Opportunity Information: Apply for PAR 16 301
Apply for PAR 16 301
- The HHS-NIH11 in the health sector is offering a public funding opportunity titled "Data Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative U24)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.233, 93.837, 93.838, 93.839, 93.840,.
- This funding opportunity was created on May 31, 2016 and posted on May 31, 2016.
- Applicants must submit their applications by Sep 13, 2019. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- 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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Opportunity Summary:
The grant opportunity titled "Data Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative U24)" (Funding Opportunity Number PAR 16 301) is a National Institutes of Health (NIH) cooperative agreement designed to fund a dedicated Data Coordinating Center (DCC) that will collaborate on investigator-initiated, multi-site clinical trials. The focus is on Phase II and later-stage clinical trials, meaning studies that are generally past early safety exploration and are aimed more at evaluating efficacy, refining dosing or implementation approaches, and generating stronger evidence that can influence clinical practice. To be responsive, the supported trials must align with the mission of the National Heart, Lung, and Blood Institute (NHLBI), which sits within the U.S. Department of Health and Human Services (HHS) and NIH, and the trial must meet NIHs definition of a clinical trial as described in NOT-OD-15-015.
This FOA is specifically about supporting the coordinating infrastructure rather than directly funding the clinical sites themselves. In practical terms, a DCC in a multi-site trial is the hub that makes the study run consistently and credibly across all participating locations. A DCC typically manages core trial data systems, develops or supports the study protocol and manual of operations, coordinates randomization and enrollment tracking, builds and maintains case report forms and databases, runs data quality control, oversees data collection schedules, supports interim monitoring and reporting, and produces the statistical analysis plans and final analyses. Because multi-site trials require uniform procedures across hospitals or clinics, the DCC also commonly helps with training and certification of site staff, ensures adherence to the protocol, supports regulatory documentation and reporting workflows, and prepares materials for oversight bodies like data and safety monitoring boards when applicable. The overall idea behind this FOA is to ensure trials have the professional coordination and data rigor needed for reliable results, especially when multiple institutions are involved.
The funding instrument is a cooperative agreement (U24), which matters because it signals substantial scientific and programmatic involvement by NIH staff compared with a standard research project grant. Under a cooperative agreement, the DCC is expected to work in close partnership with NHLBI and the clinical trial leadership. This collaborative structure is generally used when NIH anticipates ongoing engagement in trial planning, milestone tracking, performance monitoring, and ensuring that the trial operations meet federal standards for participant protections, data integrity, and reporting.
The opportunity is categorized as discretionary funding and sits in the health funding activity category. It is associated with multiple CFDA numbers (93.233, 93.837, 93.838, 93.839, 93.840), reflecting that NHLBI supports a wide range of heart, lung, blood, and sleep related research programs and that awards can map to different assistance listing areas depending on the specific clinical topic. The announcement was posted on May 31, 2016, with a closing date listed as September 13, 2019. No award ceiling, expected number of awards, or similar quantitative award details are provided in the text you supplied, which often means applicants need to consult the full FOA for budget limits, project periods, allowable cost categories, and any caps tied to scope.
Eligibility is broad and includes many types of U.S. organizations that could plausibly operate a DCC. Eligible applicants include state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofits (both with and without 501(c)(3) status); for-profit organizations other than small businesses; and small businesses. The FOA also references an "Others" category with additional eligibility details in the full announcement, which typically covers special cases or clarifies applicant types, partnerships, or consortium arrangements.
Applicants are encouraged to ensure their proposed DCC work is directly tied to NHLBIs mission and priorities, and the notice explicitly points prospective applicants to NHLBIs website for its strategic vision and research priorities. In other words, the DCC is not a general-purpose coordinating center award; it is meant to support concrete, investigator-initiated, multi-site clinical trials that fall squarely within NHLBIs scientific and public health mandate and that meet NIH requirements for what counts as a clinical trial.
Frequently Asked Questions (FAQs)
What is the title of this grant opportunity?
The opportunity is titled "Data Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative U24)."
What is the funding opportunity number (FOA number)?
The funding opportunity number is PAR 16 301.
Which federal agency is offering this opportunity?
This is a National Institutes of Health (NIH) funding opportunity. The focus is tied to the National Heart, Lung, and Blood Institute (NHLBI), which is part of NIH within the U.S. Department of Health and Human Services (HHS).
What is the purpose of this FOA?
The purpose is to fund a dedicated Data Coordinating Center (DCC) that collaborates on investigator-initiated, multi-site clinical trials. The emphasis is on providing the coordinating infrastructure that helps a multi-site trial operate consistently and produce credible, high-quality data and analyses.
What is being funded: the clinical trial sites or the coordinating center?
This FOA is specifically about supporting the coordinating infrastructure (the DCC), rather than directly funding the clinical sites themselves.
What kinds of clinical trials are targeted by this FOA?
