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: Joshua D McKean Grants Officer

Description:

The MBRP TTDA is a product-driven award mechanism intended to provide support for the translation of promising preclinical findings into products for clinical application in resource-limited settings, particularly within the pre-hospital, or early, acute phase of care environments. Applications must address one or more of the critical gaps included in the FY24 MBRP TTDA Focus Areas. Products under development must address the needs of military Service Members, Veterans, their beneficiaries, and the American public.

The product(s) to be developed may be a tangible item such as a medical device or pharmacologic agent (including, but not limited to, drugs or biologics). Knowledge products may be considered, provided that the knowledge is applicable to a technology or therapeutic under development. (A “knowledge product” is a non-materiel product that addresses an identified need in one or more of the FY24 MBRP TTDA Focus Areas. A knowledge product is based on current evidence, aims to transition clinical practice standards, training, or tools into clinical practice, or supports materiel solutions [systems to develop, acquire, provide, and sustain medical solutions and capabilities], and educates or impacts behavior throughout the continuum of care, including primary prevention of negative outcomes.)

At the time of pre-application submission the proposed product must have achieved a minimum technology readiness level (TRL) or knowledge readiness level (KRL) of 3 (Appendix II).

Proof-of-concept AND a prototype/preliminary version of the proposed product demonstrating its potential utility must be established at the time of pre-application submission. Applications must include relevant data that support the rationale for the proposed study. These data may be unpublished and/or from the published literature.

This award mechanism is intended to facilitate progression of research that is supported by significant preliminary data but has not yet advanced to the level of clinical use. Examples of the types of research that may be supported include, but are not limited to:

• Testing new therapeutic or technologic modalities (e.g., agents, delivery systems, chemical modification of lead compounds, device testing and/or validation) using established or validated preclinical systems

• Designing pilot or full-scale Good Manufacturing Practice (GMP) production of therapeutics and/or technologies for use in advanced preclinical studies

• Developing pharmacologic agents through absorption, distribution, metabolism, excretion, and toxicity studies

• Investigational New Drug- or Investigational Device Exemption-enabling studies

Clinical trials and clinical research studies ARE NOT PERMITTED under this award mechanism. Projects involving limited use of commercially available human cells or anatomical specimens are permitted, provided that the use of such specimens is necessary for device or product development. Applicants interested in proposing clinical research should consider submitting to the FY24 MBRP Patient-Centered Research Award mechanism (HT942524MBRPPCRA).

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.

Impact: The overall impact of the proposed research is a key component of this award mechanism. High-impact research will, if successful, lead to the development and translation of therapeutic or technologic advances for clinical application in the care of burn-injured casualties, such as detection, diagnosis, treatment, or burn complication prevention.

Relevance to Military Health: Relevance to the health care needs of burn-injured military Service Members is a key feature of this award.

Use of DOD or Department of Veterans Affairs (VA) Resources: Applications involving multidisciplinary collaborations among academia, industry, the military Services, the 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. Applicants are encouraged to integrate and/or align their research projects with DOD and/or VA research laboratories and programs. Collaboration with DOD or VA investigators is also encouraged. A list of websites that may be useful in identifying additional information about ongoing DOD and VA areas of research interest or potential opportunities for collaboration can be found in Appendix IV.

Rigor of Experimental Design: All projects should adhere to a core set of standards for rigorous study design and reporting to maximize the reproducibility and translational potential of preclinical research. The standards are described in SC Landis et al., 2012, A call for transparent reporting to optimize the predictive value of preclinical research, Nature 490:187-191 (www.nature.com/nature/journal/v490/n7419/full/nature11556.html). While these standards are written for preclinical studies, the basic principles of randomization, blinding, sample-size estimation, and data handling derive from well-established best practices in clinical studies. Projects that include research on animal models are required to submit Attachment 8, Animal Research Plan, as part of the application package to describe how these standards will be addressed. Applicants should consult the ARRIVE guidelines 2.0 (Animal Research: Reporting In Vivo Experiments) to ensure relevant aspects of rigorous animal research are adequately planned for and, ultimately, reported. The ARRIVE guidelines 2.0 can be found at https://arriveguidelines.org/arrive-guidelines.

The CDMRP expects to allot approximately $4.4M to fund approximately two MBRP Technology/Therapeutic Development 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 FY24 funding opportunity will be funded with FY24 funds, which will expire for use on September 30, 2030.

The funding instrument for awards made under the program announcement 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 government involvement during the project’s period of performance is the key factor in determining whether to award a grant or cooperative agreement. If “no substantial government involvement” is anticipated, a grant will be made (31 USC 6304). Conversely, if “substantial government involvement” is anticipated, a cooperative agreement will be made (31 USC 6305). Substantial involvement means that members of the U.S. government 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.

An “Other Transaction” 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 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.

The anticipated total costs budgeted for the entire period of performance for an FY24 MBRP Technology/Therapeutic Development Award should not exceed $2.2M. Refer to Section II.D.6, Funding Restrictions, for detailed funding information.

Awards supported with FY24 funds will be made no later than September 30, 2025. For additional information refer to Section II.F.1, Federal Award Notices.

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