Opportunity Information: Apply for RFA AI 23 061
The Long-Acting Drug Delivery Systems for ART Optimization in Children Living with HIV-1 II (LADDS II) funding opportunity (RFA-AI-23-061) is an NIH discretionary grant program designed to speed up the creation and refinement of long-acting drug delivery approaches that could make HIV-1 treatment for children safer, simpler, and easier to maintain over time. The central goal is to push promising long-acting antiretroviral therapy (ART) delivery platforms forward so they are better suited for pediatric use, with an emphasis on improving real-world feasibility for children and caregivers by reducing dosing frequency and supporting sustained viral suppression. A key boundary of the program is that it is "Clinical Trial Not Allowed," meaning the supported work is focused on preclinical and translational-enabling efforts rather than testing interventions in human participants under a clinical trial framework.
This NOFO specifically targets teams that already have an existing long-acting platform in early development and need support to complete well-defined preclinical activities that de-risk and accelerate translation into pediatric HIV care. In practice, that means awards are intended to help applicants perform the kinds of studies and optimization steps that typically stand between a concept-stage technology and a development candidate that is ready for later-stage advancement. While the announcement language is broad, the intent is clearly oriented toward product-focused, milestone-driven development work that can address pediatric-relevant constraints, such as age-appropriate dosing, safety considerations unique to growth and development, long-term exposure concerns, and practical administration needs.
The mechanism is an R61/R33 phased award, which generally supports an initial stage focused on feasibility and accelerated development planning and execution (R61), followed by a second stage intended for expanded development and confirmation work (R33), contingent on meeting predefined milestones and programmatic expectations. The structure is meant to keep projects moving efficiently and to prioritize efforts that demonstrate concrete progress toward a pediatric-appropriate long-acting ART delivery product. The maximum award amount listed is $850,000 (award ceiling), and the original application closing date was March 13, 2024. The opportunity falls under NIH funding activity categories tied to health and social services, and it is associated with CFDA numbers 93.242, 93.855, and 93.865.
A defining feature of LADDS II is the requirement for collaborative research partnerships with industry. That requirement signals that NIH expects applicants to align their preclinical development plans with the realities of product development, manufacturing, scale-up, regulatory expectations, and eventual implementation. In other words, the program is not just supporting academic proof-of-concept work; it is supporting development steps that are more likely to translate into an actual deployable pediatric long-acting ART option. Industry collaboration can also help ensure the platform has a viable path for formulation development, quality systems, and longer-term commercialization or distribution planning once the preclinical package is mature.
Eligibility is broad and includes many common applicant types across government, academia, nonprofits, and the private sector. Eligible applicants listed include state, county, city, township, and 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 governments; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); and small businesses. In addition, the NOFO explicitly highlights a range of other eligible applicants, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, non-U.S. entities (foreign organizations), regional organizations, Indian/Native American Tribal Governments other than federally recognized entities, and U.S. territories or possessions. This emphasis reflects an interest in inclusive participation across institutional types and geographies, including organizations that may be especially connected to communities affected by pediatric HIV.
Overall, LADDS II is best understood as a translational, product-acceleration program focused on pediatric HIV-1 treatment optimization through long-acting delivery technologies. It prioritizes preclinical optimization and development-enabling work for already-established long-acting platforms, expects active partnership with industry to keep projects aligned with real product development needs, and supports a wide range of applicant organizations capable of moving a pediatric-focused long-acting ART delivery candidate closer to future clinical readiness without conducting clinical trials under this award.Apply for RFA AI 23 061
- The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "Long-Acting Drug Delivery Systems for ART Optimization in Children Living with HIV-1 II (LADDS II) (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): 93.242, 93.855, 93.865.
- This funding opportunity was created on 2023-10-25.
- Applicants must submit their applications by 2024-03-13. (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 $850,000.00 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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Frequently Asked Questions (FAQs)
What is LADDS II (RFA-AI-23-061)?
LADDS II stands for "Long-Acting Drug Delivery Systems for ART Optimization in Children Living with HIV-1 II." It is an NIH discretionary grant program designed to accelerate the creation and refinement of long-acting drug delivery approaches for antiretroviral therapy (ART) in children living with HIV-1.
What is the main goal of this funding opportunity?
The central goal is to move promising long-acting ART delivery platforms forward so they become better suited for pediatric use. The program emphasizes real-world feasibility for children and caregivers, including reduced dosing frequency and support for sustained viral suppression over time.
What types of projects does LADDS II aim to support?
LADDS II is intended for teams that already have an existing long-acting platform in early development and need support to complete well-defined preclinical activities that reduce risk ("de-risk") and speed up translation into pediatric HIV care. The funded work is meant to address the practical development steps that typically bridge the gap between a concept-stage technology and a development candidate that is ready for later-stage advancement.
Does the program fund clinical trials in human participants?
No. A key boundary of LADDS II is that it is "Clinical Trial Not Allowed." Supported activities are focused on preclinical and translational-enabling efforts rather than testing interventions in human participants under a clinical trial framework.
