Opportunity Information: Apply for W81XWH 09 DMRDP ARATDA
Apply for W81XWH 09 DMRDP ARATDA
- The Dept. of the Army USAMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "Defense Medical Research and Development Program Applied Research and Advanced Technology Development Award" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 12.420 Military Medical Research and Development.
- This funding opportunity was created on Nov 23, 2009 and posted on Aug 27, 2009.
- Applicants must submit their applications by Dec 18, 2009. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $97,000,000.00 to eligible and selected applicants.
- The number of recipients for this funding is limited to 100 candidate(s).
- Eligible applicants include: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled Additional Information on Eligibility.
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Opportunity Summary:
The Defense Medical Research and Development Program (DMRDP) Applied Research and Advanced Technology Development Award (ARATDA) is a FY10 funding opportunity from the Department of the Army (USAMRAA) meant to push military-relevant medical solutions closer to real-world use. It was offered for the first time in FY10 and is designed to support applied research and early advanced development work that can realistically translate into better care for service members, especially for battlefield-related injuries and conditions. The program’s emphasis areas include post-traumatic stress disorder (PTSD), traumatic brain injury (TBI), prosthetics and rehabilitation needs, and restoration of eyesight/advancing eye care, along with other conditions tied directly to combat injuries and Joint Force Health Protection (JFHP) capability needs.
The focus is strictly on moving promising concepts toward feasible, deployable solutions rather than exploring basic scientific questions. In the language of the announcement, “applied research” means refining concepts into practical solutions and evaluating whether they are technically feasible, while “advanced technology development” means building and maturing candidate solutions and early prototype components until they are ready for test and evaluation in human studies or other relevant operational environments. The intent is that projects should end with deliverables positioned for human testing, such as candidate therapeutics, devices, diagnostics, clinical guidance, training or medical information systems, or other emerging technologies with a credible path toward deployment.
A key boundary is that while the awards may support human studies, they cannot fund clinical trials, and they cannot be used for fundamental basic research. Applicants are expected to already have preliminary and/or published data that supports the project’s hypothesis and aims, reinforcing that this mechanism is for work beyond early discovery. The supported work can include activities like developing and validating clinical guidance through data collection and analysis, developing new behavioral or rehabilitation interventions, preclinical testing of drugs/biologics (including ADME/tox and GLP studies) up to an Investigational New Drug (IND) stage, prototype device development up to an Investigational Device Exemption (IDE) stage, assay and reagent validation, pilot Good Manufacturing Practice (GMP) production efforts, and optimization of diagnostics or countermeasures for field deployment.
Funding is provided only through assistance agreements (grants and cooperative agreements). The total FY10 funding anticipated for applied research and advanced technology development across DMRDP was about $97 million, with the Government reserving the right to increase or decrease that amount. The announcement anticipated around 100 awards and carried no cost-sharing requirement. There was no stated award ceiling or floor in the summarized listing. The CFDA number is 12.420 (Military Medical Research and Development). The opportunity was posted August 27, 2009, and closed December 18, 2009 (archive date January 17, 2010).
Eligibility was broadly “unrestricted” by entity type, but the competition itself was intended for extramural investigators only (meaning non-DoD employees outside DoD laboratories/medical treatment facilities and non-DoD activities embedded in civilian medical centers). Intramural DoD investigators could participate as collaborators on an extramural submission, but the application had to include authorization from the intramural collaborator’s Commander or Commanding Officer.
The program is tightly scoped: every application must directly address one of the specific FY10 DMRDP Projects and one of the listed Tasks under that project area, and submissions outside those defined needs were not allowed and could be administratively withdrawn. The Government also reserved the right to reassign an application to the correct Project/Task area if it was submitted under the wrong one.
The five FY10 Project areas are: (1) Diagnosis and Treatment of Brain Injury, (2) Polytrauma and Blast Injury, (3) Operational Health and Performance, (4) Rehabilitation, and (5) Psychological Health and Well Being for Military Personnel and Families. Within these, the Tasks cover a wide range of near-term, operationally grounded needs. For TBI, priorities include identifying and characterizing mechanisms of TBI, developing far-forward deployable tools to diagnose and treat TBI (including noninvasive diagnostics and neuroprotective agents), and improving early clinical management practices. For Polytrauma and Blast Injury, the scope includes hemorrhage control and coagulopathy interventions aimed at FDA-approved and logistically supportable solutions; approaches to maintain tissue viability (such as blood substitutes/expanders); improved first-responder diagnostics and life support decision tools; advanced reconstruction for maxillofacial injuries; improved systems and practices for evacuation and aeromedical transport (including closed-loop life support delivery and litter technologies); portable forward surgical applications; integrated blast injury models and performance standards for protection systems; scar contracture mitigation; ocular and visual system injury treatments and drug delivery; a rapid handheld nucleic-acid-based whole blood screening system (initially focusing on hepatitis B and C, then HIV 1/2 and other pathogens); and extensive wound infection and antimicrobial countermeasure work that prioritizes practical, topical treatments and discourages broad drug screening campaigns.
