Opportunity Information: Apply for RFA RM 09 019
Apply for RFA RM 09 019
- The National Institutes of Health in the education health sector is offering a public funding opportunity titled "Institutional Clinical and Translational Science Award (U54)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.310 Trans NIH Research Support 93.389 National Center for Research Resources.
- This funding opportunity was created on Aug 27, 2009 and posted on Aug 27, 2009.
- Applicants must submit their applications by Jun 1, 2010. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $116,000,000.00 to eligible and selected applicants.
- Eligible applicants include: Public and State controlled institutions of higher education Private institutions of higher education.
- Other Eligible Applicants include the following This FOA is limited to current Clinical and Translational Science Award (CTSA) awardees and current or new collaborators. Because the Institutional CTSA program is focused on the development of a rigorous and robust academic discipline of clinical and translational science, the applicant institution(s) must include a graduate school accredited to award higher degrees in clinical research. Examples of acceptable higher degrees include MS and PhD in topics such as Clinical Research, Public Health, Pharmacology, Nursing and Epidemiology. Partnerships among schools of medicine, dentistry, nursing, pharmacy, osteopathy, public health, engineering and other clinically related institutions are strongly encouraged, as is the inclusion of other relevant clinical research entities and organizations. The CTSA is expected to form an integrated institutional home that includes faculty committed to developing the discipline of clinical and translational science that will transcend multiple departments, schools, clinical and research institutes and hospitals. Therefore, an institution may submit only a single application in response to this FOA. Multiple applications from different divisions, faculties, centers, schools, etc. of the same university or medical school will be returned without further consideration by the NIH. Potential applicants whose existing and long term affiliations will be disrupted by this rule must contact NIH Program Staff to determine whether they may be eligible for a waiver of the restriction. Foreign institutions are not allowed to apply for this program. Domestic institutions may use CTSA resources to support the foreign activities of projects that receive primary funding from DHHS. These activities are permitted under the UL1 and KL2 components of the CTSA only and may not include the pre doctoral TL1 component. Appropriate clearances, a mentoring plan for any foreign training and approval by NIH Program Staff are required before the use of CTSA resources begins. Applications from ineligible institutions will not be reviewed. Applicants are encouraged to demonstrate significant institutional commitment when it is offered.
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Opportunity Summary:
The Institutional Clinical and Translational Science Award (U54) funding opportunity (RFA-RM-09-019) is an NIH cooperative agreement designed specifically for institutions that already hold a Clinical and Translational Science Award (CTSA). Its core goal is to help these established CTSA sites further build out and refine the institutional environment needed to sustain clinical and translational science as a rigorous, distinct academic discipline. Rather than treating translational research support as a collection of separate services, the program pushes awardees to strengthen an integrated institutional "home" for the field, with the expectation that this home coordinates people, infrastructure, training, and leadership across multiple parts of an academic health system.
A central theme of the announcement is flexibility paired with discipline-building. NIH intends for the U54 resources to give CTSA institutions room to reconfigure and develop their existing assets, talent, and organizational structures to improve the safety, efficiency, quality, and speed of clinical and translational research. The academic home for clinical and translational science may be organized as a center, department, or institute, but it is expected to function as a hub that connects and influences multiple departments, schools, research institutes, and hospitals. Importantly, this home is not just administrative; it should include faculty who conduct original research, create and deliver graduate and postgraduate curricula, and lead institution-wide programs that knit together clinical and translational efforts across the broader enterprise.
The mechanism is a Specialized Center Cooperative Agreement (U54), which typically implies a more substantial level of NIH involvement than a standard grant. In practical terms, applicants should expect an ongoing partnership structure with NIH, consistent with cooperative agreements, where federal program staff may play an active role in coordination, expectations, and oversight relative to a traditional investigator-initiated award.
In terms of funding scale and competitiveness, NIH projected approximately $116 million in total funding available for new awards under this solicitation, with up to 12 awards anticipated. The notice also signals an intent to run similar solicitations annually for new CTSAs and competing renewals, suggesting a continuing program cadence rather than a one-time investment. Award sizes were expected to vary across institutions, largely because many CTSA proposals reflect consolidation of multiple pre-existing institutional programs and capabilities into a unified CTSA structure. The announcement indicates that annual total cost caps or targets were communicated directly to potential applicants and could be confirmed by contacting NCRR program staff, meaning budgets were not entirely open-ended and were managed with institution-specific expectations.
