Opportunity Information: Apply for PA 09 116
Apply for PA 09 116
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIAID Advanced Technology STTR (NIAID at STTR R41/R42)" 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 STTR (NIAID at STTR R41/R42) funding opportunity (PA-09-116) was a discretionary NIH grant program run through the National Institute of Allergy and Infectious Diseases (NIAID). Its core aim was to support Small Business Technology Transfer Research (STTR) projects coming from eligible small business concerns, specifically projects that are more demanding in scope than what a typical SBIR-style effort would support. In practical terms, the program was designed for technologies that need more time and a larger budget to move meaningfully toward a regulated product, rather than early discovery work that is still trying to figure out what the eventual product might be.
A central requirement was that the work qualify as "advanced technology" as defined by the announcement. Here, advanced technology meant a clearly identified product or service that would require U.S. Food and Drug Administration (FDA) approval. The FOA was not meant for broad platform exploration or upstream discovery without a defined end product. The distinction the announcement makes is important: it gives the example that a project centered on a lead compound for an AIDS drug counts as a clearly identified product, while a project that merely develops an assay to identify lead compounds does not. In other words, the agency wanted applicants who could point to a specific candidate, device, or test that is being advanced toward regulatory review, rather than tools that might eventually enable product discovery.
The FOA targeted three main technology areas under NIAID's mission. First, it supported vaccines, biologics, or drugs intended to treat infectious diseases as well as immunologic diseases, allergy, or transplantation-related conditions. Second, it supported vaccine, biologic, or drug delivery systems, meaning technologies focused on how a therapeutic is formulated, delivered, or otherwise engineered to reach its target effectively and safely. Third, it supported diagnostic assays for infectious, immunologic, or allergic diseases, including assays used as aids to transplantation, as well as therapeutic monitoring systems used in clinical trials of vaccines, biologics, drugs, or transplantation. Across these areas, the common thread was translational readiness: the proposed work needed to move a defined product or service forward along a development path where FDA oversight is expected.
Another key boundary was that applications were not allowed to include human clinical trials. That restriction signals that the FOA was intended to fund preclinical or non-human stages of development, such as optimization, analytical validation, assay development and performance studies outside of human trials, formulation work, nonclinical safety studies, and other preparatory steps that advance a product toward an Investigational New Drug (IND), Investigational Device Exemption (IDE), or similar regulatory milestone, without actually conducting a human trial under the grant.
From an administrative standpoint, this was an NIH grant mechanism under the STTR program using the R41/R42 phased structure, commonly associated with Phase I and Phase II STTR awards. The activity area was health, and it aligned with CFDA numbers 93.855 (Allergy, Immunology and Transplantation Research) and 93.856 (Microbiology and Infectious Diseases Research). Cost sharing or matching was not required. Eligibility was limited to small businesses, consistent with STTR rules. The opportunity was posted February 27, 2009, and the final closing date was January 7, 2010, with an archive date of February 7, 2010. Additional details were provided through the NIH Grants Guide link associated with PA-09-116, with support contacts routed through the NIH Office of Extramural Research (OER) webmaster for technical access or linking issues.
Overall, this FOA was best suited for small businesses partnering through STTR that already had a defined vaccine, therapeutic, delivery technology, or diagnostic/monitoring assay in hand and needed substantial support to advance it through rigorous, FDA-relevant development steps, while explicitly stopping short of running human clinical trials within the proposed project.
FAQs: NIAID Advanced Technology STTR (NIAID at STTR R41/R42) - PA-09-116
What is the NIAID Advanced Technology STTR funding opportunity (PA-09-116)?
PA-09-116 was a discretionary NIH grant program run by the National Institute of Allergy and Infectious Diseases (NIAID) under the Small Business Technology Transfer Research (STTR) mechanism using the R41/R42 phased structure (commonly associated with Phase I and Phase II STTR awards).
What was the main purpose of this FOA?
The program aimed to support STTR projects from eligible small business concerns that were more demanding in scope than a typical SBIR-style effort. It focused on technologies that needed more time and a larger budget to move meaningfully toward a regulated product, rather than early discovery work where the end product is still undefined.
Who was eligible to apply?
Eligibility was limited to small businesses, consistent with STTR rules.
What does "advanced technology" mean in this announcement?
In PA-09-116, "advanced technology" meant a clearly identified product or service that would require U.S. Food and Drug Administration (FDA) approval. The FOA was not intended for broad platform exploration or upstream discovery without a defined end product.
What kinds of projects were considered a good fit?
The FOA was best suited for small businesses (working through STTR) that already had a defined vaccine, therapeutic, delivery technology, diagnostic assay, or therapeutic monitoring system in hand and needed substantial support to advance it through rigorous, FDA-relevant development steps, stopping short of human clinical trials.
Can you give an example of what counts as a clearly identified product?
The announcement distinguishes between a project centered on a lead compound for an AIDS drug (which counts as a clearly identified product) versus a project that develops an assay to identify lead compounds (which does not). The expectation was that applicants could point to a specific candidate, device, or test being advanced toward regulatory review.
Are discovery or platform projects allowed?
The FOA was not meant for broad platform exploration or upstream discovery without a defined end product. Projects needed to be tied to a specific product or service expected to require FDA approval.
What technology areas did the FOA target under NIAID's mission?
The FOA targeted three main areas: (1) vaccines, biologics, or drugs to treat infectious diseases as well as immunologic diseases, allergy, or transplantation-related conditions; (2) vaccine, biologic, or drug delivery systems; and (3) diagnostic assays for infectious, immunologic, or allergic diseases (including assays used as aids to transplantation) as well as therapeutic monitoring systems used in clinical trials of vaccines, biologics, drugs, or transplantation.
What is meant by vaccine/biologic/drug delivery systems in this context?
Delivery systems refer to technologies focused on how a therapeutic is formulated, delivered, or otherwise engineered to reach its target effectively and safely.
What diagnostic work was within scope?
The FOA supported diagnostic assays for infectious, immunologic, or allergic diseases, including assays used as aids to transplantation. It also included therapeutic monitoring systems used in clinical trials of vaccines, biologics, drugs, or transplantation (with the important restriction that the grant itself could not include human clinical trials).
Were human clinical trials allowed under this FOA?
No. Applications were not allowed to include human clinical trials.
If human clinical trials were not allowed, what kinds of work could be supported?
The FOA was intended to support preclinical or non-human stages of development that advance a product toward regulatory milestones (such as an IND or IDE) without conducting a human trial. Examples described include optimization, analytical validation, assay development and performance studies outside of human trials, formulation work, and nonclinical safety studies.
What types of regulatory milestones were relevant to this program?
The program emphasized advancement along a development path where FDA oversight is expected, including preparatory steps toward milestones such as an Investigational New Drug (IND) application or an Investigational Device Exemption (IDE), or similar regulatory milestones.
What grant mechanisms were used?
This was an NIH STTR funding opportunity using the R41/R42 phased structure.
What was the activity area and which CFDA numbers were associated with the FOA?
The activity area was health. The FOA aligned with CFDA 93.855 (Allergy, Immunology and Transplantation Research) and 93.856 (Microbiology and Infectious Diseases Research).
Was cost sharing or matching required?
No. Cost sharing or matching was not required.
When was this opportunity posted and when did it close?
The opportunity was posted on February 27, 2009. The final closing date was January 7, 2010. The archive date was February 7, 2010.
Where could applicants find the official announcement details?
Additional details were provided through the NIH Grants Guide link associated with PA-09-116.
Who was listed for technical or access-related support?
Support contacts for technical access or linking issues were routed through the NIH Office of Extramural Research (OER) webmaster.
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