Opportunity Information: Apply for RFA HL 14 014
Apply for RFA HL 14 014
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Clinical Centers (CC) 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: Small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts Native American tribal organizations (other than Federally recognized tribal governments) Native American tribal governments (Federally recognized) City or township governments For profit organizations other than small businesses Special district governments Private institutions of higher education Public housing authorities/Indian housing authorities Public and State controlled institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education County governments.
- 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:
This grant opportunity (RFA-HL-14-014) is a National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI) funding announcement that supports the creation of Clinical Centers (CCs) for a new multicenter clinical trials network focused on the prevention and early treatment of acute lung injury (ALI), including acute respiratory distress syndrome (ARDS). The award mechanism is a U01 cooperative agreement, which means NHLBI will have substantial scientific and programmatic involvement in the work rather than acting only as a passive funder. The overall goal is to build a coordinated, trial-ready network that can rapidly design and run rigorous studies in adults who either have ALI/ARDS or are at high risk of developing it, with the broader aim of improving outcomes through better prevention strategies, earlier interventions, and more effective treatments.
The PETAL Clinical Trials Network described in the announcement is planned to include roughly 11 Clinical Centers plus a single Clinical Coordinating Center (CCC). This particular FOA only solicits applications for the Clinical Centers. A separate, parallel FOA (RFA-HL-14-015) covers the CCC, which would typically handle network-wide coordination functions such as overall trial operations, data coordination, and centralized management. Together, the CCs and the CCC are expected to function as an integrated national infrastructure capable of carrying out multiple randomized controlled trials (RCTs) in a complex, time-sensitive clinical area where patients often deteriorate quickly and where enrollment and intervention timing can be challenging.
In terms of the research agenda, the network is expected to develop and conduct at least three to five randomized controlled clinical trials over the project period. Those trials are intended to prevent ALI/ARDS in at-risk adults, treat established disease early, and/or improve clinical outcomes for patients with ALI/ARDS. While the announcement summary does not list specific interventions or protocols, it makes clear that the emphasis is on well-designed RCTs in adult populations, addressing both prevention and early treatment, and that the network structure is meant to support a portfolio of trials rather than a single study.
Clinical Centers funded under this FOA are expected to serve as high-performing enrollment and clinical research sites. A key performance expectation included in the summary is enrollment: each CC is expected to enroll about 220 patients over approximately 5.5 years. That implies sustained recruiting capacity, reliable identification of eligible patients in acute care settings, and the operational capability to implement trial procedures consistently. In practical terms, a CC would generally need strong ICU and hospital-based research infrastructure, experienced investigators and coordinators, the ability to enroll patients rapidly (often with limited windows for consent and intervention), and close collaboration with the network and CCC to ensure adherence to standardized protocols and high-quality data collection.
The opportunity is categorized as discretionary funding and falls under the NIH health research activity area, with CFDA number 93.838 (Lung Diseases Research). It does not require cost sharing or matching. The FOA was posted May 15, 2013, with an original and current closing date of July 25, 2013, and an archive date of August 25, 2013. These dates indicate the solicitation is historic, but the summary still provides a clear picture of the intended network structure and expectations for participating centers.
Eligibility is broad across U.S.-based organizations and governmental entities, reflecting the network’s need for diverse, capable clinical sites. Eligible applicants include nonprofit organizations (with or without 501(c)(3) status), public and private institutions of higher education, small businesses, for-profit organizations (other than small businesses), independent school districts, city/township, county, state, and special district governments, public housing authorities/Indian housing authorities, and federally recognized tribal governments and tribal organizations. The eligibility section also explicitly includes a range of mission-driven and designated institution types such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribal Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), faith-based or community-based organizations, regional organizations, and eligible federal agencies. At the same time, the FOA makes clear that non-U.S. entities are not eligible, and foreign components are not allowed under NIH policy definitions, meaning the network is intended to be entirely U.S.-based with no foreign institutional participation as applicants or components.
For applicants looking for the full requirements beyond this summary, the announcement points to the detailed FOA on the NIH Grants Guide website (RFA-HL-14-014). The notice also provides general NIH Office of Extramural Research (OER) webmaster contact information for access or linking issues. Overall, the opportunity is designed to fund a set of clinical centers that, together with a separately funded coordinating center, can run multiple high-impact clinical trials aimed at reducing the burden of ALI/ARDS through prevention and early treatment in adult patients.
Frequently Asked Questions (FAQ): NIH/NHLBI RFA-HL-14-014 (PETAL Clinical Centers)
1. What is RFA-HL-14-014?
RFA-HL-14-014 is a National Institutes of Health (NIH) funding opportunity announcement from the National Heart, Lung, and Blood Institute (NHLBI). It supports the creation of Clinical Centers (CCs) for a multicenter clinical trials network focused on the prevention and early treatment of acute lung injury (ALI), including acute respiratory distress syndrome (ARDS).
2. What is the main goal of this funding opportunity?
The goal is to build a coordinated, trial-ready clinical trials network that can rapidly design and conduct rigorous randomized controlled trials (RCTs) in adults with ALI/ARDS or adults at high risk of developing ALI/ARDS. The broader aim is to improve outcomes through better prevention strategies, earlier interventions, and more effective treatments.
