SBIR and STTR
Your award already covers the packaging validation.
If you hold an SBIR or STTR award, the money to validate your packaging is already in your account, and a portion of it is set aside for exactly this kind of outside specialist work. Since April 2026 you pick the provider and name them in your budget justification. You get the arithmetic that shows it fits, and paperwork you can paste in to spend it with us.
In short
Can SBIR money pay for packaging validation?
Yes. An SBIR or STTR award can pay for packaging validation. Technical and Business Assistance funds sit on top of the award, up to $6,500 in Phase I and up to $50,000 in Phase II, and since April 2026 you choose the provider and name them in your budget justification. A $2,500 gap assessment is 38 percent of a Phase I allowance. The request paperwork is ready to paste into your budget justification.
Where you stand
The money is already yours, and the deadline is already promised.
If you hold an SBIR or STTR award, you are about as ready to validate your packaging as a company gets. The money is in your account. A portion of it is set aside to spend outside the company on specialist help. And you have a submission date already promised to a federal program officer, the one date the whole award is measured against.
The catch is that packaging validation rarely gets recognized as a fundable line. It is technical, it lands late, and it sits inside a standard your team was not hired to learn. So it slips to the end, gets costed at the last minute out of general funds, and turns into a scramble in the weeks before you file.
It does not have to. The packaging evidence your submission needs can be planned, run and written by a specialist, paid for with money the award already carries for that purpose, and finished on a schedule that lines up with the date you gave your program officer.
What changed in April 2026
You now choose your own provider, and name them.
SBIR and STTR were reauthorized on 13 April 2026 by the Small Business Innovation and Economic Security Act of 2026 (S. 3971), which runs the programs through 30 September 2031 after a six-month lapse that began on 1 October 2025.
The change that matters to you rides along with it. NIH Guide Notice NOT-OD-26-075 implements a rule that agencies may no longer limit Technical and Business Assistance spending to a list of pre-selected vendors, for awards made on or after 13 April 2026. You choose the provider and name them in your budget justification.
Confirm it from the source rather than from us: the notice is NOT-OD-26-075, and the ceilings that follow are set by the Act. Your program officer or grants management specialist is the person who applies them to your specific award.
The allowance
TABA is money on top of the award, for outside help.
Technical and Business Assistance, TABA, is a statutory allowance that sits on top of your award rather than being carved out of it. It exists to pay for outside expertise your research team does not have in house, and packaging validation to ISO 11607 is squarely that kind of expertise.
The ceilings are set in the Act: up to $6,500 per Phase I project, and up to $50,000 per Phase II project, across all the years of the project. A gap assessment fits inside a Phase I allowance with room to spare. A full validation program fits inside a Phase II allowance at the low end of its range, and where it runs larger, a Phase II subcontract line carries it.
The cost
What this costs, against the budget it sits in.
Two fees, set against the SBIR figures they come out of. Each one is small enough against the budget that funding it is never a fight you have to win internally, and you can check every share yourself in a spreadsheet.
| The spend | The budget line it sits in | Its share of that line |
|---|---|---|
| The spend$2,500 gap assessment | The budget line it sits inPhase I TABA allowance, $6,500 | Its share of that line38 percent |
| The spend$2,500 gap assessment | The budget line it sits inA $323,090 Phase I award | Its share of that line0.8 percent |
| The spend$25,000 to $40,000 validation program | The budget line it sits inPhase II TABA allowance, $50,000 | Its share of that lineinside it at the low end |
| The spend$25,000 to $40,000 validation program | The budget line it sits inPhase II subcontract headroom, about $1.08 million | Its share of that line2 to 4 percent |
The last row uses the subcontracting rule rather than TABA. On a Phase II, no more than half the research effort may go to subcontractors and consultants combined, and half of the $2,153,927 Phase II budget guideline is about $1.08 million of headroom. A $25,000 to $40,000 program is 2 to 4 percent of that. The $323,090 and $2,153,927 figures are NIH budget guidelines, which is NIH's own word for them, not entitlements, and several institutes publish higher Phase I ceilings of $700,000.
