Opportunity Information: Apply for RFA DA 25 022
Advancing Technologies to Improve Delivery of Pharmacological, Gene Editing, and other Cargoes for HIV and SUD Mechanistic or Therapeutic Research (R01 Clinical Trial Optional) is a National Institutes of Health (NIH) discretionary grant opportunity focused on creating or significantly improving delivery technologies that can move therapeutic or research cargo to the right place in the body, at the right time, and at effective levels. The central theme is delivery: the funding is aimed at work that makes it more feasible to use pharmacological agents, gene editing tools, or other biological or chemical payloads in studies related to HIV and substance use disorders (SUD), either to uncover mechanisms (mechanistic research) or to advance treatment strategies (therapeutic research). The grant uses the NIH R01 mechanism, which typically supports substantial, multi-year research projects, and it is labeled "Clinical Trial Optional," meaning applicants may propose studies that include a clinical trial component if it is appropriate for the technology and aims, but they are not required to do so.
The scientific intent is to address common bottlenecks that slow down progress in HIV and SUD research: many promising drugs, biologics, nucleic acids, vectors, gene editors, or other payloads fail or underperform because they cannot be delivered efficiently, safely, or specifically to relevant tissues and cell types. This opportunity targets technology development that can overcome those barriers, such as improving targeting, crossing biological barriers, enhancing uptake into difficult-to-reach cells, controlling where and when the cargo is released, and reducing off-target distribution or toxicity. While the notice does not list specific platforms, the scope naturally includes a wide range of delivery approaches, including but not limited to engineered nanoparticles, viral and non-viral vectors, cell-based delivery, depot and long-acting formulations, tissue-targeting ligands, responsive or triggerable release systems, and methods to improve delivery to challenging anatomical compartments that matter for HIV or SUD research.
The opportunity is identified as Funding Opportunity Number RFA-DA-25-022, administered by NIH, with an activity category spanning education and health and a CFDA listing of 93.279. It is a grant (not a contract), and it falls under the "Discretionary" opportunity category. The stated original closing date is 2024-11-15, and the opportunity record was created on 2023-11-01. The listing does not provide an award ceiling or expected number of awards in the excerpt provided, so applicants would typically confirm budget limits, project period expectations, and review considerations in the full announcement text on NIH/Grants.gov.
Eligibility is broad and includes many types of U.S.-based organizations as well as certain non-U.S. entities. Eligible applicants include state, county, city or township governments, special district governments, and independent school districts; public and state-controlled institutions of higher education and private institutions of higher education; Native American tribal governments (federally recognized) and Native American tribal organizations (other than federally recognized tribal governments); public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; and small businesses. In addition, the opportunity explicitly highlights other eligible applicant 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); Indian/Native American tribal governments other than federally recognized entities; eligible federal agencies; faith-based or community-based organizations; U.S. territories or possessions; regional organizations; and non-domestic (non-U.S.) entities, meaning foreign organizations can apply if permitted under NIH rules and the specific FOA.
In practical terms, a competitive application under this program would be expected to make a clear case that the proposed delivery technology solves a meaningful problem in HIV and/or SUD research and that it can be demonstrated through rigorous experiments, performance metrics, and validation plans. Projects generally need to define what cargo is being delivered (for example, a small molecule, biologic, nucleic acid, or gene editor), where it needs to go (specific tissues, organs, or cell types relevant to HIV or SUD), what delivery barriers are being addressed (stability, targeting, penetration, immune clearance, endosomal escape, long-acting exposure, and so on), and how success will be measured (delivery efficiency, functional activity of the cargo, durability, safety, specificity, manufacturability, or translational feasibility). Because the FOA allows clinical trials but does not require them, the work could range from early-stage technology development and preclinical validation to, where justified, clinical evaluation tied directly to the delivery innovation.
Overall, this R01 opportunity is designed to accelerate the development of enabling delivery technologies that can unlock new HIV and SUD mechanistic studies and therapeutic approaches, with broad organizational eligibility and flexibility in whether clinical trials are included.Apply for RFA DA 25 022
- The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Advancing Technologies to Improve Delivery of Pharmacological, Gene Editing, and other Cargoes for HIV and SUD Mechanistic or Therapeutic Research (R01 Clinical Trial Optional)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.279.
- This funding opportunity was created on 2023-11-01.
- Applicants must submit their applications by 2024-11-15. (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 the main goal of this funding opportunity?
The goal is to create or significantly improve delivery technologies that can move therapeutic or research cargo to the right place in the body, at the right time, and at effective levels for HIV and substance use disorders (SUD) mechanistic or therapeutic research. The central theme is delivery: improving how payloads reach relevant tissues and cell types so promising approaches do not fail due to poor delivery.
What is the official title of the opportunity?
Advancing Technologies to Improve Delivery of Pharmacological, Gene Editing, and other Cargoes for HIV and SUD Mechanistic or Therapeutic Research (R01 Clinical Trial Optional).
What agency is offering this grant?
This is a National Institutes of Health (NIH) discretionary grant opportunity.
What is the Funding Opportunity Number (FOA number)?
RFA-DA-25-022.
What funding mechanism does this opportunity use?
It uses the NIH R01 mechanism, which typically supports substantial, multi-year research projects.
