Opportunity Information: Apply for RFA AI 16 042

  • The HHS-NIH11 in the health sector is offering a public funding opportunity titled "Emerging Science and Technology in Transplantation (U01)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855, 93.856,.
  • This funding opportunity was created on Jun 10, 2016 and posted on Jun 10, 2016.
  • Applicants must submit their applications by Oct 20, 2016. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • Each selected applicant is eligible to receive up to $250,000.00 in funding.
  • Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For profit organizations other than small businesses, Small businesses, Others (see text field entitled Additional Information on Eligibility for clarification).
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Opportunity Summary:

Emerging Science and Technology in Transplantation (U01) is a National Institutes of Health (NIH) cooperative agreement funding opportunity (Funding Opportunity Number RFA-AI-16-042) designed to accelerate innovation in transplantation immunology. It is housed within the U.S. Department of Health and Human Services, NIH (listed as HHS-NIH11), and it supports participation in a cooperative research group rather than isolated, single-lab projects. The central idea is to bring new tools, methods, and cross-disciplinary teams into transplant immunology, especially approaches that have not yet been widely adopted in the field, with the goal of generating fresh insights into alloimmune responses and identifying new ways to prevent rejection and extend graft survival.

The FOA sets out three scientific priority areas that applications are expected to address. The first is microbiota, reflecting increasing recognition that commensal microbial communities can shape immune development and immune tone, potentially influencing transplant outcomes such as rejection risk, infection susceptibility, and responses to immunosuppressive therapy. Projects in this area would typically aim to clarify how microbiome composition or function affects alloimmunity, how transplant and immunosuppressive regimens alter microbial ecosystems, and whether microbial signatures or interventions could be leveraged to improve graft acceptance and long-term function.

The second priority area is intravital imaging, which emphasizes advanced live imaging techniques that allow researchers to observe immune cells and graft tissues in real time within living organisms. In transplantation, these methods can reveal dynamics that traditional static assays often miss, such as how immune cells traffic to the graft, how they interact with antigen-presenting cells, and how microanatomical features of the graft or lymphoid organs influence immune activation or tolerance. By encouraging intravital imaging, the FOA is pushing for more direct, mechanistic visualization of rejection and regulatory processes as they unfold, which can strengthen causal understanding and guide therapeutic strategy.

The third priority area is targeted therapeutic delivery, focusing on methods to deliver drugs, biologics, nucleic acids, or other immunomodulatory agents more precisely to relevant cells or tissues. This can include approaches such as nanoparticle or carrier-based systems, antibody-directed delivery, tissue-targeted formulations, local release platforms, or other engineering-driven strategies. The underlying aim is to improve efficacy while reducing systemic toxicity, which is a major limitation of broad immunosuppression. In a transplant context, better targeting could help control harmful alloimmune activity while preserving protective immunity, potentially reducing complications and improving long-term graft outcomes.

Mechanistically and administratively, this opportunity uses the Cooperative Agreement (U01) funding instrument. That structure generally indicates a more active partnership between NIH program staff and awardees compared with a standard research grant, often involving coordinated milestones, shared resources, common protocols, data sharing expectations, and group governance across multiple participating teams. The FOA explicitly frames the work as participation in a cooperative research group, signaling a strong emphasis on collaboration, alignment around common goals, and integration of expertise across fields such as immunology, microbiology, imaging science, bioengineering, and drug delivery.

In terms of who can apply, eligibility is broad and includes many types of domestic organizations: state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations both with and without 501(c)(3) status; for-profit organizations other than small businesses; and small businesses. The listing also includes an "Others" category with additional eligibility details referenced in the full announcement, which typically clarifies any special conditions or allowable organizational types.

The funding details provided in the source indicate an award ceiling of $250,000, and the activity category is Health. The CFDA numbers associated with the opportunity are 93.855 and 93.856, which correspond to NIH program areas tied to allergy, immunology, and infectious disease research portfolios. Key dates show the FOA was created and posted on June 10, 2016, with an application closing date of October 20, 2016 (the original and current closing dates are the same in the source data). While the excerpt does not specify the number of expected awards, the cooperative group design implies NIH was seeking a set of coordinated projects that collectively advance these emerging technology areas in transplantation immunology rather than a single standalone effort.

Overall, the opportunity is aimed at modernizing and expanding the transplantation immunology toolkit by pulling in high-impact technologies and building new interdisciplinary collaborations. By focusing on microbiota, intravital imaging, and targeted therapeutic delivery, the FOA highlights three complementary ways to understand and ultimately control alloimmune responses: mapping immune modulation by host-microbe interactions, directly observing immune behavior in living systems, and intervening with more precise, less toxic immunomodulatory delivery methods. The intended payoff is a clearer foundational understanding of rejection biology and more practical pathways toward therapies that preserve graft function for longer periods.

FAQs: Emerging Science and Technology in Transplantation (U01) - RFA-AI-16-042

What is the Emerging Science and Technology in Transplantation (U01) opportunity?

It is a National Institutes of Health (NIH) cooperative agreement funding opportunity designed to accelerate innovation in transplantation immunology by bringing new tools, methods, and cross-disciplinary teams into the field. The Funding Opportunity Number (FOA) is RFA-AI-16-042.

Which agency is offering this funding opportunity?

The opportunity is offered through the U.S. Department of Health and Human Services (HHS), National Institutes of Health (NIH), listed as HHS-NIH11.

