Opportunity Information: Apply for PA 10 123
Apply for PA 10 123
- 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 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.)
- Each selected applicant is eligible to receive up to $300,000.00 in funding.
- Eligible applicants include: Small businesses.
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Opportunity Summary:
The NIAID Advanced Technology SBIR (NIAID AT SBIR R43/R44), Funding Opportunity Number PA-10-123, is a National Institutes of Health grant opportunity designed specifically for small business concerns that are developing later-stage, product-driven biomedical technologies. It sits within NIAID's mission areas, including Allergy, Immunology and Transplantation Research (CFDA 93.855) and Microbiology and Infectious Diseases Research (CFDA 93.856). The core idea is to support advanced technology projects that need more time and potentially more support than what standard SBIR awards typically allow, with an emphasis on moving a real, defined product toward the kind of regulatory pathway that ends in FDA review and approval.
A key requirement is that the proposed work must be centered on a clearly identified product or service that will require FDA approval and fits within NIAID's scientific scope. In practical terms, NIAID is looking for projects that are already anchored to a specific end product, such as a particular lead compound being advanced as an AIDS therapeutic, a vaccine candidate, a diagnostic device, or another defined medical product with an FDA-regulated endpoint. The FOA draws a bright line between product development and earlier discovery-enabling work. For example, a project that primarily builds an assay to help discover or screen for future lead compounds is described as not appropriate here because it does not commit to a single, identifiable FDA-bound product. Only applicants who can clearly articulate the product, the development plan, and the regulatory relevance are a good fit for this announcement.
This FOA uses the SBIR grant mechanisms R43/R44, which correspond to Phase I, Phase II, and Fast Track applications. Phase I generally supports early feasibility and proof-of-concept work, Phase II supports further R&D and development toward commercialization, and Fast Track allows applicants to propose Phase I and Phase II in a single combined application when the project is ready for that accelerated review path. The announcement also notes that it runs in parallel with a separate, scientifically identical opportunity for the STTR program (PA-10-124, using R41/R42), which is relevant for teams deciding whether their structure fits SBIR (small business-led R&D) or STTR (formal small business-research institution collaboration).
There are also firm boundaries around human clinical research. Applications submitted under this FOA must not include human clinical trials. NIAID policy referenced in the announcement indicates that investigator-initiated clinical trials should instead be pursued through the R34 mechanism, and the FOA points applicants to NIAID guidance for that pathway. In other words, this SBIR opportunity is intended to fund preclinical and product development activities that prepare a candidate technology for clinical testing, but not the clinical trial itself.
From an administrative and funding standpoint, this is a discretionary grant program with no cost sharing or matching requirement. The award ceiling listed in the source data is $300,000. The FOA explains that actual awards depend on the availability of funds and the number of high-quality applications received, meaning NIAID does not guarantee a specific number of awards. Funding decisions are expected to vary based on application merit, the proposed project duration, and the budget profile. The opportunity was originally posted March 5, 2010, later updated in the record, and has since been archived (with dates showing a final closing period ending in early 2014 and an archive date in February 2014), which matters if someone is researching it historically or looking for the most current successor announcement.
Overall, PA-10-123 is best understood as an SBIR route for small businesses that are past the purely exploratory stage and can credibly argue they are developing a specific FDA-approvable product in NIAID-relevant disease and immunology areas, while staying firmly on the non-clinical-trial side of the development pipeline.
FAQs: NIAID Advanced Technology SBIR (R43/R44) - PA-10-123
What is the NIAID Advanced Technology SBIR (PA-10-123)?
PA-10-123 is a National Institutes of Health (NIH) funding opportunity from the National Institute of Allergy and Infectious Diseases (NIAID) that uses the SBIR mechanisms R43/R44 to support later-stage, product-driven biomedical technology development by eligible small business concerns. The focus is on advancing a defined product toward an FDA-regulated endpoint.
Who is this opportunity designed for?
This opportunity is designed specifically for small business concerns pursuing advanced technology projects that are beyond purely exploratory research and are centered on moving a specific biomedical product or service toward a regulatory pathway that culminates in FDA review and approval.
What kinds of projects are a good fit for PA-10-123?
Projects are a good fit when the proposed work is anchored to a clearly identified end product or service that will require FDA approval and fits within NIAID's scientific scope. Examples mentioned include advancing a particular lead compound as an AIDS therapeutic, a vaccine candidate, a diagnostic device, or another defined medical product with an FDA-regulated endpoint.
What is the key product requirement for applicants?
The work must be centered on a clearly identified product or service that will require FDA approval. Applicants need to clearly articulate what the product is, how it will be developed, and why the work is relevant to an FDA-regulated pathway.
How does this FOA differ from earlier-stage discovery or enabling research?
This FOA draws a clear distinction between product development and earlier discovery-enabling work. A project that primarily builds an assay to support future discovery or screening (without committing to a single identifiable FDA-bound product) is described as not appropriate for this announcement.
Which NIAID mission areas does PA-10-123 fall under?
PA-10-123 sits within NIAID mission areas including Allergy, Immunology and Transplantation Research (CFDA 93.855) and Microbiology and Infectious Diseases Research (CFDA 93.856).
What grant mechanisms are used in this opportunity?
This opportunity uses the SBIR grant mechanisms R43/R44, which correspond to Phase I, Phase II, and Fast Track applications.
What is the difference between Phase I, Phase II, and Fast Track under R43/R44?
Phase I generally supports early feasibility and proof-of-concept work. Phase II supports further R&D and development toward commercialization. Fast Track allows applicants to propose Phase I and Phase II in a single combined application when the project is ready for an accelerated review path.
Is there a related STTR version of this opportunity?
Yes. The announcement notes it runs in parallel with a separate, scientifically identical opportunity for the STTR program: PA-10-124, using mechanisms R41/R42. This can matter for teams deciding whether their structure aligns better with SBIR (small business-led R&D) or STTR (formal small business-research institution collaboration).
Are human clinical trials allowed under PA-10-123?
No. Applications submitted under this FOA must not include human clinical trials.
If clinical trials are not allowed, what should applicants do if they need to run an investigator-initiated clinical trial?
The FOA references NIAID policy indicating that investigator-initiated clinical trials should instead be pursued through the R34 mechanism, and it points applicants to NIAID guidance for that pathway.
What stage of development is this SBIR intended to support if not clinical trials?
It is intended to fund preclinical and product development activities that prepare a candidate technology for clinical testing, while staying on the non-clinical-trial side of the development pipeline.
Is cost sharing or matching required?
No. This is described as a discretionary grant program with no cost sharing or matching requirement.
What is the award ceiling listed for this opportunity?
The award ceiling listed in the source data is $300,000.
Does NIAID guarantee a certain number of awards?
No. The FOA states that awards depend on the availability of funds and the number of high-quality applications received, and it does not guarantee a specific number of awards.
What factors influence funding decisions?
Funding decisions are expected to vary based on application merit, the proposed project duration, and the budget profile, in addition to the availability of funds.
When was PA-10-123 posted, and is it still active?
The opportunity was originally posted March 5, 2010, later updated in the record, and has been archived. The record indicates a final closing period ending in early 2014 and an archive date in February 2014.
Why does the archived status matter?
Because it has been archived, PA-10-123 is mainly relevant for historical reference or research. Anyone looking to apply would typically need to find the most current successor announcement rather than relying on this archived FOA.
What is the simplest way to tell if a project is a strong match for PA-10-123?
A strong match is a small business-led project that can credibly describe a specific, FDA-approvable product within NIAID's scientific areas and propose preclinical/product development work (not human clinical trials) that moves that defined product along a regulatory-relevant development plan.
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