Opportunity Information: Apply for W81XWH 15 TSCRP PCTA
Apply for W81XWH 15 TSCRP PCTA
- 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 Tuberous Sclerosis Complex Pilot 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 May 6, 2015 and posted on May 6, 2015.
- Applicants must submit their applications by Jul 27, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $960,000.00 to eligible and selected applicants.
- The number of recipients for this funding is limited to 2 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 Tuberous Sclerosis Complex (TSC) Pilot Clinical Trial Award (PCTA) is a Department of Defense funding opportunity run through the Congressionally Directed Medical Research Programs (CDMRP) and administered by the U.S. Army Medical Research Acquisition Activity (USAMRAA). It is designed to move promising ideas into early, human-focused clinical testing in TSC by supporting small, exploratory clinical studies that involve limited human exposure. The emphasis is on generating practical, decision-driving clinical data such as diagnostic or therapeutic signals, safety and tolerability information, and evidence about how an intervention works (mechanism of action). In other words, the award is meant to help researchers cross the gap between a good concept and the kind of preliminary clinical evidence needed to justify larger, definitive trials or broader clinical development.
A key point of the program is that it does not support preclinical work. The funded effort must be a clinical study involving human participants, and the study should be structured to produce preliminary data that can directly inform next steps in intervention development for TSC. The opportunity highlights that projects should aim to improve TSC outcomes by advancing interventions and/or establishing clinical biomarkers and outcome measures that can be used in later trials. Typical projects could include figuring out which patient population is most appropriate for a proposed intervention, refining the dosage, duration, or delivery approach, testing whether the intervention is feasible to deliver in the TSC community, developing or validating clinical biomarkers or endpoints that could strengthen future trials, and collecting early evidence related to both efficacy and safety. Overall, the studies are expected to be exploratory but clinically meaningful, with clear relevance to eventual patient impact.
Because this award supports clinical trials, it places strong emphasis on regulatory readiness when investigational products are involved. If the trial uses a drug that is not already FDA-approved for the intended investigational use, the applicant must submit an Investigational New Drug (IND) application to the FDA that meets the requirements in 21 CFR 312, and that IND submission must occur before the grant application deadline. Similarly, if the investigational product is a medical device, the applicant must provide evidence that an Investigational Device Exemption (IDE) application meeting 21 CFR 812 has been submitted to the FDA before the application deadline, or provide documentation that the device is exempt from IDE requirements. Beyond submission, the program requires documentation showing FDA approval of the IND/IDE or confirmation of exemption prior to programmatic review, and this documentation must be provided to the CDMRP Help Desk (help@eBRAP.org). If that documentation is not provided in time, the Government may withdraw the application, so applicants need to plan regulatory steps early and treat them as a gating requirement rather than an administrative afterthought.
From an administrative and funding standpoint, this opportunity was posted May 6, 2015, with an application deadline of July 27, 2015, and an archive date of August 26, 2015. The Funding Opportunity Number is W81XWH-15-TSCRP-PCTA, and it falls under CFDA 12.420 (Military Medical Research and Development). The instrument type is listed as a cooperative agreement and grant, indicating DoD involvement consistent with CDMRP awards while still funding investigator-led research. The program anticipated making 2 awards with an estimated total funding level of $960,000, and it did not require cost sharing or matching funds. Eligibility was listed as unrestricted, meaning the competition was broadly open to different types of applicant organizations, subject to any specific clarifications in the full announcement.
For applicants needing assistance accessing the announcement or navigating submission systems, the listed point of contact is the CDMRP Help Desk at 301-682-5507. The overall message of the PCTA is straightforward: bring a well-justified, clinically grounded pilot trial in TSC, focus on early human data that will shape future development, and arrive with FDA regulatory submissions already in motion (and ideally resolved) if an IND or IDE is required.
Frequently Asked Questions (FAQs) - DoD Tuberous Sclerosis Complex (TSC) Pilot Clinical Trial Award (PCTA)
What is the DoD Tuberous Sclerosis Complex (TSC) Pilot Clinical Trial Award (PCTA)?
The TSC Pilot Clinical Trial Award (PCTA) is a Department of Defense (DoD) funding opportunity intended to move promising tuberous sclerosis complex (TSC) ideas into early, human-focused clinical testing. It supports small, exploratory clinical studies with limited human exposure, with the goal of generating practical early clinical data that can drive next-step decisions.
Which organizations run and administer this funding opportunity?
This opportunity is run through the Congressionally Directed Medical Research Programs (CDMRP) and is administered by the U.S. Army Medical Research Acquisition Activity (USAMRAA).
What is the primary purpose of this award?
The purpose is to fund pilot clinical trials in TSC that generate preliminary, decision-driving clinical evidence. This includes early signals of diagnostic or therapeutic activity, safety and tolerability information, and evidence about how an intervention works (mechanism of action). The intent is to help bridge the gap between a strong concept and the preliminary clinical evidence needed to justify larger, definitive trials or broader clinical development.
