Opportunity Information: Apply for PA 09 115
Apply for PA 09 115
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIAID Advanced Technology SBIR (NIAID at SBIR R43/R44)" 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 Feb 27, 2009 and posted on Feb 27, 2009.
- Applicants must submit their applications by Jan 7, 2010. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Small businesses.
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Opportunity Summary:
The NIAID Advanced Technology SBIR opportunity (Funding Opportunity Number PA 09 115) was a National Institutes of Health (NIH) discretionary grant program run through the Small Business Innovation Research (SBIR) mechanisms R43/R44. It was designed specifically for small business concerns that are building advanced, FDA-regulated biomedical products and need more time and potentially larger budgets than what is typically available under standard SBIR limits. In other words, this announcement targeted later-stage, clearly product-driven R and D efforts where the end goal is a definable item that would ultimately go through the Food and Drug Administration approval pathway, rather than open-ended discovery research.
A key feature of this FOA is how it defines "advanced technology." To be considered responsive, a project had to revolve around a clearly identified product or service requiring FDA approval, and it needed to fall into one of three topic areas aligned with NIAID's mission space. The first area covers vaccines, biologics, or drugs intended to treat infectious diseases as well as immunologic diseases, allergy, or transplantation-related conditions. The second area focuses on vaccine, biologic, or drug delivery systems, meaning technologies that enable or improve how those medical products are administered or reach their targets. The third area supports assays and related diagnostic technologies for infectious, immunologic, or allergic diseases, including assays that aid transplantation, plus therapeutic monitoring systems used in clinical trials of vaccines, biologics, drugs, or transplantation. The common thread across all three areas is that the work should be moving a specific, regulated product toward readiness, rather than building general research tools without a defined clinical product endpoint.
The announcement draws a bright line between product-focused development and more exploratory platform or enabling research. It even provides an example to clarify what NIAID meant: a project centered on a lead compound for an AIDS drug is considered a clearly identified product, because it is tied to a specific therapeutic candidate that could proceed through preclinical development and, eventually, FDA review. By contrast, a project aimed at developing an assay to identify lead compounds is not considered a clearly identified product under this FOA, because it is essentially a discovery-enabling tool rather than a defined therapeutic, vaccine, delivery system, or diagnostic intended for FDA approval in the way described. That distinction matters because the FOA explicitly states that only applications meeting the advanced technology definition should be submitted.
Another important restriction is that applications were not supposed to include human clinical trials. The intent was to support advanced preclinical development and technology maturation work that still stops short of conducting clinical studies in humans. This typically implies activities like optimizing candidates or formulations, developing and validating assays for intended diagnostic or monitoring use, building and testing delivery systems, demonstrating performance in relevant preclinical models, and generating the types of data packages that position a product for subsequent regulatory steps, partnerships, or later-stage funding mechanisms that do allow clinical trials.
From an administrative standpoint, the program sat within NIH under the National Institute of Allergy and Infectious Diseases (NIAID) and aligned with CFDA program areas 93.855 (Allergy, Immunology and Transplantation Research) and 93.856 (Microbiology and Infectious Diseases Research). Eligibility was limited to small businesses, and there was no cost sharing or matching requirement. The opportunity was posted on February 27, 2009, with an original and final closing date of January 7, 2010, and it was archived on February 7, 2010. The full announcement was available through the NIH grants guide, and NIH provided technical contact support through the NIH Office of Extramural Research (OER) webmaster for access or linking issues.
Overall, this FOA was essentially a targeted SBIR pathway for small companies working on FDA-regulated, product-centric technologies in NIAID-relevant disease and immunology areas, offering a structure meant to accommodate longer timelines and larger resource needs than typical SBIR projects, while keeping the work preclinical and clearly tied to a specific end product.
Frequently Asked Questions (FAQs)
What is the NIAID Advanced Technology SBIR opportunity (PA 09 115)?
PA 09 115 was a National Institutes of Health (NIH) discretionary funding opportunity run by the National Institute of Allergy and Infectious Diseases (NIAID) using the Small Business Innovation Research (SBIR) grant mechanisms R43/R44. It was designed for small business concerns developing advanced, FDA-regulated biomedical products and was structured to better accommodate longer timelines and potentially larger budgets than standard SBIR limits.
