Opportunity Information: Apply for RFA AI 12 023
Apply for RFA AI 12 023
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Development of Medical Countermeasures for Post Exposure Mitigation/Treatment of Injuries Resulting from a Radiation/Nuclear Incident (U01)" 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 Jun 19, 2012 and posted on Jun 19, 2012.
- Applicants must submit their applications by Oct 18, 2012. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $4,000,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $350,000.00 in funding.
- Eligible applicants include: Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Independent school districts Private institutions of higher education For profit organizations other than small businesses Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Small businesses State governments Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education County governments Others (see text field entitled Additional Information on Eligibility for clarification) Special district governments.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions 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) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are not 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:
The NIH funding opportunity RFA-AI-12-023, titled "Development of Medical Countermeasures for Post Exposure Mitigation/Treatment of Injuries Resulting from a Radiation/Nuclear Incident (U01)," is a discretionary, health-focused cooperative agreement designed to strengthen the pipeline of medical countermeasures that could be used after a radiation or nuclear event. Its central purpose is to push promising candidate products further along the development pathway, specifically emphasizing therapies that can be administered after exposure and still show meaningful benefit. The announcement targets countermeasures intended to mitigate or treat radiation injuries, including the acute radiation syndromes, as well as longer-term or delayed health effects that follow an acute exposure.
A major emphasis of the opportunity is translational progress: applicants are expected to work on candidates that already have some evidence supporting post-exposure effectiveness and to generate additional development data that moves those candidates closer to eventual licensure. In practical terms, that means the research should help establish that a countermeasure is not just theoretically useful but demonstrates efficacy when given after radiation exposure, which is the real-world scenario in an incident where prophylaxis may not be possible. This focus also reflects the regulatory reality for radiation countermeasures, where demonstrating benefit and defining how and when a product should be used are critical for approval and deployment.
The second key pillar of the announcement is mechanism-of-action research tied directly to licensure requirements. Beyond showing that a candidate works, NIH is signaling that successful projects should help clarify how the countermeasure produces its protective or therapeutic effect. Mechanistic understanding can be necessary to support product approval strategies, inform dose selection, identify appropriate biomarkers or endpoints, and build a stronger scientific rationale for efficacy claims. In the context of radiation injury, where human efficacy trials may be infeasible or unethical, mechanistic and supportive evidence can be especially important for demonstrating credibility and meeting regulatory expectations.
Administratively, the funding instrument is a U01 cooperative agreement, which typically means NIH expects substantial scientific or programmatic involvement during the period of performance compared with a standard research grant. While the announcement text provided does not list all collaboration details, the cooperative structure generally implies coordinated milestones, interaction with NIH program staff, and an emphasis on deliverables that align with product development needs rather than purely exploratory research.
The opportunity was posted and created on June 19, 2012, with an original and current closing date of October 18, 2012, and an archive date of November 18, 2012. The estimated total funding available for the program was listed as $4,000,000, with an award ceiling of $350,000, indicating an intent to support multiple projects at modest-to-moderate budgets rather than a small number of very large awards. No cost sharing or matching was required, lowering barriers for participation and aligning with typical NIH research support norms.
Eligibility was broad across U.S.-based organizations and included a wide range of applicant types: state, county, city or township governments; special district governments; tribal governments (including federally recognized tribes) and tribal organizations; public and private institutions of higher education; nonprofits both with and without 501(c)(3) status; for-profit organizations other than small businesses; and small businesses. The announcement also explicitly noted additional eligible entities such as historically Black colleges and universities (HBCUs), Hispanic-serving institutions, tribally controlled colleges and universities (TCCUs), Alaska Native and Native Hawaiian serving institutions, faith-based or community-based organizations, eligible federal agencies, and U.S. territories or possessions. Foreign institutions (non-U.S. entities) were not eligible to apply, but non-domestic components of U.S. organizations could participate, and "foreign components" as defined by NIH policy were allowed, which typically means certain international activities can be included when scientifically justified and compliant with NIH rules.
From a program classification standpoint, the opportunity sits within NIH activity areas associated with infectious disease and immunology research infrastructure (CFDA 93.855 and 93.856), and it is administered by the National Institutes of Health. The full announcement was available through an NIH grants guide link, and NIH provided contact pathways through the Office of Extramural Research (OER) webmaster for access or technical linking issues. Overall, the grant is best understood as a targeted, product-oriented research support mechanism aimed at moving post-exposure radiation countermeasures closer to readiness, while also generating the mechanistic evidence base that regulators and public health planners would need to justify and guide their eventual use.
Frequently Asked Questions (FAQs)
What is the title and number of this NIH funding opportunity?
The funding opportunity is NIH RFA-AI-12-023, titled "Development of Medical Countermeasures for Post Exposure Mitigation/Treatment of Injuries Resulting from a Radiation/Nuclear Incident (U01)."
What type of funding mechanism is used?
This opportunity uses a U01 cooperative agreement mechanism.
What does a U01 cooperative agreement generally mean for applicants?
A U01 cooperative agreement typically involves substantial NIH scientific or programmatic involvement during the project period compared with a standard research grant. It commonly includes coordinated milestones, interactions with NIH program staff, and an emphasis on deliverables aligned with product-development needs rather than purely exploratory research.
