Opportunity Information: Apply for W81XWH 13 AFIRM IIRP
Apply for W81XWH 13 AFIRM IIRP
- The Dept. of the Army USAMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "Armed Forces Institute of Regenerative Medicine II (AFIRM II)" 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 Apr 16, 2012 and posted on Apr 16, 2012.
- Applicants must submit their applications by Jul 11, 2012. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $75,000,000.00 to eligible and selected applicants.
- The number of recipients for this funding is limited to 2 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 Armed Forces Institute of Regenerative Medicine II (AFIRM II) is a U.S. Army-funded research program focused on developing regenerative medicine solutions for severe battlefield injuries. The central purpose is to improve recovery and restoration for traumatically injured service members, especially Wounded Warriors, while also generating treatments and technologies that can translate to civilian trauma care. A key program objective is to move promising regenerative medicine approaches far enough along the development pathway that they are ready to enter, or be positioned to enter, human clinical testing.
AFIRM II is designed to support a spectrum of work from basic science through translational research and early clinical development. Funded activities can include foundational laboratory studies, creation and refinement of relevant animal models, and the preclinical testing needed to support an FDA-regulated investigational pathway. The program can also include Phase I and Phase II human clinical trials, but it is explicit that large-scale clinical testing is not intended to be the main thrust of this funding. In other words, AFIRM II emphasizes building the scientific and preclinical evidence base and advancing candidate therapies to the point where clinical evaluation becomes feasible, rather than primarily paying for clinical trials as the dominant activity.
A defining feature of the opportunity is its expectation of integration across disciplines and stages of development. Applicants are expected to connect basic researchers, translational scientists, and clinicians in a coordinated way so that discoveries can more efficiently mature into treatments for combat-related injuries. This reflects the practical nature of regenerative medicine for trauma, where progress often depends on aligning mechanism-focused science, engineering or biomaterials development, clinically relevant models, manufacturing considerations, and the regulatory requirements that govern human use.
The announcement also strongly pushes applicants to plan for real-world transition and eventual FDA approval. Offeror organizations are encouraged to actively seek and form partnerships with industry so that innovations are not stranded in academic or laboratory settings. The intent is that industry involvement helps drive scalable development, quality systems, manufacturing, regulatory strategy, and commercialization pathways that increase the likelihood that successful advances become deployable, FDA-approved medical products or clinically adopted restorative practices.
Collaboration with government laboratories and military or federal medical centers is encouraged when it strengthens the work. The opportunity specifically mentions potential collaboration with facilities and organizations in the Army, Navy, Air Force, NIH, and the Department of Veterans Affairs (VA), recognizing that these settings can provide unique expertise, patient populations, clinical insight, infrastructure, and mission-relevant perspectives that support translation of therapies aimed at combat injury repair.
Administratively, this opportunity (Funding Opportunity Number W81XWH-13-AFIRM-IIRP) was offered by the Department of the Army through USAMRAA and categorized under Science and Technology and other Research and Development. The funding instrument is listed as a cooperative agreement/grant, indicating that the government may have substantial involvement during the performance period compared to a standard grant. The program anticipated making 2 awards with an estimated total funding level of $75,000,000. There is no cost-sharing or matching requirement indicated. Eligibility is described as unrestricted, meaning it is broadly open to many entity types (subject to any additional eligibility clarifications in the full announcement).
Key dates in the posted source information include a posted and creation date of April 16, 2012, an original and current closing date of July 11, 2012, and an archive date of August 10, 2012. The listing is associated with CFDA number 12.420 (Military Medical Research and Development). For applicant support, the announcement points to the CDMRP Help Desk and provides phone and email contacts for assistance with accessing the full announcement and with electronic submission issues.
AFIRM II (W81XWH-13-AFIRM-IIRP) Frequently Asked Questions (FAQs)
1) What is AFIRM II?
The Armed Forces Institute of Regenerative Medicine II (AFIRM II) is a U.S. Army-funded research program focused on developing regenerative medicine solutions for severe battlefield injuries. Its purpose is to improve recovery and restoration for traumatically injured service members, including Wounded Warriors, while also generating treatments and technologies that can translate to civilian trauma care.
