Opportunity Information: Apply for RFA HL 13 017
Apply for RFA HL 13 017
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Core Clinical Centers for the Cardiothoracic Surgical Trials Network, CTSN (UM1)" 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.
- This funding opportunity was created on Mar 28, 2012 and posted on Mar 28, 2012.
- Applicants must submit their applications by Jun 13, 2012. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities City or township governments Small businesses State governments 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 Private institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments For profit organizations other than small businesses County governments Independent school districts Native American tribal governments (Federally recognized) Others (see text field entitled Additional Information on Eligibility for clarification).
- 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 Non domestic (non U.S.) Entities (Foreign Institutions) are eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:
The NIH funding opportunity RFA-HL-13-017, titled "Core Clinical Centers for the Cardiothoracic Surgical Trials Network, CTSN (UM1)," solicits applications to serve as Core Clinical Centers in the continued operation of the Cardiothoracic Surgical Trials Network (CTSN). This program is structured as a cooperative agreement (UM1), which generally means awardees are expected to work closely with NIH staff and other network partners rather than operating entirely independently. The overall aim is to support a coordinated, multi-site clinical trials infrastructure focused on cardiothoracic surgical research, with an emphasis on conducting complex and often difficult-to-enroll surgical trials in a rigorous and efficient way.
A major focus of the solicitation is the ability of applicant sites to recruit and retain participants for challenging cardiothoracic (CT) surgical trials. Because surgical trials can be particularly demanding in terms of patient eligibility constraints, timing around urgent or elective procedures, informed consent logistics, follow-up demands, and clinician equipoise, the FOA signals that NIH is looking for sites that can bring genuinely innovative, practical strategies to enrollment and long-term follow-up. In addition to new ideas, the FOA clearly values demonstrated performance, seeking applicants with a strong track record in prior trial execution. In practice, that implies an expectation that proposed Core Clinical Centers can reliably deliver on enrollment targets, protocol adherence, high-quality data capture at the clinical site level, and consistent participant follow-up, while also maintaining strong regulatory and operational compliance.
The program sits within NIH's cardiovascular research mission area and is associated with CFDA number 93.837 (Cardiovascular Diseases Research). The opportunity category is discretionary funding, and it does not require cost sharing or matching, lowering the barrier for applicants that may not have non-federal funds to contribute. The announcement was posted March 28, 2012, with an application due date of June 13, 2012, and it was later archived on July 14, 2012, which indicates it is a historical funding announcement rather than an open competition today.
This FOA is specifically for the Core Clinical Centers component of the CTSN, meaning the funded organizations would function as primary clinical trial sites within the network and would be expected to collaborate across the network on study implementation. The announcement notes that a separate solicitation, RFA-HL-13-022, covers the network Data Coordinating Center, underscoring that NIH envisioned a division of labor: Core Clinical Centers conducting on-the-ground clinical activities and a dedicated coordinating center handling network-wide data management and coordination functions. Applicants responding to this FOA would therefore be proposing to lead and perform the clinical site responsibilities rather than the central data coordinating responsibilities.
Eligibility is broad and intentionally inclusive, spanning many types of domestic and international organizations. Eligible applicants include public and private institutions of higher education; nonprofit organizations (including those with and without 501(c)(3) status); small businesses and other for-profit organizations (excluding small businesses only where specified, though the listing includes both categories); and multiple levels of government entities such as state, county, city/township, special district governments, public housing authorities/Indian housing authorities, and independent school districts. The FOA also allows applications from tribal governments (both federally recognized and other than federally recognized) and tribally controlled colleges and universities, as well as regional organizations and U.S. territories or possessions. Importantly, non-U.S. entities are explicitly eligible: foreign institutions may apply, non-domestic components of U.S. organizations are eligible, and foreign components are allowed as defined by the NIH Grants Policy Statement. The eligibility list also highlights a range of mission-focused institution types such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Alaska Native and Native Hawaiian Serving Institutions, and faith-based or community-based organizations, reflecting NIH's general interest in broad participation and potentially in access to diverse patient populations.
From an operational standpoint, a successful Core Clinical Center applicant would be expected to demonstrate the infrastructure and expertise needed to conduct high-quality cardiothoracic surgical trials. That typically includes experienced CT surgical investigators; strong clinical research staffing; robust processes for screening and enrolling surgical patients within tight clinical time windows; institutional capabilities for human subjects protections and regulatory compliance; and systems to ensure protocol fidelity, adverse event reporting, and long-term follow-up. Given the FOA's explicit emphasis on recruitment and retention innovation, applications would likely be strengthened by concrete, field-tested approaches such as streamlined pre-operative screening workflows, integration with surgical scheduling systems, patient navigation and engagement strategies tailored to high-acuity populations, and pragmatic follow-up methods that reduce burden while preserving outcome ascertainment.
The sponsoring agency is the National Institutes of Health (NIH). The announcement provides a link to the full FOA text hosted on the NIH grants site and lists NIH Office of Extramural Research (OER) webmaster contacts for technical access issues or problems linking to the announcement.
FAQs: NIH RFA-HL-13-017 (Core Clinical Centers for the Cardiothoracic Surgical Trials Network, CTSN - UM1)
What is RFA-HL-13-017?
