Opportunity Information: Apply for RFA AI 12 017
Apply for RFA AI 12 017
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Partnerships for Development of Therapeutics and Diagnostics 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 Dec 16, 2011 and posted on Dec 16, 2011.
- Applicants must submit their applications by May 24, 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 $9,300,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $750,000.00 in funding.
- Eligible applicants include: Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Private institutions of higher education Special district governments State governments Native American tribal organizations (other than Federally recognized tribal governments) Native American tribal governments (Federally recognized) Small businesses For profit organizations other than small businesses Public housing authorities/Indian housing authorities City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education Independent school districts County 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) 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 Development of Therapeutics and Diagnostics for Biodefense (R01) (Funding Opportunity Number RFA-AI-12-017) was a National Institute of Allergy and Infectious Diseases (NIAID), NIH grant opportunity designed to push promising biodefense medical countermeasures beyond early research and into practical, preclinical product development. The focus was specifically on advancing lead candidate therapeutics or diagnostics that target NIAID Category A, B, or C priority agents, meaning pathogens and biological threats that the U.S. government considers high priority for biodefense because of their potential public health impact, ease of dissemination, or ability to cause severe disease.
A central idea of this FOA was that strong partnerships are often what make the difference between an interesting academic result and a real-world product. For that reason, applications were expected to be structured around a development-oriented collaboration, and they had to show substantive investment by at least one industrial participant. In practice, this requirement signaled that NIAID wanted applicants to bring in private-sector capabilities such as manufacturing know-how, quality systems, assay development experience, regulatory planning, scale-up, and other productization skills that are usually necessary to move a candidate toward later-stage development.
The program supported preclinical development activities rather than basic discovery. While the announcement summary does not list every allowable experiment, the intent was to fund work that de-risks and matures a lead candidate so it is closer to being ready for clinical development or advanced validation. For therapeutics, that typically means optimizing and characterizing the lead, establishing or refining relevant in vitro and in vivo efficacy models, conducting preliminary safety or toxicology-enabling studies appropriate for the stage, improving formulation or delivery if needed, and generating data packages that can support a credible regulatory path. For diagnostics, that usually includes assay refinement, analytical validation work (such as sensitivity, specificity, reproducibility, and robustness), evaluation using relevant specimens or panels when available, and planning for how the test could be produced and used in realistic settings.
Applications also had to include a Product Development Strategy attachment. That requirement was an explicit push toward a product-style plan rather than a purely hypothesis-driven academic narrative. A competitive strategy in this context would normally spell out the target product profile, key development milestones and go/no-go decision points, risk management plans, the role and commitments of the industry partner(s), and how the proposed preclinical work fits into a broader pathway toward deployment, approval, or authorization. The attachment requirement also implies that reviewers would be looking for disciplined program management: clear timelines, measurable deliverables, and a logical sequence of experiments tied to development decisions.
In terms of award mechanics, this was an NIH R01 grant mechanism under the health research activity categories associated with CFDA numbers 93.855 (Allergy and Infectious Diseases Research) and 93.856 (Microbiology and Infectious Diseases Research). The opportunity was posted on December 16, 2011, with an original and current closing date of May 24, 2012, and an archive date of June 24, 2012, indicating it is no longer accepting applications. The estimated total funding listed for the FOA was $9.3 million, and the award ceiling was $750,000. The FOA stated there was no cost sharing or matching requirement, which typically means applicants were not required to provide a formal cost match, even though the program still required meaningful industry investment as part of the partnership model.
Eligibility was broad and included a wide mix of U.S. public and private institutions: nonprofits (including 501(c)(3) organizations), public and state-controlled institutions of higher education, private institutions of higher education, small businesses, for-profit entities (including those other than small businesses), state and local governments (including counties, cities/townships, special district governments, and independent school districts), public housing authorities/Indian housing authorities, and tribal governments and organizations. The eligibility language also explicitly included a range of mission-focused institutions 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 where appropriate. Importantly, the FOA allowed foreign involvement: non-U.S. entities (foreign organizations and foreign institutions) were eligible to apply, non-U.S. components of U.S. organizations were eligible, and foreign components (as defined by NIH policy) were allowed.
Operationally, the administering agency was NIH via NIAID. The FOA provided a link to the full announcement on the NIH grants site (http://grants.nih.gov/grants/guide/rfa_files/RFA-AI-12-017.html). For access or technical issues, the listed point of contact was the NIH Office of Extramural Research webmaster (FBOWebmaster@OD.NIH.GOV), reflecting standard NIH practice for resolving announcement-linking or availability problems.
Overall, the opportunity was aimed at teams that already had a credible lead candidate and were ready to do the kind of rigorous preclinical development work that makes a therapeutic or diagnostic more real, more reproducible, and more transferable into later stages. The required Product Development Strategy and the requirement for substantive industrial investment were the clearest signals that NIAID wanted projects run with a product mindset: practical milestones, partner accountability, and a clear plan for translating biodefense science into usable countermeasures.
Frequently Asked Questions (FAQs)
What is the Partnerships for Development of Therapeutics and Diagnostics for Biodefense (R01) opportunity?
