Opportunity Information: Apply for RFA AI 20 028

Partnerships for Countermeasures against Select Pathogens (R01 Clinical Trials Not Allowed) is a National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID) funding opportunity (RFA-AI-20-028; CFDA 93.855) designed to push promising medical countermeasures closer to real-world use. The central goal is to support milestone-driven, preclinical development projects that advance lead candidate therapeutics, vaccines, and related countermeasures targeting select emerging infectious diseases and pathogens prioritized by NIAID. This is an R01 grant mechanism, but it is explicitly limited to preclinical work; clinical trials are not allowed under this announcement.

A defining feature of the program is its emphasis on product-focused development rather than early discovery. Applicants are expected to propose a clear development plan built around concrete, measurable milestones that demonstrate forward progress toward a viable candidate product. In addition, each application must include a Product Development Strategy attachment. This requirement signals that NIAID is looking for projects that are organized like real development programs, with attention to practical issues such as candidate selection, preclinical testing plans, go/no-go criteria, development timelines, and other elements that show the team understands what it takes to advance a countermeasure toward later-stage development.

Another core requirement is meaningful industry participation. The FOA requires that applications demonstrate substantive investment by at least one industrial participant. In practice, this means the project should not be purely academic or government-led; it should include an industry partner that is contributing real resources, capabilities, or funding and is positioned to help drive product development. The intent is to strengthen the path to translation by combining NIH support with private-sector development experience, manufacturing know-how, regulatory familiarity, or other capabilities that are often essential for moving countermeasures out of the lab and toward readiness.

Eligibility is broad and includes a wide range of domestic and non-domestic organizations. In addition to typical NIH-eligible applicants such as state, county, city, and special district governments; independent school districts; public and state-controlled and private institutions of higher education; federally recognized tribal governments; tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); and small businesses, the FOA also highlights additional eligible groups. These include 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 agencies of the federal government; regional organizations; U.S. territories or possessions; and non-U.S. entities (foreign organizations). This wide eligibility is meant to encourage diverse partnerships and broaden participation in countermeasure development efforts.

From an administrative standpoint, the opportunity falls under the discretionary grant category with a health funding activity focus. The original closing date listed for the announcement was June 29, 2020, and the posted maximum award amount (award ceiling) was $1,050,000. The FOA was created on March 11, 2020. While the number of expected awards is not specified in the provided source data, the structure and requirements indicate a competitive program aimed at a smaller set of well-developed, partnership-based projects that can show credible progress through predefined preclinical milestones.

  • The National Institutes of Health in the health sector is offering a public funding opportunity titled "Partnerships for Countermeasures against Select Pathogens (R01 Clinical Trials 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 2020-03-11.
  • Applicants must submit their applications by 2020-06-29. (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 $1,050,000.00 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.
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Frequently Asked Questions (FAQs)

What is the Partnerships for Countermeasures against Select Pathogens opportunity?

It is a National Institutes of Health (NIH) funding opportunity from the National Institute of Allergy and Infectious Diseases (NIAID) titled "Partnerships for Countermeasures against Select Pathogens (R01 Clinical Trials Not Allowed)" (RFA-AI-20-028; CFDA 93.855). It is designed to move promising medical countermeasures closer to real-world use by supporting milestone-driven, preclinical development projects.

Which NIH Institute is sponsoring this funding opportunity?

The opportunity is sponsored by NIAID, which is part of NIH.

What is the primary goal of this FOA?

The central goal is to support product-focused, milestone-driven preclinical development that advances lead candidate therapeutics, vaccines, and related countermeasures for select emerging infectious diseases and pathogens prioritized by NIAID.

What types of projects are a good fit for this program?

Projects that are beyond early discovery and are organized like real product development programs. The FOA emphasizes advancing a lead candidate and demonstrating forward progress through concrete, measurable milestones tied to preclinical development.

Are clinical trials allowed under this announcement?

No. The announcement is explicitly limited to preclinical work, and clinical trials are not allowed.

