Notice of Intent to Compete a Limited Sources Acquisition for Domestically Manufactured AAMI Level 3 and AAMI Level 4 Surgical Gowns

Amended Posting The November 5th Notice of Intent regarding the U.S. Department of Health and Human Service (HHS) /Assistant Secretary for Preparedness and Response (ASPR)/Strategic National Stockpile (SNS)s intent to procure domestically manufactured ANSI/AAMI Level 3 and Level 4 surgical gowns is amended to make the following update: The U.S. Department of Health and Human Services (HHS)/Assistant Secretary for Preparedness and Response (ASPR)/Division of Strategic National Stockpile (DSNS) intends to award contracts for the procurement of up to 397.5 million (including optional quantities) ANSI/AAMI Level 3 and ANSI/AAMI Level 4 Surgical Gowns to be used in healthcare settings. Contracts will be awarded under the authority of Federal Acquisition Regulation (FAR) Subpart 6.302-3 Industrial mobilization; engineering, developmental, or research capability; or expert services, paragraphs (a)(2)(i) and (b)(1)(iv). Even though sources are being limited, the requirement will be competed to the maximum extent practicable; it is anticipated that a solicitation will be posted to the Governmentwide Point of Entry (GPE), www.sam.gov, classified under NAICS code 339113 with a size standard of 750 employees. Any producer or manufacturer, or the manufacturer's exclusive (or sole) distributor, that meets the requirements, product specifications, and other factors listed in the solicitation will be eligible to propose. . Under the authority of FAR 6.302-3 paragraphs (a)(2)(i) and (b)(1)(iv)(A), this action will be limited to manufacturers or the manufacturer's exclusive (or sole) distributor, for this product providing AAMI Level 3 and/or AAMI Level 4 surgical gowns manufactured within the United States or its outlying areas.[1] To be eligible to compete, an offeror must be a manufacturer, or a manufacturer's exclusive (or sole) distributor, of these products, have a FDA cleared 510(k) premarket notification, have current manufacturing operations within the United States to produce ANSI/AAMI Level 3 and/or ANSI/AAMI Level 4 surgical gowns, and meet additional SNS required product characteristics and specifications as noted in the solicitation, which will be posted to SAM.gov. The Government anticipates making multiple awards. The specifications and evaluation criteria will be provided in the solicitation. The Government will perform evaluations based on the evaluation criteria specified in the solicitation. This is a notice of intent and is not a request for competitive quotes or proposals. No solicitation is currently available. No telephonic inquiries will be accepted. Any questions or comments should be directed via e-mail ONLY to caleb.owen@hhs.gov with the Subject Line - Notice of Intent Amended - Surgical Gowns. A determination to respond to questions or comments submitted in response to this notice is solely within the discretion of the Federal Government. Thank you for your interest. [1] This means that the items must be assembled in the U.S. or its territories or tribal locations, that results in an end product where the cost of domestic components must exceed 55 percent of the cost of all the components. Component means an article, material, or supply incorporated directly into an end product. A domestic component means one that is manufactured/sourced in the United States, or its territories or tribal locations. Original Posting The U.S. Department of Health and Human Services (HHS)/Assistant Secretary for Preparedness and Response (ASPR)/Division of Strategic National Stockpile (DSNS) intends to negotiate on a noncompetitive basis a limited sources acquisition with Brightstar Innovations Group, LLC, String King, and AirBoss Defense Group, LLC, under authority of Federal Acquisition Regulation (FAR) Subpart 6.302-3 Industrial mobilization; engineering, developmental, or research capability; or expert services, paragraphs (a)(2)(i) and (b)(1)(vi), for the procurement of up to 397.5 million (including optional quantities) AAMI Level 3 and AAMI Level 4 Surgical Gowns to be used in healthcare settings. The three vendors listed above are the only known vendors that are either the manufacturer, or are partnered with a manufacturer as their exclusive (or sole) distributor for this product, that have a FDA cleared 510(k) premarket notification, have current manufacturing operations within the United States to produce AAMI Level 3 and AAMI Level 4 surgical gowns, and meet additional SNS required product characteristics and specifications including: Commercially available ANSI/AAMI PB70 Level 3 or Level 4 Materiel made of woven fabric, non-woven fabric and composites Disposable, single use Sterile, with sterility assurance level of at least 10-6 Does not contain natural rubber latex Has received FDA Clearance for Product Code FYA Surgical gown color shall be Blue Gown provides full coverage Under the authority of FAR 6.302-3 paragraphs (a)(2)(i) and FAR 6.302-3 (a)(2)(i) and (b)(1)(vi), current production requirements will be divided among two or more contractors to provide for an adequate industrial mobilization base. Offerors must already be listed as a contract manufacturer assigned to the 510(k) in the FDA Establishment, Registration, & Device Listing, and be either a : (A) Sole Authorized reseller of Surgical Gowns (Level 3 and Level 4) that are manufactured in the United States; or (B) Manufacturer of Surgical Gowns (Level 3 and Level 4) that are manufactured in the United States. This action is limited to products manufactured within the United States. The required quantity consists of 132.5M Medical Surgical Gowns to be procured for the base quantity, across an anticipated delivery period of 12 months, and the remainder of the required Surgical Gowns will be included under an option with an ordering period of 36 months, for a total contract length of three years; the ordering period for the optional quantity will begin at time of award. This will enable the United States to establish an industrial manufacturing base to ensure sufficient availability of such items during national emergencies such as pandemics or other public health events. This notice of intent is NOT a request for competitive quotes or proposals, and no solicitation is available. Vendors that believe they can provide this requirement are encouraged to identify themselves and give written notification, as well as a capability statement, to the Contracting Officer below by 12:00 p.m. Eastern Standard Time on Friday, Nov. 12, 2021. A determination by the Government not to compete the proposed requirement based on responses to this notice is solely within the discretion of the Government. Information will be considered solely for the purpose of determining whether to conduct a competitive procurement. No telephonic inquiries will be accepted. Any questions or comments should be directed via e-mail ONLY to the attention of Caleb Owen, Contracting Officer at Caleb.Owen@hhs.gov.