Opportunity Information: Apply for W81XWH 13 PHTBI TED
Apply for W81XWH 13 PHTBI TED
- The Dept. of the Army USAMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "DoD Psychological Health and Traumatic Brain Injury TBI Endpoints Development Award" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 12.420 Military Medical Research and Development.
- This funding opportunity was created on Nov 6, 2013 and posted on Nov 6, 2013.
- Applicants must submit their applications by Feb 13, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $17,000,000.00 to eligible and selected applicants.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled Additional Information on Eligibility.
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Opportunity Summary:
The DoD Psychological Health and Traumatic Brain Injury (PH/TBI) Research Program TBI Endpoints Development (TED) Award (Funding Opportunity Number W81XWH-13-PHTBI-TED) is a Department of the Army/USAMRAA cooperative agreement opportunity focused on one specific gap in the traumatic brain injury field: the lack of validated, qualified endpoints that can be reliably used to judge whether a diagnostic approach or a treatment is truly effective for mild to moderate TBI (mTBI to modTBI). In practical terms, an "endpoint" is the kind of measurable outcome a clinical study uses to determine success or failure, such as a clinical scale, cognitive performance measure, biomarker, imaging readout, functional assessment, or other standardized metric. The program is built around the idea that many candidate endpoints already exist, but too many have not been rigorously validated and positioned for broad adoption in research studies and clinical trials, especially in ways that can stand up to regulatory expectations.
The core purpose of the TED Award is to stand up a collaborative, multidisciplinary research team tasked with advancing clinically relevant endpoints for trials involving diagnosis, treatment, and rehabilitation in mTBI to modTBI. Rather than funding isolated projects, the mechanism emphasizes a team structure that can integrate expertise across disciplines such as neurology, neuropsychology, rehabilitation medicine, imaging, biomarker science, biostatistics, clinical trial methodology, and regulatory science. The expectation is that this kind of coordinated approach will produce endpoints that are not only scientifically credible, but also practical to implement in real-world research settings and eventually useful for supporting regulatory approvals. That regulatory angle is a key feature of the opportunity: the endpoints developed should be able to function as reference measures of diagnostic or therapeutic effectiveness, meaning they should be robust enough to help decision-makers evaluate whether an intervention works.
The announcement also clearly draws a boundary around what it will and will not fund. This award is not intended to directly support the creation of new TBI drugs, therapies, diagnostics, or medical devices. Instead, it supports the development and advancement of the measurement tools and outcome markers that trials rely on. The logic is that without dependable endpoints, even promising diagnostics and treatments can be harder to evaluate, compare, or move through the evidence pipeline. By improving endpoints, the program aims to improve the entire downstream ecosystem for TBI research, including study design quality, comparability across trials, and the credibility of results used to guide clinical practice and policy.
From an administrative standpoint, this was a discretionary funding opportunity using a cooperative agreement instrument, which typically implies substantial programmatic involvement by the funding agency during performance (more interaction and coordination than a standard grant). The opportunity fell under the Science and Technology and other Research and Development activity category, with CFDA number 12.420 (Military Medical Research and Development). It anticipated a single award (Expected Awards: 1) with an estimated total funding amount of $17,000,000 and no cost-sharing or matching requirement. Eligibility was listed as unrestricted, meaning open to a wide range of applicant organizations, subject to any additional eligibility clarifications in the full announcement.
Key dates show it was posted and created on November 6, 2013, with an original and current closing date of February 13, 2014, and it was archived on March 15, 2014. For access issues or questions about the full announcement, applicants were directed to the CDMRP Help Desk (301-682-5507, help@cdmrp.org).
Frequently Asked Questions (FAQs)
What is the name of this funding opportunity?
This opportunity is the DoD Psychological Health and Traumatic Brain Injury (PH/TBI) Research Program TBI Endpoints Development (TED) Award.
What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number is W81XWH-13-PHTBI-TED.
Which agency is offering the award?
The award is offered through the Department of the Army/USAMRAA under the Department of Defense PH/TBI Research Program.
What type of funding instrument is used?
The opportunity uses a cooperative agreement instrument, which generally means the funding agency expects substantial programmatic involvement during the period of performance (more coordination and interaction than a standard grant).
What problem or gap is this award intended to address?
The award targets a specific gap in traumatic brain injury research: the lack of validated, qualified endpoints that can be reliably used to determine whether diagnostic approaches or treatments are effective for mild to moderate TBI (mTBI to modTBI).
What does "endpoint" mean in this announcement?
In this context, an endpoint is a measurable outcome used in a clinical study to determine success or failure. Examples provided include clinical scales, cognitive performance measures, biomarkers, imaging readouts, functional assessments, or other standardized metrics.
What is the core purpose of the TED Award?
The core purpose is to establish a collaborative, multidisciplinary research team to advance clinically relevant endpoints for trials involving diagnosis, treatment, and rehabilitation in mTBI to modTBI.
Is this award meant to fund a single project or a team?
The mechanism emphasizes a coordinated team structure rather than isolated projects, with the intent to integrate multiple disciplines toward advancing endpoints.
What kinds of expertise are expected to be part of the team?
The announcement highlights integration across disciplines such as neurology, neuropsychology, rehabilitation medicine, imaging, biomarker science, biostatistics, clinical trial methodology, and regulatory science.
Why is the regulatory angle emphasized?
A key feature is that endpoints should be positioned to stand up to regulatory expectations and function as reference measures of diagnostic or therapeutic effectiveness to support decision-making about whether an intervention works.
Does the award fund the development of new TBI drugs, therapies, diagnostics, or medical devices?
No. The announcement explicitly states the award is not intended to directly support the creation of new TBI drugs, therapies, diagnostics, or medical devices.
What does the award fund if it does not fund new treatments or devices?
It funds the development and advancement of measurement tools and outcome markers (endpoints) that clinical trials and research studies rely on to evaluate diagnostic and therapeutic effectiveness.
Why invest in endpoints instead of directly funding treatments?
The rationale given is that without dependable endpoints, promising diagnostics and treatments can be difficult to evaluate, compare, or move through the evidence pipeline. Improved endpoints are intended to strengthen study design quality, comparability across trials, and the credibility of results used to guide practice and policy.
What TBI severity range is the focus of this program?
The focus is on mild to moderate traumatic brain injury (mTBI to modTBI).
What activity category does this opportunity fall under?
The opportunity fell under the Science and Technology and other Research and Development activity category.
What is the CFDA number associated with this program?
The CFDA number listed is 12.420 (Military Medical Research and Development).
How many awards were expected?
The opportunity anticipated a single award (Expected Awards: 1).
What was the estimated total funding amount?
The estimated total funding amount was $17,000,000.
Is cost sharing or matching required?
No. The announcement indicates there was no cost-sharing or matching requirement.
Who was eligible to apply?
Eligibility was listed as unrestricted, meaning it was open to a wide range of applicant organizations (subject to any additional eligibility clarifications in the full announcement).
When was the opportunity posted?
The opportunity was posted and created on November 6, 2013.
What was the application closing date?
The original and current closing date listed was February 13, 2014.
Is this opportunity still open?
No. The opportunity was archived on March 15, 2014.
Who should applicants contact for access issues or questions about the full announcement?
Applicants were directed to the CDMRP Help Desk at 301-682-5507 or help@cdmrp.org.
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