What grant mechanism does this opportunity use?

This funding opportunity uses the NIH R01 grant mechanism.

What does "milestone-driven" mean in the context of this FOA?

Applicants are expected to propose a clear development plan built around concrete, measurable milestones that demonstrate progress toward a viable candidate product. The milestones function as practical indicators of advancement and are aligned with preclinical development activities.

What is meant by "product-focused development" (as opposed to discovery research)?

The FOA is aimed at development activities that move a specific lead candidate toward later-stage development readiness, rather than exploratory or early discovery research. Applications should show an organized plan for advancing a candidate through preclinical steps.

Is a Product Development Strategy required?

Yes. Each application must include a Product Development Strategy attachment.

What should the Product Development Strategy cover?

Based on the FOA description, it should reflect a practical development program and address elements such as candidate selection, preclinical testing plans, go/no-go criteria, and development timelines, demonstrating the team understands what it takes to advance a countermeasure toward later-stage development.

Is an industry partner required?

Yes. The FOA requires meaningful industry participation and expects substantive investment by at least one industrial participant.

What does "substantive investment" by an industrial participant mean?

The project should not be purely academic or government-led. The industry participant should contribute real resources, capabilities, or funding, and be positioned to help drive product development in a way that supports translation beyond the lab.

Why does the FOA emphasize industry participation?

The stated intent is to strengthen the path to translation by combining NIH support with private-sector development experience and capabilities that are often needed to move countermeasures toward readiness, such as manufacturing know-how and regulatory familiarity.

Who is eligible to apply?

Eligibility is broad and includes domestic and non-domestic organizations. Examples listed include various government entities (state, county, city, special district), independent school districts, public and private institutions of higher education, federally recognized tribal governments and tribal organizations, public housing authorities/Indian housing authorities, nonprofits with or without 501(c)(3) status (other than institutions of higher education), for-profit organizations (other than small businesses), small businesses, and additional highlighted groups such as minority-serving institutions and other community-based organizations.

Are non-U.S. (foreign) organizations eligible?

Yes. The eligibility list explicitly includes non-U.S. entities (foreign organizations).

Are U.S. territories or possessions eligible to apply?

Yes. The FOA explicitly includes U.S. territories or possessions among eligible applicants.

Are tribal entities eligible to apply?

Yes. The eligibility list includes federally recognized tribal governments, tribal organizations, and Tribally Controlled Colleges and Universities (TCCUs).

Are minority-serving institutions specifically included as eligible applicants?

Yes. The FOA highlights multiple categories, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), and TCCUs.

Are faith-based or community-based organizations eligible?

Yes. Faith-based or community-based organizations are explicitly listed among eligible groups.

Are federal government agencies eligible to apply?

Yes. The FOA includes eligible agencies of the federal government.

What is the funding category and activity focus for this opportunity?

The opportunity is listed under the discretionary grant category with a health funding activity focus.

What is the CFDA number for this opportunity?

The CFDA number provided is 93.855.

What is the FOA identifier?

The FOA identifier provided is RFA-AI-20-028.

What is the maximum award amount (award ceiling) listed?

The posted maximum award amount (award ceiling) is $1,050,000.

When was the FOA created?

The FOA was created on March 11, 2020.

What was the original closing date listed for this announcement?

The original closing date listed was June 29, 2020.

How many awards are expected to be made?

The number of expected awards is not specified in the provided information.

What kinds of pathogens or diseases does the FOA target?

The FOA targets select emerging infectious diseases and pathogens prioritized by NIAID.

What kinds of countermeasures are in scope?

The description specifically mentions lead candidate therapeutics, vaccines, and related countermeasures.

What does the FOA suggest about competitiveness or project maturity?

While the expected number of awards is not stated, the structure and requirements described (milestone-driven preclinical development, product-focused planning, and required industry investment) indicate the program is aimed at well-developed, partnership-based projects that can show credible progress through predefined preclinical milestones.

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