FDA Subcutaneous Injection Site Simulator (SCISSOR)

The U.S. Food and Drug Administration’s Division of Pharmaceutical Quality Research V is soliciting a Subcutaneous Injection Site Simulator (SCISSOR) under solicitation number 75F40126Q134239, a small business set-aside under NAICS code 334516 with a response deadline extended to August 5, 2026, at 2:00 p.m. CDT. This firm-fixed-price contract requires the design, delivery, installation, and validation of a single integrated system featuring at least six independently temperature-controlled chambers (32–37°C) for simulating subcutaneous tissue, enabling simultaneous in vitro bioequivalence testing of in situ forming drug products. The system must support automated injection, real-time optical detection, fraction collection, and software-based monitoring with unattended operation for 24 or more hours, and must be expandable for future enhancements. All deliverables include calibration tools, initial consumables, validation kits, Installation Qualification documentation, comprehensive user manuals, and on-site training for FDA personnel. The system must comply fully with Section 508 accessibility standards, requiring an Accessibility Conformance Report based on VPAT Version 2.5, and adhere to Buy American Act and Executive Order 14005 requirements with full country of origin disclosures. The contract mandates electronic submission of all proposals via email only, with acceptable formats limited to .docx, .xlsx, and .pdf; submissions must exclude macros, executable code, or scripts. Offerors must be registered in SAM.gov with a validated Unique Entity Identifier and self-certify as a small business under the 1,000-employee size standard. Evaluation follows a lowest price technically acceptable (LPTA) methodology: technical acceptability is a mandatory pass/fail gate, and only technically compliant proposals are considered for price evaluation. Acceptance occurs at the FDA’s facility in Silver Spring, Maryland, under FOB Destination terms. Invoicing must be submitted exclusively through the Treasury’s Invoice Processing Platform (IPP), with no hardcopy or WAWF submissions permitted. Required attachments include detailed technical specifications, maintenance schedules, safety data sheets for consumables, and compliance certifications. The system must interface with Rainbow R2 spectrophotometers, use standard HPLC vials, and meet implied ISO/IEC 17025-level quality control through documented calibration and audit trails. A one-year manufacturer warranty is required, and