Opportunity Information: Apply for RFA HL 10 007
Apply for RFA HL 10 007
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Prematurity and Respiratory Outcomes Program (PROP) (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 Mar 10, 2009 and posted on Mar 10, 2009.
- Applicants must submit their applications by Jun 2, 2009. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $18,500,000.00 to eligible and selected applicants.
- Eligible applicants include: Small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education Independent school districts Native American tribal governments (Federally recognized) Special district governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities City or township governments County governments State governments Native American tribal organizations (other than Federally recognized tribal governments) Others (see text field entitled Additional Information on Eligibility for clarification) For profit organizations other than small businesses Private institutions of higher education.
- 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 Prematurity and Respiratory Outcomes Program (PROP) (U01) is a National Heart, Lung, and Blood Institute (NHLBI) cooperative research initiative designed to improve understanding of why premature newborns are at elevated risk for respiratory disease and to translate that knowledge into better outcomes during the first year of life. The core scientific focus is on molecular mechanisms that drive respiratory vulnerability in preterm infants, with the expectation that participating teams will move beyond descriptive clinical associations and instead test clearly defined, biologically grounded hypotheses. A central feature of the program is the development and validation of innovative biomarkers, especially molecular and functional measures that can (1) define and stratify specific cohorts of premature infants, (2) predict the severity and trajectory of respiratory outcomes within those cohorts, and (3) potentially serve as surrogate endpoints to evaluate whether risk can be modified through interventions or changes in care.
Structurally, PROP is set up as a coordinated, multi-site collaborative network rather than a set of independent projects. The program will include up to five Clinical Research Centers (CRCs), a Steering Committee to oversee governance and scientific direction, and a Data Coordinating Center (DCC) responsible for network-level data management and coordination. Each CRC is expected to recruit or study a defined cohort and put forward a detailed hypothesis about a specific mechanism contributing to respiratory disease risk. CRC applications are expected to be multidisciplinary by design, bringing together neonatology and pediatric pulmonology with advanced technology expertise, such as bioengineering approaches, molecular genetics and genomics, or sophisticated imaging methods. NHLBI strongly encourages the multiple principal investigator (multiple PI) model, reflecting the expectation that meaningful progress in this area requires integrated clinical and basic or translational science leadership.
The funding mechanism is a Research Project Cooperative Agreement (U01), which signals an active partnership between NHLBI and awardees. In practice, this typically means there will be substantial programmatic coordination, shared protocols or common data elements, and network-wide collaboration facilitated through the Steering Committee and the DCC, rather than each site operating entirely independently. The opportunity is identified as Funding Opportunity Number RFA-HL-10-007, categorized as discretionary funding and aligned with CFDA 93.838 (Lung Diseases Research). No cost sharing or matching is required.
In terms of budget and awards, NHLBI anticipated committing about $1.5 million in total costs for FY2010, with a program ceiling of up to $18.5 million in total costs across a five-year project period. The agency planned to make awards for up to five CRCs plus one DCC, reflecting the intent to support both on-the-ground clinical research capacity and centralized coordination and analytics. The announcement was posted March 10, 2009, with an original (and final) closing date of June 2, 2009, and an archive date of July 3, 2009.
Eligibility is broad and includes a wide range of domestic and non-domestic organizations. Eligible applicants include higher education institutions (public, state-controlled, and private), nonprofits (including those with and without 501(c)(3) status), for-profit organizations (including small businesses), state and local governments, school districts, public housing authorities, and tribal governments and organizations. The eligibility list also explicitly includes entities such as historically Black colleges and universities (HBCUs), Hispanic-serving institutions, tribally controlled colleges and universities (TCCUs), Alaska Native and Native Hawaiian-serving institutions, faith-based or community-based organizations, U.S. territories or possessions, and foreign organizations or other non-U.S. entities, among others. The sponsoring agency is the National Institutes of Health (NIH) through NHLBI, and the full announcement was made available via the NIH Grants Guide (RFA HL 10 007).
Prematurity and Respiratory Outcomes Program (PROP) (U01) - FAQs
1) What is the Prematurity and Respiratory Outcomes Program (PROP)?
PROP is a National Heart, Lung, and Blood Institute (NHLBI) cooperative research initiative focused on improving understanding of why premature newborns are at elevated risk for respiratory disease and translating that knowledge into better outcomes during the first year of life.
2) What is the main scientific focus of this opportunity?
The program centers on molecular mechanisms that drive respiratory vulnerability in preterm infants. Participating teams are expected to move beyond descriptive clinical associations and test clearly defined, biologically grounded hypotheses.
3) What kind of research approach does PROP prioritize?