Does this award fund preclinical (non-human) research?
No. A key point is that the program does not support preclinical work. The funded effort must be a clinical study involving human participants.
What type of study is expected under this award?
The program expects a clinical study in human participants that is exploratory but clinically meaningful, structured to produce preliminary data that directly informs next steps in intervention development for TSC.
What kinds of outcomes or data should a project aim to generate?
Projects should focus on generating practical clinical data, such as:
- Diagnostic or therapeutic signals
- Safety and tolerability information
- Mechanism of action evidence (how an intervention works)
- Evidence that helps determine the best next steps for later-stage trials or development
How should the proposed work relate to patient impact in TSC?
Projects should aim to improve TSC outcomes by advancing interventions and/or establishing clinical biomarkers and outcome measures that can be used in later trials. The emphasis is on relevance to eventual patient impact, even though the studies are pilot and exploratory.
What are examples of projects that fit this opportunity?
Examples highlighted include pilot efforts to:
- Identify the most appropriate patient population for a proposed intervention
- Refine dosage, duration, or delivery approach
- Test feasibility of delivering an intervention in the TSC community
- Develop or validate clinical biomarkers or endpoints to strengthen future trials
- Collect early evidence related to both efficacy and safety
Is this award intended to fund large, definitive clinical trials?
No. The award is designed for small, exploratory clinical studies with limited human exposure. The goal is to produce preliminary evidence that supports decisions about whether and how to proceed to larger trials.
What is meant by "limited human exposure" in this program?
Based on the description provided, the program supports small, exploratory clinical studies rather than broad or late-stage testing. The emphasis is on early human data collection rather than extensive enrollment or long-term exposure.
What is the Funding Opportunity Number for this award?
The Funding Opportunity Number is W81XWH-15-TSCRP-PCTA.
What CFDA number is associated with this opportunity?
This opportunity falls under CFDA 12.420 (Military Medical Research and Development).
What is the award mechanism (funding instrument type)?
The instrument type is listed as a cooperative agreement and grant, indicating DoD involvement consistent with CDMRP awards while still funding investigator-led research.
How much funding was anticipated and how many awards were expected?
The program anticipated making 2 awards with an estimated total funding level of $960,000.
Is cost sharing or matching funds required?
No. The opportunity states that cost sharing or matching funds are not required.
Who was eligible to apply?
Eligibility was listed as unrestricted, meaning the competition was broadly open to different types of applicant organizations, subject to any specific clarifications in the full announcement.
When was this opportunity posted and what were the key dates?
The opportunity was posted May 6, 2015. The application deadline was July 27, 2015. The archive date was August 26, 2015.
What regulatory requirements apply if the clinical trial involves an investigational drug?
If the trial uses a drug that is not already FDA-approved for the intended investigational use, the applicant must submit an Investigational New Drug (IND) application to the FDA meeting 21 CFR 312 requirements. Importantly, the IND submission must occur before the grant application deadline.
What regulatory requirements apply if the clinical trial involves an investigational medical device?
If the investigational product is a medical device, the applicant must provide evidence that an Investigational Device Exemption (IDE) application meeting 21 CFR 812 has been submitted to the FDA before the application deadline, or provide documentation that the device is exempt from IDE requirements.
Does the program require only submission of the IND/IDE, or does it also require FDA approval/exemption confirmation?
Both are addressed. Submission (IND or IDE) must occur before the application deadline when required. In addition, documentation showing FDA approval of the IND/IDE or confirmation of exemption must be provided prior to programmatic review.
Where must applicants send the FDA IND/IDE approval or exemption confirmation documentation?
The documentation must be provided to the CDMRP Help Desk at help@eBRAP.org.
What happens if the FDA IND/IDE approval or exemption documentation is not provided in time?
If the documentation is not provided prior to programmatic review as required, the Government may withdraw the application. The program description emphasizes that applicants should treat regulatory steps as a gating requirement and plan early.
How early should applicants plan for IND/IDE-related steps?
The program indicates that IND/IDE submission (or IDE exemption documentation) must be completed before the application deadline, and approval/exemption confirmation must be in hand before programmatic review. That structure implies applicants need to plan regulatory actions early rather than treating them as a last-minute administrative task.
Who can applicants contact for help with the announcement or submission systems?
Applicants can contact the CDMRP Help Desk at 301-682-5507 for assistance accessing the announcement or navigating submission systems.
What is the overall message or main expectation of the PCTA program?
The program message is: propose a well-justified, clinically grounded pilot trial in TSC, focus on early human data that will shape future development decisions, and ensure FDA regulatory submissions are already in motion (and ideally resolved) when an IND or IDE is required.
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