Opportunity Information: Apply for RFA AI 11 024

  • The National Institutes of Health in the health sector is offering a public funding opportunity titled "Improved Diagnostic Capabilities for Select Biodefense and Emerging Pathogens (R21/R33)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855 Allergy, Immunology and Transplantation Research 93.856 Microbiology and Infectious Diseases Research.
  • This funding opportunity was created on Mar 17, 2011 and posted on Mar 17, 2011.
  • Applicants must submit their applications by Jul 14, 2011. (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 $200,000.00 in funding.
  • Eligible applicants include: Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) Others (see text field entitled Additional Information on Eligibility for clarification) County governments City or township governments Public housing authorities/Indian housing authorities Small businesses Native American tribal organizations (other than Federally recognized tribal governments) For profit organizations other than small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts State governments Public and State controlled institutions of higher education Special district governments Private institutions of higher education.
  • 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) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Foreign (non U.S.) components of U.S. Organizations are allowed.
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Opportunity Summary:

The NIH funding opportunity titled "Improved Diagnostic Capabilities for Select Biodefense and Emerging Pathogens (R21/R33)" (Funding Opportunity Number RFA-AI-11-024) was a discretionary grant program aimed at advancing diagnostic tools for pathogens of biodefense concern and for emerging infectious disease threats. The core purpose was to push research along the spectrum from basic discovery into translational development, with an emphasis on diagnostics that are meaningfully improved over existing options and, where appropriate, capable of being used in field settings. In practical terms, the opportunity was geared toward projects that could strengthen detection and identification of high-consequence pathogens, including work that supports faster, more sensitive, more specific, more robust, or more deployable diagnostic approaches.

This announcement used the R21/R33 phased innovation mechanism. That structure is typically intended to help investigators move from an early, proof-of-concept stage (R21) into a more advanced development and validation stage (R33) once predefined milestones are met. In the context of this opportunity, applicants were expected to propose a development path where early work could establish feasibility and key performance characteristics, and later work could translate that into a more mature diagnostic capability, such as a refined assay, platform, workflow, or prototype that is closer to real-world use. The emphasis on "field appropriate" diagnostics signals interest in tools that can function outside highly resourced laboratory environments, for example with simpler sample processing, fewer instrumentation requirements, improved stability of reagents, quicker turnaround times, or usability by operators who are not specialized research laboratorians.

The program fell under NIH health research activity categories tied to infectious diseases and immune-related research, specifically CFDA 93.856 (Microbiology and Infectious Diseases Research) and 93.855 (Allergy, Immunology and Transplantation Research). While the scientific scope was centered on diagnostics, these program classifications reflect the broader infectious disease and host-response context that often shapes what a useful diagnostic needs to measure, whether that is direct pathogen detection, antigen detection, nucleic acid signatures, or host biomarkers that support differential diagnosis. The sponsoring agency was the National Institutes of Health, and the posted and creation dates were March 17, 2011, with a single original and current closing date of July 14, 2011. The opportunity later moved to archive status on August 14, 2011.

From a funding perspective, the announcement listed an estimated total funding amount of $4,000,000 and an award ceiling of $200,000. It explicitly stated that there was no cost sharing or matching requirement, meaning applicants were not required to contribute non-federal funds as a condition of receiving an award. The funding instrument type was a grant, and the opportunity category was discretionary, which is standard for NIH research project funding where awards are made based on scientific merit review and program priorities rather than formula-based allocation.

Eligibility was broad and designed to include a wide range of research and development performers. Eligible applicants included public and private institutions of higher education, nonprofit organizations with or without 501(c)(3) status, for-profit organizations (including small businesses and other for-profit entities), and multiple levels of government such as state, county, city or township governments, special district governments, independent school districts, and public housing authorities/Indian housing authorities. The announcement also included tribal governments and tribal organizations, including Federally recognized tribal governments and other tribal entities. Additional eligible categories explicitly listed included historically underserved and mission-focused institutions and organizations such as Historically Black Colleges and Universities (HBCUs), Hispanic Serving Institutions, Alaska Native and Native Hawaiian Serving Institutions, and Tribally Controlled Colleges and Universities (TCCUs), as well as faith-based and community-based organizations. Importantly, the eligibility language also allowed participation by non-U.S. entities (foreign organizations), U.S. territories or possessions, and foreign components of U.S. organizations, along with regional organizations and eligible federal agencies, reflecting a recognition that emerging pathogen threats and biodefense preparedness can involve international collaboration, specialized facilities, or geographically distributed expertise.

The official public listing provided an additional information link hosted on the NIH grants site (http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-11-024.html), which would have contained the detailed scientific requirements, review criteria, and any pathogen or use-case priorities. For access and technical issues, the contact point given was the NIH Office of Extramural Research (OER) webmaster via FBOWebmaster@OD.NIH.GOV, specifically for problems accessing the announcement or linking to it electronically.

Overall, this opportunity was designed to strengthen the diagnostic pipeline for select biodefense and emerging pathogens by supporting research that does not stop at basic findings, but instead aims to convert promising ideas into practical diagnostic capabilities, including those suitable for use in constrained or field environments, under a structured phased award mechanism intended to de-risk development and reward milestone-driven progress.

