AoI-0004 DOMESTIC INDUSTRIAL BASE EXPANSION OF ISOLATION AND SURGICAL DISPOSABLE GOWNS MANUFACTURING AND MEDICAL GRADE MMF FOR PRODUCTION (Revision 3).pdf

AoI-0004 DOMESTIC INDUSTRIAL BASE EXPANSION OF ISOLATION AND SURGICAL (L2/L3/L4)

DISPOSABLE GOWNS MANUFACTURING AND MEDICAL GRADE MAN-MADE FIBERS FOR

PRODUCTION

GENERAL INFORMATION

1. Gowns Industrial Base Expansion Area of Interest (AoI) Background

The recent COVID-19 Public Health Emergency has illuminated the importance of increasing the United States’ domestic manufacturing and automation capacity for isolation and surgical (L2/L3/L4) disposable gowns and medical grade man-made fibers (MMF). The United States Government (USG) requires innovation to ensure medical professionals have access to the latest and safest personal protective equipment (PPE) available. The USG believes this starts with the man-made fiber (MMF) raw material development. Distributors and providers in the U.S. typically rely on overseas manufacturers to provide the least expensive product, driving domestic suppliers to move out of the market or not develop future MMF technologies.

Specifically, our research indicates that U.S. manufacturers have been hesitant to develop new MMF due to concerns with loss of intellectual property as fiber development transitions to manufacturing (typically overseas due to labor costs, leading to the U.S. losing its competitive advantage). The USG promotes the development of new fibers and technologies that can transition rapidly to U.S. manufacturing that will improve personal protections and produce products at a lower cost, ultimately, weaning the U.S. off overseas manufacturers.

The intent of this AoI is to understand the industry’s domestic manufacturing and automation innovations associated with the manufacturing of isolation and surgical (L2/L3/L4) disposable gowns and medical grade MMF. The country’s ability to increase and further automate domestic manufacturing is critical to not only respond to the current pandemic or future pandemics but also to ensure the security of gown manufacturing within the US.

The Office of the Secretary of Defense for Acquisition and Sustainment (OSD(A&S)) Joint Rapid Acquisition Cell (JRAC), Defense Assisted Acquisition (DA2), Personal Protective Equipment (PPE) Team and Department of the Air Force Acquisition Team (DAF ACT) need to understand industry’s ability to:

• Through manufacturing automation innovations, expand 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, Level 4).

• Expand the domestic industrial base for the production of 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 COVID-19 pandemic identified a critical shortage in medical gowns in the United States, PRODUCTION 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.

2. AoI Expansion Request

This AoI solicits solution briefs to support Health and Human Services Assistant Secretary for Preparedness and Response (HHS/ASPR) priorities for meeting public health/pandemic needs to innovatively expand the domestic production capacity of domestic isolation domestic isolation and surgical (L2/L3/L4) disposable gowns and medical grade MMF within the next 6-24 months.

Offerors can respond to any or all sections based on their resident expertise and ability to expand domestic manufacturing. The DA2 would like to understand industries’ ability to expand their domestic capacity to produce these gowns and MMF. The below addresses each area of the AoI regarding manufacturing of:

A. Domestic sterile disposable gowns

a. Isolation gowns, Level 2 (non-surgical)

b. Surgical gowns, Level 3 and 4

B. Medical grade MMF

This effort is to carry out various provisions of the Defense Production Act. As such, and for purposes of the Defense Production Act, “domestic sources” generally means:

A business concern –

a) that performs in the United States or Canada substantially all of the research and development, engineering, manufacturing, and production activities required of such business concern under a contract with the United States relating to a critical component or a critical technology item; and

b) that procures from business concerns described in subparagraph (a) substantially all of any components and assemblies required under a contract with the United States relating to a critical component or critical technology item.

All resultant contracts of this AoI will be subject to the Priority Access language identified in the Commercial Solutions Opening and below.

By entering into this [CONTRACT/AWARD/AGREEMENT)], the [CONTRACTOR/RECIPIENT/AWARDEE] agrees to be legally bound to provide the U.S.

