Sponsor Deadline
Posted: 9/9/2024

Clinical and Translational Science Award (UM1 Clinical Trial Optional)

This Notice of Funding Opportunity announcement (NOFO) invites applications for the Clinical and Translational Science Award (CTSA) Program hubs that will be part of a national, collaborative consortium focused on bringing more treatments to all people more quickly through advancing clinical and translational science (CTS) by (1) developing, demonstrating, and disseminating scientific and operational innovations that improve the efficiency and effectiveness of clinical translation from identification to first-in-human studies to medical practice implementation to community health dissemination; (2) promoting partnerships and collaborations to facilitate and accelerate translational research projects locally, regionally, and nationally; (3) creating, providing, and disseminating innovative research programs and partnerships across institutions and communities to address health disparities and deliver the benefits of translational science to all; (4) creating and implementing scientific and operational innovations that increase the quality, safety, efficiency, effectiveness, and informativeness of clinical research; (5) providing a national resource for the rapid response to urgent public health needs; and (6) creating, providing, and disseminating CTS training for clinical research professionals of all disciplines on the research team.

This NOFO is part of a required set of companion applications: the Clinical and Translational Science Award (UM1) and companion Institutional Career Development Award (K12 – NOT-TR-24-008). The remaining NOFOs in the suite are optional and include the Ruth L. Kirschstein National Research Service Award (NRSA) institutional training programs (T32 predoctoral and T32 postdoctoral – NOT-TR-24-008), the Research Education Grant (R25 – NOT-TR-24-008), and the Specialized Innovation Program (RC2 – PAR-24-054). These optional NOFOs are only available to CTSA Program UM1 applicants and award recipients. Applications to the companion NOFOs cannot be awarded until an award has been issued for the UM1. (See Section III. Eligibility Information of this NOFO and the respective NOFOs for more information).

Deadlines:

  • Letter of Intent Due Date(s): 30 days before the application due date
  • Application Due Dates: March 13, 2025; May 28, 2025; Sep 29, 2025; Jan 28, 2026; May 28, 2026; Sep 28, 2026; Jan 28, 2027; May 28, 2027; Sep 28, 2027

PAR-24-272 Expiration Date September 29, 2027

Eligibility Requirements

The CTSA application may include domestic institutions of higher education, universities, medical research institutions / academic health centers, or non-profit research organizations other than institutions of higher education that conduct clinical and translational research; however, a graduate school accredited to award higher degrees related to clinical or translational science (e.g., M.S. or Ph.D. in topics such as Clinical Research, Public Health, Pharmacology, Nursing, Informatics, Health Economics, or Epidemiology) must be included (applicant or partnering institution). Partnerships are encouraged among various disciplines including medicine, dentistry, nursing, pharmacy, osteopathy, public health, engineering and others. Organizations with active grants funded under NOFOs PAR-15-304, PAR-18-464, PAR-18-940 & PAR-21-293 that have more than 16 months of support remaining on the day of the submission deadline are not eligible to apply. NCATS encourages multiple institutions to participate in a single hub application, where this may further advance the goals of the program. A single contact institution would receive and administer the award.

For the purposes of this NOFO, NIH funding to the Partner/Partnering Institution must be included for determination of maximum direct cost budget requests. Partner/Partnering Institution(s) must be effectively integrated into the proposed activities of the CTSA UM1 hub and are necessary for attaining its strategic goals and research priorities. An organization named as Partner/Partnering Institution in a CTSA UM1 application (and subsequent UM1 award), or a CTSA UL1 award funded previously under PAR-18-940, PAR-18-464, PAR-15-304 or PAR-21-293 may be listed as a Partner with only one UM1 or UL1 unless the UM1 and UL1 are from the same organization.

An organization named as a Partner Institution in a CTSA UM1 application, UM1 award, or a CTSA UL1 award funded previously under PAR-18-940PAR-18-464 or PAR-15-304PAR-21-293 may not apply as an applicant organization to this NOFO under the following scenarios:

  • While the UM1 application or UL1 award on which they are listed as a Partner is under review consideration
  • While the UM1 application or UL1 award on which they are listed as a Partner is under consideration for funding
  • While the UM1 application or UL1 award on which they are listed as a Partner is funded

CTSA UM1 applications from organizations named as a Partner Institution in a funded CTSA UM1 or CTSA UL1 award are not allowed, except under rare circumstances with compelling justification.

A list of partnering institutions of active CTSA UL1/UM1 awards will be updated on an annual basis (by October 1, here: https://ncats.nih.gov/research/research-activities/ctsa/applicant-information/CPUBRT). Applicants are strongly encouraged to verify their budget tier calculation with NCATS in advance of application submission through the CTSA NOFO Questions mailbox (send to: CTSANOFOQuestions@mail.nih.gov). Applicants should list the primary applicant organization and any partner institution(s) that contribute to the budget tier calculation (See Section IV. Application and Submission, R&R Budget). Requests to verify the budget tier calculation should be submitted by the institution’s authorized organization representative. Once NCATS verification is received and recorded, the applicant should include a note in the R&R Budget Section of the application that NCATS has reviewed and accepted the funding calculation prior to submission.

For the required (K12) and optional companion applications (T32s, R25, RC2), only the primary UM1 hub institution is eligible to apply; Partner/Partnering and/or Collaborator/Collaborating institutions are not eligible. Further, the primary institution is limited, if awarded, to one award each for the required and optional companion applications except for the optional RC2 (PAR-24-054) which is limited to two awards per institution.

This NOFO only accepts applications that are part of a collaborative set of multiple applications.

This NOFO is part of a required set of companion applications: the Clinical and Translational Science Award (UM1) and companion institutional research career development (K12 – NOT-TR-24-008). The remaining NOFOs in the suite are optional and include the Ruth L. Kirschstein National Research Service Award (NRSA) institutional training programs (T32 predoctoral and T32 postdoctoral – NOT-TR-24-008), the Research Education Grant (R25 – NOT-TR-24-008), and the Specialized Innovation Program (RC2 – PAR-24-054). These optional NOFOs are only available to CTSA Program UM1 applicants and award recipients. Applications to the companion NOFOs cannot be awarded until an award has been issued for the UM1. Adhering to the submission eligibility below, a set must contain 1 application to this UM1 NOFO and 1 application to the K12 NOFO; it may also contain 1 application to the T32 predoc NOFO, 1 application to T32 postdoc NOFO, 1 application to R25 NOFO, and/or up to 2 applications for the RC2 NOFO.