Opportunity Information: Apply for RFA HL 10 025

  • The National Institutes of Health in the health sector is offering a public funding opportunity titled "Effectiveness Research on Smoking Cessation in Hospitalized Patients Research Coordinating Unit (U01)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.837 Cardiovascular Diseases Research 93.838 Lung Diseases Research.
  • This funding opportunity was created on Nov 16, 2009 and posted on Nov 16, 2009.
  • Applicants must submit their applications by Jan 19, 2010. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • The funding agency has allocated a total of $600,000.00 to eligible and selected applicants.
  • Each selected applicant is eligible to receive up to $400,000.00 in funding.
  • Eligible applicants include: State governments City or township governments Independent school districts Special district governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education Private institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) For profit organizations other than small businesses Native American tribal organizations (other than Federally recognized tribal governments) Small businesses Others (see text field entitled Additional Information on Eligibility for clarification) Public housing authorities/Indian housing authorities County governments.
  • 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) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession.
Apply for RFA HL 10 025

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Opportunity Summary:

The Effectiveness Research on Smoking Cessation in Hospitalized Patients Research Coordinating Unit (U01) opportunity (RFA HL 10 025) is a National Institutes of Health funding announcement led by the National Heart, Lung, and Blood Institute (NHLBI). It is designed to fund a single organization to serve as the central Research Coordinating Unit (RCU) for a set of separately funded primary research sites (PRSs) that will be running effectiveness studies on smoking cessation interventions that begin during a hospital stay and continue after discharge. In other words, this grant is not mainly about running a cessation trial at one hospital; it is about creating the coordination backbone that helps multiple independently operated trials function like a coherent research network.

The larger research program behind this RCU award is tied to a companion funding announcement (RFA HL 10 020) that supports the PRSs. Those PRSs are expected to test how well proven smoking cessation approaches can be translated into real-world hospital workflows and post-discharge care in ways that can be broadly implemented in routine clinical practice. A major emphasis of the PRS studies is practicality and scalability: taking strategies that work in controlled settings and evaluating how they perform when implemented across typical inpatient environments, with continued support once patients leave the hospital. Another key element is economic evaluation, since the PRS projects are expected to assess the cost-effectiveness of the interventions they test. NHLBI, along with the National Institute on Drug Abuse (NIDA) and the National Cancer Institute (NCI), anticipated investing about $21.1 million total over four years to fund roughly five to six PRS awards under the companion announcement, creating the network that the RCU will coordinate.

The RCU itself has a clearly defined support role. While the PRSs will plan, direct, and execute their own studies and will handle their own data management and statistical analyses, the RCU is responsible for the cross-site structure that makes collaboration possible and data sharing usable. The RCU must plan, arrange, and support meetings of a Steering Committee and its subcommittees, with the goal of helping the PRSs align on common measures, methods, and compatible data management procedures. The RCU also supports and coordinates the semiannual meetings of a Data and Safety Monitoring Board (DSMB) appointed by NHLBI, ensuring that oversight activities are organized and consistent across the research program. In addition, the RCU provides the infrastructure needed for data aggregation and data sharing across PRSs, which is essential when multiple independent studies need to contribute to pooled analyses, harmonized reporting, or shared resources.

This funding uses the NIH cooperative agreement mechanism (U01), which typically indicates substantial scientific or programmatic involvement by NIH staff during the life of the award compared with a traditional research project grant. The project period is four years. NHLBI expected to make one RCU award with an estimated total of $600,000 in total costs across the four-year period, and the award was subject to the availability of funds and the receipt of a sufficient number of high-quality applications. The listed award ceiling was $400,000, indicating constraints on how large any single year or total budget request could be, depending on how the ceiling is applied in the announcement materials.

Eligibility for this opportunity was broad and included many types of U.S.-based organizations: state, county, city/township, and special district governments; public housing authorities/Indian housing authorities; federally recognized tribal governments and other tribal organizations; public and private institutions of higher education; nonprofit organizations (with or without 501(c)(3) status); for-profit organizations other than small businesses; small businesses; and other categories described in the full announcement. The eligibility description also explicitly included various mission-focused institutions and organizations 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 and community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions. No cost sharing or matching was required.

Key administrative details reflect that this was a time-limited, archived opportunity. It was posted on November 16, 2009, with an original and current closing date of January 19, 2010, and an archive date of February 19, 2010. The activity category was health, and the listed CFDA numbers aligned with cardiovascular and lung diseases research (93.837 and 93.838). The full announcement was hosted through the NIH grants guide, and contact support for technical access issues was routed to the NIH Office of Extramural Research (OER) webmaster email provided in the notice.

In practical terms, the RCU award was meant for an organization capable of high-quality research coordination: convening committees, facilitating agreement on standardized measures, supporting formal safety and oversight processes through DSMB meeting coordination, and building secure, workable systems for aggregating and sharing data across multiple independent projects. The overall intent was to make sure that the separate PRS trials could generate findings that are comparable, combinable when appropriate, and more useful to clinicians and health systems seeking to implement effective inpatient-to-outpatient smoking cessation programs at scale.

Frequently Asked Questions (FAQ)

What is this funding opportunity?

This opportunity is the "Effectiveness Research on Smoking Cessation in Hospitalized Patients Research Coordinating Unit (U01)" (RFA HL 10 025), a National Institutes of Health (NIH) funding announcement led by the National Heart, Lung, and Blood Institute (NHLBI).

What is the main purpose of the award?

