Opportunity Information: Apply for PA 14 307
Apply for PA 14 307
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Platform Delivery Technologies for Nucleic Acid Therapeutics (R43/R44)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.350 National Center for Advancing Translational Sciences.
- This funding opportunity was created on Aug 4, 2014 and posted on Aug 4, 2014.
- Applicants must submit their applications by Sep 7, 2016. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Small businesses.
- Other Eligible Applicants include the following Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity. A small business concern is one that, at the time of award of Phase I and Phase II, meets all of the following criteria 1. Is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor 2. Is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there must be less than 50 percent participation by foreign business entities in the joint venture 3. (i) SBIR and STTR. Be a concern which is more than 50 directly owned and controlled by one or more individuals (who are citizens or permanent resident aliens of the United States), other business concerns (each of which is more than 50 directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States), or any combination of these OR (ii) SBIR only. Be a concern which is more than 50 owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these. No single venture capital operating company, hedge fund, or private equity firm may own more than 50 of the concern OR (iii) SBIR and STTR. Be a joint venture in which each entity to the joint venture must meet the requirements set forth in paragraph 3 (i) or 3 (ii) of this section. A joint venture that includes one or more concerns that meet the requirements of paragraph (ii) of this section must comply with 121.705(b) concerning registration and proposal requirements. 4. Has, including its affiliates, not more than 500 employees.
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Opportunity Summary:
Platform Delivery Technologies for Nucleic Acid Therapeutics (R43/R44) is an NIH small business funding opportunity (SBIR/STTR-style phased awards) aimed at pushing forward practical, broadly usable delivery platforms for nucleic acid medicines. The central problem it targets is that many nucleic acid therapeutics (for example, DNA-, RNA-, or oligonucleotide-based approaches) have strong potential to treat or prevent disease, but their clinical impact is often limited by the difficulty of getting these molecules into the right cells and tissues safely, efficiently, and reproducibly. This program is designed to motivate small companies to create new delivery technologies and products that can move beyond one-off solutions and become platform tools that can be adapted across multiple nucleic acid modalities and disease areas.
The opportunity is listed as a discretionary grant under Funding Opportunity Number PA-14-307, titled "Platform Delivery Technologies for Nucleic Acid Therapeutics (R43/R44)." It sits within the NIH funding ecosystem and is associated with the National Center for Advancing Translational Sciences (NCATS) under CFDA 93.350. There is no cost sharing or matching requirement, which matters for early-stage companies because it reduces the need for additional committed funds to participate. The announcement was posted on August 4, 2014, and the application window ran through September 7, 2016, with the archive date listed as October 8, 2016.
The structure implied by R43/R44 is the classic two-phase small business pathway: Phase I (R43) generally supports early feasibility and proof-of-concept work, while Phase II (R44) supports more substantial R&D to further develop the technology toward commercialization and real-world deployment. In practice, this means applicants are expected to propose a technical plan that starts with a clear demonstration that the delivery concept works and can be measured, then progresses toward optimization, reproducibility, manufacturability, and readiness for downstream translation. Because the emphasis is on delivery as a platform, the strongest projects typically focus on enabling capabilities such as improved tissue targeting, intracellular trafficking, endosomal escape, reduced toxicity or immunogenicity, enhanced stability in vivo, scalable formulation or manufacturing approaches, and delivery that can be generalized to multiple nucleic acid payloads rather than being locked to a single candidate therapy.
Eligibility is limited strictly to United States small business concerns. To qualify, an applicant must be organized for profit and have a place of business in the U.S., operating primarily within the U.S. or making a meaningful contribution to the U.S. economy through taxes or the use of American products, materials, or labor. The business must fit an allowable legal form (such as an individual proprietorship, partnership, LLC, corporation, joint venture, association, trust, or cooperative), and if it is a joint venture there must be less than 50 percent participation by foreign business entities. Ownership and control rules follow SBIR/STTR standards: in many cases the firm must be more than 50 percent owned and controlled by U.S. citizens or permanent resident aliens (either directly by individuals or through qualifying entities), while SBIR-only rules can also allow majority ownership by multiple venture capital operating companies, hedge funds, or private equity firms as long as no single one owns more than 50 percent. Finally, the firm (including affiliates) must have no more than 500 employees at the time of award for both Phase I and Phase II.
Overall, the program is best understood as a commercialization-oriented R&D push: NIH is using grant funding to reduce the technical risk of enabling delivery technologies that could unlock a wide range of nucleic acid therapeutics. The focus is not simply on discovering a new nucleic acid drug, but on building the delivery methods, systems, and products that make nucleic acid treatments workable in real biological settings. Applicants that fit the intent are typically those developing delivery vehicles, formulations, targeting strategies, or device-enabled delivery approaches that can be validated with strong, quantitative data and then matured into products that can be partnered, licensed, or used to support multiple therapeutic pipelines.