Eligibility is tightly constrained. Only current CTSA awardees and their current or new collaborators are eligible, and foreign institutions are explicitly not allowed to apply. The applicant institution (or consortium) must include a graduate school accredited to award higher degrees in clinical research or closely related areas, with examples including MS or PhD programs in Clinical Research, Public Health, Pharmacology, Nursing, and Epidemiology. NIH strongly encourages broad partnerships across health-professional and clinically relevant schools (medicine, dentistry, nursing, pharmacy, osteopathy, public health, engineering, and others) and the inclusion of other relevant clinical research entities. This reflects the translational mission: moving discoveries across disciplines and settings requires a campus-wide and health-system-wide structure rather than a narrow departmental footprint.
A notable administrative constraint is the one-application-per-institution rule. Because the program is intended to create a single integrated institutional home for the discipline, an institution may submit only one application in response to the FOA. Separate submissions from different divisions, centers, schools, or similar units within the same university or medical school would be returned without review. Institutions anticipating disruptions to existing or long-term affiliations due to this rule were directed to contact NIH program staff to discuss whether a waiver might be possible, but the default expectation is a unified, institutionally coordinated application.
Cost sharing is not required. The FOA does, however, encourage applicants to demonstrate meaningful institutional commitment when it is offered, which commonly means showing how the institution will support the program through leadership support, protected time, space, matching resources, or long-term sustainability plans even when formal cost sharing is not mandated.
The opportunity was posted August 27, 2009, with an original and current closing date of June 1, 2010, and an archive date of July 2, 2010. The sponsoring agency is NIH (with program references to NCRR, reflecting the organizational structure at the time). The funding activity category is listed under education and health, and the CFDA numbers associated include 93.310 (Trans-NIH Research Support) and 93.389 (National Center for Research Resources), aligning the program with broad NIH research infrastructure and capacity-building aims.
Finally, while foreign institutions cannot apply, the announcement allows domestic awardees to use certain CTSA resources to support foreign activities only under specific CTSA components and conditions. Foreign activities are permitted under the UL1 and KL2 components (and not the predoctoral TL1 component), must relate to projects primarily funded by DHHS, and require appropriate clearances, a mentoring plan for any foreign training, and NIH program staff approval before resources can be used. This underscores a controlled approach to international work: allowed when it strengthens DHHS-funded research aims and training, but limited and carefully reviewed.
Frequently Asked Questions (FAQs)
What is the Institutional Clinical and Translational Science Award (U54) opportunity?
It is an NIH cooperative agreement (U54) funding opportunity (RFA-RM-09-019) designed for institutions that already hold a Clinical and Translational Science Award (CTSA). The purpose is to help established CTSA sites strengthen and refine the institutional environment needed to sustain clinical and translational science as a rigorous, distinct academic discipline.
Who is eligible to apply?
Eligibility is limited to current CTSA awardees and their current or new collaborators. Foreign institutions are not allowed to apply.
Can a foreign institution apply or be the applicant organization?
No. Foreign institutions are explicitly not allowed to apply under this opportunity.
What is the main goal of this U54 program?
The core goal is to help CTSA institutions build out and refine an integrated institutional "home" for clinical and translational science, coordinating people, infrastructure, training, and leadership across multiple parts of an academic health system. The program emphasizes discipline-building rather than treating translational research support as a collection of separate services.
What does NIH mean by creating an institutional "home" for clinical and translational science?
The "home" is expected to function as a hub that connects and influences multiple departments, schools, research institutes, and hospitals. It may be organized as a center, department, or institute. It is not intended to be only administrative; it should include faculty conducting original research, delivering graduate and postgraduate curricula, and leading institution-wide programs that integrate clinical and translational efforts.
What funding mechanism is used and what does it imply?