RFA-HL-13-017 is an NIH funding opportunity titled "Core Clinical Centers for the Cardiothoracic Surgical Trials Network, CTSN (UM1)." It solicits applications from organizations that want to serve as Core Clinical Centers supporting the continued operation of the Cardiothoracic Surgical Trials Network (CTSN).
What is the main purpose of this funding opportunity?
The purpose is to support a coordinated, multi-site clinical trials infrastructure focused on cardiothoracic surgical research, with an emphasis on conducting complex and often difficult-to-enroll surgical trials in a rigorous and efficient way.
What type of award mechanism is used?
This opportunity uses a cooperative agreement mechanism (UM1). Under a cooperative agreement, awardees are expected to work closely with NIH staff and other network partners rather than operating entirely independently.
What organizations are expected to do as Core Clinical Centers?
Core Clinical Centers are expected to function as primary clinical trial sites within the CTSN. This includes implementing studies on the ground and collaborating across the network on study implementation.
Is this funding opportunity focused on data coordinating activities?
No. This FOA is specifically for Core Clinical Centers. A separate solicitation, RFA-HL-13-022, covers the network Data Coordinating Center, indicating NIH planned a division of labor between clinical site responsibilities and network-wide data management/coordination functions.
What is the key emphasis for applicants according to the FOA?
A major emphasis is the ability to recruit and retain participants for challenging cardiothoracic surgical trials. The FOA indicates NIH is looking for genuinely innovative, practical strategies for enrollment and long-term follow-up, along with demonstrated performance in prior trial execution.
Why does the FOA emphasize recruitment and retention?
The FOA highlights that surgical trials can be particularly demanding due to patient eligibility constraints, timing around urgent or elective procedures, informed consent logistics, follow-up demands, and clinician equipoise. Because of these challenges, strong and innovative enrollment and retention approaches are viewed as critical.
What kind of prior experience appears to be valued?
The FOA values a strong track record in prior trial execution. This implies an expectation that Core Clinical Centers can reliably deliver on enrollment targets, maintain protocol adherence, capture high-quality data at the clinical site level, and ensure consistent participant follow-up while maintaining regulatory and operational compliance.
Does this opportunity require cost sharing or matching funds?
No. The opportunity does not require cost sharing or matching, which can reduce barriers for applicants that do not have non-federal funds to contribute.
What is the program area and CFDA number associated with this opportunity?
The program is within NIH's cardiovascular research mission area and is associated with CFDA number 93.837 (Cardiovascular Diseases Research).
Who is the sponsoring agency?
The sponsoring agency is the National Institutes of Health (NIH).
What is the opportunity category?
The opportunity category is discretionary funding.
Is this a currently open funding opportunity?
No. The announcement was posted March 28, 2012, had an application due date of June 13, 2012, and was archived on July 14, 2012. That indicates it is a historical funding announcement rather than an open competition today.
Who is eligible to apply?
Eligibility is broad and includes many types of domestic and international organizations. Examples listed include public and private institutions of higher education; nonprofit organizations (with and without 501(c)(3) status); for-profit organizations (including small businesses and other for-profits); and a wide range of government entities.
Are government entities eligible, and which types are mentioned?
Yes. The FOA lists multiple levels of government entities, including state, county, city/township, special district governments, public housing authorities/Indian housing authorities, and independent school districts.
Are tribal entities eligible?
Yes. The FOA allows applications from tribal governments (both federally recognized and other than federally recognized) and from tribally controlled colleges and universities.
Are U.S. territories or possessions eligible?
Yes. The eligibility list includes U.S. territories or possessions and also mentions regional organizations.
Are non-U.S. (foreign) organizations eligible to apply?
Yes. Non-U.S. entities are explicitly eligible. Foreign institutions may apply, non-domestic components of U.S. organizations are eligible, and foreign components are allowed as defined by the NIH Grants Policy Statement.
Does the FOA mention specific types of mission-focused or minority-serving institutions?
Yes. The eligibility list highlights institution types such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Alaska Native and Native Hawaiian Serving Institutions, and faith-based or community-based organizations.
What capabilities would a successful Core Clinical Center typically need to show?
The FOA indicates the need for infrastructure and expertise to conduct high-quality cardiothoracic surgical trials. This typically includes experienced CT surgical investigators, strong clinical research staffing, robust screening and enrollment processes that work within tight clinical time windows, institutional capabilities for human subjects protections and regulatory compliance, and systems supporting protocol fidelity, adverse event reporting, and long-term follow-up.
What kinds of recruitment and follow-up strategies are suggested as potentially strengthening an application?
The FOA emphasizes innovation and practical approaches. Examples described include streamlined pre-operative screening workflows, integration with surgical scheduling systems, patient navigation and engagement strategies tailored to high-acuity populations, and pragmatic follow-up methods that reduce burden while preserving outcome ascertainment.
What kinds of trial execution expectations are implied for funded sites?
Based on the FOA description, sites are expected to meet enrollment targets, adhere to protocols, capture high-quality clinical site data, maintain consistent participant follow-up, and keep strong regulatory and operational compliance.
Where can applicants find the full FOA text or get help accessing it?
The announcement references a link to the full FOA text hosted on the NIH grants site and lists NIH Office of Extramural Research (OER) webmaster contacts for technical access issues or problems linking to the announcement.
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