Long-acting Drug Delivery Systems for ART Optimization in HIV-1 Infected Children (R61/R33 Clinical Trial Not Allowed) | RFA AI 18 057

Opportunity Information: Apply for RFA AI 18 057

This NIH funding opportunity (RFA AI 18 057) supports research aimed at speeding up the development of safe, effective long-acting drug delivery systems (LA-DDS) that can make antiretroviral therapy (ART) simpler and more practical for children living with HIV-1. The central idea is that long-acting formulations or devices could reduce how often a child needs to take medicine, which can ease day-to-day treatment burdens, improve adherence, and potentially lead to better long-term viral suppression. The FOA is focused on moving promising long-acting delivery approaches forward by funding targeted preclinical work that helps refine these technologies and prepare them for eventual pediatric use. Importantly, this announcement does not allow clinical trials, so the work is meant to remain in the preclinical and product optimization space rather than enrolling human participants.

The FOA uses an R61/R33 phased innovation structure, which is designed to push projects through a milestone-driven pipeline. In practical terms, applicants are expected to propose a set of well-defined, measurable preclinical activities that address key development questions and de-risk the technology. The R61 phase generally corresponds to an early, time-limited stage where feasibility and critical proof-of-concept milestones are met, while the R33 phase typically supports more advanced preclinical development once those milestones are achieved. The overall intent is acceleration: the program is looking for teams that already have an existing long-acting delivery platform at an early product development stage and can use this support to optimize it and generate the kinds of data needed to move more rapidly toward translation for children with HIV-1.

A defining requirement of this opportunity is collaboration with industry. Applicants must form collaborative research partnerships with industry as part of the project, reflecting NIH interest in practical development pathways that can realistically lead to manufacturable, scalable products. This emphasis suggests the FOA is not just looking for exploratory academic concepts, but for projects that can connect engineering/pharmaceutics innovation with real-world development considerations, such as formulation robustness, release characteristics, stability, and other factors that influence the likelihood of eventual adoption in pediatric care.

Eligible applicants are broad and include many types of U.S. organizations and governments, such as state, county, city or township 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/Indian housing authorities; nonprofits (both 501(c)(3) and non-501(c)(3), excluding institutions of higher education in those categories); for-profit organizations other than small businesses; small businesses; and other entities. The FOA also explicitly highlights additional eligible applicant categories, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, faith-based or community-based organizations, Hispanic-serving institutions, HBCUs, Indian/Native American tribal governments that are not federally recognized, non-U.S. (foreign) organizations, regional organizations, tribally controlled colleges and universities, and U.S. territories or possessions. This wide eligibility is meant to encourage a diverse set of teams to participate, while still requiring the industry partnership component.

From an administrative standpoint, this is a discretionary grant opportunity under the NIH, with the funding activity categorized under health and associated with CFDA number 93.855. The opportunity was created on November 20, 2018, and the original application closing date listed is March 13, 2019. The public synopsis does not provide an award ceiling or the expected number of awards, indicating those specifics were either not stated in the summary record or were to be detailed in the full FOA. Overall, the program is best understood as a translational, milestone-oriented preclinical funding mechanism intended to help convert existing long-acting ART delivery platforms into optimized candidates that are better positioned for future pediatric development, while keeping the funded scope strictly non-clinical.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Long-acting Drug Delivery Systems for ART Optimization in HIV-1 Infected Children (R61/R33 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 2018-11-20.
• Applicants must submit their applications by 2019-03-13. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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 RFA AI 18 057

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