Opportunity Information: Apply for RFA DE 19 010
The Limited Competition: Dental, Oral and Craniofacial Tissue Regeneration Consortium (DOCTRC) funding opportunity (RFA-DE-19-010) is a National Institutes of Health cooperative agreement (U24; clinical trial not allowed) from the Department of Health and Human Services. Its central goal is to support the operation of an established, multidisciplinary consortium designed to move promising approaches for regenerating and reconstructing dental, oral, and craniofacial (DOC) tissues along the translational pipeline so they are ready to enter clinical trials. In practical terms, the award is meant to strengthen and coordinate the infrastructure, expertise, and shared resources that help multiple research projects clear key preclinical and regulatory hurdles on the path to first-in-human testing, without directly funding or conducting clinical trials under this mechanism.
This FOA specifically targets Stage 3 of the DOCTRC effort. Rather than building a brand-new consortium from scratch, it supports continued operation of Resource Centers (RCs) and their associated Interdisciplinary Translational Projects (ITPs) that were developed during Stage 2. The idea is that the core teams and project portfolios already exist, and Stage 3 funding is focused on execution: using centralized capabilities to accelerate progress, improve rigor and reproducibility, and reduce avoidable delays that commonly occur when tissue regeneration technologies transition from academic proof-of-concept to clinically viable products or procedures.
A defining feature of the opportunity is the consortium model anchored by Resource Centers. These RCs are expected to provide the technical support and research capacity that individual translational projects often cannot efficiently assemble on their own. That support can include access to specialized scientific and engineering expertise relevant to DOC regeneration, shared facilities and platforms, consultation on product development strategy, and the administrative backbone needed to coordinate multi-site, multi-disciplinary work. Just as importantly, the RCs are expected to contribute regulatory and industrial know-how, helping projects align preclinical studies with the kinds of evidence packages typically needed to justify initiating human trials. The emphasis is on guiding ITPs through the preclinical stage toward readiness for clinical trial initiation, not on running the trials themselves.
Because this is a cooperative agreement (rather than a standard grant), the funding relationship is structured to involve substantial programmatic engagement from NIH. Cooperative agreements commonly reflect a high level of coordination, milestone-driven management, and active collaboration between the awardees and the funding institute. In the context of this FOA, that cooperative structure fits the goal of operating a consortium: it supports shared planning, common standards, and coordinated decision-making across resource centers and translational projects, so that progress toward clinical readiness is more systematic and less fragmented.
The opportunity is described as a limited competition, meaning it is not intended as an open-ended call for any new applicant to propose an entirely new DOCTRC-like entity. Instead, it is designed to support the specific consortium framework and components that were assembled in earlier stages of the DOCTRC initiative. Applicants therefore should expect that the program is focused on continuation, operation, and optimization of an existing network of RCs and ITPs, with clear expectations for consortium-level services and outcomes that collectively push multiple DOC regeneration strategies closer to clinical translation.
In terms of scope, the program sits within the NIH health research mission (CFDA 93.121) and targets advances in regeneration and reconstruction relevant to dentistry, oral health, and craniofacial structures. The work implied by this FOA typically spans multidisciplinary areas such as biomaterials and scaffolds, stem cell and cell-based therapies, tissue engineering, biologics, device development, surgical reconstruction approaches, and other strategies aimed at restoring function and structure in DOC tissues. The consortium format is intended to connect clinical insight, foundational science, translational engineering, manufacturing and quality considerations, and regulatory planning into a coherent pathway that can generate credible preclinical evidence suitable for moving into a clinical trial program under an appropriate mechanism.
Eligibility is broad on paper, including many types of domestic organizations: state, county, and local governments; public and private institutions of higher education; tribal governments and tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations (with or without 501(c)(3) status); for-profit organizations (including small businesses); and other applicants as allowed by the FOA’s additional eligibility language. Even with that broad list, the limited-competition nature and the Stage 2 to Stage 3 continuation emphasis are central, so competitiveness would be tied to fit with the established DOCTRC structure and readiness to operate consortium-level capabilities rather than proposing isolated, stand-alone research aims.
