Alberta Idealized Nasal Inlet (AINI), or equivalent instrument, with an Alberta Nasal Leak (or equivalent) test kit
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), is conducting market research through a Sources Sought Notice (SSN) to identify capable sources for an Alberta Idealized Nasal Inlet (AINI), or equivalent instrument, and an Alberta Nasal Leak (or equivalent) test kit. This equipment is crucial for nasal deposition testing of spray dried powders for intranasal drug delivery. This is not a solicitation, and no contract will be awarded from this announcement. Capability statements are due by April 8, 2026, at 3:00 PM Central Time.
Scope of Requirements
The FDA requires a turn-key solution for newly manufactured equipment, including:
- Alberta Idealized Nasal Inlet (AINI) or equivalent: Must seamlessly integrate with Copley Scientific Next Generation Impactor (NGI) and Fast Screening Impactor (FSI) systems, accurately mimic deposition behavior for drug sample collection, be easily separable for drug recovery, and include mensuration and test certificates.
- Alberta Nasal Leak (or equivalent) Test Kit: Must verify AINI system integrity, detect and quantify air leakage, include all necessary components and instructions, and be compatible with the AINI system and associated impactor devices.
- Delivery, Installation, Training, and Warranty: Requires installation by factory-certified personnel, an onsite factory acceptance test, validation documentation, operations/maintenance manuals, on-site operator training for 3-5 users, and a minimum one-year warranty from FDA acceptance. All services (delivery, installation, verification, training) must be completed within 90 days of contract award.
Contract & Timeline
- Type: Sources Sought / Market Research (Product Service Code: 6640 - Laboratory Equipment And Supplies)
- Response Due: April 8, 2026, 3:00 PM Central Time
- Published: April 1, 2026
- Agency: Health And Human Services / FOOD AND DRUG ADMINISTRATION
Eligibility & Submission
- Target Audience: Primarily seeking small business sources under NAICS 334516 (Analytical Laboratory Instrument Manufacturing, size standard 1,000 employees). Other than small businesses, especially those offering domestic products, are also encouraged to respond.
- Submission: Interested contractors must email capability statements to Suzanne Martella (suzanne.martella@fda.hhs.gov). Responses must demonstrate capability, not just affirm it. Weblinks will not be opened.
- Required Information: Business details (name, UEI, address, website, size status, POC), past performance (last 3 years), descriptive literature, technical information demonstrating specification compliance, GSA Schedule/SINs (if applicable), BIC contract info (if applicable), subcontracting opportunities for large businesses, standard commercial warranty/payment terms, place of manufacture, and informational pricing.
Additional Notes
This notice is for market research only; no contract will be awarded. The government will not reimburse costs associated with this announcement and reserves the right to use any non-proprietary technical information provided.