Opportunity Information: Apply for RFA HL 21 007
The Limited Competition: Sickle Pan-African Research Consortium Clinical Coordinating Center (U24 Clinical Trial Optional) opportunity (RFA-HL-21-007) is a National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI) cooperative agreement designed to keep the Sickle Pan-African Research Consortium (SPARCO) moving forward by funding a single Clinical Coordinating Center (CCC). This is a limited competition specifically seeking an application from the existing SPARCO Hub in Tanzania to continue serving as the coordinating backbone for the next phase of the consortium. The overall purpose is to strengthen and expand a sub-Saharan Africa-wide sickle cell disease research and care infrastructure that can support rigorous epidemiologic, translational, and clinical studies over the long term.
At the center of the FOA is the expectation that the Tanzania-based CCC will coordinate an expanded SPARCO that includes the established sites in Ghana, Nigeria, and Tanzania, while also bringing in up to three additional sites from other sub-Saharan African countries. These coordinated sites, together with the Sickle Africa Data Coordinating Center (SADaCC; referenced separately under RFA-HL-21-008), will collectively form the Sickle Cell Disease in Sub-Saharan Africa (SSA) Network. The network is positioned as a sustainable, shared platform meant to accelerate sickle cell disease research by making it easier to identify patients, track outcomes, compare findings across countries, and support future studies that require consistent data and coordinated operations.
A major deliverable emphasized in the announcement is the expansion of a sickle hemoglobinopathy registry database. The registry is expected to do more than store data; it should enable patient tracking and follow-up across time and across sites, effectively acting as an infrastructure backbone for future investigations. The FOA specifically calls for a practical, well-justified plan that identifies the key database elements to collect and explains how those data will be harmonized across countries and clinical settings. That includes aligning sickle cell disease phenotype definitions, creating or adopting common ontologies, and putting in place consistent approaches so that a diagnosis, complication, treatment exposure, or outcome means the same thing from one site to another. In practice, this is meant to reduce fragmentation and make multi-site analyses and comparisons credible and efficient.
Because this is a cooperative agreement, the CCC is also expected to operate in close coordination with multiple partners and oversight bodies. The FOA highlights integration of consortium activities with the Data Coordinating Center (SADaCC), NHLBI program leadership, the network Steering Committee, and an Observational Study Monitoring Board (OSMB). The CCC is expected to help ensure that governance, study operations, safety and monitoring practices for observational work, data flows, and reporting are all aligned across the network. It also must connect its activities to existing training programs so that the network is not just collecting data, but also building lasting research and clinical capacity in participating countries.
Beyond research coordination, the FOA explicitly includes an implementation and care-improvement dimension. Applicants are expected to describe how they will help develop regionally appropriate standards of sickle cell disease care, reflecting the realities of sub-Saharan African health systems, available diagnostics, medication access, and referral pathways. The CCC is also expected to organize research and clinical skill development activities, which signals that workforce development (training in good clinical practice, research methods, standardized clinical assessment, and study conduct) is part of the intended impact. This focus recognizes that sustainable progress depends on building local expertise and consistent clinical and research practices, not only on funding individual studies.
The CCC role also extends to coordinating the sites so they can design, launch, and run multi-site sickle cell disease cohort studies, including the practical work of developing protocols, supporting site readiness, standardizing procedures, and enabling consistent follow-up over time. In addition to cohort studies, the FOA calls out implementation research focused on preventive and therapeutic practices, meaning the network is expected to evaluate how to effectively deliver and scale interventions in real-world settings, not just whether those interventions work in ideal conditions. Taken together, the CCC is expected to serve as the operational engine that aligns people, processes, data standards, and study execution across a growing African network.
Administratively, this opportunity is categorized as discretionary funding and uses the cooperative agreement funding instrument, reflecting substantial NIH involvement in steering and coordination. The activity area is health (CFDA 93.839). Although the general eligibility list includes a broad range of U.S.-style organizational categories, the FOA text makes clear the competition is limited and is seeking the application from the current SPARCO Hub in Tanzania. The posting indicates an expected single award, with an original closing date of June 8, 2020, and lists an award ceiling of 0 (which generally indicates applicants should refer to the FOA details for budget guidance rather than relying on a fixed cap in the summary field).Apply for RFA HL 21 007
- The Department of Health and Human Services, National Institutes of Health in the health sector is offering a public funding opportunity titled "Limited Competition: Sickle Pan-African Research Consortium Clinical Coordinating Center (U24 Clinical Trial Optional)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.839.
- This funding opportunity was created on Mar 12, 2020.
- Applicants must submit their applications by Jun 08, 2020. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The number of recipients for this funding is limited to 1 candidate(s).
- 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 (see text field entitled Additional Information on Eligibility for clarification).
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FAQs: Limited Competition: Sickle Pan-African Research Consortium Clinical Coordinating Center (U24 Clinical Trial Optional) - RFA-HL-21-007
What is this funding opportunity?
This opportunity is a National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI) cooperative agreement intended to fund a single Clinical Coordinating Center (CCC) to keep the Sickle Pan-African Research Consortium (SPARCO) moving forward into its next phase.
What is the official title and FOA number?
The opportunity is titled "Limited Competition: Sickle Pan-African Research Consortium Clinical Coordinating Center (U24 Clinical Trial Optional)" and the FOA number is RFA-HL-21-007.
Which NIH Institute is sponsoring this FOA?
The FOA is sponsored by NIH's National Heart, Lung, and Blood Institute (NHLBI).
What type of award mechanism is used?
