SPECIAL NOTICE
99 -- Request for Information - Domestic Industrial Base Expansion of Isolation and Surgical (L2/L3) Disposable Gowns Manufacturing and Medical Grade Man-Made Fibers for Production
- Notice Date
- 7/9/2021 4:28:50 AM
- Notice Type
- Special Notice
- NAICS
- 315280
— Other Cut and Sew Apparel Manufacturing
- Contracting Office
- DEPT OF THE AIR FORCE
- ZIP Code
- 00000
- Response Due
- 7/23/2021 12:00:00 PM
- Archive Date
- 08/07/2021
- Point of Contact
- Amanda Ragan
- E-Mail Address
-
Amanda.Ragan@us.af.mil
(Amanda.Ragan@us.af.mil)
- Description
- Domestic Industrial Base Expansion of Isolation and Surgical (L2/L3) Disposable Gowns Manufacturing and Medical Grade Man-Made Fibers for Production *Note: Multiple NAICS Codes are applicable (313110 and 315280) PURPOSE/DESCRIPTION The Department of Health and Human Services (HHS), in collaboration with the Air Force�s Acquisition COVID-19 Task Force (DAF ACT) is conducting a Request for Information (RFI) for information and planning purposes to identify potential sources that possess the expertise, capabilities, and experience to meet qualification requirements for: Expanding the domestic industrial base for the production of U.S. Food & Drug Administration (FDA), 510(k) cleared isolation and surgical medical gowns (described in 21 Code of Federal Regulations (CFR) 878.4040). �The disposable sterile isolation gowns (non-surgical) are FDA Class I and Association of the Advancement of Medical Instrumentation (AAMI) Level 2 and the disposable sterile surgical gowns are FDA Class II (AAMI Level 3). Expanding the domestic industrial base for the production of the man-made fibers (MMF) (e.g. medical grade spunbond-meltblown-spunbond (SMS) or similar material) that support the disposable sterile non-surgical (FDA Class I) and sterile surgical gowns (FDA Class II). The intent of this RFI is to understand the Industry�s ability to increase domestic disposable medical gowns and/or the materials to produce disposable sterile medical gowns by building a competitive and sustainable U.S. manufacturing base. �The COVID-19 pandemic caused a critical shortage of medical gowns in the United States, limiting the nation�s ability to provide personnel protective equipment (PPE) to our medical community.� It is estimated that less than ten percent of U.S. demand is manufactured domestically for these specific gowns.� As the U.S. expands production, the U.S. Government (USG) would like to understand Industry�s ability to increase domestic manufacturing in disposable medical gowns and the key MMF materials for supporting disposable gown manufacturing. CAUTION: This market survey is being conducted to identify potential sources that may possess the expertise, capabilities, and experience to meet qualification requirements to manufacture isolation and surgical disposable sterile gowns and/or the non-woven fibers/fabrics for production necessary to expand the domestic industrial base.� The level of security clearance and amount of foreign participation in this requirement has not been determined. �Contractors/Institutions responding to this market research are placed on notice that participation in this survey may not ensure participation in future solicitations or contract awards.� The Government will not reimburse participants for any expenses associated with their participation in this survey. INSTRUCTIONS: The document below contains a description of the isolation and surgical gowns and the non-woven fibers/fabrics requirement and a Contractor Capability Survey. �The Survey allows Contractors to provide their company�s capability. If, after reviewing these documents, you desire to participate in the market research, you should provide documentation that supports your company�s capability in meeting these requirements. �Failure to provide documentation may result in the Government being unable to adequately assess your capabilities. If you lack sufficient experience in a particular area, please provide details explaining how you would overcome the lack of experience/capabilities in order to perform that portion of the requirement (i.e., teaming, subcontracting, etc.) Identify any areas of work that your organization believes should be broken out exclusively for Small Business. Both large and small businesses are encouraged to participate in this Market Research.� Joint ventures or teaming arrangements are encouraged. Interested parties shall respond to this RFI in a White Paper that is in a Microsoft Word for Office 2000 compatible format. Reponses to Part II of the Vendor Survey shall be limited to five (5) pages and submitted to the PCO via email only. �Any proprietary information shall be clearly marked and segregated. �Responses are due no later than 3:00 PM EDT on 23 July 2021. Questions relative to this market survey should be addressed to the PCO, Mrs. Amanda S. Ragan at amanda.ragan@us.af.mil. SUPPLEMENTAL INFORMATION: The aforementioned White Paper will be in response to Parts I and II of the vendor and capability survey questions identified in this notice's attachment with no graphics, photos, designs, etc. Only Part II is limited to the five (5) pages, and the response to Part I is not included in the overall page count.
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/6a7f4c508edf4b4a9b106b3d8e3be2a0/view)
- Record
- SN06056348-F 20210711/210709230114 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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