The Department of Defense is offering the Neurofibromatosis Clinical Trial Award to support clinical research for the treatment of neurofibromatosis and Schwannomatosis. This grant does not fund preclinical research but focuses on addressing critical needs of the NF community, such as complications with high mortality or morbidity, refining imaging techniques, and translational research for therapeutic development. Applicants must propose a single clinical trial with a distinct study design, specifying the type of trial (Phase 0, Phase I, Phase II). Funding may be withdrawn if Investigational New Drug or Investigational Device Exemption approval is not obtained within 6 months of the award date. The proposed trial should commence within 12 months of the award date. Closing date for applications is April 14, 2009.
Opportunity ID: 44814
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | W81XWH-09-NFRP-CTA |
| Funding Opportunity Title: | DOD Neurofibromatosis Clinical 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: | Jan 20, 2009 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | Apr 14, 2009 |
| Current Closing Date for Applications: | Apr 14, 2009 |
| Archive Date: | May 14, 2009 |
| Estimated Total Program Funding: | $2,200,000 |
| 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 (CTA) mechanism was first offered in FY99. Since that time, 21 Clinical Trial Award proposals have been received, and 5 have been recommended for funding. The NFRP CTA supports clinical research with the potential to have a major impact on the treatment or management of neurofibromatosis and/or Schwannomatosis. Funding from this award mechanism cannot be used for preclinical research studies. PIs seeking funding for a preclinical research project should apply to the Investigator-Initiated Research Award mechanism. Areas of Encouragement (Revised for FY09): The FY09 NFRP encourages research proposals that specifically address the critical needs of the NF community in the following areas: Complications of NF with high mortality such as neoplasms and cerebrovascular abnormalities; DOD Neurofibromatosis Clinical Trial Award 3 Complications of NF with high morbidity such as skeletal maladies, learning deficits, hormone-associated effects, and pain; Refinement and standardization of imaging techniques, molecular and cellular markers, and quality of life metrics for use in future clinical trials; and Translational research such as the development or preclinical testing of therapeutic agents for the treatment of NF. Each application should contain only one clinical trial with a distinct study design. Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications should be submitted or approved prior to application submission. The Government reserves the right to withdraw funding if IND/IDE approval is not received within 6 months of the award date. Principal Investigators (PIs) must clearly specify in the Clinical Protocol (main body of the application) which type of clinical trial is being proposed: Phase 0, Phase I, Phase II, or a combination. For descriptions of each type of clinical trial, please refer to www.fda.gov/cder/guidance/6384dft.htm and http://www.clinicaltrials.gov. Refer to the Application Instructions and General Information, Appendix 6, for helpful information about distinguishing clinical trials and clinical research. The proposed clinical trial is expected to begin within 12 months of the award date. See the Program Announcement for the full Funding Opportunity Description. |
| Link to Additional Information: | – |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
PA HELP: 301-619-7079; cdmrp.pa@amedd.army.mil
eReceipt HELP: 301-682-5507; help@cdmrp.org Email:cdmrp.pa@amedd.army.mil |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
Folder 44814 Full Announcement-1 -> NF09 CTA_PA FINAL 20 JAN 09.pdf
Folder 44814 Full Announcement-1 -> biosketch.pdf
Folder 44814 Full Announcement-1 -> Budget Form Reader.pdf
Packages
| Agency Contact Information: | PA HELP: 301-619-7079; cdmrp.pa@amedd.army.mil eReceipt HELP: 301-682-5507; help@cdmrp.org Email: cdmrp.pa@amedd.army.mil |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| 12.420 | PKG00010071 | Jan 20, 2009 | Apr 14, 2009 | View |
Package 1
Mandatory forms
44814 RR_SF424-1.1.pdf
44814 RR_PerformanceSite-1.1.pdf
44814 RR_KeyPersonExpanded-1.1.pdf
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