PROP emphasizes hypothesis-driven research that targets specific mechanisms contributing to respiratory disease risk in preterm infants, rather than studies limited to observational correlations.
4) What role do biomarkers play in PROP?
A central feature of PROP is the development and validation of innovative biomarkers, especially molecular and functional measures.
5) What are the intended uses of biomarkers in this program?
Biomarkers are expected to help: (1) define and stratify specific cohorts of premature infants, (2) predict the severity and trajectory of respiratory outcomes within those cohorts, and (3) potentially serve as surrogate endpoints to evaluate whether risk can be modified through interventions or changes in care.
6) Is PROP designed as independent projects or as a coordinated network?
PROP is structured as a coordinated, multi-site collaborative network rather than a collection of independent projects.
7) What are the major components of the PROP network?
The program includes up to five Clinical Research Centers (CRCs), a Steering Committee for governance and scientific direction, and a Data Coordinating Center (DCC) responsible for network-level data management and coordination.
8) What is expected of a Clinical Research Center (CRC) applicant?
Each CRC is expected to recruit or study a defined cohort and propose a detailed hypothesis about a specific mechanism contributing to respiratory disease risk in preterm infants.
9) What kinds of expertise are CRC applications expected to include?
CRC applications are expected to be multidisciplinary, combining neonatology and pediatric pulmonology with advanced technology expertise such as bioengineering approaches, molecular genetics and genomics, or sophisticated imaging methods.
10) Does NHLBI encourage the multiple principal investigator (multiple PI) model?
Yes. NHLBI strongly encourages the multiple PI model, reflecting the expectation that meaningful progress requires integrated clinical and basic or translational science leadership.
11) What is the funding mechanism for this opportunity?
The opportunity uses a Research Project Cooperative Agreement (U01) mechanism.
12) What does a U01 cooperative agreement imply about NHLBI involvement?
A U01 signals an active partnership between NHLBI and awardees. This typically includes substantial programmatic coordination, shared protocols or common data elements, and network-wide collaboration facilitated through the Steering Committee and the DCC.
13) What is the Funding Opportunity Number for this announcement?
The Funding Opportunity Number is RFA-HL-10-007.
14) What CFDA program is this aligned with?
This opportunity is aligned with CFDA 93.838 (Lung Diseases Research).
15) Is cost sharing or matching required?
No. The announcement specifies that no cost sharing or matching is required.
16) What level of funding was anticipated for FY2010?
NHLBI anticipated committing about $1.5 million in total costs for FY2010.
17) What was the overall program ceiling and project period?
The program ceiling was up to $18.5 million in total costs across a five-year project period.
18) How many awards were planned under this program?
NHLBI planned to make awards for up to five Clinical Research Centers (CRCs) plus one Data Coordinating Center (DCC).
19) Who is the sponsoring agency?
The sponsoring agency is the National Institutes of Health (NIH) through the National Heart, Lung, and Blood Institute (NHLBI).
20) Where was the full announcement published?
The full announcement was made available via the NIH Grants Guide (RFA HL 10 007).
21) When was the announcement posted?
The announcement was posted on March 10, 2009.
22) What was the application closing date?
The original (and final) closing date was June 2, 2009.
23) When was the archive date for this opportunity?
The archive date was July 3, 2009.
24) What types of organizations were eligible to apply?
Eligibility was broad and included a wide range of domestic and non-domestic organizations, such as higher education institutions, nonprofits (with or without 501(c)(3) status), for-profit organizations (including small businesses), and various government entities.
25) Are foreign (non-U.S.) entities eligible?
Yes. The eligibility list explicitly includes foreign organizations and other non-U.S. entities.
26) Are specific institution types explicitly included in the eligibility list?
Yes. The eligibility list explicitly includes categories such as historically Black colleges and universities (HBCUs), Hispanic-serving institutions, tribally controlled colleges and universities (TCCUs), Alaska Native and Native Hawaiian-serving institutions, faith-based or community-based organizations, U.S. territories or possessions, tribal governments and organizations, and others.
27) Is this opportunity described as discretionary funding?
Yes. It is categorized as discretionary funding.
28) What is the core goal of the program in terms of patient impact?
The program aims to translate mechanistic understanding and biomarker development into improved respiratory outcomes for preterm infants during the first year of life.
29) How does the network governance work in PROP?
Governance and scientific direction are overseen by a Steering Committee, with data management and coordination handled by the Data Coordinating Center (DCC).
30) Why does the program emphasize shared protocols and common data elements?
Because PROP is a cooperative, multi-site network, shared protocols or common data elements support coordinated research execution, cross-site consistency, and network-wide collaboration.
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