What is the central purpose of this opportunity?
The central purpose is to strengthen the pipeline of medical countermeasures that could be used after a radiation or nuclear incident by advancing promising candidate products further along the development pathway, with a specific emphasis on therapies that can be administered after exposure and still provide meaningful benefit.
What kinds of countermeasures are targeted?
The announcement targets medical countermeasures intended to mitigate or treat radiation injuries, including acute radiation syndromes, as well as longer-term or delayed health effects that follow an acute exposure.
Is the opportunity focused on pre-exposure prevention or post-exposure treatment?
The emphasis is on post-exposure mitigation and treatment, reflecting real-world incident scenarios where prophylaxis may not be possible and countermeasures must demonstrate efficacy when administered after exposure.
What stage of research is NIH emphasizing?
The opportunity emphasizes translational progress. Applicants are expected to work on candidates that already have some evidence supporting post-exposure effectiveness and to generate additional development data that moves those candidates closer to eventual licensure.
Does NIH require evidence that the product works when given after radiation exposure?
Yes. A core expectation described is that research should help establish that a countermeasure demonstrates efficacy when administered after radiation exposure, not only in theory but in ways relevant to incident response use.
Why is mechanism-of-action research highlighted in this opportunity?
Mechanism-of-action research is highlighted as a second key pillar tied to licensure requirements. NIH signals that successful projects should help clarify how the countermeasure produces its protective or therapeutic effect, which can support product approval strategies, dose selection, biomarker or endpoint identification, and a stronger scientific rationale for efficacy.
How does the licensure context influence the scientific expectations?
The announcement frames the work as product-oriented and aligned with eventual licensure. For radiation countermeasures, where human efficacy trials may be infeasible or unethical, mechanistic and supportive evidence can be especially important for credibility and regulatory expectations.
What is the estimated total funding available under this program?
The estimated total funding available was listed as $4,000,000.
What is the award ceiling for individual awards?
The award ceiling was listed as $350,000.
What does the stated total funding and award ceiling suggest about the program’s intent?
Based on the listed estimated total funding and the award ceiling, the program appears structured to support multiple projects at modest-to-moderate budgets rather than a small number of very large awards.
Is cost sharing or matching required?
No. The opportunity states that no cost sharing or matching was required.
When was this funding opportunity created and posted?
The opportunity was created and posted on June 19, 2012.
What were the closing date and archive date?
The original and current closing date was October 18, 2012, and the archive date was November 18, 2012.
Who can apply (in general terms)?
Eligibility was broad across U.S.-based organizations and included government entities, higher education institutions, nonprofits (with and without 501(c)(3) status), for-profit organizations other than small businesses, and small businesses.
Which government entities were listed as eligible?
Eligible government entities included state governments; county governments; city or township governments; special district governments; tribal governments (including federally recognized tribes); and U.S. territories or possessions. Eligible federal agencies were also explicitly noted.
Are tribal organizations and tribal colleges included?
Yes. Tribal organizations were listed as eligible, and tribally controlled colleges and universities (TCCUs) were explicitly noted among eligible entities.
Are institutions of higher education eligible?
Yes. Public and private institutions of higher education were listed as eligible.
Are nonprofits eligible, including those without 501(c)(3) status?
Yes. The eligibility list included nonprofits with 501(c)(3) status and nonprofits without 501(c)(3) status.
Are for-profit organizations eligible?
Yes. For-profit organizations other than small businesses were listed as eligible, and small businesses were also listed as eligible.
Are faith-based or community-based organizations eligible?
Yes. Faith-based or community-based organizations were explicitly noted as eligible entities.
Are minority-serving institutions specifically mentioned as eligible?
Yes. The announcement explicitly noted eligibility for historically Black colleges and universities (HBCUs), Hispanic-serving institutions, Alaska Native and Native Hawaiian serving institutions, and tribally controlled colleges and universities (TCCUs).
Can foreign institutions apply?
No. Foreign institutions (non-U.S. entities) were not eligible to apply.
Are any international activities allowed if a U.S. organization is the applicant?
Yes. The information provided states that non-domestic components of U.S. organizations could participate and that "foreign components" as defined by NIH policy were allowed, generally meaning certain international activities can be included when scientifically justified and compliant with NIH rules.
Which agency administers this opportunity?
The opportunity is administered by the National Institutes of Health (NIH).
How is this opportunity classified in terms of program or activity areas?
The opportunity is associated with NIH activity areas linked to infectious disease and immunology research infrastructure, referenced under CFDA 93.855 and 93.856.
Where could applicants find the full announcement?
The full announcement was available through an NIH grants guide link.
Who is listed as a contact for access or technical linking issues?
NIH provided contact pathways through the Office of Extramural Research (OER) webmaster for access or technical linking issues.
What is the overall takeaway on what NIH is trying to fund here?
This opportunity is best understood as targeted, product-oriented research support intended to move post-exposure radiation countermeasures closer to readiness, while also generating mechanistic evidence relevant to regulatory approval and real-world use after a radiation or nuclear incident.
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