Opportunity Information: Apply for PAR 16 300
Apply for PAR 16 300
- The HHS-NIH11 in the health sector is offering a public funding opportunity titled "Clinical Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative UG3/UH3)" 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 Clinical Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative UG3/UH3) opportunity, listed as PAR 16-300, is a National Institutes of Health (NIH) funding announcement from HHS-NIH (NHLBI) that supports the creation and operation of a Clinical Coordinating Center (CCC) for investigator-initiated, multi-site clinical trials. The focus is on Phase II and later-stage clinical trials, and every supported trial must fit the research mission of the National Heart, Lung, and Blood Institute (NHLBI). In addition, proposed studies must meet the NIH definition of a clinical trial as referenced in NOT-OD-15-015, which generally means the work involves prospectively assigning human participants to an intervention to evaluate effects on health-related biomedical or behavioral outcomes.
This program uses a cooperative agreement mechanism (UG3/UH3), which typically signals a more hands-on partnership with NIH compared to standard research grants. In practical terms, applicants should expect substantial NIH scientific or programmatic involvement during both the planning/start-up stage and the later implementation stage. The UG3/UH3 structure is commonly designed as a phased approach: an initial phase is used to complete critical preparatory activities and demonstrate readiness, followed by a subsequent phase that supports full execution once pre-specified milestones are met. For a clinical coordinating center, that usually aligns with building the operational foundation first (protocol finalization support, site start-up systems, manuals of procedures, data flow plans, training, regulatory workflows), then moving into active coordination while the trial is enrolling, delivering interventions, collecting data, and following participants.
The core purpose of the award is to fund a centralized coordinating hub that can manage and standardize trial operations across multiple study sites. Although the short description does not list specific required tasks, a CCC in NIH multi-site trials generally handles functions such as overall trial management, coordination among clinical sites, participant recruitment and retention support, training and certification of site staff, development of study documentation and operational manuals, monitoring study performance and protocol adherence, regulatory and safety coordination (often in collaboration with safety oversight entities), communication infrastructure for investigators and sites, and high-quality trial conduct consistent with Good Clinical Practice expectations. Because the FOA is specifically aimed at investigator-initiated trials, the coordinating center is meant to enable researchers to run complex, multi-site trials by providing the operational backbone needed to implement the protocol consistently and efficiently across locations.
The announcement is categorized under the Health funding activity area and is tied to multiple CFDA numbers (93.233, 93.837, 93.838, 93.839, 93.840), reflecting NHLBI program areas and the broader NIH assistance listing structure. The eligible applicant pool is broad and includes many types of domestic organizations: state, county, and local 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 and other eligible tribal organizations; public housing/Indian housing authorities; nonprofit organizations with and without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories as stated); for-profit organizations other than small businesses; and small businesses. The eligibility text also references an “Others” category, indicating there may be additional clarifications in the full FOA.
The opportunity was created and posted on May 31, 2016, with an application closing date of September 13, 2019 (both original and current closing dates shown as the same). The listing does not provide an award ceiling amount or the expected number of awards in the excerpt provided, which means applicants would need to consult the full FOA for budget guidance, limits, and anticipated award volume if those details were specified elsewhere.
Finally, because the trials must align with NHLBI’s mission and priorities, applicants are directed to consult the NHLBI website for up-to-date strategic vision and research priority areas. In effect, a competitive application would not only describe strong coordinating center capabilities and an operational plan suitable for multi-site Phase II+ trials, but would also clearly justify why the supported trial(s) fall squarely within NHLBI’s heart, lung, blood, and sleep-related research mission and meet NIH’s clinical trial policy requirements.
Frequently Asked Questions (FAQs)
What is the name and identifier of this funding opportunity?
The opportunity is titled "Clinical Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative UG3/UH3)" and is listed as PAR 16-300.
Which agency is offering this opportunity?
This is a National Institutes of Health (NIH) funding announcement from HHS-NIH, specifically associated with the National Heart, Lung, and Blood Institute (NHLBI).
What is the main purpose of this award?
The purpose is to support the creation and operation of a centralized Clinical Coordinating Center (CCC) that provides the operational backbone for investigator-initiated, multi-site clinical trials. The CCC is intended to help standardize and manage trial operations across multiple study sites.
