NEI Regenerative Medicine Clinical Trial Planning Grant (R34 - Clinical Trials Not Allowed) | PAR 22 070

Opportunity Information: Apply for PAR 22 070

The NEI Regenerative Medicine Clinical Trial Planning Grant (R34 - Clinical Trials Not Allowed) is a National Institutes of Health funding opportunity from the National Eye Institute (NEI) designed to support planning activities that move promising regenerative medicine approaches for the eye closer to eventual human testing, without actually conducting a clinical trial under this award. It sits under the NEI Audacious Goal Initiative (AGI), which is a focused effort to push beyond incremental advances in vision science and accelerate strategies aimed at restoring vision by regenerating key retinal cells and rebuilding functional connections. The central premise is that replacing or regenerating specific retinal neurons, and ensuring they integrate properly into existing retinal circuitry, could ultimately restore meaningful vision in people with blinding retinal diseases.

Scientifically, the opportunity is tightly aligned with AGI priorities: photoreceptors (PRCs) and retinal ganglion cells (RGCs). Photoreceptors, commonly referred to as rods and cones, are the light-sensing cells that convert light into neural signals. Retinal ganglion cells receive processed retinal signals and transmit them through the optic nerve to the brain, making them essential for visual communication from the eye to the central nervous system. While regenerative successes have been demonstrated in animal models such as fish and mice, the AGI emphasis is on bridging the gap to humans, where the biological, technical, and translational hurdles are substantially higher. This R34 mechanism is meant to fund the practical groundwork needed to prepare for future clinical evaluation, such as developing a robust clinical protocol concept, establishing feasibility, refining operational plans, and addressing regulatory and logistical requirements that typically determine whether a first-in-human study is realistic and well-designed.

As indicated by the title and mechanism, clinical trials are not allowed as part of this grant. In practice, that means applicants should propose pre-trial planning and preparation rather than enrolling participants or delivering an investigational intervention in humans. The scope generally fits activities like building the clinical development roadmap, specifying endpoints and outcome measures, planning patient selection criteria, outlining statistical and data management approaches, developing safety monitoring concepts, and coordinating the interdisciplinary pieces required for later-stage translation. The grant is categorized as a discretionary grant in the health funding activity area, and it is associated with CFDA number 93.867.

The opportunity (Funding Opportunity Number PAR 22 070) is open to a wide range of applicant organizations, reflecting NIH and NEI interest in drawing on expertise across academia, nonprofits, government, and industry. Eligible applicants include 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; tribal organizations that are not federally recognized; public housing authorities and Indian housing authorities; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; small businesses; and other eligible entities. The announcement also highlights additional eligible applicant categories that can be particularly relevant for broadening participation and capacity building, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and non-U.S. entities (foreign organizations).

From a funding perspective, the listed award ceiling is $150,000. The source data does not specify the anticipated number of awards (it is left blank), so applicants would typically look to the full FOA text and NIH guidance for any additional details about budget structure, project period expectations, and review considerations. The original closing date shown is January 19, 2022, and the posting creation date is November 16, 2021. Even though those dates indicate this particular listing is from a prior cycle, the program description provides a clear picture of the intent: to enable well-justified, carefully constructed clinical trial plans that accelerate the transition of retinal regenerative approaches targeting PRCs and RGCs toward eventual human studies, while keeping the R34 focused on planning and readiness rather than execution of a clinical trial.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NEI Regenerative Medicine Clinical Trial Planning Grant (R34 - Clinical Trials Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.867.
• This funding opportunity was created on 2021-11-16.
• Applicants must submit their applications by 2022-01-19. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $150,000.00 in funding.
• 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.

Apply for PAR 22 070

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