Opportunity Information: Apply for PAR 10 017
Apply for PAR 10 017
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NEI Clinical Study 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): 93.867 Vision Research.
- This funding opportunity was created on Oct 29, 2009 and posted on Oct 29, 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: Private institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses For profit organizations other than small businesses.
- 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) Non domestic (non U.S.) Entities (Foreign Organizations) Tribally Controlled Colleges and Universities (TCCUs) .
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Opportunity Summary:
The NEI Clinical Study Planning Grant Program (R34), Funding Opportunity Number PAR-10-017, is a National Institutes of Health (NIH) grant run through the National Eye Institute (NEI) to help research teams get large vision-related clinical studies ready to launch. NEI funds major clinical vision research efforts such as randomized clinical trials and large epidemiologic studies, but those kinds of projects require a very high level of operational detail at the time of application. Specifically, NEI expects applicants to clearly lay out the scientific rationale, study design, analytic approach, protocols and procedures, staffing and organizational structure, facilities and environment, and any collaborative or multi-site arrangements. The agency points out that the best way to present and manage this level of detail is through a well-developed Manual of Procedures (MOP), which is often expensive and time-consuming to create. This R34 is designed to cover that planning burden so that the later, full-scale clinical study application is stronger, more realistic, and more fully operationalized.
In practical terms, the R34 supports the core planning work that has to happen before a definitive clinical trial or epidemiologic study can begin. A central deliverable is the Manual of Procedures, which typically captures the step-by-step workflows for how the study will actually run, including standardized procedures across sites, data collection and management processes, quality control and assurance steps, training plans, safety and oversight processes, and documentation for consistent implementation. Beyond writing and refining the MOP itself, the grant can also support preliminary work that makes the eventual larger study feasible and credible. That can include small pilot or feasibility activities to refine study procedures, test recruitment approaches, or assess whether enrollment targets are realistic. Importantly, the opportunity is not limited to only one type of clinical research design; it is intended to be applicable to both clinical trials and epidemiologic studies in vision research.
The funding mechanism is the Clinical Study Planning Grant Program for Clinical Trials (R34). Awards are discretionary and depend on two things: the availability of funds and the submission of enough strong, meritorious applications. The project period is capped at two years total, reflecting that this is meant for planning and preparation rather than running the full study. The budget is limited to direct costs of up to $150,000 per year, which sets expectations that applicants should focus on essential planning tasks, targeted preliminary assessments, and concrete operational development work that directly strengthens the readiness of a subsequent full-scale application.
Eligibility is fairly broad and includes a wide range of organizations that might lead or coordinate clinical vision research. Eligible applicants include public and state-controlled institutions of higher education, private institutions of higher education, nonprofits (including both 501(c)(3) and certain non-501(c)(3) entities), small businesses, and for-profit organizations that are not small businesses. The eligibility list also explicitly includes several categories often highlighted in federal biomedical funding, such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, faith-based or community-based organizations, eligible federal agencies, and non-U.S. entities (foreign organizations). The opportunity does not require cost sharing or matching.
Administratively, the opportunity was posted and created on October 29, 2009, with an original and final closing date listed as January 7, 2013, and an archive date of February 7, 2013. The CFDA number is 93.867 (Vision Research), placing it squarely within NIH vision research funding. The full announcement was hosted on the NIH grants site under the provided link, and NIH Office of Extramural Research (OER) contact support is listed for access or technical linking issues.
FAQs: NEI Clinical Study Planning Grant Program (R34) - PAR-10-017
What is the NEI Clinical Study Planning Grant Program (R34)?
It is an NIH National Eye Institute (NEI) funding opportunity designed to support the planning work needed to prepare large vision-related clinical studies (such as randomized clinical trials and large epidemiologic studies) to be ready to launch.
What is the Funding Opportunity Number for this program?
The Funding Opportunity Number is PAR-10-017.
Which NIH institute runs this grant opportunity?
