Opportunity Information: Apply for PA 16 184
Apply for PA 16 184
- The HHS-NIH11 in the health sector is offering a public funding opportunity titled "Strategies for the Improvement of HIV Envelope Protein Expression and Yield (R43/R44)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855, 93.856,.
- This funding opportunity was created on Apr 12, 2016 and posted on Apr 12, 2016.
- Applicants must submit their applications by Apr 05, 2019. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Small businesses.
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Opportunity Summary:
The Strategies for the Improvement of HIV Envelope Protein Expression and Yield (R43/R44) funding opportunity (PA 16-184) is an NIH small business-focused grant program designed to accelerate practical, commercially viable solutions for making HIV envelope (Env) proteins easier to produce at high quality and in higher quantities. The core problem it targets is that HIV Env proteins, which are central to many vaccine and antibody-related research efforts, can be difficult to express consistently, can yield low amounts, and may require complicated purification steps that are hard to scale or standardize. This FOA is meant to drive innovation that directly improves Env protein expression and overall yield, while also supporting the development of faster, broadly applicable purification approaches that can reliably produce material suitable for clinical research use.
This opportunity uses the Small Business Innovation Research (SBIR) mechanism, specifically the R43/R44 pathway, which corresponds to the typical Phase I and Phase II SBIR structure. In practice, that means the program supports early proof-of-concept work (Phase I, R43) followed by a larger stage focused on further development and validation (Phase II, R44), with an emphasis on advancing technologies that could realistically move toward productization and broader adoption. The announcement explicitly encourages collaboration between small business concerns (the eligible applicant type) and academic partners, reflecting the idea that academic groups often contribute novel platform concepts and deep technical expertise, while small companies are positioned to translate those ideas into standardized, scalable, and market-ready products or services.
From a technical standpoint, the FOA is looking for innovative strategies and enabling technologies that address three closely related needs: better expression of HIV Env proteins, higher yield of usable product, and rapid "universal" purification platforms. "Universal" in this context signals interest in methods that are not narrowly tailored to a single Env construct but can be applied broadly across different Env variants or design formats, ideally simplifying downstream workflows. Just as important, the purification approaches are expected to align with regulatory expectations for clinical research materials, meaning applicants should be thinking about reproducibility, robustness, quality attributes, and documentation-friendly processes that could be compatible with producing proteins used in clinical studies, not just exploratory lab experiments. The FOA also highlights commercial potential as a requirement, so successful projects are expected to have a plausible pathway to becoming a product, platform, or service offering that others can adopt.
Administratively, the opportunity is a discretionary grant under the NIH umbrella within the U.S. Department of Health and Human Services (Agency listed as HHS-NIH11). It falls under the health funding activity category and is associated with CFDA numbers 93.855 and 93.856. The announcement was created and posted on April 12, 2016, and the listed closing date for applications was April 5, 2019. While the source data provided does not specify an award ceiling or the expected number of awards, the intent is clearly to support SBIR-appropriate development work that can demonstrate measurable improvements in Env production and purification and position the resulting technology for continued development and commercialization.
Frequently Asked Questions (FAQs)
What is the funding opportunity called?
The opportunity is titled Strategies for the Improvement of HIV Envelope Protein Expression and Yield (R43/R44) and is identified as PA 16-184.
Which agency is offering this grant?
This is an NIH funding opportunity under the U.S. Department of Health and Human Services. The agency is listed as HHS-NIH11.
What type of grant mechanism does this opportunity use?
The opportunity uses the Small Business Innovation Research (SBIR) mechanism, specifically the R43/R44 pathway.
What do R43 and R44 mean in this context?
R43 and R44 correspond to the typical SBIR structure:
- R43 (Phase I): early proof-of-concept work
- R44 (Phase II): a larger stage focused on further development and validation
Who is this program designed for?
This program is small business-focused. The eligible applicant type described is a small business concern (consistent with SBIR).
Is collaboration with academic partners allowed or encouraged?
Yes. The announcement explicitly encourages collaboration between small businesses and academic partners, reflecting the idea that academic groups may contribute platform concepts and technical expertise while small companies translate them into standardized, scalable, market-ready solutions.
What problem is this FOA trying to solve?
The FOA targets practical barriers to producing HIV envelope (Env) proteins, including inconsistent expression, low yields, and complicated purification steps that are difficult to scale or standardize.
What are HIV Env proteins, and why do they matter for this opportunity?
HIV envelope (Env) proteins are central to many vaccine and antibody-related research efforts. This funding opportunity is focused on making Env proteins easier to produce at high quality and in higher quantities.
What kinds of projects is the FOA looking to fund?
The FOA is looking for innovative strategies and enabling technologies that address three closely related needs:
- Better expression of HIV Env proteins
- Higher yield of usable product
- Rapid, broadly applicable ("universal") purification platforms
What does "universal purification" mean in this FOA?
"Universal" signals interest in purification methods that are not narrowly tailored to a single Env construct. The goal is broader applicability across different Env variants or design formats to simplify downstream workflows.
Does the FOA emphasize scalability and standardization?
Yes. A core motivation is to reduce reliance on complicated purification steps that are hard to scale or standardize and to support approaches that can be used reliably across contexts.
Are projects expected to produce material suitable for clinical research use?
Yes. The purification approaches are expected to align with regulatory expectations for clinical research materials, including considerations such as reproducibility, robustness, quality attributes, and documentation-friendly processes.
Is this FOA meant for exploratory lab research only?
No. While it supports R&D, the stated intent is to accelerate practical solutions that can produce reliable material suitable for clinical research use, not just exploratory experiments.
Is commercialization important for this opportunity?
Yes. The FOA highlights commercial potential as a requirement. Projects are expected to have a plausible pathway to productization and broader adoption (as a product, platform, or service).
What kind of outcomes would be considered responsive to the FOA's intent?
Based on the description, responsive outcomes would demonstrate measurable improvements in Env protein expression and overall yield, along with faster, broadly applicable purification approaches that are robust and compatible with clinical research expectations.
What is the funding activity category?
The opportunity is listed under the health funding activity category.
What CFDA numbers are associated with this opportunity?
The opportunity is associated with CFDA numbers 93.855 and 93.856.
When was this funding opportunity posted?
The announcement was created and posted on April 12, 2016.
What was the closing date for applications?
The listed closing date for applications was April 5, 2019.
Does the provided information include an award ceiling or the expected number of awards?
No. The source data provided does not specify an award ceiling or the expected number of awards.
How does this FOA relate to Phase I vs. Phase II development?
The program is structured to support initial proof-of-concept work (Phase I, R43) and then support further development and validation (Phase II, R44), with an emphasis on solutions that can realistically move toward commercialization.
What is the overall goal of the program in plain terms?
The program is designed to help small businesses develop commercially viable ways to produce HIV Env proteins more consistently, at higher quality, and in higher quantities, while also simplifying purification in a way that can be broadly used and compatible with clinical research needs.
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