The FOA focuses on Phase II and later-stage clinical trials. These are studies generally beyond early safety exploration and aimed more at evaluating efficacy, refining dosing or implementation approaches, and generating stronger evidence that can influence clinical practice.
Do supported trials need to align with a specific institute mission?
Yes. To be responsive, the supported trials must align with the mission of NHLBI (heart, lung, blood, and sleep related research areas) and should reflect NHLBI priorities as described in its strategic vision and research priorities.
Does the proposed study need to meet NIH's definition of a clinical trial?
Yes. The trial must meet NIH's definition of a clinical trial as described in NIH notice NOT-OD-15-015.
What is a Data Coordinating Center (DCC) in the context of a multi-site trial?
A DCC is the operational and data "hub" for a multi-site clinical trial. It helps ensure the study runs consistently across participating locations and that data are collected, managed, and analyzed in a way that supports reliable results.
What types of responsibilities can a DCC cover under this FOA?
Based on the description provided, a DCC typically supports activities such as:
- Managing core trial data systems
- Developing or supporting the study protocol and the manual of operations
- Coordinating randomization and enrollment tracking
- Building and maintaining case report forms (CRFs) and databases
- Running data quality control and overseeing data consistency across sites
- Overseeing data collection schedules and operational reporting
- Supporting interim monitoring and reporting
- Preparing statistical analysis plans and conducting final analyses
- Helping with training and certification of site staff to maintain uniform procedures
- Supporting regulatory documentation and reporting workflows
- Preparing materials for oversight bodies such as data and safety monitoring boards (when applicable)
What is the funding instrument used for this opportunity?
The funding instrument is a cooperative agreement (U24).
What does it mean that this award is a cooperative agreement (U24)?
A cooperative agreement indicates substantial scientific and programmatic involvement by NIH staff compared with a standard research project grant. Under this structure, the DCC is expected to work in close partnership with NHLBI and the clinical trial leadership, with ongoing engagement in areas such as planning, milestone tracking, performance monitoring, and ensuring compliance with federal expectations for participant protections, data integrity, and reporting.
Is this considered discretionary funding, and what is the funding activity category?
Yes. The opportunity is categorized as discretionary funding, and it falls under the health funding activity category.
Which CFDA (Assistance Listing) numbers are associated with this FOA?
The opportunity is associated with multiple CFDA numbers: 93.233, 93.837, 93.838, 93.839, and 93.840.
Why are there multiple CFDA numbers tied to the same FOA?
The multiple CFDA numbers reflect that NHLBI supports a wide range of heart, lung, blood, and sleep related research programs, and awards may map to different assistance listing areas depending on the specific clinical topic.
When was this FOA posted, and what is the listed closing date?
The announcement was posted on May 31, 2016, and the closing date listed is September 13, 2019.
Are there published award ceilings, expected numbers of awards, or other quantitative award details in the provided text?
No. The information provided does not include an award ceiling, an expected number of awards, or similar quantitative award details.
If budget limits or project period details are not included here, where are they typically found?
When those details are not included in a summary, they are typically provided in the full FOA, including information on budget limits, project periods, allowable cost categories, and any caps tied to scope.
Who is eligible to apply for this opportunity?
Eligibility is broad and includes many U.S. organization types that could plausibly operate a DCC, including:
- State governments
- County governments
- City or township governments
- Special district governments
- Independent school districts
- Public and state-controlled institutions of higher education
- Private institutions of higher education
- Federally recognized Native American tribal governments
- Other Native American tribal organizations
- Public housing authorities/Indian housing authorities
- Nonprofits with 501(c)(3) status
- Nonprofits without 501(c)(3) status
- For-profit organizations other than small businesses
- Small businesses
What does the FOA mean by an "Others" eligibility category?
The FOA references an "Others" category with additional eligibility details in the full announcement. This typically covers special cases or clarifies applicant types, partnerships, or consortium arrangements, but the specific details are not included in the text provided here.
Is this DCC award intended to be a general-purpose coordinating center?
No. The description emphasizes that it is not a general-purpose coordinating center award. It is intended to support concrete, investigator-initiated, multi-site clinical trials that fall within NHLBI's scientific and public health mandate and meet NIH requirements for a clinical trial.
What is the main reason NIH would fund a DCC for a multi-site trial?
The stated rationale is to ensure trials have professional coordination and data rigor needed for reliable results, especially when multiple institutions are involved and uniform procedures are required across hospitals or clinics.
What kinds of NIH involvement should applicants expect under this FOA?
Because it is a cooperative agreement, applicants should expect close collaboration with NHLBI and trial leadership, including NIH engagement in trial planning, milestone tracking, performance monitoring, and oversight expectations related to participant protections, data integrity, and reporting.
How should applicants think about responsiveness to NHLBI priorities when proposing a DCC?
Applicants are encouraged to ensure the proposed DCC work is directly tied to NHLBI's mission and priorities, and the FOA points prospective applicants to NHLBI's strategic vision and research priorities as the guideposts for alignment.
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