Opportunity Information: Apply for RFA HL 12 016
Apply for RFA HL 12 016
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Clinical Trials Development Resource for Hematologic Disorders (U24)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.839 Blood Diseases and Resources Research.
- This funding opportunity was created on May 2, 2011 and posted on May 2, 2011.
- Applicants must submit their applications by Oct 13, 2011. (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 $300,000.00 in funding.
- Eligible applicants include: Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses City or township governments Native American tribal organizations (other than Federally recognized tribal governments) For profit organizations other than small businesses State governments County governments Independent school districts Private institutions of higher education Special district governments Public and State controlled 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) 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 Organizations) are not eligible to apply. Foreign (non U.S.) components of U.S. Organizations are allowed.
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Opportunity Summary:
The Clinical Trials Development Resource for Hematologic Disorders (U24) funding opportunity (RFA-HL-12-016) was a National Heart, Lung, and Blood Institute (NHLBI) cooperative agreement intended to build a centralized, ready-to-use support resource that investigators could tap while designing and preparing multi-site clinical trials in hematologic (blood) disorders. Instead of directly funding the execution of large trials, this program focused on strengthening the front-end development work that determines whether a complex trial is feasible, well designed, and operationally sound. The core goal was to provide a structured "consultant resource" made up of experienced clinical trial experts who could advise awardees supported under two specific NHLBI mechanisms: the Clinical Trials Planning Studies for Rare Thrombotic and Hemostatic Disorders (U34; RFA-HL-12-023) and the NHLBI Clinical Trial Pilot Studies (R34; PAR-10-005). In practice, this meant the U24 awardee would function as an expert hub, helping multiple independent research teams refine protocols and trial operations so their proposed multi-site studies were more likely to launch successfully and produce reliable, interpretable results.
The activity category was health, under CFDA 93.839 (Blood Diseases and Resources), and the funding instrument was a cooperative agreement. That cooperative structure matters because it signals an active partnership with NHLBI rather than a hands-off grant: the institute typically expects substantial involvement in planning, coordination, and oversight to ensure the resource aligns with NHLBI priorities and effectively serves the trial-planning community it is meant to support. The opportunity explicitly encouraged applications from academic institutions, especially those with established clinical trial infrastructure such as Clinical Trial Units, Schools of Public Health, and Clinical and/or Translational Science Awards (CTSA) programs. The emphasis on these environments reflects the need for mature operational capacity and real-world experience with multi-site trials, including project management, biostatistics, clinical operations, regulatory navigation, and data systems.
In terms of what the resource was supposed to deliver, the FOA framed it as access to expert consultants who could assist investigators with the complex building blocks of trial development. While the announcement text provided here does not list every service line, the intent is clear: support the technical and operational planning steps that commonly limit multi-site hematology trials, particularly in rare thrombotic and hemostatic disorders where recruitment, endpoint selection, and harmonizing practices across sites can be difficult. A resource like this typically helps investigators troubleshoot study design issues, strengthen feasibility assessments, refine eligibility criteria, improve recruitment and retention strategies, standardize outcome definitions, plan data and safety monitoring approaches, and ensure that the protocol, statistical plan, and operations are aligned with multi-site realities. The overall value proposition is to reduce avoidable trial start-up failures and improve the quality and consistency of trial planning so that promising concepts can move efficiently from planning and pilot phases into fully powered multi-site studies when appropriate.
Eligibility was broad across U.S.-based organizations, spanning public and private institutions of higher education, nonprofits (including 501(c)(3) and certain non-501(c)(3) entities), small businesses, for-profit organizations other than small businesses, and various units of local, county, state, and tribal governments, along with specific categories such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian Serving Institutions, faith-based or community-based organizations, regional organizations, and U.S. territories or possessions. Non-U.S. entities were not eligible to apply, although foreign components of U.S. organizations were allowed. There was no cost sharing or matching requirement, which lowered barriers for institutions that might otherwise struggle to contribute significant non-federal funds.
Key administrative details include a posted and created date of May 2, 2011, an original and current closing date of October 13, 2011, and an archive date of November 13, 2011, indicating that this was a time-limited, now-archived solicitation. The listed award ceiling was $300,000, suggesting a modest budget designed to support a consultative and coordinating resource rather than a large operational trial network. For applicants and users, the full announcement was hosted on the NIH Grants Guide, and technical access issues were routed to the NIH Office of Extramural Research (OER) webmaster contact provided in the listing.
Frequently Asked Questions (FAQs)
What is the Clinical Trials Development Resource for Hematologic Disorders (U24)?
It was an NHLBI cooperative agreement (U24) designed to build a centralized, ready-to-use support resource that investigators could use while designing and preparing multi-site clinical trials in hematologic (blood) disorders. The focus was on strengthening the early development and planning work that helps determine whether a complex clinical trial is feasible, well designed, and operationally sound.
What was the main purpose of this funding opportunity?
The main purpose was to create an expert "consultant resource" (a hub of clinical trial experts) that could advise and support investigators as they plan and prepare multi-site clinical trials in hematologic disorders, with particular relevance to rare thrombotic and hemostatic disorders.