2) What is the main goal of this funding opportunity?
A central objective is to advance promising regenerative medicine approaches far enough along the development pathway that they are ready to enter, or are positioned to enter, human clinical testing. The emphasis is on building the scientific and preclinical evidence base and enabling a credible, FDA-regulated investigational pathway.
3) What kinds of research does AFIRM II support?
AFIRM II is designed to support a spectrum of work from basic science through translational research and early clinical development. Funded activities can include foundational laboratory studies, creation and refinement of relevant animal models, and preclinical testing needed to support an FDA-regulated investigational pathway.
4) Are human clinical trials allowed under AFIRM II?
Yes. The program can include Phase I and Phase II human clinical trials. However, large-scale clinical testing is not intended to be the main thrust of this funding.
5) Does AFIRM II primarily fund large clinical trials?
No. The program explicitly states that large-scale clinical testing is not intended to be the dominant activity. AFIRM II emphasizes advancing candidate therapies to the point where clinical evaluation becomes feasible, rather than primarily paying for clinical trials as the primary focus.
6) What does the program mean by "integration across disciplines and stages of development"?
The opportunity expects coordinated work that connects basic researchers, translational scientists, and clinicians so discoveries can mature into treatments more efficiently. This reflects the practical requirements of regenerative medicine for trauma, where progress often depends on aligning mechanism-focused science, engineering or biomaterials development, clinically relevant models, manufacturing considerations, and regulatory requirements for human use.
7) Is planning for FDA approval and real-world transition expected?
Yes. The announcement strongly encourages applicants to plan for real-world transition and eventual FDA approval, including development considerations that support deployable, FDA-approved medical products or clinically adopted restorative practices.
8) Are partnerships with industry encouraged?
Yes. Offeror organizations are encouraged to actively seek and form partnerships with industry so innovations do not remain confined to academic or laboratory settings. The intent is for industry involvement to support scalable development, quality systems, manufacturing, regulatory strategy, and commercialization pathways.
9) Are collaborations with government laboratories or federal medical centers encouraged?
Yes. Collaboration with government laboratories and military or federal medical centers is encouraged when it strengthens the work. The opportunity specifically notes potential collaboration with facilities and organizations in the Army, Navy, Air Force, NIH, and the Department of Veterans Affairs (VA).
10) Why does AFIRM II encourage collaborations with military and federal health organizations?
These settings can provide unique expertise, mission-relevant perspectives, infrastructure, clinical insight, and potentially relevant patient populations that support translation of therapies aimed at combat injury repair.
11) Who is the funding agency for this opportunity?
The opportunity was offered by the Department of the Army through USAMRAA (U.S. Army Medical Research Acquisition Activity).
12) What is the Funding Opportunity Number for AFIRM II?
The Funding Opportunity Number is W81XWH-13-AFIRM-IIRP.
13) What is the assistance listing or CFDA number associated with this opportunity?
The listing is associated with CFDA number 12.420 (Military Medical Research and Development).
14) What type of funding instrument is used?
The funding instrument is listed as a cooperative agreement/grant. This indicates the government may have substantial involvement during the performance period compared to a standard grant.
15) How many awards were anticipated, and what was the estimated total funding?
The program anticipated making 2 awards with an estimated total funding level of $75,000,000.
16) Is cost sharing or matching required?
No cost-sharing or matching requirement is indicated in the provided information.
17) Who is eligible to apply?
Eligibility is described as unrestricted, meaning it is broadly open to many entity types, subject to any additional eligibility clarifications in the full announcement.
18) What category is this opportunity listed under?
It is categorized under Science and Technology and other Research and Development.
19) What were the key dates for this opportunity?
The posted and creation date was April 16, 2012. The original and current closing date was July 11, 2012. The archive date was August 10, 2012.
20) Where can applicants get help with the application or submission process?
For applicant support, the announcement points to the CDMRP Help Desk and provides phone and email contacts for assistance with accessing the full announcement and with electronic submission issues.
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