Opportunity Information: Apply for PA 16 182
Apply for PA 16 182
- 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 (R41/R42)" 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 funding opportunity titled "Strategies for the Improvement of HIV Envelope Protein Expression and Yield (R41/R42)" (Funding Opportunity Number: PA-16-182) is a discretionary NIH grant program under the U.S. Department of Health and Human Services. It uses the Small Business Technology Transfer (STTR) mechanism, specifically the R41 (Phase I) and R42 (Phase II) award types, which are designed to support early-stage development and then further research and development toward a product. The overall focus is on advancing practical, innovative solutions that can make HIV envelope (Env) proteins easier to produce at higher yields and with consistent quality suitable for clinical research settings.
The core goal of the announcement is to stimulate collaborations between eligible small business concerns and nonprofit research institutions to develop technologies that improve HIV Env protein expression and manufacturing outcomes. HIV Env proteins are central to many HIV vaccine and antibody-related research programs, but they are often difficult to express and purify in ways that preserve correct structure, maintain consistency from batch to batch, and scale to quantities needed for advanced testing. This FOA targets innovations that address those bottlenecks, with an emphasis on approaches that can reliably increase expression levels, improve overall yield, and streamline purification so that the resulting material is usable for clinical research purposes.
A major priority called out in the description is the development of rapid, universal purification platforms for HIV Env proteins. In practice, this points to purification strategies that are broadly applicable across different Env variants or constructs, reduce processing time and complexity, and produce a consistent product. The FOA also highlights that the technologies should meet the requirements of regulatory agencies for clinical research use. That language typically signals an expectation that applicants will consider quality and compliance factors early, such as reproducibility, product characterization, process controls, and the kinds of documentation and standards that become important when materials are intended for use in regulated or near-regulated environments (for example, materials supporting clinical investigations).
Commercial potential is explicitly required. This means applicants are expected to propose solutions that are not just academically interesting, but that could realistically be translated into products or services that can be sustained in the marketplace. Examples could include improved expression systems, optimized production cell lines, novel vectors or constructs that boost Env expression, new formulation or stabilization methods that preserve functional conformation, or platform purification methods that could be offered as a kit, reagent system, contract service, or scalable manufacturing workflow. The STTR structure also reinforces commercialization goals by requiring a formal partnership between a small business and a nonprofit research institution, leveraging academic expertise while keeping product development and commercialization planning anchored in the small business.
Eligibility is limited to small businesses, consistent with the STTR program rules, and the project itself is expected to be a cooperative effort between the small business concern and a nonprofit research institution. The funding activity category is Health, and the listed CFDA numbers are 93.855 and 93.856, which correspond to NIH programs associated with infectious disease and allergy/immunology research areas. The administering agency is NIH (listed as HHS-NIH11 in the source data). The FOA was created and posted on April 12, 2016, and the closing date shown is April 5, 2019. The source data does not specify an award ceiling or the expected number of awards, which usually means applicants would need to consult the full FOA text for budget guidelines, phase-specific limits, project periods, and any special review considerations.
In short, PA-16-182 is aimed at enabling better, faster, and more scalable production of HIV envelope proteins by funding STTR projects that combine small business commercialization capability with nonprofit research expertise. The desired outputs are improved expression and yield and broadly usable purification approaches that can produce Env proteins at a quality level appropriate for clinical research use, with a clear path toward commercialization.
Frequently Asked Questions (FAQs)
What is the name of this funding opportunity?
The funding opportunity is titled "Strategies for the Improvement of HIV Envelope Protein Expression and Yield (R41/R42)."
What is the funding opportunity number?
The funding opportunity number is PA-16-182.
Which federal department and agency administer this program?
This is a discretionary NIH grant program under the U.S. Department of Health and Human Services (HHS), administered by the National Institutes of Health (NIH) (listed as HHS-NIH11 in the source data).
What type of grant mechanism does this opportunity use?
This opportunity uses the Small Business Technology Transfer (STTR) mechanism.
Which award types (phases) are supported under this STTR opportunity?
The FOA supports R41 (Phase I) and R42 (Phase II) award types. Phase I supports early-stage development, and Phase II supports further research and development toward a product.
What is the overall purpose of PA-16-182?
The overall purpose is to advance practical, innovative solutions that make HIV envelope (Env) proteins easier to produce at higher yields and with consistent quality suitable for clinical research settings.
What specific technical problems is the FOA trying to solve?
The FOA targets common bottlenecks in HIV Env protein production, including difficulty expressing and purifying Env proteins in ways that preserve correct structure, ensure batch-to-batch consistency, and scale to quantities needed for advanced testing.
What kinds of improvements does NIH want to see for HIV Env protein production?
The FOA emphasizes approaches that can reliably increase expression levels, improve overall yield, and streamline purification so the resulting Env protein material is usable for clinical research purposes.
Is there a priority area highlighted in the announcement?
Yes. A major priority is the development of rapid, universal purification platforms for HIV Env proteins.
What does "rapid, universal purification platforms" mean in the context of this FOA?
Based on the description, it refers to purification strategies that are broadly applicable across different Env variants or constructs, reduce processing time and complexity, and produce a consistent product.
Does the FOA focus on product quality and consistency?
Yes. The description highlights the need for correct structure, consistency from batch to batch, and outputs suitable for clinical research use.
Are applicants expected to consider regulatory expectations?
Yes. The FOA notes that technologies should meet the requirements of regulatory agencies for clinical research use, signaling an expectation that quality and compliance factors are considered early (such as reproducibility, product characterization, and process controls).
Is commercialization required, or is basic academic research enough?
Commercial potential is explicitly required. Applicants are expected to propose solutions that can realistically be translated into products or services that can be sustained in the marketplace, not only academically interesting research.
How does the STTR structure support commercialization goals?
The STTR structure requires a formal partnership between a small business and a nonprofit research institution, leveraging academic expertise while keeping product development and commercialization planning anchored in the small business.
Who is eligible to apply?
Eligibility is limited to small businesses, consistent with STTR program rules.
Is a partner organization required?
Yes. The project is expected to be a cooperative effort between an eligible small business concern and a nonprofit research institution.
What kinds of project outputs or solution types are suggested by the FOA?
Examples mentioned include improved expression systems, optimized production cell lines, novel vectors or constructs that boost Env expression, new formulation or stabilization methods that preserve functional conformation, and platform purification methods that could be offered as a kit, reagent system, contract service, or scalable manufacturing workflow.
What is the main scientific focus area (topic) of the funded projects?
The focus is on technologies to improve HIV envelope (Env) protein expression, yield, purification, and manufacturing outcomes, with an emphasis on consistent quality appropriate for clinical research settings.
What is the funding activity category?
The listed funding activity category is Health.
What CFDA numbers are associated with this opportunity?
The listed CFDA numbers are 93.855 and 93.856.
When was this FOA created and posted?
The FOA was created and posted on April 12, 2016.
What is the closing date shown in the source data?
The closing date shown is April 5, 2019.
Does the provided information list an award ceiling or the expected number of awards?
No. The source data does not specify an award ceiling or the expected number of awards.
Where would an applicant typically find budget guidelines and phase-specific limits?
Because the source data does not include those details, applicants would typically need to consult the full FOA text for budget guidelines, phase-specific limits, project periods, and any special review considerations.
What is the key takeaway of PA-16-182 in plain terms?
PA-16-182 funds STTR projects that bring small businesses and nonprofit research institutions together to make HIV Env proteins faster and easier to produce at higher yields, with consistent, clinically usable quality and a clear path to commercialization.
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