Opportunity Information: Apply for PA 09 179
Apply for PA 09 179
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Development of In Vitro Assays to Assess the Potency of Botulinum Neurotoxin Type A (SBIR R43/R44)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103 Food and Drug AdministrationResearch 93.853 Extramural Research Programs in the Neurosciences and Neurological Disorders 93.856 Microbiology and Infectious Diseases Research.
- This funding opportunity was created on Apr 29, 2009 and posted on Apr 29, 2009.
- Applicants must submit their applications by May 7, 2012. (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:
This grant opportunity, PA 09 179, is a National Institutes of Health (NIH) Funding Opportunity Announcement that uses the Small Business Innovation Research (SBIR) program to support small businesses working on better ways to measure the potency of botulinum neurotoxin type A (BoNT/A) without relying on animal testing. The central aim is very practical: to push development of in vitro, non-animal assays that can function in a real-world Good Manufacturing Practice (GMP) commercial setting and ultimately be suitable for routine commercial product release testing. In other words, the government is looking for assay methods and supporting reagents that a manufacturer could realistically adopt as part of regulated quality control to confirm that a BoNT/A product meets potency requirements before it is released to market.
The FOA is structured around the SBIR grant mechanisms R43 and R44, which cover Phase I, Phase II, and a Fast Track option. Phase I generally supports early feasibility and proof-of-concept work, while Phase II is intended for more advanced development, optimization, and validation steps that move a technology toward commercialization. The Fast Track option is designed to accelerate progress by allowing applicants to propose a combined Phase I and Phase II plan under a single application pathway. This FOA is also explicitly paired with a parallel announcement of identical scientific scope for the Small Business Technology Transfer (STTR) program (PA 09 178, using R41/R42), which is relevant for teams that want or need a formal collaboration structure with a research institution.
The scientific and operational emphasis is on assays that can replace animal-based potency tests for BoNT/A, particularly in ways compatible with GMP workflows. That implies the agency expects applicants to think beyond a lab-only prototype and address issues that matter for regulated manufacturing, such as robustness, reproducibility, standardization, appropriate controls, assay qualification/validation approaches, reagent consistency, and the practicality of implementing the method for lot release. The end goal is not simply to publish an assay concept, but to deliver a test system (and associated reagents) that can be used as part of commercial release testing for botulinum toxin type A products.
Eligibility is limited to small business concerns, consistent with SBIR rules, and there is no cost sharing or matching requirement. The opportunity is listed as a discretionary grant in the health funding category, with CFDA numbers reflecting relevant federal research areas: 93.103 (Food and Drug Administration Research), 93.853 (Neurosciences and Neurological Disorders extramural research), and 93.856 (Microbiology and Infectious Diseases research). The announcement was posted on April 29, 2009, with an original and current closing date of May 7, 2012, and an archive date of June 7, 2012, indicating it is no longer open but provides a clear picture of the government priorities and expectations at the time.
Funding levels and the number of awards were not fixed in advance. Instead, awards were contingent on available funds and the submission of enough high-quality, scientifically meritorious applications. That means the final award count and total dollars depended on how compelling the proposals were, how long the projects were planned to run, and what budgets were justified. For applicants, this structure typically signals that reviewers and program staff would weigh not only technical innovation, but also feasibility, relevance to the stated GMP and commercial release-testing goals, and a credible path toward a deliverable assay platform suitable for industry adoption.
For reference and administrative support, the FOA points to an NIH Grants Guide webpage for the full announcement and provides contact information for the NIH Office of Extramural Research (OER) webmaster for technical access or linking problems.
Frequently Asked Questions (FAQs): NIH SBIR FOA PA-09-179 (BoNT/A Non-Animal Potency Assays)
What is grant opportunity PA-09-179?
PA-09-179 is a National Institutes of Health (NIH) Funding Opportunity Announcement (FOA) that uses the Small Business Innovation Research (SBIR) program to support small businesses developing improved ways to measure the potency of botulinum neurotoxin type A (BoNT/A) without relying on animal testing.
What is the main goal of this FOA?
The central goal is to advance in vitro (non-animal) potency assays and supporting reagents that can work in a real-world Good Manufacturing Practice (GMP) commercial environment and be suitable for routine commercial product release testing.
