Department of Defense (DOD) Fiscal Year 2006 (FY06) Neurofibromatosis Research Program (NFRP) Clinical Tri.al Award

The summary for the Department of Defense (DOD) Fiscal Year 2006 (FY06) Neurofibromatosis Research Program (NFRP) Clinical Tri.al 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) Clinical Tri.al Award: The intent of the Clinical Trial Award is to sponsor clinical research with the potential to have a major impact on the treatment and/or management of NF1, NF2, and/or Schwannomatosis. Funding from this award mechanism cannot be used for preclinical research studies. Clinical Trial Awards will support Phase I and Phase II clinical trials (separate discussions are provided below for each type of clinical trial). Applicants must clearly specify in their proposals which type of clinical trial is being proposed, either Phase I or Phase II. Each proposal should contain only one clinical trial with a distinct study design. Clinical trials must begin within 6 months of the award date. If an Investigational New Drug (IND) or Investigational Device Exemption (IDE) is required, additional time may be granted. However, preference will be given to proposals that have U.S. Food and Drug Administration (FDA) approval at the time the award is made. Local Institutional Review Board (IRB) approvals should be in process or completed before submission of the proposal to the Clinical Trial Award mechanism. 1. Phase I Clinical Trials: These trials should focus on determining the safety, toxicity, tolerability, and pharmacokinetics/pharmacodynamics of new interventions or devices or treatment schedules in humans. It is expected that this award will allow the recipient the opportunity to obtain the data and experience necessary to conduct a Phase II clinical trial, if appropriate. Applicants for Phase I trials must include a clear scientific rationale for the trial as well as adequate preclinical supplemental data to support the feasibility of their hypotheses and approaches. Applicants must include a detailed plan for completing the Phase I trial during the performance period of the award and a clear experimental and appropriately powered statistical plan to perform the clinical trial. Phase I applicants are encouraged to pursue correlative studies. 2. Phase II Clinical Trials: These trials should focus on defining the efficacy of new interventions or devices. Applicants for Phase II clinical trials must include Phase I or pilot clinical trial data, adequate preclinical supplemental data to support the feasibility of their hypotheses and approaches, and a detailed plan for completion of the Phase II clinical trial during the award. Applicants also must include a clear experimental and appropriately powered statistical plan to perform the Phase II clinical trial. Applicants are encouraged to submit studies that further test the safety of a novel combination of agents before it is used on a larger number of participants in a Phase III clinical trial. Applicants also are encouraged to pursue correlative studies. If the trial is multi-institutional, applicants should include plans for communication and real-time data transfer between the collaborating institutions as well as how specimens and/or imaging products obtained during the study will be handled in the appropriate sections of the Clinical Protocol (see Subsection V.K). An intellectual and material property plan agreed upon by all participating institutions is also required for multi-institutional clinical trials as part of the Supporting Documentation (see Subsection V.L). 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 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
Federal Grant Title: Department of Defense (DOD) Fiscal Year 2006 (FY06) Neurofibromatosis Research Program (NFRP) Clinical Tri.al Award
Federal Agency Name: Dept of the Army USAMRAA
Grant Categories: Science and Technology
Type of Opportunity: Mandatory
Funding Opportunity Number: W81XWH-06-NFRP-CTA
Type of Funding: Grant Cooperative Agreement
CFDA Numbers: 12.420
CFDA Descriptions: Military Medical Research and Development
Current Application Deadline: No deadline provided
Original Application Deadline: Apr 25, 2006 Deadline for submittals is 5:00PM Ea
Posted Date: Feb 01, 2006
Creation Date: Feb 01, 2006
Archive Date: May 25, 2006
Total Program Funding: $3,000,000
Maximum Federal Grant Award:
Minimum Federal Grant Award:
Expected Number of Awards: 2
Cost Sharing or Matching: Yes
Applicants Eligible for this Grant
Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility"
Link to Full Grant Announcement
Information not provided
Grant Announcement Contact
Joseph Little
Specialist
Phone 301-619-2546 [email protected] Email for POC for this synopsis
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