The funding details provided indicate an award ceiling of $4,000,000 and an expectation of two awards. That combination suggests the program is intended to fund a small number of large, coordinating hubs with enough resources to provide meaningful shared services, manage consortium operations, and deliver specialized technical and regulatory assistance across multiple translational projects. The FOA was created on March 11, 2019, with an original closing date of June 11, 2019, placing it firmly in a time-limited solicitation window for that program year.
Overall, this opportunity is best understood as operational and translational infrastructure funding for a specialized consortium in dental, oral, and craniofacial tissue regeneration. The core deliverable is not a single discovery or a single product, but a functioning, multidisciplinary support ecosystem that helps a portfolio of translational projects generate the preclinical evidence, development planning, and regulatory positioning needed to credibly advance toward clinical trials, while staying within a U24 framework where clinical trials themselves are not allowed under the award.Apply for RFA DE 19 010
- The Department of Health and Human Services, National Institutes of Health in the health sector is offering a public funding opportunity titled "Limited Competition: Dental, Oral and Craniofacial Tissue Regeneration Consortium (U24 Clinical Trial Not Allowed)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.121.
- This funding opportunity was created on Mar 11, 2019.
- Applicants must submit their applications by Jun 11, 2019. (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 $4,000,000.00 in funding.
- The number of recipients for this funding is limited to 2 candidate(s).
- 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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Frequently Asked Questions (FAQs)
What is the DOCTRC funding opportunity (RFA-DE-19-010)?
It is a National Institutes of Health (NIH) cooperative agreement funding opportunity to support the continued operation of the Dental, Oral and Craniofacial Tissue Regeneration Consortium (DOCTRC). The mechanism is U24, and clinical trials are not allowed under this award.
Which federal agency and department sponsor this opportunity?
This opportunity is sponsored by the National Institutes of Health (NIH) under the Department of Health and Human Services (HHS).
What is the central goal of this program?
The central goal is to support the operation of an established, multidisciplinary consortium that helps move promising approaches for regenerating and reconstructing dental, oral, and craniofacial (DOC) tissues along the translational pipeline so they are ready to enter clinical trials. The emphasis is on strengthening infrastructure, expertise, and shared resources that help multiple projects clear key preclinical and regulatory hurdles.
Does this award fund or conduct clinical trials?
No. The mechanism is U24 and is described as "clinical trial not allowed." The program is intended to prepare projects for clinical trials by advancing preclinical and regulatory readiness, but it does not directly fund or run human trials under this award.
What does it mean that this is a cooperative agreement?
A cooperative agreement indicates substantial NIH programmatic involvement. In this context, it implies active collaboration, coordination, and likely milestone-driven management between NIH and awardees to support consortium-wide planning, common standards, and coordinated decision-making across Resource Centers and projects.
What does "limited competition" mean for applicants?
It means this is not an open call to create a brand-new consortium from scratch. The opportunity is designed to support the specific DOCTRC framework and components established in earlier stages, with an emphasis on continuation, operation, and optimization of an existing network of Resource Centers (RCs) and associated Interdisciplinary Translational Projects (ITPs).
What stage of the DOCTRC effort does this FOA support?
This FOA targets Stage 3 of the DOCTRC effort. It supports continued operation of Resource Centers and their associated Interdisciplinary Translational Projects that were developed during Stage 2, focusing on execution and accelerating progress toward clinical readiness.
What are Resource Centers (RCs) in the DOCTRC model?
Resource Centers are consortium hubs expected to provide centralized technical support and research capacity that individual translational projects may not be able to efficiently build alone. They serve as anchors for shared expertise, facilities, platforms, and operational coordination across multiple disciplines and sites.
What kinds of support are Resource Centers expected to provide?
Based on the description, RC support can include specialized scientific and engineering expertise relevant to DOC regeneration, shared facilities and platforms, consultation on product development strategy, administrative coordination for multi-site work, and regulatory and industrial know-how to help align preclinical studies with the evidence typically needed to justify initiating human trials.
