Planning for Product Development Strategy (R34 Clinical Trial Not Allowed) | PAR 24 029

Opportunity Information: Apply for PAR 24 029

The National Institutes of Health (NIH) is offering a discretionary grant opportunity titled "Planning for Product Development Strategy (R34 Clinical Trial Not Allowed)" under funding opportunity number PAR-24-029 (CFDA 93.855). This opportunity is designed to fund early, planning-focused work that helps investigators and organizations build a clear, end-to-end product development strategy for next-generation HIV-related drug products. The emphasis is on creating a comprehensive and realistic development plan that positions a candidate therapy or prevention approach to move from research findings toward a package that can support submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA). As an R34 mechanism, it is focused on preparatory and strategy development activities rather than executing a clinical trial, and the NOFO explicitly states that clinical trials are not allowed under this announcement.

The scientific scope centers on HIV and closely related needs, including next-generation treatments for HIV, as well as treatments or strategies that address HIV-associated comorbidities, coinfections, and complications. It also includes preventive strategies for HIV, reflecting NIH interest not only in treatment innovations but also in approaches that could reduce acquisition, transmission, or downstream health impacts. A key goal is to bridge the common gap between academic or preclinical discoveries and the structured, regulated development pathway required for eventual human testing and product approval. In practical terms, applicants are expected to use the award period to define the development roadmap: what studies are needed, what regulatory expectations must be met, how manufacturing and quality will be handled, what nonclinical evidence is required, and how all of that will be assembled into an IND-enabling plan.

The funding instrument is a grant, and the activity category is health. The award ceiling is listed as $225,000. While the number of expected awards is not specified in the provided source data, the presence of an award cap signals that NIH anticipates funding targeted planning packages rather than large-scale experimental programs. The original closing date is December 4, 2026, and the opportunity record shows a creation date of August 14, 2023, indicating an announcement that may remain open across multiple receipt dates or cycles up to the listed end date (applicants should still verify the current submission schedule and any specific due dates within the full NOFO).

Eligibility is broad and includes a wide range of organizational types commonly allowed under NIH programs. Eligible applicants include state, county, city or township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; Native American tribal governments (federally recognized); Native American tribal organizations (other than federally recognized tribal governments); public housing authorities and Indian housing authorities; and both nonprofit and for-profit entities (including for-profit organizations other than small businesses and small businesses). The announcement also highlights additional eligible categories such as 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 even non-domestic (non-U.S.) entities (foreign organizations). This broad eligibility signals that NIH is open to supporting planning efforts wherever strong translational HIV science and development capabilities exist, including community-rooted institutions and international partners when appropriate.

Overall, this NOFO is best understood as a structured planning award meant to de-risk and professionalize the path from discovery to an IND-ready development program for HIV therapeutics or prevention products. It supports the kind of coordinated, regulatory-aware strategy development that is often necessary before larger preclinical development awards or later-stage translational funding can be competitive. Applicants considering this opportunity should align their proposed work with IND-enabling translation needs (planning, regulatory strategy, and product development readiness) rather than clinical testing, since the mechanism specifically excludes clinical trials.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Planning for Product Development Strategy (R34 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): 93.855.
• This funding opportunity was created on 2023-08-14.
• Applicants must submit their applications by 2026-12-04. (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 $225,000.00 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.

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