Opportunity Information: Apply for PA 10 124
Apply for PA 10 124
- 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 Dec 12, 2012 and posted on Mar 5, 2010.
- Applicants must submit their applications by Jan 7, 2014. (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 (R41/R42) funding opportunity (PA-10-124) is a National Institutes of Health (NIH) grant program from the National Institute of Allergy and Infectious Diseases (NIAID) designed specifically for small business concerns that are developing higher-cost, longer-timeline technologies than what is typically supported under standard small business programs. The core idea is to help small businesses move beyond early feasibility work and push a well-defined, regulated product or service closer to real-world use, particularly when the development path requires a larger budget and more time because it involves regulatory approval.
A key requirement is that the project must qualify as an "advanced technology" effort as NIAID defines it: the work needs to be centered on a clearly identified product or service that will require U.S. Food and Drug Administration (FDA) approval and that fits squarely within NIAID's mission areas. In practical terms, this is meant to fund product-driven development rather than general research tool-building. The announcement even gives a straightforward example of what NIAID considers appropriate: a project focused on advancing a lead compound for an AIDS drug is product-specific and FDA-relevant, so it fits. By contrast, a project aimed at developing an assay to identify lead compounds is more of an enabling research tool and does not itself represent a defined FDA-regulated product, so it would not be a good match for this FOA. The emphasis is on applications that can point to a specific deliverable (such as a therapeutic candidate, vaccine-related product, diagnostic, or other FDA-regulated health technology) and a development path that logically leads toward FDA review.
Another important boundary is that applications submitted under this opportunity must not include human clinical trials. NIAID policy at the time of this announcement indicated that investigator-initiated clinical trials should be submitted using the R34 mechanism instead, and the FOA directs applicants to NIAID guidance on that clinical trial pathway. So while the funded work can support preclinical development and other preparatory steps that move a product toward the clinic, the actual conduct of human clinical trials is explicitly outside the scope for submissions to this program.
On the funding structure, this FOA uses the Small Business Technology Transfer Research (STTR) mechanisms R41 (Phase I) and R42 (Phase II), and it also allows Fast-Track applications that combine Phase I and Phase II planning into a single, coordinated submission. STTR programs generally require a formal collaboration between the small business and a nonprofit research institution, reflecting the intent to translate innovations that arise through joint small business-academic partnerships. This STTR FOA runs in parallel with an equivalent NIAID announcement for the SBIR program (PA-10-123) that uses the R43/R44 mechanisms, meaning applicants should choose the mechanism that best fits their organizational setup and collaboration model while targeting the same overall scientific and product-development goals.
In terms of what is available, the FOA makes clear that the number of awards and total dollars are not fixed in advance. Funding decisions depend on the availability of appropriated funds and on receiving enough high-quality, meritorious applications. Award sizes and counts will vary based on the proposed duration, costs, and overall strength of the applications, which is a typical NIH approach for discretionary grant competitions where budgets flex with the quality and needs of the submitted projects.
From an administrative and categorization standpoint, the opportunity is a discretionary grant in the health funding category and is associated with CFDA programs 93.855 (Allergy, Immunology and Transplantation Research) and 93.856 (Microbiology and Infectious Diseases Research). It does not require cost sharing or matching. Eligibility is limited to small businesses. The opportunity was originally posted March 5, 2010, with later administrative dates listed in the record, and it ultimately moved through closing and archiving windows (with the final archive date shown as February 7, 2014). Applicants looking for the full announcement were directed to the NIH Grants Guide page for PA-10-124, and technical access issues were routed to the NIH Office of Extramural Research webmaster contact.
FAQs: NIAID Advanced Technology STTR (R41/R42) - PA-10-124
What is the NIAID Advanced Technology STTR (R41/R42) opportunity (PA-10-124)?
PA-10-124 is a National Institutes of Health (NIH) funding opportunity from the National Institute of Allergy and Infectious Diseases (NIAID) under the Small Business Technology Transfer Research (STTR) program. It is designed for small business concerns developing higher-cost, longer-timeline technologies than what is typically supported under standard small business programs, with a focus on moving a well-defined, regulated product or service closer to real-world use.
