Opportunity Information: Apply for PA 09 094
Apply for PA 09 094
- The National Institutes of Health in the education environment food and nutrition health sector is offering a public funding opportunity titled "New Technologies for Liver Disease STTR (R41/R42)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.113 Environmental Health 93.273 Alcohol Research Programs 93.279 Drug Abuse and Addiction Research Programs 93.286 Discovery and Applied Research for Technological Innovations to Improve Human Health 93.393 Cancer Cause and Prevention Research 93.394 Cancer Detection and Diagnosis Research 93.395 Cancer Treatment Research 93.847 Diabetes, Digestive, and Kidney Diseases Extramural Research.
- This funding opportunity was created on Feb 12, 2009 and posted on Feb 12, 2009.
- Applicants must submit their applications by Jan 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:
The New Technologies for Liver Disease STTR (R41/R42) opportunity (Funding Opportunity Number PA 09 094) is a National Institutes of Health (NIH) discretionary grant program aimed at bringing small business innovators into liver disease research and product development. Its core intent is to stimulate practical, translational work that can lead to real-world tools and interventions for liver disease, aligning with priorities described in the trans-NIH Action Plan for Liver Disease Research. The program is specifically structured for the Small Business Technology Transfer (STTR) mechanism, which is designed to support projects where a small business formally collaborates with a research institution to move early-stage science toward commercializable health technologies.
The scientific scope is broad but clearly centered on new or improved technologies for the diagnosis, monitoring, management, treatment, and prevention of liver diseases. The announcement encourages small businesses to develop resources and research tools (for example, enabling platforms, assays, or datasets), instrumentation (such as imaging or analytical systems), biomarkers (including markers that reflect disease activity, severity, or stage), devices, drugs, and other novel approaches that meaningfully improve how liver disease is identified and managed. A major emphasis is placed on making liver disease assessment more reliable and practical in clinical or real-world settings, including efforts to reduce reliance on invasive procedures.
Several focus areas are highlighted. One is the development of dependable diagnostic methods for liver diseases, including biomarkers that can indicate disease activity and stage. Another is the creation of noninvasive tests capable of assessing key pathological features such as inflammation, fibrosis, and hepatic fat. This reflects a clear interest in technologies that can detect and track liver injury and progression without procedures like biopsy, potentially enabling earlier detection, better risk stratification, and more frequent monitoring. The FOA also supports therapeutic and preventive innovation, including drugs as well as complementary and alternative modalities, biologics, and molecular reagents. In practice, this could cover a wide range of modalities, from small molecules and biologic therapies to targeted molecular tools that affect pathways relevant to liver injury, fibrosis, metabolic liver disease, or other etiologies.
From a funding and project-structure standpoint, the FOA uses the STTR R41/R42 mechanisms and accepts Phase I, Phase II, and Fast Track applications. Phase I generally supports proof-of-concept and feasibility work, Phase II supports further development and validation toward commercialization, and Fast Track is intended to speed the transition by allowing coordinated Phase I and Phase II consideration. The announcement also notes that it runs in parallel with a companion FOA of the same scientific scope (PA 09 095) that uses the SBIR mechanisms (R43/R44), which is relevant for applicants deciding whether STTR or SBIR is the better fit based on collaboration requirements and project structure.
Eligibility is limited to small businesses, consistent with STTR program rules. The announcement indicates there is no cost sharing or matching requirement. Funding levels and the number of awards are not preset; awards depend on the availability of funds and, importantly, on the quantity and quality of applications received, along with proposed project duration and costs. In other words, this is a merit-driven competition where budget and award counts can fluctuate based on the applicant pool and program priorities at the time of review.
Administrative details place the posting and creation date at February 12, 2009, with an original and current closing date listed as January 7, 2012, and an archive date of February 7, 2012, indicating the opportunity is historical/archived rather than currently open. The program is associated with multiple CFDA numbers spanning environmental health, alcohol research, drug abuse and addiction research, technology innovation to improve human health, cancer research categories, and diabetes/digestive/kidney diseases research, reflecting the cross-cutting nature of liver disease and the NIH institutes and centers that may have been involved in supporting relevant projects.
In practical terms, the opportunity was designed to help small businesses turn promising liver-focused innovations into usable products and approaches, especially those that improve noninvasive diagnosis and monitoring, identify meaningful biomarkers, and advance therapies or preventive strategies. The overarching theme is translational impact: tools and interventions that can move from development into clinical and public health use, supporting better outcomes for people affected by liver disease.
Frequently Asked Questions (FAQs): New Technologies for Liver Disease STTR (R41/R42) - PA 09 094
What is the New Technologies for Liver Disease STTR (R41/R42) opportunity (PA 09 094)?
PA 09 094 is an NIH discretionary grant opportunity that uses the Small Business Technology Transfer (STTR) mechanism (R41/R42). It was designed to bring small business innovators into liver disease research and product development, with an emphasis on practical, translational technologies that can become real-world tools and interventions for liver disease.
What is the core purpose of this funding opportunity?
