6835--Bulk Oxygen Contract

l gas supply, FDA, CGMP, Vermont licensing, equipment, delivery, maintenance, and technical requirements through a properly licensed and qualified medical gas subcontractor or supplier? If not, please confirm which specific licenses, registrations, and certifications must be held directly in the name of the prime contractor at the time of quote submission. Additionally, please confirm how the Nonmanufacturer Rule and VAAR 852.219-76 will apply when the small business prime is supplying medical grade oxygen manufactured and delivered by another qualified company. Government Answer: Yes. A small business prime contractor may satisfy the medical gas supply, FDA, CGMP, Vermont licensing, equipment, delivery, maintenance, and technical requirements through a properly licensed and qualified medical gas subcontractor or supplier, provided that: Prime Contractor Responsibility. The small business prime contractor remains fully responsible to the Government for all performance, compliance, quality assurance, and regulatory requirements specified in the Statement of Work. Subcontracting does not relieve the prime of accountability. Subcontractor Qualifications. Any subcontractor or supplier furnishing medical-grade oxygen or performing delivery, maintenance, or technical support shall: Be properly licensed, registered, and certified in accordance with all applicable FDA, CGMP, state of Vermont, and other regulatory requirements for medical gas supply and service; Maintain all required registrations and certifications in the subcontractor's own name for the duration of contract performance; and Comply with all applicable technical and safety standards referenced in the SOW (NFPA 50, NFPA 99, 21 CFR Parts 210 and 211, 29 CFR 1910.104, etc.). Nonmanufacturer Rule and VAAR 852.219-76 Compliance. A small business prime contractor may supply medical-grade oxygen manufactured by a non-small manufacturer through a subcontract or supplier relationship, consistent with the SBA Nonmanufacturer Rule (NMR) class waiver applicable to NAICS 325120 and the provisions of FAR 52.219-33. Such an arrangement is expressly contemplated under the NMR waiver, which permits small business nonmanufacturers/resellers to furnish the product of a non-small manufacturer without violating the limitations on subcontracting. VAAR 852.219-76 (Limitations on Subcontracting � Certificate of Compliance for Supplies and Products) applies to the small business prime's overall subcontracting activity. The prime shall comply with the subcontracting limitations set forth in that clause, which generally permit a small business supply contractor to subcontract for up to a threshold percentage (e.g., 30-40% depending on product type) of the total contract value, provided that cost of materials are excluded from the subcontracting calculation. Oxygen product cost is typically considered a material cost and is therefore excluded from the subcontracting percentage calculation. Documentation and Compliance. The small business prime shall: Identify its subcontractors and suppliers in its quote or contract proposal; Provide evidence of each subcontractor's relevant licenses, registrations, and certifications upon request; Ensure all subcontractor representations and certifications comply with applicable regulations; and Maintain and provide to the Government, upon request, copies of subcontract documents, quality assurance records, and evidence of subcontractor compliance with the SOW requirements for the full period of performance, consistent with VAAR 852.219-76(b). Sole Point of Accountability. The Government shall look to the small business prime contractor as the sole point of accountability for all contract performance. The prime is responsible for managing, monitoring, and ensuring subcontractor performance; coordinating delivery, maintenance, and technical support; and taking corrective action if the subcontractor fails to meet any SOW requirement. REMINDER TO OFFERORS The new response due date is September 18, 2026, at 5:00 PM Eastern Time. All quotes must be submitted electronically to Kenya.Mitchell1@va.gov and David.Valenzuela2@va.gov by the stated date and time. End of Amendment 0005