Opportunity Information: Apply for RFA AG 23 008
The grant opportunity titled "Pharmacokinetic and Pharmacodynamic (PK/PD) Studies of mTOR Inhibitors on Aging-Related Indications (U01 Clinical Trial Required)" (Funding Opportunity Number RFA-AG-23-008) is a National Institutes of Health (NIH) call for clinical-trial-based research that focuses on how mTOR inhibitors behave in the body (pharmacokinetics, or PK) and what biological effects they produce (pharmacodynamics, or PD) in older adults. The central purpose is to generate rigorous, comparable PK/PD evidence for mTOR-modulating drugs in people who either have specific aging-related diseases or who are relatively healthy but at elevated risk for multiple aging-associated conditions. In practical terms, NIH is looking for studies that can clarify dosing, exposure, biological response, and mechanistic signals in relevant older populations, so that the field can better understand how mTOR inhibition might influence aging-related pathways and outcomes.
This FOA uses the U01 mechanism, which is a cooperative agreement. That matters because it signals substantial NIH program involvement beyond a typical research grant. Individual research teams would receive their own awards to run their PK/PD studies, but they would not operate in isolation. Instead, each funded project is expected to function as part of a coordinated network. The network structure is intended to promote active collaboration across studies, including sharing information and lessons learned in real time, working toward harmonized or aligned measurements where feasible, and pooling data across sites and projects. The overall aim of this network requirement is to support broader conclusions than any single study could provide, particularly around how mTOR modulation affects multiple aging-related outcomes and underlying mechanisms across different populations and conditions.
The scientific scope centers specifically on PK/PD studies of mTOR inhibitors, meaning proposals should be designed to measure drug exposure and time course (for example, concentration over time, distribution, metabolism, and clearance) alongside measurable biological responses that reflect target engagement or downstream pathway effects. Because the FOA emphasizes aging-related indications, the populations of interest include groups living with different age-associated diseases as well as relatively healthy older adults who are still at risk for developing a range of aging conditions. This framing encourages applications that can illuminate whether PK/PD profiles differ by disease state, age-related physiology, comorbidities, or other factors common in older populations, and whether PD readouts align with hypothesized mechanisms of mTOR-related aging biology.
Administratively, the opportunity is categorized as discretionary funding and sits in the health funding activity category, with CFDA number 93.866. The sponsoring agency is NIH, and the original closing date listed is 2022-06-15, with a creation date of 2022-01-05. The FOA title includes "Clinical Trial Required," indicating that the proposed work must include a clinical trial component rather than being purely observational or preclinical, and applicants should be prepared to meet NIH expectations for clinical trial design, conduct, and oversight consistent with a U01 cooperative agreement.
Eligibility is broad and includes many types of domestic organizations and governmental entities. Eligible applicants listed include state, county, and city or 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; tribal organizations other than federally recognized tribal governments; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (excluding institutions of higher education where applicable); for-profit organizations other than small businesses; small businesses; and an "other" category. The FOA also explicitly highlights additional eligible applicant categories such as 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 government agencies, regional organizations, and U.S. territories or possessions, reinforcing an intent to include a wide range of institutions and communities in this research area.
At the same time, the FOA draws clear boundaries around foreign participation. Non-domestic (non-U.S.) entities and foreign institutions are stated as not eligible to apply as applicant organizations. However, non-domestic components of U.S. organizations are eligible, and foreign components are allowed as defined in the NIH Grants Policy Statement. In other words, the main applicant organization must be domestic and eligible, but collaborations that involve certain foreign components may still be permissible under NIH policy, provided the application structure follows those rules.
Overall, the opportunity is best understood as NIH support for coordinated, networked clinical PK/PD research on mTOR inhibitors aimed at aging-related conditions and risk states in older adults. The emphasis on collaboration, harmonization, and pooled analyses suggests NIH is trying to accelerate comparability and generalizability in this space, so that findings about dosing, exposure-response relationships, and mechanistic biomarkers can be interpreted across multiple studies rather than remaining siloed within individual trials.Apply for RFA AG 23 008
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Pharmacokinetic and Pharmacodynamic (PK/PD) Studies of mTOR Inhibitors on Aging-Related Indications (U01 Clinical Trial Required)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.866.
- This funding opportunity was created on 2022-01-05.
- Applicants must submit their applications by 2022-06-15. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- 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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Frequently Asked Questions (FAQs)
1) What is the title of this funding opportunity?
The funding opportunity is titled "Pharmacokinetic and Pharmacodynamic (PK/PD) Studies of mTOR Inhibitors on Aging-Related Indications (U01 Clinical Trial Required)."
2) What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is RFA-AG-23-008.
3) Which agency is sponsoring this grant opportunity?
The sponsoring agency is the National Institutes of Health (NIH).
4) What is the funding mechanism and what does it imply?
This FOA uses the U01 mechanism, which is a cooperative agreement. That means NIH expects substantial program involvement compared to a typical research grant, and funded teams are expected to operate as part of a coordinated network rather than as fully independent, stand-alone projects.
