Platform Delivery Technologies for Nucleic Acid Therapeutics (R43/R44) | PAR 17 035

FAQs: Platform Delivery Technologies for Nucleic Acid Therapeutics (R43/R44) (NIH SBIR)

1) What is this funding opportunity?

Platform Delivery Technologies for Nucleic Acid Therapeutics (R43/R44) is a National Institutes of Health (NIH) small business funding opportunity aimed at advancing delivery technologies that help nucleic acid-based therapeutics move from concept to real-world treatment or prevention of human disease.

2) What is the main goal of the program?

The central goal is to incentivize broadly useful, platform-style delivery approaches and enabling products. The emphasis is not on funding a single drug candidate, but on solving a key bottleneck in the field: delivering nucleic acids into the right cells and tissues safely and efficiently, in a clinically meaningful way.

3) What kinds of technologies does this opportunity focus on?

It targets innovations that make it easier to deliver nucleic-acid payloads into the body and into cells where they can function. The focus is on delivery technologies that can be used across multiple therapeutic programs, rather than one narrow, single-use solution.

4) What therapeutic payloads are mentioned as in-scope?

The opportunity explicitly mentions delivery of modalities such as DNA, RNA, antisense oligonucleotides, siRNA, mRNA, gene-editing components, or other nucleic-acid payloads.

5) Which NIH grant mechanisms are used for this opportunity?

This is an NIH SBIR/STTR-family opportunity using the R43 and R44 activity codes, which correspond to Small Business Innovation Research (SBIR) phased development awards.

6) What is the difference between R43 and R44 in this announcement?

R43 is typically aligned with early feasibility and proof-of-concept work (Phase I). R44 is used for more advanced development activities (Phase II), including scaling, optimization, and validation, with an expectation that successful projects progress toward commercialization and real-world deployment.

7) What types of project work does NIH expect delivery platforms to go through under this program?

The program is meant to support iterative technical maturation often required for delivery platforms, such as prototype formulation, initial in vitro studies, in vivo biodistribution, dosing strategy refinement, and manufacturability considerations.

8) Who is eligible to apply?

Eligibility is focused on small businesses that meet NIH small business requirements. The applicant organization must be a U.S.-based small business under the terms described in the opportunity information provided.

9) Are foreign institutions eligible to apply?

No. Foreign institutions are explicitly not eligible to apply.

10) Are non-U.S. components of U.S. organizations eligible to apply?

No. Non-U.S. components of U.S. organizations are also explicitly not eligible to apply.

11) Is any foreign involvement allowed at all?

The opportunity notes that foreign components (as defined under the NIH Grants Policy Statement) may be allowed in certain cases. In practical terms, this usually means limited, well-justified elements of work could be performed abroad if necessary for the project and if they comply with NIH policy.

12) What does the term "foreign component" mean in the context of this opportunity?

The announcement references the NIH Grants Policy Statement definition. Based on the information provided, the key point is that a foreign component can sometimes be permitted in limited and justified circumstances, but it does not make a foreign institution eligible as the applicant and does not permit a non-U.S. organizational component to apply.

13) What is the sponsoring agency?

The sponsor is the National Institutes of Health (NIH).

14) How is this opportunity categorized administratively?

It is categorized as a discretionary grant under the health funding activity category.

15) What is the Funding Opportunity Number?

The Funding Opportunity Number provided is PAR 17 035.

16) When was this funding opportunity created?

The creation date listed is 2016-10-27.

17) What is the closing date listed for this announcement?

The original closing date listed is 2019-09-05, indicating the formal submission window associated with this announcement.

18) Are award amounts, award ceilings, or the number of expected awards provided?

No. Award ceiling and expected awards are not specified in the provided data. Applicants typically need to consult the full funding announcement for budget guidance, any caps, and institute-specific expectations.

19) What CFDA numbers are associated with this opportunity?

The listing includes CFDA numbers 93.286, 93.350, 93.855, and 93.856.

20) Is commercialization an expected outcome?

Yes. The R44 (Phase II) description includes an expectation that successful projects progress toward commercialization and real-world deployment, reflecting the product-oriented nature of the SBIR phased development structure.

21) What makes this opportunity different from funding a single therapeutic candidate?

This opportunity prioritizes platform approaches and enabling technologies that can generalize across multiple nucleic acid therapeutic programs. The intent is to remove delivery barriers that limit efficacy, safety, tissue targeting, durability, and translation from lab studies to human use, rather than focusing on just one drug candidate.

22) What problem area is this program trying to address in the field?

It targets one of the biggest bottlenecks in nucleic acid therapeutics: getting nucleic acids into the right cells and tissues safely, efficiently, and in a clinically meaningful way.