Pharmacokinetics (PK) and Pharmacodynamics (PD) of THC in Cannabis and Cannabis Products (R01 - Clinical Trial Optional) | RFA DA 22 028

Opportunity Information: Apply for RFA DA 22 028

The National Institutes of Health (NIH) released a discretionary grant funding opportunity, RFA-DA-22-028, titled "Pharmacokinetics (PK) and Pharmacodynamics (PD) of THC in Cannabis and Cannabis Products (R01 - Clinical Trial Optional)." The central goal of the announcement is to fund research that clarifies how delta-9-tetrahydrocannabinol (THC), as it appears in cannabis and in commercially available cannabis products, moves through the body (pharmacokinetics) and produces measurable biological and behavioral effects (pharmacodynamics). The FOA is designed to support both human and animal studies, and it uses the NIH R01 mechanism, meaning it is oriented toward hypothesis-driven, research-intensive projects that can generate robust, generalizable evidence. Clinical trials are allowed but not required, which makes the opportunity flexible for applicants proposing anything from controlled laboratory studies to observational or mechanistic work, depending on what is best suited to answer the scientific questions.

From a practical standpoint, this opportunity is focused on improving the evidence base around THC exposure and THC-related effects across different routes of administration and product types, which is increasingly relevant as cannabis markets expand and diversify. Projects under this FOA would generally be expected to produce high-quality PK data (for example, absorption rates, blood or plasma concentration-time profiles, distribution, metabolism, and elimination patterns) and PD data (for example, acute impairment, cognitive or psychomotor outcomes, physiological responses, or other measurable functional or clinical endpoints). By explicitly naming both cannabis and cannabis products, the FOA signals interest not just in THC as a pure compound, but in THC as delivered through real-world formulations and preparations that people and animals may actually use, which can affect onset, intensity, and duration of effects.

The funding instrument is a grant, and the activity category is listed under education and health, with CFDA number 93.279. The listed award ceiling is $500,000, indicating the maximum award amount per project under the terms presented in the summary data. The original closing date for submissions was February 9, 2022, and the opportunity record shows a creation date of September 8, 2021. While the summary does not specify the exact number of expected awards, the intent is clearly to stimulate multiple studies that collectively strengthen scientific understanding of THC PK/PD relationships, which can inform public health, clinical guidance, and future research directions.

Eligibility is broad and includes a wide range of domestic applicants such as state, county, city, and 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; public housing authorities and Indian housing authorities; tribal organizations that are not federally recognized governments; nonprofit organizations with and without 501(c)(3) status (excluding institutions of higher education in that category); for-profit organizations (other than small businesses); and small businesses. The FOA also highlights additional eligible applicant categories that NIH sometimes calls out to encourage diverse participation, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and even non-domestic (non-U.S.) entities, meaning foreign organizations may apply when consistent with NIH policy and the specifics of the announcement.

Overall, the opportunity is aimed at advancing rigorous, mechanistic knowledge about THC exposure and effects, using PK and PD approaches in humans and animals to address real gaps in what is known about cannabis and THC-containing products. The R01 format and the clinical trial optional designation together suggest NIH is seeking well-justified, methodologically strong proposals that can meaningfully improve how THC dose, product characteristics, route of use, and timing relate to measurable outcomes in the body and brain.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Pharmacokinetics (PK) and Pharmacodynamics (PD) of THC in Cannabis and Cannabis Products (R01 - Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.279.
• This funding opportunity was created on 2021-09-08.
• Applicants must submit their applications by 2022-02-09. (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 $500,000.00 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 DA 22 028

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