Opportunity Information: Apply for RFA AG 15 006

  • The National Institutes of Health in the health sector is offering a public funding opportunity titled "Clinical Trial on the Effects of Interventions Aiming to Reduce Chronic Inflammation in Older Adults Pilot Phase (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 Jun 5, 2014 and posted on Jun 5, 2014.
  • Applicants must submit their applications by Oct 8, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • The funding agency has allocated a total of $1,857,000.00 to eligible and selected applicants.
  • Each selected applicant is eligible to receive up to $1,857,000.00 in funding.
  • The number of recipients for this funding is limited to 1 candidate(s).
  • Eligible applicants include: City or township governments Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Public and State controlled institutions of higher education County governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Special district governments Small businesses State governments Independent school districts Private institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Native American tribal governments (Federally recognized) 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 not allowed.
Apply for RFA AG 15 006

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Opportunity Summary:

The Clinical Trial on the Effects of Interventions Aiming to Reduce Chronic Inflammation in Older Adults Pilot Phase (U01) (Funding Opportunity Number RFA-AG-15-006) was a National Institutes of Health (NIH) discretionary funding opportunity in the health and aging research area (CFDA 93.866). The central goal of the announcement was to support the early, preparatory work needed to design and successfully launch a larger, full-scale intervention study testing whether lowering persistent, low-grade chronic inflammation in older adults can improve, preserve, or meaningfully affect mobility and mobility-related limitations. Rather than funding a definitive large trial right away, this FOA focused on generating the practical evidence and study infrastructure needed to make a subsequent major trial scientifically strong and operationally feasible.

The work supported under this FOA was intended to take the form of a pilot clinical study (or more than one pilot study) and/or rigorous secondary analyses. In practical terms, that means applicants were expected to use the award period to answer the kinds of questions that determine whether a full intervention trial is worth doing and how it should be built. Examples of the types of information this pilot phase is meant to produce include feasibility data (such as recruitment and retention of older adults, adherence to an intervention, and the ability to deliver the intervention consistently), early signals about biological response (whether the intervention measurably reduces inflammatory markers associated with chronic low-grade inflammation), and the best ways to measure mobility outcomes in this population. Secondary analyses could be used to refine the rationale, identify the most suitable target populations, determine which inflammation and mobility measures are most informative, and improve estimates needed for sample size planning and study power calculations for a later, larger clinical trial.

The funding mechanism was a cooperative agreement (U01), which generally indicates that NIH expected to have substantial scientific and programmatic involvement during the conduct of the project compared with a standard research grant. This structure is often used when a project requires close coordination, milestone-based progress, or collaborative problem-solving between the funded research team and the agency, especially for clinical trial planning and pilot testing where protocol details and operational decisions can strongly influence whether a later definitive trial succeeds.

NIH anticipated making one award under this FOA. The estimated total funding amount was $1,857,000, and the award ceiling was also $1,857,000, suggesting a single, relatively large pilot effort intended to produce a clear, actionable foundation for a subsequent intervention study. Cost sharing or matching was not required, which is typical for NIH opportunities and reduces financial barriers for eligible institutions.

The eligibility was broad and included many types of U.S.-based organizations that could credibly conduct clinical research with older adult populations. Eligible applicants included state, county, city/township, and special district governments; public and private institutions of higher education; independent school districts; federally recognized tribal governments and other tribal organizations; public housing authorities; nonprofits both with and without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses. The FOA also explicitly listed additional eligible categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as faith-based or community-based organizations and eligible federal agencies. At the same time, it clearly restricted non-U.S. participation: non-domestic (non-U.S.) entities and foreign institutions were not eligible to apply, non-domestic components of U.S. organizations were not eligible, and foreign components as defined by NIH policy were not allowed.

From an administrative standpoint, the opportunity was posted on June 5, 2014, with an original and current closing date of October 8, 2014, and it was archived on November 8, 2014. Applicants and interested parties were directed to the full announcement on the NIH grants website, and NIH provided a general Office of Extramural Research (OER) webmaster contact for access or linking issues. Overall, the FOA was designed as a targeted, one-award pilot initiative to reduce uncertainty and de-risk a larger clinical trial by collecting the key preliminary evidence needed to test whether interventions that reduce chronic inflammation can translate into real-world functional benefits for older adults, particularly in the domain of mobility limitations.

Frequently Asked Questions (FAQs)

What is the name of this funding opportunity?

The opportunity is titled "Clinical Trial on the Effects of Interventions Aiming to Reduce Chronic Inflammation in Older Adults Pilot Phase (U01)." The Funding Opportunity Number (FON) is RFA-AG-15-006.

Which agency offered this grant?

This was a National Institutes of Health (NIH) discretionary funding opportunity, with the full announcement hosted on the NIH grants website.