What are Interdisciplinary Translational Projects (ITPs)?
ITPs are the translational projects associated with the Resource Centers that the consortium helps advance. The focus is on helping these projects move through key preclinical and regulatory steps so they are positioned to enter clinical trials under an appropriate (separate) mechanism.
What is the main deliverable of this program?
The primary deliverable is a functioning consortium-level support ecosystem (infrastructure, expertise, coordination, and shared resources) that helps a portfolio of translational projects generate credible preclinical evidence and regulatory positioning needed to advance toward clinical trials.
What kinds of research or technology areas fall within the program scope?
The scope targets regeneration and reconstruction relevant to dentistry, oral health, and craniofacial structures. The described multidisciplinary areas include biomaterials and scaffolds, stem cell and cell-based therapies, tissue engineering, biologics, device development, surgical reconstruction approaches, and other strategies aimed at restoring function and structure in DOC tissues.
What does "moving along the translational pipeline" mean in this FOA?
In this FOA, it refers to advancing DOC tissue regeneration approaches from academic proof-of-concept toward clinically viable products or procedures by strengthening rigor and reproducibility, coordinating shared development resources, and addressing preclinical and regulatory hurdles that commonly delay first-in-human readiness.
How does the program address preclinical and regulatory readiness?
The consortium is expected to guide projects through preclinical stages and help align studies with the types of evidence packages generally needed to support initiation of human trials. This includes leveraging regulatory and industry know-how and centralized capabilities to reduce avoidable delays as technologies transition toward clinical programs.
Is this program focused on a single project or multiple projects?
It is designed to support a consortium that helps multiple translational projects (ITPs). The intent is to provide shared services and coordinated expertise that benefit a portfolio of approaches rather than funding a single stand-alone research aim.
What is the CFDA number associated with this opportunity?
The opportunity is described as being within the NIH health research mission and references CFDA 93.121.
Who is eligible to apply?
Eligibility is described broadly and includes many types of domestic organizations: state, county, and local governments; public and private institutions of higher education; tribal governments and tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations (with or without 501(c)(3) status); for-profit organizations (including small businesses); and other applicants as allowed by the FOA's additional eligibility language.
If eligibility is broad, what determines fit or competitiveness?
The limited-competition nature and Stage 2 to Stage 3 continuation emphasis are central. Competitiveness would be tied to fit with the established DOCTRC structure and the ability to operate consortium-level capabilities (Resource Center functions and coordination) rather than proposing isolated, stand-alone research plans.
What is the maximum award amount (ceiling)?
The provided funding details indicate an award ceiling of $4,000,000.
How many awards are expected?
The opportunity indicates an expectation of two awards.
What does the combination of a $4,000,000 ceiling and only two awards suggest?
It suggests the program is intended to fund a small number of large, coordinating hubs with sufficient resources to provide meaningful shared services, manage consortium operations, and deliver specialized technical and regulatory assistance across multiple translational projects.
When was this FOA created and when did it close?
The FOA was created on March 11, 2019, with an original closing date of June 11, 2019.
What is explicitly out of scope under this U24 award?
Clinical trials are explicitly not allowed. The award is framed around preclinical readiness, regulatory positioning, and consortium operations rather than conducting first-in-human studies.
What is the practical difference between "preparing for clinical trials" and "running clinical trials" in this FOA?
Preparing for clinical trials refers to generating credible preclinical evidence, improving rigor and reproducibility, coordinating development resources, and shaping regulatory strategy so projects are positioned to enter trials later. Running clinical trials would involve conducting human studies, which this U24 mechanism does not allow.
Why does the program emphasize centralized consortium capabilities?
The description highlights that individual translational projects often cannot efficiently assemble specialized expertise, shared platforms, regulatory planning, and multi-site coordination on their own. Centralized Resource Centers are intended to reduce fragmentation and delays and to make progress toward clinical readiness more systematic.
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