Department of Defense Traumatic Brain Injury Advanced Technology - Therapeutic Development Award

The summary for the Department of Defense Traumatic Brain Injury Advanced Technology - Therapeutic Development 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 Traumatic Brain Injury Advanced Technology - Therapeutic Development Award: The Traumatic Brain Injury (TBI) Advanced Technology - Therapeutic Development Award supports demonstration studies of pharmaceuticals (drugs, biologics, and vaccines) and medical devices in preclinical systems and/or the testing of therapeutics and devices in clinical studies. The intent of the TBI Advanced Technology - Therapeutic Development Award is to assess therapeutics and devices for the treatment, prevention, detection, and diagnosis for TBI.The overall goal of this award mechanism is to accelerate the introduction of improved therapies for TBI into the clinical setting by supporting (1) the generation of the preclinical data (e.g., Good Laboratory Practice [GLP] animal safety and toxicity, identifying endpoints of clinical efficacy or its surrogate in animal models, and data collection sufficient to support an investigational new drug [IND] or investigational device exemption [IDE] application) necessary to conduct clinical trials after completion of the proposed research and/or (2) the generation of safety and/or efficacy data (e.g., Phase I or Phase I/II clinical studies) on therapeutics and devices in clinical trials. The proposed studies are expected to be empirical in nature and product-driven and are expected to be at or beyond Biomedical Technology Readiness Level (TRL) 5 (for descriptions of TRL(s) please see pp 126-138 of the document located at http://www.ceros.org/documents/TRA_Deskbook).Proposals must include preliminary and/or published data relevant to the development process covered by the research in their proposals. Applicants must explain clearly how the proposed products are directly relevant and applicable to proposed or future clinical studies for individuals with TBI. Successful TBI Advanced Technology - Therapeutic Development Award proposals will clearly outline the necessary steps to ultimately provide military-relevant health products or technologies positioned for advanced development that target TBI prevention, detection/diagnosis, and treatment. A plan for further product or technology development and/or transition to advanced development (including potential funding and resources) is required. It is envisioned that access to Active Duty, National Guard, Reserve troops, and/or Military patient populations will be coordinated through a centralized DOD coordinating office, to be established prior to final recommendation of proposals for funding. Research proposal submissions that include Active duty, National Guard, Reserve troops, and/or Military patient populations must be accompanied by a Clinical Protocol (Appendix 7). Those proposals that score favorably during the scientific peer review and require access to Military patient populations will be forwarded to the centralized DOD coordinating office for consideration and review for availability and access to military patient populations prior to being recommended for funding. Please do not contact any Commander of Active duty, National Guard, Reserve troops and/or Military patient populations at this time or during preparation of your proposal submission. However we highly encourage you to collaborate with military researchers and clinicians. Access to Military populations will be handled by the coordinating center only. If selected for funding you will be provided guidance on how to obtain access to the appropriate population. Submissions that propose to recruit patients from Department of Veterans Affairs (VA) Medical Centers or use information from VA data systems must include an investigator with a VA appointment. This individual may be the principal investigator for the entire proposal or a VA collaborator willing to assume the role of principal VA investigator for the VA component of the proposal.Currently, there is a very limited ability to conduct human research in the CENTCOM Area of Responsibility. At present, this capability exists solely within select elements of the Multi-National Corps Iraq (MNC-I). There is no ability to conduct human research in Afghanistan at present. All research conducted within MNC-I must be in collaboration with an in theatre military investigator, undergo an in theatre review, and be approved by the MNC-I Command and the MNC-I designated Institutional Review Board. Given the constraints of wartime operations, investigators without an ongoing collaboration with a military investigator should strongly consider alternatives to the conduct of research in the wartime theatre. Note: DOD-supported human subjects research can only be conducted by institutions (to include those in theatre) with approved Federal Assurances of Compliance from Human Research Protection. It is strongly suggested that PTSD and TBI research involve civilian and non-deployed military trauma populations.
Federal Grant Title: Department of Defense Traumatic Brain Injury Advanced Technology - Therapeutic Development Award
Federal Agency Name: Dept of the Army USAMRAA
Grant Categories: Science and Technology
Type of Opportunity: Discretionary
Funding Opportunity Number: W81XWH-07-TBI-AT-TDA
Type of Funding: Cooperative Agreement Grant
CFDA Numbers: 12.420
CFDA Descriptions: Military Medical Research and Development
Current Application Deadline: No deadline provided
Original Application Deadline: Nov 13, 2007
Posted Date: Jul 24, 2007
Creation Date: Nov 09, 2007
Archive Date: Dec 13, 2007
Total Program Funding: $8,000,000
Maximum Federal Grant Award:
Minimum Federal Grant Award:
Expected Number of Awards: 2
Cost Sharing or Matching: No
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"
Grant Announcement Contact
Pam Fisher
Grants Officer
Phone 301-619-2805 [email protected] Contracting/Grant Officer
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