FAQs: Improved Diagnostic Capabilities for Select Biodefense and Emerging Pathogens (R21/R33) (RFA-AI-11-024)

What is this funding opportunity?

This was an NIH discretionary grant funding opportunity titled "Improved Diagnostic Capabilities for Select Biodefense and Emerging Pathogens (R21/R33)," Funding Opportunity Number RFA-AI-11-024. It supported research and development intended to improve diagnostic tools for pathogens of biodefense concern and emerging infectious disease threats.

What was the main goal of the program?

The core purpose was to move diagnostic research along the spectrum from basic discovery into translational development, with an emphasis on diagnostics that are meaningfully improved over existing options and, where appropriate, usable in field settings.

What kinds of improvements were NIH looking for in diagnostics?

The opportunity emphasized diagnostics that could be faster, more sensitive, more specific, more robust, or more deployable than existing approaches. It also highlighted practical improvements that support real-world use, including field-appropriate operation.

What does "field appropriate" mean in this context?

"Field appropriate" signaled interest in diagnostic tools that can function outside highly resourced laboratory environments. Examples described in the opportunity included simpler sample processing, fewer instrumentation requirements, improved reagent stability, quicker turnaround times, and usability by operators who are not specialized research laboratorians.

What is the R21/R33 phased innovation mechanism?

This announcement used the R21/R33 phased innovation structure, which is typically designed to help investigators progress from an early proof-of-concept stage (R21) to a more advanced development and validation stage (R33) after meeting predefined milestones.

How were applicants expected to use the R21 phase versus the R33 phase?

Applicants were expected to propose a development path where early work (R21) establishes feasibility and key performance characteristics, and later work (R33) translates that progress into a more mature diagnostic capability, such as a refined assay, platform, workflow, or prototype closer to real-world use.

What types of diagnostic approaches were within scope?

The scientific scope centered on diagnostics, and the description noted that useful diagnostics may measure direct pathogen detection, antigen detection, nucleic acid signatures, or host biomarkers that support differential diagnosis.

Which pathogens were targeted?

The opportunity focused on "select biodefense and emerging pathogens." The provided summary does not list specific pathogens, and the detailed priorities would have been found in the official NIH posting linked in the announcement.

Who sponsored this funding opportunity?

The sponsoring agency was the National Institutes of Health (NIH).

What were the relevant NIH/CFDA program classifications?

The program was associated with CFDA 93.856 (Microbiology and Infectious Diseases Research) and CFDA 93.855 (Allergy, Immunology and Transplantation Research).

Was this a discretionary or formula grant?

This was a discretionary grant program, which is typical for NIH research project funding where awards are made based on scientific merit review and program priorities rather than a formula allocation.

What was the funding instrument type?

The funding instrument type was a grant.

How much total funding was estimated for the program?

The announcement listed an estimated total funding amount of $4,000,000.

What was the award ceiling?

The award ceiling listed in the announcement was $200,000.

Was cost sharing or matching required?

No. The opportunity explicitly stated there was no cost sharing or matching requirement.

When was the opportunity posted and when did it close?

The posted and creation dates were March 17, 2011, and the single original/current closing date was July 14, 2011.

Is this opportunity still open?

No. The opportunity moved to archive status on August 14, 2011.

What kinds of organizations were eligible to apply?

Eligibility was broad. Eligible applicants included public and private institutions of higher education; nonprofit organizations with or without 501(c)(3) status; for-profit organizations (including small businesses and other for-profit entities); and various government entities (state, county, city/township, special districts, independent school districts, and public housing authorities/Indian housing authorities).

Were tribal governments and tribal organizations eligible?

Yes. The eligibility language included federally recognized tribal governments and other tribal entities, as well as tribal organizations.

Were institutions like HBCUs, HSIs, AN/NH-serving institutions, and TCCUs included in eligibility?

Yes. The eligibility categories explicitly listed Historically Black Colleges and Universities (HBCUs), Hispanic Serving Institutions, Alaska Native and Native Hawaiian Serving Institutions, and Tribally Controlled Colleges and Universities (TCCUs).

Could faith-based or community-based organizations apply?

Yes. Faith-based and community-based organizations were explicitly included among eligible applicant categories.

Were non-U.S. (foreign) organizations allowed to participate?

Yes. The eligibility language allowed foreign organizations, U.S. territories or possessions, and foreign components of U.S. organizations. It also mentioned regional organizations and eligible federal agencies.

Where could applicants find the official detailed announcement?

The public listing referenced an NIH grants page for additional information: http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-11-024.html

Who was the contact for access or technical issues with the announcement?

For problems accessing the announcement or linking to it electronically, the contact listed was the NIH Office of Extramural Research (OER) webmaster at FBOWebmaster@OD.NIH.GOV.

What kind of end product did NIH want to see by the later phase of the project?

The opportunity emphasized translating early findings into a more mature diagnostic capability, such as a refined assay, platform, workflow, or prototype that is closer to real-world use, particularly where field deployment is appropriate.

Does the summary specify the exact milestones required to transition from R21 to R33?

No. The summary notes that transition depends on meeting predefined milestones, but it does not list the specific milestones. Those would typically be defined in the full funding opportunity details.

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