Opportunity Information: Apply for RFA HL 11 028
Apply for RFA HL 11 028
- The National Institutes of Health in the education health sector is offering a public funding opportunity titled "Blood and Marrow Transplant Clinical Trials Network (BMT CTN) Data Coordinating Center (U10)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.395 Cancer Treatment Research 93.839 Blood Diseases and Resources Research.
- This funding opportunity was created on Aug 11, 2010 and posted on Aug 11, 2010.
- Applicants must submit their applications by Oct 13, 2010. (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 For profit organizations other than small businesses Others (see text field entitled Additional Information on Eligibility for clarification) Nonprofits having a 501(c)(3) status with the IRS, other than 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.
- 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) Tribally Controlled Colleges and Universities (TCCUs) .
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Opportunity Summary:
The Blood and Marrow Transplant Clinical Trials Network (BMT CTN) Data Coordinating Center (DCC) opportunity (Funding Opportunity Number RFA-HL-11-028) is a National Institutes of Health cooperative agreement designed to support the central coordinating hub for a large, multicenter clinical trials network focused on hematopoietic stem cell transplantation (HSCT), also known as blood and marrow transplantation. The program is jointly sponsored by the National Heart, Lung, and Blood Institute (NHLBI) and the National Cancer Institute (NCI). Its overall aim is to improve outcomes for both children and adults undergoing HSCT by enabling efficient, high-quality comparisons of new treatment approaches and management strategies across multiple transplant centers.
This solicitation is an open competition tied to the renewal of an existing network, meaning NIH is seeking applicants to take on (or continue) the role of the single Data Coordinating Center for the next project period. Only one DCC award is expected to be made under this announcement. The DCC is expected to serve as the operational and analytic backbone of the BMT CTN by providing medical and scientific leadership support, statistical expertise, and comprehensive data management services. In practical terms, the DCC would typically be responsible for coordinating protocol implementation across sites, building and managing the trial databases, ensuring data quality and integrity, supporting trial monitoring and reporting, and helping drive analyses and publication-quality results. The announcement also makes clear that the DCC is expected to provide regulatory and operational support, which commonly includes assistance with required clinical trial documentation, compliance processes, and coordination activities that keep multi-site trials running smoothly and consistently.
The funding mechanism is a U10 NIH Cooperative Clinical Research Agreement. A cooperative agreement indicates that this is not a standard, hands-off grant; instead, NIH anticipates substantial scientific and programmatic involvement during the conduct of the project. Applicants should therefore expect ongoing collaboration with NIH staff and alignment with network-wide priorities, timelines, and governance structures typical of large clinical trials networks.
In terms of scale, NHLBI and NCI indicate an intention to commit up to $63.5 million over six years to support the broader BMT CTN program, including up to 19 Core Clinical Centers with HSCT expertise plus the single DCC. While this total covers both the clinical centers and the coordinating infrastructure, the key point for this FOA is that the DCC is a central, network-wide function and only one organization (or leading organization of a consortium, if allowed) will be selected to perform it.
Eligibility is broad and includes public and state-controlled institutions of higher education, private institutions of higher education, nonprofit organizations (including 501(c)(3) and non-501(c)(3) entities), and for-profit organizations other than small businesses. The eligibility language also explicitly notes inclusion of various institution types and community-focused entities, such as Alaska Native and Native Hawaiian Serving Institutions, Hispanic-Serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), eligible federal agencies, and faith-based or community-based organizations, as applicable under NIH rules. There is no cost sharing or matching requirement stated.
Key administrative details from the announcement include a posted date of August 11, 2010, with an original and current closing date of October 13, 2010, and an archive date of November 13, 2010. The CFDA program areas associated with this funding include 93.395 (Cancer Treatment Research) and 93.839 (Blood Diseases and Resources Research). Applicants interested in participating as clinical transplant sites rather than as the DCC are directed to the companion announcement for Core Clinical Centers (RFA-HL-11-013), which outlines the responsibilities for participating transplant centers, while this FOA focuses specifically on the centralized coordinating role.
The full announcement was hosted by NIH and linked in the notice (http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-11-028.html). For access or technical issues, the contact provided is the NIH Office of Extramural Research (OER) Webmaster (FBOWebmaster@OD.NIH.GOV).
Frequently Asked Questions (FAQs)
What is this funding opportunity?
This opportunity is for the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) Data Coordinating Center (DCC) under Funding Opportunity Number (FOA) RFA-HL-11-028. It is a National Institutes of Health (NIH) cooperative agreement to support the central coordinating hub for a large, multicenter clinical trials network focused on hematopoietic stem cell transplantation (HSCT), also known as blood and marrow transplantation.