5) Is a clinical trial required under this FOA?
Yes. The FOA title includes "Clinical Trial Required," indicating that the proposed work must include a clinical trial component and cannot be purely observational or preclinical.
6) What is the central scientific purpose of this FOA?
The purpose is to generate rigorous, comparable pharmacokinetic (PK) and pharmacodynamic (PD) evidence for mTOR-modulating drugs in older adults, including those with aging-related diseases and those who are relatively healthy but at elevated risk for multiple aging-associated conditions.
7) What types of drugs are the focus of this opportunity?
The scientific scope centers on mTOR inhibitors (mTOR-modulating drugs).
8) What does "PK/PD" mean in the context of this FOA?
PK (pharmacokinetics) refers to how a drug behaves in the body over time, such as concentration over time, distribution, metabolism, and clearance. PD (pharmacodynamics) refers to the biological effects the drug produces, including measures that can reflect target engagement or downstream pathway effects.
9) What kinds of research questions is NIH trying to answer through these studies?
NIH is looking for studies that clarify dosing, exposure, biological response, and mechanistic signals in relevant older populations, so the field can better understand how mTOR inhibition might influence aging-related pathways and outcomes.
10) Who are the intended study populations?
The populations of interest include older adults who have specific aging-related diseases, as well as relatively healthy older adults who are still at elevated risk for developing multiple aging-associated conditions.
11) Does the FOA encourage studying differences in PK/PD across subgroups?
Yes. The FOA framing supports applications that can illuminate whether PK/PD profiles differ by disease state, age-related physiology, comorbidities, or other factors common in older populations, and whether PD readouts align with hypothesized mechanisms of mTOR-related aging biology.
12) Are funded projects expected to collaborate with each other?
Yes. Each funded project is expected to function as part of a coordinated network. NIH describes active collaboration across studies, including sharing information and lessons learned in real time, aligning or harmonizing measurements where feasible, and pooling data across sites and projects.
13) Why does the FOA emphasize a coordinated network and pooled analyses?
The network requirement is intended to support broader conclusions than any single study could provide, particularly around how mTOR modulation affects multiple aging-related outcomes and underlying mechanisms across different populations and conditions. The goal is to improve comparability and generalizability of findings across studies.
14) What general types of measurements are expected in proposed studies?
Proposals should be designed to measure drug exposure and time course (PK) alongside measurable biological responses (PD) that reflect target engagement or downstream pathway effects.
15) What is the funding category and activity area?
The opportunity is categorized as discretionary funding and is in the health funding activity category.
16) What is the CFDA number associated with this opportunity?
The CFDA number listed is 93.866.
17) What are the key dates listed for this opportunity?
The creation date listed is 2022-01-05, and the original closing date listed is 2022-06-15.
18) What types of organizations are eligible to apply?
Eligibility is broad and includes many domestic organizations and governmental entities, including state, county, and city or township governments; special district governments; independent school districts; public housing authorities/Indian housing authorities; public and state-controlled institutions of higher education; private institutions of higher education; nonprofits with and without 501(c)(3) status (excluding institutions of higher education where applicable); for-profit organizations other than small businesses; small businesses; and other eligible entity types listed in the FOA.
19) Are tribal entities and tribal organizations eligible?
Yes. Eligible applicants include federally recognized Native American tribal governments and tribal organizations other than federally recognized tribal governments.
20) Does the FOA explicitly encourage applications from specific institution types or communities?
Yes. The FOA highlights additional eligible categories such as 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 government agencies; regional organizations; and U.S. territories or possessions.
21) Are non-U.S. (foreign) institutions eligible to apply as the main applicant?
No. Non-domestic (non-U.S.) entities and foreign institutions are stated as not eligible to apply as applicant organizations.
22) Are any foreign components allowed at all?
Yes. Non-domestic components of U.S. organizations are eligible, and foreign components are allowed as defined in the NIH Grants Policy Statement. The main applicant organization must still be domestic and otherwise eligible.
23) If a project includes a foreign component, what is the key constraint described in the FOA summary?
The key constraint is that the applicant organization must be a domestic eligible entity, while foreign components may be included only in ways that are permissible under NIH policy (as referenced in the NIH Grants Policy Statement).
24) What does the FOA suggest about expectations for clinical trial oversight?
Because the FOA is "Clinical Trial Required" and uses a U01 cooperative agreement, applicants should be prepared to meet NIH expectations for clinical trial design, conduct, and oversight consistent with a cooperative agreement structure.
25) In plain terms, what kind of project is a good fit for this FOA?
A good fit is a clinical-trial-based PK/PD study of an mTOR inhibitor in older adults (either with aging-related diseases or at elevated risk while relatively healthy) that generates rigorous exposure and biological response evidence and is designed to collaborate within a coordinated NIH-supported network, including alignment of measurements and potential pooled analyses.
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