Opportunity Information: Apply for RFA AG 24 044
The National Institutes of Health (NIH) is soliciting applications under the funding opportunity titled "Pharmacokinetic and Pharmacodynamic (PK/PD) Studies of mTOR Inhibitors on Aging-Related Indications (U01 Clinical Trial Required)" (Funding Opportunity Number RFA-AG-24-044). This program is focused on generating high-quality human data on how mTOR inhibitor drugs behave in the body (pharmacokinetics, or PK) and what biological effects they produce (pharmacodynamics, or PD) when used in people who either have aging-related diseases or are relatively healthy older adults who are at elevated risk for developing a range of aging-associated conditions. The intent is to better characterize dosing, exposure, and mechanistic effects of mTOR modulation across relevant older populations, with an emphasis on outcomes and pathways tied to aging biology.
The award mechanism is a U01 cooperative agreement, which generally means NIH expects substantial scientific or programmatic involvement during the project period compared with a standard research grant. A clinical trial is required, indicating that applicants must propose a study that meets NIH’s definition of a clinical trial and includes prospective assignment to an intervention and assessment of health-related biomedical or behavioral outcomes. While each project will be funded as an individual award, the funded studies will be expected to operate as a coordinated network. In practice, that network requirement is meant to promote active collaboration among awardees, including regular exchange of information, potential development of harmonized or comparable measures across studies, and pooling of data when feasible. The broader goal of this networked approach is to enable cross-study analyses that can assess mTOR inhibitor effects on multiple aging-related outcomes, and to compare how different patient groups, risk profiles, or disease contexts may influence PK/PD relationships and downstream biological mechanisms.
The NOFO sits within NIH’s health research portfolio (CFDA 93.866) and is categorized as a discretionary funding opportunity in the health activity area. The opportunity’s original closing date was 2023-11-07, and the posting lists the creation date as 2023-07-26. The award ceiling and expected number of awards are not specified in the provided listing, which often indicates that budgets and the number of awards depend on application quality, program priorities, and available appropriations.
Eligibility is broad and includes many types of domestic organizations and governments. 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; Native American tribal organizations that are not federally recognized tribal governments; public housing authorities and Indian housing authorities; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; and small businesses. The notice also explicitly highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, eligible federal agencies, tribal governments that are not federally recognized, and U.S. territories or possessions.
The NOFO draws clear boundaries around foreign involvement. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply as applicant organizations, and non-domestic components of U.S. organizations are also not eligible to apply. However, foreign components are allowed as defined in the NIH Grants Policy Statement, meaning a U.S.-based applicant may include certain foreign elements (for example, specific collaborations or performance sites) if they meet NIH policy requirements and are well-justified scientifically.
Overall, this opportunity is designed to build a coordinated set of clinical PK/PD studies that clarify how mTOR inhibitors engage targets and influence aging-relevant biology in older adults and in populations with aging-related diseases. By requiring awardees to work as a network and encouraging harmonization and data pooling, NIH is aiming to make the resulting evidence more comparable and more useful for understanding broader effects across conditions, not just within a single isolated study.Apply for RFA AG 24 044
- 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 2023-07-26.
- Applicants must submit their applications by 2023-11-07. (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)
What is the funding opportunity being offered?
The National Institutes of Health (NIH) is soliciting applications for the funding opportunity titled "Pharmacokinetic and Pharmacodynamic (PK/PD) Studies of mTOR Inhibitors on Aging-Related Indications (U01 Clinical Trial Required)" under Funding Opportunity Number RFA-AG-24-044.
What is the main purpose of this NIH program?
The program is intended to generate high-quality human data on how mTOR inhibitor drugs behave in the body (pharmacokinetics, PK) and what biological effects they produce (pharmacodynamics, PD). The emphasis is on understanding dosing, exposure, and mechanistic effects of mTOR modulation in older populations, including people with aging-related diseases and relatively healthy older adults at elevated risk for aging-associated conditions.
What types of studies are expected to be proposed?
Applicants are expected to propose clinical PK/PD studies in humans focused on mTOR inhibitors, with outcomes and biological pathways tied to aging biology. The funding opportunity specifically requires that the proposed research meet NIH's definition of a clinical trial.
Is a clinical trial required under this opportunity?
Yes. The NOFO is explicitly labeled "Clinical Trial Required." Applicants must propose a study that meets NIH's definition of a clinical trial, including prospective assignment of participants to an intervention and the assessment of health-related biomedical or behavioral outcomes.
Who is the intended study population?
The program focuses on studies in people who either have aging-related diseases or are relatively healthy older adults who are at elevated risk for developing a range of aging-associated conditions.
What does "PK/PD" mean in the context of this opportunity?
PK (pharmacokinetics) refers to how a drug behaves in the body, such as exposure over time. PD (pharmacodynamics) refers to the biological effects the drug produces, including mechanistic effects and pathway engagement. This opportunity is focused on generating human data on both PK and PD for mTOR inhibitors in aging-relevant contexts.
