MMF RFI Final.pdf

Request for Information

Subject: Domestic Industrial Base Expansion of Medical Grade Man-Made Fibers for Production of PPE

Date Posted: August 26, 2022

Response Date: September 9, 2022

Classification Code: NAICS 325220 – Artificial and Synthetic Fibers and Filaments Manufacturing

Contracting Office Address:

Assistant Secretary for Preparedness and Response/ Domestic Strategic National Stockpile

(ASPR/DSNS) Office of Resource Management (ORM)/SNS Contracts Branch 2945 Flowers Road Atlanta, GA 30341

Point of Contact: Caleb Owen, Contracting Officer, email: caleb.owen@hhs.gov

Place of Performance: The United States

Archive: 15 days after the response date

Instructions:

Each response must include:

Company Name

Company

Address

DUNS/Unique

Identifier Company Point of Contact, phone #, and email address Designation as large or small business and any applicable socioeconomic status

Please limit responses to fifteen (15) pages regarding your capabilities. Not included in this page limit are any market research reports that you wish to submit to aid the government in its understanding of the current state of the United Stated PPE and MMF markets.

Not responding to this request does not preclude participation in future solicitations. General questions regarding this RFI may be submitted via email to caleb.owen@hhs.gov no later than August 31, 2022. Please note, the

Government may be unable to provide direct responses to any questions received. However, consideration will be given to all feedback, and any feedback received may be used to make appropriate acquisition decisions for anticipated requirements.

Information from this Request for Information (RFI) may lead to one-on-one market research discussions and/or other approaches to industry engagement. Partial responses are acceptable.

Disclaimer:

This RFI is issued for information and planning purposes only and does not constitute a solicitation. All information received in response to the RFI that is marked as proprietary will be handled accordingly by the

Government. In accordance with FAR 15.201, responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI.

mailto:caleb.owen@hhs.gov

This is a Request for Information only. It is not a request for proposals and does not commit the Government to issue a solicitation, make an award, or pay any costs associated with responding to this announcement. All information submitted in response to the RFI shall remain with the Government and will not be returned.

Request for Information Description:

The purpose of this RFI is to gain knowledge regarding current/future production and market capacity to manufacture and sustain created capacity within the United States without further Government support, for manufacture of medical-grade man-made-fibers (MMF). MMF are non-woven staple fibers (e.g., spunbond, meltblown, spunbond‐meltblown‐spunbond (SMS) or similar material) which are the feedstock in the production of surgical and other medical gowns, surgical masks, and other essential personal protective equipment (PPE) needed by hospitals. Currently, the US is at a competitive disadvantage relative to foreign suppliers of MMF.

The US Government (USG) intends to support domestic manufacturing facility(ies) through scale and process optimization/quality (e.g., automation, polymer chemistry, biodegradability, innovation, etc.) to improve the competitive balance and to ensure that the US possesses a reliable, domestic MMF source(s) at all times, particularly during periods of global supply chain uncertainty. While the initial establishment of this capability within the United States requires USG intervention, the Contractor must have a comprehensive plan to sustain this capability within the United States that does not rely upon additional USG funding beyond the life of the initial USG contract, which is anticipated to be no more than five years.

The Government is interested in obtaining the answers to the below questions as well as any other relevant market research, manufacturing economics, technical manufacturing information or literature that you possess and believe will be relevant to this acquisition. Specifically, the Government is interested in knowing your proposed business plan, current and projected manufacturing capabilities, capacity expansion plan, and associated costs over time, up to the next five years, to reach sustainability in the commercial market.

Technical Requirements

The Government is looking to acquire a sustainable, competitive manufacturing capacity for the production of large scale of MMF within the United States. The Government hopes to acquire capacity to produce at least 150 million metric tons of MMF per year, but realizes that it may need to make multiple awards to reach this amount.

Interested vendors may propose any reasonable approach to accomplish the needed capacity, but must bear in mind the importance of sustainment in the commercial market.

Other key elements that should be considered by interested parties:

a. Strategy to source all raw materials, supplies, and reagents required for MMF production using United

States domestic sources to the greatest extent feasible.

b. Strategy to recruit, train, and maintain a skilled workforce.

c. Strategy to ensure that the newly established MMF manufacturing capacity meets all U.S. Food and Drug

Administration (FDA) requirements and guidelines for medical-grade MMF to be used in production of

PPE.

d. Strategy to ensure planning, permits, execution, and follow through required to obtain any and all required certifications and validations of the MMF manufacturing capacity and ensure that all work performed is in compliance with federal, state, and local regulations.

e. Strategy to ensure, maintain, operate, and service all equipment and tooling acquired by the potential

Offeror to produce MMF.