What research area did this opportunity focus on?

The focus area was health and aging research, specifically chronic low-grade inflammation in older adults and how interventions that reduce inflammation might affect mobility and mobility-related limitations.

What was the central goal of the announcement?

The central goal was to support early, preparatory work needed to design and successfully launch a later, full-scale intervention study. The larger goal of that later trial would be to test whether lowering persistent, low-grade chronic inflammation in older adults can improve, preserve, or meaningfully affect mobility and mobility-related limitations.

Was this funding intended to pay for a definitive large clinical trial right away?

No. This FOA was designed as a pilot phase effort rather than funding a definitive large trial immediately. It aimed to generate practical evidence and build study infrastructure to make a subsequent major trial scientifically strong and operationally feasible.

What types of work were expected to be supported under this FOA?

The FOA was intended to support a pilot clinical study (or more than one pilot study) and/or rigorous secondary analyses. The expectation was that the award period would be used to answer key design and feasibility questions for a later large intervention trial.

What is meant by a "pilot phase" in this context?

In this context, the pilot phase refers to early-stage work that helps determine whether a larger intervention trial is worth doing and, if so, how it should be designed and run. This includes collecting feasibility data, building operational capacity, and generating evidence needed for later sample size and power planning.

What kinds of feasibility information was the pilot phase expected to produce?

Examples included recruitment and retention of older adults, adherence to the intervention, and the ability to deliver the intervention consistently.

What biological outcomes were emphasized in the pilot work?

The FOA emphasized early signals about biological response, such as whether the intervention measurably reduces inflammatory markers associated with chronic low-grade inflammation.

What outcomes related to function were emphasized?

The FOA emphasized mobility outcomes in older adults, including identifying the best ways to measure mobility and mobility-related limitations in the target population.

How could secondary analyses be used under this FOA?

Secondary analyses could be used to refine the scientific rationale, identify the most suitable target populations, determine which inflammation and mobility measures are most informative, and improve estimates needed for sample size planning and study power calculations for a later, larger clinical trial.

What funding mechanism was used for this opportunity?

The mechanism was a cooperative agreement (U01).

What does a U01 cooperative agreement imply about NIH involvement?

A U01 generally indicates that NIH expected substantial scientific and programmatic involvement during the conduct of the project, compared with a standard research grant. The structure is often used when close coordination, milestone-based progress, or collaborative problem-solving is important, especially for clinical trial planning and pilot testing.

How many awards did NIH anticipate making under this FOA?

NIH anticipated making one award.

What was the estimated total funding amount for this FOA?

The estimated total funding amount was $1,857,000.

What was the award ceiling?

The award ceiling was also $1,857,000, aligning with the plan to make a single award at approximately that level.

Was cost sharing or matching required?

No. Cost sharing or matching was not required.

Who was eligible to apply?

Eligibility was broad for U.S.-based organizations capable of conducting clinical research with older adult populations. Eligible applicants included state, county, city/township, and special district governments; public and private institutions of higher education; independent school districts; federally recognized tribal governments and other tribal organizations; public housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses.

Were minority-serving institutions specifically included as eligible applicants?

Yes. The FOA explicitly listed categories including Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs).

Could faith-based or community-based organizations apply?

Yes. The FOA explicitly included faith-based or community-based organizations among eligible categories.

Were federal agencies eligible to apply?

Yes. The FOA listed eligible federal agencies as eligible applicants.

Are non-U.S. (foreign) institutions eligible to apply?

No. Non-domestic (non-U.S.) entities and foreign institutions were not eligible to apply.

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

No. Non-domestic components of U.S. organizations were not eligible.

Are foreign components (as defined by NIH policy) allowed?

No. Foreign components, as defined by NIH policy, were not allowed.

What was the CFDA number for this opportunity?

The CFDA number listed was 93.866.

When was the opportunity posted?

The opportunity was posted on June 5, 2014.

What was the application due date?

The original and current closing date was October 8, 2014.

Is this opportunity still open?

No. The FOA was archived on November 8, 2014.

Where were applicants directed to find the full announcement?

Applicants and interested parties were directed to the full announcement on the NIH grants website.

Who was listed as a contact for access or linking issues?

NIH provided a general Office of Extramural Research (OER) webmaster contact for access or linking issues.

What problem was this FOA designed to solve before launching a larger trial?

It was designed to reduce uncertainty and de-risk a larger clinical trial by collecting the key preliminary evidence needed to test whether interventions that reduce chronic inflammation can translate into real-world functional benefits for older adults, especially related to mobility limitations.

What would a successful pilot effort be expected to enable later?

A successful pilot effort would be expected to provide the practical evidence, measurement approaches, feasibility findings, and planning estimates needed to support a later, major intervention study that is scientifically strong and operationally feasible.

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