Who ran this program?
The program was administered within NIH by NIAID (National Institute of Allergy and Infectious Diseases).
What is the purpose of this FOA?
The purpose was to support later-stage, clearly product-driven research and development aimed at moving a definable biomedical product or service toward FDA approval. It was not intended for open-ended discovery research.
What does "advanced technology" mean under this FOA?
Under this FOA, "advanced technology" meant a project centered on a clearly identified product or service that would require FDA approval. To be responsive, the project also had to fall within one of three topic areas aligned with NIAID's mission (vaccines/biologics/drugs; delivery systems; diagnostics/assays and therapeutic monitoring systems tied to regulated products).
What kinds of projects were considered responsive topic areas?
Responsive projects had to focus on a clearly identified, FDA-regulated product or service in one of these areas:
- Vaccines, biologics, or drugs to treat infectious diseases and/or immunologic diseases, allergy, or transplantation-related conditions
- Vaccine, biologic, or drug delivery systems (technologies that enable or improve administration or targeting)
- Assays and related diagnostic technologies for infectious, immunologic, or allergic diseases (including assays that aid transplantation), plus therapeutic monitoring systems used in clinical trials of vaccines, biologics, drugs, or transplantation
What is the key emphasis: product development or discovery research?
The emphasis was product-focused development. The FOA drew a clear line between advancing a specific regulated product versus conducting exploratory platform work or building general discovery tools without a defined clinical product endpoint.
Can you give an example of a project that qualifies as a clearly identified product?
Yes. The FOA gave an example that a project centered on a lead compound for an AIDS drug qualifies because it is tied to a specific therapeutic candidate that could proceed through preclinical development and eventually an FDA review pathway.
What is an example of a project that would not qualify under the "clearly identified product" requirement?
A project aimed at developing an assay to identify lead compounds would not qualify as a clearly identified product under this FOA, because it is positioned as a discovery-enabling tool rather than a defined therapeutic, vaccine, delivery system, or diagnostic intended to proceed through FDA approval as described.
Were human clinical trials allowed under this opportunity?
No. Applications were not supposed to include human clinical trials. The intent was to support advanced preclinical development and technology maturation work that stops short of conducting clinical studies in humans.
What types of work fit the "preclinical" intent described in the FOA?
Based on the description, this typically included activities such as optimizing candidates or formulations, developing and validating assays for intended diagnostic or monitoring use, building and testing delivery systems, demonstrating performance in relevant preclinical models, and generating data packages to position a product for later regulatory steps, partnerships, or later-stage funding that allows clinical trials.
What SBIR mechanisms were used for this funding opportunity?
This FOA used the SBIR mechanisms R43/R44.
Who was eligible to apply?
Eligibility was limited to small businesses (small business concerns).
Was cost sharing or matching required?
No. The opportunity stated there was no cost sharing or matching requirement.
What CFDA program areas did this FOA align with?
This FOA aligned with CFDA program areas 93.855 (Allergy, Immunology and Transplantation Research) and 93.856 (Microbiology and Infectious Diseases Research).
When was this funding opportunity posted and when did it close?
The opportunity was posted on February 27, 2009. The original and final closing date was January 7, 2010.
Is this opportunity still active?
No. It was archived on February 7, 2010.
Where could applicants access the full announcement?
The full announcement was available through the NIH Grants Guide.
Who provided technical contact support for access or linking issues?
NIH provided technical contact support through the NIH Office of Extramural Research (OER) webmaster for access or linking issues.
Why did this FOA mention longer timelines and potentially larger budgets?
It was designed for companies building advanced, FDA-regulated products that may need more time and potentially larger budgets than what is typically available under standard SBIR limits, reflecting the resource demands of later-stage, product-driven preclinical development.
What is the main "fit test" for whether an application belonged under this FOA?
The main fit test was whether the proposed work advanced a clearly identified, FDA-regulated product or service in one of the three specified topic areas, and whether it remained preclinical (no human clinical trials).
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