Combat Casualty Care - Multi-Domain Lifesaving Trauma Innovations (MuLTI) Award

Description

The JPC-6/CCCRP expects to allot approximately $10.7 million (M) of the FY19, $9.9M of the FY20, and $9.5M of the FY21 DHP RDT&E appropriations to fund approximately 12 to 30 FY19 DMRDP JPC-6/CCCRP MuLTI Award proposals/applications, depending on the quality and number of proposals/applications received. Funding of applications received in response to this BAA is contingent upon the availability of Federal funds for this program. The funding estimated for this BAA is approximate and subject to realignment. Proposals/Applications received in response to both the FY19 DMRDP JPC-6/CCCRP MuLTI Award extramural BAA and intramural Funding Opportunity 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 anticipated total costs (direct and indirect) budgeted for the entire period of performance for an FY19 MuLTI Award will not exceed: • $2.5M total costs for studies involving prospective accrual of human subjects and clinical trials • $1.0M total costs for all other research Refer to Section II.D.6, Funding Restrictions, for detailed funding information. The USAMRMC 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, Title 31 United States Code Sections 6301-6308 (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, DoD FY19 DMRDP JPC-6/CCCRP MuLTI Award 10 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. Production and Testing of Prototypes (Contracts only): USAMRAA may include an optional line item for the provision of advanced component development or for the delivery of initial or additional prototype units. However, such a contract addition shall be subject to the limitations contained in Section 819 of the National Defense Authorization Act (NDAA) for Fiscal Year 2010, as modified in Section 811 of the NDAA for Fiscal Year 2015. 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. This BAA may support preclinical research, clinical research, and Phase 0 and Phase I clinical trials/testing. A clinical trial is defined as a prospective accrual of human subjects where an intervention (e.g., device, drug, biologic, surgical procedure, rehabilitative modality, behavioral intervention, or other) is tested on a human subject for a measurable outcome with respect to safety, effectiveness, efficacy, and/or exploratory information. This outcome represents a direct effect on the human subject of that intervention or interaction. For further definitions, categories, and resource information for human subject research, see the Human Subject Resource Document provided at https://ebrap.org/eBRAP/public/Program.htm. Phase II and Phase III 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. Recruitment Milestones: For research involving human subject enrollment, the proposal/application must indicate the quarterly enrollment targets across all sites in Attachment 5: Statement of Work. Successful applicants will work with USAMRAA to establish milestones for human subject recruitment. Continued support for the project will be based upon satisfactory progress in meeting the established milestones. Research Involving an 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 that an Investigational New Drug (IND) application that meets all DoD FY19 DMRDP JPC-6/CCCRP MuLTI Award 11 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 is required. If the investigational product is a device, evidence that an Investigational Device Exemption (IDE) application that meets all requirements under 21 CFR 812 has been reviewed and approved by the FDA has been submitted or will be submitted to the FDA within 60 days of award is required. 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. Multi-Institutional Clinical Trials: If the proposed clinical trial is multi-institutional, plans for the multi-institutional structure governing the research protocol(s) should be outlined in Attachment 14: Study Personnel and Organization. The lead organization 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. A single Institutional Review Board (IRB) or Ethics Committee (EC) pathway is strongly recommended whenever possible. The master protocol and consent form must be reviewed by the USAMRMC Office of Research Protections (ORP) Human Research Protection Office (HRPO) prior to distribution to the additional sites for IRB/EC review. Communication and data transfer among the collaborating institutions, as well as how specimens and/or imaging products obtained during the study will be handled, should be included in the appropriate sections of the proposal/application. A separate intellectual and material property plan agreed upon by all participating institutions is also required for multi-institutional clinical trials. 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 USAMRMC ORP HRPO, prior to research implementation. This administrative review requirement is in addition to the local IRB or EC review. Local IRB/EC approval at the time of submission is not required. The HRPO is mandated to comply with specific laws and requirements governing all research involving human anatomical substances, human subjects, or human cadavers that is supported by the DoD. These laws and requirements will necessitate information in addition to that supplied to the IRB/EC. Allow a minimum of 2 to 4 months for HRPO regulatory review and approval processes. Additional time for regulatory reviews may be needed for clinical studies taking place in international settings. When possible, protocols should be written for research with human subjects and/or human anatomical substances that are specific to the DoD-supported effort outlined in the submitted proposal/application as a stand-alone study. Submission to HRPO of protocols involving more than the scope of work in the DoD-funded award will require HRPO review of the entire protocol (DoD and non-DoD funded). DoD human subjects protection requirements may be applied to non-DoD funded work and necessitate extensive revisions to the protocol. Refer to the General Submission Instructions, Appendix 1, Section B, and the Human Subject Resource Document available on the eBRAP “Funding Opportunities & Forms” web page (https://ebrap.org/eBRAP/public/Program.htm) for additional information. If the IRB determines that a trial presents greater than minimal risk to human subjects, the DoD requires an independent research monitor with expertise consistent with the nature of risk(s) identified within the research protocol. If applicable, refer to the General Submission DoD FY19 DMRDP JPC-6/CCCRP MuLTI Award 12 Instructions, Appendix 1, Section B, for more information on study reporting authorities and responsibilities of the research monitor. Research Involving Animals: All DoD-funded research involving new and ongoing research with animals must be reviewed and approved by the USAMRMC 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. Specific documents relating to the use of animals in th

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