Opportunity Information: Apply for RFA HL 24 010
The Blood and Marrow Transplant Clinical Trials Network - Core Clinical Centers (UG1 Clinical Trial Optional) funding opportunity (RFA-HL-24-010) is an NIH cooperative agreement designed to strengthen and operate a coordinated clinical trials network focused on improving hematopoietic cell transplantation (HCT) and related novel cell therapy (CT) strategies. The central aim is to move the field forward for all patients who may benefit from transplant or cellular therapies, with a clear emphasis on populations that are often hardest to study and treat, including people with rare, complex non-malignant blood disorders as well as patients with hematologic cancers. Rather than funding isolated single-site studies, the opportunity is structured to support an organized network capable of running multi-center trials, harmonizing procedures, and generating results that can change clinical practice.
A core feature of the program is the support for key network infrastructure. NIH intends to fund a Data Coordinating Center (DCC) along with multiple core clinical centers. The DCC typically provides the operational backbone for a network: coordinating protocol development and trial operations, managing data systems, ensuring data quality, supporting statistical design and analysis, and helping with regulatory and reporting requirements. The core clinical centers are the frontline sites where patients are enrolled and treated under study protocols, where transplant and cell therapy procedures are performed, and where outcomes are systematically collected over long follow-up periods. In addition to funding the network infrastructure, the initiative also supports a limited number of trials directly under this program, while anticipating that additional studies will be brought into the network through partnerships and co-funding arrangements.
The opportunity explicitly recognizes why transplant and cell therapy trials are unusually challenging to run within standard grant timeframes. Many target diseases are rare, which makes participant accrual slow and can require enrollment windows that extend as long as five years. There are also practical complexities related to cell collection, processing, manufacturing, and distribution, which can introduce delays and require stringent quality and coordination across sites. On top of that, many clinically meaningful endpoints in this space are long-term and sometimes composite measures, such as disease-free survival or chronic graft-versus-host disease (GVHD)-free survival, which may only be evaluable two or more years after transplant. Because of these realities, NIH indicates that a seven-year program period is needed to properly conduct and complete the types of trials this network is meant to support, rather than forcing studies to end before the most important outcomes can be measured.
This is a discretionary NIH funding opportunity using the cooperative agreement mechanism (UG1), which generally means the NIH will have substantial scientific and/or programmatic involvement in how the network operates compared with a traditional research project grant. The "clinical trial optional" label signals that applicants may propose activities that include clinical trials, but a clinical trial is not strictly required for every application; the emphasis is on building and maintaining the capacity to run and support these trials within the network structure.
Eligibility is broad across U.S.-based organizations and government entities. Eligible applicants include state, county, city/township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofits with or without 501(c)(3) status (excluding those that are institutions of higher education in those specific categories); for-profit organizations (other than small businesses) and small businesses; public housing authorities/Indian housing authorities; and federally recognized Native American tribal governments, as well as certain tribal organizations not otherwise classified as federally recognized tribal governments. The announcement also calls out additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions. At the same time, it draws firm limits around foreign involvement: non-U.S. entities are not eligible to apply, non-domestic components of U.S. organizations are not eligible, and foreign components (as NIH defines them in policy) are not allowed under this opportunity.
Administrative details in the source data indicate the sponsoring agency is the National Institutes of Health, with activity falling under education and health categories and CFDA/assistance listings including 93.395 and 93.839. The original closing date listed is October 2, 2023, and an award ceiling of $150,000 is shown in the provided record, though in practice applicants typically confirm current budget guidance and any per-site or per-component limits in the full NIH notice and related budget instructions for network awards. The overall intent remains consistent throughout: create a durable, well-coordinated national clinical trials network that can carry complex HCT and cell therapy studies from design through long-term follow-up, while also serving as a platform for additional trials funded through R01 collaborations, industry partnerships, and foundation support.Apply for RFA HL 24 010
- The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "The Blood and Marrow Transplant Clinical Trials Network - Core Clinical Centers (UG1 Clinical Trial Optional)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.395, 93.839.
- This funding opportunity was created on 2023-06-20.
- Applicants must submit their applications by 2023-10-02. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $150,000.00 in funding.
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.
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Frequently Asked Questions (FAQs)
What is the RFA-HL-24-010 funding opportunity?
RFA-HL-24-010 is an NIH cooperative agreement opportunity titled "The Blood and Marrow Transplant Clinical Trials Network - Core Clinical Centers (UG1 Clinical Trial Optional)." It is designed to strengthen and operate a coordinated clinical trials network focused on improving hematopoietic cell transplantation (HCT) and related novel cell therapy (CT) strategies.
What is the main purpose of this program?
The main purpose is to support an organized national network that can run multi-center clinical studies in HCT and cellular therapies, harmonize procedures across sites, and produce results that can meaningfully change clinical practice. The program emphasizes building durable network capacity rather than funding isolated, single-site studies.
What patient populations and conditions does the program emphasize?
The opportunity places clear emphasis on populations that are often hardest to study and treat, including people with rare, complex non-malignant blood disorders as well as patients with hematologic cancers. The overarching aim is to move the field forward for all patients who may benefit from transplant or cellular therapies.
