Opportunity Information: Apply for PA 14 308
Apply for PA 14 308
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Platform Delivery Technologies for Nucleic Acid Therapeutics (R41/R42)" 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 (R41/R42), Funding Opportunity Number PA 14-308, is an NIH discretionary grant program designed to push forward practical, broadly usable delivery systems for nucleic acid-based medicines. The central goal is to spur small businesses to create new platform technologies and products that can reliably deliver nucleic acids into cells and tissues, supporting the treatment or prevention of human disease. In other words, the emphasis is not simply on a single drug candidate, but on enabling delivery approaches that can be applied across multiple nucleic acid modalities and disease areas, addressing one of the biggest bottlenecks in the field: getting these molecules to the right place in the body, into the right cells, at effective levels, with acceptable safety.
This opportunity uses the SBIR Phase I and Phase II mechanism (R41/R42), which is built around early-stage feasibility followed by more advanced development and validation. Phase I typically supports proof-of-concept work that reduces key technical risks, while Phase II supports more substantial R and D aimed at developing, optimizing, and demonstrating the technology in more rigorous and relevant settings. The activity category is Health, and the sponsoring agency is the National Institutes of Health, with the CFDA listing 93.350 associated with the National Center for Advancing Translational Sciences. The program is explicitly framed to incentivize commercialization-focused R and D by small businesses, meaning the expected outputs tend to be tangible deliverables such as delivery platforms, formulations, materials, devices, enabling methods, or other product-like technologies that can form the basis of downstream therapeutic programs and licensing or partnership activity.
Eligibility is limited to United States small business concerns. To qualify, an applicant must be a for-profit entity with a place of business in the United States and operations primarily within the United States (or otherwise make a significant contribution to the U.S. economy through taxes or use of U.S. products, materials, or labor). Acceptable legal structures include sole proprietorships, partnerships, LLCs, corporations, joint ventures, associations, trusts, or cooperatives, with additional limits for joint ventures to ensure foreign entities do not hold 50 percent or more participation. Ownership and control requirements follow SBIR rules, allowing majority ownership by U.S. citizens or permanent residents, or by other qualifying U.S.-owned businesses, and in certain SBIR cases allowing majority ownership by multiple venture capital operating companies, hedge funds, or private equity firms so long as no single such entity owns more than 50 percent. The firm must also have no more than 500 employees including affiliates, which is the standard SBA size limit for SBIR eligibility in most cases.
From an administrative standpoint, this was a posted NIH funding announcement dated August 4, 2014, with an original and final closing date of September 7, 2016, and an archive date of October 8, 2016. It was offered as a grant (not a contract), with no cost sharing or matching requirement, which is important for early-stage technology development where requiring match could limit participation by smaller or newer companies. The full announcement was hosted on the NIH grants site under the PA 14-308 notice, and NIH Office of Extramural Research support contacts were provided for applicants who encountered technical access or linking issues.
Overall, the opportunity is best understood as a targeted SBIR pathway for companies building the next generation of delivery solutions that make nucleic acid therapeutics more viable in real clinical settings. It aims to strengthen the translational pipeline by backing platform delivery innovations that can unlock efficacy, improve tissue targeting, increase cellular uptake, enhance stability, and reduce toxicity or immunogenicity, ultimately enabling more nucleic acid therapies to reach patients.
Frequently Asked Questions (FAQs)
What is the name of this funding opportunity?
The opportunity is titled Platform Delivery Technologies for Nucleic Acid Therapeutics (R41/R42).
What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number is PA 14-308.
Which agency sponsors this program?
The sponsoring agency is the National Institutes of Health (NIH).
What is the activity category for this opportunity?
The activity category is Health.
Is this a grant or a contract?
This opportunity was offered as a grant (not a contract).
What mechanism does this opportunity use?
It uses the SBIR Phase I and Phase II mechanism under R41/R42.
What is the purpose of this SBIR program?
The central purpose is to push forward practical, broadly usable delivery systems for nucleic acid-based medicines by supporting commercialization-focused research and development by small businesses.
What kinds of technologies is NIH trying to advance through this announcement?
The focus is on platform delivery technologies that can reliably deliver nucleic acids into cells and tissues. The intent is to enable delivery approaches that are usable across multiple nucleic acid modalities and disease areas, rather than supporting only a single therapeutic candidate.
Does the program emphasize a single drug candidate or a platform approach?
The emphasis is on a platform approach. The opportunity is framed around enabling delivery technologies that can be applied broadly across nucleic acid therapeutics, not simply advancing one specific drug candidate.
What problem area is this opportunity trying to address?
It targets a major bottleneck in nucleic acid therapeutics: getting nucleic acids to the right place in the body, into the right cells, at effective levels, with acceptable safety.
What is the typical goal of SBIR Phase I under this opportunity?
Phase I typically supports early-stage feasibility and proof-of-concept work intended to reduce key technical risks for the proposed delivery platform.
What is the typical goal of SBIR Phase II under this opportunity?
Phase II typically supports more substantial research and development to develop, optimize, and demonstrate the technology in more rigorous and relevant settings.
Who is eligible to apply?
Eligibility is limited to United States small business concerns that meet SBIR requirements.
What type of organization must the applicant be?
The applicant must be a for-profit entity with a place of business in the United States and operations primarily within the United States, or otherwise make a significant contribution to the U.S. economy through taxes or use of U.S. products, materials, or labor.
Which legal structures are acceptable for applicants?
Acceptable legal structures include sole proprietorships, partnerships, LLCs, corporations, joint ventures, associations, trusts, or cooperatives.
Are there any special limitations for joint ventures?
Yes. Joint ventures are subject to additional limits intended to ensure that foreign entities do not hold 50 percent or more participation.
What are the ownership and control requirements?
Ownership and control follow SBIR rules, including majority ownership by U.S. citizens or permanent residents, or by other qualifying U.S.-owned businesses. In certain SBIR cases, majority ownership by multiple venture capital operating companies, hedge funds, or private equity firms is allowed, as long as no single such entity owns more than 50 percent.
Is there an employee size limit for eligibility?
Yes. The firm must have no more than 500 employees, including affiliates (the standard SBA size limit for SBIR eligibility in most cases, as described in the opportunity summary).
Is cost sharing or matching required?
No. The announcement specifies no cost sharing or matching requirement.
When was this funding announcement posted?
The announcement was posted on August 4, 2014.
What were the closing dates for this opportunity?
The original and final closing date listed was September 7, 2016.
When was this opportunity archived?
The archive date was October 8, 2016.
Where was the full announcement hosted?
The full announcement was hosted on the NIH grants website under the PA 14-308 notice.
Is there a CFDA listing associated with this opportunity?
Yes. The CFDA listing referenced is 93.350, associated with the National Center for Advancing Translational Sciences.
What kinds of deliverables does the program expect from awardees?
The program is framed to incentivize commercialization-focused R&D, so expected outputs tend to be tangible deliverables such as delivery platforms, formulations, materials, devices, enabling methods, or other product-like technologies that can support downstream therapeutic programs and partnering activity.
What improvements in delivery performance are highlighted as program aims?
The opportunity highlights delivery innovations that can unlock efficacy, improve tissue targeting, increase cellular uptake, enhance stability, and reduce toxicity or immunogenicity, helping nucleic acid therapies become more viable in real clinical settings.
Who could applicants contact if they had technical access or linking issues?
The announcement notes that NIH Office of Extramural Research support contacts were provided for applicants who experienced technical access or linking issues.
Browse more opportunities from the same category: Health
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Previous opportunity: Platform Delivery Technologies for Nucleic Acid Therapeutics (R43/R44)
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