Request for Information - Disposable Gowns Mfg and Medical Grade Man-Made Fibers for Production.doc

Domestic Industrial Base Expansion of Isolation and Surgical (L2/L3) Disposable Gowns Manufacturing and Medical Grade Man-Made Fibers for Production

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:

1) 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).

2) 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:

1. 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.

2. 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.

3. 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.)

a. Identify any areas of work that your organization believes should be broken out exclusively for Small Business.

4. Both large and small businesses are encouraged to participate in this Market Research. Joint ventures or teaming arrangements are encouraged.

5. 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.

6. Questions relative to this market survey should be addressed to the PCO, Mrs. Amanda S. Ragan at amanda.ragan@us.af.mil.

CONTRACTOR CAPABILITY SURVEY

Part I. Business Information

Please provide the following business information for your company/institution and for any teaming or joint venture partners:

Company/Institute Name:

Address:

Point of Contact:

CAGE Code:

· Phone Number:

· E-mail Address:

· Web Page URL:

Government Proposed North American Industry Classification System (NAICS) Codes: 313110, 315280

Based on the Government proposed NAICS Code, state whether your company is:

· Small Business

(Yes / No)

· Woman Owned Small Business

(Yes / No)

· Small Disadvantaged Business

· 8(a) Certified

· HUBZone Certified

· Veteran Owned Small Business

(Yes / No)

· Service Disabled Veteran Small Business (Yes / No)

· System for Award Management (SAM) (Yes / No)

· A statement as to whether your company is domestically or foreign owned (if foreign, please indicate the country of ownership).

Responses to the Capability Survey Part I and Part II must be received no later than 3:00 PM EDT on 23 July 2021. Please ensure data is in a readable electronic format that can be received through a firewall. Attachments shall not to exceed 10 MB per email. Multiple emails are acceptable. Responses must be sent via email to the PCO, Amanda Ragan at amanda.ragan@us.af.mil. Questions relative to this market research should be addressed to the PCO.

Part II. Capability Survey Questions A. General Capability Questions:

1. Describe briefly the capabilities (automation, # lines, lean manufacturing, green manufacturing, etc.) of your facility and nature of the goods and/or services you provide. Include a description of your staff composition and management structure.

2. Describe your company's experience on previous projects similar in complexity to this requirement. Include contract numbers, a brief description of the work performed, period of performance, agency/organization supported, and individual point of contact (Contracting Officer or Program Manager).

3. Describe your company's capabilities for generating, handling, processing and storing classified material and data.

4. Describe your company's capabilities and experience in generating technical data, engineering drawings and manuals. Identify what software programs are utilized to generate these data products and what formats are available for delivered items.

5. What is your company’s current maximum capacity per month for this particular type of requirement? Provide information on any facility reserves you may possess to increase capacity in the event of an immediate need do to critical operational mission requirements.

6. What quality assurance processes and test qualification practices does your company employ? Provide a description of your quality program as it relates to and will comply with 21 CFR 820, Quality System Regulation.

7. Surgical gowns and Isolation gowns are regulated by the FDA. The disposable isolation gowns (non-surgical) are FDA Class I /AAMI Level 2 and the disposable surgical gowns are FDA Class II /AAMI Level 3; both require a 510(k) premarket notification. Has this been completed? If not, what is the timeline for completion? Provide a description of proposed regulatory activities.

8. Surgical gowns and Isolation gowns must meet the FDA recognized standard (liquid barrier, sterility, biocompatibility, etc.). Please provide a list of recognized standards that your gowns will comply with and information on the test plan (including where the testing will be conducted) for meeting the standard.

9. Ensure labeling of gowns meet the FDA requirements per FDA regulations and guidance. Provide information on proposed labeling.

10. What is your process of sterilization and how will you ensure that the surgical and isolation gowns are sterile prior to packaging?

B. Commerciality Questions:

1. Is there established catalog or market prices for our requirement?

2. If you offer this product and/or service to both U.S. Government and commercial sources, is the same workforce used for both the U.S. Government and general public?

3. Is our requirement offered to both under similar terms and conditions? Briefly describe any differences.

4. Describe your standard warranty and return process for goods and services furnished to the government for items similar in nature to this requirement.

C. Requested Information for Gowns Manufacturing, Medical Grade MMF/fabrics and Innovation

1. Please identify MMF (SMS or similar material that meets or could meet FDA approval/testing)) concerns with the increase in domestic isolation and surgical gown production.

2. Do you currently make MMF (SMS or similar material that meets or could meet FDA approval and testing) for isolation gowns and/or surgical gowns? Alternatively, do you manufacture both the MMF and gowns?

3. Have you produced FDA 510(k) cleared isolation and surgical gowns? Please provide applicable 510(k) numbers.

4. Have you registered with FDA? Please provide registration number.

5. How many metric tons of MMF (or the fiber you are making) can be produced annually?

6. If you are making MMF to support other industries, do you have the ability to pivot production toward isolation and/or surgical gown manufacturing?

7. Have you considered fiber innovation and polymer research in healthcare textiles through advances in medical textiles (biodegradable, reusable, recyclable, higher performing, etc.)? What support would you need from the U.S. Government to do this?

8. Have you considered other methods to increase manufacturing automation in order to drive down labor costs / overall product cost, through sonic welding, other manufacturing processes, packaging, lean manufacturing assembly methods, etc.?

9. What would be needed to incentivize companies to expand economies of scale within the U.S. to add capacity and vertically integrate?

10. Identify barriers to domestic production and their impacts (i.e. regulatory, legal, legislative, policy, decreased business due to higher production costs, etc.).

a. What would help alleviate these concerns for accelerating your manufacturing timelines in order to escalate production within six months or less?

b. Alternatively, accelerating within six to 12 months?

11. To facilitate this, are there any capital investments (by type) that would be needed?

12. What would be your Industry’s strategies to maintain domestic capability throughout the supply chain?

13. What would be your recommendations for USG strategies to maintain domestic capability throughout the supply chain?

14. Would you be willing to provide a supply chain resiliency risk mitigation strategy to address any issues with unforeseen disruptions to production, e.g., unforeseen environmental events, power outage, labor shortages, critical equipment failures, cyber incidents, etc.?

15. What would be your plan to build and implement a sustainable business model for other domestic MMF / gown companies?

16. Do you currently rely on foreign suppliers within your supply chain? How many suppliers are being used? What is the risk mitigation if the source cannot supply reliably? What would it take to source from domestic sources? How do you ensure Trade Agreements Act compliance for federal contractors? If you have to start with foreign suppliers, will you agree to become domestically sourced as soon as possible in order to facilitate Berry Amendment Act (U.S. Code Title 10, Section 2533a) compliance?

17. Describe partnerships, licensing arrangements or other commercial agreements that might help to reach scale more quickly and what terms and conditions would be required.

18. Are there any business constraints to setting up a contract with the government in terms of minimum contract length (18 months, 2 years, etc.) or minimum quantity (metric tons of MMF)?