It was a National Institute of Allergy and Infectious Diseases (NIAID), NIH funding opportunity (Funding Opportunity Number RFA-AI-12-017) that used the NIH R01 mechanism to support development-focused partnerships working on biodefense medical countermeasures. The intent was to move promising therapeutic or diagnostic leads beyond early research into practical, preclinical product development.
What types of products were in scope?
The FOA focused on lead candidate therapeutics and lead candidate diagnostics intended for biodefense use. The emphasis was on advancing a candidate that already exists (a "lead") toward readiness for later-stage development.
Which biological threats were targeted?
Projects had to target NIAID Category A, B, or C priority agents. These are pathogens and biological threats considered high priority for biodefense due to factors like potential public health impact, ease of dissemination, or ability to cause severe disease.
Was this program for basic research or product development?
This program supported preclinical development rather than basic discovery. The stated intent was to fund work that de-risks and matures a lead candidate so it is closer to being ready for clinical development (for therapeutics) or advanced validation and realistic use (for diagnostics).
What kinds of activities were generally expected for therapeutic development?
Based on the FOA description, typical therapeutic preclinical development activities could include lead optimization and characterization, establishing or refining relevant in vitro and in vivo efficacy models, preliminary safety or toxicology-enabling studies appropriate for the stage, formulation or delivery improvements if needed, and generating data packages consistent with a credible regulatory path.
What kinds of activities were generally expected for diagnostic development?
Based on the FOA description, diagnostic development commonly included assay refinement and analytical validation work such as sensitivity, specificity, reproducibility, and robustness. It also included evaluation using relevant specimens or panels when available, and planning for how the test could be produced and used in realistic settings.
What was the key partnership requirement?
Applications were expected to be built around a development-oriented collaboration and had to show substantive investment by at least one industrial participant. The FOA positioned partnerships as central to translating academic results into real-world products.
What did "substantive industrial investment" imply in practice?
The FOA emphasized the value of private-sector capabilities needed to "productize" a candidate, such as manufacturing know-how, quality systems, assay development experience, regulatory planning, scale-up, and other practical development skills. The application was expected to demonstrate meaningful engagement and commitment from an industry participant.
Was cost sharing or matching required?
No. The FOA stated there was no cost sharing or matching requirement. At the same time, the program still required meaningful industry investment as part of the partnership model, even if that was not framed as formal cost match.
What is the Product Development Strategy attachment?
The application had to include a Product Development Strategy attachment. This requirement pushed applicants to provide a product-style plan rather than relying only on a hypothesis-driven academic narrative.
What would a strong Product Development Strategy typically include?
In the context described by the FOA, a competitive strategy would usually define a target product profile, key development milestones, go/no-go decision points, risk management plans, the role and commitments of the industry partner(s), and how the preclinical work fits into a broader pathway toward deployment, approval, or authorization. The FOA also implied reviewers would look for clear timelines, measurable deliverables, and a logical sequence of development decisions.
What funding mechanism was used?
The FOA used the NIH R01 grant mechanism.
Which CFDA program areas were associated with this opportunity?
The FOA was associated with CFDA 93.855 (Allergy and Infectious Diseases Research) and 93.856 (Microbiology and Infectious Diseases Research).
How much total funding was estimated for the FOA?
The estimated total funding listed for the FOA was $9.3 million.
What was the award ceiling?
The award ceiling listed for the FOA was $750,000.
When was the opportunity posted and when did it close?
The FOA was posted on December 16, 2011. The original and current closing date was May 24, 2012. The archive date was June 24, 2012.
Is this funding opportunity still accepting applications?
No. The archive date and the stated closing date indicate the FOA is no longer accepting applications.
Who administered the program?
The administering agency was NIH through the National Institute of Allergy and Infectious Diseases (NIAID).
Who was eligible to apply?
Eligibility was broad and included U.S. public and private institutions such as nonprofits (including 501(c)(3) organizations), public and state-controlled institutions of higher education, private institutions of higher education, small businesses, for-profit entities (including those other than small businesses), and various units of state and local government (including counties, cities/townships, special district governments, and independent school districts). Public Housing Authorities/Indian Housing Authorities, tribal governments and organizations, and other mission-focused institutions were also included.
Were specific institution types explicitly included (HBCUs, Hispanic-serving institutions, etc.)?
Yes. The FOA explicitly included institution types 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). It also referenced faith-based and community-based organizations where appropriate.
Could non-U.S. organizations participate or apply?
Yes. The FOA allowed foreign involvement, stating that non-U.S. entities (foreign organizations and foreign institutions) were eligible to apply, non-U.S. components of U.S. organizations were eligible, and foreign components (as defined by NIH policy) were allowed.
Where could applicants find the full announcement?
The FOA provided a link to the NIH grants page for the full announcement: http://grants.nih.gov/grants/guide/rfa_files/RFA-AI-12-017.html
Who was the contact for access or technical issues with the announcement?
For access or technical issues, the listed contact was the NIH Office of Extramural Research webmaster at FBOWebmaster@OD.NIH.GOV.
What kinds of teams was this FOA designed for?
The FOA was aimed at teams that already had a credible lead candidate and were ready to conduct rigorous preclinical development work. The required Product Development Strategy and the requirement for substantive industrial investment signaled an expectation of disciplined, product-minded project execution with partner accountability and practical milestones.
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