The Department of Defense offers the Neurofibromatosis Clinical Trial Award to support the rapid implementation of clinical trials aimed at impacting the treatment or management of NF. Projects may include evaluating new products, pharmacologic agents, devices, clinical guidance, and emerging technologies. The funding is specifically for clinical trials, ranging from proof-of-concept to large-scale efficacy studies in relevant patient populations. Preclinical research studies are not eligible for this award. Applicants should provide scientific rationale and preliminary data for pilot and Phase I, II trials. The focus is on interventions tested on human subjects for measurable outcomes. Deadline for applications is July 24, 2014.
Opportunity ID: 256029
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | W81XWH-14-NFRP-CTA |
| Funding Opportunity Title: | DoD Neurofibromatosis Clinial Trial Award |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement Grant |
| Category of Funding Activity: | Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 2 |
| Assistance Listings: | 12.420 — Military Medical Research and Development |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | May 27, 2014 |
| Last Updated Date: | May 28, 2014 |
| Original Closing Date for Applications: | Jul 24, 2014 |
| Current Closing Date for Applications: | Jul 24, 2014 |
| Archive Date: | Aug 23, 2014 |
| Estimated Total Program Funding: | $2,880,000 |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility” |
| Additional Information on Eligibility: | – |
Additional Information
| Agency Name: | Dept. of the Army — USAMRAA |
| Description: | The NFRP Clinical Trial Award mechanism was first offered in FY99. Since then, 40 Clinical Trial Award applications have been received, and 11 have been recommended for funding.The NFRP Clinical Trial Award supports the rapid implementation of clinical trials with the potential to have a major impact on the treatment or management of NF. Clinical trials may be designed to evaluate promising new products, pharmacologic agents (drugs or biologics), devices, clinical guidance, and/or emerging approaches and technologies. Proposed projects may range from small proof-of-concept (i.e., pilot, first in human, or Phase 0) trials to demonstrate feasibility or inform the design of more advanced trials, through large-scale trials to determine efficacy in relevant patient populations.Funding from this award mechanism must support a clinical trial and may not be used for preclinical research studies. A clinical trial is defined as a prospective accrual of human subjects where an intervention (e.g., device, drug, biologic, surgical procedure, rehabilitative modality, behavioral intervention, or other) is tested on a human subject for a measurable outcome with respect to exploratory information, safety, effectiveness, and/or efficacy. This outcome represents a direct effect on the human subject of that intervention or interaction. Principal Investigators (PIs) seeking funding for a preclinical research project should consider one of the other award mechanisms/funding opportunities being offered. The term human subjects is used in this Program Announcement/Funding Opportunity to refer to individuals who will be recruited for or who will participate in the proposed clinical trial. For more information, a Human Subject Resource Document is provided at https://ebrap.org/eBRAP/public/Program.htm.For Pilot trials inclusion of scientific rationale and/or preliminary data relevant to the proposed pilot clinical trial is required.For Phase I, II trials, scientific rationale and preliminary data relevant to the proposed clinical trial are required. |
| Link to Additional Information: | – |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Phone: 301-682-5507
Email: help@eBRAP.org Email:help@eBRAP.org |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| Modification necessary to correct Estimated Total Program Funding. | May 28, 2014 | |
| May 28, 2014 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | W81XWH-14-NFRP-CTA |
| Funding Opportunity Title: | DoD Neurofibromatosis Clinial Trial Award |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement Grant |
| Category of Funding Activity: | Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 2 |
| Assistance Listings: | 12.420 — Military Medical Research and Development |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | May 27, 2014 |
| Last Updated Date: | May 28, 2014 |
| Original Closing Date for Applications: | Jul 24, 2014 |
| Current Closing Date for Applications: | Jul 24, 2014 |
| Archive Date: | Aug 23, 2014 |
| Estimated Total Program Funding: | $2,880,000 |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility” |
| Additional Information on Eligibility: | – |
Additional Information
| Agency Name: | Dept. of the Army — USAMRAA |