What problem is NIH trying to solve through this announcement?
This FOA targets the need to replace animal-based potency tests for BoNT/A with practical, standardized, robust in vitro alternatives that manufacturers could adopt for regulated quality control and lot release.
What types of projects does this FOA encourage?
Projects focused on developing non-animal, in vitro assays (and associated reagents) to measure BoNT/A potency, with clear attention to real manufacturing needs such as robustness, reproducibility, standardization, controls, reagent consistency, and validation/qualification approaches suitable for GMP workflows and commercial lot release.
Is this FOA about publishing research, or about building something industry can use?
The emphasis is on delivering a test system that can realistically be implemented for routine commercial release testing, not simply demonstrating an assay concept for publication.
Which NIH small business program mechanism is used in PA-09-179?
PA-09-179 uses SBIR grant mechanisms R43 and R44, supporting Phase I, Phase II, and a Fast Track option.
What is the difference between SBIR Phase I and Phase II under this FOA?
Phase I generally supports early feasibility and proof-of-concept work. Phase II supports more advanced development, optimization, and validation steps that move the technology toward commercialization and practical deployment.
What is the SBIR Fast Track option in this FOA?
The Fast Track option allows applicants to propose a combined Phase I and Phase II plan under a single application pathway, with the intent of accelerating progress from feasibility to later-stage development.
Is there a related STTR opportunity for the same topic?
Yes. This FOA is explicitly paired with a parallel announcement with identical scientific scope for the Small Business Technology Transfer (STTR) program: PA-09-178, using mechanisms R41 and R42.
When might the paired STTR FOA be relevant instead of SBIR?
The paired STTR announcement is relevant for teams that want or need a formal collaboration structure with a research institution, as indicated in the FOA description.
Who is eligible to apply to PA-09-179?
Eligibility is limited to small business concerns, consistent with SBIR rules.
Is cost sharing or matching required?
No. The FOA states there is no cost sharing or matching requirement.
What setting does NIH expect the assay to work in?
The FOA emphasizes assays compatible with a GMP commercial setting, meaning applicants are expected to address practical implementation factors needed for regulated manufacturing and lot release testing.
What assay characteristics are highlighted as important for GMP and release testing?
The FOA highlights considerations such as robustness, reproducibility, standardization, appropriate controls, assay qualification/validation approaches, reagent consistency, and practical implementation for lot release.
What is meant by "routine commercial product release testing" in the context of this FOA?
It refers to potency testing used as part of regulated quality control to confirm a BoNT/A product meets potency requirements before release to market, using an assay system suitable for repeated, standardized use in manufacturing workflows.
Does this FOA fund only assay methods, or also reagents?
The FOA indicates interest in both assay methods and supporting reagents needed to enable reliable, implementable in vitro potency testing for BoNT/A.
What type of award is this listed as?
The opportunity is listed as a discretionary grant in the health funding category.
What CFDA numbers are associated with this FOA?
The FOA references CFDA numbers 93.103 (Food and Drug Administration Research), 93.853 (Neurosciences and Neurological Disorders extramural research), and 93.856 (Microbiology and Infectious Diseases research).
When was PA-09-179 posted?
The announcement was posted on April 29, 2009.
What was the closing date for applications?
The original and current closing date listed is May 7, 2012.
Is this funding opportunity still open?
No. The archive date is June 7, 2012, which indicates the FOA is no longer open.
Were funding levels or the number of awards predetermined?
No. Funding levels and the number of awards were not fixed in advance and were contingent on available funds and the receipt of sufficient numbers of high-quality, scientifically meritorious applications.
What factors influenced whether awards were made under this FOA?
Awards depended on available funds and the submission of enough compelling applications. The FOA description indicates that technical innovation, feasibility, relevance to GMP and commercial release-testing goals, and a credible path toward an industry-adoptable deliverable assay platform were important considerations.
Where can applicants find the full FOA text?
The FOA points to an NIH Grants Guide webpage for the full announcement.
Who is listed as a contact for technical access or linking problems?
The FOA provides contact information for the NIH Office of Extramural Research (OER) webmaster for technical access or linking issues.
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