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.
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-ind-application. 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, 202 3. 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, 202 9. 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 402 2. 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/nature1155 6. 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.