Opportunity Information: Apply for RFA AG 15 013

  • The National Institutes of Health in the health sector is offering a public funding opportunity titled "Analyses of Datasets on Older Populations with High Prevalence of Mobility Disability to Develop Clinically Meaningful Diagnostic Cut Points for Low Muscle Mass and/or Low Muscle Strength (U01)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.866 Aging Research.
  • This funding opportunity was created on Sep 16, 2014 and posted on Sep 16, 2014.
  • Applicants must submit their applications by Jan 15, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • The funding agency has allocated a total of $750,000.00 to eligible and selected applicants.
  • The number of recipients for this funding is limited to 1 candidate(s).
  • Eligible applicants include: Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Native American tribal organizations (other than Federally recognized tribal governments) Independent school districts Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities For profit organizations other than small businesses Others (see text field entitled Additional Information on Eligibility for clarification) State governments City or township governments Public and State controlled institutions of higher education County governments Special district governments Private institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education.
  • Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are not eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Apply for RFA AG 15 013

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Opportunity Summary:

This NIH funding opportunity (RFA-AG-15-013) is a cooperative agreement (U01) aimed at improving how clinicians and researchers define "low muscle mass" and "low muscle strength" in older adults, specifically in ways that matter for real-world mobility disability. The core idea is practical: if treatments or interventions are designed to prevent or reduce mobility disability by targeting low muscle mass and/or weakness, then clinical trials and clinical decision-making need clear, evidence-based thresholds (diagnostic cut points) that identify the people whose muscle deficits are truly likely to contribute to disability. Without clinically meaningful cut points, studies may enroll people whose muscle mass or strength is not low enough to be driving their mobility problems, making it harder to detect whether an intervention works.

The FOA invites applicants to analyze existing datasets, or datasets where data collection will be finished within one year of the FOA date. The emphasis is on older populations with a high prevalence of mobility disability, because prior work proposing cut points often relied on cohorts with relatively few individuals who actually had mobility disability. By focusing on datasets enriched for disability, the funded analyses are expected to better capture the relationship between muscle mass, strength, physical function impairments, and meaningful mobility outcomes. In other words, the goal is to move beyond abstract or purely statistical definitions of "low" and instead produce thresholds that align with increased risk or presence of mobility limitations that patients and clinicians care about.

A key expectation is that the proposed analyses will build on and expand earlier studies that have already suggested candidate thresholds for low muscle mass and weakness. Rather than starting from scratch, applicants are supposed to test, refine, and evaluate these cut points using more disability-heavy samples and potentially more diverse populations. The work should clarify how muscle mass and muscle strength relate to each other (since they do not always track together in older adults), how each relates to impaired physical function, and how these relationships should influence where cut points are set. The intended output is stronger evidence to support diagnostic definitions that can be used consistently across research studies and, ultimately, in clinical contexts.

Applicants are encouraged to combine datasets from multiple studies if that helps achieve sufficient sample size and a high enough number of mobility-disabled participants to support robust analyses. However, the FOA signals that combining data only makes sense if the measures can be harmonized across studies. At a minimum, the combined datasets should include (1) at least one objective measure of muscle mass measured at the same anatomic site(s) across included studies, (2) at least one direct measure of muscle strength that is common across the datasets, (3) gait speed, and (4) self-reported mobility status in older adults. The announcement also encourages examining additional related measures such as other strength tests, muscle power, and broader physical performance batteries like the Short Physical Performance Battery (SPPB), as these may help connect muscle characteristics to functional and disability outcomes in a way that supports clinically sensible thresholds.

From an administrative standpoint, this is a discretionary NIH aging research opportunity (CFDA 93.866) with no cost sharing requirement. The agency planned to make one award, with an estimated total funding level of $750,000. Because the mechanism is a cooperative agreement (U01), recipients should expect substantial NIH program involvement compared to a standard research project grant, typically meaning more interaction around analytic plans, milestones, and deliverables. The original posting date was September 16, 2014, with an application closing date of January 15, 2015, and an archive date of February 15, 2015.

Eligibility is broad and includes many types of domestic organizations and governments, such as nonprofits (with or without 501(c)(3) status), for-profit entities (including small businesses), public and private institutions of higher education, state and local governments, tribal governments and tribal organizations, public housing authorities, independent school districts, and various designated institutional types (for example, HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, and Alaska Native/Native Hawaiian-serving institutions). Foreign organizations and foreign institutions are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible, but foreign components (as NIH defines them) may be allowed under NIH policy.

Overall, the opportunity is best understood as a targeted push to standardize and validate diagnostic thresholds for sarcopenia-related traits (low muscle mass and weakness) in populations where mobility disability is common, using large-scale secondary data analysis and, where useful, pooled multi-cohort datasets. The anticipated impact is better-designed intervention trials and clearer clinical identification of older adults most likely to benefit from treatments aimed at improving muscle-related contributors to mobility disability.

Frequently Asked Questions (FAQs)

What is this NIH funding opportunity?

