SPECIAL NOTICE
65 -- Notice of Intent to Negotiate a Noncompetitive Limited Sources Acquisition for Domestically Manufactured AAMI Level 3 and AAMI Level 4 Surgical Gowns
- Notice Date
- 11/9/2021 9:03:40 AM
- Notice Type
- Special Notice
- NAICS
- 339113
— Surgical Appliance and Supplies Manufacturing
- Contracting Office
- ASPR OFFICE OF THE ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE Washington DC 20201 USA
- ZIP Code
- 20201
- Solicitation Number
- 75A50122QTBD
- Response Due
- 11/12/2021 9:00:00 AM
- Archive Date
- 11/20/2021
- Point of Contact
- Caleb Owen, Phone: 2026040900
- E-Mail Address
-
caleb.owen@hhs.gov
(caleb.owen@hhs.gov)
- Description
- 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.
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/8402ad2371ad4131a1cda6fcfee873ae/view)
- Record
- SN06173713-F 20211111/211110201531 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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