Opportunity Information: Apply for RFA AI 21 007
Innovation for Tuberculosis Vaccine Discovery (ITVD) (R61/R33 Clinical Trial Not Allowed), Funding Opportunity Number RFA-AI-21-007, is a National Institutes of Health (NIH) discretionary grant program focused on accelerating the early discovery and preclinical development of new tuberculosis (TB) vaccine candidates. The core purpose is to fund the design of novel TB vaccine concepts that use innovative scientific approaches, and then push the most promising candidates forward into testing in relevant preclinical animal models. The emphasis is on moving beyond conventional ideas by supporting creative, potentially high-impact strategies that could expand the TB vaccine pipeline.
A defining feature of this opportunity is its milestone-driven, two-phase structure using the R61/R33 mechanism. The first phase (R61) is intended for high-risk, exploratory work where investigators generate proof-of-concept data, refine vaccine designs, and establish feasibility. This phase is deliberately geared toward innovation, where outcomes are uncertain but the potential payoff is high. The second phase (R33) supports more advanced activities, particularly preclinical animal model testing, but it is not automatic. Progression from R61 to R33 depends on whether the project meets predefined scientific milestones and go/no-go criteria. In practice, this structure is meant to keep projects focused on measurable progress, encourage disciplined development planning, and ensure that additional funding is concentrated on candidates that demonstrate strong potential based on early results.
The scope of supported work centers on vaccine discovery and preclinical evaluation rather than human studies. The announcement explicitly states that clinical trials are not allowed, which signals that applicants should not propose any clinical testing in humans under this mechanism. Instead, the program is aimed at the earlier parts of the translational pathway: designing and engineering vaccine candidates, generating supporting immunogenicity or mechanistic evidence, and evaluating candidates in animal models appropriate for TB preclinical research.
From an eligibility standpoint, the opportunity is broadly open to a wide range of domestic and international organizations. Eligible applicants include various levels of government (state, county, city/township, and special district governments), federally recognized Native American tribal governments, and Native American tribal organizations other than federally recognized tribal governments. It also includes public housing authorities/Indian housing authorities, independent school districts, and both public/state-controlled and private institutions of higher education. Nonprofit organizations are eligible whether or not they hold 501(c)(3) status, and for-profit organizations (including small businesses) can also apply. In addition, the opportunity highlights expanded categories of eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, U.S. territories or possessions, and non-U.S. entities (foreign organizations) as well as regional organizations. This broad eligibility is consistent with the global importance of TB and the need to draw on diverse scientific and institutional capabilities.
Administratively, the opportunity sits within NIH under the health research activity category and is associated with CFDA number 93.855. The listing indicates an original closing date of 2021-06-30 and a creation date of 2021-02-19. While the summary data provided does not specify an award ceiling or the expected number of awards, the overall design of the program makes clear that funding decisions are tied closely to the feasibility of the proposed milestones and the likelihood that the work can yield a viable vaccine candidate ready for rigorous preclinical assessment.
Overall, ITVD (R61/R33) is designed for teams proposing bold TB vaccine ideas with a clear, testable development path. It supports projects that can define concrete milestones early, generate decisive preclinical evidence, and demonstrate that an innovative candidate warrants continued investment, all while keeping the work firmly in the non-clinical, preclinical stage.Apply for RFA AI 21 007
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Innovation for Tuberculosis Vaccine Discovery (ITVD) (R61/R33 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): 93.855.
- This funding opportunity was created on 2021-02-19.
- Applicants must submit their applications by 2021-06-30. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- 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.
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Frequently Asked Questions (FAQs)
What is the Innovation for Tuberculosis Vaccine Discovery (ITVD) opportunity?
Innovation for Tuberculosis Vaccine Discovery (ITVD) is an NIH discretionary grant program focused on accelerating early discovery and preclinical development of new tuberculosis (TB) vaccine candidates. It supports the design of novel TB vaccine concepts using innovative scientific approaches and advances the most promising candidates into relevant preclinical animal model testing.
What is the Funding Opportunity Number (FOA) for this program?
The Funding Opportunity Number is RFA-AI-21-007.
What grant mechanism does ITVD use?
ITVD uses the milestone-driven, two-phase R61/R33 mechanism.
How does the two-phase R61/R33 structure work?
