Opportunity Information: Apply for PA 09 178
Apply for PA 09 178
- 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 (STTR R41/R42)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103 Food and Drug AdministrationResearch 93.853 Extramural Research Programs in the Neurosciences and Neurological Disorders.
- 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, titled "Development of In Vitro Assays to Assess the Potency of Botulinum Neurotoxin Type A (STTR R41/R42)" (Funding Opportunity Number PA-09-178), was issued by the National Institutes of Health and is focused on replacing animal-based potency testing for botulinum neurotoxin type A (BoNT/A) with new, non-animal in vitro methods that can realistically operate in a Good Manufacturing Practice (GMP) commercial setting. The core intent is highly practical: applicants are expected to build assays and associated reagents that are suitable for routine commercial release testing of BoNT/A products, meaning the final output should be something a manufacturer could use to confirm product potency as part of standard lot release and quality control workflows.
The program uses the Small Business Technology Transfer (STTR) mechanism, specifically the R41 (Phase I) and R42 (Phase II) award structures, and it also allows Fast Track applications that propose a seamless path from early feasibility work to later-stage development. Because it is an STTR opportunity, it is designed for small business concerns that will formally partner with a nonprofit research institution, reflecting the STTR goal of moving innovations from research settings into commercial products. The announcement notes that it runs in parallel with a separate but scientifically identical funding announcement (PA-09-179) using the SBIR mechanisms (R43/R44), giving small companies two closely related pathways depending on whether they are better positioned for an STTR collaboration model or an SBIR model.
From a technical and regulatory standpoint, the emphasis on GMP compatibility signals that NIH is not merely looking for a proof-of-concept laboratory assay. The desired deliverables are assays that can be standardized, validated, and executed reliably in an industrial quality environment, where consistency, robustness, documentation, and reproducibility matter as much as scientific novelty. In practice, this points toward methods that can be controlled with defined reagents, have clear acceptance criteria, perform well across operators and sites, and support the needs of regulated manufacturing. The overarching goal is to enable potency assessment without relying on animals, aligning scientific progress with ethical considerations and modern testing expectations.
Funding levels and the number of awards were not fixed in the announcement. Instead, NIH indicated that awards would depend on the availability of funds and the number of high-quality applications received, with final award amounts varying based on application merit, proposed project duration, and budgeted costs. There is no cost sharing or matching requirement, which lowers the barrier for small businesses that may not have significant non-federal resources to commit.
Eligibility is limited to small businesses. The opportunity is categorized as discretionary and uses the grant funding instrument type, with activity categories tied to health and to NIH/FDA-related research program areas (CFDA 93.103 and 93.853). The opportunity was posted and created on April 29, 2009, with an original and current closing date of May 7, 2012, and it was archived on June 7, 2012. While the archived status means it is no longer open for submission, the announcement remains useful as a template for the kinds of development milestones, validation expectations, and commercialization-oriented assay design goals that NIH has historically prioritized for BoNT/A potency testing alternatives.
For additional details, the full announcement was made available through the NIH Grants Guide webpage (http://grants.nih.gov/grants/guide/pa-files/PA-09-178.html). The listed contact for access or linking issues was the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.
Frequently Asked Questions (FAQs)
What is the title and funding opportunity number for this grant?
The opportunity is titled "Development of In Vitro Assays to Assess the Potency of Botulinum Neurotoxin Type A (STTR R41/R42)" and the Funding Opportunity Number is PA-09-178.
Which agency issued this opportunity?
This opportunity was issued by the National Institutes of Health (NIH).
What is the main purpose of the grant?
The core goal is to replace animal-based potency testing for botulinum neurotoxin type A (BoNT/A) with new, non-animal in vitro methods that can realistically operate in a Good Manufacturing Practice (GMP) commercial setting.
What type of toxin and potency testing does this program focus on?
The scientific focus is on assessing potency for botulinum neurotoxin type A (BoNT/A), specifically by developing in vitro assays intended to serve as alternatives to animal-based potency tests.
What does NIH mean by expecting assays suitable for "routine commercial release testing"?
The announcement emphasizes practical deliverables: applicants are expected to build assays and associated reagents that a manufacturer could use in standard lot release and quality control workflows to confirm product potency.
Is this grant looking for basic research or a manufacturing-ready approach?
The emphasis on GMP compatibility indicates the program is not just seeking a proof-of-concept laboratory assay. The intended output is an assay that can be standardized, validated, and executed reliably in an industrial quality environment.
What is meant by GMP compatibility in the context of this opportunity?
GMP compatibility implies the assay should support consistency, robustness, documentation, and reproducibility expected in regulated manufacturing. The description points toward methods with defined reagents, clear acceptance criteria, reliable performance across operators and sites, and suitability for regulated quality operations.
What are the expected deliverables besides the assay itself?
The opportunity describes building assays and associated reagents. It also highlights the importance of standardization, validation, reliability, and reproducibility in a commercial GMP setting, which implies deliverables aligned with those needs.
What funding mechanism does this opportunity use?
This is an STTR opportunity using the R41 (Phase I) and R42 (Phase II) award structures.
Does the opportunity allow Fast Track applications?
Yes. The announcement allows Fast Track applications proposing a seamless path from early feasibility work to later-stage development.
Who is eligible to apply?
Eligibility is limited to small businesses.
Does the STTR mechanism require a partner organization?
Yes. Because this is an STTR opportunity, it is designed for small business concerns that will formally partner with a nonprofit research institution.
Is there a related SBIR version of this opportunity?
Yes. The announcement notes it runs in parallel with a separate but scientifically identical funding announcement (PA-09-179) using the SBIR mechanisms (R43/R44).
How should a company decide between the STTR and SBIR pathways mentioned?
Based on the information provided, the choice depends on whether the company is better positioned for an STTR collaboration model (small business partnering with a nonprofit research institution) or an SBIR model (referenced as a separate, scientifically identical announcement).
Are the funding levels and number of awards fixed?
No. The announcement did not fix funding levels or the number of awards. NIH indicated awards would depend on the availability of funds and the number of high-quality applications received.
What factors influence the final award amount?
The final award amounts were described as varying based on application merit, proposed project duration, and budgeted costs.
Is cost sharing or matching required?
No. The opportunity states there is no cost sharing or matching requirement.
What is the funding instrument type and how is the opportunity categorized?
The opportunity uses the grant funding instrument type and is categorized as discretionary.
What activity areas or program categories are associated with this opportunity?
The activity categories are tied to health and to NIH/FDA-related research program areas, with CFDA references listed as 93.103 and 93.853.
When was this opportunity posted and when did it close?
It was posted and created on April 29, 2009. The original and current closing date listed is May 7, 2012.
Is this funding opportunity still open?
No. The opportunity is archived and is no longer open for submission. It was archived on June 7, 2012.
Does the archived announcement still have any practical value?
Yes. The description notes it can still be useful as a template for the kinds of development milestones, validation expectations, and commercialization-oriented assay design goals NIH has historically prioritized for BoNT/A potency testing alternatives.
Where can the full announcement be found?
The full announcement was made available through the NIH Grants Guide webpage at http://grants.nih.gov/grants/guide/pa-files/PA-09-178.html.
Who should be contacted for access or linking issues related to the announcement?
The listed contact for access or linking issues is the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.
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