaborations among academia, industry, the military Services, the U.S. Department of Veterans Affairs (VA), and other federal government agencies are highly encouraged. These relationships can leverage knowledge, infrastructure, and access to unique clinical populations that the collaborators bring to the research effort, ultimately advancing research that is of significance to Service Members, Veterans, and/or their Families. If the proposed research relies on access to unique resources or databases, the application must describe the access at the time of submission and include a plan for maintaining access as needed throughout the proposed research.

Innovative research involving nuclear medicine and related techniques to support early diagnosis, more effective treatment, and improved health outcomes of active-duty Service Members and their Families is encouraged. Such research could improve diagnostic and targeted treatment capabilities through noninvasive techniques and may drive the development of precision imaging and advanced targeted therapies.

The CDMRP intends that information, data, and research resources generated under awards funded by this program announcement be made available to the research community (which includes both scientific and consumer advocacy communities) and to the public at large.

The funding instrument for awards made under this BAA will be assistance agreements, contracts, or Other Transactions. 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. The USAMRDC will also consider the use of Other Transactions (OTs) as a vehicle for award, in accordance with the conditions in 10 USC 4021 and 10 USC 4022.

An assistance agreement can take the form of a grant or cooperative agreement. The level of involvement on the part of the CDMRP during the project’s period of performance is the key factor in determining whether to award a grant or cooperative agreement. If “no substantial involvement” on the part of the CDMRP is anticipated, a grant will be made (31 USC 6304). Conversely, if “substantial involvement” on the part of the CDMRP is anticipated, a cooperative agreement will be made (31 USC 6305). Substantial involvement means that, after award, CDMRP staff will assist, guide, coordinate, or participate in project activities.

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 (31 USC 6303).

An “Other Transaction” is appropriate to carry out certain prototypes, research, and production projects (10 USC 4021 and 10 USC 4022). Other Transaction authorities were created to provide the flexibility necessary to adopt and incorporate business practices that reflect commercial industry standards and best practices into its award instruments.

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 FY24 CRRP TRA Award should not exceed $1.1M. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.

Awards supported with FY24 funds will be made no later than September 30, 2025.

The CDMRP expects to allot approximately $3.3M to fund approximately three CRRP TRA Awards. Funding of applications/proposals received is contingent upon the availability of federal funds for this program, the number of applications/proposals received, the quality and merit of the applications/proposals as evaluated by peer and programmatic review, and the requirements of the government. Funds to be obligated on any award resulting from this funding opportunity will be available for use for a limited time period based on the fiscal year of the funds. It is anticipated that awards made from this FY24 funding opportunity will be funded with FY24 funds, which will expire for use on September 30, 2030.

Grantor Contact Information: CDMRP Help Desk Phone: 301-682-5507 Email: help@eBRAP.org