What is the funding instrument or mechanism for this opportunity?

The funding instrument is a Cooperative Agreement (U01). This typically indicates substantial involvement and partnership with NIH program staff and an emphasis on coordinated efforts across multiple teams.

Is this intended for single-lab projects or collaborative group work?

This opportunity is framed as participation in a cooperative research group rather than isolated, single-lab projects. It emphasizes collaboration, shared goals, and integration of expertise across disciplines.

What is the primary purpose or goal of this FOA?

The goal is to modernize and expand the transplantation immunology toolkit by introducing approaches not yet widely adopted in the field, generating new insights into alloimmune responses, and identifying new ways to prevent rejection and extend graft survival.

What scientific areas does the FOA prioritize?

Applications are expected to address one or more of three priority areas: microbiota, intravital imaging, and targeted therapeutic delivery.

What does the microbiota priority area focus on?

The microbiota area reflects the idea that commensal microbial communities can influence immune development and immune tone, which may affect transplant outcomes. Projects in this area would typically explore how microbiome composition or function affects alloimmunity, how transplants and immunosuppressive regimens alter microbial ecosystems, and whether microbial signatures or interventions could be used to improve graft acceptance and long-term function.

What does the intravital imaging priority area focus on?

Intravital imaging emphasizes advanced live imaging techniques to observe immune cells and graft tissues in real time in living organisms. These approaches can help reveal dynamic processes relevant to transplantation, such as immune cell trafficking to the graft, interactions with antigen-presenting cells, and the influence of microanatomical features on immune activation or tolerance.

What does the targeted therapeutic delivery priority area focus on?

This area focuses on methods to deliver drugs, biologics, nucleic acids, or other immunomodulatory agents more precisely to relevant cells or tissues. Examples mentioned include nanoparticle or carrier-based systems, antibody-directed delivery, tissue-targeted formulations, and local release platforms, with the aim of improving efficacy and reducing systemic toxicity.

How does this FOA aim to improve transplant outcomes?

By advancing tools to (1) understand immune modulation through host-microbe interactions, (2) directly visualize immune behavior during rejection or regulation in living systems, and (3) intervene with more precise immunomodulatory delivery methods. The intended payoff is stronger understanding of rejection biology and clearer pathways toward therapies that preserve graft function longer.

What does "alloimmune responses" mean in the context of this FOA?

In this FOA, alloimmune responses refer to immune responses directed against a transplanted graft. Understanding these responses is central to preventing rejection and improving long-term graft survival.

What types of disciplines or expertise are encouraged for projects under this FOA?

The FOA highlights integration of expertise across fields such as immunology, microbiology, imaging science, bioengineering, and drug delivery, reflecting its cross-disciplinary and technology-driven emphasis.

What kinds of administrative and coordination features are implied by the U01 cooperative agreement structure?

The U01 structure generally implies active partnership with NIH program staff and coordinated project features such as shared resources, common protocols, data-sharing expectations, group governance, and potentially coordinated milestones across participating teams.

What is the award ceiling listed for this opportunity?

The source information indicates an award ceiling of $250,000.

What is the activity category for this funding opportunity?

The activity category is Health.

What CFDA numbers are associated with this FOA?

The CFDA numbers listed are 93.855 and 93.856, which are NIH program areas tied to allergy, immunology, and infectious disease research portfolios.

When was this FOA created and posted?

The FOA was created and posted on June 10, 2016.

What is the application due date for this FOA?

The application closing date is October 20, 2016 (the source shows the original and current closing dates as the same).

Does the provided information state how many awards NIH expects to make?

No. The excerpt does not specify the number of expected awards. However, the cooperative group design suggests NIH was seeking a coordinated set of projects rather than a single standalone effort.

Who is eligible to apply for this opportunity?

Eligibility is broad and includes: state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status; for-profit organizations other than small businesses; and small businesses. The listing also includes an "Others" category with additional eligibility details referenced in the full announcement.

Are small businesses eligible to apply?

Yes. Small businesses are listed among eligible applicants.

Are for-profit organizations eligible to apply?

Yes. For-profit organizations other than small businesses are listed among eligible applicants, and small businesses are also explicitly listed as eligible.

Are universities and colleges eligible to apply?

Yes. Public and state-controlled institutions of higher education and private institutions of higher education are listed as eligible.

Are government entities eligible to apply?

Yes. State, county, and local governments, special district governments, and independent school districts are listed as eligible.

Are tribal entities eligible to apply?

Yes. Federally recognized Native American tribal governments and other tribal organizations are listed as eligible.

Are nonprofit organizations eligible to apply?

Yes. Nonprofit organizations with 501(c)(3) status and nonprofit organizations without 501(c)(3) status are listed as eligible.

What makes this opportunity different from standard NIH research grants (based on the description provided)?

Based on the description, the key difference is the cooperative agreement (U01) structure and the explicit emphasis on participating in a cooperative research group. This implies a more coordinated, NIH-partnered, collaboration-heavy approach compared with isolated projects.

What kinds of outcomes or deliverables does the FOA appear to be aiming for?

The FOA aims for fresh mechanistic insights into alloimmune responses, improved ability to observe rejection and regulation in vivo, and development or application of more precise therapeutic delivery strategies that could reduce systemic toxicity and improve graft survival.

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