For Operational Health and Performance, the Tasks emphasize predictive models and standards related to musculoskeletal injury and load carriage, interactions between nutrition/dietary supplements and medications or medical events, performance sustainment in extreme environments (heat, cold, altitude) including predictive altitude illness models and potential preventive/early treatment pharmaceuticals, and improvements to post-deployment longitudinal cohort study criteria and design to better capture long-term risks and protective factors. For Rehabilitation, priorities include complex neuromusculoskeletal injury rehabilitation (including cases with TBI/PTSD comorbidities), return-to-duty and community reintegration outcome measures, amputee technologies and residual limb health, fitness and exercise systems for amputees, heterotopic ossification prevention, chronic pain best practices and objective diagnostics tied to traumatic/war-related injuries, selected regenerative medicine applications (excluding CNS/spinal cord repair and excluding infection control), and restoration/rehabilitation of sensory system injuries affecting vision, hearing, and balance. For Psychological Health and Well Being, Tasks include suicide prevention tools and standardized intake criteria, improved cognitive-behavioral interventions for suicidality, accelerated cognitive behavioral therapy approaches for combat-related PTSD, methods to prevent health risk behaviors and address PTSD with comorbidities (depression, anger, grief, guilt), resilience-building approaches (including complementary methods such as yoga and positive psychology), and evidence-based programs that strengthen military family and community resilience during deployment and separation.
Overall, ARATDA is a translation-focused mechanism aimed at turning credible, data-supported medical ideas into mature candidates that can move into later-stage human testing pathways, with strong preference for solutions that can work in far-forward, resource-constrained military settings. Separate future DMRDP announcements were expected to cover the gaps this mechanism explicitly excludes, particularly clinical trials and fundamental basic research.
FAQs: DMRDP Applied Research and Advanced Technology Development Award (ARATDA) (FY10)
What is the DMRDP ARATDA (FY10) grant opportunity?
The Defense Medical Research and Development Program (DMRDP) Applied Research and Advanced Technology Development Award (ARATDA) is a FY10 Department of the Army (USAMRAA) funding opportunity designed to move military-relevant medical solutions closer to real-world use. It focuses on applied research and early advanced development that can translate into improved care for service members, particularly for battlefield-related injuries and conditions.
What is the main goal of this award mechanism?
The goal is translation: advancing promising, data-supported concepts into feasible, deployable solutions. Projects are expected to end with tangible deliverables positioned for later-stage test and evaluation (for example, readiness for human studies), rather than generating basic scientific knowledge.
Is this opportunity intended for basic research?
No. The announcement specifically excludes fundamental basic research. The mechanism is intended for work beyond early discovery, supported by preliminary and/or published data.
Are clinical trials allowed under this award?
No. While the awards may support human studies, they cannot fund clinical trials.
What does "applied research" mean in this announcement?
In this opportunity, applied research means refining concepts into practical solutions and evaluating technical feasibility, with a clear focus on translation toward real-world use.
What does "advanced technology development" mean in this announcement?
Advanced technology development refers to building and maturing candidate solutions and early prototype components until they are ready for test and evaluation in human studies or other relevant operational environments.
What kinds of deliverables are projects expected to produce?
Projects are intended to conclude with deliverables positioned for human testing pathways, such as candidate therapeutics, devices, diagnostics, clinical guidance, training tools, medical information systems, or other emerging technologies with a credible path toward deployment.
What topic areas does the program emphasize?
Key emphasis areas include post-traumatic stress disorder (PTSD), traumatic brain injury (TBI), prosthetics and rehabilitation needs, and restoration of eyesight/advancing eye care, as well as other conditions tied directly to combat injuries and Joint Force Health Protection (JFHP) capability needs.
What are the five FY10 DMRDP Project areas applicants must align with?
The five FY10 Project areas are: (1) Diagnosis and Treatment of Brain Injury, (2) Polytrauma and Blast Injury, (3) Operational Health and Performance, (4) Rehabilitation, and (5) Psychological Health and Well Being for Military Personnel and Families.
Do applicants need to align to specific Projects and Tasks?
Yes. Every application must directly address one specific FY10 DMRDP Project area and one of the listed Tasks under that Project area. Submissions that do not fit the defined needs were not allowed and could be administratively withdrawn.
What happens if an application is submitted under the wrong Project/Task area?
The Government reserved the right to reassign an application to the correct Project/Task area if it was submitted under the wrong one.
What types of activities are supported by ARATDA?
Supported activities include development and validation of clinical guidance (through data collection and analysis), development of new behavioral or rehabilitation interventions, preclinical testing of drugs/biologics (including ADME/tox and GLP studies) up to an IND stage, prototype device development up to an IDE stage, assay and reagent validation, pilot GMP production efforts, and optimization of diagnostics or countermeasures for field deployment.
Does the announcement support work leading up to IND or IDE milestones?