What is meant by "mTOR inhibitors" in this program?
The NOFO is focused on drugs that inhibit mTOR (mechanistic target of rapamycin) and seeks to better understand dosing, exposure, and mechanistic effects of mTOR modulation in older adult populations and aging-related indications.
What award mechanism is being used?
The award mechanism is a U01 cooperative agreement.
What is a U01 cooperative agreement, and how is it different from a standard grant?
A U01 cooperative agreement generally means NIH expects substantial scientific or programmatic involvement during the project period compared with a standard research grant. While each funded project is an individual award, NIH involvement and coordination expectations are typically higher under a cooperative agreement mechanism.
Will funded projects operate independently or as part of a larger group?
Funded studies will be expected to operate as a coordinated network. This is intended to promote active collaboration among awardees, including regular information exchange, potential development of harmonized or comparable measures, and pooling of data when feasible.
Why does NIH want a coordinated network of studies?
The network approach is intended to enable cross-study analyses, improve comparability across studies, and support broader assessments of mTOR inhibitor effects across multiple aging-related outcomes. It also aims to help compare how PK/PD relationships and biological mechanisms may differ across patient groups, risk profiles, or disease contexts.
Are applicants expected to harmonize measures across studies?
The listing indicates an expectation of collaboration and encourages the potential development of harmonized or comparable measures across studies. This is part of the networked approach and supports cross-study analyses and data pooling when feasible.
Is data pooling part of the program expectations?
Yes, when feasible. The coordinated network is intended to support pooling of data to enable cross-study analyses and improve the usefulness of results across conditions and populations.
How is this opportunity categorized in federal funding terms?
The NOFO is within NIH's health research portfolio (CFDA 93.866) and is categorized as a discretionary funding opportunity in the health activity area.
What is the Funding Opportunity Number (NOFO number)?
The Funding Opportunity Number is RFA-AG-24-044.
What was the original closing date for this opportunity?
The original closing date listed for the opportunity was 2023-11-07.
What is the posting or creation date listed for this opportunity?
The posting lists a creation date of 2023-07-26.
Is the award ceiling specified in the provided information?
No. The provided listing does not specify an award ceiling.
Is the expected number of awards specified in the provided information?
No. The provided listing does not specify the expected number of awards.
What does it mean when the award ceiling and number of awards are not specified?
In the provided description, the absence of an award ceiling and expected number of awards is described as something that often indicates budgets and the number of awards depend on application quality, program priorities, and available appropriations.
What types of organizations are eligible to apply?
Eligibility is broad and includes many types of domestic organizations and governments. 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
- Private institutions of higher education
- Federally recognized Native American tribal governments
- Native American tribal organizations (other than federally recognized tribal governments)
- Public housing authorities and Indian housing authorities
- Nonprofits with 501(c)(3) status (other than institutions of higher education)
- Nonprofits without 501(c)(3) status (other than institutions of higher education)
- For-profit organizations other than small businesses
- Small businesses
Are specific types of institutions explicitly highlighted as eligible?
Yes. The notice explicitly highlights additional eligible applicant categories, including:
- Alaska Native and Native Hawaiian Serving Institutions
- Asian American Native American Pacific Islander Serving Institutions (AANAPISISs)
- Hispanic-serving Institutions
- Historically Black Colleges and Universities (HBCUs)
- Tribally Controlled Colleges and Universities (TCCUs)
- Faith-based or community-based organizations
- Regional organizations
- Eligible federal agencies
- Tribal governments that are not federally recognized
- U.S. territories or possessions
Are foreign (non-U.S.) organizations eligible to apply as the applicant organization?
No. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply as applicant organizations under the boundaries described in the provided information.
Are non-domestic components of U.S. organizations eligible to apply?
No. Non-domestic components of U.S. organizations are also not eligible to apply, based on the foreign involvement limits described.
Are foreign components allowed in any form?
Yes, foreign components are allowed as defined in the NIH Grants Policy Statement. The provided information indicates that a U.S.-based applicant may include certain foreign elements (such as collaborations or performance sites) if they meet NIH policy requirements and are scientifically well-justified.
What is the overall goal of the research portfolio funded by this opportunity?
The overall goal is to build a coordinated set of clinical PK/PD studies that clarify how mTOR inhibitors engage targets and influence aging-relevant biology in older adults and in populations with aging-related diseases. The networked design is intended to make evidence more comparable and useful for understanding broader effects across conditions, not only within single isolated studies.
Does this opportunity focus only on people with diagnosed diseases?
No. It includes people with aging-related diseases as well as relatively healthy older adults who are at elevated risk for developing aging-associated conditions.
What kinds of outcomes are emphasized by the program?
The emphasis is on outcomes and pathways tied to aging biology, alongside PK/PD characterization (dosing, exposure, and mechanistic effects) of mTOR modulation across relevant older populations.
Are awardees expected to collaborate regularly?
Yes. The coordinated network requirement is meant to promote active collaboration among awardees, including regular exchange of information.
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