I Compared the Old vs. New NIH SBIR Program || Here's What Founders MUST Know for the Sept. 2026

So with the passing of the recent Reauthorization Act, most founders think the NIH just simply updated a couple of things in their solicitation for this September 2026 cycle. But that's quite not true. I did a deep dive in the brand new solicitation so you didn't have to, and I was shocked with some of the changes coming our way. So if you founders aren't aware of them, you could find yourself automatically disqualified over issues you might not even know existed. So make sure to watch until the end of this video where I'll walk you through some of the 10 biggest changes every founder needs to understand before applying for the NIH SBIR/STTR program in 2026. 2026 and beyond. Yes, that means we're talking about changing the budgets, the language you have to use, and sensitive partnering issues that could immediately get you booted. So let's jump into it. Hey guys, welcome back to the channel. If you're new here, I'm Stacy L Chin, a professional federal grants and contracting consultant who has helped to raise over $50 million of non-dilutive funding for startups developing innovations in biotech, climate, and defense. So the new NIH SBIR and STTR program just underwent one of the biggest overhauls I've ever seen. On the surface, it looks like the NIH simply released a brand new omnibus solicitation, but after looking into it deeper, I I can tell you that's not exactly what happened. For instance, the NIH has now completely changed how clinical trial applications are being submitted. They've created a brand new pathway that allows some companies to skip Phase 1 entirely. They've also dramatically changed the budget ceilings, introduced new national security and foreign collaboration restrictions, along with new cybersecurity requirements, tightened up compliance rules, and now putting more emphasis on commercialization than ever before. There's a bunch of others after this too. So in this video, I'm gonna break down the top 10 biggest changes, what they mean in plain English, and how that can impact your funding strategy be in 2026 and forward. Also, one quick note: for the rest of this video, I'm going to refer to the NIH's new omnibus solicitation PA-27-100 as the new parent omnibus, and I'll refer to the previous omnibus solicitations PA-24-245 and PA-24-246 as the old parent solicitation. I'll leave a link to the new funding parent solicitations in the description below so you can check that out. And before we dive into it, I want to ask you for a really quick favor. If you don't mind taking a second to subscribe to this channel, that helps us out tremendously to reach more founders looking for non-dilutive funding. It is completely free and one of the easiest ways to help us create content like this. Thank you so much, and now let's jump into it. Number 1: the two clinical trial twins collapse into one clinical trial optional parent solicitation. If you applied to the NIH SBIR program before, you probably asked yourself, to apply to the clinical trial requires solicitation, or to apply to the clinical trial not allow solicitation? That is the question, because if you pick the wrong one, your application could be dead upon arrival. Well, here's some good news: in the new parent omnibus, that is now gone. The NIH has now merged both pathways into a single funding clinical trial optional opportunity. So whether your project includes a clinical trial option or not, you'll still submit through the same parent omnibus solicitation and then identify your clinical trial status within the application itself. That might sound like an administrative change, but actually it's a meaningful simplification for our founders. Bottom line, there's now only one front door instead of two, making it much easier to determine whether your application— and reduces the risk of submitting through the wrong mechanism. And that's a win for us founders, in my opinion. Number 2, per IC budget ceilings now appear in the NOFO and they run far above SBA guidelines. So depending on the institute, NIH Phase I budgets can now be as high as $400,000 or even $700,000, while some Phase II awards can reach $2.5 million to even $3 million before any additional waivers are required. So how the heck did this all happen? Well, now NIH made institute fit way more important of a criteria than ever before, and this is one of the biggest practical changes in the new solicitation. So for many founders, choosing the right NIH institute home can mean the difference between a standard size award and millions of dollars of additional funding. In the past, agencies made issue a Phase 1 award up to $223,090 and a Phase 2 award up to $2.1 million in the old parent omnibus solicitation. Then you have to dig through each individual institute's website or a PDF file to figure out whether a higher budget was available through a budget waiver. But now the NIH has made things simple and put those numbers directly into the new parent omnibus solicitation. Woo! And for many institutes, those funding limits are much higher than the traditional SBIR/STTR caps. Here's a quick table of that breakdown of the budget limits per institute. And what makes this especially important is that the institute assignment now has real budget implications. The same technology could have drastically different funding ceilings depending on which NIH institute ultimately accepts and funds that application. Number 3, the Direct-to-Phase-II SBIR/STTR opportunity is now added to the parent omnibus solicitation. If your technology is beyond the proof of concept stage, you could skip Phase I altogether. NIH is now providing a faster path to larger awards for company if ready. So for founders, this could actually dramatically accelerate the funding process and potentially unlock millions of dollars of non-diluted funding much sooner. Under the old parent omnibus solicitations, companies generally had to start Phase 1 before becoming eligible for Phase 2 funding. But now, under the new parent omnibus solicitation, this now introduces a direct Phase 2 pathway. So that means if you already demonstrate technical feasibility, whether it's through investor funding, university research, internal R&D, or any other non-SBIR source, you may actually be able to apply directly to Phase 2 funding. And here's the key detail: the NIH does require the feasibility work to have been funded by NIH or even by the federal government. They care that you've proven the technology works. Number 4, the FDA has officially joined the full partner across the board. If you're developing a new medical device innovation, diagnostic, digital health platform, or any FDA-regulated technology, it's worth paying attention now. The process is becoming much more unified and easier to navigate, which is fantastic news for you founders. So for startups targeting FDA-funded SBIR opportunities, there's now one front door instead of multiple competing pathways. For instance, under the old parent omnibus solicitations, the FDA only participated in the clinical trial not allowed solicitation. If your project involved a clinical trial, you completely navigating a different funding pathway, and under the new parent omnibus solicitation brings the NIH, the CDC, and the FDA together under a single parent funding