Did this opportunity fund the actual conduct of large clinical trials?
No. This program was not intended to directly fund the execution of large trials. Instead, it focused on front-end development activities such as protocol refinement, feasibility and operational planning, and other preparatory steps that help trials launch successfully and produce interpretable results.
Who was the sponsoring institute?
The opportunity was sponsored by the National Heart, Lung, and Blood Institute (NHLBI).
What is the FOA number for this opportunity?
The FOA number was RFA-HL-12-016.
What kind of award mechanism was used?
The funding instrument was a cooperative agreement, meaning NHLBI typically has substantial involvement in planning, coordination, and oversight to ensure the resource aligns with NHLBI priorities and effectively serves the intended trial-planning community.
What does "cooperative agreement" imply for how the project would operate?
Based on the description provided, it implies an active partnership with NHLBI rather than a hands-off grant. NHLBI involvement would generally be expected in aspects such as planning, coordination, and oversight so the resulting resource meets the goals of supporting multi-site trial development.
What disease and research area did this opportunity fall under?
The activity category was health, and it was aligned with hematologic (blood) disorders, including rare thrombotic and hemostatic disorders.
What CFDA program was associated with this opportunity?
The CFDA listing was 93.839, Blood Diseases and Resources.
Who was intended to use the U24 resource once it was established?
The U24 resource was intended to support investigators who were already funded under two specific NHLBI mechanisms: Clinical Trials Planning Studies for Rare Thrombotic and Hemostatic Disorders (U34; RFA-HL-12-023) and NHLBI Clinical Trial Pilot Studies (R34; PAR-10-005).
Which related NHLBI mechanisms were specifically mentioned as being served by this resource?
The resource was meant to advise awardees supported under (1) U34: Clinical Trials Planning Studies for Rare Thrombotic and Hemostatic Disorders (RFA-HL-12-023) and (2) R34: NHLBI Clinical Trial Pilot Studies (PAR-10-005).
What did the U24 awardee organization actually do in practice?
The U24 awardee would function as an expert hub, helping multiple independent research teams refine protocols and trial operations so their proposed multi-site studies were more likely to launch successfully and yield reliable, interpretable results.
What types of expertise was this centralized resource expected to provide?
The description emphasizes experienced clinical trial experts and mature operational capacity, including real-world multi-site trial experience. Examples of relevant capabilities mentioned include project management, biostatistics, clinical operations, regulatory navigation, and data systems.
What kinds of trial-development support would this resource likely provide?
While the provided text does not list every service line, it indicates support for the technical and operational planning steps that often limit multi-site hematology trials. The description points to assistance such as troubleshooting study design issues, strengthening feasibility assessments, refining eligibility criteria, improving recruitment and retention strategies, standardizing outcome definitions, planning data and safety monitoring approaches, and ensuring the protocol, statistical plan, and operations are aligned with multi-site realities.
Why was this resource especially relevant for rare thrombotic and hemostatic disorders?
The description highlights that in rare thrombotic and hemostatic disorders, challenges like recruitment, endpoint selection, and harmonizing practices across multiple sites can be particularly difficult. The U24 resource was intended to help investigators address these barriers during the planning and preparation phases.
What was the overall value proposition of the program?
The program aimed to reduce avoidable trial start-up failures and improve the quality and consistency of trial planning, helping promising concepts move more efficiently from planning and pilot phases into fully powered multi-site studies when appropriate.
What types of institutions were explicitly encouraged to apply?
Applications were explicitly encouraged from academic institutions, especially those with established clinical trial infrastructure such as Clinical Trial Units, Schools of Public Health, and Clinical and/or Translational Science Awards (CTSA) programs.
Why did the FOA emphasize institutions with established clinical trial infrastructure?
The emphasis reflects the need for mature operational capacity and real-world experience with multi-site trials, including expertise and systems that support project management, biostatistics, clinical operations, regulatory navigation, and data systems.
Who was eligible to apply?
Eligibility was broad across U.S.-based organizations. It included public and private institutions of higher education; nonprofits (including 501(c)(3) and certain non-501(c)(3) entities); small businesses; for-profit organizations other than small businesses; and various units of local, county, state, and tribal governments. It also included specific categories such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian Serving Institutions, faith-based or community-based organizations, regional organizations, and U.S. territories or possessions.
Were non-U.S. organizations eligible to apply?
No. Non-U.S. entities were not eligible to apply. However, foreign components of U.S. organizations were allowed.
Was cost sharing or matching required?
No. There was no cost sharing or matching requirement.
What was the award ceiling?
The listed award ceiling was $300,000, indicating a budget sized to support a consultative and coordinating resource rather than a large clinical trial network.
When was the opportunity posted and when did it close?
The posted/created date was May 2, 2011. The original and current closing date was October 13, 2011.
Is this funding opportunity still open?
No. The listing indicates it was time-limited and is now archived. The archive date was November 13, 2011.
Where was the full announcement hosted?
The full announcement was hosted on the NIH Grants Guide.
Who handled technical access issues related to the announcement?
Technical access issues were routed to the NIH Office of Extramural Research (OER) webmaster contact provided in the listing.
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