Opportunity Information: Apply for PA 16 038
Apply for PA 16 038
- The HHS-NIH11 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,.
- This funding opportunity was created on Nov 18, 2015 and posted on Nov 18, 2015.
- Applicants must submit their applications by Jan 07, 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 $150,000.00 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 NEI Clinical Study Planning Grant Program (R34), funding opportunity PA-16-038, is a National Eye Institute (NEI) grant mechanism meant to help research teams do the up-front planning work required before launching large, multi-site, or otherwise complex clinical vision studies. NEI regularly funds major clinical research efforts such as randomized clinical trials and epidemiologic studies, but those projects demand highly detailed and carefully documented plans at the time of application. This opportunity exists because producing that level of detail is expensive and time-consuming, and investigators often need dedicated support to finalize a study protocol, confirm feasibility, and organize all operational details in a way that meets NEI expectations for larger-scale studies.
A central product supported by this planning grant is a Manual of Procedures (MOP). The MOP is essentially the operational blueprint for the study: it lays out the study rationale, design, analytic approach, and step-by-step protocols and procedures, along with details on staffing, study organization, participating sites, data collection and management, quality control, and collaborative arrangements. NEI emphasizes the MOP because it is one of the clearest ways to demonstrate that a proposed clinical trial or epidemiologic study is ready to run and that procedures will be implemented consistently across investigators and sites. This FOA is designed specifically to fund the activities needed to refine and lock down these elements so that a subsequent large-scale application can be more rigorous and implementation-ready.
Beyond writing and assembling the MOP, the R34 can also support preliminary work that reduces uncertainty around study feasibility. That can include pilot or preparatory efforts to fine-tune recruitment strategies, test and standardize study procedures, and document whether the target population can realistically be enrolled at the pace and scale needed. In practical terms, this means the award can be used to resolve common pre-launch problems: confirming that eligibility criteria are workable, ensuring outcomes can be measured reliably, validating data collection workflows, aligning multiple sites on uniform procedures, and strengthening the overall protocol so it can stand up to scientific and operational scrutiny.
The program is housed within the U.S. Department of Health and Human Services under NIH (agency listed as HHS-NIH11) and falls under the health funding category, with CFDA numbers 93.867. The funding instrument is a discretionary grant. The listed award ceiling is $150,000, signaling that this mechanism is intended for targeted planning and feasibility activities rather than full study execution. The opportunity was created and posted on November 18, 2015, and the final listed closing date in the provided record is January 7, 2019.
Eligibility is broad and includes many types of institutions and organizations that conduct clinical and population-based health research. Eligible applicants include state, county, city, township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized tribal governments and certain tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (as long as they are not institutions of higher education in those categories); for-profit organizations other than small businesses; and small businesses. The listing also notes an “Others” category with additional eligibility details referenced elsewhere in the full announcement.
Overall, this NEI R34 planning grant is best understood as bridge support that helps teams turn a promising concept for a major clinical trial or epidemiologic vision study into a fully specified, operationally feasible project. It focuses on protocol refinement, study infrastructure planning, and creation of a detailed MOP, along with limited preliminary work to reduce risk and strengthen the scientific and practical foundation for a later, larger clinical study application.
Frequently Asked Questions (FAQs) - NEI Clinical Study Planning Grant Program (R34), PA-16-038
What is the NEI Clinical Study Planning Grant Program (R34), PA-16-038?
This is a National Eye Institute (NEI) funding opportunity designed to support the up-front planning work needed before launching a large, multi-site, or otherwise complex clinical vision study. It exists to help research teams create the detailed, well-documented plans NEI expects for major clinical research efforts (such as randomized clinical trials and epidemiologic studies).
Which federal agency sponsors this opportunity?
The program is housed within the U.S. Department of Health and Human Services (HHS) under the National Institutes of Health (NIH), with the agency listed as HHS-NIH11. The specific institute is the National Eye Institute (NEI).
What is the main purpose of this R34 planning grant?
The main purpose is to fund the planning activities that make a future large-scale clinical trial or epidemiologic vision study more rigorous and ready to implement. This includes refining the study protocol, confirming feasibility, and organizing operational details to meet NEI expectations for larger applications.
