The Department of Defense (DoD) is offering this grant to advance combat readiness and translational medical research.

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 FY20 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. Research of interest may

include knowledge products, “knowledge resulting from research with the potential to improve

individual or public health,”2 and solutions that can accelerate the introduction of military-

relevant health products or technologies into clinical and/or operational use. 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. Projects should consider the varied expertise levels of the 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 non-hospital settings in theater, but 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.

Preclinical research, including animal studies, that is already supported by substantial

preliminary or published data and strongly validates clinical translation is appropriate for this

award mechanism.

Research involving human subjects and human anatomical substances is permitted; however, clinical

trials are not allowed under this funding opportunity. 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.

The proposed research must be relevant to active duty Service members, Veterans, military

beneficiaries, and/or the American public.

The anticipated total costs budgeted for the entire period of performance for an FY20 CRRP RDTRA

will not exceed $2M. Refer to Section II.D.5, Funding Restrictions, for detailed funding

information.

Awards will be made no later than September 30, 2021. For additional information refer to Section

II.F.1, Federal Award Notices.

The CDMRP expects to allot approximately $8.0M to fund approximately 4 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 FY20 funding

opportunity will be funded with FY20 funds, which will expire for use on

September 30, 2026.

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.

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.

Research Involving a U.S. Food and Drug Administration (FDA)-Regulated Drug, Biologic, or Device: 

If the study proposed involves the use of a drug or biologic that has not been approved by the FDA

for the proposed investigational use, evidence is required that an Investigational New Drug (IND)

application that meets all requirements under the Code of Federal Regulations, Title 21, Part 312

(21 CFR 312) has been submitted or will be submitted to the FDA within 60 days of award. If the

investigational product is a device, evidence is required that an Investigational Device Exemption

(IDE) application, that meets all requirements under 21 CFR 812, has been submitted or will be

submitted to the FDA within 60 days of award. The Government reserves the right to withdraw

funding if the IND or IDE application has not been submitted to the FDA within 60 days of the DoD

award date or if the documented application status of the IND or IDE has not been obtained within

12 months of the award date.

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 Institutional Review Board (IRB) or Ethics Committee

(EC) review. Local IRB/EC approval at the time of submission is not required. Allow a minimum of

2 to 3 months for HRPO regulatory review and approval processes. Refer to the General Submission

Instructions, Appendix 1, and the Human Subject Resource Document available on the electronic

Biomedical Research Application Portal (eBRAP) “Funding Opportunities & Forms” web page

(https://ebrap.org/eBRAP/public/Program.htm) for additional information. If the proposed research

is cooperative (i.e., involving 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.