| Description: | The NFRP Clinical Trial Award mechanism was first offered in FY99. Since then, 40 Clinical Trial Award applications have been received, and 11 have been recommended for funding.The NFRP Clinical Trial Award supports the rapid implementation of clinical trials with the potential to have a major impact on the treatment or management of NF. Clinical trials may be designed to evaluate promising new products, pharmacologic agents (drugs or biologics), devices, clinical guidance, and/or emerging approaches and technologies. Proposed projects may range from small proof-of-concept (i.e., pilot, first in human, or Phase 0) trials to demonstrate feasibility or inform the design of more advanced trials, through large-scale trials to determine efficacy in relevant patient populations.Funding from this award mechanism must support a clinical trial and may not be used for preclinical research studies. A clinical trial is defined as a prospective accrual of human subjects where an intervention (e.g., device, drug, biologic, surgical procedure, rehabilitative modality, behavioral intervention, or other) is tested on a human subject for a measurable outcome with respect to exploratory information, safety, effectiveness, and/or efficacy. This outcome represents a direct effect on the human subject of that intervention or interaction. Principal Investigators (PIs) seeking funding for a preclinical research project should consider one of the other award mechanisms/funding opportunities being offered. The term human subjects is used in this Program Announcement/Funding Opportunity to refer to individuals who will be recruited for or who will participate in the proposed clinical trial. For more information, a Human Subject Resource Document is provided at https://ebrap.org/eBRAP/public/Program.htm.For Pilot trials inclusion of scientific rationale and/or preliminary data relevant to the proposed pilot clinical trial is required.For Phase I, II trials, scientific rationale and preliminary data relevant to the proposed clinical trial are required. |
| Link to Additional Information: | – |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Phone: 301-682-5507
Email: help@eBRAP.org Email:help@eBRAP.org |
DISPLAYING: Synopsis 1
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | W81XWH-14-NFRP-CTA |
| Funding Opportunity Title: | DoD Neurofibromatosis Clinial Trial Award |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement Grant |
| Category of Funding Activity: | Science and Technology and other Research and Development |
| Category Explanation: | – |
| Expected Number of Awards: | 2 |
| Assistance Listings: | 12.420 — Military Medical Research and Development |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | May 28, 2014 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Jul 24, 2014 |
| Archive Date: | Aug 23, 2014 |
| Estimated Total Program Funding: | $2,088,000 |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility” |
| Additional Information on Eligibility: | – |
Additional Information
| Agency Name: | Dept. of the Army — USAMRAA |
| Description: | The NFRP Clinical Trial Award mechanism was first offered in FY99. Since then, 40 Clinical Trial Award applications have been received, and 11 have been recommended for funding.
The NFRP Clinical Trial Award supports the rapid implementation of clinical trials with the potential to have a major impact on the treatment or management of NF. Clinical trials may be designed to evaluate promising new products, pharmacologic agents (drugs or biologics), devices, clinical guidance, and/or emerging approaches and technologies. Proposed projects may range from small proof-of-concept (i.e., pilot, first in human, or Phase 0) trials to demonstrate feasibility or inform the design of more advanced trials, through large-scale trials to determine efficacy in relevant patient populations. Funding from this award mechanism must support a clinical trial and may not be used for preclinical research studies. A clinical trial is defined as a prospective accrual of human subjects where an intervention (e.g., device, drug, biologic, surgical procedure, rehabilitative modality, behavioral intervention, or other) is tested on a human subject for a measurable outcome with respect to exploratory information, safety, effectiveness, and/or efficacy. This outcome represents a direct effect on the human subject of that intervention or interaction. Principal Investigators (PIs) seeking funding for a preclinical research project should consider one of the other award mechanisms/funding opportunities being offered. The term human subjects is used in this Program Announcement/Funding Opportunity to refer to individuals who will be recruited for or who will participate in the proposed clinical trial. For more information, a Human Subject Resource Document is provided at https://ebrap.org/eBRAP/public/Program.htm. For Pilot trials inclusion of scientific rationale and/or preliminary data relevant to the proposed pilot clinical trial is required. For Phase I, II trials, scientific rationale and preliminary data relevant to the proposed clinical trial are required. |
| Link to Additional Information: | – |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Phone: 301-682-5507
Email: help@eBRAP.org Email:help@eBRAP.org |
Related Documents
Folder 256029 Full Announcement-1 -> NFRP_FY14 CTA PA_GG.pdf
Folder 256029 Full Announcement-1 -> NFRP_FY14 CTA IND Documentation Form_ GG.pdf
Packages
| Agency Contact Information: | Phone: 301-682-5507 Email: help@eBRAP.org Email: help@eBRAP.org |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| 12.420 | PKG00197418 | May 27, 2014 | Jul 24, 2014 | View |
Package 1
Mandatory forms
256029 RR_SF424_2_0-2.0.pdf
256029 RR_Budget_1_3-1.3.pdf
256029 RR_KeyPersonExpanded_2_0-2.0.pdf
256029 PerformanceSite_2_0-2.0.pdf
Optional forms
256029 RR_SubawardBudget30_1_3-1.3.pdf
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