This NIH funding opportunity (RFA-AG-15-013) supports research to improve how clinicians and researchers define "low muscle mass" and "low muscle strength" in older adults, specifically in ways that are meaningfully tied to real-world mobility disability.

What is the main purpose of the project(s) funded under this FOA?

The main purpose is to develop, test, refine, and evaluate evidence-based diagnostic cut points (thresholds) for low muscle mass and/or low muscle strength that better identify older adults whose muscle deficits are likely to contribute to mobility disability. The goal is to ensure that clinical trials and clinical decision-making use thresholds that align with outcomes that matter to patients and clinicians, rather than purely statistical definitions of "low."

Why does NIH emphasize "clinically meaningful" cut points?

If cut points are not clinically meaningful, studies may enroll people whose muscle mass or strength is not low enough to be driving their mobility problems. That can dilute the study sample, making it harder to detect whether an intervention that targets muscle deficits actually works for preventing or reducing mobility disability.

What mechanism is being used for this award?

The FOA uses a cooperative agreement mechanism (U01).

What does it mean that this is a cooperative agreement (U01)?

A U01 typically involves substantial NIH program involvement compared to a standard research project grant. Recipients should expect more interaction with NIH around analytic plans, milestones, and deliverables.

How many awards did NIH plan to make?

The agency planned to make one award.

What is the estimated total funding level for this opportunity?

The estimated total funding level was $750,000.

Is cost sharing or matching required?

No. The FOA states there is no cost sharing requirement.

What is the CFDA number for this opportunity?

The CFDA number is 93.866.

What kinds of research activities are invited?

The FOA invites applicants to analyze existing datasets, or datasets where data collection will be finished within one year of the FOA date. The focus is on secondary data analysis and, where helpful and feasible, pooled analyses across multiple cohorts with harmonized measures.

Why does the FOA emphasize datasets with a high prevalence of mobility disability?

Prior work proposing cut points often relied on cohorts with relatively few individuals who had mobility disability. By using disability-enriched datasets, the analyses are expected to better capture relationships between muscle mass, strength, physical function impairments, and meaningful mobility outcomes, supporting thresholds that are more relevant to real-world disability risk or presence.

Does the FOA expect applicants to start from scratch in defining cut points?

No. A key expectation is that proposed analyses build on and expand earlier studies that have already suggested candidate thresholds. Applicants are expected to test, refine, and evaluate existing candidate cut points using disability-heavy samples and potentially more diverse populations.

What relationships is the FOA trying to clarify?

The work is intended to clarify how muscle mass and muscle strength relate to each other (including the fact that they do not always track together in older adults), how each relates to impaired physical function, and how these relationships should influence where diagnostic cut points are set.

What outcomes or endpoints are most important to this FOA?

The FOA is centered on mobility disability and mobility limitations that are meaningful to patients and clinicians, and on connecting muscle measures (mass and strength) to physical function impairments and real-world mobility outcomes.

Can applicants combine datasets from multiple studies?

Yes. Applicants are encouraged to combine datasets from multiple studies if that helps achieve sufficient sample size and a high enough number of mobility-disabled participants to support robust analyses.

Are there conditions for combining datasets?

Yes. Combining data is expected to be appropriate only if the measures can be harmonized across studies.

What minimum measures should be available in combined datasets?

At a minimum, combined datasets should include: (1) at least one objective measure of muscle mass measured at the same anatomic site(s) across included studies, (2) at least one direct measure of muscle strength that is common across the datasets, (3) gait speed, and (4) self-reported mobility status in older adults.

What additional measures does the FOA encourage applicants to examine?

The announcement encourages examining additional related measures such as other strength tests, muscle power, and broader physical performance batteries like the Short Physical Performance Battery (SPPB), because these may help link muscle characteristics to functional and disability outcomes in support of clinically sensible thresholds.

Who is eligible to apply?

Eligibility is broad and includes many types of domestic organizations and governments. Examples listed include: nonprofits (with or without 501(c)(3) status), for-profit entities (including small businesses), public and private institutions of higher education, state and local governments, tribal governments and tribal organizations, public housing authorities, independent school districts, and designated institutional types such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, and Alaska Native/Native Hawaiian-serving institutions.

Are foreign organizations eligible to apply?

No. Foreign organizations and foreign institutions are not eligible to apply.

Are non-U.S. components of U.S. organizations eligible?

No. Non-U.S. components of U.S. organizations are not eligible.

Are foreign components allowed in any way?

Foreign components (as NIH defines them) may be allowed under NIH policy, even though foreign organizations and non-U.S. components of U.S. organizations are not eligible to apply.

What is the practical impact NIH is aiming for?

The anticipated impact is better-designed intervention trials and clearer clinical identification of older adults most likely to benefit from treatments aimed at improving muscle-related contributors to mobility disability, by standardizing and validating diagnostic thresholds for low muscle mass and weakness.

What was the timeline for this FOA?

The original posting date was September 16, 2014. The application closing date was January 15, 2015. The archive date was February 15, 2015.

What does it mean that the FOA is archived?

Based on the provided information, the FOA has an archive date of February 15, 2015, indicating it is no longer an active solicitation under that posting.

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