What kind of research does this program support?
The program is focused on Phase II and later-stage, investigator-initiated, multi-site clinical trials, and each supported trial must fit within the NHLBI research mission (heart, lung, blood, and sleep-related research areas).
Do proposed studies need to meet the NIH definition of a clinical trial?
Yes. Proposed studies must meet the NIH definition of a clinical trial as referenced in NOT-OD-15-015, which generally involves prospectively assigning human participants to an intervention to evaluate effects on health-related biomedical or behavioral outcomes.
What funding mechanism is used (grant type)?
This program uses a cooperative agreement mechanism (UG3/UH3), which typically involves substantial NIH scientific or programmatic involvement compared to standard research grants.
What does the UG3/UH3 phased structure mean for applicants?
The UG3/UH3 structure is described as a phased approach. An initial phase supports critical planning and start-up activities and demonstrating readiness, and a later phase supports full implementation once pre-specified milestones are met.
What kinds of activities might be included in the UG3 (planning/start-up) phase for a CCC?
Based on the description, the start-up phase often aligns with building operational foundations such as supporting protocol finalization, putting site start-up systems in place, developing manuals of procedures, planning data flow, training, and establishing regulatory workflows.
What kinds of activities might be included in the UH3 (implementation) phase for a CCC?
The implementation phase generally corresponds to active coordination while the trial is enrolling participants, delivering interventions, collecting data, and following participants, with the CCC managing and standardizing operations across the sites.
What are typical responsibilities of a Clinical Coordinating Center (CCC) in an NIH multi-site trial?
While the excerpt does not list mandatory tasks, it notes that a CCC in NIH multi-site trials generally handles functions such as overall trial management; coordination among clinical sites; participant recruitment and retention support; training and certification of site staff; development of study documentation and operational manuals; monitoring study performance and protocol adherence; regulatory and safety coordination (often in collaboration with safety oversight entities); communication infrastructure for investigators and sites; and supporting high-quality trial conduct consistent with Good Clinical Practice expectations.
Is this opportunity intended for investigator-initiated trials or institute-led trials?
It is specifically aimed at investigator-initiated trials. The CCC is intended to enable researchers to run complex, multi-site trials by providing centralized operational support.
What is meant by “cooperative agreement” in this context?
The description indicates that applicants should expect substantial NIH scientific or programmatic involvement during both the planning/start-up stage and the implementation stage, reflecting a more hands-on partnership model than a typical research grant.
What is the funding activity area?
The announcement is categorized under the Health funding activity area.
Which CFDA numbers are associated with this listing?
The listing references multiple CFDA numbers: 93.233, 93.837, 93.838, 93.839, and 93.840.
Who is eligible to apply?
The eligible applicant pool described is broad and includes many types of domestic organizations, 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 eligible Native American tribal organizations
- Public housing/Indian housing authorities
- Nonprofit organizations with 501(c)(3) status (excluding institutions of higher education in that nonprofit category as stated)
- Nonprofit organizations without 501(c)(3) status (excluding institutions of higher education in that nonprofit category as stated)
- For-profit organizations other than small businesses
- Small businesses
Does the listing mention any additional eligibility category?
Yes. The eligibility text references an “Others” category, indicating there may be additional clarifications in the full FOA.
When was the opportunity created and posted?
The opportunity was created and posted on May 31, 2016.
What is the application closing date?
The application closing date shown is September 13, 2019 (the excerpt indicates both the original and current closing dates are the same).
Does the excerpt provide an award ceiling or the expected number of awards?
No. The excerpt does not provide an award ceiling amount or the expected number of awards. Budget limits, guidance, and anticipated award volume (if available) would need to be checked in the full FOA.
How important is alignment with NHLBI’s mission and priorities?
Alignment is central. The description emphasizes that every supported trial must fit the NHLBI mission and that applicants are directed to consult the NHLBI website for up-to-date strategic vision and research priority areas.
What does a competitive application generally need to demonstrate, based on this excerpt?
Based on the information provided, a competitive application would be expected to clearly present strong coordinating center capabilities and an operational plan suitable for multi-site Phase II and later-stage trials, and it would need to justify that the supported trial(s) fall within NHLBI’s mission areas and comply with NIH clinical trial policy requirements.
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