Yes. The opportunity explicitly includes preclinical drug/biologic testing up to an Investigational New Drug (IND) stage and prototype device development up to an Investigational Device Exemption (IDE) stage.
Does the opportunity support GMP-related work?
Yes. Pilot Good Manufacturing Practice (GMP) production efforts are listed among the types of supported activities.
What funding instruments are used for this opportunity?
Funding is provided only through assistance agreements, specifically grants and cooperative agreements.
What was the anticipated total funding for FY10 applied research and advanced technology development in DMRDP?
The anticipated total FY10 funding across DMRDP for applied research and advanced technology development was about $97 million, with the Government reserving the right to increase or decrease that amount.
How many awards were anticipated?
The announcement anticipated around 100 awards.
Was cost sharing required?
No. The announcement stated there was no cost-sharing requirement.
Was there a stated minimum or maximum award amount?
No award ceiling or floor was stated in the summarized listing provided.
What is the CFDA number for this program?
The CFDA number is 12.420 (Military Medical Research and Development).
When was the opportunity posted and when did it close?
The opportunity was posted on August 27, 2009, and it closed on December 18, 2009 (archive date January 17, 2010).
Who was eligible to apply?
Eligibility was described as broadly "unrestricted" by entity type, but the competition was intended for extramural investigators only.
What does "extramural investigators only" mean here?
It refers to non-DoD employees outside DoD laboratories/medical treatment facilities and non-DoD activities embedded in civilian medical centers. In other words, the submission must be led extramurally.
Can intramural DoD investigators participate?
Yes. Intramural DoD investigators could participate as collaborators on an extramural submission, but the application had to include authorization from the intramural collaborator's Commander or Commanding Officer.
What are some example priorities within the TBI-related Project area?
Priorities include identifying and characterizing mechanisms of TBI; developing far-forward, deployable tools to diagnose and treat TBI (including noninvasive diagnostics and neuroprotective agents); and improving early clinical management practices.
What are some example priorities within Polytrauma and Blast Injury?
Examples include hemorrhage control and coagulopathy interventions aimed at FDA-approved and logistically supportable solutions; approaches to maintain tissue viability (such as blood substitutes/expanders); improved first-responder diagnostics and life-support decision tools; advanced reconstruction for maxillofacial injuries; improved evacuation and aeromedical transport systems (including closed-loop life support delivery and litter technologies); portable forward surgical applications; integrated blast injury models and performance standards for protection systems; scar contracture mitigation; ocular and visual system injury treatments and drug delivery; development of a rapid handheld nucleic-acid-based whole blood screening system; and wound infection and antimicrobial countermeasure work emphasizing practical topical treatments and discouraging broad drug screening campaigns.
What pathogens were highlighted for the handheld blood screening system task?
The initial focus was on hepatitis B and C, followed by HIV 1/2 and other pathogens.
What are some example priorities within Operational Health and Performance?
Tasks emphasize predictive models and standards related to musculoskeletal injury and load carriage; interactions between nutrition/dietary supplements and medications or medical events; performance sustainment in extreme environments (heat, cold, altitude) including predictive altitude illness models and potential preventive/early treatment pharmaceuticals; and improvements to post-deployment longitudinal cohort study criteria and design to better capture long-term risks and protective factors.
What are some example priorities within Rehabilitation?
Priorities include rehabilitation for complex neuromusculoskeletal injuries (including cases with TBI/PTSD comorbidities); return-to-duty and community reintegration outcome measures; amputee technologies and residual limb health; fitness and exercise systems for amputees; heterotopic ossification prevention; chronic pain best practices and objective diagnostics tied to traumatic/war-related injuries; selected regenerative medicine applications (excluding CNS/spinal cord repair and excluding infection control); and restoration/rehabilitation of sensory system injuries affecting vision, hearing, and balance.
Are there explicit exclusions within Rehabilitation priorities?
Yes. The regenerative medicine scope explicitly excludes CNS/spinal cord repair and excludes infection control.
What are some example priorities within Psychological Health and Well Being?
Tasks include suicide prevention tools and standardized intake criteria; improved cognitive-behavioral interventions for suicidality; accelerated cognitive behavioral therapy approaches for combat-related PTSD; methods to prevent health risk behaviors and address PTSD with comorbidities (including depression, anger, grief, and guilt); resilience-building approaches (including complementary methods such as yoga and positive psychology); and evidence-based programs strengthening military family and community resilience during deployment and separation.
How important is "far-forward" or resource-constrained usability?
The opportunity expresses a strong preference for solutions that can work in far-forward, resource-constrained military settings, reflecting the operational focus of the Tasks and the emphasis on deployability.
What stage of research is this award intended to support?
This award is intended for applied research and early advanced development, where concepts are already supported by preliminary and/or published data and are ready to be refined, matured, and positioned for later-stage human testing pathways.
What did the announcement suggest about future opportunities for clinical trials or basic research?
Separate future DMRDP announcements were expected to cover gaps explicitly excluded by this mechanism, particularly clinical trials and fundamental basic research.
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