The part you forward
The budget justification, ready to paste in.
Drop the block that matches your phase into your application, fill the fields in square brackets, and the language your agency asks for is already there: the scope of the assistance, the vendor, the fee, the timeline, and the expected benefit stated as risk taken off the submission.
Fields in square brackets are yours to fill in. Nothing else needs changing.
For a Phase I TABA request. The gap assessment is a fixed $2,500, which is 38 percent of the $6,500 Phase I allowance.
Technical and Business Assistance request (Phase I). Vendor: Probity Sciences, a packaging validation consultancy for medical device manufacturers working to ISO 11607. Scope of assistance: a Packaging Standards Gap Assessment of the sterile barrier system for [device], a Class [class] device sterilized by [sterilization method]. Probity Sciences reads the existing packaging documentation clause by clause against ISO 11607-1 and its 2023 amendment and reports, in writing, where the evidence needed for a premarket submission is complete and where it is not. Fee: $2,500, fixed. Timeline: ten business days from receipt of the documents, ahead of a [target submission date] submission. Expected benefit: a reduced risk that the packaging section of the submission draws an FDA Additional Information request and costs the project a review cycle. The assessment finds and reports the gaps before the submission is filed, while there is still time to close them.
For a Phase II subcontract line. It counts toward the 50 percent subcontracting limit, and a typical program is 2 to 4 percent of that headroom.
Subcontract line (Phase II). Subrecipient: Probity Sciences, a packaging validation consultancy for medical device manufacturers working to ISO 11607. Scope of work: the full ISO 11607 packaging validation program for [device], a Class [class] device sterilized by [sterilization method]. This covers the validation plan and sampling rationale, protocol authoring, selection and qualification of the accredited test laboratory, management of the study, and the submission-ready evidence package. Accredited laboratory testing is charged at cost. Estimated cost: $[amount]. Professional fees are fixed at scoping; a typical program runs $25,000 to $40,000 all in, including laboratory charges at cost. Period of performance: [start date] to [target submission date]. Expected benefit: the packaging evidence the submission requires is planned, run and documented by a specialist, so the internal team does not have to learn ISO 11607 in order to file on time. Note: this is a subcontract and counts toward the Phase II subcontracting limit, which allows no more than 50 percent of the research effort to go to subcontractors and consultants combined.
Setting us up as a vendor
How your application names your provider.
Your budget justification names Probity Sciences as the provider, with the scope, the fee and the timeline from the block above. That is what the agency asks for: a description of the assistance, the vendor, and the expected benefit.
For your own supplier file, the quality policy, the independence declaration, the scope of services and the W-9 are sent on request, so your purchasing controls have what they need before a purchase order is raised.
Choosing a provider
You choose your provider, and you justify the choice.
Probity Sciences is not a federally approved, preferred, preselected or listed vendor, and since April 2026 no provider is. NOT-OD-26-075 stops an agency steering TABA money to pre-selected vendors, so the choice of provider is yours and the justification for it is yours to write.
We also do not advise you on what is allowable on your federal award, and you should be wary of anyone selling you validation who does. What is allowable is set by the Act, by NOT-OD-26-075 and by your agency's own solicitation, and the person who confirms it for your specific award is your program officer or your grants management specialist. Ask them before you commit the funds. We will give them the scope, the fee and the timeline in writing so the answer is easy.
Next
Send us the device and the submission date.
Thirty minutes, no slides. Tell us the device, the sterilization method and the date you promised your program officer, and we will tell you which piece of packaging evidence is actually on your critical path, what it costs, and which of the two blocks above fits your award. If your packaging file already holds together, you will hear that plainly, and there is nothing to buy.
Or email directly, and get a personal reply the same business day, from the specialist who would run the work.
Check my packaging: $2,500 gap assessment