Maintain N95 Respirator Industrial Expansion Capacity - Moldex-Metric, Inc.

This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice and attached RFP. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. This will be a sole source contract to Moldex-Metric, Inc., in accordance with FAR 6.302-3 and the attached Justification and Approval. Department of Health and Human Services (DHHS) has a requirement to ensure access to N95 respirators in the event of health emergencies, such as the current COVID-19 pandemic. This requirement is to maintain the initial investment of production capacity of N95 respirators and to preserve capability to rapidly ramp up production in event of an emergency. The company will provide a strategic business plan that identifies required funding needed to address how they will be ready to achieve the anticipated maximum N95 demand if and when, the United States Government (USG) determines the need. The strategic plan will include: (1) the manufacturers maximum production capacity to manufacture NIOSH0approved, surgical and/or non-surgical N95 respirators per month, (2) the schedule and associated timeline to rapidly expand respirator production and reach full production capacity within 90 or 120 days upon request, (3) the warehousing and stocking of necessary raw materials from supplier approved sources, (4) how production lines/machines will be cycled to ensure they are validated and in good working order along with the required regulatory compliance, (5) how they will guarantee and maintain their supply chain functionality and responsibilities through contracts, and (6) how they will train and staff for full manufacturing capacity should the need arise to ramp to maximum manufacturing production capacity over the next 10 years. As a part of the contract actions contemplated, the USG will also require and incorporate priority access to N95 respirator stocks and production capacity for a period of 10 years after initial contract completion to provide the DHHS opportunities for follow-on contracts in the future. The anticipated period of performance (PoP) will be 3 (three) years or 36 months.