PRODUCTION

Government with Priority Access for a 10-year period, starting from the completion of the capacity/expansion project that is the subject of this [CONTRACT/AWARD/AGREEMENT], notwithstanding the conclusion of any other commitments at the end of this [CONTRACT/AGREEMENT/AWARD]’s period of performance. “Priority Access” is defined, for the purposes of this [CONTRACT/AGREEMENT/AWARD], as: “upon a determination by the HHS Secretary that [FILL IN DESCRIPTION] is needed to prepare for or respond to a disease, health condition or other threat to the public health that causes a public health emergency or a credible risk of such an emergency, the U. S. Government has priority access to [CAPACITIES THAT THE U.S. GOVERNMENT WILL RECEIVE PRIORITY ACCESS TO] over any other non-rated ((Defense Priorities and Allocations System (DPAS)/ Health Resources Priority and Allocations System (HRPAS)) contract or order, and, for the purpose of assuring such priority, shall be required to accept and perform such DPAS/HRPAS rated contracts or orders in preference to any other non-rated (DPAS/HRPAS) rated contracts/orders during this 10 year period.” If the [CONTRACTOR/RECIPIENT/AWARDEE] novates or otherwise transfers responsibility for performance under this [CONTRACT/AWARD/AGREEMENT] and the commitments herein to any other entity, the Priority Access requirement shall follow the transfer, and this language concerning Priority Access shall be included in any transfer agreement and affirmed by the transferee. The parties agree to negotiate in good faith for continued U.S. Government Priority Access, as defined herein, to extend beyond this 10-year period.

A. DOMESTIC ISOLATION AND SURGICAL (L2/L3/L4) DISPOSABLE GOWNS PRODUCTION – In 2004, the FDA recognized the consensus standard American National Standards Institute/Association of the Advancement of Medical Instrumentation (ANSI/AAMI) PB70:2003, “Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.” New terminology in the standard describes the barrier protection levels of gowns and other protective apparel intended for use in health care facilities and specifies test methods and performance results necessary to verify and validate that the gown provides the newly defined levels of protection. This AOI focuses on three of the gowns defined below based on given demand signals.

1) Disposable sterile isolation gowns (non-surgical)

a. FDA Class I devices (exempt from premarket review)

b. AAMI Level 2

i. Level 2: Low risk, to be used, for example, during blood draw, suturing, in the Intensive Care Unit (ICU) or a pathology lab.

c. Product Code: OEA

2) Disposable sterile surgical gowns

a. FDA Class II medical device, requires 510(k) premarket notification

b. AAMI Level 3

i. Level 3: Moderate risk, to be used, for example, during arterial blood draw, inserting an Intravenous (IV) line, in the Emergency Room, or for trauma cases.

c. AAMI Level 4

i. Level 4: High risk, to be used, for example, during long, fluid intense procedures, surgery, when pathogen resistance is needed or infectious diseases are suspected (non-airborne).

d. Product Code: FYA

For the questions below, please answer your company’s manufacturing/automation expansion based on producing sterile isolation gowns, sterile surgical gowns or both.

1) What would be required for your company to increase domestic production of FDA

Class I disposable isolation gowns (AAMI Level 2), FDA Class II sterile disposable surgical gowns (AAMI Level 3, Level 4) or all three gowns?

2) Provide a list of your company’s current manufacturing location (if applicable) for producing FDA Class I disposable isolation gowns (AAMI Level 2), FDA Class II sterile disposable surgical gowns (AAMI Level 3, Level 4) or all three and the manufacturing production capacity. An example format is shown in Table 1.

Table 1- Sample list of current FDA Class I disposable isolation gowns (AAMI Level 2), FDA Class II sterile disposable surgical gowns (AAMI Level 3, Level 4) or all three disposable isolation gown capacity

LOCATION

QUANTITY OF DISPOSABLE TYPE

GOWNS/MONTH

3) Alternatively, do you manufacture both the gowns and MMF?

