Opportunity Information: Apply for W81XWH 09 NFRP CTA
Apply for W81XWH 09 NFRP 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 Neurofibromatosis 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 Jan 20, 2009 and posted on Jan 20, 2009.
- Applicants must submit their applications by Apr 14, 2009. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $2,200,000.00 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 Neurofibromatosis Clinical Trial Award (CTA) is a Department of Defense funding opportunity run through the Neurofibromatosis Research Program (NFRP) to support clinical trials that could meaningfully change how neurofibromatosis (NF) and/or schwannomatosis are treated or managed. This mechanism is specifically meant for clinical research rather than bench or animal work; in other words, the money is not intended to pay for preclinical studies. Applicants who want support for preclinical projects are directed to a different NFRP mechanism, the Investigator Initiated Research Award. Historically, this CTA mechanism has been relatively selective: since it started in FY99, 21 proposals were received and 5 were recommended for funding at the time this announcement was written.
For FY09, the program highlights several priority areas that reflect major unmet needs in the NF community. A key emphasis is on life-threatening NF complications (high mortality), including tumors (neoplasms) and cerebrovascular abnormalities. It also encourages work on highly debilitating complications (high morbidity) that severely affect day-to-day functioning, such as skeletal problems, learning and cognitive deficits, hormone-related effects, and pain. Another major theme is improving the tools needed to run strong trials in the future, including refining and standardizing imaging approaches, developing and validating molecular and cellular biomarkers, and strengthening quality-of-life measures that can be used as trial endpoints. The announcement also references translational research related to therapy development and preclinical testing of therapeutic agents; however, the CTA itself is positioned as a clinical trial mechanism, and applicants are expected to propose an actual clinical trial rather than a purely preclinical development effort.
The application structure is tightly defined: each submission must propose only one clinical trial, and it must have a distinct, clearly described study design. The Principal Investigator is required to state what phase of trial is being proposed (Phase 0, Phase I, Phase II, or a combination) directly in the clinical protocol section of the application. The solicitation points applicants to FDA and ClinicalTrials.gov resources for definitions of trial phases and to program guidance (Application Instructions and General Information, Appendix 6) to help distinguish between clinical trials and other forms of clinical research.
There are important regulatory readiness expectations tied to drug or device studies. If the trial requires an Investigational New Drug (IND) application or an Investigational Device Exemption (IDE), that IND/IDE should be submitted or already approved before the grant application is submitted. After an award is made, the government can withdraw funding if IND/IDE approval is not obtained within six months of the award date. Operationally, the program also expects speed and feasibility: the proposed clinical trial is expected to begin within 12 months of the award date, signaling that applicants should have sites, recruitment plans, protocols, and oversight processes realistically lined up.
Administratively, this opportunity (Funding Opportunity Number W81XWH 09 NFRP CTA) was posted January 20, 2009 and closed April 14, 2009 (archived May 14, 2009). It is offered by the Department of the Army (USAMRAA) under CFDA 12.420 (Military Medical Research and Development). The award instrument is listed as a cooperative agreement and/or grant, with an anticipated two awards and an estimated total of $2.2 million. Cost sharing is not required, and eligibility is described as unrestricted (open broadly to entity types), subject to any additional clarifications in the full announcement. For access or submission support, the announcement provides contacts through the CDMRP help resources (PA HELP and eReceipt HELP).
Frequently Asked Questions (FAQs) - DOD Neurofibromatosis Clinical Trial Award (CTA)
1) What is the DOD Neurofibromatosis Clinical Trial Award (CTA)?
The DOD Neurofibromatosis Clinical Trial Award (CTA) is a Department of Defense funding opportunity under the Neurofibromatosis Research Program (NFRP) that supports clinical trials intended to meaningfully change how neurofibromatosis (NF) and/or schwannomatosis are treated or managed.
2) What types of projects is this award intended to support?
This mechanism is intended specifically for clinical research in the form of a clinical trial. Applicants are expected to propose an actual clinical trial with a distinct, clearly described study design.
3) Are preclinical studies (bench, lab, or animal work) supported under this CTA?
No. The CTA is positioned as a clinical trial mechanism and is not intended to pay for preclinical studies such as bench or animal work.
