Opportunity Information: Apply for RFA FD 22 023
The Analgesic, Anesthetic and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks and Pediatric Anesthesia Safety Initiative (ACTTION/PASI) (U01) funding opportunity (RFA-FD-22-023) is a cooperative agreement offered by the U.S. Department of Health and Human Services, Food and Drug Administration (FDA). It sits within a research and development and consumer protection/science and technology context (CFDA 93.103). The central aim is to fund the development and ongoing operation of an organizational infrastructure that can sustain a broad, national-scale public-private partnership focused on improving how analgesic, anesthetic, and addiction-related therapies are studied, evaluated, and advanced, with an additional dedicated emphasis on pediatric anesthesia safety through the Pediatric Anesthesia Safety Initiative (PASI). The listing explicitly notes "Clinical Trial Not Allowed," meaning the award is not intended to directly run clinical trials under this mechanism, even though the partnership may support work that strengthens the pipeline and readiness for future trials.
In practical terms, the grant is designed to pay for the backbone of a networked collaboration, not just a single research project. That includes the operational and governance functions that make a large partnership work over time, such as coordinating stakeholders across academia, industry, government, and other relevant groups; building processes for prioritizing needs and selecting initiatives; creating common tools and standards; supporting working groups; and maintaining the administrative and scientific coordination required to keep efforts aligned with FDA priorities. The opportunity also signals that, in addition to the infrastructure itself, certain specific projects carried out under ACTTION and PASI may be supported, as long as they fit the program purpose and do not constitute prohibited clinical trial activity under this award. In other words, the expectation is a durable platform that can generate, organize, and translate scientific and regulatory-relevant work, with the ability to execute targeted supporting projects that strengthen the evidence ecosystem around pain management, anesthesia, and addiction, including pediatric considerations.
This is a U01 cooperative agreement, which generally indicates substantial federal scientific or programmatic involvement compared with a standard grant. Applicants should expect an active partnership with FDA in shaping priorities, coordinating activities, and ensuring the infrastructure and outputs remain aligned with the initiative's goals. The structure is meant to enable translation and innovation across a broad landscape: improving clinical trial methodologies and endpoints (without actually running trials here), supporting harmonized approaches to outcome measures, encouraging data standardization and sharing practices, and identifying gaps where new methods, tools, or consensus guidance are needed. For PASI, the emphasis is on pediatric anesthesia safety, which often involves unique challenges such as age-specific physiology, limited pediatric datasets, ethical constraints, and the need for specialized safety monitoring and evaluation frameworks.
Eligibility is broad and includes many types of domestic organizations that can credibly host and manage a complex partnership: state, county, city/township, and special district governments; independent school districts; public and state-controlled and private institutions of higher education; federally recognized tribal governments and other tribal organizations; public/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than IHEs); for-profit organizations (other than small businesses); and small businesses. This wide eligibility reflects the infrastructure nature of the award and the public-private partnership model, where the lead organization must be able to coordinate across sectors and manage administrative, scientific, and potentially subcontracted activities.
Financially, the award ceiling is $3,000,000, with an anticipated single award (ExpectedAwards: 1). That single-award structure implies the FDA is seeking one primary coordinating entity to serve as the hub for ACTTION/PASI partnership operations during the project period. The funding opportunity was created February 7, 2022, with an original closing date of April 11, 2022. Overall, the program is best understood as an investment in sustained capacity: building a stable, well-governed partnership framework that can continually generate high-value, FDA-relevant scientific work products and coordination efforts in analgesics, anesthetics, addiction-related therapeutics, and pediatric anesthesia safety, while stopping short of directly conducting clinical trials under this specific award mechanism.Apply for RFA FD 22 023
- The Department of Health and Human Services, Food and Drug Administration in the consumer protection, science and technology and other research and development sector is offering a public funding opportunity titled "Analgesic, Anesthetic and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks and Pediatric Anesthesia Safety Initiative (ACTTION/PASI) (U01) Clinical Trial Not Allowed)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103.
- This funding opportunity was created on Feb 07, 2022.
- Applicants must submit their applications by Apr 11, 2022. (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 $3,000,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For profit organizations other than small businesses, Small businesses.
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| Biosimilar User Fee Act (BsUFA) Research Grant (U01) Clinical Trials Optional Apply for RFA FD 22 026 Funding Number: RFA FD 22 026 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $1,000,000 |
| Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01) Clinical Trials Required Apply for FOR FD 23 007 Funding Number: FOR FD 23 007 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $650,000 |
| Designing and performing a virtual bioequivalence trial for physiologically-based pharmacokinetic and other mechanism-based models Apply for RFA FD 23 016 Funding Number: RFA FD 23 016 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $500,000 |
| Synthesis and Biological Activity Assessment of Different Diastereomers in siRNA Drug LEQVIO (Inclisiran) (U01) Clinical Trial Not Allowed Apply for RFA FD 23 012 Funding Number: RFA FD 23 012 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $1,200,000 |
| Evaluation of oral modified release drug tablet to support the approval of additional strengths Apply for RFA FD 23 013 Funding Number: RFA FD 23 013 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $450,000 |
| Novel approaches to support therapeutic development in ultra-rare cancers Apply for RFA FD 23 008 Funding Number: RFA FD 23 008 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $2,500,000 |
| In Vitro Based Approaches to Evaluate the Bioequivalence of Prospective Generic Rectal and Vaginal Products (U01) Clinical Trial Not Allowed Apply for RFA FD 23 014 Funding Number: RFA FD 23 014 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $1,000,000 |
| Applied Regulatory Science Research to Understand Factors that Affect the Safety and Efficacy of Underrepresented Populations in Oncology Therapeutic Development (U01) Clinical Trial Optional Apply for RFA FD 23 006 Funding Number: RFA FD 23 006 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $2,500,000 |
| Site Selection in Oncology Clinical Trials: Considerations for Selecting Sites in Limited Geographic Regions or Areas of Political Unrest, Limiting Inspection Capabilities (U13) Clinical Trial not allowed. Apply for RFA FD 23 007 Funding Number: RFA FD 23 007 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $300,000 |
| Development and Validation of a Multi-functional, Multi-purpose Quantitative Tool for Dermal Physiologically-Based Pharmacokinetic (PBPK) Modeling (U01) Clinical Trial Optional Apply for RFA FD 23 015 Funding Number: RFA FD 23 015 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $750,000 |
| Pediatric Device Consortia Grants Program (P50) Clinical Trials Optional Apply for RFA FD 23 024 Funding Number: RFA FD 23 024 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $5,000,000 |
| Natural History and Biomarker Studies of Rare Neurodegenerative Diseases (U01) Clinical Trials Optional Apply for RFA FD 23 028 Funding Number: RFA FD 23 028 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $2,000,000 |
| Education and Training Program for Outsourcing Facility Industry (UE5) Clinical Trials Not Allowed Apply for RFA FD 23 029 Funding Number: RFA FD 23 029 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $5,500,000 |
| Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01) Clinical Trials Required Apply for RFA FD 23 001 Funding Number: RFA FD 23 001 Agency: Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $650,000 |
| Population Pharmacokinetic Modeling of Systemic Pharmacokinetic Data to Inform Bioequivalence in Regional Lung Exposure (U01) Clinical Trial Not Allowed Apply for RFA FD 23 017 Funding Number: RFA FD 23 017 Agency: Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $500,000 |
| Biosimilar User Fee Act (BsUFA) Research Grant (U01) Clinical Trials Optional Apply for RFA FD 23 026 Funding Number: RFA FD 23 026 Agency: Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $2,000,000 |
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