Opportunity Information: Apply for RFA AI 13 013

  • The National Institutes of Health in the health sector is offering a public funding opportunity titled "Partnerships for Biodefense (R01)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855 Allergy and Infectious Diseases Research 93.856 Microbiology and Infectious Diseases Research.
  • This funding opportunity was created on Feb 26, 2013 and posted on Feb 26, 2013.
  • Applicants must submit their applications by Jul 2, 2013. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • The funding agency has allocated a total of $20,000,000.00 to eligible and selected applicants.
  • Each selected applicant is eligible to receive up to $750,000.00 in funding.
  • Eligible applicants include: County governments Others (see text field entitled Additional Information on Eligibility for clarification) Small businesses For profit organizations other than small businesses Native American tribal governments (Federally recognized) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education State governments Special district governments Public housing authorities/Indian housing authorities Public and State controlled institutions of higher education City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education.
  • Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:

Partnerships for Biodefense (R01) (Funding Opportunity Number RFA-AI-13-013) is a National Institute of Allergy and Infectious Diseases (NIAID), NIH grant program designed to push promising biodefense medical countermeasures beyond basic discovery and into practical, preclinical product development. The focus is on advancing lead candidates for therapeutics, vaccines (and enabling or related platform technologies), and diagnostics that target NIAID-designated Category A, B, or C priority agents, meaning pathogens and threats considered significant for public health and national security. In practical terms, this FOA is meant for teams that already have a credible lead and want to generate the kind of preclinical evidence, development planning, and technical progress that would support later-stage development and, ultimately, real-world use.

A central feature of this opportunity is that it is explicitly partnership-driven. Applications must demonstrate substantive investment by at least one industrial participant, signaling that NIAID is looking for projects with genuine commercial or translational commitment rather than purely academic interest. This industrial participation is meant to bring product development discipline, manufacturing and quality considerations, regulatory awareness, and a path toward eventual deployment. Alongside that requirement, applicants must include a Product Development Strategy attachment. That attachment functions as a roadmap that explains how the project will mature the lead candidate or diagnostic toward a defined development milestone, including the planned studies, decision points, risk management, and how the team will handle typical preclinical development needs (for example, assay development, characterization, formulation, stability, animal model work when appropriate, and planning for regulatory interactions). The overall expectation is that the application reads like a structured development effort, not just a collection of experiments.

The grant mechanism is an R01 research project grant, and the activity category is health. The FOA is listed under CFDA (now Assistance Listing) numbers 93.855 (Allergy and Infectious Diseases Research) and 93.856 (Microbiology and Infectious Diseases Research). The opportunity did not require cost sharing or matching, so applicants were not obligated to contribute non-federal funds as a formal match, even though meaningful industry investment was still required as part of the program’s partnership model.

In terms of funding scale, NIAID estimated total program funding at about $20,000,000 for the announcement. The award ceiling was $750,000, which sets the upper bound on how much a single award could receive under the terms summarized here. The announcement was posted on February 26, 2013, with an original and current closing date of July 2, 2013, and an archive date of August 2, 2013, indicating this was a time-limited solicitation rather than an open-standing program announcement.

Eligibility was broad and included many organization types across the public, private, nonprofit, and educational sectors. Eligible applicants included state, county, city or township governments; special district governments; independent school districts; public housing authorities/Indian housing authorities; public and state-controlled institutions of higher education; private institutions of higher education; nonprofits both with and without 501(c)(3) status (other than institutions of higher education); small businesses; and for-profit organizations other than small businesses. It also included Native American tribal governments (federally recognized) and other tribal organizations. The FOA further clarified additional eligible applicants such as historically Black colleges and universities (HBCUs), Hispanic-serving institutions, tribally controlled colleges and universities (TCCUs), Alaska Native and Native Hawaiian serving institutions, and Asian American Native American Pacific Islander serving institutions (AANAPISIs), as well as faith-based or community-based organizations and eligible federal agencies. Importantly, foreign participation was allowed: non-U.S. entities (foreign organizations and foreign institutions) could apply, non-U.S. components of U.S. organizations were eligible, and foreign components as defined by NIH policy were permitted. That flexibility reflects the global nature of emerging infectious disease expertise and biodefense-relevant capabilities.

Administratively, the sponsoring agency is the National Institutes of Health, with NIAID as the issuing institute. The FOA’s support and access notes direct applicants who have trouble accessing the full announcement or linking to it to contact the NIH Office of Extramural Research (OER) webmaster (FBOWebmaster@OD.NIH.GOV). The full announcement was linked through the NIH grants guide at the provided URL.

Taken together, the program can be understood as a translational biodefense funding lane for teams that can show: (1) a plausible lead candidate or diagnostic concept against a priority agent, (2) a serious preclinical development plan presented as a Product Development Strategy, and (3) real industry engagement with tangible investment, all aimed at producing development-ready outputs rather than purely exploratory science.

Partnerships for Biodefense (R01) (RFA-AI-13-013) - FAQs

What is the Partnerships for Biodefense (R01) funding opportunity?

Partnerships for Biodefense (R01) (Funding Opportunity Number RFA-AI-13-013) is a National Institute of Allergy and Infectious Diseases (NIAID), NIH program intended to move promising biodefense medical countermeasures beyond basic discovery and into practical, preclinical product development.