Is this a grant or a contract?
This opportunity is a grant, not a contract.
What does "Clinical Trial Optional" mean for this R01?
It means applicants may propose studies that include a clinical trial component if it fits the technology and aims, but a clinical trial is not required. Projects may range from early-stage development and preclinical validation to (when justified) clinical evaluation tied directly to the delivery innovation.
What research areas does the opportunity focus on?
The focus is on enabling delivery technologies for studies related to HIV and substance use disorders (SUD). Projects can be mechanistic (to uncover biological mechanisms) or therapeutic (to advance treatment strategies), as long as improved delivery is a core innovation and need.
What kinds of "cargo" are relevant under this funding opportunity?
The opportunity targets delivery approaches for pharmacological agents, gene editing tools, and other biological or chemical payloads used in HIV and/or SUD research. Examples mentioned or implied include drugs, biologics, nucleic acids, vectors, gene editors, and other payload types where delivery limitations reduce effectiveness.
What types of delivery problems is NIH trying to solve here?
The intent is to address common bottlenecks where promising interventions underperform because they cannot be delivered efficiently, safely, or specifically to relevant tissues and cell types. Emphasis areas include improving targeting, crossing biological barriers, enhancing uptake into difficult-to-reach cells, controlling when/where cargo is released, and reducing off-target distribution or toxicity.
What delivery approaches or platforms are within scope?
The excerpt does not list a required platform and suggests broad scope. Approaches naturally included can involve engineered nanoparticles, viral and non-viral vectors, cell-based delivery, depot and long-acting formulations, tissue-targeting ligands, responsive or triggerable release systems, and methods to improve delivery to challenging anatomical compartments relevant to HIV or SUD research.
Does the opportunity require a specific disease area, HIV or SUD?
The opportunity is aimed at HIV and SUD research. Proposed delivery technology should solve a meaningful problem in HIV and/or SUD research and be justified in that context.
What makes an application competitive based on the description provided?
A competitive application would clearly explain how the proposed delivery technology solves an important delivery barrier in HIV and/or SUD research and demonstrate the approach through rigorous experiments, defined performance metrics, and validation plans. It should specify what cargo is delivered, where it needs to go (relevant tissues/organs/cell types), which delivery barriers are being addressed (for example stability, targeting, penetration, immune clearance, endosomal escape, long-acting exposure), and how success will be measured (delivery efficiency, functional activity, durability, safety, specificity, manufacturability, translational feasibility).
What is the opportunity category?
It is listed as a discretionary opportunity.
What is the CFDA listing associated with this opportunity?
93.279.
What activity category is this opportunity associated with?
The activity category spans education and health (as described in the provided listing summary).
When is the closing date?
The stated original closing date is 2024-11-15.
When was the opportunity record created?
The opportunity record was created on 2023-11-01.
Are the award ceiling or number of expected awards provided here?
No. The excerpt provided does not include an award ceiling or expected number of awards. Applicants would typically confirm budget limits, project period expectations, and review considerations in the full announcement text on NIH/Grants.gov.
Who is eligible to apply?
Eligibility is broad and includes many U.S.-based organizations and certain non-U.S. entities. Eligible applicants include 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; Native American tribal governments (federally recognized) and Native American tribal organizations (other than federally recognized tribal governments); public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; and small businesses.
Are minority-serving institutions (MSIs) and similar organizations explicitly included as eligible applicants?
Yes. The opportunity explicitly highlights eligibility for 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); and Indian/Native American tribal governments other than federally recognized entities.
Can federal agencies apply?
Yes. Eligible federal agencies are explicitly listed among eligible applicant categories.
Are faith-based or community-based organizations eligible?
Yes. Faith-based or community-based organizations are explicitly listed among eligible applicant categories.
Are U.S. territories or possessions eligible?
Yes. U.S. territories or possessions are explicitly listed among eligible applicant categories.
Can non-U.S. (foreign) organizations apply?
The opportunity indicates that non-domestic (non-U.S.) entities are included among eligible applicant categories, meaning foreign organizations can apply if permitted under NIH rules and the specific FOA.
Does the opportunity restrict proposals to a single delivery technology type?
No restriction is stated in the excerpt. The description emphasizes delivery innovation broadly and notes that specific platforms are not listed, implying multiple delivery technology types are within scope as long as they address delivery barriers for HIV and/or SUD research.
What kinds of biological barriers or delivery hurdles are specifically mentioned?
Examples described include difficulty crossing biological barriers, poor uptake into hard-to-reach cells, limited control over where and when cargo is released, off-target distribution, toxicity, stability challenges, immune clearance, and endosomal escape. Long-acting exposure and depot/long-acting approaches are also referenced as within the natural scope.
Do projects need to demonstrate outcomes beyond just "getting cargo to the tissue"?
Based on the excerpt, the expectation is to measure success using performance metrics such as delivery efficiency and functional activity of the cargo, along with durability, safety, specificity, manufacturability, and translational feasibility where relevant.
Is this opportunity limited to therapeutic research only?
No. The opportunity explicitly includes both mechanistic research (to uncover mechanisms) and therapeutic research (to advance treatment strategies), as long as the delivery technology is central.
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