Opportunity Information: Apply for PAR 14 348
Apply for PAR 14 348
- 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 Sep 25, 2014 and posted on Sep 25, 2014.
- Applicants must submit their applications by Nov 14, 2016. (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: Native American tribal organizations (other than Federally recognized tribal governments) County governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Public and State controlled institutions of higher education Independent school districts State governments Public housing authorities/Indian housing authorities For profit organizations other than small businesses City or township governments Others (see text field entitled Additional Information on Eligibility for clarification) Special district governments Small businesses Native American tribal governments (Federally recognized) Nonprofits having 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 Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) 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 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. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:
Planning Grants for Clinical Trials of High Relevance to the NIGMS Mission (R34) is a National Institutes of Health (NIH) funding opportunity (PAR-14-348) designed to pay for the upfront work needed to properly design and set up a clinical trial that fits the mission of the National Institute of General Medical Sciences (NIGMS). Rather than funding the full clinical trial itself, this mechanism supports the practical planning and infrastructure-building steps that are often required before a rigorous, compliant, and executable trial can begin. The intent is to give investigators protected time and resources to turn a clinical trial concept into a well-specified, operationally ready project with clear procedures, oversight, and analysis strategies.
The award supports concrete planning activities that directly enable trial execution. Examples include writing a Manual of Procedures that standardizes how the trial will be run across staff and sites, drafting a Data Safety and Monitoring Board (DSMB) charter to define safety oversight and decision-making rules, and building the data management and statistical analysis plans that will govern how data are captured, cleaned, protected, and analyzed. It can also cover work to establish and coordinate recruitment sites, develop training materials so personnel follow consistent protocols, and prepare preliminary regulatory materials and submissions needed to move the study toward required approvals. In other words, the grant is meant for the essential operational pieces that reduce uncertainty and improve readiness for a subsequent definitive clinical trial application.
A key feature of the announcement is its connection to a later, full clinical trial proposal. After completing the R34 planning period successfully, applicants may be positioned to submit an R01 application to NIGMS to conduct the clinical trial itself, provided the trial remains highly relevant to the NIGMS mission (the announcement points to NOT-GM-14-130 regarding the later R01 step). The R34 therefore functions as a bridge between an early clinical trial idea and a full-scale, fundable, well-designed trial proposal.
From an administrative standpoint, this is a discretionary grant opportunity in the health category, listed under CFDA 93.859 (Biomedical Research and Research Training). The funding opportunity was posted on September 25, 2014, and the final application due date was November 14, 2016, with an archive date of December 15, 2016. The listed award ceiling is $100,000, indicating the mechanism is intended for focused planning work rather than large-scale trial operations. There is no cost sharing or matching requirement, which simplifies budgeting for eligible applicants.
Eligibility is broad and includes many types of U.S.-based organizations: public and private institutions of higher education, nonprofits (including 501(c)(3) and certain non-501(c)(3) entities), for-profit organizations other than small businesses, small businesses, state and local governments (including county, city/township, special district), independent school districts, and public housing authorities/Indian housing authorities. The announcement also calls out additional eligible groups such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, tribally controlled colleges and universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and other minority-serving institutions, along with faith-based or community-based organizations and eligible federal agencies. Foreign organizations and foreign institutions are not eligible to apply directly, but non-U.S. components of U.S. organizations may be eligible, and foreign components are allowed as defined by NIH policy, which can matter for trials involving international collaborators or specialized capabilities abroad.
For full details, the official NIH posting is linked at http://grants.nih.gov/grants/guide/pa-files/PAR-14-348.html. Assistance for accessing or linking to the announcement is routed through the NIH Office of Extramural Research (OER) webmaster at FBOWebmaster@OD.NIH.GOV.
Frequently Asked Questions (FAQs)
What is "Planning Grants for Clinical Trials of High Relevance to the NIGMS Mission (R34)"?
This opportunity (NIH FOA PAR-14-348) is a planning grant from the National Institutes of Health (NIH) intended to support the upfront work needed to properly design and set up a clinical trial that aligns with the mission of the National Institute of General Medical Sciences (NIGMS). It is focused on making a clinical trial concept operationally ready.
Does this R34 funding pay for conducting the full clinical trial?
No. This mechanism is described as supporting planning and infrastructure-building steps rather than funding the full clinical trial itself. The goal is to prepare a trial to be rigorous, compliant, and executable before a later definitive trial application is submitted.
What is the main purpose of this planning grant?
The intent is to provide investigators protected time and resources to turn a clinical trial concept into a well-specified project with clear procedures, oversight, and analysis strategies, so that the trial is ready to execute and can support a subsequent full clinical trial proposal.