What makes this opportunity different from a typical single-site clinical research grant?
Instead of supporting standalone studies at one institution, this opportunity supports a coordinated clinical trials network. The network model is intended to enable multi-center trials, shared standards and operating procedures, and consistent long-term outcome collection across participating sites.
What is a UG1 cooperative agreement, and how does it affect NIH involvement?
UG1 is a cooperative agreement mechanism. In general, cooperative agreements involve substantial NIH scientific and/or programmatic involvement in how the supported program operates compared with a traditional research project grant. This structure is commonly used for large, coordinated efforts such as clinical trial networks.
What does "Clinical Trial Optional" mean for applicants?
"Clinical Trial Optional" means an application may include clinical trials, but proposing a clinical trial is not strictly required for every application. The emphasis is on building and maintaining the capacity to run and support trials within the network structure.
What components of the network are expected to be supported?
The program is structured to support key network infrastructure, including a Data Coordinating Center (DCC) and multiple core clinical centers. Core clinical centers are the sites where patients are enrolled and treated under study protocols and where outcomes are collected over long follow-up periods.
What does the Data Coordinating Center (DCC) typically do in a clinical trials network?
The DCC typically provides the operational backbone for a network. Functions described include coordinating protocol development and trial operations, managing data systems, ensuring data quality, supporting statistical design and analysis, and helping with regulatory and reporting requirements.
What do the core clinical centers do?
Core clinical centers serve as the frontline study sites. They enroll and treat patients under network protocols, perform transplant and cell therapy procedures, and systematically collect outcomes, including long-term follow-up data.
Does this program fund clinical trials directly?
Yes, the initiative supports a limited number of trials directly under this program. It also anticipates that additional studies will be brought into the network through partnerships and co-funding arrangements.
How might additional trials be added beyond those directly supported by this program?
The opportunity anticipates additional trials entering the network through partnerships and co-funding, including collaborations supported through R01 mechanisms as well as industry partnerships and foundation support, using the network as a platform for execution.
Why does NIH indicate a longer program period is necessary for these trials?
NIH notes that transplant and cell therapy trials can be unusually challenging to run within standard grant timeframes. Many target diseases are rare, making accrual slow and potentially requiring enrollment windows up to five years. In addition, clinically meaningful endpoints may not be evaluable until two or more years after transplant.
What operational challenges in HCT and cell therapy trials are highlighted?
The opportunity highlights practical complexities related to cell collection, processing, manufacturing, and distribution. These can introduce delays and require stringent quality control and coordination across sites.
What kinds of endpoints or outcomes does the opportunity mention as long-term or complex?
Examples mentioned include long-term and sometimes composite endpoints such as disease-free survival or chronic graft-versus-host disease (GVHD)-free survival. These endpoints may only be evaluable two or more years after transplant.
What is the program period described for this opportunity?
NIH indicates that a seven-year program period is needed to properly conduct and complete the types of trials the network is meant to support, including long enrollment periods and long-term follow-up to capture key outcomes.
Who is eligible to apply?
Eligibility is broad across U.S.-based organizations and government entities. Eligible applicants include various levels of government (state, county, city/township, special district), independent school districts, public and private institutions of higher education, nonprofits (with or without 501(c)(3) status, within the listed categories), for-profit organizations (other than small businesses) and small businesses, public housing authorities/Indian housing authorities, and federally recognized Native American tribal governments, among others listed in the opportunity description.
Are minority-serving institutions and community-based organizations included as eligible applicants?
Yes. The announcement calls out eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), and also includes faith-based or community-based organizations.
Are U.S. territories or possessions eligible?
Yes. The opportunity description includes regional organizations and U.S. territories or possessions among eligible applicant types.
Are foreign organizations eligible to apply?
No. The opportunity states that non-U.S. entities are not eligible to apply.
Can a U.S. organization include a non-domestic component in its application?
No. The opportunity indicates that non-domestic components of U.S. organizations are not eligible under this program.
Are foreign components allowed under NIH definitions and policies?
No. The opportunity states that foreign components (as NIH defines them in policy) are not allowed.
Which federal agency sponsors this opportunity?
The sponsoring agency listed is the National Institutes of Health (NIH).
What categories does the opportunity fall under?
The source data indicates the activity falls under education and health categories.
Are CFDA/assistance listings provided for this opportunity?
Yes. The provided record includes assistance listings 93.395 and 93.839.
What closing date is shown in the provided record?
The original closing date listed in the provided record is October 2, 2023.
What award ceiling is shown in the provided record?
The provided record shows an award ceiling of $150,000. The description also notes that, in practice, applicants typically confirm current budget guidance and any per-site or per-component limits in the full NIH notice and related budget instructions for network awards.
Does the opportunity emphasize building infrastructure in addition to running studies?
Yes. A central feature is support for network infrastructure such as the DCC and core clinical centers, enabling coordinated protocol development, harmonized procedures, consistent data management, and long-term follow-up across multiple sites.
What is the overall intent of the program as described?
The overall intent is to create a durable, well-coordinated national clinical trials network capable of carrying complex HCT and cell therapy studies from design through long-term follow-up, while serving as a platform for additional trials supported through collaborations and partnerships.
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