The funding instrument is a cooperative agreement (U24), meaning NHLBI is expected to have substantial involvement in program steering and coordination rather than acting only as a funder.
Is a clinical trial required?
The FOA is "Clinical Trial Optional," which indicates that a clinical trial is not required for this award mechanism based on the title provided.
Who is eligible to apply?
Although general eligibility categories may appear broad in summary listings, the FOA is explicitly described as a limited competition seeking an application from the existing SPARCO Hub in Tanzania.
How many awards are expected?
The posting indicates an expected single award.
What is the overall purpose of the CCC?
The CCC is meant to serve as the coordinating backbone for an expanded SPARCO, strengthening and expanding a sub-Saharan Africa-wide sickle cell disease research and care infrastructure that can support rigorous epidemiologic, translational, and clinical studies over the long term.
What countries and sites are expected to be included in the expanded SPARCO?
The CCC is expected to coordinate the established sites in Ghana, Nigeria, and Tanzania, and to bring in up to three additional sites from other sub-Saharan African countries.
How does SPARCO relate to the Sickle Cell Disease in Sub-Saharan Africa (SSA) Network?
The coordinated SPARCO sites, together with the Sickle Africa Data Coordinating Center (SADaCC, referenced under RFA-HL-21-008), are described as collectively forming the Sickle Cell Disease in Sub-Saharan Africa (SSA) Network.
What is SADaCC and how does it connect to this FOA?
SADaCC is the Sickle Africa Data Coordinating Center and is referenced as a separate component under a different FOA (RFA-HL-21-008). The CCC funded under this FOA is expected to integrate consortium activities with SADaCC to support coordinated operations and shared data goals across the network.
What major deliverable does the FOA emphasize?
A major deliverable is the expansion of a sickle hemoglobinopathy registry database that supports longitudinal patient tracking and follow-up across time and across sites.
What is the expected purpose of the registry database?
The registry is expected to function as more than a data repository. It should enable patient tracking and follow-up across sites and over time, acting as a backbone infrastructure to support future investigations and multi-site analyses.
What does the FOA require regarding data elements and database planning?
The FOA calls for a practical, well-justified plan that identifies key database elements to be collected and explains how those data will be harmonized across countries and clinical settings.
What does "harmonization" mean in the context of this FOA?
Harmonization refers to aligning how sites define and record sickle cell disease phenotypes and related concepts so that diagnoses, complications, treatment exposures, and outcomes are consistently defined and comparable across countries and clinical environments.
Does the FOA address common definitions or ontologies?
Yes. It explicitly includes aligning phenotype definitions and creating or adopting common ontologies so the same clinical and research terms mean the same thing across participating sites.
Why is the FOA focused on consistent definitions across sites?
The stated intent is to reduce fragmentation and make multi-site comparisons and analyses credible and efficient across multiple countries and clinical settings.
What coordinating bodies and oversight partners must the CCC work with?
The CCC is expected to operate in close coordination with SADaCC, NHLBI program leadership, the network Steering Committee, and an Observational Study Monitoring Board (OSMB).
What is the role of the Observational Study Monitoring Board (OSMB) in this structure?
Based on the FOA description, the OSMB is part of the oversight structure for observational work, and the CCC is expected to help ensure safety and monitoring practices for observational studies are aligned across the network.
What governance and operational responsibilities are implied for the CCC?
The CCC is expected to help align governance, study operations, safety and monitoring practices for observational work, data flows, and reporting across the network.
Does the FOA include a training or capacity-building expectation?
Yes. The CCC must connect its activities to existing training programs, and workforce development is described as part of the intended impact, including development of research and clinical skills and consistent practices.
What kinds of skill development activities are mentioned?
The FOA references research and clinical skill development and gives examples in scope such as training in good clinical practice, research methods, standardized clinical assessment, and study conduct.
Is this FOA only about research coordination, or does it include care improvement?
It includes both. Beyond research coordination, it explicitly includes an implementation and care-improvement dimension, including work toward regionally appropriate standards of sickle cell disease care.
What does the FOA mean by "regionally appropriate standards of care"?
It refers to standards that reflect sub-Saharan African health system realities such as available diagnostics, medication access, and referral pathways, rather than assuming identical resources or workflows across all settings.
What kinds of studies is the CCC expected to enable?
The CCC is expected to coordinate sites to design, launch, and run multi-site sickle cell disease cohort studies and to support the practical work needed for multi-site research execution.
What operational work is described for launching multi-site cohort studies?
The FOA mentions developing protocols, supporting site readiness, standardizing procedures, and enabling consistent follow-up over time.
Does the FOA mention implementation research?
Yes. It calls out implementation research focused on preventive and therapeutic practices, with an emphasis on evaluating how to deliver and scale interventions in real-world settings.
What is meant by real-world evaluation of preventive and therapeutic practices?
The FOA frames this as learning how interventions can be effectively delivered and scaled in routine conditions, not only whether they work under ideal or tightly controlled circumstances.
What is the activity area and CFDA listing?
The activity area is health, and the CFDA number listed is 93.839.
Is this considered discretionary funding?
Yes. Administratively, it is categorized as discretionary funding.
What is the application due date shown in the posting?
The posting lists an original closing date of June 8, 2020.
Is there a stated award ceiling?
The posting lists an award ceiling of 0, which typically signals that applicants should rely on the FOA itself for budget guidance rather than a fixed cap shown in the summary field.
What does it mean that the CCC should act as the "operational engine" for the network?
In the FOA's framing, it means aligning people, processes, data standards, and study execution across an expanded, multi-country network so research and care-improvement work can be carried out consistently and efficiently.
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