The core purpose is to stimulate translational work that moves early-stage science toward commercializable health technologies for liver disease. The opportunity aligns with priorities described in the trans-NIH Action Plan for Liver Disease Research and focuses on outcomes that can be used in clinical or real-world settings.
Which funding mechanism does this program use?
This opportunity uses the NIH STTR mechanisms: R41 (Phase I) and R42 (Phase II). It also accepts Fast Track applications, which allow coordinated consideration of Phase I and Phase II.
What types of applications are accepted under PA 09 094?
The FOA accepts Phase I, Phase II, and Fast Track applications. Phase I generally supports feasibility and proof-of-concept work, Phase II supports further development and validation toward commercialization, and Fast Track is intended to speed the transition between phases.
Who is eligible to apply?
Eligibility is limited to small businesses, consistent with STTR program rules.
Does the STTR mechanism require collaboration with a research institution?
Yes. The STTR mechanism is designed for projects in which a small business formally collaborates with a research institution to advance early-stage research toward commercializable technologies.
What liver disease topic areas does the program support?
The scope is broad, but centered on new or improved technologies for the diagnosis, monitoring, management, treatment, and prevention of liver diseases. The emphasis is on technologies that meaningfully improve how liver disease is identified and managed.
What kinds of technologies are encouraged?
The FOA encourages development of resources and research tools (such as enabling platforms, assays, or datasets), instrumentation (including imaging or analytical systems), biomarkers, devices, drugs, and other novel approaches that improve liver disease detection and management.
Is there a particular emphasis on noninvasive approaches?
Yes. A major emphasis is on making liver disease assessment more reliable and practical in clinical or real-world settings, including efforts to reduce reliance on invasive procedures. The FOA highlights interest in noninvasive tests that can assess inflammation, fibrosis, and hepatic fat.
What diagnostic developments are specifically highlighted?
Highlighted areas include developing dependable diagnostic methods for liver diseases and biomarkers that can indicate disease activity, severity, or stage. The FOA also supports technologies that can detect and track liver injury and progression without procedures like biopsy.
What pathological features do the noninvasive tests aim to assess?
The FOA specifically mentions noninvasive assessment of inflammation, fibrosis, and hepatic fat, reflecting interest in tools that can characterize liver disease progression and key pathological changes.
Does the FOA support therapeutic and preventive innovations?
Yes. The FOA supports therapeutic and preventive innovation, including drugs as well as complementary and alternative modalities, biologics, and molecular reagents.
What kinds of therapeutic modalities could fit within scope?
Based on the FOA description, the scope could include small molecules, biologic therapies, complementary and alternative modalities, biologics, and molecular reagents, particularly those relevant to pathways involved in liver injury, fibrosis, metabolic liver disease, or other liver disease etiologies.
How does Phase I differ from Phase II in this opportunity?
Phase I generally supports proof-of-concept and feasibility work. Phase II supports further development and validation toward commercialization. Fast Track allows coordinated Phase I and Phase II consideration to speed the transition.
What is the Fast Track option intended to do?
Fast Track is intended to speed the transition from Phase I to Phase II by enabling coordinated consideration of both phases within a single, linked submission approach.
Is there a companion opportunity using a different small business mechanism?
Yes. This FOA runs in parallel with a companion FOA (PA 09 095) of the same scientific scope that uses the SBIR mechanisms (R43/R44). This is relevant when deciding whether STTR or SBIR is the best fit for the project structure and collaboration needs.
How are award amounts and the number of awards determined?
Funding levels and the number of awards are not preset. Awards depend on the availability of funds and on the quantity and quality of applications received, as well as proposed project duration and costs.
Is cost sharing or matching required?
No. The FOA indicates there is no cost sharing or matching requirement.
Is this funding opportunity currently open?
No. The administrative details indicate this opportunity is historical/archived. The posting/creation date is February 12, 2009, the original and current closing date is listed as January 7, 2012, and the archive date is February 7, 2012.
When was the FOA posted and when did it close?
The FOA posting/creation date is February 12, 2009. The original and current closing date is listed as January 7, 2012, and it was archived on February 7, 2012.
What does it mean that this is an NIH discretionary grant program?
Based on the FOA description, it is an NIH program where awards are made competitively and depend on factors like funds availability and application quality, rather than being guaranteed or formula-based.
Which NIH priorities does this program align with?
The program aligns with priorities described in the trans-NIH Action Plan for Liver Disease Research, with a strong theme of translational impact and real-world usability.
Why does the FOA list multiple CFDA numbers?
The FOA is associated with multiple CFDA numbers spanning areas such as environmental health, alcohol research, drug abuse and addiction research, technology innovation to improve human health, cancer research categories, and diabetes/digestive/kidney diseases research. This reflects the cross-cutting nature of liver disease and the multiple NIH institutes and centers that may support relevant projects.
What is the overarching theme of projects supported by this FOA?
The overarching theme is translational impact: supporting small businesses in turning liver-focused innovations into usable products and approaches, especially those that improve noninvasive diagnosis and monitoring, identify meaningful biomarkers, and advance therapies or preventive strategies.
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