Opportunity Information: Apply for PAR 11 287
Apply for PAR 11 287
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Planning Grants for Clinical Trials of High Relevance to the NIGMS Mission (R34)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.859 Biomedical Research and Research Training.
- This funding opportunity was created on Oct 21, 2013 and posted on Aug 1, 2011.
- Applicants must submit their applications by Nov 1, 2013. (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 $100,000.00 in funding.
- Eligible applicants include: For profit organizations other than small businesses Native American tribal governments (Federally recognized) Small businesses Public and State controlled institutions of higher education County governments Special district governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) State governments City or township governments Public housing authorities/Indian housing authorities Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts.
- 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) 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 eligible to apply.
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Opportunity Summary:
Planning Grants for Clinical Trials of High Relevance to the NIGMS Mission (R34) is an NIH funding opportunity designed to help investigators get a proposed clinical trial fully ready for a larger, definitive application. The main idea is to allow an early round of peer review focused on whether the scientific rationale for the trial is strong, and then provide limited, targeted support so the research team can complete the key planning work that must be in place before launching a full-scale clinical trial. In practice, this mechanism is meant to reduce preventable delays and weaknesses that often show up when a trial is submitted or started without enough operational groundwork.
The R34 planning grant supports the practical infrastructure and oversight setup that makes a later trial application credible and executable. Typical supported activities include writing a detailed Manual of Procedures that standardizes how the trial will be run across staff and sites, developing a Data Safety and Monitoring Board (DSMB) charter or comparable safety oversight plan, and creating robust data management and statistical analysis plans. It can also cover work to establish and qualify recruitment and study sites, draft and organize training materials so personnel can follow uniform procedures, and prepare early regulatory submissions and documentation needed for approvals. The emphasis is on completing the essential pre-trial tasks that demonstrate the team can conduct the study with appropriate rigor, participant protections, and operational control.
A key feature of this opportunity is that it functions as a bridge to a later, investigator-initiated full clinical trial application, typically an R01, provided the proposed clinical trial aligns closely with the National Institute of General Medical Sciences (NIGMS) mission and the planning phase is completed successfully. The planning award is not intended to fund the entire clinical trial itself; instead, it positions the applicant to submit a stronger, more complete R01 by resolving design details, oversight structures, data workflows, and site readiness issues ahead of time. In other words, the R34 is meant to de-risk the eventual trial launch by ensuring the foundational components are thoughtfully built and reviewed before major resources are committed.
Administratively, this is a discretionary NIH grant program under Funding Opportunity Number PAR-11-287, categorized under biomedical research and research training (CFDA 93.859). The award ceiling listed is $100,000, and there is no cost sharing or matching requirement. Eligibility is broad across many U.S.-based organization types, including public and private institutions of higher education, nonprofits (including 501(c)(3) organizations), small businesses, for-profit organizations (other than small businesses), and a range of government entities (state, county, city/township, special district). It also includes specific categories such as historically Black colleges and universities, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian-serving institutions, faith-based or community-based organizations, and certain eligible federal agencies. Foreign institutions are not eligible to apply, although non-U.S. components of U.S. organizations are eligible.
The opportunity was originally posted on August 1, 2011, with later administrative dates reflecting record creation and closing timelines (original closing date October 24, 2013; current closing date November 1, 2013; archive date December 1, 2013). Full details were provided through the NIH Grants Guide link associated with the announcement. For technical access or linking issues, the contact listed is the NIH Office of Extramural Research (OER) webmaster.
Frequently Asked Questions (FAQs)
What is the Planning Grants for Clinical Trials of High Relevance to the NIGMS Mission (R34) opportunity?
This NIH funding opportunity supports a clinical trial planning phase so a proposed trial can be fully prepared for a later, larger clinical trial application. It is designed to enable an early round of peer review focused on the strength of the scientific rationale and to provide limited, targeted funding for essential pre-trial planning work.
What is the main purpose of this R34 planning grant?
The purpose is to reduce preventable delays and weaknesses that can occur when a clinical trial is submitted or launched without sufficient operational groundwork. The award supports the infrastructure, procedures, and oversight planning needed to make a later full clinical trial application credible and executable.