Which NIH institutes sponsor this program?
The program is jointly sponsored by the National Heart, Lung, and Blood Institute (NHLBI) and the National Cancer Institute (NCI).
What is the overall goal of the BMT CTN program?
The overall aim is to improve outcomes for both children and adults undergoing HSCT by enabling efficient, high-quality comparisons of new treatment approaches and management strategies across multiple transplant centers.
What is being funded specifically under this FOA?
This FOA focuses specifically on selecting a single Data Coordinating Center (DCC) for the BMT CTN. The DCC serves as the operational and analytic backbone of the network.
How many awards will be made?
Only one DCC award is expected to be made under this announcement.
Is this a new program or a renewal?
This solicitation is an open competition tied to the renewal of an existing network. NIH is seeking applicants to take on (or continue) the role of the single DCC for the next project period.
What funding mechanism is used for this award?
The funding mechanism is a U10 NIH Cooperative Clinical Research Agreement.
What does a cooperative agreement (U10) mean in practice?
A cooperative agreement indicates this is not a standard, hands-off grant. NIH anticipates substantial scientific and programmatic involvement during the conduct of the project, so applicants should expect ongoing collaboration with NIH staff and alignment with network-wide priorities, timelines, and governance structures typical of large clinical trials networks.
What are the expected core functions of the Data Coordinating Center (DCC)?
Based on the announcement description, the DCC is expected to provide medical and scientific leadership support, statistical expertise, and comprehensive data management services for the BMT CTN. The DCC typically coordinates protocol implementation across sites, builds and manages trial databases, ensures data quality and integrity, supports trial monitoring and reporting, and helps drive analyses and publication-quality results.
Does the DCC provide regulatory and operational support?
Yes. The announcement states that the DCC is expected to provide regulatory and operational support, which commonly includes assistance with required clinical trial documentation, compliance processes, and coordination activities that keep multi-site trials running smoothly and consistently.
What is the scale of the broader BMT CTN program described in the announcement?
NHLBI and NCI indicate an intention to commit up to $63.5 million over six years to support the broader BMT CTN program, including up to 19 Core Clinical Centers plus the single DCC. This total reflects support for both the clinical centers and the coordinating infrastructure across the network.
Does the $63.5 million figure represent the DCC budget alone?
No. The announcement describes up to $63.5 million over six years for the broader BMT CTN program, which includes the Core Clinical Centers and the coordinating infrastructure (including the DCC). The FOA itself is specifically for the DCC role.
Who is eligible to apply?
Eligibility is broad and includes public and state-controlled institutions of higher education, private institutions of higher education, nonprofit organizations (including 501(c)(3) and non-501(c)(3) entities), and for-profit organizations other than small businesses.
Are specific institution types explicitly included in the eligibility language?
Yes. The eligibility language explicitly notes inclusion of various institution types and community-focused entities, such as Alaska Native and Native Hawaiian Serving Institutions, Hispanic-Serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), eligible federal agencies, and faith-based or community-based organizations, as applicable under NIH rules.
Is cost sharing or matching required?
No cost sharing or matching requirement is stated in the provided announcement summary.
What are the key dates for this FOA?
The posted date is August 11, 2010. The original and current closing date is October 13, 2010. The archive date is November 13, 2010.
What does it mean that the FOA has an archive date?
The archive date (November 13, 2010) indicates the announcement has been archived. The provided details also list the closing date as October 13, 2010.
What are the CFDA program areas associated with this funding?
The CFDA program areas listed are 93.395 (Cancer Treatment Research) and 93.839 (Blood Diseases and Resources Research).
Where can applicants find the full NIH announcement?
The full announcement was hosted by NIH and linked as: http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-11-028.html
Who should apply if they want to participate as a clinical transplant site rather than as the DCC?
Organizations interested in participating as clinical transplant sites (rather than serving as the DCC) are directed to the companion announcement for Core Clinical Centers: RFA-HL-11-013.
What is the relationship between this DCC FOA and the Core Clinical Centers FOA?
This FOA (RFA-HL-11-028) is focused on the centralized coordinating role (the DCC). The companion FOA (RFA-HL-11-013) outlines responsibilities for participating transplant centers as Core Clinical Centers.
What types of trials or clinical focus areas are implied by this network?
The network focus described is hematopoietic stem cell transplantation (HSCT), also known as blood and marrow transplantation, and the conduct of multicenter clinical trials intended to compare new treatment approaches and management strategies to improve outcomes for children and adults undergoing HSCT.
What contact is provided for access or technical issues with the announcement?
For access or technical issues, the contact provided is the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.
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