RFA-DE-27-002: Accelerating Product Excellence in Innovation and for Clinical Adoption (APEx) (U24 Clinical Trial Not Allowed)

RFA-DE-27-002: Accelerating Product Excellence in Innovation and for Clinical Adoption (APEx) (U24 Clinical Trial Not Allowed)

Historical reference

The APEx application window is closed. The official Notice of Funding Opportunity (NOFO) listed one application due date: July 10, 2026, by 5:00 PM local time of the applicant organization. The announcement says that no late applications will be accepted and gives an expiration date of July 11, 2026. As of this page’s review, the official record does not announce a next APEx application cycle. Do not treat this page as an invitation to submit a new application; it is an archive of the closed RFA-DE-27-002 opportunity and its requirements.

The opportunity was issued by the National Institutes of Health through the National Institute of Dental and Craniofacial Research, with the National Eye Institute and National Institute of Arthritis and Musculoskeletal and Skin Diseases listed as participating components. The official full announcement is the primary source for the details below.

At a glance

The official key-date table also records the posted date as May 4, 2026, the earliest submission date as June 10, 2026, scientific merit review in November 2026, advisory council review in January 2027, and an earliest start date in April 2027. Those later dates describe the review and award schedule for the closed submission window; they are not additional application deadlines. The archived page previously treated them as future submission dates, which was incorrect.

What APEx was designed to support

APEx was not a conventional single-project research award. The NOFO sought applications to form one Resource Center (RC) that could support a coordinated group of Interdisciplinary Translational Projects (ITPs). The subject areas included therapeutics, including adult stem-cell-based treatments, sensors, and diagnostics related to tissue engineering and regenerative medicine. The RC was expected to bring together clinical, scientific, industrial, regulatory, and commercialization expertise.

The intended work was product development at a preclinical stage. The announcement describes support for validation, manufacturing, and preclinical testing of promising products, with the goal of moving the strongest projects toward clinical adoption. The stated end point was not the conduct of a clinical trial under this award. Instead, APEx aimed to help products reach a position with regulatory approvals for first-in-human studies, associated clinical study protocols, and synthesis and manufacturing protocols ready for later clinical-trial initiation through an appropriate mechanism.

That distinction matters when reading the title. “Clinical Trial Not Allowed” is a binding scope limitation, not a suggestion to omit a minor form. The NOFO specifically excludes clinical trials and first-in-human clinical studies. It permits human-subject activities that are not NIH-defined clinical trials, but an application needed to make that boundary clear. Discovery research was also described as nonresponsive when the proposed approaches were not sufficiently mature to show significant promise in animal models or other validated human-relevant model systems and readiness to advance toward clinical trials on an APEx-relevant schedule.

Resource Center and ITP expectations

The RC model was the central design requirement. A credible application needed more than a list of unrelated laboratory projects. It needed to explain the scientific and technical focus of the RC, how the RC supported APEx goals, and why the selected ITPs belonged together. The full announcement required a detailed initial cohort of 4–6 ITPs and an expansion plan toward approximately 10 ITPs once the RC was fully operational.

The research strategy needed to describe the RC’s organizational, administrative, and leadership structure. This included evidence of successful collaboration or other indicators that the proposed team could operate the center, including relevant experience interacting with the Food and Drug Administration and shepherding products through regulatory processes. The strategy also needed a rationale for expecting the selected ITPs to produce innovative technologies within the APEx period.

The required project logic was milestone-driven. Applications were expected to define successful outcomes for individual ITPs and for the RC as a whole, explain how the most promising ITPs would receive support, and describe go/no-go decisions for continued ITP support. The announcement also contemplated selecting additional ITPs at later stages of translational development when existing projects exited the program. That structure means the proposal had to explain how portfolio decisions would be made, not merely describe an initial set of experiments.

The RC’s technical and operational resources were also part of the case for support. The required discussion could include standard operating procedures, clinical protocol development, animal-model support with emphasis on large-animal models, human-based new approach methods where feasible, synthesis, quality control, Good Laboratory Practice and Good Manufacturing Practice planning, scale-up protocols, standardization, storage, transportation, and other methods needed to advance products. The purpose of listing these elements was to show that the RC could coordinate a translational path rather than only generate preliminary data.

Eligibility and leadership requirements

The NOFO accepted a broad range of U.S. applicant organizations. Eligible categories included public and private institutions of higher education; nonprofits with or without 501(c)(3) status outside higher education; small businesses and other for-profit organizations; state, county, city or township, special-district, and eligible federal governments; federally recognized and other tribal governments; independent school districts; public housing authorities; tribal organizations; faith-based or community-based organizations; and regional organizations.

