Opportunity Information: Apply for RFA OD 22 003

The Center for Coordination of Analysis, Science, Enhancement, and Logistics (CASEL) in Tobacco Regulatory Science is a National Institutes of Health (NIH) cooperative agreement funding opportunity (U54; clinical trial not allowed) designed to create a central hub that supports and coordinates tobacco regulatory science research. Rather than primarily funding a single stand-alone research project, this opportunity focuses on building an operational and scientific coordination center that can organize, integrate, and accelerate research activities and outputs that are directly relevant to the U.S. Food and Drug Administration (FDA) Center for Tobacco Products (CTP). In practical terms, CASEL is meant to strengthen how tobacco regulatory science projects work together by improving communication, harmonizing approaches, and streamlining logistics so that evidence can move more efficiently from research groups into the kinds of findings that can inform federal tobacco product regulation.

The core purpose of CASEL is coordination and operations management for research programs that support FDA CTPs regulatory responsibilities under the Family Smoking Prevention and Tobacco Control Act (FSPTCA). The FOA emphasizes leadership, facilitation, and collaboration across investigators and programs in tobacco regulatory science. By serving as a connector across multiple research efforts, CASEL is positioned to help identify important findings sooner, integrate results across studies, and promote consistent scientific practices that make evidence more usable for regulatory decision-making. The intent is that better coordination reduces duplication, highlights gaps where additional research is needed, and helps translate complex and sometimes fragmented scientific outputs into coherent, regulator-relevant insights.

This opportunity is issued as a discretionary program under a cooperative agreement mechanism, meaning NIH will likely have substantial involvement in program oversight and direction compared to a standard grant. The activity category is health, and the listing is associated with CFDA number 93.077. The award ceiling listed for the opportunity is $3,800,000, indicating a relatively large budget consistent with building and running a coordinating center with significant management responsibilities and broad reach across multiple tobacco regulatory science activities. The FOA was created on March 7, 2022, and the original closing date was July 14, 2022.

Eligibility is broad and includes many types of U.S.-based organizations and governmental entities. Eligible applicants include state, county, city or township, and 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 Native American tribal organizations. It also includes public housing authorities and Indian housing authorities, nonprofits with and without 501(c)(3) status (as long as they are not institutions of higher education in those nonprofit categories), for-profit organizations other than small businesses, and small businesses. The FOA also explicitly highlights additional eligible applicant types such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribal Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions.

At the same time, there are clear limits related to foreign participation. Non-domestic (non-U.S.) entities (foreign organizations and foreign institutions) are not eligible to apply as the applicant organization, and non-domestic components of U.S. organizations are also not eligible to apply. However, the FOA allows foreign components as defined in the NIH Grants Policy Statement, meaning certain project elements or collaborations may be permitted to occur internationally under NIH rules, even though the applicant institution itself must be domestic.

Overall, CASEL is best understood as an infrastructure and leadership award for tobacco regulatory science: its value is in coordinating people, data, methods, communication, and operational workflows so that research funded or aligned with tobacco regulatory priorities can be more consistent, connected, and actionable for FDA CTP. The U54 cooperative agreement structure, the emphasis on coordination and logistics, and the clinical trial not allowed designation all point to a center whose main deliverables are organization, synthesis, facilitation, and scientific integration in support of the federal tobacco regulatory mission, rather than conducting clinical trials.

  • The National Institutes of Health in the health sector is offering a public funding opportunity titled "Center for Coordination of Analysis, Science, Enhancement, and Logistics (CASEL) in Tobacco Regulatory Science (U54 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): 93.077.
  • This funding opportunity was created on 2022-03-07.
  • Applicants must submit their applications by 2022-07-14. (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 $3,800,000.00 in funding.
  • 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.
Apply for RFA OD 22 003

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