The program is structured in two phases. The first phase (R61) supports high-risk, exploratory research to generate proof-of-concept data, refine vaccine designs, and establish feasibility. The second phase (R33) supports more advanced work, particularly preclinical animal model testing, but only if the project meets predefined scientific milestones and go/no-go criteria established for the R61 phase.
Is transition from the R61 phase to the R33 phase automatic?
No. Progression from R61 to R33 depends on whether the project achieves predefined milestones and meets go/no-go criteria.
What kinds of research activities are supported during the R61 phase?
The R61 phase is intended for innovative, high-risk exploratory work such as generating proof-of-concept data, refining vaccine designs, and demonstrating feasibility. The emphasis is on creative approaches where outcomes may be uncertain but the potential impact is high.
What kinds of research activities are supported during the R33 phase?
The R33 phase supports more advanced preclinical activities, especially testing vaccine candidates in relevant preclinical animal models for TB research, assuming the R61 milestones are successfully met.
Are clinical trials allowed under this opportunity?
No. The announcement states that clinical trials are not allowed. Applicants should not propose any clinical testing in humans under this mechanism.
Does the program support human studies of TB vaccines?
No. The scope is focused on vaccine discovery and preclinical evaluation rather than human studies, with an emphasis on non-clinical, preclinical stages.
What is the primary scientific focus of this program?
The primary focus is to move beyond conventional ideas by funding innovative TB vaccine concepts and advancing promising candidates through early development into rigorous preclinical evaluation in appropriate animal models.
What is meant by "milestone-driven" in this funding opportunity?
"Milestone-driven" means projects are expected to define measurable scientific milestones and go/no-go criteria, and continued support (including transition to the second phase) depends on meeting those predefined milestones.
What stage of the vaccine development pipeline does ITVD target?
ITVD targets the early translational pathway: designing and engineering vaccine candidates, generating supporting immunogenicity or mechanistic evidence, and evaluating candidates in relevant preclinical animal models.
Who is eligible to apply?
Eligibility is broad and includes domestic and international organizations across many categories, including government entities, tribal governments and tribal organizations, public housing authorities/Indian housing authorities, independent school districts, institutions of higher education (public/state-controlled and private), nonprofit organizations (with or without 501(c)(3) status), and for-profit organizations (including small businesses).
Are non-U.S. (foreign) organizations eligible to apply?
Yes. Non-U.S. entities (foreign organizations) are listed among eligible applicants, and regional organizations are also included.
Are for-profit organizations and small businesses eligible?
Yes. For-profit organizations, including small businesses, are eligible applicants.
Are nonprofit organizations required to have 501(c)(3) status to apply?
No. Nonprofit organizations are eligible whether or not they hold 501(c)(3) status.
Are U.S. territories or possessions included in eligibility?
Yes. U.S. territories or possessions are explicitly included among eligible applicants.
Are tribal entities eligible?
Yes. Federally recognized Native American tribal governments are eligible, and Native American tribal organizations other than federally recognized tribal governments are also included.
Are specific institution types called out as eligible (for example, HBCUs or Hispanic-serving institutions)?
Yes. The opportunity highlights eligibility for Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), and Tribally Controlled Colleges and Universities (TCCUs), among other categories.
Are faith-based or community-based organizations eligible to apply?
Yes. Faith-based or community-based organizations are included in the highlighted eligibility categories.
What agency is sponsoring this program?
The program is administered under the National Institutes of Health (NIH) and is categorized under health research.
What is the CFDA number associated with this opportunity?
The opportunity is associated with CFDA number 93.855.
What is the original closing date listed for this opportunity?
The listing indicates an original closing date of 2021-06-30.
When was this opportunity created?
The listing indicates a creation date of 2021-02-19.
Does the provided information specify an award ceiling or the expected number of awards?
No. The summary data provided does not specify an award ceiling or the expected number of awards.
How are funding decisions and continued support described in this opportunity?
The program design ties funding decisions closely to the feasibility and clarity of proposed milestones and the likelihood that the work can produce a viable vaccine candidate ready for rigorous preclinical assessment. Continued support, including the R61-to-R33 transition, is based on meeting predefined milestones and go/no-go criteria.
What type of project team is this opportunity designed for?
It is designed for teams proposing bold TB vaccine ideas with a clear, testable development path, and a plan to generate decisive preclinical evidence while remaining firmly in the non-clinical stage.
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