Opportunity Information: Apply for RFA HL 10 016
Apply for RFA HL 10 016
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Lung Transplantation Planning Grants for Clinical Trials of Novel Therapies (R34)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.838 Lung Diseases Research.
- This funding opportunity was created on Sep 30, 2009 and posted on Sep 30, 2009.
- Applicants must submit their applications by Feb 3, 2010. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $1,500,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $450,000.00 in funding.
- Eligible applicants include: For profit organizations other than small businesses Independent school districts Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education State governments County governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education Special district governments Public housing authorities/Indian housing authorities Others (see text field entitled Additional Information on Eligibility for clarification) City or township governments Public and State controlled institutions of higher education 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) 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 Lung Transplantation Planning Grants for Clinical Trials of Novel Therapies (R34) opportunity (Funding Opportunity Number RFA-HL-10-016) was a National Institutes of Health program run through the National Heart, Lung, and Blood Institute (NHLBI) aimed at helping research teams get truly ready to launch strong, competitive clinical trials in lung transplantation. Rather than paying for a full-scale trial itself, this announcement focused on the planning, organizing, and early groundwork that has to be in place before a major trial can be designed and submitted with confidence. The central idea was to support the practical steps that turn a promising concept into a trial that is feasible, scientifically solid, and likely to have real clinical impact for transplant patients.
The purpose of the grant was to fund the early-stage activities needed to build a robust clinical trial proposal that tests new strategies to improve lung transplantation. This included approaches to enhance the quality of donor lungs available for transplant and to improve the management and long-term outcomes of lung transplant recipients. NHLBI emphasized interventions relevant to complications that happen during and after transplantation, reflecting a priority on issues that directly affect survival, graft function, rejection, infection risk, and overall patient outcomes. Importantly, reviewers were instructed not only to evaluate the planning work itself, but also to consider the significance and potential impact of the full-scale clinical trial(s) that the investigators intended to propose after the planning period ended.
The FOA laid out typical planning-grant activities that applicants were expected to tackle. Teams could use funds to assemble and coordinate a research group, usually anchored by a principal clinical site and supported by multiple collaborating or ancillary sites, which is often necessary in transplantation because patient numbers are limited at any single center. Applicants were encouraged to define and prioritize the most important research questions, assess feasibility issues such as how eligible participants would be identified and recruited, and estimate patient availability across sites. They could also conduct preliminary studies or gather key data needed to justify trial design choices, and develop one or more clinical trial protocols with enough detail to support a later investigator-initiated clinical trial application. A core requirement was that the application make a clear case that the proposed planning work was both necessary and sufficient to enable the next step: submission of a competitive, full clinical trial proposal.
This funding used the NIH R34 mechanism, which is specifically designed for clinical trial planning. That choice signals that NHLBI wanted well-developed trial concepts that were close to being ready, but still needed structured, funded planning to reduce uncertainty and strengthen the eventual trial application. The expected outcome of the award period was not simply papers or pilot observations, but a credible, well-justified clinical trial application that could be submitted after the R34 work was completed.
On funding levels, NHLBI stated an intention to commit about $1.5 million in total costs in fiscal year 2010 for this program. The total amount that could be awarded across the program was capped at $3 million in total costs for the full 2-year project period, and NHLBI anticipated making up to two awards. The listed award ceiling was $450,000. The project period for an award under this FOA was two years, consistent with a planning timeline focused on protocol finalization, feasibility confirmation, and trial-readiness deliverables.
Eligibility was broad and included many organization types. Eligible applicants included for-profit organizations (other than small businesses) and small businesses, nonprofit organizations with and without 501(c)(3) status, public and private institutions of higher education, independent school districts, and a wide range of government entities (state, county, city/township, special district governments, and public housing authorities/Indian housing authorities). The eligibility language also included tribal governments and tribal organizations, as well as additional categories such as Alaska Native and Native Hawaiian Serving Institutions, Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, U.S. territories or possessions, and even non-U.S. entities (foreign organizations) and regional organizations. No cost sharing or matching was required.
Key administrative details from the posting show that the FOA was posted and created on September 30, 2009, with an original and current closing date of February 3, 2010, and it was archived on March 6, 2010. The activity fell under the health category and referenced CFDA 93.838 (Lung Diseases Research). Overall, the opportunity was designed as a focused bridge between innovation and execution: it helped teams do the detailed planning work that makes a lung transplantation clinical trial realistic, defensible, and ready to compete for larger-scale NIH clinical trial support.
Frequently Asked Questions (FAQs)
What is this funding opportunity?
This opportunity is the Lung Transplantation Planning Grants for Clinical Trials of Novel Therapies (R34), Funding Opportunity Number (FON) RFA-HL-10-016. It was a National Institutes of Health (NIH) program run through the National Heart, Lung, and Blood Institute (NHLBI) focused on helping teams plan and organize future clinical trials in lung transplantation.