Does this award fund the full clinical trial?
No. The R34 is not intended to fund the entire clinical trial. It funds planning and readiness activities so the team can submit a stronger, more complete full clinical trial application later (typically an investigator-initiated R01), assuming the trial aligns with the NIGMS mission and planning is successfully completed.
How does this R34 relate to a later R01 clinical trial application?
This mechanism is intended to serve as a bridge to a later, definitive clinical trial application (often an R01). The planning award helps resolve design details, oversight structures, data workflows, and site readiness issues in advance, which helps de-risk the eventual trial launch.
What kinds of activities are typically supported with R34 planning funds?
Supported activities are focused on essential pre-trial tasks that demonstrate the team can run the study with appropriate rigor, participant protections, and operational control. Examples include developing trial operations documentation, oversight plans, data systems planning, and site and staffing readiness work.
Can R34 funds be used to write a Manual of Procedures?
Yes. Creating a detailed Manual of Procedures that standardizes how the trial will be run across staff and sites is specifically described as a typical supported activity.
Can the grant support safety oversight planning, such as a DSMB charter?
Yes. Developing a Data Safety and Monitoring Board (DSMB) charter, or a comparable safety oversight plan, is listed as a typical supported activity.
Are data management and statistical analysis plans supported under this planning mechanism?
Yes. The opportunity notes support for creating robust data management plans and statistical analysis plans as part of getting the trial ready for a later definitive application.
Can planning funds be used to help set up recruitment and study sites?
Yes. The R34 can cover work to establish and qualify recruitment and study sites so that site readiness issues are addressed before a full clinical trial is proposed for implementation.
Does the R34 support development of training materials for trial personnel?
Yes. Drafting and organizing training materials so personnel can follow uniform procedures is identified as a supported planning activity.
Can the grant support early regulatory submissions and documentation?
Yes. Preparing early regulatory submissions and documentation needed for approvals is included among the types of planning work supported.
What is meant by "limited, targeted support" in this program?
The program description emphasizes that funding is meant to support key planning tasks (such as operational documents, oversight structures, data workflows, site readiness, training, and regulatory preparation), rather than supporting the full conduct of the clinical trial.
What is the funding opportunity number for this program?
The Funding Opportunity Number is PAR-11-287.
What is the CFDA number and category associated with this opportunity?
The opportunity is listed under CFDA 93.859 and categorized under biomedical research and research training.
What is the award ceiling for this planning grant?
The award ceiling listed for this opportunity is $100,000.
Is cost sharing or matching required?
No. The opportunity states there is no cost sharing or matching requirement.
Who is eligible to apply?
Eligibility is broad across many U.S.-based organization types, including public and private institutions of higher education, nonprofits (including 501(c)(3) organizations), small businesses, for-profit organizations (other than small businesses), and many government entities (including state, county, city/township, and special district governments). Specific eligible categories also include historically Black colleges and universities, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian-serving institutions, faith-based or community-based organizations, and certain eligible federal agencies.
Are foreign institutions eligible to apply?
No. Foreign institutions are not eligible to apply.
Are non-U.S. components of U.S. organizations allowed?
Yes. While foreign institutions cannot apply, the opportunity indicates that non-U.S. components of U.S. organizations are eligible.
What does "high relevance to the NIGMS mission" imply for applicants?
The program is intended for clinical trials that align closely with the National Institute of General Medical Sciences (NIGMS) mission. The planning award is positioned as a pathway to a later full clinical trial application when that mission alignment is present and the planning phase is completed successfully.
When was this opportunity originally posted, and what are the key dates mentioned?
The opportunity was originally posted on August 1, 2011. Administrative dates referenced include an original closing date of October 24, 2013, a current closing date of November 1, 2013, and an archive date of December 1, 2013.
Where were the full details provided?
Full details were provided through the NIH Grants Guide link associated with the announcement.
Who is the contact for technical access or linking issues?
For technical access or linking issues, the listed contact is the NIH Office of Extramural Research (OER) webmaster.
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