Analgesic, Anesthetic and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) (U01) Clinical Trials Not Allowed | RFA FD 21 026

Opportunity Information: Apply for RFA FD 21 026

The grant opportunity titled "Analgesic, Anesthetic and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) (U01) Clinical Trials Not Allowed" (Funding Opportunity Number RFA FD 21 026) is a discretionary funding program offered by the U.S. Department of Health and Human Services through the Food and Drug Administration (FDA). It uses a cooperative agreement mechanism (U01), which typically means the awardee is expected to work closely with the FDA during the project period, with meaningful federal involvement in planning, coordination, and oversight compared to a standard grant.

The core purpose of this announcement is to fund the development and ongoing maintenance of an organizational infrastructure that can support a broad, public-private partnership under the FDA's ACTTION Initiative. In practical terms, the emphasis is on building and sustaining the backbone functions needed to run a large collaborative network focused on advancing the science and methods behind clinical trial translation and innovation in three major areas: analgesics (pain treatments), anesthetics (agents and approaches used for anesthesia), and addiction-related therapeutics and interventions. The infrastructure focus usually implies activities such as establishing governance and operating procedures, coordinating stakeholders, managing communications, supporting scientific working groups, developing shared tools or standards, enabling data and project management capabilities, and creating processes that help move ideas into well-designed research efforts that can inform regulatory science and product development.

While the primary focus is the partnership infrastructure, the opportunity also notes that specific projects under the ACTTION Initiative may be funded as part of the award. That suggests the award could support targeted, mission-aligned efforts that fit within the ACTTION framework, such as developing trial methodologies, outcome measures, biomarkers, endpoints, or other translational and regulatory science resources that improve how studies in pain, anesthesia, and addiction are designed and interpreted. However, the announcement is explicit that clinical trials are not allowed under this particular funding opportunity, meaning applicants should not propose conducting interventional studies that assign human participants to interventions to evaluate health outcomes. Instead, proposals would be expected to concentrate on network operations, coordination, planning, tool development, and other non-trial activities that strengthen the field and enable better future research.

Eligibility is broad and includes many types of organizations: state, county, and local governments; special districts; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; other tribal organizations; public or Indian housing authorities; nonprofit organizations both with and without 501(c)(3) status (excluding universities where specified); for-profit organizations other than small businesses; small businesses; and other entities as described in the full eligibility clarification section. This wide eligibility reflects the program's public-private partnership orientation and allows academic institutions, nonprofits, industry, and governmental entities to participate, either as direct applicants or as collaborators/subrecipients.

From an administrative standpoint, the opportunity falls under activity categories that include consumer protection, food and nutrition, science and technology, and other research and development, and it is associated with CFDA number 93.103. The posting lists an award ceiling of $600,000 and anticipates making a single award, indicating the FDA intended to support one main coordinating entity or hub to carry out the infrastructure and partnership functions. The opportunity was created on March 17, 2021, with an original closing date of May 24, 2021, placing it in a defined application window.

Overall, this funding opportunity is best understood as support for the operational and scientific coordination engine behind the ACTTION public-private partnership, with the goal of improving the translational pipeline and the quality and consistency of methods used in analgesic, anesthetic, and addiction-related development. It is designed for applicants that can demonstrate the capacity to organize diverse stakeholders, manage a collaborative network, and deliver tangible infrastructure and method-development outputs without conducting clinical trials under this award.

• The Department of Health and Human Services, Food and Drug Administration in the consumer protection, food and nutrition, 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 (ACTTION) (U01) Clinical Trials 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 Mar 17, 2021.
• Applicants must submit their applications by May 24, 2021. (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 $600,000.00 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, Others (see text field entitled Additional Information on Eligibility for clarification).

Apply for RFA FD 21 026

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