Opportunity Information: Apply for W81XWH 12 TSCRP CTA
Apply for W81XWH 12 TSCRP CTA
- 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 FY12 Tuberous Sclerosis Complex Clinical Trial 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 Mar 22, 2012 and posted on Mar 22, 2012.
- Applicants must submit their applications by May 31, 2012. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $1,600,000.00 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 FY12 Tuberous Sclerosis Complex (TSC) Clinical Trial Award (Funding Opportunity Number W81XWH-12-TSCRP-CTA) is a Department of Defense funding opportunity run through the U.S. Army Medical Research Acquisition Activity (USAMRAA) under the TSC Research Program. Its purpose is to move promising TSC interventions forward by supporting human clinical studies that could meaningfully improve how tuberous sclerosis complex is treated or managed. The core emphasis is on near-term clinical impact rather than basic or exploratory laboratory work.
This award mechanism is specifically designed to fund clinical trials, including pilot trials and early-stage Phase 0, Phase I, or Phase II studies. In practical terms, that means the funding is aimed at first-in-human or early efficacy and safety testing, feasibility work, dose-finding, and other early clinical evaluations that can set the stage for later, larger trials or changes in clinical practice. A key restriction is that the budget must be used to conduct the clinical trial itself; the announcement explicitly states that funds may not be used for preclinical research studies, so applicants need to be ready to execute a human trial rather than proposing animal studies, in vitro experiments, or other preparatory lab research as the main work.
The opportunity was offered as a discretionary program under the Science and Technology / Research and Development funding activity category, with support provided through either a cooperative agreement or a grant, depending on the final award structure. The estimated total available funding was $1,600,000, with an expectation of making one award. There was no cost sharing or matching requirement, which typically makes the program more accessible to a wider range of applicants who may not have additional funds to contribute.
Eligibility was listed as unrestricted, meaning it was open to any type of applicant entity (for example, academic institutions, nonprofits, companies, and other organizations), subject to any additional clarifications that may have been included in the full announcement under eligibility details. The program is associated with CFDA number 12.420 (Military Medical Research and Development), which is the catalog listing used to track and classify this type of federal assistance.
Timing details show the announcement was posted on March 22, 2012, with an original and current closing date of May 31, 2012, and an archive date of June 30, 2012. For support with accessing the full announcement or submission systems, the listed point of contact was the CDMRP Help Desk (PA HELP and eReceipt HELP) at 301-682-5507 and help@cdmrp.org.
Overall, the grant opportunity is best understood as targeted funding for early-stage, high-impact TSC clinical trials, with a strong requirement that the proposed work be an actual clinical trial in humans and not a preclinical research plan.
FAQs: DOD FY12 Tuberous Sclerosis Complex (TSC) Clinical Trial Award (W81XWH-12-TSCRP-CTA)
What is the DOD FY12 TSC Clinical Trial Award?
It is a Department of Defense funding opportunity under the Tuberous Sclerosis Complex (TSC) Research Program, administered through the U.S. Army Medical Research Acquisition Activity (USAMRAA). The award is intended to move promising TSC interventions forward by supporting human clinical studies that could meaningfully improve how TSC is treated or managed.
What is the main goal of this funding opportunity?
The main goal is near-term clinical impact: supporting clinical research in humans that can improve TSC treatment or management in a practical timeframe, rather than supporting basic, exploratory, or purely laboratory-focused work.
What types of studies does this award support?
This mechanism is specifically designed to fund clinical trials in humans, including pilot trials and early-stage Phase 0, Phase I, or Phase II studies.
Does the program support pilot or early-stage clinical trials?
Yes. The announcement explicitly includes pilot trials and Phase 0, Phase I, and Phase II clinical studies.
What kinds of clinical trial activities are considered aligned with this award?
The description emphasizes first-in-human or early evaluation activities such as feasibility work, dose-finding, and early efficacy and safety testing, along with other early clinical evaluations that can help enable later, larger trials or inform clinical practice.
Is preclinical research allowed under this award?
No. The announcement states that funds may not be used for preclinical research studies. Applicants need to be positioned to execute a human clinical trial rather than proposing animal studies, in vitro experiments, or other preparatory lab research as the main effort.
Can the budget be used for animal studies or lab experiments to prepare for a clinical trial?
The opportunity description indicates the budget must be used to conduct the clinical trial itself and explicitly prohibits using funds for preclinical research studies. Based on the provided information, the funding is intended for the human trial rather than preparatory preclinical work.
What is the Funding Opportunity Number (FON) for this program?
The Funding Opportunity Number is W81XWH-12-TSCRP-CTA.
Which agency administers this opportunity?
The opportunity is run through USAMRAA (U.S. Army Medical Research Acquisition Activity) under the Department of Defense TSC Research Program.
What funding mechanism is used (grant vs. cooperative agreement)?
Support was to be provided through either a cooperative agreement or a grant, depending on the final award structure.
How much total funding was expected to be available?
The estimated total available funding was $1,600,000.
How many awards were expected?
The opportunity anticipated making one award.
Is cost sharing or matching required?
No. There was no cost sharing or matching requirement listed.
Who was eligible to apply?
Eligibility was listed as unrestricted, meaning it was open to any type of applicant entity (such as academic institutions, nonprofits, companies, and other organizations), subject to any additional details that may have been included in the full announcement.
What is the CFDA number associated with this opportunity?
The program is associated with CFDA 12.420 (Military Medical Research and Development).
When was the opportunity posted?
The announcement was posted on March 22, 2012.
What was the application deadline?
The original and current closing date was May 31, 2012.
When was the opportunity archived?
The archive date was June 30, 2012.
What kind of funding activity category does this fall under?
It was offered as a discretionary program under the Science and Technology / Research and Development funding activity category.
Where can applicants get help with accessing the full announcement or submission systems?
Support contact information listed for help was the CDMRP Help Desk (PA HELP and eReceipt HELP) at 301-682-5507 and help@cdmrp.org.
Is this opportunity focused on basic laboratory research?
No. The core emphasis is on near-term clinical impact via human clinical studies, rather than basic or exploratory laboratory work.
How should an applicant think about fit for this award?
Based on the description, the best fit is a project that is ready to conduct an actual clinical trial in humans for a promising TSC intervention, particularly a pilot or early-phase study designed to generate meaningful clinical evidence and support next-step development.
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