For reference and full details, the announcement link provided is: http://grants.nih.gov/grants/guide/pa-files/PA-14-307.html. If there are access or linking issues, the NIH Office of Extramural Research (OER) webmaster contact listed is FBOWebmaster@OD.NIH.GOV.
FAQs: Platform Delivery Technologies for Nucleic Acid Therapeutics (R43/R44) - NIH (PA-14-307)
What is the purpose of this funding opportunity?
This NIH small business funding opportunity supports the development of practical, broadly usable delivery platforms for nucleic acid therapeutics. It targets a common barrier in the field: many DNA-, RNA-, and oligonucleotide-based medicines are limited in clinical impact because it is difficult to deliver these molecules to the right cells and tissues safely, efficiently, and reproducibly.
What types of therapeutics does it focus on?
The program is aimed at nucleic acid therapeutics, including DNA-based, RNA-based, and oligonucleotide-based approaches. The emphasis is on delivery technologies that can support these modalities in real biological settings.
Is this opportunity about developing a new drug candidate or a delivery platform?
The main focus is delivery as a platform. The intent is not simply to discover a single nucleic acid drug, but to build delivery methods, systems, or products that make nucleic acid therapeutics workable and that can be adapted across multiple payloads and disease areas.
What does "platform delivery technology" mean in this context?
In this announcement, "platform" means a delivery approach intended to be broadly usable rather than a one-off solution. Strong projects are typically those that can be generalized to multiple nucleic acid payloads (different DNA/RNA/oligonucleotide cargos) and potentially multiple disease applications.
What is the Funding Opportunity Number (FOA) and title?
The FOA is PA-14-307, titled "Platform Delivery Technologies for Nucleic Acid Therapeutics (R43/R44)."
Which NIH organization is associated with this opportunity?
The opportunity is associated with the National Center for Advancing Translational Sciences (NCATS).
What is the CFDA number listed for this program?
The CFDA number provided is 93.350.
What kind of grant mechanism is this?
This is an NIH small business opportunity using the R43/R44 phased award structure, which is commonly associated with SBIR/STTR-style funding.
How do the R43 and R44 phases differ?
Phase I (R43) generally supports early feasibility and proof-of-concept work. Phase II (R44) generally supports more substantial R&D to further develop the technology toward commercialization and real-world deployment.
What kinds of technical progress are applicants expected to show across phases?
Based on the program description, applicants are expected to begin with a clear, measurable demonstration that the delivery concept works (feasibility/proof-of-concept), then progress toward optimization, reproducibility, manufacturability, and readiness for downstream translation and commercialization.
What technical areas are highlighted as strong fits for this program?
The description emphasizes enabling delivery capabilities such as improved tissue targeting, intracellular trafficking, endosomal escape, reduced toxicity or immunogenicity, enhanced in vivo stability, scalable formulation or manufacturing approaches, and delivery approaches that can be generalized across multiple nucleic acid payloads.
Who is eligible to apply?
Eligibility is limited strictly to United States small business concerns.
What organizational requirements apply to the small business?
The business must be organized for profit and have a place of business in the United States. It must operate primarily within the U.S. or make a meaningful contribution to the U.S. economy through taxes or through the use of American products, materials, or labor.
What legal forms of business are allowed?
Allowable forms include an individual proprietorship, partnership, LLC, corporation, joint venture, association, trust, or cooperative.
Are there restrictions related to foreign participation in a joint venture?
Yes. If the applicant is a joint venture, there must be less than 50 percent participation by foreign business entities.
What ownership and control rules apply?
Ownership and control follow SBIR/STTR standards as described in the opportunity summary. In many cases, the firm must be more than 50 percent owned and controlled by U.S. citizens or permanent resident aliens (directly by individuals or through qualifying entities). The summary also notes that SBIR-only rules can allow majority ownership by multiple venture capital operating companies, hedge funds, or private equity firms, as long as no single entity owns more than 50 percent.
Is there an employee headcount limit?
Yes. The firm (including affiliates) must have no more than 500 employees at the time of award for both Phase I and Phase II.
Is cost sharing or matching required?
No. The opportunity states there is no cost sharing or matching requirement.
What is the overall emphasis of the program?
The program is framed as a commercialization-oriented R&D push. NIH is using grant funding to reduce the technical risk of enabling delivery technologies that could unlock a wide range of nucleic acid therapeutics and be matured into products that can be partnered, licensed, or used to support multiple therapeutic pipelines.
When was the announcement posted and what were the application dates?
The announcement was posted on August 4, 2014. The application window ran through September 7, 2016, and the archive date is listed as October 8, 2016.
Where can I find the full FOA details?
The reference link provided is: http://grants.nih.gov/grants/guide/pa-files/PA-14-307.html.
Who should be contacted if there are access or linking issues with the FOA page?
The NIH Office of Extramural Research (OER) webmaster contact listed is FBOWebmaster@OD.NIH.GOV.
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