Opportunity Information: Apply for RFA HL 16 016
Apply for RFA HL 16 016
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Prematurity Related Ventilatory Control (Pre Vent) Role in Respiratory Outcomes Leadership and Data Coordinating Center (LDCC) (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 Jun 5, 2015 and posted on Jun 5, 2015.
- Applicants must submit their applications by Oct 20, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Public housing authorities/Indian housing authorities Special district governments Private institutions of higher education Public and State controlled institutions of higher education Independent school districts Nonprofits having 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) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education County governments For profit organizations other than small businesses Small businesses State governments City or township governments Others (see text field entitled Additional Information on Eligibility for clarification).
- 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 Foreign Institutions 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 allowed.
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Opportunity Summary:
The Prematurity Related Ventilatory Control (Pre Vent) Role in Respiratory Outcomes Leadership and Data Coordinating Center (LDCC) (U01) opportunity (Funding Opportunity Number RFA-HL-16-016) is a National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH) cooperative agreement designed to fund a single institution to serve as the program-wide Leadership and Data Coordinating Center for the Pre Vent observational research program. The core scientific purpose of the overall program is to better understand why premature infants experience unstable oxygenation and disordered breathing control, and how those problems translate into later illness or death. The LDCC award is intended to provide the operational leadership, coordination, and data infrastructure needed to run a prospective observational cohort focused on ventilatory control mechanisms during and after the Neonatal Intensive Care Unit (NICU) period, so the field can move closer to identifying preventive strategies for infants at highest risk.
From a research standpoint, the opportunity is centered on ventilatory control biology and physiology in prematurity. NHLBI highlights mechanisms such as chemoreceptor responses (how infants sense oxygen and carbon dioxide), mechanoreceptor inputs (how stretch and mechanical signals from the lung and chest wall influence breathing), and developmental factors that affect maturation of respiratory control systems. The overarching idea is that immaturity or dysfunction in these control systems can drive intermittent hypoxemia, apnea, or other forms of oxygenation instability, which may then contribute to important clinical outcomes. By using a prospective cohort approach, the program aims to capture exposures and measurements in real time, track infants through and beyond the NICU, and connect physiologic patterns and mechanistic signals to later respiratory morbidity and mortality. NHLBI frames this as a foundational step toward new preventive interventions, meaning the immediate focus is observation and mechanism discovery rather than testing a specific treatment.
As the Leadership and Data Coordinating Center, the funded awardee would be expected to function as the central hub that makes a multi-site observational program work. In practical terms, this typically includes setting up and maintaining the study operations backbone: developing and harmonizing protocols across participating clinical sites, supporting regulatory and human-subjects processes, building data collection systems, ensuring data quality and consistency, and providing statistical and analytic leadership for the cohort. The LDCC role also commonly involves project management for timelines and deliverables, convening investigator meetings, coordinating communication across sites, overseeing standard operating procedures, managing core documentation, and producing reports for NHLBI program staff under the cooperative agreement structure. Because this is a U01, NIH and NHLBI staff generally have substantial scientific and programmatic involvement compared with a standard investigator-initiated grant, so the LDCC would also be expected to work closely with NHLBI on governance, study milestones, and program direction.
Administratively, this opportunity falls under a discretionary funding category and uses the Cooperative Agreement funding instrument (U01). It is associated with CFDA number 93.838 (Lung Diseases Research). NHLBI expected to make one award, emphasizing that a single LDCC would coordinate the broader observational program. There is no cost sharing or matching requirement stated in the source information, which generally means applicants are not required to commit non-federal funds as a condition of the award.
Eligibility is broad and includes many types of domestic organizations, reflecting NHLBI’s interest in attracting an institution capable of running a complex coordinating center. Eligible applicants include public and private institutions of higher education, nonprofit organizations (with or without 501(c)(3) status), state and local governments (including counties and cities/townships), independent school districts, special district governments, public housing authorities/Indian housing authorities, small businesses, and for-profit organizations other than small businesses. The announcement also explicitly notes additional eligible categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as faith-based or community-based organizations and certain regional organizations. Foreign institutions and other non-U.S. entities are not eligible to apply, and non-domestic components of U.S. organizations are not eligible; however, foreign components, as defined by NIH policy, are allowed, which can matter when a primarily U.S.-based project needs limited international expertise or resources consistent with NIH rules.
The announcement timeline reflects that this was posted on June 5, 2015, with an original and current closing date of October 20, 2015, and an archive date of November 20, 2015. That means the specific solicitation is historical/archived, but the summary still captures how NHLBI structured the Pre Vent coordinating center concept and what kinds of capabilities NIH sought in an LDCC for a neonatal respiratory control cohort.
For applicants looking for the official announcement text and full requirements, the funding opportunity pointed to the NIH Grants Guide link at http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-16-016.html. The listed contact for technical issues accessing the announcement was the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV, which is typical for problems related to the online posting or linkage rather than scientific questions about the program.
Frequently Asked Questions (FAQs)
What is the name of this grant opportunity?