4) Provide a list of your company’s ability to expand capacity of FDA Class I disposable isolation gowns (AAMI Level 2), FDA Class II disposable surgical gowns (AAMI Level 3, Level 4) or all three in the US. (Are automated lines throughout manufacturing, state of the art technology, etc. being used?) An example format is shown in Table 2.

a. The timeline to initial disposable isolation gown production should take into consideration FDA Class I 510(k) certification if applicable, completion of applicable permits, other regulatory requirements and/or quality management systems, equipment purchases and installation, facility set up (utilities, water treatment, testing etc.).

Table 2- Sample List of Production Data for FDA Class I disposable isolation gowns (AAMI Level 2), FDA Class II sterile disposable surgical gowns (AAMI Level 3, Level 4) or all three disposable isolation gown capacity

QUNTITY OF

DISPOSABLE ISOLATION

GOWNS (M)/MONTH

COST FOR

AUTOMATED

LINES ($)

FACILITY

COST($)

TOTAL

COST ($)

TIMELINE FROM

CONTRACT

AWARD

(MONTHS)

5) Have you registered with FDA and listed any Class II disposable surgical gowns (AAMI

Level 3, Level 4)?

a. Please provide documentation showing the legal use (or acquisition) of your 510(k)

6) Please provide a clear description of the process and the equipment regulatory approval and timeline information.

7) One aspect of this investment, is the establishment of dedicated research and development (R&D) capabilities for the development and fielding of new MMF that offers enhanced quality and protection to frontline medical workers as well as provide domestic sources a competitive advantage over overseas suppliers.

a. How would you leverage, develop, or insert technologies into improving MMF capabilities?

b. How would you establish MMF R&D capabilities?

8) Explain what method you used to justify and prioritize your chosen location(s).

PRODUCTION

9) Address required capital investments and additional projected costs (i.e. facilities, labor etc., real property (upgrade or purchase).

10) Estimate the change in market cost of disposable isolation gowns as a result of this investment in increased manufacturing and automation production capacity.

11) Have you considered:

a. Other methods to develop advanced manufacturing automation technologies in order to drive down labor costs / overall product cost, through sonic welding, other manufacturing processes, packaging, lean manufacturing assembly methods, etc.?

b. Innovating in manufacturing line flexibility, toward enabling simple and rapid shifts between the manufacture of different products and improving the potential to serve in warm-basing to permit shifting production when requested or if market demand shifts?

c. What support would you need from the U.S. Government to do this?

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

13) What would be your plan to build and implement a sustainable business model for other domestic MMF / gown companies? Describe plans to remain commercially viable without continual government demand or investment.

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

15) Is there an opportunity for cost-sharing? Provide either a dollar amount or percentage of proposed cost.

16) Please provide multiple options with low, medium and high levels of investment for increased manufacturing and automation. Please provide details on the cost and benefit of each level of investment.

17) This contract is to increase the US industrial base only. There is no implied or explicit intent to follow this contract with further contractual arrangements with the government to purchase gloves. Your proposal must prepare your company to be self-

PRODUCTION

sufficient and not dependent on any further government investment. If you place any contingencies in your proposal for future product purchases, your proposal will be disqualified.

18) This solicitation is not intended for gown distributors or resellers, but is focused solely on manufacturing, MMF research and development, and automation capacity.

19) Do you have a documented supply chain strategy? If so, how does it integrate and add value to your overall business operations strategy or plan?

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

20) Does your supply chain design increase your supply chain’s resiliency? If so, describe how your design increases resiliency in two ways:

a. How it anticipates and resists disruption?

b. When/if disrupted how does it quickly recover?

21) 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.

22) Do you currently rely on foreign suppliers within your supply chain?

a. How many suppliers are being used?

b. What is the risk mitigation if the source cannot supply reliably?

c. What would it take to source from domestic sources?

d. How do you ensure Trade Agreements Act compliance for federal contractors?

e. 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?

