Opportunity Information: Apply for RFA RM 13 012
Apply for RFA RM 13 012
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIH Health Care Systems Research Collaboratory Demonstration Projects for Pragmatic Clinical Trials Focusing on Multiple Chronic Conditions (UH2/UH3)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.310 Trans NIH Research Support.
- This funding opportunity was created on Aug 7, 2013 and posted on Aug 6, 2013.
- Applicants must submit their applications by Dec 2, 2013. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Special district governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Others (see text field entitled Additional Information on Eligibility for clarification) State governments Independent school districts Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Small businesses County governments Native American tribal governments (Federally recognized) Native American tribal organizations (other than Federally recognized tribal governments) Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities Private 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:
This NIH funding opportunity (RFA-RM-13-012) supports large, real-world pragmatic clinical trial Demonstration Projects that test better ways to manage patients who have multiple chronic conditions. The goal is to generate practical evidence that can be implemented in routine care, rather than tightly controlled studies done in a single clinic or under ideal research conditions. Projects funded under this announcement are required to operate within the NIH Health Care Systems Research Collaboratory, an NIH Common Fund effort designed to help health systems and researchers run efficient, scalable pragmatic trials by sharing methods, tools, and infrastructure.
A key requirement is that each proposed trial must be conducted across at least two or more health care systems (HCS). In other words, the project cannot be limited to one hospital, one clinic network, or one delivery organization. The multi-system requirement is meant to ensure that results are more generalizable, that implementation challenges are addressed in different operational environments, and that the trial demonstrates how evidence can travel across organizational boundaries where patients actually receive care.
The award mechanism is a cooperative agreement using a two-phase UH2/UH3 structure. The first phase (UH2) is a one-year, milestone-driven planning period. During this planning year, teams are expected to do the practical and technical work needed to prove the trial can actually be executed at scale across participating health systems. This typically includes finalizing protocols, confirming data availability and quality within electronic health records or other system data sources, securing health system commitments, ensuring feasible recruitment and workflow integration, addressing human subjects and regulatory planning, and completing any pilot testing needed to demonstrate readiness. The second phase (UH3) is the implementation phase, where the pragmatic trial is carried out. Transition to UH3 is not automatic; it depends on an administrative review confirming that the UH2 milestones and feasibility expectations have been met and that funds are available. Even though the project has two phases, the application must be submitted as a single combined UH2/UH3 application, with applicants following the FOA instructions to clearly lay out plans, milestones, and deliverables for both phases.
From an administrative standpoint, this is a discretionary funding opportunity offered by the National Institutes of Health, categorized under health, and issued as a cooperative agreement. A cooperative agreement generally means NIH will have substantial scientific/programmatic involvement compared with a standard grant, which aligns with the Collaboratory model where projects often coordinate with NIH and Collaboratory cores around trial design, informatics, ethics/regulatory approaches, and dissemination.
Eligibility is broad and includes many types of U.S.-based organizations that can lead or participate in these kinds of system-level clinical trials. Eligible applicants include state, county, city/township, and special district governments; public and private institutions of higher education; nonprofit organizations (including 501(c)(3) and certain non-501(c)(3) nonprofits); for-profit organizations other than small businesses; and small businesses. The FOA also lists a range of other eligible entities such as faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and several categories of minority-serving institutions (for example, HBCUs, Hispanic-serving institutions, AANAPISIs, Alaska Native and Native Hawaiian-serving institutions, and tribally controlled colleges and universities). Foreign institutions are not eligible to apply, and foreign components are not allowed under NIH policy for this announcement.
Timing details in the posting indicate the FOA was posted in early August 2013 with an original and current closing date of December 2, 2013, and it was archived on January 2, 2014. The CFDA listing referenced is 93.310 (Trans-NIH Research Support), and there is no cost-sharing or matching requirement. For further official details, the full announcement was made available through NIH’s grants guide, and NIH provided an Office of Extramural Research (OER) webmaster contact for access and linking issues.
Frequently Asked Questions (FAQs)
What is this funding opportunity?
This is an NIH funding opportunity announcement (FOA) identified as RFA-RM-13-012. It supports large, real-world pragmatic clinical trial Demonstration Projects focused on improving the management of patients with multiple chronic conditions.
What is the main goal of the projects funded under this FOA?
The goal is to generate practical evidence that can be implemented in routine care settings. The emphasis is on real-world, pragmatic trials rather than tightly controlled studies conducted in a single clinic or under ideal research conditions.
What types of studies does this FOA prioritize?
The FOA prioritizes large, real-world pragmatic clinical trials that test better ways to manage patients who have multiple chronic conditions, with an emphasis on approaches that can be scaled and used in everyday health care operations.
Are projects required to be part of any NIH initiative or network?
Yes. Projects funded under this announcement are required to operate within the NIH Health Care Systems Research Collaboratory, an NIH Common Fund effort intended to help health systems and researchers run efficient, scalable pragmatic trials by sharing methods, tools, and infrastructure.