The award is intended to fund one organization to serve as the central Research Coordinating Unit (RCU) for a network of separately funded primary research sites (PRSs) conducting effectiveness studies on smoking cessation interventions that start during hospitalization and continue after discharge.

Is this grant meant to fund a smoking cessation trial at a single hospital?

No. The focus is not primarily on running one cessation trial at one hospital. The focus is building and operating the coordination backbone that helps multiple independently operated PRS trials function as a coherent research network.

Who is leading this NIH opportunity?

NHLBI is the lead institute for this opportunity.

Are other NIH institutes involved in the larger research program?

Yes. The broader PRS network was anticipated to be supported by NHLBI along with the National Institute on Drug Abuse (NIDA) and the National Cancer Institute (NCI).

How does this RCU opportunity relate to other funding announcements?

This RCU award is tied to a companion funding announcement (RFA HL 10 020) that supports the primary research sites (PRSs). The PRSs conduct the individual effectiveness studies; the RCU coordinates cross-site collaboration and shared infrastructure.

What types of interventions are being studied by the primary research sites (PRSs)?

The PRSs are expected to test how well proven smoking cessation approaches can be translated into real-world hospital workflows and post-discharge care, aiming for broad implementation in routine clinical practice.

What is emphasized in the PRS effectiveness studies?

A major emphasis is practicality and scalability, meaning the studies focus on how interventions perform in typical inpatient environments and with continued support after patients leave the hospital.

Is cost-effectiveness part of the overall research program?

Yes. The PRS projects are expected to include economic evaluation, including assessing the cost-effectiveness of the interventions they test.

How many RCU awards were expected?

NHLBI expected to make one RCU award.

What is the project period for the RCU award?

The project period is four years.

What level of funding was anticipated for the RCU?

NHLBI estimated total funding of about $600,000 in total costs across the four-year period for the single RCU award, subject to the availability of funds and receipt of enough high-quality applications.

Was there an award ceiling?

Yes. The listed award ceiling was $400,000, indicating constraints on how large a budget request could be, depending on how the ceiling is applied in the announcement materials.

What mechanism is used for this award?

This opportunity uses the NIH cooperative agreement mechanism (U01), which typically means substantial scientific or programmatic involvement by NIH staff during the life of the award compared with a traditional research project grant.

What does the RCU do if PRSs manage their own studies and analyses?

Even though PRSs plan and execute their own studies and handle their own data management and statistical analyses, the RCU provides the cross-site structure needed for collaboration, alignment on common elements, and usable data sharing across the network.

What committees and meetings must the RCU support?

The RCU must plan, arrange, and support meetings of a Steering Committee and its subcommittees, and also support and coordinate the semiannual meetings of a Data and Safety Monitoring Board (DSMB) appointed by NHLBI.

What is the purpose of the Steering Committee support?

The Steering Committee support is intended to help PRSs align on common measures, methods, and compatible data management procedures so that results across independently run studies can be compared and, when appropriate, combined.

What is the RCU's role regarding the Data and Safety Monitoring Board (DSMB)?

The RCU coordinates the semiannual DSMB meetings (the DSMB is appointed by NHLBI) to help ensure oversight activities are organized and consistent across the research program.

Does the RCU perform the statistical analyses for the PRSs?

No. The PRSs handle their own data management and statistical analyses. The RCU's role is to provide infrastructure for data aggregation and data sharing across PRSs.

What does "data aggregation and data sharing" mean in this context?

It refers to building the infrastructure needed so that multiple independent studies can contribute to pooled analyses, harmonized reporting, or shared resources, and so that cross-site data sharing is workable and usable.

What kind of organization is this award best suited for?

It is best suited for an organization capable of high-quality research coordination, including convening committees, facilitating agreement on standardized measures, supporting formal oversight processes through DSMB meeting coordination, and building secure systems for aggregating and sharing data across multiple independent projects.

Who is eligible to apply?

Eligibility was broad and included many U.S.-based organizations, such as state, county, city/township, and special district governments; public housing authorities/Indian housing authorities; federally recognized tribal governments and other tribal organizations; public and private institutions of higher education; nonprofit organizations (with or without 501(c)(3) status); for-profit organizations other than small businesses; small businesses; and other categories described in the full announcement.

Are specific mission-focused institutions and community organizations included in eligibility?

Yes. The eligibility description explicitly included HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities (TCCUs), Alaska Native and Native Hawaiian serving institutions, faith-based and community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions.

Is cost sharing or matching required?

No. No cost sharing or matching was required.

When was the opportunity posted and when did it close?

It was posted on November 16, 2009. The original and current closing date was January 19, 2010.

Is this opportunity still open?

No. It was a time-limited opportunity and is archived. The archive date was February 19, 2010.

What is the activity category and what CFDA numbers are associated with it?

The activity category was health. The listed CFDA numbers were 93.837 and 93.838.

Where was the full announcement hosted?

The full announcement was hosted through the NIH grants guide.

Who was listed as the contact for technical access issues?

For technical access issues, contact support was routed to the NIH Office of Extramural Research (OER) webmaster email provided in the notice.

How many primary research sites (PRSs) were expected to be funded in the companion program?

NHLBI, along with NIDA and NCI, anticipated investing about $21.1 million total over four years to fund roughly five to six PRS awards under the companion announcement (RFA HL 10 020).

What is the overall goal of coordinating the PRSs through an RCU?

The goal is to ensure that separate PRS trials generate findings that are comparable, combinable when appropriate, and more useful to clinicians and health systems seeking to implement effective inpatient-to-outpatient smoking cessation programs at scale.

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