Opportunity Information: Apply for PA 10 045
Apply for PA 10 045
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Clinical Trial Planning Grants for Critical Illness and Injury in Aging (R34)" 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 Dec 1, 2009 and posted on Dec 1, 2009.
- Applicants must submit their applications by Jan 7, 2013. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments State governments Special district governments Native American tribal governments (Federally recognized) Private institutions of higher education For profit organizations other than small businesses Small businesses Independent school districts Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Others (see text field entitled Additional Information on Eligibility for clarification) Public and State controlled institutions of higher education County governments 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 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.
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Opportunity Summary:
The Clinical Trial Planning Grants for Critical Illness and Injury in Aging (R34) opportunity (Funding Opportunity Number PA-10-045) is a National Institutes of Health grant program led by the National Institute on Aging (NIA) that supports the structured planning work needed to launch large, definitive clinical trials focused on older adults facing critical illness or injury. The core aim is to help applicants build a strong, well-justified Phase III or Phase IV clinical trial protocol before submitting a full-scale trial application. In practical terms, the program is meant to “set the table” for a later, competitive clinical trial proposal by allowing early peer review of the trial’s rationale and design and by funding the essential organizational and operational groundwork that makes a complex trial feasible, safe, and methodologically sound.
This R34 mechanism is specifically about planning and preparation rather than generating new scientific justification. The announcement makes an important boundary clear: it is not intended to fund preliminary data collection or pilot studies meant to support the scientific rationale for the trial. Instead, it emphasizes concrete planning deliverables such as assembling and coordinating the research team, establishing tools and processes for data management, putting research oversight structures in place, developing realistic recruitment and retention strategies, and producing a detailed protocol along with a Manual of Procedures (MOP). The MOP is a key product in many NIH clinical trials because it translates the protocol into step-by-step operational guidance, helping ensure consistent implementation across sites and staff and supporting trial quality and reproducibility.
The FOA uses the NIH Clinical Trial Planning Grant (R34) funding instrument and is positioned alongside related NIH announcements that support research through other common mechanisms: an R01 for a full research project grant, an R03 for smaller projects, and an R21 for exploratory or developmental work (PA-10-042, PA-10-043, and PA-10-044, respectively). That parallel structure signals that NIA is supporting a pipeline of research activities, with this particular announcement narrowly focused on preparing for later-stage (Phase III/IV) clinical trials in the critical illness and injury space as it relates to aging.
Funding decisions under this opportunity are contingent on the availability of funds and the receipt of a sufficient number of high-quality applications, and the announcement does not promise a fixed number of awards. There is no cost sharing or matching requirement. The opportunity is categorized as a discretionary grant in the health area under CFDA 93.866 (Aging Research). Key dates provided in the source listing show the FOA was posted on December 1, 2009, with an original and current closing date of January 7, 2013, and an archive date of February 7, 2013, meaning it is no longer active as a current competition but remains a useful reference for the type of work NIH expects under an R34 planning mechanism.
Eligibility is broad and includes many types of domestic and non-domestic organizations. Eligible applicants include nonprofit organizations (with or without 501(c)(3) status), public and private institutions of higher education, for-profit organizations (including small businesses), and multiple levels of government (state, county, city/township, special district), as well as public housing authorities/Indian housing authorities. The eligibility list also explicitly includes Native American tribal governments (federally recognized), tribal organizations (other than federally recognized governments), and a range of mission-serving institutions and communities, such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Alaska Native and Native Hawaiian Serving Institutions, and Tribally Controlled Colleges and Universities (TCCUs). It also allows faith-based or community-based organizations, eligible federal agencies, U.S. territories or possessions, regional organizations, and foreign (non-U.S.) entities.
Overall, the program is best understood as targeted support for the behind-the-scenes development work that turns a promising clinical question about critical illness or injury in older adults into a rigorous, trial-ready plan. The intended outcome is not a set of pilot results, but a complete, well-constructed Phase III or IV trial package: a finalized protocol, operational manuals, data and safety oversight plans, recruitment approaches, and management infrastructure that together position the team to submit a strong subsequent application to actually conduct the clinical trial.
Frequently Asked Questions (FAQs)
What is the Clinical Trial Planning Grants for Critical Illness and Injury in Aging (R34) opportunity?
This opportunity (Funding Opportunity Number PA-10-045) is a National Institutes of Health (NIH) clinical trial planning grant program led by the National Institute on Aging (NIA). It supports the structured planning work needed to prepare a large, definitive clinical trial focused on older adults experiencing critical illness or injury.