The geographic rule was narrower than the organization list. Non-U.S. entities were not eligible to apply. Non-U.S. components of U.S. organizations were also not eligible, and foreign components as defined in the NIH Grants Policy Statement were not allowed. A U.S. lead organization therefore could not use the broad domestic eligibility list as a reason to assume that an international operating component was acceptable.

The PD(s)/PI(s) were required to collectively contribute at least 3 person-months, or 25% FTE, to the program during the funded period. Greater effort was expected when a PD or PI also led an ITP, with the level tied to that project’s needs. This requirement should be read alongside the RC’s administrative burden: leadership had to cover scientific coordination, project selection, progress tracking, collaboration, regulatory planning, and communication with NIH staff.

An applicant organization could submit more than one application when each application was scientifically distinct. NIH would not accept duplicate or highly overlapping applications under review at the same time. The NOFO did not require cost sharing. If an applicant proposed voluntary cost sharing, it had to be clearly identified, described, and justified in the budget justification, with the applicable federal requirements still applying.

Funding and cooperative-agreement structure

The participating NIH components intended to commit an estimated total of $6,000,000 per year to fund one RC and its associated ITPs. An application’s budget was limited to $4,000,000 in direct costs per year and had to reflect the actual needs of the proposed project. The maximum project period was 5 years. These figures describe the award structure in the closed NOFO; they do not guarantee an award amount for any applicant.

The U24 cooperative-agreement mechanism also carried substantial NIH involvement after award. The announcement describes NIH scientific and program staff assisting, guiding, coordinating, and participating in project activities. The recipient would be expected to manage the U24 administratively, cooperate with NIDCR and participating component staff, maintain common standard operating procedures and technical formats for data deposition, support rigor and reproducibility, and adhere to timelines and milestones. NIH staff could monitor the RC and ITPs through progress reports, teleconferences, site visits or discussions, and negotiated project-specific milestones. Continued funding depended on meeting the applicable milestones and maintaining sufficient performance to meet the project aims.

Application process that applied to the closed cycle

The specific application package had to be accessed through NIH ASSIST, Grants.gov Workspace, or an institutional system-to-system solution. The submission options were electronic. Paper applications were not accepted. Applicants had to follow the Research (R) Instructions in the NIH How to Apply – Application Guide together with the program-specific instructions in this NOFO. The Research Strategy section for this opportunity was limited to 30 pages.

Before submission, the applicant organization needed active registrations in the systems named by the NOFO: System for Award Management, including the organization’s Unique Entity Identifier; eRA Commons; and Grants.gov. PD(s)/PI(s) needed eRA Commons accounts and ORCID registration, and the Commons ID had to appear in the Senior/Key Person Profile credentials. The organization had to use the same UEI across its registrations and application. Registration problems were not a valid reason for a late submission.

The electronic workflow had two important verification points. First, the application needed to pass the Grants.gov submission process, including correction of errors by the due date and time. Second, the applicant needed to track the submission in eRA Commons and view it before the deadline to confirm that it was accurate and successfully received. The official instructions recommended submitting early enough to correct errors. For this opportunity, the final cutoff was July 10, 2026 at 5:00 PM local time of the applicant organization, and no late applications were accepted.

Planning checklist for an archived opportunity

Because this cycle is closed and no next round is announced in the official record, the most useful way to use this page is as a planning reference for a possible future announcement. Any future applicant should re-check the new notice instead of carrying these dates forward.

For the program design, verify that the proposed RC has a defined scientific focus, credible leadership, regulatory and commercialization experience, and resources that can support multiple projects. Make the initial 4–6 ITP cohort coherent and show how the center could expand toward approximately 10 ITPs. Define measurable outcomes, milestone gates, and a fair process for continuing, exiting, or adding projects.

For scope, keep the proposal in preclinical development. Explain how the work can prepare products, protocols, manufacturing processes, and regulatory packages for later clinical activity without proposing a clinical trial or first-in-human study under APEx. Separate shared RC services from ITP work in the narrative and budget. Make the roles of the PD(s)/PI(s), project leaders, operations staff, regulatory specialists, and collaborators easy to audit.

For submission, confirm the current NIH application guide, current registration requirements, page limits, application forms, and due date in the next official NOFO if one is issued. The record for RFA-DE-27-002 contains no announced 2027 application deadline. Until NIH publishes another announcement, this page should remain marked as a historical reference rather than presenting the closed opportunity as available funding.