opportunity. Now that doesn't mean the FDA is suddenly funding clinical trials, but rather the FDA Center still does not accept clinical trial proposals under this mechanism. But it does mean founders no longer have to sort through separate omnibus solicitations just to determine whether FDA is participating. Number 5: a hard no late application rule. Under the previous old omnibus solicitations, late submissions could sometimes be accepted under NIH's standard late submission policies. So that means there was some flexibility under special circumstances. But now under the new parent omnibus solicitation, let's just say don't plan to submit your proposal at 4:55 PM on deadline day. The NIH effectively moved to a zero tolerance policy on late submissions, which will not be accepted, period. So for founders, that means deadline management is now more important than ever before. So if your application isn't submitted on time, you're not getting a second chance or a grace period. Number 6: foreign risk denial disclosure regime is dramatically expanded. And this is probably the biggest compliance change in the new parent solicitation. And that's because the national security review is now a core part of the NIH funding process. So centers should make sure they understand any potential disclosures or eligibility issues long before they hit that submit button. In the past, under the old parent omnibus solicitation, this focused more on foreign disclosure requirements and reporting obligations. But under the new parent omnibus solicitation, everything goes much further. The NIH now includes an expanded denial of awards framework that can make an application ineligible based on certain foreign affiliations, ownership structures, talent recruitment programs, or connections to federally designated watchlists. And here's the part that completely caught my attention. If the NIH identifies one of these risks, applicants generally do not get an opportunity to fix the issue before a funding decision is made. And the new progress also requires an SBA disclosure form for owners and other covered individuals during the just-in-time stage, adding another layer of scrutiny before an award can even be issued. So for most founders, this won't change anything, but for companies with international ownership, foreign affiliates, overseas investors, or complex corporate structures, this is something that has to be evaluated early on, not at the last minute. Number 7, a categorical bar on funded foreign subawards. This is a major policy change that could affect a surprising number of startups pursuing NIH SBIR funding this year and beyond. So international collaboration is still possible, but sending NIH SBIR or CTR funds to a foreign subawardee is no longer an option under the new parent omnibus solicitation. So if your proposal includes a foreign subaward or a foreign subcontract, NIH will consider the applicant as non-compliant, and it will not be reviewed for funding under this program. Now, that does not mean all international relationships are prohibited. Foreign consultants, international collaborators who are not receiving subaward funding, and purchases from foreign vendors can still be allowed. But the key distinction is whether federal SBIR dollars are flowing through a foreign subaward or subcontract arrangement. And for many applicants, this won't change anything, but companies working with overseas research institutions CROs, development partners, or affiliate organizations. This is a critical issue you have to identify before you start building the budget or even application from the get-go. Number 8, new policy and priorities overlays tied to the current administration. Winning an NIH SBIR/STTR award isn't about having just a great technology or an innovation. It's increasingly important to understand the policy environment your application is entering and ensuring your proposal aligns with the priorities outlined in the solicitation. The new parent omnibus solicitation includes several policy directives and certifications that simply weren't present in the old parent omnibus solicitations, because now the NIH is placing a greater emphasis on agency priorities, administration priorities, and specific strategic initiatives outlined by the HHS and the NIH directors. So for founders, the practical impact is straightforward. Reviewers will still evaluate your science, your team, and your commercialization plan, but it's becoming increasingly important to understand how your project aligns with the broader priorities NIH is emphasizing. And perhaps most importantly, NIH explicitly notes that awards might be subjected to termination if they no longer support agency priorities or program objectives. Number 9: Cybersecurity compliance is now a built-in award condition. And this is one of the changes that most founders will overlook until it's too late. If you're pursuing an NIH SBIR or STTR funding and handling patient data, health information, or sensitive systems, make sure your cybersecurity house is in order. What used to be an IT issue is now becoming a grant compliance issue. The new parent omnibus introduces a formal cybersecurity framework for awardees that handle sensitive information or access to HHS systems. Companies may now be expected to maintain core cybersecurity practices such as multi-factor authentication, employee security training, system backups and anti-malware protections, incident response procedures, and also document asset inventories. There's also a new reporting requirement. Certain cybersecurity instances may need to be reported to HHS within 48 hours. For startups, this means cybersecurity is no longer something you can figure out after you get funded, and that's because NIH is treating it as a core part of doing business with the federal government. And finally, number 10, a companion structured and review refresh. Under the new parent omnibus solicitation at NIH, they're pushing towards a commercialization-first mindset more than ever before. Yes, strong science is still essential, but founders who can clearly demonstrate market need, commercial strategy, and why federal funding can accelerate the path to impact will be the strongest position. The new NIH ecosystem has been reorganized, creating a more structured pathway from Phase 1 all the way through later stages of commercialization. And while reviewers are still evaluating the science, the NIH has modernized the review framework and placed even greater emphasis on commercialization, especially for Phase 2 and Fast-Track applications. In plain English, NIH is asking themselves a tougher question, not just does the technology work, but rather now does this become a real product, a real company, and actually will have real impact in society if successful. So with that, thank you so much for watching till the end of this video. I hope you found these tips helpful as you work to secure more non-diluted funding for your startup. And if you enjoyed this video, I would greatly appreciate if you like and subscribe to this channel so that you can learn new ways to keep your equity throughout your fundraising journey. And also don't forget to check out our website for more resources, tips, advice, and templates to help you secure more non-dilutive funding. And thank you for joining me again, and I'll see you in a video very soon.