Which federal agency and institute sponsor this opportunity?

The sponsoring agency is the National Institutes of Health (NIH), and the issuing institute is the National Institute of Allergy and Infectious Diseases (NIAID).

What is the goal of this FOA?

The goal is to advance credible lead candidates (or diagnostics) by generating preclinical evidence, development planning, and technical progress that supports later-stage development and eventual real-world use.

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

This FOA is meant for teams that already have a plausible lead candidate and want to run a structured preclinical development effort (not just exploratory research) to reach defined development milestones.

What product areas are supported?

The FOA focuses on therapeutics, vaccines (including enabling or related platform technologies), and diagnostics.

Which threats or pathogens does the FOA target?

Projects must target NIAID-designated Category A, B, or C priority agents, which are pathogens and threats considered significant to public health and national security.

What does it mean that this opportunity is "partnership-driven"?

The FOA explicitly requires a partnership approach, including substantive investment by at least one industrial participant. The intent is to fund projects with real translational and commercialization commitment, not purely academic interest.

Is industrial participation required?

Yes. Applications must demonstrate substantive investment by at least one industrial participant.

Why does NIAID require an industrial participant?

The industrial partner requirement is intended to bring product development discipline, manufacturing and quality considerations, regulatory awareness, and a clearer path toward eventual deployment.

What is the grant mechanism used for this program?

The grant mechanism is an R01 research project grant.

What is the activity category?

The activity category is health.

What are the CFDA (Assistance Listing) numbers associated with this FOA?

The FOA is listed under 93.855 (Allergy and Infectious Diseases Research) and 93.856 (Microbiology and Infectious Diseases Research).

Is cost sharing or matching required?

No. The opportunity did not require cost sharing or matching. Applicants were not obligated to provide a formal non-federal match, even though meaningful industry investment was still required as part of the partnership model.

How much total funding was expected for this announcement?

NIAID estimated total program funding at about $20,000,000 for the announcement.

What is the maximum award amount (award ceiling)?

The award ceiling was $750,000.

When was the FOA posted?

The announcement was posted on February 26, 2013.

What were the closing date and archive date?

The original and current closing date was July 2, 2013, and the archive date was August 2, 2013.

Does this appear to be a time-limited solicitation?

Yes. The presence of a specific closing date and an archive date indicates this was a time-limited solicitation rather than an open-standing program announcement.

What attachment is required in the application?

Applicants must include a Product Development Strategy attachment.

What is the purpose of the Product Development Strategy attachment?

It functions as a roadmap describing how the project will mature the lead candidate or diagnostic toward a defined development milestone, including planned studies, decision points, and risk management.

What kinds of preclinical development elements are expected to be addressed in the Product Development Strategy?

The FOA expects a development-oriented plan that can include items such as assay development, characterization, formulation, stability, animal model work (when appropriate), and planning for regulatory interactions.

How should the overall application read, based on the FOA description?

The application is expected to read like a structured product development effort rather than a collection of disconnected experiments.

What types of organizations are eligible to apply?

Eligibility is broad and includes organizations across public, private, nonprofit, and educational sectors, including many types of governments, higher education institutions, nonprofits, and businesses (including small businesses and for-profit entities other than small businesses).

Are state and local governments eligible?

Yes. Eligible applicants included state, county, city or township governments, and special district governments.

Are K-12 related entities eligible?

Independent school districts were listed among eligible applicant types.

Are public housing authorities eligible?

Yes. Public housing authorities and Indian housing authorities were included as eligible applicants.

Are colleges and universities eligible?

Yes. Both public and state-controlled institutions of higher education and private institutions of higher education were eligible.

Are nonprofit organizations eligible?

Yes. Nonprofits with and without 501(c)(3) status (other than institutions of higher education) were listed as eligible.

Are for-profit organizations eligible?

Yes. Small businesses and for-profit organizations other than small businesses were included as eligible applicants.

Are tribal governments and tribal organizations eligible?

Yes. Native American tribal governments (federally recognized) and other tribal organizations were included.

Are minority-serving institutions specifically included?

Yes. The FOA explicitly listed HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities (TCCUs), Alaska Native and Native Hawaiian serving institutions, and AANAPISIs as additional eligible applicants.

Are faith-based or community-based organizations eligible?

Yes. The FOA stated that faith-based or community-based organizations were eligible.

Are federal agencies eligible to apply?

Yes. The FOA included eligible federal agencies among the eligible applicant types.

Is foreign participation allowed?

Yes. Non-U.S. entities (foreign organizations and foreign institutions) could apply, non-U.S. components of U.S. organizations were eligible, and foreign components (as defined by NIH policy) were permitted.

Where can applicants get help if they cannot access the full announcement or have link issues?

The FOA directs applicants who have trouble accessing the full announcement or linking to it to contact the NIH Office of Extramural Research (OER) webmaster at FBOWebmaster@OD.NIH.GOV.

What is the main takeaway for applicants considering this FOA?

The program supports translational biodefense projects that can show (1) a credible lead candidate or diagnostic concept against a Category A, B, or C priority agent, (2) a serious preclinical plan presented as a Product Development Strategy, and (3) real industry engagement with tangible investment aimed at development-ready outputs.

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