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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ACTTION/PASI (U01) Grant (RFA-FD-22-023) - Frequently Asked Questions
What is this funding opportunity?
This is the Analgesic, Anesthetic and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks and Pediatric Anesthesia Safety Initiative (ACTTION/PASI) (U01) cooperative agreement funding opportunity (RFA-FD-22-023) offered by the U.S. Department of Health and Human Services (HHS), Food and Drug Administration (FDA), under CFDA 93.103.
What is the main purpose of the award?
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. The partnership is 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).
Is this grant intended to fund clinical trials?
No. The opportunity explicitly states "Clinical Trial Not Allowed." The award is not intended to directly run clinical trials under this mechanism, even if the partnership supports work that improves readiness for future trials.
If clinical trials are not allowed, what kinds of activities does the grant support?
The grant is designed to support the "backbone" functions of a networked collaboration rather than a single, stand-alone research project. Supported activities include building and operating the partnership infrastructure, establishing governance, coordinating stakeholders, creating shared tools and standards, supporting working groups, and providing ongoing administrative and scientific coordination aligned with FDA priorities.
Does the opportunity support any projects, or only infrastructure?
In addition to the infrastructure itself, the listing indicates that 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.
What does it mean that this is a U01 cooperative agreement?
A U01 cooperative agreement generally indicates substantial federal scientific or programmatic involvement compared with a standard grant. Under this structure, applicants should expect active partnership with FDA in shaping priorities, coordinating activities, and keeping the infrastructure and outputs aligned with the initiative's goals.
What is meant by a "public-private partnership" in this context?
It refers to a coordinated collaboration that brings together stakeholders across academia, industry, government, and other relevant groups to prioritize needs, select initiatives, develop shared methods or standards, and produce work products that support improvements in analgesic, anesthetic, and addiction-related therapeutic development and evaluation, including pediatric anesthesia safety considerations.
What subject areas does ACTTION/PASI focus on?
The focus areas include analgesics, anesthetics, and addiction-related therapies, along with a dedicated emphasis on pediatric anesthesia safety through PASI.
What is the Pediatric Anesthesia Safety Initiative (PASI) emphasis?
PASI focuses on pediatric anesthesia safety, which the opportunity notes can involve unique challenges such as age-specific physiology, limited pediatric datasets, ethical constraints, and the need for specialized safety monitoring and evaluation frameworks.
What types of outputs or improvements is the partnership expected to enable?
The structure is intended to enable translation and innovation across a broad landscape. Examples described in the opportunity include improving clinical trial methodologies and endpoints (without conducting trials under this award), supporting harmonized approaches to outcome measures, encouraging data standardization and sharing practices, and identifying gaps where new methods, tools, or consensus guidance are needed.
Who is eligible to apply?
Eligibility is broad and includes many types of domestic organizations capable of hosting and managing a complex partnership, including:
- State, county, city/township, and special district governments
- Independent school districts
- Public and state-controlled institutions of higher education
- 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)
- Small businesses
Does the opportunity favor a particular type of applicant organization?
The information provided emphasizes that eligibility is broad because the award is infrastructure-focused and designed for a public-private partnership model. The lead organization is expected to credibly host and manage the administrative and scientific coordination needed to run a complex, cross-sector partnership.
How much funding is available?
The award ceiling is $3,000,000.
How many awards does FDA expect to make?
The opportunity anticipates a single award (ExpectedAwards: 1), indicating FDA is seeking one primary coordinating entity to serve as the hub for ACTTION/PASI partnership operations during the project period.
What does the single-award structure imply for the program?
It implies that one funded recipient will act as the central hub responsible for coordinating the partnership's operations, governance, and aligned activities across the national-scale collaboration.
What federal agency is offering this opportunity?
The opportunity is offered by the U.S. Department of Health and Human Services (HHS), Food and Drug Administration (FDA).
What is the program context or category listed for this opportunity?
It sits within a research and development and consumer protection/science and technology context, and is listed under CFDA 93.103.
What are examples of partnership "backbone" functions mentioned in the opportunity?
Examples include coordinating stakeholders; establishing processes for prioritizing needs and selecting initiatives; creating common tools and standards; supporting working groups; and maintaining the administrative and scientific coordination needed to keep efforts aligned with FDA priorities.
What is meant by "translation and innovation" here?
As described, it means building a durable platform that can generate, organize, and translate scientific and regulatory-relevant work, including developing or improving methods, tools, standardized measures, and shared practices that strengthen the evidence ecosystem for analgesics, anesthetics, addiction-related therapeutics, and pediatric anesthesia safety.
What does the opportunity say about alignment with FDA priorities?
It indicates FDA will have substantial involvement typical of a U01 cooperative agreement, and that partnership activities and outputs are expected to remain aligned with FDA priorities and the initiative's goals.
When was the funding opportunity created and when did it close?
The opportunity was created on February 7, 2022, and had an original closing date of April 11, 2022.
What is the overall takeaway for what this program funds?
Overall, it is an investment in sustained capacity: building and operating a stable, well-governed partnership framework that can continually generate high-value, FDA-relevant scientific work products and coordination efforts across analgesics, anesthetics, addiction-related therapeutics, and pediatric anesthesia safety, without directly conducting clinical trials under this award.
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