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.Apply for RFA OD 22 003
- 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.
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FAQs: CASEL in Tobacco Regulatory Science (NIH Cooperative Agreement U54; Clinical Trial Not Allowed)
What is the CASEL funding opportunity?
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 intended to create a central coordination hub for tobacco regulatory science research. It is designed to support and connect multiple research efforts rather than primarily funding a single stand-alone research project.
What is the main purpose of CASEL?
The core purpose is coordination and operations management for research programs that support the U.S. Food and Drug Administration (FDA) Center for Tobacco Products (CTP) regulatory responsibilities under the Family Smoking Prevention and Tobacco Control Act (FSPTCA). CASEL is intended to improve how tobacco regulatory science projects work together by strengthening communication, harmonizing approaches, and streamlining logistics.
How is CASEL different from a typical research grant?
CASEL is structured as an infrastructure and leadership award focused on building and running a coordinating center. The emphasis is on organizing, integrating, and accelerating regulator-relevant research activities and outputs, rather than primarily executing a single research study.
What kind of award mechanism is used for CASEL?
This opportunity uses a U54 cooperative agreement mechanism (clinical trial not allowed). As a cooperative agreement, NIH is expected to have substantial involvement in program oversight and direction compared to a standard grant.
Are clinical trials allowed under this FOA?
No. The opportunity is explicitly designated as "clinical trial not allowed."
What does CASEL aim to improve across tobacco regulatory science projects?
CASEL aims to strengthen coordination across investigators and programs by improving communication, harmonizing scientific approaches, and streamlining operational logistics. The intent is to reduce duplication, identify gaps where additional research may be needed, and make evidence more consistent and usable for regulatory decision-making.
How does CASEL support FDA CTP?
CASEL is intended to help research outputs move more efficiently into findings that can inform federal tobacco product regulation. By integrating results across studies and promoting consistent practices, it helps translate complex and fragmented scientific outputs into coherent, regulator-relevant insights for FDA CTP.
What types of deliverables are emphasized for CASEL?
The emphasis is on organization, synthesis, facilitation, integration, and operational workflows that support tobacco regulatory science. The center is meant to coordinate people, data, methods, and communications so research aligned with tobacco regulatory priorities becomes more connected and actionable for FDA CTP.
What is the activity category for this opportunity?
The activity category listed for the opportunity is health.
What is the CFDA number associated with this funding opportunity?
The listing is associated with CFDA number 93.077.
What is the award ceiling?
The award ceiling listed for the opportunity is $3,800,000.
When was the funding opportunity created and when did it close?
The FOA was created on March 7, 2022, and the original closing date was July 14, 2022.
Who is eligible to apply?
Eligibility is broad and includes many 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.
Are any specific institution types explicitly highlighted as eligible?
Yes. The FOA 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.
Are foreign organizations eligible to apply as the applicant?
No. Non-domestic (non-U.S.) entities (foreign organizations and foreign institutions) are not eligible to apply as the applicant organization.
Can a non-domestic component of a U.S. organization apply?
No. Non-domestic components of U.S. organizations are also not eligible to apply.
Are foreign collaborations or international project elements allowed at all?
Yes, foreign components may be allowed as defined in the NIH Grants Policy Statement. This means certain project elements or collaborations may be permitted to occur internationally under NIH rules, even though the applicant institution itself must be domestic.
Is CASEL intended to fund a single research project?
No. The opportunity is described as focusing on building an operational and scientific coordination center rather than primarily funding a single stand-alone research project.
What is the overall goal of creating a central coordinating hub?
The overall goal is to organize, integrate, and accelerate tobacco regulatory science research activities and outputs so that evidence can move more efficiently from research groups into findings that can inform federal tobacco product regulation.
Why does the FOA emphasize harmonizing approaches and consistent scientific practices?
The FOA frames harmonization and consistency as ways to make evidence more usable for regulatory decision-making by improving comparability across studies, enabling integration of results, and helping ensure outputs are coherent and directly relevant to FDA CTP needs.
What law is referenced as the basis for FDA CTP regulatory responsibilities supported by this program?
The FOA references the Family Smoking Prevention and Tobacco Control Act (FSPTCA).
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