The mechanism is a Specialized Center Cooperative Agreement (U54). Cooperative agreements typically involve substantial NIH involvement compared with standard grants, meaning applicants should expect an ongoing partnership structure with NIH program staff, including coordination, expectations, and oversight.
How much funding was expected to be available and how many awards were anticipated?
NIH projected approximately $116 million in total funding for new awards under this solicitation, with up to 12 awards anticipated.
Were award budgets standardized across institutions?
No. The announcement indicates award sizes were expected to vary across institutions because many proposals consolidate multiple pre-existing institutional programs and capabilities into a unified CTSA structure.
Were there budget caps or targets?
The FOA indicates that annual total cost caps or targets were communicated directly to potential applicants and could be confirmed by contacting NCRR program staff. In other words, budgets were not fully open-ended and were managed with institution-specific expectations.
Is cost sharing required?
No. Cost sharing is not required. However, applicants are encouraged to demonstrate meaningful institutional commitment when offered (for example, through leadership support, protected time, space, matching resources, or sustainability plans).
Is there a limit on how many applications an institution can submit?
Yes. An institution may submit only one application in response to the FOA. The program is intended to create a single integrated institutional home for the discipline.
What happens if different units of the same institution submit separate applications?
Separate submissions from different divisions, centers, schools, or similar units within the same university or medical school would be returned without review.
Are waivers available for the one-application-per-institution rule?
The default expectation is a unified, institutionally coordinated application. However, institutions anticipating disruptions to existing or long-term affiliations due to this rule were directed to contact NIH program staff to discuss whether a waiver might be possible.
Does the applicant institution need a graduate school component?
Yes. The applicant institution (or consortium) must include a graduate school accredited to award higher degrees in clinical research or closely related areas.
What kinds of degree programs satisfy the graduate school requirement?
Examples provided include MS or PhD programs in Clinical Research or related fields such as Public Health, Pharmacology, Nursing, and Epidemiology.
Does NIH encourage partnerships across multiple schools and entities?
Yes. NIH strongly encourages broad partnerships across health-professional and clinically relevant schools (including medicine, dentistry, nursing, pharmacy, osteopathy, public health, engineering, and others) and inclusion of other relevant clinical research entities.
What kinds of improvements is the program trying to drive?
NIH intends for U54 resources to help institutions reconfigure and develop existing assets, talent, and organizational structures to improve the safety, efficiency, quality, and speed of clinical and translational research.
Is this opportunity meant to fund a collection of separate services?
No. A central theme is that translational research support should not be treated as a set of disconnected services. Instead, the program pushes awardees to strengthen an integrated institutional environment and coordinating hub for the field.
Is this a one-time solicitation, or part of an ongoing program?
The notice signals an intent to run similar solicitations annually for new CTSAs and competing renewals, suggesting an ongoing cadence rather than a one-time investment.
What are the key dates for this opportunity?
The opportunity was posted on August 27, 2009. The original and current closing date was June 1, 2010. The archive date was July 2, 2010.
Which agency sponsored the opportunity?
The sponsoring agency is NIH, with program references to NCRR as the organizational structure at the time.
What activity categories and CFDA numbers are associated with this program?
The funding activity category is listed under education and health. The CFDA numbers include 93.310 (Trans-NIH Research Support) and 93.389 (National Center for Research Resources).
Can CTSA resources be used for foreign activities even though foreign institutions cannot apply?
Yes, but only under specific CTSA components and conditions described in the announcement. Foreign activities are permitted under the UL1 and KL2 components (not the predoctoral TL1 component), must relate to projects primarily funded by DHHS, and require appropriate clearances, a mentoring plan for any foreign training, and NIH program staff approval before resources can be used.
Which CTSA components allow foreign activities, and which do not?
Foreign activities are permitted under UL1 and KL2. They are not permitted under the predoctoral TL1 component, based on the conditions described in the announcement.
What approvals or documentation are required for allowable foreign activities?
Allowable foreign activities require appropriate clearances, a mentoring plan for any foreign training, and NIH program staff approval before CTSA resources can be used.
What is the relationship between foreign activities and DHHS funding?
Foreign activities must relate to projects that are primarily funded by DHHS, and they are subject to additional review and approval requirements.
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