Opportunity Information: Apply for RFA HL 14 015
Apply for RFA HL 14 015
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Clinical Coordinating Center (CCC) for the NHLBI Prevention and Early Treatment of Acute Lung Injury (PETAL) Clinical Trials Network (U01)" 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 May 15, 2013 and posted on May 15, 2013.
- Applicants must submit their applications by Jul 25, 2013. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Independent school districts Private institutions of higher education State governments Native American tribal organizations (other than Federally recognized tribal governments) Special district governments Others (see text field entitled Additional Information on Eligibility for clarification) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education County governments Public housing authorities/Indian housing authorities For profit organizations other than small businesses Native American tribal governments (Federally recognized) Public and State controlled 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) 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 not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
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Opportunity Summary:
The grant opportunity RFA-HL-14-015 is a National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI) funding announcement for a Clinical Coordinating Center (CCC) to support a new multicenter clinical trials network focused on the Prevention and Early Treatment of Acute Lung Injury (ALI), also referred to as the PETAL Clinical Trials Network. The network is designed to bring together about 11 Clinical Centers (CCs) plus one central CCC to plan, launch, and run randomized controlled trials aimed at preventing ALI/ARDS, treating early disease, and improving outcomes in adult patients who either have Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS) or are at high risk of developing it. The overall purpose is to create a standing, trial-ready infrastructure that can efficiently design and execute rigorous studies in a critically ill population where timing, standardization, and coordination across hospitals are essential.
This award uses the U01 cooperative agreement mechanism, which matters because it signals an active partnership between the awardees and NHLBI rather than a hands-off research grant. Under a cooperative agreement, the CCC is expected to work closely with NHLBI staff on network governance, study prioritization, protocol development, and operational decisions, while still retaining scientific and operational responsibilities typical of a coordinating center. In practical terms, the CCC functions as the operational hub for the entire PETAL Network, supporting consistent trial implementation across the clinical sites, enabling common procedures, and ensuring the network can reliably produce high-quality evidence from randomized trials in ALI/ARDS prevention and early treatment.
The CCC-focused announcement runs in parallel with a separate companion FOA for the Clinical Centers (RFA-HL-14-014). Together, the two announcements are intended to establish the full network: clinical sites that enroll participants and deliver interventions, and a coordinating center that provides the centralized capabilities needed to operate multiple complex trials over time. The anticipated project period is seven years, reflecting the expectation that the network will be a long-term platform capable of running more than one trial and maintaining readiness to initiate new studies as priorities evolve.
From an administrative standpoint, this FOA is categorized as discretionary funding and falls under the health activity area, specifically CFDA 93.838 (Lung Diseases Research). There is no cost sharing or matching requirement stated, which generally means applicants are not required to provide non-federal funds to receive the award (though normal NIH cost principles and budgeting rules still apply). The funding announcement was posted on May 15, 2013, with an original and current application closing date of July 25, 2013, and an archive date of August 25, 2013, indicating it was a time-limited solicitation for establishing this particular network structure.
Eligibility is broad and includes many types of domestic organizations that can credibly host and operate a large clinical trials coordinating center. Eligible applicants listed include public and state-controlled and private institutions of higher education, nonprofits with or without 501(c)(3) status (excluding certain higher-education categories as specified), small businesses, for-profit organizations (including those other than small businesses), and multiple levels of government (state, county, city/township, special district, and independent school districts), as well as public housing authorities/Indian housing authorities. The FOA also explicitly includes a range of mission-driven and historically underrepresented institution types 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 Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), along with faith-based or community-based organizations, regional organizations, eligible federal agencies, U.S. territories or possessions, and tribal governments (federally recognized and other than federally recognized). At the same time, the announcement clearly excludes non-U.S. (foreign) institutions from applying, prohibits non-domestic components of U.S. organizations, and does not allow foreign components as defined by the NIH Grants Policy Statement, keeping the network fully domestic in operation and oversight.
The scientific and clinical focus is tightly framed around adult patients and the continuum of risk through early disease: prevention in those at risk for ALI/ARDS, early treatment once disease emerges, and interventions designed to improve clinical outcomes. Because ALI/ARDS often develops rapidly and is managed in high-acuity settings like intensive care units, a network like PETAL is intended to standardize eligibility determination, enrollment processes, intervention delivery, and outcome assessment across many hospitals. The CCC’s central role in supporting these goals typically includes network-wide trial coordination tasks such as harmonizing protocols, facilitating site training and certification, maintaining consistent data collection standards, coordinating trial monitoring and reporting, supporting communications among sites and with NHLBI, and generally ensuring that multicenter randomized controlled trials are executed efficiently and uniformly across the entire network.
The sponsoring agency is the NIH, and the primary institute is NHLBI. The official funding opportunity title is "Clinical Coordinating Center (CCC) for the NHLBI Prevention and Early Treatment of Acute Lung Injury (PETAL) Clinical Trials Network (U01)," and the funding opportunity number is RFA-HL-14-015. The full announcement is linked through NIH at http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-14-015.html. For access issues or technical problems with the announcement link, the contact listed is the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.
Frequently Asked Questions (FAQs): RFA-HL-14-015
What is RFA-HL-14-015?
