Opportunity Information: Apply for RFA HL 21 013
The grant opportunity "Disease Modifying Therapies for Chronic Lung Disease (R61/R33 Clinical Trial Required)" (Funding Opportunity Number RFA-HL-21-013) is a National Institutes of Health (NIH) program led by the National Heart, Lung, and Blood Institute (NHLBI). Its central goal is to fund multiple Protocol Leadership Groups (PLGs) to run phase II clinical trials that evaluate innovative disease-modifying therapies (DMTs) for chronic lung diseases. The work is intended to happen within the NHLBI Pulmonary Trials Cooperative (PTC), a coordinated clinical trials network designed to support several trials at the same time rather than funding isolated, one-off studies.
A key feature of this initiative is its network structure. The PTC is built around multiple PLGs plus a single Network Management Core (NEMO). In practical terms, PLGs are expected to be the scientific and operational leaders for individual phase II protocols, handling the design and execution of specific trials. NEMO serves as the centralized coordinating and management hub for the network, helping standardize operations and enabling multiple studies to run in parallel with shared infrastructure and consistent oversight. The emphasis on multiple simultaneous phase II trials signals that the program is looking for a pipeline of mid-stage clinical evaluations that can efficiently test different candidate therapies across chronic lung disease areas.
The funding mechanism is an R61/R33 phased award, and a clinical trial is required. This mechanism generally supports a milestone-driven transition from an initial, more exploratory or start-up phase (R61) into a follow-on phase (R33) once predefined criteria are met. In the context of this FOA, the milestone-based approach aligns with the goal of quickly standing up rigorous phase II studies and ensuring that only projects meeting operational and scientific benchmarks move forward to the later stage of support.
The opportunity is categorized as a discretionary grant in the health funding area (CFDA 93.838) and is open to a broad range of applicant organizations. Eligible applicants include various levels of government (state, county, city/township, special district), educational entities (independent school districts, public and state-controlled institutions of higher education, and private institutions of higher education), tribal governments and organizations (including federally recognized tribal governments and tribal organizations other than federally recognized governments), public housing authorities/Indian housing authorities, nonprofits (both 501(c)(3) and non-501(c)(3), other than institutions of higher education), for-profit organizations (other than small businesses), and small businesses. The FOA also explicitly calls out additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, eligible federal agencies, Indian/Native American tribal governments other than federally recognized, and U.S. territories or possessions.
There are important limits and allowances related to foreign involvement. Non-domestic (non-U.S.) entities and non-U.S. institutions are not eligible to apply as primary applicants. However, non-domestic components of U.S. organizations are eligible, and foreign components (as defined by the NIH Grants Policy Statement) are allowed. In other words, the awardee organization must be U.S.-based, but certain parts of the work may still be carried out internationally if structured as an allowable foreign component under NIH policy.
The source data provided indicates an original closing date of July 28, 2022, and a creation date of April 30, 2020. The award ceiling and expected number of awards are not specified in the excerpt, but the stated intent to support multiple PLGs suggests more than one award is anticipated, consistent with establishing a network capable of running multiple concurrent phase II trials. Overall, the opportunity is geared toward teams that can lead well-designed, milestone-driven phase II clinical trials within a coordinated NHLBI network, with the larger objective of advancing disease-modifying approaches for chronic lung diseases rather than only symptomatic treatment.Apply for RFA HL 21 013
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Disease Modifying Therapies for Chronic Lung Disease (R61/R33 Clinical Trial Required)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.838.
- This funding opportunity was created on 2020-04-30.
- Applicants must submit their applications by 2022-07-28. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- 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.
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Frequently Asked Questions (FAQs)
What is the name of this grant opportunity and who leads it?
The opportunity is titled "Disease Modifying Therapies for Chronic Lung Disease (R61/R33 Clinical Trial Required)" (Funding Opportunity Number RFA-HL-21-013). It is an NIH program led by the National Heart, Lung, and Blood Institute (NHLBI).
What is the main goal of this funding opportunity?
The central goal is to fund multiple Protocol Leadership Groups (PLGs) to run phase II clinical trials that evaluate innovative disease-modifying therapies (DMTs) for chronic lung diseases. The program is designed to support a pipeline of mid-stage clinical evaluations rather than isolated, one-off studies.
Are clinical trials required under this FOA?
Yes. This FOA is explicitly labeled "Clinical Trial Required", and the intended work includes running phase II clinical trials.
What kind of clinical trials is the program focused on?
The program focuses on phase II clinical trials intended to evaluate disease-modifying therapies for chronic lung diseases, emphasizing rigorous, milestone-driven execution within a coordinated network environment.