3. What award mechanism is used for this opportunity?
This opportunity uses the U01 cooperative agreement mechanism. Under a cooperative agreement, NHLBI will have substantial scientific and programmatic involvement in the work, rather than acting only as a passive funder.
4. What network is being created under this FOA?
The announcement describes the PETAL Clinical Trials Network, a planned multicenter infrastructure intended to run multiple RCTs related to ALI/ARDS prevention and early treatment in adults.
5. How many sites are expected to be part of the PETAL network?
The planned network structure includes roughly 11 Clinical Centers (CCs) plus a single Clinical Coordinating Center (CCC).
6. Does this FOA fund the Clinical Coordinating Center (CCC)?
No. RFA-HL-14-014 solicits applications only for the Clinical Centers. A separate, parallel FOA (RFA-HL-14-015) covers the Clinical Coordinating Center (CCC).
7. What is the Clinical Coordinating Center (CCC) expected to do?
Based on the summary, the CCC would typically handle network-wide coordination functions such as overall trial operations, data coordination, and centralized management, helping the CCs and CCC operate as an integrated national infrastructure.
8. What types of studies is the network expected to conduct?
The network is expected to develop and conduct randomized controlled clinical trials (RCTs) focused on preventing ALI/ARDS in at-risk adults, treating established ALI/ARDS early, and/or improving clinical outcomes in adults with ALI/ARDS.
9. How many clinical trials are expected during the project period?
The network is expected to develop and conduct at least three to five randomized controlled clinical trials over the project period.
10. Are specific interventions or protocols listed in the summary?
No. The summary does not list specific interventions or trial protocols. It emphasizes well-designed RCTs in adult populations addressing prevention and early treatment, supported by a network designed to run a portfolio of trials rather than a single study.
11. Who is the target patient population for the trials?
The focus is on adults who either have ALI/ARDS or are at high risk of developing ALI/ARDS, with an emphasis on prevention and early treatment in a time-sensitive clinical setting.
12. What are Clinical Centers (CCs) expected to do?
Clinical Centers funded under this FOA are expected to serve as high-performing enrollment and clinical research sites. They are expected to identify eligible patients in acute care settings, enroll participants rapidly, implement trial procedures consistently, and collaborate closely with the network and the CCC to support standardized protocols and high-quality data collection.
13. What are the enrollment expectations for each Clinical Center?
Each Clinical Center is expected to enroll about 220 patients over approximately 5.5 years, indicating the need for sustained recruiting capacity and reliable screening and enrollment workflows.
14. What kind of infrastructure is implied for a successful Clinical Center?
The summary indicates a need for strong ICU and hospital-based research infrastructure, experienced investigators and coordinators, the ability to enroll patients rapidly (often with limited windows for consent and intervention), and the operational capability to implement standardized trial procedures and data collection across the network.
15. What type of funding is this categorized as?
The opportunity is categorized as discretionary funding and falls under the NIH health research activity area.
16. What is the CFDA number associated with this opportunity?
The CFDA number listed is 93.838, associated with Lung Diseases Research.
17. Is cost sharing or matching required?
No. The summary states that cost sharing or matching is not required.
18. When was the FOA posted, and what were the closing dates?
The FOA was posted on May 15, 2013. The original and current closing date was July 25, 2013. The archive date was August 25, 2013.
19. Is this a current funding opportunity?
Based on the dates provided (closing date in 2013 and archive date in 2013), this solicitation is historic. The summary still describes the intended structure, expectations, and scope for participating Clinical Centers within the PETAL network.
20. Who is eligible to apply?
Eligibility is broad across U.S.-based organizations and governmental entities. Eligible applicants include nonprofit organizations (with or without 501(c)(3) status), public and private institutions of higher education, small businesses, for-profit organizations (other than small businesses), independent school districts, city/township governments, county governments, state governments, special district governments, public housing authorities/Indian housing authorities, federally recognized tribal governments, and tribal organizations.
21. Are certain designated institution types explicitly included in eligibility?
Yes. The eligibility section explicitly includes institution types such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribal Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), faith-based or community-based organizations, regional organizations, and eligible federal agencies.
22. Are non-U.S. entities eligible to apply?
No. The FOA indicates that non-U.S. entities are not eligible.
23. Are foreign components allowed?
No. The summary states that foreign components are not allowed under NIH policy definitions, meaning the network is intended to be entirely U.S.-based with no foreign institutional participation as applicants or components.
24. Where can applicants find the full funding announcement?
The summary points applicants to the detailed FOA on the NIH Grants Guide website under RFA-HL-14-014 for full requirements beyond the summary.
25. Is there contact information for technical issues accessing the FOA?
Yes. The notice references general NIH Office of Extramural Research (OER) webmaster contact information for access or linking issues.
26. What is the overall expected outcome of funding these Clinical Centers?
The intent is to fund a set of Clinical Centers that, together with a separately funded Clinical Coordinating Center, can run multiple high-impact RCTs aimed at reducing the burden of ALI/ARDS through prevention and early treatment in adult patients.
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Previous opportunity: Clinical Coordinating Center (CCC) for the NHLBI Prevention and Early Treatment of Acute Lung Injury (PETAL) Clinical Trials Network (U01)
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