What does "Clinical Trial Not Allowed" mean in practical terms for applicants?
Based on the description provided, applicants should plan projects around preclinical optimization and translational-enabling studies (for example, development and refinement work that prepares a platform for future clinical readiness), rather than clinical trial testing in humans within this award.
What is meant by "long-acting drug delivery" in this program context?
In this NOFO, "long-acting" refers to ART delivery approaches intended to reduce how often a child needs to be dosed, making HIV-1 treatment safer, simpler, and easier to maintain long-term while supporting sustained viral suppression.
Why is this opportunity focused specifically on children living with HIV-1?
The opportunity is specifically oriented toward pediatric HIV-1 treatment optimization. It highlights pediatric-relevant constraints such as age-appropriate dosing, safety considerations unique to growth and development, concerns related to long-term exposure, and practical administration needs for children and caregivers.
What makes a project a good fit for LADDS II?
A good fit is a product-focused, milestone-driven development project built around an already-established long-acting ART delivery platform that needs targeted preclinical optimization and development-enabling work to improve pediatric suitability and real-world feasibility.
Is this program meant for early concept-stage ideas?
The NOFO specifically targets teams that already have an existing long-acting platform in early development. Awards are intended to support preclinical activities that help move a platform beyond concept-stage toward a development candidate suitable for later-stage advancement.
What is the funding mechanism for LADDS II?
The mechanism is an R61/R33 phased award. This structure supports an initial phase (R61) focused on feasibility and accelerated development planning/execution, followed by a second phase (R33) intended for expanded development and confirmation work.
How does the R61 to R33 transition work?
The R33 phase is contingent on meeting predefined milestones and programmatic expectations. The phased structure is designed to keep projects moving efficiently and to prioritize efforts that demonstrate concrete progress toward a pediatric-appropriate long-acting ART delivery product.
What is the maximum award amount?
The maximum award amount listed (award ceiling) is $850,000.
What was the original application closing date?
The original application closing date was March 13, 2024.
Which organization is offering this funding opportunity?
This is an NIH (National Institutes of Health) discretionary grant program.
What are the CFDA numbers associated with this opportunity?
The opportunity is associated with CFDA numbers 93.242, 93.855, and 93.865.
What funding activity categories does this opportunity fall under?
The opportunity falls under NIH funding activity categories tied to health and social services.
Is collaboration with industry required?
Yes. A defining feature of LADDS II is the requirement for collaborative research partnerships with industry.
Why does LADDS II require industry collaboration?
The requirement signals that NIH expects applicants to align preclinical development plans with product development realities such as manufacturing, scale-up, regulatory expectations, and eventual implementation. The intent is to support development steps that are more likely to translate into a deployable pediatric long-acting ART option, not just academic proof-of-concept work.
What kinds of product-development considerations does the program emphasize?
The program emphasizes practical, translational considerations, including manufacturing and scale-up readiness, regulatory expectations, formulation development, quality systems, and longer-term commercialization or distribution planning once the preclinical package is mature.
Who is eligible to apply?
Eligibility is broad and includes many applicant types across government, academia, nonprofits, and the private sector, as listed in the NOFO summary provided.
Are state and local governments eligible?
Yes. Eligible applicants include state, county, city, township, and special district governments, as well as independent school districts.
Are colleges and universities eligible?
Yes. Eligible applicants include public and state-controlled institutions of higher education and private institutions of higher education.
Are tribal entities eligible?
Yes. Eligible applicants include federally recognized Native American tribal governments and tribal organizations that are not federally recognized governments. The NOFO also emphasizes eligibility for Indian/Native American Tribal Governments other than federally recognized entities.
Are nonprofits eligible?
Yes. Eligible applicants include nonprofits with 501(c)(3) status and nonprofits without 501(c)(3) status (other than institutions of higher education).
Are for-profit organizations eligible?
Yes. Eligible applicants include for-profit organizations (other than small businesses) and small businesses.
Are public housing authorities eligible?
Yes. Public housing authorities/Indian housing authorities are listed as eligible applicants.
Are U.S. territories or possessions eligible?
Yes. U.S. territories or possessions are explicitly highlighted among eligible applicants.
Are non-U.S. entities (foreign organizations) eligible?
Yes. The NOFO explicitly highlights non-U.S. entities (foreign organizations) as eligible applicants.
Are faith-based or community-based organizations eligible?
Yes. Faith-based or community-based organizations are explicitly highlighted among eligible applicants.
Are minority-serving institutions and similar organizations specifically encouraged or included?
Yes. The NOFO explicitly highlights Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), and Tribally Controlled Colleges and Universities (TCCUs), reflecting an interest in inclusive participation across institutional types and geographies.
What is the overall emphasis of LADDS II in plain terms?
LADDS II is best understood as a translational, product-acceleration program focused on pediatric HIV-1 treatment optimization through long-acting delivery technologies. It prioritizes preclinical optimization and development-enabling work for already-established platforms, requires industry partnership to keep projects aligned with real product development needs, and does not support clinical trials under this award.
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