Further, interested parties are encouraged to develop innovative capabilities for the development and fielding of new MMF that offers enhanced quality and protection to frontline medical workers as well as provides domestic sources a competitive advantage over overseas suppliers. If applicable, the interested party shall confirm freedom to operate with respect to any existing, essential patents and propose a strategy to ensure that any patents or intellectual property gained through execution of this work will be retained within the US. Of particular interest to the Government are advances that enhance, advance, and fully integrate technologies related to automation, continuous polymerization, polymer chemistry, durability, reusability (i.e., multi-use), comfort, and increased biodegradability in landfills, soil, seawater, and wastewater. Inclusion of any of these innovations should be accompanied with a description of relevant testing, validation, or other assurances of specifications/successful implementation and execution.

As the purpose of an anticipated acquisition is to improve US competitiveness in the global market, interested partied must be wholly US-owned and all manufacturing must take place within the United States.

Questions:

NOTE: The sole purpose of this RFI is to assist HHS/ASPR in understanding the service provider landscape, identify good ideas and strategies, and avoid solicitation or contracting parameters which would be detrimental to

HHS/ASPR's mission or industry's ability to provide innovative and cost-effective solutions. ASPR does not plan to respond back to companies that submit responses to this RFI except perhaps to ask a clarifying question regarding a response provided by a company.

HHS/ASPR appreciates feedback on any or all of the following questions:

1. MMF Production:

a. What raw material/polymers/chemicals, etc. are needed to produce the requisite MMF feedstock? Is there a universal or common feedstock for the production of MMF? Are these raw materials domestically available at a non-prohibitive price? What additional sources are anticipated to be used to obtain key starting materials for MMF production? How is supply chain resilience built into your process?

b. How much MMF do you believe your entity could produce on an annual basis? What resources would be needed to sustain that production? What would be the associated annual costs? (See also: manufacturing line question below.)

c. Could you demonstrate improvements or innovations to the current product characteristics of medical-grade fibers (e.g., biodegradability, are bio-derived, recyclable, anti-microbial, decrease production costs, etc.)? Could these improvements/innovations meet FDA and NIOSH requirements? Could these improvements/innovations make your production more economically competitive with foreign made supply of MMF?

2. Past Performance:

Do you have previous experience with MMF or related manufacturing? If not, do you have experience in large scale manufacturing?

3. Manufacturing Line Development:

a. What upgrades, new equipment, adaptations to existing equipment, and/or additional construction would need to take place at your existing US facility(ies) to allow for the increased production of MMF in a commercially sustainable manner? What are the associated costs? Please include as much detail as possible such as costs associated with design, materials, construction, training, sustainment, and any other relevant costs over an up-to five-year period.

b. What sort of timeline would be necessary to implement the manufacturing line improvements/complete the construction necessary to allow you to produce MMF at a commercially sustainable level? Please provide as much detail as possible.

4. Sustainment:

a. How would you assess the current commercial market for MMF in the United States? How would it be impacted by this acquisition?

b. What type(s) of MMF are most needed by PPE manufacturers? Given present market conditions, can these MMF type(s) be produced domestically in a cost-efficient matter that would allow for commercial sustainment over a reasonable time period, say 15-20 years? If not, what are the biggest hurdles that the industry faces for sustainment? What would you propose to overcome these hurdles?

c. Do you have existing relationships with PPE manufacturers that have an immediate need for

MMF, and are these manufacturers located within the United States or outside the United States?

d. Do you believe you would be able to establish and maintain the relationships with PPE manufacturers in the United States in such a way as to allow for the ongoing sustainment of MMF production without additional Government investment?

5. Management:

What personnel would be necessary to create and sustain MMF manufacturing at a commercially sustainable level? Do you already employ the key personnel needed for this project and, if so, can you provide background information as to why you believe they will be able to oversee successful completion of this project? What subcontractors would been needed to complete the proposed expansion work?

6. Do you have any other suggestions or ideas for HHS/ASPR to consider when it posts a solicitation?