Is this grant meant to pay for a full clinical trial?
No. This R34 announcement supported planning, organizing, and early groundwork needed to prepare a strong, competitive clinical trial application. The goal was to make teams truly ready to launch a high-quality trial, rather than to fund the full-scale trial itself.
What is the main purpose of the R34 planning grant in this FOA?
The purpose was to fund early-stage activities needed to build a robust clinical trial proposal that tests new strategies to improve lung transplantation. This includes planning work that strengthens feasibility, scientific rigor, and readiness to submit a later investigator-initiated clinical trial application.
What kinds of clinical trial topics were emphasized?
NHLBI emphasized novel therapies and strategies aimed at improving lung transplantation, including (1) enhancing the quality of donor lungs available for transplant and (2) improving management and long-term outcomes of lung transplant recipients. The FOA highlighted interventions relevant to complications during and after transplantation, such as issues affecting survival, graft function, rejection, infection risk, and overall patient outcomes.
What were reviewers expected to evaluate?
Reviewers were instructed to evaluate both the planning work proposed under the R34 and the significance and potential impact of the full-scale clinical trial(s) the investigators intended to propose after the planning period.
What are examples of planning activities that could be supported?
The FOA described typical R34 planning-grant activities such as assembling and coordinating a research team, organizing a structure with a principal clinical site and multiple collaborating or ancillary sites, defining and prioritizing key research questions, assessing feasibility (including participant identification and recruitment), estimating patient availability across sites, conducting preliminary studies or collecting key data needed to support design choices, and developing one or more clinical trial protocols in sufficient detail to enable a later clinical trial application.
Why did the FOA encourage multiple sites?
In transplantation research, patient numbers can be limited at any single center. The FOA anticipated that applicants may need a principal clinical site supported by collaborating or ancillary sites to assess feasibility, recruitment, and patient availability and to strengthen the eventual trial plan.
What was the key deliverable expected by the end of the award?
The expected outcome was a credible, well-justified clinical trial application that could be submitted after the R34 planning work was completed. The FOA emphasized trial-readiness rather than simply producing publications or pilot observations.
What does it mean that this used the NIH R34 mechanism?
The R34 mechanism is specifically designed for clinical trial planning. In this FOA, that signaled that NHLBI wanted trial concepts that were close to ready but still needed structured, funded planning to reduce uncertainty and strengthen the eventual full clinical trial application.
How long was the project period?
The project period was two years, aligned with a planning timeline focused on protocol finalization, feasibility confirmation, and trial-readiness deliverables.
How much funding was available overall?
NHLBI stated an intention to commit about $1.5 million in total costs in fiscal year 2010 for this program. The total amount that could be awarded across the program was capped at $3 million in total costs for the full 2-year project period.
How many awards did NHLBI anticipate making?
The FOA anticipated making up to two awards.
What was the listed award ceiling?
The listed award ceiling was $450,000.
Who was eligible to apply?
Eligibility was broad. Eligible applicants included for-profit organizations (other than small businesses) and small businesses; nonprofit organizations with and without 501(c)(3) status; public and private institutions of higher education; independent school districts; and many government entities (state, county, city/township, special district governments, and public housing authorities/Indian housing authorities).
Did eligibility include tribal governments and tribal organizations?
Yes. The eligibility language included tribal governments and tribal organizations, as well as categories such as Tribally Controlled Colleges and Universities (TCCUs).
Did eligibility include minority-serving institutions and similar organizations?
Yes. The FOA eligibility language included Alaska Native and Native Hawaiian Serving Institutions, Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), and other listed organization types.
Could faith-based or community-based organizations apply?
Yes. Faith-based or community-based organizations were included in the eligibility language.
Could federal agencies apply?
Yes. The eligibility language included eligible federal agencies.
Were non-U.S. (foreign) entities allowed to apply?
Yes. The eligibility language included non-U.S. entities (foreign organizations) and regional organizations.
Was cost sharing or matching required?
No. The FOA stated that no cost sharing or matching was required.
What were the key dates for this opportunity?
The FOA was posted and created on September 30, 2009. The original and current closing date was February 3, 2010. The opportunity was archived on March 6, 2010.
Which NIH institute ran the program?
The program was run through the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH).
What category and CFDA listing did the opportunity reference?
The activity fell under the health category and referenced CFDA 93.838 (Lung Diseases Research).
What is the overall goal of this opportunity in practical terms?
It was designed as a bridge between innovation and execution in lung transplantation research by funding the detailed planning work that makes a clinical trial realistic, defensible, feasible across sites, and ready to compete for larger-scale NIH clinical trial support.
What did applicants need to demonstrate in their R34 application?
A core requirement was to make a clear case that the proposed planning work was both necessary and sufficient to enable the next step: submission of a competitive, full clinical trial proposal after the planning period.
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