This opportunity is run through the National Eye Institute (NEI) at the National Institutes of Health (NIH).
What kinds of studies is this planning grant intended to support?
The program is intended to support planning for major clinical vision research efforts, including randomized clinical trials and large epidemiologic studies.
Is this grant meant to pay for conducting the full clinical study?
No. The R34 is focused on planning and preparation rather than running the definitive full-scale clinical study. It is meant to make a later full-scale application stronger and more operationally detailed.
Why does NEI offer a planning grant for these studies?
NEI expects large clinical trials and epidemiologic studies to have a very high level of operational detail at the time of application (for example, protocols, procedures, staffing, and multi-site coordination). Developing that level of detail, especially through a Manual of Procedures, can be expensive and time-consuming, so this grant is intended to cover that planning burden.
What is the main deliverable expected under this R34?
A central deliverable is a well-developed Manual of Procedures (MOP) that documents how the study will run in practice.
What is a Manual of Procedures (MOP) in this context?
The MOP typically captures step-by-step workflows for implementing the study, including standardized procedures across sites, data collection and management processes, quality control and assurance steps, training plans, safety and oversight processes, and documentation needed for consistent implementation.
What types of planning activities can the R34 support besides writing the MOP?
In addition to writing and refining the Manual of Procedures, the grant can support preliminary work that improves feasibility and credibility of the later large study, such as small pilot or feasibility activities to refine study procedures, test recruitment approaches, or assess whether enrollment targets are realistic.
Is the R34 limited to only clinical trials?
No. The opportunity is intended to be applicable to both clinical trials and epidemiologic studies in vision research.
What operational details does NEI expect applicants to lay out for major clinical vision studies?
NEI expects applicants to clearly describe the scientific rationale, study design, analytic approach, protocols and procedures, staffing and organizational structure, facilities and environment, and any collaborative or multi-site arrangements.
What is the funding mechanism used for this opportunity?
The mechanism is the Clinical Study Planning Grant Program for Clinical Trials (R34).
How long can the project period last?
The project period is capped at two years total.
What is the maximum budget allowed under this planning grant?
The budget is limited to direct costs of up to $150,000 per year.
What does the budget cap suggest about the scope of work?
The budget limit sets expectations that the project will focus on essential planning tasks, targeted preliminary assessments, and concrete operational development work that strengthens readiness for a subsequent full-scale application.
Are awards guaranteed if an application is submitted?
No. Awards are discretionary and depend on the availability of funds and the submission of enough strong, meritorious applications.
Is cost sharing or matching required?
No. The opportunity does not require cost sharing or matching.
What types of organizations are eligible to apply?
Eligibility includes public and state-controlled institutions of higher education, private institutions of higher education, nonprofits (including 501(c)(3) and certain non-501(c)(3) entities), small businesses, and for-profit organizations that are not small businesses.
Are minority-serving institutions specifically included in the eligibility list?
Yes. The eligibility list explicitly includes Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), and Alaska Native and Native Hawaiian Serving Institutions.
Are faith-based or community-based organizations eligible?
Yes. Faith-based or community-based organizations are explicitly included as eligible applicants.
Can federal agencies apply?
Yes. Eligible federal agencies are included in the eligibility list.
Are non-U.S. (foreign) organizations eligible to apply?
Yes. The eligibility list includes non-U.S. entities (foreign organizations).
What is the CFDA number for this opportunity and what program area does it relate to?
The CFDA number is 93.867, which is Vision Research.
When was this funding opportunity posted and created?
It was posted and created on October 29, 2009.
What were the closing dates for this opportunity?
The original and final closing date listed is January 7, 2013.
When was the opportunity archived?
The archive date is February 7, 2013.
Where was the full announcement hosted?
The full announcement was hosted on the NIH grants site under the provided link in the opportunity materials.
Who is listed for technical or access support related to the announcement link?
NIH Office of Extramural Research (OER) contact support is listed for access or technical linking issues.
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