What does it mean to "operate within" the NIH Health Care Systems Research Collaboratory?
Based on the FOA description, operating within the Collaboratory means coordinating with the Collaboratory model of shared methods, tools, and infrastructure, and working in an environment where NIH and Collaboratory resources support pragmatic trial design and execution across health systems.
Is there a minimum number of health care systems required for a proposed trial?
Yes. Each proposed trial must be conducted across at least two or more health care systems (HCS). A single-system project (one hospital, one clinic network, or one delivery organization) does not meet this requirement.
Why does the FOA require trials to include two or more health care systems?
The multi-system requirement is intended to make results more generalizable, address implementation challenges across different operational environments, and demonstrate how evidence can move across organizational boundaries where patients actually receive care.
Can a project be limited to one hospital or one clinic network?
No. The FOA explicitly states the trial cannot be limited to one hospital, one clinic network, or one delivery organization. It must span at least two or more health care systems.
What is the award mechanism used for this opportunity?
The award mechanism is a cooperative agreement using a two-phase UH2/UH3 structure.
What is a cooperative agreement in this context?
This opportunity is issued as a cooperative agreement, which generally means NIH will have substantial scientific and/or programmatic involvement compared with a standard grant. This aligns with the Collaboratory model where projects often coordinate with NIH and Collaboratory cores around areas such as trial design, informatics, ethics and regulatory approaches, and dissemination.
How does the UH2/UH3 two-phase structure work?
The project has two phases: (1) UH2, a one-year, milestone-driven planning period, and (2) UH3, the implementation phase where the pragmatic trial is carried out. The application is submitted as a single combined UH2/UH3 application with plans, milestones, and deliverables for both phases.
How long is the UH2 planning phase?
The UH2 phase is one year and is described as a milestone-driven planning period.
What kinds of activities are expected during the UH2 planning year?
During UH2, teams are expected to complete the practical and technical work needed to show the trial can be executed at scale across participating health systems. The FOA description includes activities such as finalizing protocols, confirming data availability and quality (for example, in electronic health records or other system data sources), securing health system commitments, ensuring feasible recruitment and workflow integration, addressing human subjects and regulatory planning, and completing any pilot testing needed to demonstrate readiness.
Is the transition from UH2 to UH3 automatic?
No. Transition to UH3 is not automatic. It depends on an administrative review confirming that UH2 milestones and feasibility expectations have been met and that funds are available.
What happens during the UH3 phase?
UH3 is the implementation phase, where the pragmatic trial is carried out.
Do applicants submit separate applications for UH2 and UH3?
No. Even though the award has two phases, the FOA requires submission of a single combined UH2/UH3 application. Applicants are expected to clearly lay out plans, milestones, and deliverables for both phases following FOA instructions.
What types of organizations are eligible to apply?
Eligibility is broad and includes many U.S.-based organizations. Eligible applicants include state, county, city/township, and special district governments; public and private institutions of higher education; nonprofit organizations (including 501(c)(3) and certain non-501(c)(3) nonprofits); for-profit organizations other than small businesses; and small businesses.
Are community-based or faith-based organizations eligible?
Yes. The FOA lists faith-based or community-based organizations among eligible entities.
Are U.S. territories or possessions eligible to apply?
Yes. The FOA lists U.S. territories or possessions among eligible entity types.
Are minority-serving institutions included in the eligibility list?
Yes. The FOA includes several categories of minority-serving institutions, including (as examples provided) HBCUs, Hispanic-serving institutions, AANAPISIs, Alaska Native and Native Hawaiian-serving institutions, and tribally controlled colleges and universities.
Are foreign institutions eligible to apply?
No. Foreign institutions are not eligible to apply under this announcement.
Are foreign components allowed?
No. The FOA states that foreign components are not allowed under NIH policy for this announcement.
Is cost-sharing or matching required?
No. The posting indicates there is no cost-sharing or matching requirement.
What is the CFDA number associated with this opportunity?
The CFDA listing referenced is 93.310 (Trans-NIH Research Support).
When was the FOA posted, and what were the relevant dates?
The posting indicates the FOA was posted in early August 2013. The original and current closing date listed is December 2, 2013, and the FOA was archived on January 2, 2014.
Where can applicants find the official announcement details?
The full announcement was made available through NIH's grants guide. The posting also notes an Office of Extramural Research (OER) webmaster contact for access and linking issues.
Which NIH category does this funding opportunity fall under?
Administratively, it is described as a discretionary funding opportunity offered by the National Institutes of Health, categorized under health, and issued as a cooperative agreement.
What is the intended real-world focus of these pragmatic trials?
The FOA emphasizes trials designed to produce evidence that can be implemented in routine care, addressing real operational environments across multiple health care systems rather than a single controlled setting.
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