What kinds of studies does this planning grant relate to?
The description highlights major clinical research efforts such as randomized clinical trials and epidemiologic studies in vision research. The R34 is positioned as support for planning those types of complex clinical studies rather than running them.
Why does NEI offer a planning grant instead of requiring all details in a single large application?
NEI expects large, complex clinical studies to be supported by highly detailed and carefully documented plans at the time of application. Producing that level of detail is expensive and time-consuming, so this opportunity provides dedicated support to finalize the protocol, confirm feasibility, and organize operational elements before a later large-scale submission.
What is a Manual of Procedures (MOP), and why is it emphasized?
A Manual of Procedures (MOP) is described as the operational blueprint for the study. NEI emphasizes it because it is one of the clearest ways to show that a proposed clinical trial or epidemiologic study is ready to run and that procedures will be implemented consistently across investigators and sites.
What typically goes into the Manual of Procedures (MOP) for this program?
Based on the opportunity description, the MOP can include the study rationale, study design, analytic approach, and step-by-step protocols and procedures, plus operational details such as staffing, study organization, participating sites, data collection and management, quality control, and collaborative arrangements.
Is producing the MOP the only activity supported by the R34?
No. In addition to writing and assembling the MOP, the R34 can support preliminary work that reduces uncertainty around feasibility, such as pilot or preparatory efforts to fine-tune recruitment strategies, test and standardize study procedures, and document whether the target population can realistically be enrolled at the needed pace and scale.
What are examples of feasibility or preparatory work mentioned for this R34?
The description includes activities like refining recruitment strategies, testing and standardizing study procedures, confirming that eligibility criteria are workable, ensuring outcomes can be measured reliably, validating data collection workflows, and aligning multiple sites on uniform procedures.
Does this grant pay for executing a full clinical trial or epidemiologic study?
The opportunity is described as targeted planning and feasibility support rather than full study execution. The award ceiling and the focus on protocol refinement and MOP development indicate it is intended as bridge support before a later, larger clinical study application.
What is the funding instrument type for this opportunity?
The funding instrument is a discretionary grant.
What is the award ceiling for the NEI R34 planning grant?
The listed award ceiling is $150,000.
What funding category does this opportunity fall under?
The opportunity is listed under the health funding category.
What is the CFDA number associated with this opportunity?
The opportunity lists CFDA number 93.867.
When was this funding opportunity created and posted?
The record states it was created and posted on November 18, 2015.
What is the final listed closing date in the provided record?
The final listed closing date in the provided record is January 7, 2019.
Who is eligible to apply for this R34 planning grant?
Eligibility is broad and includes: 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 tribal governments; certain tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (with the noted limitation that they are not institutions of higher education in those categories); for-profit organizations other than small businesses; and small businesses.
Does the listing mention any additional or special eligibility category?
Yes. The listing notes an "Others" category, with additional eligibility details referenced elsewhere in the full announcement.
What problem is this grant meant to solve for research teams?
It is meant to address the reality that developing the highly detailed plans required for a major clinical trial or epidemiologic study is expensive and time-consuming. The R34 provides support to finalize the study protocol, confirm feasibility, and document operational plans so a later large-scale application is more complete and credible.
How does this R34 help with multi-site or complex study operations?
It supports the work needed to standardize and document procedures so they can be implemented consistently across investigators and participating sites. The MOP is specifically framed as a key tool for laying out uniform protocols, staffing and organization plans, data collection and management approaches, quality control, and collaborative arrangements.
What does "bridge support" mean in the context of this R34?
In this context, it means the grant helps teams move from a promising concept to a fully specified, operationally feasible clinical study plan. The supported work strengthens scientific and practical readiness for a subsequent, larger clinical study application.
What outcomes or deliverables does NEI appear to expect from this planning period?
A central expected product is a detailed Manual of Procedures (MOP). The description also emphasizes feasibility-confirming outputs such as refined recruitment approaches, standardized procedures, validated workflows for data collection, and documentation showing the study can enroll the target population at the necessary pace and scale.
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