Opportunity Information: Apply for PAR 16 085

  • The HHS-NIH11 in the health sector is offering a public funding opportunity titled "NIA Clinical Research Project Planning Grant Program (R34)" 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 Jan 15, 2016 and posted on Jan 15, 2016.
  • Applicants must submit their applications by Mar 16, 2019. (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 $225,000.00 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 (see text field entitled Additional Information on Eligibility for clarification).
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Opportunity Summary:

The NIA Clinical Research Project Planning Grant Program (R34), listed as PAR-16-085, is a discretionary NIH grant opportunity from the U.S. Department of Health and Human Services (HHS), specifically the National Institutes of Health (NIH) and the National Institute on Aging (NIA). It is designed to strengthen the pipeline of aging-related clinical trials and clinical research projects by funding the detailed planning work that needs to happen before a full-scale study can be launched. The underlying goal is to help investigators produce clinical studies that are not only scientifically strong, but also operationally realistic, well-governed, and ready to execute in a way that yields reliable evidence about treatments, interventions, and health outcomes connected to aging and age-related conditions.

This FOA focuses on the practical building blocks that often determine whether a clinical study succeeds once recruitment and implementation begin. Supported planning activities include developing a complete study protocol, building a Manual of Procedures (MOP), creating or refining data collection instruments and case report forms, and preparing a data and safety monitoring plan. In other words, the R34 is meant to fund the structured startup phase where teams lock down study design details, standardize workflows across staff and sites, and create the documentation and oversight plans that allow the eventual clinical project or trial to run consistently, safely, and in compliance with expectations for human subjects research. The FOA explicitly points applicants toward the NIA Clinical Research Study Investigators Toolbox as a guide for what strong startup and planning materials should look like.

The funding instrument type is a grant, and the activity category is health. The opportunity is associated with CFDA numbers 93.866 (and also lists 93.866 again in the source set), which corresponds to NIA-related assistance programs. The award ceiling is listed as $225,000, indicating the maximum funding amount available per award under the announcement. While the source text shows an "ExpectedAwards:" field, it does not provide a number, so the posting does not specify how many awards were anticipated at the time the opportunity was published.

Eligibility is broad and spans many types of U.S.-based organizations that commonly participate in federally funded health research. Eligible applicants 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; Native American tribal organizations other than federally recognized tribal governments; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) IRS status (excluding higher education institutions in those nonprofit categories as written); for-profit organizations other than small businesses; small businesses; and other applicants as allowed under additional eligibility language referenced by the listing. This breadth reflects the reality that aging-related clinical research infrastructure can sit in universities, medical centers, community-based organizations, tribes and tribal entities, private research organizations, and public-sector agencies.

In terms of timeline, the opportunity was created and posted on January 15, 2016. The closing date shown in the provided data is March 16, 2019 (with both the original and current closing date matching), meaning the specific posting described here reflects an application window that ended on that date. Even though that deadline has passed for this particular listing, the summary still captures the core intent and structure of the R34 mechanism as presented: support the upfront planning work that makes later-stage NIA-supported clinical trials and clinical research projects more rigorous, organized, and ready for successful execution.

Frequently Asked Questions (FAQs): NIA Clinical Research Project Planning Grant Program (R34) - PAR-16-085

What is PAR-16-085?

PAR-16-085 is the Funding Opportunity Announcement (FOA) for the NIA Clinical Research Project Planning Grant Program (R34). It is a discretionary NIH grant opportunity offered by the U.S. Department of Health and Human Services (HHS) through the National Institutes of Health (NIH), specifically the National Institute on Aging (NIA).

What is the purpose of the NIA R34 Clinical Research Project Planning Grant?

The purpose of this R34 program is to strengthen the pipeline of aging-related clinical trials and clinical research projects by funding the detailed planning work that must be completed before launching a full-scale study. The program is focused on helping investigators develop studies that are scientifically strong, operationally realistic, well-governed, and ready to execute in a way that produces reliable evidence related to treatments, interventions, and health outcomes associated with aging and age-related conditions.

What types of projects does this FOA aim to support?

This FOA is intended to support the startup and planning phase for aging-related clinical trials and clinical research projects. The emphasis is on practical planning deliverables and operational preparation that help ensure the later clinical study can be run consistently, safely, and in compliance with human subjects research expectations.

What kinds of planning activities are supported under this R34?

Supported planning activities include developing a complete study protocol, building a Manual of Procedures (MOP), creating or refining data collection instruments and case report forms, and preparing a data and safety monitoring plan. The goal is to fund the structured pre-launch work where teams finalize study design details, standardize workflows across staff and sites, and produce essential documentation and oversight plans.

Does the R34 fund the full clinical trial or clinical research project?

Based on the information provided, the R34 is designed to fund the detailed planning work that happens before a full-scale clinical study is launched, rather than the full implementation phase itself.

Why does the FOA emphasize manuals, protocols, and standardized procedures?

The FOA emphasizes these planning components because they often determine whether a clinical study succeeds once recruitment and implementation begin. Planning deliverables like a finalized protocol, an MOP, standardized instruments, and oversight plans help ensure consistent execution across staff and sites and support safe, compliant study operations.

Is there a recommended resource for applicants preparing planning materials?

Yes. The FOA explicitly points applicants to the NIA Clinical Research Study Investigators Toolbox as a guide for what strong startup and planning materials should look like.

Which federal agencies are sponsoring this opportunity?

This opportunity is sponsored by HHS through NIH, specifically the National Institute on Aging (NIA).

What is the funding instrument and activity category?

The funding instrument type is a grant, and the activity category is health.

What is the maximum award amount (award ceiling) for this FOA?

The award ceiling listed for this opportunity is $225,000, which indicates the maximum funding amount available per award under the announcement.

How many awards were expected to be made?

The provided data includes an "ExpectedAwards:" field but does not list a number. Based on the information provided, the posting does not specify how many awards were anticipated at the time it was published.

What CFDA number is associated with this opportunity?

The opportunity is associated with CFDA number 93.866 (listed in the source data), which corresponds to NIA-related assistance programs.

Who is eligible to apply?

Eligibility is broad and includes many U.S.-based organizations involved in health research. 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 / Indian housing authorities
  • Nonprofit organizations with or without 501(c)(3) IRS status (excluding higher education institutions in those nonprofit categories as written)
  • For-profit organizations (other than small businesses)
  • Small businesses
  • Other applicants as allowed under additional eligibility language referenced by the listing

Does this program allow tribal entities to apply?

Yes. The eligibility list includes federally recognized Native American tribal governments and Native American tribal organizations other than federally recognized tribal governments.

Are both nonprofit and for-profit organizations eligible?

Yes. The eligibility list includes nonprofit organizations (with or without 501(c)(3) status, with the noted exclusion language in the listing) as well as for-profit organizations other than small businesses and small businesses.

When was this opportunity posted?

The opportunity was created and posted on January 15, 2016.

What was the application closing date for this specific listing?

The closing date shown in the provided data is March 16, 2019 (with the original and current closing date matching). This indicates the application window for this particular posting ended on that date.

Is this FOA still open for applications?

Based on the provided closing date (March 16, 2019), this specific listing reflects an application window that has already ended.

What is the main outcome the R34 is trying to achieve?

The main outcome is to help investigators develop aging-related clinical studies that are ready to execute, with strong scientific rationale and practical operational plans. The intent is to improve rigor, organization, governance, and readiness so that later clinical research produces reliable evidence on interventions, treatments, and outcomes related to aging and age-related conditions.

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