SmartTots (Strategies for Mitigating Anesthesia-Related neuroToxicity in Tots) Public-Private Partnership (PPP) under PASI (Pediatric Anesthesia Safety Initiative) (U01) Clinical Trials Not Allowed | RFA FD 21 25

Opportunity Information: Apply for RFA FD 21 25

The SmartTots Public-Private Partnership (PPP) under the FDA Pediatric Anesthesia Safety Initiative (PASI) is a federal funding opportunity designed to build and sustain the core organizational infrastructure needed to run a broad, multi-stakeholder partnership focused on pediatric anesthesia safety. The central aim is not to fund a single isolated research study, but to support the coordination, governance, and operational backbone that allows a national-scale collaboration to function effectively. While the main emphasis is on infrastructure, the announcement also notes that specific PASI-related projects may be supported under this umbrella, as long as they fit the program scope and requirements. Clinical trials are not allowed under this opportunity, which signals that the funded work is expected to focus on activities such as coordination, prioritization, data and knowledge sharing, planning, and other non-trial research or programmatic efforts that strengthen the overall PASI partnership.

This opportunity is offered by the Department of Health and Human Services, Food and Drug Administration (FDA), and uses a cooperative agreement mechanism (U01). A cooperative agreement typically means the FDA expects to have substantial involvement in the funded activities, such as participating in planning, providing input on priorities, and collaborating on oversight and coordination, rather than acting as a hands-off funder. The funding opportunity number is RFA-FD-21-25, and it falls under CFDA 93.103. The activity category is described broadly as research and development within science and technology, reflecting that the partnership infrastructure is intended to support ongoing scientific and public health work related to anesthesia safety in young children.

In practical terms, the award is intended to help an organization serve as the hub for the SmartTots/PASI public-private partnership. That can include maintaining partnership structures, organizing meetings and working groups, facilitating communication between public and private participants, supporting strategic planning, establishing processes to identify and prioritize research gaps, and enabling collaboration across sectors. Because this is framed as infrastructure support, the funded entity would typically be expected to manage the partnership in a way that keeps efforts aligned, avoids duplication, and accelerates progress on shared pediatric anesthesia safety goals, particularly around concerns of anesthesia-related neurotoxicity in very young children.

The program is structured to make a single award (expected awards: 1), which reinforces the idea of selecting one lead organization to coordinate and administer the partnership framework. The award ceiling is $450,000, indicating the maximum funding level anticipated for the supported period under this announcement. The original posting date (creation date) is March 17, 2021, with an original closing date of May 24, 2021, which situates the opportunity in the 2021 funding cycle.

Eligibility is broad and intentionally inclusive, consistent with the public-private partnership model. Eligible applicants include multiple levels of government (state, county, city/township, special districts), public and private institutions of higher education, independent school districts, federally recognized tribal governments and other tribal organizations, public housing authorities/Indian housing authorities, nonprofits with or without 501(c)(3) status, for-profit organizations (including those other than small businesses), and small businesses. The listing also includes an “Others” category with additional eligibility details referenced in the full announcement. This wide eligibility range is meant to allow a capable entity, whether academic, nonprofit, governmental, or industry-connected, to take on the role of organizing and sustaining the PASI-aligned SmartTots partnership infrastructure.

Overall, the SmartTots (PASI) U01 opportunity is best understood as funding the operational engine behind a coordinated national effort on pediatric anesthesia safety rather than funding a clinical trial. It supports the systems, collaboration, and structured partnership activities needed to keep PASI functioning effectively and to enable targeted PASI projects that can be pursued without running clinical trials under this specific award.

• The Department of Health and Human Services, Food and Drug Administration in the natural resources, science and technology and other research and development sector is offering a public funding opportunity titled "SmartTots (Strategies for Mitigating Anesthesia-Related neuroToxicity in Tots) Public-Private Partnership (PPP) under PASI (Pediatric Anesthesia Safety Initiative) (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 $450,000.00 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).

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