Opportunity Information: Apply for W81XWH 14 DMRDP CRMRP RMCTA
Apply for W81XWH 14 DMRDP CRMRP RMCTA
- The Dept. of the Army USAMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "Clinical and Rehabilitative Medicine Research Program Regenerative Medicine Clinical Trial 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 Oct 28, 2013 and posted on Oct 28, 2013.
- Applicants must submit their applications by Feb 11, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $11,100,000.00 to eligible and selected applicants.
- The number of recipients for this funding is limited to 5 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 Clinical and Rehabilitative Medicine Research Program (CRMRP) Regenerative Medicine Clinical Trial Award (RMCTA) is a FY14 funding opportunity from the Department of the Army (USAMRAA) under the Defense Medical Research and Development Program (DMRDP). It is designed specifically to fund Phase I or Phase II clinical trials in regenerative medicine and reconstruction, with an emphasis on conditions and injuries that matter to military service members and veterans. A central requirement is that the proposed work must be clinical trial research; award funds cannot be used to support preclinical studies, meaning applicants need to be ready to test an intervention in people rather than generate additional animal or laboratory proof-of-concept data.
The program is focused on four priority areas: extremity regeneration, craniomaxillofacial regeneration, vascularized composite allotransplantation (VCA), and genitourinary or lower abdomen reconstruction. In practical terms, this points to clinical trials aimed at restoring function and form after severe trauma or tissue loss, such as limb injuries, complex facial and jaw reconstruction needs, transplantation of composite tissues (for example, hand or face transplants that include multiple tissue types), and reconstruction needs involving the urinary or lower abdominal region. Applications must clearly align with at least one of these focus areas; proposals outside these topics would not be responsive to the intent of the award.
Military relevance is not optional. Every application must explicitly explain how the clinical trial addresses the health care needs of service members and veterans, even though the trial does not have to enroll military participants. This is an important distinction: the science and the clinical problem being addressed must be directly meaningful for military medicine and rehabilitation, but the study population can be civilian if the rationale for relevance is strong and clearly explained.
From an administrative standpoint, the opportunity was posted on October 28, 2013, with an application deadline of February 11, 2014, and an archive date of March 13, 2014. The funding opportunity number is W81XWH-14-DMRDP-CRMRP-RMCTA, and it falls under CFDA 12.420 (Military Medical Research and Development). The mechanism allows for funding as a cooperative agreement and/or a grant, indicating that, depending on the award structure, there may be varying levels of program involvement during the project period. The government anticipated making about five awards, with an estimated total funding pool of $11.1 million, and there is no cost sharing or matching requirement.
Eligibility was listed as unrestricted, meaning the opportunity was broadly open to different types of applicants (such as academic institutions, nonprofits, companies, and other organizations), subject to any additional eligibility language that might have appeared in the full announcement. For support accessing the full announcement, the posting provided a CDMRP Help Desk contact at 301-682-5507.
Regenerative Medicine Clinical Trial Award (RMCTA) - FAQ
1) What is the RMCTA funding opportunity?
The Regenerative Medicine Clinical Trial Award (RMCTA) is a FY14 funding opportunity under the Clinical and Rehabilitative Medicine Research Program (CRMRP), managed by the Department of the Army (USAMRAA) within the Defense Medical Research and Development Program (DMRDP). It is intended to support clinical trial research in regenerative medicine and reconstruction.
2) What types of studies does RMCTA fund?
This award is designed specifically to fund Phase I or Phase II clinical trials in regenerative medicine and reconstruction. A core requirement is that the proposed work must be clinical trial research (i.e., testing an intervention in people).
3) Are preclinical studies allowed under this award?
No. Award funds cannot be used to support preclinical studies. Applicants are expected to be ready to test an intervention in humans rather than generate additional animal or laboratory proof-of-concept data.
4) What are the program priority areas?
The RMCTA focuses on four priority areas:
- Extremity regeneration
- Craniomaxillofacial regeneration
- Vascularized composite allotransplantation (VCA)
- Genitourinary or lower abdomen reconstruction
5) Do applications have to fit within one of the four priority areas?
Yes. Applications must clearly align with at least one of the listed focus areas. Proposals outside these topics would not be responsive to the intent of the award.
6) What kinds of injuries or conditions are emphasized?
The emphasis is on conditions and injuries that matter to military service members and veterans, including restoration of function and form after severe trauma or tissue loss. Examples described include limb injuries, complex facial and jaw reconstruction needs, transplantation of composite tissues (such as hand or face transplants involving multiple tissue types), and reconstruction involving the urinary or lower abdominal region.
7) What does "military relevance" mean for this opportunity?
Military relevance is required. Each application must explicitly explain how the proposed clinical trial addresses the health care needs of service members and veterans. The clinical problem and rationale must be directly meaningful for military medicine and rehabilitation.
8) Do clinical trials have to enroll military service members or veterans?
No. The trial does not have to enroll military participants, but the application must clearly justify how the work is relevant to service members and veterans.
9) Who is the sponsoring/issuing organization?
The opportunity is from the Department of the Army (USAMRAA) under the Defense Medical Research and Development Program (DMRDP), within the CRMRP.
10) What is the funding opportunity number?
The funding opportunity number is W81XWH-14-DMRDP-CRMRP-RMCTA.
11) What CFDA program does this fall under?
This opportunity falls under CFDA 12.420 (Military Medical Research and Development).
12) What award mechanisms are used (grant vs cooperative agreement)?
The mechanism allows for funding as a cooperative agreement and/or a grant. This indicates that, depending on the award structure, there may be varying levels of program involvement during the project period.
13) How many awards were expected?
The government anticipated making about five awards.
14) What was the estimated total funding available?
The estimated total funding pool was $11.1 million.
15) Is cost sharing or matching required?
No. There is no cost sharing or matching requirement.
16) Who was eligible to apply?
Eligibility was listed as unrestricted, meaning the opportunity was broadly open to different types of applicants (such as academic institutions, nonprofits, companies, and other organizations), subject to any additional eligibility language that might have appeared in the full announcement.
17) When was the opportunity posted?
The opportunity was posted on October 28, 2013.
18) What was the application deadline?
The application deadline was February 11, 2014.
19) When was the archive date?
The archive date was March 13, 2014.
20) How can applicants get help accessing the full announcement?
For support accessing the full announcement, the posting provided the CDMRP Help Desk at 301-682-5507.
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