Site Selection in Oncology Clinical Trials: Considerations for Selecting Sites in Limited Geographic Regions or Areas of Political Unrest, Limiting Inspection Capabilities (U13) Clinical Trial not allowed. | RFA FD 23 007

Opportunity Information: Apply for RFA FD 23 007

This funding opportunity, RFA-FD-23-007, is a discretionary cooperative agreement (U13) offered by the U.S. Department of Health and Human Services through the Food and Drug Administration (FDA). It is focused on consumer protection and science and technology research and development (CFDA 93.103). The grant is specifically for organizing a series of conferences and workshops, and it is explicitly marked "Clinical Trial not allowed," meaning the funded activities are not meant to run or support an actual clinical trial. Instead, the goal is to convene experts and stakeholders to examine a practical and increasingly important problem in oncology drug development: how to appropriately select clinical trial sites when studies are conducted in limited geographic regions or in areas affected by political unrest, particularly when these conditions make FDA inspection and oversight difficult.

The central purpose of the project is to produce structured, FDA-informed discussions that explore the risks, limitations, and decision-making challenges that arise when oncology clinical trials intended to support FDA regulatory approval rely on sites located in regions where routine monitoring and on-site inspections may be restricted, delayed, or impossible. In oncology, where trials often involve high-risk therapies, complex endpoints, and vulnerable patient populations, the quality and reliability of clinical trial data depends heavily on factors like site capability, staff training, infrastructure, adherence to good clinical practice, and the ability to verify source data. When trial activity is concentrated in only a few regions, or when instability affects local governance, travel, safety, or communications, those normal safeguards can be harder to apply. This FOA is designed to bring those issues into the open through targeted workshops and develop a shared understanding of what sponsors, investigators, IRBs, regulators, and other parties should consider when choosing sites under such constraints.

Because the award mechanism is a cooperative agreement, the FDA is expected to have substantial input into the agenda and execution of the conference series. That usually implies more direct federal involvement than a standard grant, with the intent that the resulting meetings address real regulatory and scientific needs rather than purely academic topics. The funded organization would typically be responsible for planning and running the conferences, recruiting speakers and participants, developing meeting materials, and producing outputs such as proceedings, summaries, best-practice considerations, or publicly useful recommendations. The emphasis is on thoughtful examination of site selection challenges, including how limitations on inspections might affect confidence in data integrity, participant protections, protocol compliance, and the overall acceptability of evidence intended for regulatory submissions in oncology.

The opportunity was created on December 26, 2022, and had an original closing date of March 7, 2023. The expected number of awards was one, indicating FDA intended to fund a single coordinating organization to run this effort as a unified program rather than splitting the work across multiple recipients. The maximum award amount listed is $300,000, which is consistent with conference and workshop support rather than large-scale research funding. Eligible applicants are broad and include state, county, and local governments; special districts; independent school districts; public and private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status; for-profit organizations (including those other than small businesses); small businesses; and other applicants as described in the full eligibility text. This wide eligibility range aligns with the nature of U13 conference grants, where suitable conveners could include academic centers, professional societies, nonprofits, or other organizations with demonstrated capacity to host credible scientific and policy-focused meetings.

In practical terms, this FOA is about strengthening the foundation for sound regulatory-grade oncology evidence when trials are conducted under real-world constraints. By supporting structured conversations with substantial FDA input, it aims to clarify the considerations that should guide where oncology trials are placed, how risks can be assessed and mitigated when inspection capability is limited, and what approaches may help maintain participant protections and data credibility despite geopolitical or geographic barriers.

• 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 "Site Selection in Oncology Clinical Trials: Considerations for Selecting Sites in Limited Geographic Regions or Areas of Political Unrest, Limiting Inspection Capabilities (U13) 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 Dec 26, 2022.
• Applicants must submit their applications by Mar 07, 2023. (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 $300,000.00 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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