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.Apply for RFA AI 18 057
- 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.
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Frequently Asked Questions (FAQs)
What is this NIH funding opportunity?
This is an NIH funding opportunity (RFA AI 18 057) that supports research to speed up development of safe, effective long-acting drug delivery systems (LA-DDS) for antiretroviral therapy (ART) for children living with HIV-1.
What is the main goal of the program?
The main goal is to accelerate preclinical research that helps refine and optimize long-acting ART delivery approaches so they are better positioned for eventual pediatric use. The intent is to reduce how often children need to take medicine and make treatment simpler and more practical.
Why is the FOA focused on long-acting drug delivery for pediatric HIV-1?
The FOA is centered on the idea that long-acting formulations or devices could reduce dosing frequency, ease day-to-day treatment burdens, improve adherence, and potentially support better long-term viral suppression for children living with HIV-1.
Does this funding opportunity allow clinical trials?
No. This announcement does not allow clinical trials. The supported work must remain in the preclinical and product optimization space and should not involve enrolling human participants.
What types of research activities are expected under this FOA?
Applicants are expected to propose targeted, milestone-driven preclinical activities that answer key development questions and de-risk the technology. The emphasis is on refining promising long-acting delivery approaches and generating data needed to move toward translation for pediatric use.
What does LA-DDS mean in this opportunity?
LA-DDS refers to long-acting drug delivery systems. In the context of this FOA, it means formulations or devices intended to deliver antiretroviral therapy over longer periods to reduce dosing frequency for pediatric patients.
What is the funding mechanism used for this opportunity?
The FOA uses an R61/R33 phased innovation structure. This is a milestone-driven approach designed to move projects through a development pipeline from early feasibility work to more advanced preclinical development.
How do the R61 and R33 phases differ?
Based on the synopsis, the R61 phase generally corresponds to an early, time-limited stage focused on feasibility and achieving critical proof-of-concept milestones. The R33 phase typically supports more advanced preclinical development after successful completion of the R61 milestones.
What kind of projects is NIH trying to fund through this FOA?
The program is looking for teams that already have an existing long-acting delivery platform at an early product development stage and can use NIH support to optimize it and produce preclinical data that supports faster translation toward pediatric HIV-1 use.
Is this FOA intended for exploratory or basic academic concepts?
The synopsis emphasizes practical development pathways and manufacturable, scalable products. This suggests the FOA is not focused on purely exploratory academic concepts, but rather on advancing existing platforms with real-world development considerations.
Is an industry collaboration required?
Yes. A defining requirement is collaboration with industry. Applicants must form collaborative research partnerships with industry as part of the project.
Why does the FOA require an industry partnership?
The synopsis indicates NIH interest in practical development pathways that can realistically lead to manufacturable, scalable products. Industry collaboration is required to help connect innovation with product development considerations needed for eventual pediatric care adoption.
What kinds of development considerations does NIH emphasize?
The synopsis highlights considerations such as formulation robustness, release characteristics, stability, and other factors that influence the likelihood that a product can be manufactured, scaled, and eventually adopted in pediatric care.
Who is eligible to apply?
Eligibility is broad and includes many 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 (501(c)(3) and non-501(c)(3), excluding institutions of higher education in those nonprofit categories); for-profit organizations other than small businesses; small businesses; and other entities.
Are foreign (non-U.S.) organizations eligible to apply?
Yes. The synopsis explicitly includes non-U.S. (foreign) organizations among the highlighted eligible applicant categories.
Are U.S. territories or possessions eligible?
Yes. The synopsis explicitly includes U.S. territories or possessions among the highlighted eligible applicant categories.
Does the FOA highlight eligibility for specific institution types?
Yes. The FOA 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, tribally controlled colleges and universities, regional organizations, and certain tribal government and tribal organization categories.
What federal program area and identifier are associated with this opportunity?
This is a discretionary grant opportunity under NIH, categorized under health, and associated with CFDA number 93.855.
When was this opportunity created and when did it close?
The opportunity was created on November 20, 2018, and the original application closing date listed in the synopsis is March 13, 2019.
Does the synopsis list the award ceiling or the expected number of awards?
No. The public synopsis does not provide an award ceiling or the expected number of awards. Those details were either not stated in the summary record or were intended to be included in the full FOA.
What is the overall takeaway about what NIH is trying to do with this FOA?
Overall, this is a translational, milestone-oriented preclinical funding mechanism meant to accelerate the optimization of existing long-acting ART delivery platforms so they can move more rapidly toward eventual pediatric development, while keeping the funded scope strictly non-clinical and requiring industry collaboration.
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