Development of HIV Broadly Neutralizing Antibody Susceptibility Assays (R61/R33 Clinical Trial Not Allowed) | RFA AI 22 022

Frequently Asked Questions (FAQs)

What is the funding opportunity RFA-AI-22-022 about?

RFA-AI-22-022 is a National Institutes of Health (NIH) funding opportunity titled "Development of HIV Broadly Neutralizing Antibody Susceptibility Assays (R61/R33 Clinical Trial Not Allowed)." It supports the development of laboratory assays that can measure how susceptible HIV is to broadly neutralizing antibodies (bNAbs), with the goal of producing methods that are usable in clinical laboratory settings.

What is the main purpose of this grant program?

The program aims to accelerate creation of HIV bNAb susceptibility assays, especially projects that may be considered too early-stage or too risky for conventional funding but could have high payoff if successful. The intent is to push beyond basic research prototypes toward assays that can realistically be run, reproduced, and interpreted in clinical laboratories supporting clinical studies and patient-oriented research.

Which NIH activity code and structure does this opportunity use?

This opportunity uses the R61/R33 phased innovation structure. It is milestone-driven and designed to support an initial development phase followed by a later-stage verification and validation phase if milestones are achieved.

What happens in the R61 phase?

The R61 phase is the early, high-risk development phase. It focuses on designing new or improved susceptibility assays and generating feasibility evidence. Applicants are expected to show the method can work in principle, produce interpretable outputs, and has a credible path to clinical utility.

What happens in the R33 phase?

If predefined milestones are met, projects can transition to the R33 phase. This phase emphasizes more rigorous assay verification and late-stage validation so the method matures into a robust, reproducible, clinically meaningful assay with demonstrated performance characteristics suitable for broader adoption in clinical laboratories.

Is this opportunity milestone-driven?

Yes. The R61/R33 structure is explicitly milestone-driven, meaning applicants should define clear milestones for feasibility (R61) and for verification/validation and performance demonstration (R33) to support a potential phase transition.

What kind of assays is NIH trying to stimulate through this FOA?

The focus is on laboratory assays that measure HIV susceptibility to broadly neutralizing antibodies (bNAbs). While no single technical approach is dictated, the clear intent is to move beyond exploratory techniques toward standardized procedures that can be implemented consistently across clinical laboratory environments.

Why are HIV bNAb susceptibility assays important?

HIV is genetically diverse and can escape immune pressure. Assays that quantify or help predict whether a virus is sensitive or resistant to specific bNAbs can inform clinical research decisions, such as selecting antibodies for trials, interpreting trial outcomes, and monitoring resistance patterns.

Does the FOA require a specific assay technology or platform?

No. The announcement does not dictate a single technical approach. It emphasizes innovation together with practical readiness and standardization appropriate for clinical laboratory use.

What does "clinical laboratory settings" imply for applicants?

It means applicants should plan beyond a bench prototype. Proposed methods should have a plausible path to being run, reproduced, and interpreted in laboratories that support clinical studies and patient-oriented research, including attention to practical constraints like robustness and inter-lab reproducibility.

Are clinical trials allowed under this funding opportunity?

No. The FOA title explicitly states "Clinical Trial Not Allowed." The supported work should focus on assay development, verification, and validation activities rather than interventional clinical trial testing.

If clinical trials are not allowed, can the work still support clinical research?

Yes. Even though clinical trials are not allowed, the assays are intended to be usable in clinical laboratory contexts and to support clinical research by helping with antibody selection, outcome interpretation, and resistance monitoring.

What types of teams are encouraged to apply?

Collaborative and interdisciplinary teams are strongly encouraged, especially partnerships that bridge academia and industry. The translation from concept to a validated clinical-lab-ready assay often benefits from combining expertise in virology, immunology, assay engineering, biostatistics, quality systems, clinical laboratory operations, and potentially product development and manufacturing considerations.

Why does the FOA emphasize academia-industry collaboration?

Because developing an assay that is not only innovative but also clinically implementable often requires capabilities that span discovery science and practical deployment, including standardization, operational fit in clinical labs, and considerations related to scaling and reproducibility.

What practical performance or implementation factors does NIH highlight?

The FOA highlights practical constraints and readiness factors such as throughput, cost, robustness, and inter-lab reproducibility, alongside the need for interpretable outputs and clinically meaningful performance characteristics.

What is the CFDA number and general program area?

The opportunity is listed as CFDA 93.855 and is described as a discretionary grant program in the health area.

What is the funding mechanism and category?

The mechanism is a grant, and the funding category is discretionary.

Who is eligible to apply?

Eligibility is broad and includes state, county, city or township, and 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/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (outside of higher education); for-profit organizations (other than small businesses); and small businesses.

Are specific institution types explicitly highlighted as eligible?

Yes. The announcement highlights additional eligible applicants such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions.

Can non-U.S. institutions apply directly?

No. Non-U.S. institutions are not eligible to apply directly for this opportunity.

Can a U.S.-based applicant include foreign collaborators or activities?

Yes. While non-U.S. institutions cannot apply directly and non-U.S. components of U.S. organizations are not eligible, foreign components (as defined under the NIH Grants Policy Statement) are allowed when included by a U.S.-based applicant and when justified and compliant with NIH policy.

When was this opportunity created and what was the original closing date?

The opportunity was created on March 10, 2022, and the original closing date was August 3, 2022.

What is NIH ultimately expecting as an output from funded projects?

NIH is aiming for susceptibility assay methods that progress from feasibility to a more mature, verified and validated approach with demonstrated performance characteristics, suitable for consistent implementation in clinical laboratory environments.

Does this FOA support only incremental improvements, or also new approaches?

The emphasis is on innovation paired with practical readiness. That framing supports both novel assay concepts and improved methods, as long as the work moves toward standardized, clinically implementable susceptibility testing.