Advancing Translation of Long-Acting Strategies for HIV and HIV-Associated Co-infections (AT LASt) (R61/R33 Clinical Trial Not Allowed) | RFA AI 24 076

Frequently Asked Questions (FAQs)

What is the AT LASt funding opportunity (RFA-AI-24-076)?

AT LASt stands for Advancing Translation of Long-Acting Strategies for HIV and HIV-Associated Co-infections. It is an NIH discretionary grant opportunity intended to move promising long-acting and sustained-release (LA/SR) drug or delivery approaches closer to real-world clinical development by funding preclinical, translational work.

What is the main goal of this program?

The central goal is to support preclinical work that strengthens the safety, performance, and translational readiness of LA/SR technologies for HIV and key HIV-associated co-infections, with the aim of producing the type of nonclinical evidence package that positions a product for an FDA Investigational New Drug (IND) submission.

Which diseases and indications are in scope?

The opportunity focuses on LA/SR approaches aimed at preventing or treating HIV and the HIV-associated co-infections specifically named in the information provided: tuberculosis (TB), hepatitis B (HBV), and hepatitis C (HCV).

Is this opportunity focused on clinical trials in humans?

No. Clinical trials are not allowed under this mechanism. The funded scope is intended to remain in the preclinical and preparatory translational space, not human efficacy or safety testing.

What kinds of projects are a good fit for AT LASt?

Projects are expected to focus on LA/SR products that have a strong scientific rationale and a clear competitive advantage over existing options. A good fit includes candidates that already show effectiveness in relevant nonclinical or animal models and that can credibly advance toward IND-enabling readiness.

What does "long-acting and sustained-release (LA/SR)" mean in this context?

In this program, LA/SR refers to drug products or delivery systems designed to maintain drug exposure over extended periods, enabling intermittent dosing (for example, a single injection, topical application, or oral administration given at extended intervals) or continuous delivery (for example, implants or transdermal patches).

What types of delivery approaches are mentioned as examples?

The information provided cites intermittent dosing approaches such as single injection, topical application, or oral administration at extended intervals, and continuous delivery platforms such as implants or transdermal patches.

Does the program support very early-stage concept ideas?

The emphasis is on candidates that are beyond early concept work. Applicants should be prepared to show existing effectiveness in relevant nonclinical or animal models and a plausible path toward translational development that culminates in IND-enabling readiness.

What does the program mean by a "competitive advantage" over existing options?

The program highlights advantages such as improvements in dosing frequency, adherence, durability of drug exposure, tolerability, or practicality of delivery compared with existing approaches.

What is meant by "translation to IND" and why does it matter here?

Translation to IND refers to progressing a product toward an FDA Investigational New Drug submission. This matters because the supported activities are expected to reduce risk and address regulator-relevant questions through preclinical work that supports IND-enabling readiness.

What kinds of activities are expected to be supported (at a high level)?

While the provided text does not list required experiments, it indicates work that typically aligns with formulation optimization for long-duration release, dose and exposure justification, pharmacokinetics and pharmacodynamics appropriate to extended dosing intervals, biodistribution considerations for delivery systems, and nonclinical safety and tolerability packages that support advancement toward FDA filing.

Are specific experiments or a required preclinical study list provided in the information available here?

No. The notice text described here does not enumerate specific required experiments. It communicates the intent and examples of the kinds of preclinical steps that are generally aligned with IND-directed translation.

What funding mechanism is used for this opportunity?

The mechanism listed is R61/R33, which commonly indicates a phased, milestone-driven approach: an initial phase focused on feasibility and key early translational tasks, followed by a later phase supporting more advanced development once predefined milestones are met.

What should applicants assume about how projects will be managed or evaluated under an R61/R33 structure?

The R61/R33 structure signals that funders will likely look for a tightly planned progression with measurable milestones and clear go/no-go criteria, rather than open-ended exploratory research.

Who is eligible to apply?

Eligibility is broad and includes U.S. and non-U.S. organizations. 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 tribal governments; tribal organizations that are not federally recognized; public housing authorities and Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding higher education institutions in those nonprofit categories); for-profit organizations (other than small businesses); and small businesses.

Are non-U.S. entities eligible?

Yes. The information provided explicitly includes non-domestic (non-U.S.) entities as eligible applicants.

Are small businesses eligible to apply?

Yes. Small businesses are listed among eligible applicants.

Are for-profit companies eligible to apply?

Yes. For-profit organizations (other than small businesses) are listed as eligible, and small businesses are also eligible (listed separately).

Are nonprofits eligible to apply, and is 501(c)(3) status required?

Nonprofits with or without 501(c)(3) status are included as eligible applicants (excluding higher education institutions in those nonprofit categories).

Are tribal and tribally affiliated organizations eligible?

Yes. Federally recognized tribal governments are eligible, as are tribal organizations that are not federally recognized. The information also highlights Tribally Controlled Colleges and Universities (TCCUs) among eligible applicant types.

Are minority-serving institutions and community/faith-based organizations eligible?

Yes. The NOFO highlights eligible applicant types including Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, HBCUs, TCCUs, and faith-based or community-based organizations.

Are U.S. territories or possessions eligible to apply?

Yes. U.S. territories or possessions are explicitly mentioned among eligible applicant types.

What is the funding instrument type?

The funding instrument type is a Grant.

What is the program area or category?

The opportunity is in the health category.

What CFDA number is associated with this opportunity?

The CFDA number listed is 93.855.

What is the application deadline?

The original closing date listed is March 13, 2025.

When was this opportunity created?

The opportunity was created on November 22, 2024.

Is the award ceiling provided in the information available here?

No. The award ceiling is not specified in the provided source text. Applicants would need to consult the full NOFO for budget limits.

Is the expected number of awards provided in the information available here?

No. The expected number of awards is not specified in the provided source text. The full NOFO would need to be consulted for this information.

Where can applicants find details like budget limits, project period, review criteria, and required milestones?

The information provided indicates applicants should consult the full NOFO for budget limits, project period expectations, review criteria, and any required milestones or product development plan elements.

What stage of development should a proposed LA/SR candidate be at to be competitive?

The opportunity is best suited for teams with a credible LA/SR candidate or platform already supported by persuasive nonclinical data, including effectiveness in relevant nonclinical or animal models, and a clear plan to build toward IND-enabling readiness.

What is the practical focus of funded work, in plain terms?

In practical terms, the program is aimed at shortening the distance between strong preclinical proof-of-concept and regulator-ready development by funding nonclinical work that increases confidence in safety, performance, and translational readiness for LA/SR approaches targeting HIV and/or HIV-linked co-infections.