The opportunity is titled "Prematurity Related Ventilatory Control (Pre Vent) Role in Respiratory Outcomes Leadership and Data Coordinating Center (LDCC) (U01)." The Funding Opportunity Number (FON) is RFA-HL-16-016.
Which agency is offering this funding opportunity?
This is an NIH opportunity from the National Heart, Lung, and Blood Institute (NHLBI), under the National Institutes of Health (NIH).
What type of award mechanism is being used?
The funding instrument is a Cooperative Agreement (U01). Under a U01, NIH/NHLBI staff typically have substantial scientific and programmatic involvement compared with many investigator-initiated mechanisms.
What is the main purpose of the program this LDCC would support?
The program aims to better understand why premature infants experience unstable oxygenation and disordered breathing control, and how those problems relate to later illness or death. The emphasis is on ventilatory control mechanisms during and after the Neonatal Intensive Care Unit (NICU) period.
Is this opportunity focused on observational research or testing an intervention?
Based on the provided information, the immediate focus is observational and mechanistic discovery. The program is described as a prospective observational cohort intended to connect physiologic patterns and mechanistic signals to later outcomes, as a foundational step toward future preventive strategies rather than testing a specific treatment right away.
What does "LDCC" mean in this context?
LDCC stands for Leadership and Data Coordinating Center. The awardee is expected to serve as the central hub that provides operational leadership, coordination, and data infrastructure for the broader Pre Vent observational research program.
How many awards did NHLBI expect to make?
NHLBI expected to make one award, meaning a single institution would serve as the program-wide LDCC.
What kinds of activities would the LDCC be expected to perform?
Based on the description provided, the LDCC would typically be responsible for setting up and maintaining the study operations backbone across multiple sites. This includes developing and harmonizing protocols, supporting regulatory and human-subjects processes, building data collection systems, ensuring data quality and consistency, providing statistical and analytic leadership, managing timelines and deliverables, convening investigator meetings, coordinating communication across sites, overseeing standard operating procedures, maintaining core documentation, and producing reports for NHLBI program staff under the cooperative agreement structure.
What scientific areas are highlighted as central to the program?
The opportunity centers on ventilatory control biology and physiology in prematurity, including mechanisms such as chemoreceptor responses (sensing oxygen and carbon dioxide), mechanoreceptor inputs (mechanical/stretch signals from the lung and chest wall), and developmental factors that affect maturation of respiratory control systems.
What clinical or physiologic problems is the program trying to understand?
The program is aimed at understanding how immaturity or dysfunction in respiratory control systems can drive intermittent hypoxemia, apnea, or other forms of oxygenation instability, and how these patterns may contribute to later respiratory morbidity and mortality.
What kind of study design is referenced?
The program is described as a prospective observational cohort, capturing exposures and measurements in real time and tracking infants through and beyond the NICU period.
What is the CFDA number associated with this opportunity?
The opportunity is associated with CFDA 93.838 (Lung Diseases Research).
Is cost sharing or matching required?
No cost sharing or matching requirement is stated in the provided information, which generally means applicants are not required to commit non-federal funds as a condition of the award.
Who is eligible to apply?
Eligibility is broad for domestic organizations and includes: public and private institutions of higher education; nonprofit organizations (with or without 501(c)(3) status); state and local governments (including counties and cities/townships); independent school districts; special district governments; public housing authorities/Indian housing authorities; small businesses; and for-profit organizations other than small businesses.
Are minority-serving institutions and community-based organizations included as eligible applicants?
Yes. The announcement explicitly notes additional eligible categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs). It also notes faith-based or community-based organizations and certain regional organizations as eligible.
Are foreign institutions eligible to apply?
No. Foreign institutions and other non-U.S. entities are not eligible to apply based on the provided information.
Are non-U.S. components of U.S. organizations eligible?
No. Non-domestic components of U.S. organizations are not eligible, according to the provided information.
Are foreign components allowed at all?
Yes. While foreign institutions cannot apply and non-domestic components are not eligible, foreign components (as defined by NIH policy) are allowed. This can matter when a primarily U.S.-based project needs limited international expertise or resources consistent with NIH rules.
What was the posting date and closing date for this opportunity?
The opportunity was posted on June 5, 2015. The original and current closing date was October 20, 2015.
Is this funding opportunity still open?
No. The archive date was November 20, 2015, and the closing date was October 20, 2015. Based on the provided timeline, the solicitation is historical/archived.
Where can the official announcement text be found?
The official announcement text was referenced at: http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-16-016.html
Who was listed as the contact for technical issues accessing the announcement?
The listed contact for technical issues related to accessing the announcement was the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.
What does the "cooperative agreement" structure imply for how the project would be run?
Based on the provided description, a U01 cooperative agreement typically involves substantial NIH/NHLBI scientific and programmatic involvement. The LDCC would be expected to work closely with NHLBI on governance, study milestones, and program direction.
What is the role of the LDCC in multi-site coordination?
The LDCC is described as the central hub for a multi-site observational program, supporting harmonized protocols, consistent operations, data collection systems, quality assurance, communication across sites, and program-wide reporting.
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