RFA-HL-14-015 is a National Institutes of Health (NIH) funding opportunity announcement from the National Heart, Lung, and Blood Institute (NHLBI) to support a single Clinical Coordinating Center (CCC) for the Prevention and Early Treatment of Acute Lung Injury (PETAL) Clinical Trials Network.
What is the official title of this funding opportunity?
The official title is "Clinical Coordinating Center (CCC) for the NHLBI Prevention and Early Treatment of Acute Lung Injury (PETAL) Clinical Trials Network (U01)."
Which agency and institute sponsor this opportunity?
The sponsoring agency is the NIH, and the primary institute is the NHLBI.
What is the PETAL Clinical Trials Network?
PETAL is a multicenter clinical trials network designed to plan, launch, and run randomized controlled trials focused on preventing Acute Lung Injury (ALI)/Acute Respiratory Distress Syndrome (ARDS), treating early disease, and improving outcomes in adult patients with ALI/ARDS or at high risk of developing it.
How is the PETAL Network structured?
The network is intended to include about 11 Clinical Centers (CCs) that enroll participants and deliver interventions, plus one central Clinical Coordinating Center (CCC) that serves as the operational hub for the network.
What is being funded under RFA-HL-14-015?
This announcement funds the Clinical Coordinating Center (CCC), which provides centralized coordination and operational capabilities needed to run multiple complex, multicenter randomized trials over time within the PETAL Network.
Is there a companion funding opportunity for the Clinical Centers?
Yes. This CCC announcement runs in parallel with a companion FOA for the Clinical Centers: RFA-HL-14-014.
What is the primary purpose of creating a CCC for PETAL?
The purpose is to create a standing, trial-ready infrastructure that can efficiently design and execute rigorous multicenter randomized controlled trials in a critically ill population where timing, standardization, and coordination across hospitals are essential.
What types of studies is the PETAL Network expected to conduct?
The network is designed to conduct randomized controlled trials aimed at (1) preventing ALI/ARDS in adults at high risk, (2) treating early ALI/ARDS, and (3) improving clinical outcomes in adult patients across this risk-to-early-disease continuum.
Which patient population is the scientific focus of this network?
The focus is on adult patients who have ALI/ARDS or who are at high risk of developing ALI/ARDS.
What award mechanism is used for this opportunity?
This opportunity uses the U01 cooperative agreement mechanism.
What does it mean that this is a U01 cooperative agreement?
A U01 cooperative agreement indicates an active partnership between awardees and NHLBI. The CCC is expected to work closely with NHLBI staff on network governance, study prioritization, protocol development, and operational decisions, while still carrying scientific and operational responsibilities typical of a coordinating center.
What role does the CCC play within the PETAL Network?
The CCC functions as the operational hub for the PETAL Network, supporting consistent trial implementation across sites, enabling common procedures, and helping ensure the network produces high-quality evidence from multicenter randomized trials in ALI/ARDS prevention and early treatment.
What are examples of CCC responsibilities described in the announcement?
Responsibilities typically include harmonizing protocols, facilitating site training and certification, maintaining consistent data collection standards, coordinating trial monitoring and reporting, supporting communications among sites and with NHLBI, and ensuring trials are executed efficiently and uniformly across all participating hospitals.
How long is the anticipated project period?
The anticipated project period is seven years.
Why is the project period seven years?
The seven-year period reflects expectations that PETAL will be a long-term platform capable of running more than one trial and maintaining readiness to initiate new studies as priorities evolve.
What is the CFDA number and program area for this funding opportunity?
The activity area is health, and the CFDA listing is 93.838 (Lung Diseases Research).
Is cost sharing or matching required?
No cost sharing or matching requirement is stated in the provided information.
What type of funding is this categorized as?
This FOA is categorized as discretionary funding.
When was the announcement posted?
The announcement was posted on May 15, 2013.
What were the application due dates for this opportunity?
The original and current application closing date listed is July 25, 2013.
Is this opportunity still active?
The archive date is August 25, 2013, indicating it was a time-limited solicitation for establishing this specific network structure.
Who is eligible to apply?
Eligibility is broad and includes many types of domestic organizations, including public and state-controlled and private institutions of higher education; nonprofits with or without 501(c)(3) status (excluding certain higher-education categories as specified); small businesses; for-profit organizations (including those other than small businesses); and multiple levels of government (state, county, city/township, special district, and independent school districts), as well as public housing authorities/Indian housing authorities.
Are minority-serving and mission-driven institutions included as eligible applicants?
Yes. The FOA explicitly includes institution types 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 Asian American Native American Pacific Islander Serving Institutions (AANAPISIs). It also includes faith-based or community-based organizations, regional organizations, eligible federal agencies, U.S. territories or possessions, and tribal governments (federally recognized and other than federally recognized).
Are foreign (non-U.S.) institutions eligible to apply?
No. The announcement excludes non-U.S. (foreign) institutions from applying.
Can a U.S. organization include non-domestic components or foreign components?
No. The FOA prohibits non-domestic components of U.S. organizations and does not allow foreign components as defined by the NIH Grants Policy Statement.
Where can the full funding announcement be found?
The full announcement is available through NIH at: http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-14-015.html.
Who should be contacted for technical problems accessing the announcement link?
For access issues or technical problems with the announcement link, the contact listed is the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.
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