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 21 025

Opportunity Information: Apply for RFA FD 21 025

This funding opportunity, titled SmartTots (Strategies for Mitigating Anesthesia-Related neuroToxicity in Tots) Public-Private Partnership (PPP) under the FDA Pediatric Anesthesia Safety Initiative (PASI), is a cooperative agreement (U01) offered by the U.S. Department of Health and Human Services through the Food and Drug Administration (FDA). The core goal is not to run clinical trials, but to build and sustain the organizational backbone needed to operate a broad, multi-stakeholder public-private partnership focused on pediatric anesthesia safety, especially the scientific and public health questions around potential neurodevelopmental risks associated with anesthesia exposure in very young children. In other words, the award is aimed at creating the structure that allows partners to coordinate, set priorities, share data and expertise appropriately, and move the field forward in a coherent way, rather than funding a single isolated research study.

The announcement emphasizes infrastructure development and maintenance. That typically means establishing governance and decision-making processes, coordinating participating organizations across government, academia, industry, foundations, and professional societies, and creating practical systems for project planning and oversight. The partnership framework is intended to support a portfolio of PASI-related activities, and the opportunity explicitly notes that specific projects under PASI may also be funded. Those projects would generally be expected to align with PASI goals and fit within the "clinical trials not allowed" limitation, meaning the work is more likely to involve activities such as coordinating preclinical research, supporting observational or epidemiologic efforts that do not meet the definition of a clinical trial, developing standardized approaches to outcome measurement, creating shared resources, convening expert workshops, improving communication strategies, and identifying evidence gaps and research priorities.

From an administrative standpoint, this is a discretionary grant mechanism using a cooperative agreement, which usually signals substantial involvement by the funding agency compared with a standard research project grant. Under a U01, FDA typically plays an active role in shaping milestones, participating in steering or oversight committees, and helping ensure the partnership stays aligned with public health and regulatory-relevant objectives. The program sits within FDA's broader mission areas reflected in the activity categories listed (consumer protection and research and development), and it is associated with CFDA number 93.103.

Eligibility is intentionally broad, reflecting the public-private partnership concept. Eligible applicants include multiple levels of government (state, county, city/township, special districts), public and independent school districts, public and state-controlled institutions of higher education, private institutions of higher education, tribal governments and tribal organizations, public housing/Indian housing authorities, nonprofit organizations with or without 501(c)(3) status, for-profit organizations (including those other than small businesses), small businesses, and even individuals, with an "others" category pointing to additional clarifications in the full text. This wide net is consistent with the idea that the award supports coordination across sectors, and that effective partnership management can be housed in a variety of organizational settings depending on capacity, experience, and neutrality.

The practical funding details in the notice indicate a single anticipated award with an award ceiling of $450,000. The opportunity number is RFA-FD-21-025, it was created on April 16, 2021, and the original application closing date was May 24, 2021. Taken together, the scope and the single expected award suggest FDA was looking for one lead organization to serve as the central hub or coordinating center for SmartTots under PASI, with responsibility for maintaining the partnership infrastructure and enabling additional PASI-aligned activities to proceed in a coordinated, strategically prioritized way, all while staying within the boundary that clinical trials are not supported under this specific announcement.

• 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 "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 Apr 16, 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, Individuals, For profit organizations other than small businesses, Small businesses, Others (see text field entitled Additional Information on Eligibility for clarification).

Apply for RFA FD 21 025

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