23) If you are purchasing equipment/machines from a foreign source, please provide information of the source and timelines of purchase to machine set up.

a. If foreign workers will be assisting with the equipment set up, are work visas being considered and will there be impacts to the timeline.

PRODUCTION

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

25) 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 (x tons of MMF)?

26) Do you have a business continuity plan and have you identified critical equipment and power sources to maintain that equipment during an outage, cyber incident, etc.?

27) Do you currently comply with 21 CFR 820 standards, (no exceptions)? If not what would be needed to do so?

a. What other regulatory and quality standards would be needed to implement production, e.g. ISO 13485, ISO 9001?

28) What safety, health & environmental (SHE) certifications would be needed (e.g., Responsible Care certification, ISO 14001, OHSAS 18001, etc.)? What timelines would be needed for each of these certifications if not already obtained?

29) Please ensure that you provide as much information as you can and that it is thorough and accurate since this is the only information being evaluated moving forward in the CSO Process. You will be competing with other offerors for the gown industrial base expansion.

30) Provide any additional relevant information for consideration by the review team.

B. MEDICAL GRADE MMF FOR DISPOSABLE GOWN PRODUCTION – Non woven fabrics such as spunbond, meltblown, SMS, variations or other new fiber technology for medical grade PPE are used to keep patients and healthcare personnel from transmitting infection.

1) How can medical man-made fabrics (MMF) innovations benefit the defense/industrial textile industry?

2) Have you considered performing polymer and/or fiber Research & Development to innovate in healthcare textiles for advancement in any of the following areas?

a. Use of environmentally safe, renewable and sustainable domestic feedstocks

b. Biodegradability of fabrics (for permissible products)

c. Sustained anti-microbial and anti-viral attributes

d. Improved performance characteristics, including but not limited to durability, reusability (i.e. multi-use), and comfort

3) How can reusable gowns reduce environmental impact? What barriers exist for adoption of reusable gowns and what MMF improvements/interventions are needed to facilitate this transition?

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

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

6) One aspect of this investment, is the establishment of dedicated research and development (R&D) capabilities for the development and fielding of new MMF that offer enhanced quality and protection to frontline medical workers as well as provide domestic sources a competitive advantage over overseas suppliers.

a. How would you leverage, develop, or insert technologies into improving MMF capabilities?

b. How would you establish MMF R&D capabilities?

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

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

9) Provide the MMF manufacturing location, a list of your company’s current domestic MMF production type (spunbond, meltblown, SMS, etc.), capacity in tons and gown type equivalent/year (if known) for making FDA Class I disposable isolation gowns (AAMI Level 2), FDA Class II sterile disposable surgical gowns (AAMI Level 3, Level 4) or all three. (Example in Table 3.)

a. The timeline to initial material production (ramp up to full production) should take into consideration completion of applicable permits, equipment purchases and installation, facility set up (utilities, water treatment, testing etc.).

Table 3 Sample list of current MMF capacity

MMF

TYPE

QUANTITY

(TONS/YEAR)

GOWN TYPE

EQUIVALENT/YEAR

START OF

RAMP UP

PRODUCTION

FULL

DATE

TOTAL

COST

10) Explain what method you used to justify and prioritize your chosen location(s).

a) Does this include existing property or new real property?

11) Address required capital investments and additional projected costs (i.e. facilities, labor etc.).

12) Estimate the change in market cost as a result of this investment in increased material capacity.

13) 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?

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

15) What would be your plan to build and implement a sustainable business model for other domestic MMF / gown companies? Describe plans to remain commercially viable without continual government demand or investment.

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

17) Is there an opportunity for cost-sharing? Provide either a dollar amount or percentage of proposed cost.

PRODUCTION

18) Please provide multiple options with low, medium and high levels of investment. Is it possible to compress your production schedule? If so, please provide details on the cost and benefit of each level of investment.

19) This contract is to increase the US industrial base only. There is no implied or explicit intent to follow this contract with further contractual arrangements with the government to purchase material. Your proposal must prepare your company to be self-sufficient and not dependent on any further government investment. If you place any contingencies in your proposal for future product purchases, your proposal will be disqualified.