Who is this funding opportunity designed for?
This opportunity is designed specifically for small business concerns. It is an STTR program, which generally requires a formal collaboration between the small business and a nonprofit research institution.
What is the main goal of this FOA?
The main goal is to help small businesses move beyond early feasibility work and advance a clearly defined product or service toward practical use, particularly when development requires a larger budget and more time due to the need for regulatory approval (including FDA review).
What does NIAID mean by an "advanced technology" project under this FOA?
To qualify as an "advanced technology" effort as described in the opportunity, the project must be centered on a clearly identified product or service that will require U.S. Food and Drug Administration (FDA) approval and must fit within NIAID mission areas. The emphasis is product-driven development rather than general research tool-building.
What kinds of deliverables are expected from an application?
The FOA emphasizes applications that can point to a specific deliverable, such as a therapeutic candidate, a vaccine-related product, a diagnostic, or another FDA-regulated health technology, along with a development path that logically leads toward FDA review.
Can this FOA be used to build general research tools or enabling assays?
The FOA indicates that projects aimed at enabling research tools (for example, developing an assay to identify lead compounds) are not a good match if they do not themselves represent a defined FDA-regulated product. The program is intended for product-specific, FDA-relevant development.
Does the funded work need to be relevant to NIAID mission areas?
Yes. A key requirement is that the product or service must fit squarely within NIAID mission areas, in addition to requiring FDA approval.
Are human clinical trials allowed under PA-10-124?
No. Applications submitted under this opportunity must not include human clinical trials. The FOA explicitly states that human clinical trials are outside the scope for submissions to this program.
If human clinical trials are not allowed, what mechanism did NIAID point to for investigator-initiated clinical trials?
NIAID policy referenced in the opportunity indicated that investigator-initiated clinical trials should be submitted using the R34 mechanism, and the FOA directs applicants to NIAID guidance on that clinical trial pathway.
What stages of STTR funding are used in this FOA?
This FOA uses the STTR mechanisms R41 (Phase I) and R42 (Phase II).
Does the FOA allow Fast-Track applications?
Yes. The FOA allows Fast-Track applications that combine Phase I and Phase II planning into a single, coordinated submission.
How does STTR collaboration factor into eligibility and project structure?
As an STTR program, it generally requires a formal collaboration between the small business and a nonprofit research institution, reflecting the intent to translate innovations arising through joint small business-academic partnerships.
Is there a related SBIR opportunity tied to the same goals?
Yes. This STTR FOA runs in parallel with an equivalent NIAID announcement for the SBIR program (PA-10-123), which uses the R43/R44 mechanisms. Applicants are expected to choose the mechanism that best fits their organizational setup and collaboration model while targeting similar scientific and product-development goals.
How many awards will be made, and how much funding is available?
The FOA states that the number of awards and total dollars are not fixed in advance. Funding decisions depend on the availability of appropriated funds and the receipt of a sufficient number of high-quality, meritorious applications. Award sizes and counts may vary based on proposed duration, costs, and application strength.
Is cost sharing or matching required?
No. The opportunity does not require cost sharing or matching.
How is this opportunity categorized administratively?
It is described as a discretionary grant in the health funding category and is associated with CFDA programs 93.855 (Allergy, Immunology and Transplantation Research) and 93.856 (Microbiology and Infectious Diseases Research).
Where were applicants directed to find the full FOA text?
Applicants were directed to the NIH Grants Guide page for PA-10-124 for the full announcement.
Where were technical access issues directed?
Technical access issues were routed to the NIH Office of Extramural Research webmaster contact, as noted in the opportunity record.
When was the opportunity posted, and what is known about closing/archiving?
The opportunity was originally posted on March 5, 2010. The record also indicates it moved through closing and archiving windows, with a final archive date shown as February 7, 2014.
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