Noninvasive mTBI Tool RFI | HU000120R0047

Opportunity Information: Apply for HU000120R0047

The "Noninvasive mTBI Tool RFI" (Funding Opportunity Number HU000120R0047) is a Request for Information issued by the Uniformed Services University of the Health Sciences (USU), a Department of Defense-linked institution that supports military medicine leadership and medical research and development. This notice is not a grant solicitation and it does not commit the government to fund anything; it is strictly meant to gather information for planning purposes. USU, working through its Traumatic Brain Injury Research Consortium (TBIRC), is trying to map the current landscape of available and emerging assessment technologies that could improve how mild traumatic brain injury (mTBI), commonly referred to as concussion, is detected, managed, and studied in both military and potentially comparable civilian contexts.

The core purpose of the RFI is to identify non-invasive (or largely non-invasive) biomedical tools that could add measurable value beyond today’s usual clinical approach. USU emphasizes that current standards of care in military settings include tools like the Military Acute Concussion Evaluation 2 (MACE2), clinician judgment, and neuroimaging when clinically indicated. They are specifically interested in technologies that can be evaluated head-to-head against these standards, either as stand-alone tools or as part of a combined, multimodal assessment approach.

USU outlines three main areas where these technologies might be useful. First, they want to know whether non-invasive tools can function as initial screening or diagnostic aids for people who have been exposed to events that raise mTBI risk (for example, blasts, falls, vehicle accidents, or training incidents) but who have not yet been formally diagnosed. The emphasis here is on early identification and decision support in situations where symptoms can be subtle, delayed, or confounded by stress, fatigue, or other injuries. Second, they want to understand whether these tools can provide prognostic insight after a concussion is diagnosed, especially information that could help predict recovery trajectories and support return-to-activity or return-to-duty decisions compared with existing protocols. Third, they are interested in whether these technologies could improve clinical research by helping define inclusion and exclusion criteria for therapeutic trials in mTBI, with a stated priority on studies that address functional deficits and symptom management.

Across all three areas, the RFI highlights practical, real-world considerations that matter for adoption in military medicine. One key requirement is quantifying the "added value" of a tool: not just whether it produces a signal, but whether it improves accuracy, confidence, triage, prognosis, or treatment decisions beyond what clinicians already get from standard evaluations. Another requirement is determining the best setting and timing for use, such as at the point of injury, in an emergency department or urgent care clinic, in primary care, in rehabilitation, or in longer-term specialty concussion clinics. Timing is treated as its own variable, since some tools may be most informative immediately after exposure while others may be better during sub-acute recovery or when guiding referrals and treatment adjustments. USU also asks for ideas on how to generate effectiveness data and how to design training and clinical support mechanisms that would make it easier for clinicians to actually use these tools consistently, recognizing that even FDA-cleared technologies often see incomplete adoption in practice.

The RFI lists several example categories of candidate technologies, noting that devices in each category may already have FDA-cleared indications. These include quantitative EEG-based multimodal approaches, blood biomarkers (with the caveat that blood draws are an invasive step even if the analysis itself is otherwise straightforward), eye tracking technologies, automated neurocognitive testing, and near-infrared spectroscopy (NIRS). While the title emphasizes noninvasive assessment, the inclusion of blood biomarkers signals that USU is also open to minimally invasive options if they are clinically valuable and operationally feasible.

In terms of what USU wants respondents to send, the RFI is framed around three question sets. Respondents are asked to describe what kinds of clinical study designs and methodologies could assess utility for one or more technologies, including studies that compare technologies against one another and against standard care, and studies that determine which phase of care each tool best fits. USU also asks whether any of the technologies are mature enough to be incorporated into interventional clinical trials (therapeutic or preventive), and requests details on relevant ongoing research, the development stage, and any applicable regulatory status such as Investigational Device Exemption (IDE) or Investigational New Drug (IND) considerations. A second question focuses on novel study approaches that could improve understanding and clinical adoption, explicitly acknowledging that FDA clearance alone has not solved adoption barriers. A third question asks for approaches that can distinguish how well these tools work across contexts, including civilian sports-related concussion, civilian non-sport mTBI, military blast-related exposures (training or combat), and military non-blast injuries.

The submission instructions are structured like a typical government RFI rather than a proposal call. Responses had to be no more than five pages, submitted by email (mTBItechnologies@usuhs.edu) by 11:59 PM Eastern on July 27, 2020. Telephone inquiries were not accepted, and cost or pricing information was explicitly prohibited. USU also warns that generic marketing materials that do not address the government’s specific questions would not be reviewed, and asks respondents to clearly label which technology categories and areas of interest their response addresses. The notice further explains standard RFI protections and limitations: proprietary markings will be handled accordingly, the government can use or disclose submitted information as legally appropriate, submissions will not be returned, and responding does not create any contractual obligation or guarantee of future funding opportunities. Eligible applicants are listed as unrestricted, reflecting that this is an information-gathering exercise open to a wide range of potential respondents, especially those able to discuss or support clinical studies, ideally involving military populations and collaborations with military treatment facilities, labs, or researchers.

• The Uniformed Services Univ. of the Health Sciences in the health sector is offering a public funding opportunity titled "Noninvasive mTBI Tool RFI" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 12.750.
• This funding opportunity was created on 2020-04-23.
• Applicants must submit their applications by 2020-07-27. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Unrestricted.

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