20) This solicitation is not intended for material distributors or resellers, but is focused solely on material manufacturing capacity.

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

22) Do you have a documented supply chain strategy? If so, how does it integrate and add value to your overall business operations strategy or plan?

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

23) Does your supply chain design increase your supply chain’s resiliency? If so, describe how your design increases resiliency in two ways:

a. How it anticipates and resists disruption?

b. When/if disrupted how does it quickly recover?

24) 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.

25) Do you currently rely on foreign suppliers within your supply chain?

a. How many suppliers are being used?

b. What is the risk mitigation if the source cannot supply reliably?

c. What would it take to source from domestic sources?

d. How do you ensure Trade Agreements Act compliance for federal contractors?

PRODUCTION

e. 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?

26) If you are purchasing equipment/machines from a foreign source, please provide information of the source and timelines of purchase to machine set up.

a. If foreign workers will be assisting with the equipment set up, are work visas being considered and will there be impacts to the timeline.

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

28) 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 (x tons of MMF)?

29) Please ensure that you provide as much information as you can and that it is thorough and accurate since this is the only information being evaluated moving forward in the CSO Process. You will be competing with other offerors for the MMF material industrial base expansion.

30) Do you have a business continuity plan and have you identified critical equipment and power sources to maintain that equipment during an outage, cyber incident, etc.?

31) What regulatory and quality standards would be needed to implement production, e.g.

ISO 9001?

32) What safety, health & environmental (SHE) certifications would be needed (e.g., Responsible Care certification, ISO 14001, OHSAS 18001, etc.)? What timelines would be needed for each of these certifications if not already obtained?

33) Provide any additional relevant information for consideration by the review team.

3. SPIRAL 1 through 3– Submission Requirements

ALL overarching CSO submission requirements are applicable to any AOI submission.

1) All guidance governing the content and evaluation criteria for required submission can be found the below at the following JRAC DA2 CSO link:

https://sam.gov/opp/7504925c5ade4052a4c46f2513b5d9b6/view/.

https://sam.gov/opp/7504925c5ade4052a4c46f2513b5d9b6/view/

PRODUCTION

2) Solutions briefs for this Area of Interest shall be submitted at the email below:

gownsmmf.cso.dafact@afwerx.af.mil

3) Once submission is received, offerors will receive a Response Submission Number via email.

Please ensure that your solution brief has your firm’s point of contact information to include Name, Title, Phone number and Email.

4 . AoI Open Period

1) Questions pertinent to this AoI should be sent to gownsmmf.cso.dafact@afwerx.af.mil by 4:00 PM CST, 12 November 2021.

2) Solution Briefs may be submitted immediately upon reviewing this AOI. Solution briefs will be accepted until 07 December 2021, 4:00 PM CST.

a) Amendments to previously submitted solutions will be accepted. Solution amendments shall be clearly marked and the original tracking number shall be included in the subject of the email.

3) Evaluations will begin within two business days of the posting of this AOI.

4) Questions concerning this AOI can be sent to the following email:

gownsmmf.cso.dafact@afwerx.af.mil

Companies are advised that any Prototype Other Transaction Agreement (OTA) awarded in response to this Area of Interest may result in the award of a follow-on production contract or transaction without the use of competitive procedures. The follow-on production contact or transaction will be available for use by one or more organizations in the Department of Defense and, as a result, the magnitude of the follow-on production contract or agreement could be significantly larger than that of the prototype OTA. As such, any Prototype Other Transaction Agreement will include the following statement relative to the potential for follow-on production: "In accordance with 10 U.S.C. 2371b(f), and upon a determination that the prototype project for this transaction has been successfully completed, this competitively awarded prototype OTA may result in the award of a follow-on production contract or transaction without the use of competitive procedures.

mailto:gownsmmf.cso.dafact@afwerx.af.mil mailto:gownsmmf.cso.dafact@afwerx.af.mil