Opportunity Information: Apply for FOR FD 20 008
This grant opportunity, titled "Incorporating cost effectiveness and societal outcomes into FDA opioids model (U01)" (FOR FD 20 008), is a cooperative agreement offered by the U.S. Department of Health and Human Services through the Food and Drug Administration (FDA). Its central aim is to expand and strengthen the FDA's existing opioid crisis modeling and policy analysis tool by adding two major dimensions that are often underrepresented in opioid policy evaluation: broader social outcomes and cost effectiveness. Rather than focusing only on clinical endpoints or narrow measures of harm, the project is designed to help decision makers see a more complete picture of how opioid-related policies play out across health, wellbeing, and economic impacts.
A key theme of the opportunity is integrating societal outcomes into the model. In practice, that means building in measures such as quality of life and the consequences of untreated or inadequately treated pain, alongside the more commonly modeled outcomes related to misuse, addiction, overdoses, and mortality. The intent is to ensure that policy analysis does not unintentionally ignore real tradeoffs, such as the possibility that stricter controls could reduce diversion and overdose risk while also increasing suffering for some patients if pain management becomes harder to access. By embedding these kinds of social and patient-centered outcomes, the resulting model can support more balanced policy comparisons and can better reflect the lived experience of affected groups, including patients, families, and communities.
The second major focus is cost effectiveness. The FDA is seeking work that can incorporate economic evaluation into the opioid policy model, enabling analysis of both costs and outcomes in a structured way. This includes accounting for the costs of interventions and policies, as well as downstream economic consequences tied to healthcare utilization, treatment services, societal productivity, and other resource impacts. The goal is not simply to attach price tags to policies, but to allow decision makers to compare options on a common footing, weighing expected benefits against expected costs and understanding where limited resources might achieve the greatest overall impact.
To achieve these goals, the award anticipates substantial model development work. Applicants are expected to integrate new structural components (meaning new modules or mechanisms inside the model), bring in new data sources, and conduct new analyses to connect those data and structures to policy-relevant outputs. In other words, this is not a simple update to parameters; it is more like a major upgrade that changes what the model can represent and what questions it can credibly answer. The outcome should be a more holistic decision-support tool capable of evaluating opioid-related policies with attention to clinical outcomes, societal wellbeing, and economic value.
A notable part of the description is the recognition that data on opioid interventions can be limited or fragmented, especially when it comes to costs and social outcomes. Because of that, the project is also expected to include studies or data-collection efforts to fill gaps. This could involve gathering information on the costs of implementing particular policies, measuring quality-of-life impacts, documenting how interventions affect access to pain treatment, or capturing other real-world details that are necessary to evaluate policies accurately. The message is that model improvement depends not only on better modeling techniques but also on better inputs, and the award supports generating those inputs when existing evidence is insufficient.
From an administrative standpoint, the funding instrument is a U01 cooperative agreement, which typically implies substantial federal involvement during the project rather than a hands-off grant. The opportunity is listed under CFDA (now often referred to as Assistance Listing) number 93.103, and falls within the FDA's broader public health mission related to consumer protection and health outcomes. The anticipated number of awards is one, suggesting the agency intends to fund a single team or consortium to carry out an integrated body of work rather than splitting the effort across multiple smaller awards.
Eligibility is broad and includes many organization types: 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; nonprofits with and without 501(c)(3) status; for-profit organizations (including other than small businesses); small businesses; and other entities as described in the full announcement. This wide eligibility aligns with the multidisciplinary nature of the work, which can require expertise in health economics, epidemiology, public health, clinical pain management, substance use research, systems modeling, and policy analysis, as well as the ability to collect or assemble real-world data.
Finally, some of the listing fields provide only limited award-size information. The award ceiling is shown as 0, which usually indicates that a fixed ceiling is not specified in the summary record and applicants would need to consult the full notice for budget expectations and constraints. The record also notes a creation date of May 25, 2021, with the closing date indicated as an archiving forecast, suggesting the opportunity may have been time-limited and later archived; the authoritative details would be in the complete solicitation text. Overall, the opportunity is aimed at producing an enhanced FDA opioid policy model that better captures human outcomes and economic tradeoffs, supported by targeted data development where evidence is currently thin.Apply for FOR FD 20 008
- The Department of Health and Human Services, Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "Incorporating cost effectiveness & societal outcomes into FDA opioids model (U01)" 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 25, 2021.
- Applicants must submit their applications by Archiving forecast. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- 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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