INCLUDE (INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE) Predoctoral to Postdoctoral Fellow Transition Award (F99/K00 Clinical Trial Not Allowed) | RFA OD 23 016

Opportunity Information: Apply for RFA OD 23 016

The INCLUDE Predoctoral to Postdoctoral Fellow Transition Award (F99/K00; Clinical Trial Not Allowed) is an NIH grant opportunity designed to help outstanding doctoral students bridge the gap between completing their PhD and launching a focused postdoctoral program centered on Down syndrome research. The overall goal is to grow the pipeline of scientists working in the Down syndrome space by pulling in talented trainees who may be coming from many different research backgrounds, not just traditional Down syndrome labs. In practice, this award supports a two-stage training path: an F99 phase that backs the final part of the applicant's doctoral training, followed by a K00 phase that provides mentored postdoctoral support once the individual has moved into a postdoctoral position and is continuing to build expertise and independence in Down syndrome related research.

A key feature of this opportunity is its intentionally broad disciplinary reach. NIH is explicitly inviting applications from graduate students in fields such as genetics, biochemistry, data science, imaging, engineering, neurobiology, and other relevant areas that could be leveraged to answer important questions about Down syndrome and co-occurring conditions across the lifespan. That emphasis on "co-occurring conditions across the lifespan" reflects the INCLUDE initiative's wider interest in understanding the many health and developmental issues that can accompany Down syndrome at different stages of life, and in encouraging research approaches that connect basic biology, translational work, and population-level or technology-driven methods where appropriate.

The announcement strongly encourages prospective applicants to contact INCLUDE Program Staff before putting significant time into an application. That is a practical signal that NIH expects applicants to confirm fit with program goals, clarify any eligibility or scope questions (especially around what types of studies are considered allowable), and make sure the proposed training and research plan aligns with what the initiative is trying to build. Since the FOA explicitly states "Clinical Trial Not Allowed," the supported work must not propose a clinical trial as defined by NIH policy; applicants would need to design projects that stay on the non-clinical-trial side of NIH rules, even if the work is clinically relevant or uses human data in an observational or secondary-analysis framework consistent with NIH guidance.

In terms of who can apply, the eligible applicant organizations are broad across the U.S. research ecosystem. Eligible applicants include public and state-controlled institutions of higher education, private institutions of higher education, nonprofits with 501(c)(3) status (other than institutions of higher education), for-profit organizations (other than small businesses), small businesses, and other categories included in the NIH eligibility list. The notice also highlights categories of institutions that NIH particularly calls out as eligible and relevant, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), and Tribally Controlled Colleges and Universities (TCCUs). While these categories do not exclude other eligible U.S. institutions, their inclusion underscores the initiative's interest in broadening participation and strengthening research training pathways across a diverse set of organizations and communities.

There are important restrictions related to foreign involvement. Non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply as the applicant organization, and non-domestic components of U.S. organizations are also not eligible to apply. At the same time, "foreign components" are allowed as defined in the NIH Grants Policy Statement, meaning certain parts of the research or collaboration may occur outside the U.S. under NIH's foreign component rules, as long as the primary applicant organization remains eligible and the arrangement is properly justified and compliant.

Administratively, this is an NIH discretionary grant opportunity (Funding Opportunity Number RFA-OD-23-016) in the health funding activity category, run under the National Institutes of Health. The original closing date listed is 2023-07-01, and multiple CFDA/assistance listing numbers are associated with the opportunity (93.121, 93.233, 93.837, 93.838, 93.839, 93.840, 93.846, 93.866, 93.867), reflecting NIH program and institute participation tied to the broader INCLUDE initiative. The award ceiling and expected number of awards are not specified in the provided listing, which is common in some NIH announcements where budgets and award counts can depend on appropriations, meritorious applications, and program priorities.

In short, this F99/K00 mechanism is meant for exceptional PhD trainees who want a structured, mentored, and well-supported transition into a postdoc specifically aimed at advancing Down syndrome related science. The FOA is especially trying to attract strong candidates from many disciplines, encourage early communication with NIH program staff, and build a larger, more diverse community of researchers capable of addressing the complex, lifespan-spanning set of co-occurring conditions and biological questions associated with Down syndrome.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "INCLUDE (INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE) Predoctoral to Postdoctoral Fellow Transition Award (F99/K00 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.121, 93.233, 93.837, 93.838, 93.839, 93.840, 93.846, 93.866, 93.867.
• This funding opportunity was created on 2023-05-08.
• Applicants must submit their applications by 2023-07-01. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Public and State controlled institutions of higher education, Nonprofits having 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.

Apply for RFA OD 23 016

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