Department of Defense (DOD) Fiscal Year 2006 (FY06) Neurofibromatosis Research Program (NFRP) NF Consortium Award

The summary for the Department of Defense (DOD) Fiscal Year 2006 (FY06) Neurofibromatosis Research Program (NFRP) NF Consortium Award grant is detailed below. This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, and a sampling of similar government grants. Verify the accuracy of the data FederalGrants.com provides by visiting the webpage noted in the Link to Full Announcement section or by contacting the appropriate person listed as the Grant Announcement Contact. If any section is incomplete, please visit the website for the Dept of the Army USAMRAA, which is the U.S. government agency offering this grant.

Department of Defense (DOD) Fiscal Year 2006 (FY06) Neurofibromatosis Research Program (NFRP) NF Consortium Award: The FY06 NFRP NF Consortium Award will support a major goal/product-driven consortium of exceptional investigators to accelerate the clinical translation of basic NF1 research and ultimately decrease the overall impact of the disease. The consortium shall conceive, develop, and conduct collaborative pilot and Phase I and II clinical evaluations of promising therapeutic agents or approaches for the management or treatment of NF1. The consortium shall include 5 to 10 participant clinical research sites with clinical trials experience and multidisciplinary expertise in supporting NF1 clinical research. The consortium also shall have a single Operations Center responsible for providing operational and data management/analysis support to implement consortium protocols in a timely manner. Although there is also a critical need for better treatments for NF2 and Schwannomatosis, the FY06 NF Consortium Award is intended to fund an NF1 consortium. However, the funded consortium may expand to encompass NF2- and Schwannomatosis-directed studies at the discretion of its Governing Body and the USAMRMC. As stated in the FY05 NFRP NF Consortium Development Operations Center Award and FY05 NFRP NF Consortium Development Site Award program announcements, recipients of those awards must jointly compete for the FY06 NF Consortium Award. This mechanism is also open to any group of institutions that wishes to form an NF1 clinical consortium. A Letter of Intent (LOI) is required and must be submitted by March 7, 2006. All proposals must include at least one protocol for an NF1 therapeutic clinical trial (i.e., not a natural history study protocol) and associated clinical documents. Investigational New Drug (IND) and/or Institutional Review Board (IRB) approvals should be in process or completed before submission of the proposal to the NF Consortium Award mechanism. Clinical trials must begin within 6 months of the award date. If an IND or Investigational Device Exemption (IDE) is required, additional time may be granted. However, preference will be given to protocols that have US Food and Drug Administration (FDA) approval at the time the award is made. Please note that all DOD-funded research involving human subjects, human anatomical substances, and/or cadavers must be reviewed and approved by the USAMRMC Human Subjects Research Review Board (HSRRB) in addition to local IRBs. The HSRRB has different requirements than the local IRBs. The average time to obtain HSRRB approval is approximately 6 months. Therefore, it is strongly suggested that the applicant plan the budget and timeline accordingly. In addition to trials proposed as part of the FY06 NF Consortium Award submission, the consortium will be permitted at any time during the performance period of this award to submit additional clinical protocols for review and funding through the NFRP Clinical Trial Award mechanism and/or award mechanisms offered through other funding agencies. The NFRP Clinical Trial Award is expected to be openly competed each fiscal year pending receipt of appropriations by the NFRP. Please note that all clinical protocols funded through the NFRP Clinical Trial Award mechanism must receive local IRB and HSRRB approval before implementation by the consortium. The NFRP anticipates that the development, submission, review, and implementation of new clinical protocols by the consortium will be carried out as follows: . The Governing Body, which includes Principal Investigators (PIs) from each participating site, Operations Center representatives, and consumer advocates, will develop recommendations for new clinical trials based on proposals from participating sites and/or external institutions. Collaboration with institutions outside the consortium to develop and implement clinical trials is encouraged. . The Operations Center will coordinate and oversee the development of protocols and associated clinical documents for each proposed clinical trial. All protocols and associated documents will be presented to the Governing Body for internal review and approval before submission to the NFRP and/or other funding agency. The Operations Center also will coordinate the submission of protocols and related documents for IRB approval at participating institutions. . The Operations Center will prepare submissions to the NFRP Clinical Trial Award mechanism (pending the receipt of appropriations by the NFRP) and/or award mechanisms offered by other funding agencies. . The Governing Body will prioritize the proposals/protocols that were recommended for funding by the NFRP Integration Panel and/or other funding agency and prepare for their implementation as funding becomes available. After the initial 6 months of the performance period of the award, the consortium is expected to have two or more clinical trials open at any given time. In addition, the consortium is expected to present one or more clinical trials each year for consideration. Furthermore, each site should maintain accrual of 10 to 12 evaluable individuals with NF1 per year.