What does "disease-modifying therapy (DMT)" mean in the context of this opportunity?
Based on the information provided, the program aims to advance therapies intended to modify the underlying course of chronic lung disease, rather than focusing only on symptomatic treatment.
What is the NHLBI Pulmonary Trials Cooperative (PTC) and why does it matter?
The work is intended to occur within the NHLBI Pulmonary Trials Cooperative (PTC), a coordinated clinical trials network designed to support multiple trials running at the same time. This network approach is meant to make it easier to run concurrent phase II studies using shared infrastructure and consistent oversight.
How is the PTC structured?
The PTC is built around multiple Protocol Leadership Groups (PLGs) plus a single Network Management Core (NEMO). PLGs lead individual protocols, while NEMO serves as the central coordinating and management hub for the network.
What is a Protocol Leadership Group (PLG) expected to do?
PLGs are expected to be the scientific and operational leaders for individual phase II protocols. They are responsible for the design and execution of specific clinical trials within the network.
What is NEMO and what role does it play?
NEMO (the Network Management Core) is described as the centralized coordinating and management hub for the network. It helps standardize operations and enables multiple studies to run in parallel with shared infrastructure and consistent oversight.
Does the program fund one project or multiple projects at the same time?
The program emphasizes multiple simultaneous phase II trials and intends to fund multiple PLGs. While an exact number of awards is not specified in the provided excerpt, the described structure indicates that more than one award is anticipated to support a functional network of concurrent trials.
What funding mechanism is used?
This opportunity uses the R61/R33 phased award mechanism.
What does the R61/R33 phased award mean for applicants?
The R61/R33 mechanism is described as a milestone-driven transition from an initial phase (R61), which may cover exploratory or start-up activities, into a follow-on phase (R33) once predefined criteria are met. In this FOA, that milestone-based approach is intended to support standing up rigorous phase II studies quickly and to ensure that only projects meeting operational and scientific benchmarks proceed to later-stage support.
Is this a discretionary grant and what is the funding area?
Yes. The opportunity is categorized as a discretionary grant in the health funding area.
What CFDA number is associated with this opportunity?
The CFDA number provided is 93.838.
Who is eligible to apply?
The FOA is open to a broad range of applicant organizations, including:
- Government entities: state, county, city/township, and special district governments
- Education: independent school districts; public and state-controlled institutions of higher education; private institutions of higher education
- Tribal entities: federally recognized tribal governments and tribal organizations other than federally recognized governments
- Public housing authorities/Indian housing authorities
- Nonprofits: 501(c)(3) and non-501(c)(3), other than institutions of higher education
- For-profit organizations (other than small businesses)
- Small businesses
Are specific institution types explicitly called out as eligible?
Yes. The FOA explicitly calls out additional eligible applicant categories, including:
- Alaska Native and Native Hawaiian Serving Institutions
- Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
- Hispanic-serving Institutions
- Historically Black Colleges and Universities (HBCUs)
- Tribally Controlled Colleges and Universities (TCCUs)
- Faith-based or community-based organizations
- Regional organizations
- Eligible federal agencies
- Indian/Native American tribal governments other than federally recognized
- U.S. territories or possessions
Can non-U.S. (foreign) organizations apply as the primary applicant?
No. Non-domestic (non-U.S.) entities and non-U.S. institutions are not eligible to apply as primary applicants under this opportunity.
Is any foreign involvement allowed?
Yes, with limits. The provided information states that non-domestic components of U.S. organizations are eligible, and foreign components (as defined by the NIH Grants Policy Statement) are allowed. This means the awardee organization must be U.S.-based, but certain parts of the work may be conducted internationally if structured as an allowable foreign component under NIH policy.
What are the key dates listed for this opportunity?
The source data provided lists a creation date of April 30, 2020 and an original closing date of July 28, 2022.
Is the award ceiling listed?
No. The provided excerpt does not specify an award ceiling.
Is the expected number of awards listed?
No. The provided excerpt does not specify the expected number of awards, although it states the intent to support multiple PLGs, which suggests multiple awards to enable a network running several trials concurrently.
What makes this opportunity different from a typical single-project clinical trial grant?
This opportunity emphasizes a network model (the PTC) designed to support several phase II trials in parallel with shared infrastructure and centralized coordination through NEMO, rather than funding isolated, one-off trials managed independently.
What is the overall program emphasis for the supported trials?
The overall emphasis is on advancing disease-modifying approaches for chronic lung diseases and running these studies in a coordinated, milestone-driven fashion within an NHLBI-supported clinical trials network.
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