4) If I want funding for a preclinical project, what should I apply for instead?
Applicants seeking support for preclinical projects are directed to a different NFRP mechanism: the Investigator Initiated Research Award.
5) How competitive has this funding mechanism been historically?
The announcement describes this mechanism as relatively selective. Since it began in FY99, 21 proposals were received and 5 were recommended for funding at the time the announcement was written.
6) What FY09 research priorities does the program highlight?
For FY09, the program highlights priority areas reflecting unmet needs in the NF community, including life-threatening complications (high mortality), highly debilitating complications (high morbidity), and improvements to tools needed to run strong clinical trials in the future.
7) What life-threatening NF complications are emphasized?
The solicitation emphasizes life-threatening NF complications with high mortality, including tumors (neoplasms) and cerebrovascular abnormalities.
8) What highly debilitating complications are encouraged as areas of focus?
The announcement encourages studies addressing highly debilitating complications (high morbidity) that severely affect daily functioning, including skeletal problems, learning and cognitive deficits, hormone-related effects, and pain.
9) Does the program support development of trial tools and endpoints?
Yes. A major theme is strengthening the tools needed for strong trials, including refining and standardizing imaging approaches, developing and validating molecular and cellular biomarkers, and strengthening quality-of-life measures that can serve as trial endpoints.
10) The announcement mentions translational research and preclinical testing. Does that mean a non-trial translational project is eligible under this CTA?
While the announcement references translational research related to therapy development and preclinical testing, the CTA itself is positioned as a clinical trial mechanism. Applicants are expected to propose an actual clinical trial rather than a purely preclinical development effort.
11) How many clinical trials can be proposed in a single application?
Each submission must propose only one clinical trial.
12) What are the requirements for the clinical trial design in the application?
The submission must include a distinct, clearly described study design for the proposed trial.
13) Do applicants need to specify the trial phase?
Yes. The Principal Investigator is required to state what phase of trial is being proposed (Phase 0, Phase I, Phase II, or a combination) directly in the clinical protocol section of the application.
14) Where does the solicitation point applicants for definitions of clinical trial phases?
The solicitation points applicants to FDA and ClinicalTrials.gov resources for definitions of trial phases.
15) Where can applicants find guidance to distinguish a clinical trial from other clinical research?
The announcement points applicants to program guidance in the Application Instructions and General Information, Appendix 6, to help distinguish between clinical trials and other forms of clinical research.
16) What is expected regarding IND or IDE readiness for drug or device studies?
If the trial requires an Investigational New Drug (IND) application or an Investigational Device Exemption (IDE), the IND/IDE should be submitted or already approved before the grant application is submitted.
17) Can funding be withdrawn if IND/IDE approval is not obtained after award?
Yes. After an award is made, the government can withdraw funding if IND/IDE approval is not obtained within six months of the award date.
18) When is the proposed clinical trial expected to begin?
The proposed clinical trial is expected to begin within 12 months of the award date.
19) What does the 12-month start expectation imply for applicants?
It implies applicants should have feasibility elements realistically lined up, such as sites, recruitment plans, protocols, and oversight processes, so the trial can begin within the expected timeframe.
20) What is the Funding Opportunity Number for this CTA?
The Funding Opportunity Number is W81XWH 09 NFRP CTA.
21) Which organization is offering this opportunity?
The opportunity is offered by the Department of the Army (USAMRAA) under the Department of Defense program framework described in the announcement.
22) What is the CFDA number associated with this opportunity?
The CFDA number listed is 12.420 (Military Medical Research and Development).
23) What type of award instrument is expected?
The award instrument is listed as a cooperative agreement and/or grant.
24) How many awards were anticipated and what was the estimated total funding?
The announcement anticipated two awards with an estimated total of $2.2 million.
25) Is cost sharing required?
No. Cost sharing is not required.
26) Who is eligible to apply?
Eligibility is described as unrestricted (open broadly to entity types), subject to any additional clarifications in the full announcement.
27) When was this opportunity posted and when did it close?
The opportunity was posted on January 20, 2009 and closed on April 14, 2009. It was archived on May 14, 2009.
28) Where can applicants get help with access or submission issues?
The announcement provides contacts through CDMRP help resources, including PA HELP and eReceipt HELP.
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