What is the main purpose of this R34 planning grant?
The core purpose is to help applicants develop a strong, well-justified Phase III or Phase IV clinical trial protocol and the operational foundation required to submit a later, full-scale clinical trial application.
What types of clinical trials is this R34 meant to prepare for?
This planning grant is aimed at preparing Phase III or Phase IV clinical trials in the area of critical illness and injury as it relates to aging (older adult populations).
Is this grant meant to fund the actual clinical trial?
No. This R34 mechanism is for planning and preparation work. It is intended to "set the table" for a later competitive application to conduct the full-scale clinical trial.
Does the R34 support generating new scientific justification for the trial?
No. The announcement emphasizes that the R34 is specifically about planning and preparation rather than generating new scientific justification for the trial.
Can the R34 be used to collect preliminary data or run a pilot study?
No. The opportunity explicitly states it is not intended to fund preliminary data collection or pilot studies designed to support the scientific rationale for the trial.
What kinds of activities or deliverables does the R34 support?
The R34 supports concrete planning deliverables, such as assembling and coordinating the research team; building data management tools and processes; establishing research oversight structures; developing recruitment and retention strategies; and producing a detailed clinical trial protocol and a Manual of Procedures (MOP).
What is a Manual of Procedures (MOP), and why is it important here?
A Manual of Procedures (MOP) is a key product for many NIH clinical trials because it turns the protocol into step-by-step operational guidance. It helps ensure consistent implementation across sites and staff and supports trial quality and reproducibility.
How does this FOA fit with other NIH funding mechanisms mentioned?
This FOA uses the NIH Clinical Trial Planning Grant (R34) instrument and is positioned alongside related NIH announcements supporting other mechanisms: R01 (full research project), R03 (small research projects), and R21 (exploratory/developmental research), referenced as PA-10-042, PA-10-043, and PA-10-044. The R34 in this set is narrowly focused on planning for later-stage (Phase III/IV) trials.
Who leads this funding opportunity at NIH?
The program is led by the National Institute on Aging (NIA) within the National Institutes of Health (NIH).
What is the subject area and CFDA number for this opportunity?
The opportunity is categorized as a discretionary grant in the health area under CFDA 93.866 (Aging Research).
Is there a cost sharing or matching requirement?
No. The opportunity states there is no cost sharing or matching requirement.
Are awards guaranteed, and is there a fixed number of awards?
No. Funding decisions are contingent on the availability of funds and the receipt of a sufficient number of high-quality applications. The announcement does not promise a fixed number of awards.
Is this funding opportunity still active?
No. Key dates indicate the FOA was posted on December 1, 2009, had an original and current closing date of January 7, 2013, and an archive date of February 7, 2013. This means it is no longer active as a current competition, though it remains a reference for what NIH expects under an R34 planning mechanism.
What organizations are eligible to apply?
Eligibility is broad and includes many types of domestic and non-domestic organizations. Eligible applicants include nonprofit organizations (with or without 501(c)(3) status), public and private institutions of higher education, and for-profit organizations (including small businesses).
Are government entities eligible to apply?
Yes. Eligible applicants include multiple levels of government, including state, county, city/township, and special district governments, as well as public housing authorities/Indian housing authorities.
Are tribal governments and tribal organizations eligible?
Yes. The eligibility list explicitly includes Native American tribal governments (federally recognized) and tribal organizations (other than federally recognized tribal governments).
Are minority-serving and mission-serving institutions included in eligibility?
Yes. The eligibility list includes Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Alaska Native and Native Hawaiian Serving Institutions, and Tribally Controlled Colleges and Universities (TCCUs).
Are faith-based or community-based organizations eligible?
Yes. The eligibility list allows faith-based or community-based organizations.
Can federal agencies apply?
Yes. Eligible applicants include eligible federal agencies.
Are U.S. territories and possessions eligible?
Yes. The eligibility list includes U.S. territories or possessions and regional organizations.
Are foreign (non-U.S.) entities eligible?
Yes. The eligibility list explicitly includes foreign (non-U.S.) entities.
What is the intended end product of the R34 planning period?
The intended outcome is a complete, trial-ready Phase III or Phase IV package: a finalized protocol, operational manuals (including the MOP), data and safety oversight plans, recruitment and retention approaches, and the management infrastructure needed to support a strong subsequent application to conduct the clinical trial.
What is the overall focus area for the planned trials?
The focus is on critical illness and injury in older adults, aligning with aging research priorities.
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