What types of activities can the R34 support?
The award supports concrete planning activities that directly enable trial execution. Examples provided include developing a Manual of Procedures, drafting a Data Safety and Monitoring Board (DSMB) charter, building data management and statistical analysis plans, establishing and coordinating recruitment sites, developing training materials for consistent protocol adherence, and preparing preliminary regulatory materials and submissions needed to move the study toward approvals.
What is a Manual of Procedures in the context of this grant?
A Manual of Procedures is described as a document that standardizes how the trial will be run across staff and sites, helping ensure consistent implementation of the protocol and operations.
What is a DSMB charter and why is it mentioned?
A DSMB charter is referenced as a planning product that defines safety oversight and decision-making rules for the clinical trial. The R34 can support drafting this charter as part of setting up proper oversight.
Can the R34 cover data management and statistical planning work?
Yes. The opportunity specifically notes that it can support development of the data management plan and statistical analysis plans that govern how data are captured, cleaned, protected, and analyzed.
Can the R34 be used to help set up recruitment sites and train personnel?
Yes. Examples include establishing and coordinating recruitment sites and developing training materials so personnel follow consistent protocols.
Does the grant support regulatory preparation?
Yes. The description notes that the R34 can cover preparation of preliminary regulatory materials and submissions needed to move the study toward required approvals.
How does this R34 relate to a later R01 clinical trial application?
The announcement describes the R34 as a bridge to a later, full clinical trial proposal. After completing the R34 planning period successfully, applicants may be positioned to submit an R01 application to NIGMS to conduct the clinical trial, provided the trial remains highly relevant to the NIGMS mission. The opportunity points to NOT-GM-14-130 regarding the later R01 step.
What agency is offering this funding opportunity?
This is an NIH funding opportunity associated with the National Institute of General Medical Sciences (NIGMS).
What is the funding opportunity number and title?
The opportunity is titled "Planning Grants for Clinical Trials of High Relevance to the NIGMS Mission (R34)" and is identified as PAR-14-348.
What is the CFDA number and program category?
The opportunity is listed under CFDA 93.859 (Biomedical Research and Research Training) and is described as a discretionary grant opportunity in the health category.
What is the maximum award amount (award ceiling) listed?
The listed award ceiling is $100,000, indicating the mechanism is intended for focused planning work rather than large-scale trial operations.
Is cost sharing or matching required?
No. The opportunity states there is no cost sharing or matching requirement.
When was this funding opportunity posted?
The funding opportunity was posted on September 25, 2014.
What was the final application due date?
The final application due date listed was November 14, 2016.
When was the archive date?
The archive date listed is December 15, 2016.
Who is eligible to apply?
Eligibility is broad and includes many types of U.S.-based organizations, such as public and private institutions of higher education, nonprofits (including 501(c)(3) and certain non-501(c)(3) entities), for-profit organizations other than small businesses, small businesses, state and local governments (including county, city/township, special districts), independent school districts, and public housing authorities/Indian housing authorities.
Are minority-serving institutions specifically included as eligible?
Yes. The announcement calls out eligible groups such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, tribally controlled colleges and universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and other minority-serving institutions.
Are faith-based or community-based organizations eligible?
Yes. The eligibility section explicitly includes faith-based or community-based organizations.
Are federal agencies eligible to apply?
Yes. The eligibility description includes eligible federal agencies.
Can foreign organizations apply directly?
No. Foreign organizations and foreign institutions are not eligible to apply directly under this opportunity.
Are any foreign components allowed?
Yes. While foreign organizations cannot apply directly, the description notes that non-U.S. components of U.S. organizations may be eligible, and foreign components are allowed as defined by NIH policy. This may be relevant for trials involving international collaborators or specialized capabilities abroad.
Where can applicants find the official NIH posting for this opportunity?
The official NIH posting is linked at: http://grants.nih.gov/grants/guide/pa-files/PAR-14-348.html.
Who should be contacted for help accessing or linking to the announcement?
Assistance for accessing or linking to the announcement is routed through the NIH Office of Extramural Research (OER) webmaster at FBOWebmaster@OD.NIH.GOV.
What does it mean that this grant is focused on "planning and infrastructure-building"?
Based on the description, it means the grant supports the essential operational pieces that reduce uncertainty and improve readiness for a subsequent definitive clinical trial application, such as standardized procedures, oversight documents, recruitment coordination, staff training materials, and data/statistical plans.
What is the key deciding factor mentioned for moving from the R34 to a later R01?
The description emphasizes that the clinical trial must remain highly relevant to the NIGMS mission for a later R01 step.
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