Pediatric and Perinatal COVID-19 Registry (U18) Clinical Trials Optional | RFA FD 21 035

Opportunity Information: Apply for RFA FD 21 035

The Pediatric and Perinatal COVID-19 Registry (U18) Clinical Trials Optional funding opportunity (RFA FD 21 035) is a cooperative agreement offered by the U.S. Department of Health and Human Services, Food and Drug Administration (FDA). It was created on May 3, 2021, with an original application deadline of July 6, 2021. The program is structured to fund a single award (expected awards: 1) with an award ceiling of $2,000,000, reflecting an emphasis on building one coordinated, high-impact national resource rather than supporting many smaller, disconnected efforts.

The central purpose of the award is to support the development of a compendium-type resource that brings together and harmonizes information from pediatric and perinatal COVID-19 registries, natural history studies, and other relevant data sources. In practical terms, the aim is not simply to create another standalone registry, but to build an organized, usable resource that can incorporate multiple datasets and make them more valuable when viewed together. This kind of compendium approach is meant to improve consistency across data sources, enable comparisons, and support more reliable analyses about how COVID-19 affects pregnant people and their infants.

A key focus of the program is linking mother-infant pair data for mothers who are COVID-19 positive, so that researchers and public health stakeholders can better understand outcomes in neonates and infants who were exposed to SARS-CoV-2 during the perinatal period and/or who test positive themselves. The opportunity specifically highlights identifying both short-term and longer-term outcomes, which signals interest in immediate neonatal outcomes as well as developmental, clinical, and health trajectories that may emerge later in infancy. By emphasizing mother-infant linkage, the program underscores the importance of connecting maternal infection timing, severity, and context with neonatal and infant outcomes, rather than treating maternal and pediatric data as separate silos.

The funding instrument is a cooperative agreement (U18), which typically indicates substantial involvement or partnership from the funding agency compared to a standard grant. While applicants would carry out the day-to-day work, a cooperative agreement format often means the FDA expects active collaboration, alignment with agency priorities, and ongoing coordination around deliverables, data standards, and overall project direction. The activity category is listed broadly across consumer protection, food and nutrition, science and technology, and other research and development, consistent with FDA interests in evidence generation and data infrastructure that can inform regulatory science and public health decision-making.

Eligibility is broad and includes many types of organizations that could realistically build and maintain a large-scale data resource. Eligible applicants include state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories); for-profit organizations other than small businesses; small businesses; and other applicants as described in the opportunity’s additional eligibility text. This wide eligibility suggests the FDA was open to proposals from academic medical centers, research institutes, nonprofits that manage registries, government public health entities, and private-sector groups with the technical capacity to integrate and steward complex health datasets.

Overall, this opportunity is about building infrastructure: a consolidated, curated, and linkable resource for pediatric and perinatal COVID-19 data, designed to make it easier to study the real-world natural history of SARS-CoV-2 exposure and infection around birth. By supporting the integration of registries and related datasets, the FDA’s intent is to strengthen the evidence base on outcomes for exposed or infected neonates and infants, improve the ability to track those outcomes over time, and enable more informative analyses than any single registry could provide on its own. The “Clinical Trials Optional” label indicates that applicants were not required to propose a clinical trial to be responsive to the announcement, but could include clinical trial elements if appropriate to the project’s objectives.

• 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 "Pediatric and Perinatal COVID-19 Registry (U18) Clinical Trials Optional" 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 May 03, 2021.
• Applicants must submit their applications by Jul 06, 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 $2,000,000.00 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, Others (see text field entitled Additional Information on Eligibility for clarification).

Apply for RFA FD 21 035

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