AoI-0003 N95 Respirator Industrial Base Capacity Preservation Area of Interest (Revision 6).pdf

AoI‐0003 N95 RESPIRATOR INDUSTRIAL BASE CAPACITY PRESERVATION

1. N95 Respirator Industrial Base Capacity Preservation Area of Interest (AoI) Background

The current COVID‐19 Public Health Emergency has illuminated the importance of preserving the United States’ domestic capacity to manufacture N95 Respirators. The intent of this AoI is to understand the industry’s ability to preserve domestic production capacity of National

Institute for Occupational Safety and Health (NIOSH) approved non-surgical N95 Respirators, by providing a warm supply chain that can rapidly expand to meet domestic medical emergencies within the specified timeframe. The country’s ability to preserve domestic manufacturing is critical to respond to the current pandemic or future pandemics as well as to ensure the security of N95 Respirator 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 preserve existing domestic production capacity of non-surgical NIOSH N95

Respirators by providing a warm supply chain that can rapidly expand to meet domestic medical emergencies.

2. AoI Expansion Request

This AoI solicits solution briefs to support the Department of Health and Human Services

Assistant Secretary for Preparedness and Response (DHHS/ASPR) priorities for meeting public health/pandemic needs to preserve domestic production capacity of non-surgical NIOSH approved N95 Respirators by providing a warm supply chain that can rapidly expand to meet domestic medical emergencies. The overall goal would be for two to three U.S. manufacturers to maintain the capability to meet a demand target of 100M masks monthly at full manufacturing capacity but maintain a minimum viable capability at 20 – 30% of that capacity, with timelines to rapidly expand mask production (90 days (objective) and 120 days

(threshold) should the USG need the capability. It is expected manufacturers would store these masks at a warehouse, where USG could draw upon stocks to satisfy their daily requirements. Only current domestic manufactures of non-surgical NIOSH approved N95

Respirators will be considered for this AOI. Distributors will not be considered.

This AoI is specific to the CDC NIOSH under 42 CFR part 84 approved non-surgical N95 respirators.

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.

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.

3. Specific Information for N95 RESPIRATOR DOMESTIC PRODCUCTION CAPACITY

PRESERVATION:

Domestic NIOSH Approved N95 Respirator Production Capacity Preservation: The National

Institute for Occupational Safety and Health (NIOSH) approves respirators in accordance with

42 CFR Part 84. Part 84 certification regulation provides for nine classes of filters (three levels of filter efficiency, with three categories of resistance to filter efficiency degradation). The three levels of filter efficiency are 95%, 99%, and 99.97%. The three categories of resistance to filter efficiency degradation are labeled N (Not resistant to oil), R (Resistant to oil), and P (oil

Proof). These certification categories apply only to nonpowered, air‐purifying, particulate‐filter respirators. This AOI is specific to the CDC NIOSH under 42 CFR part 84 approved non-surgical

N95 respirators.

For the following questions, please answer your company’s current manufacturing capacity based on producing non-surgical NIOSH approved N95 respirators:

1. Is your company a current manufacturer, not distributor, of NIOSH approved non-surgical N95 respirators?

2. What is your company’s maximum production rate of NIOSH approved non-surgical N95 respirators per month? Please also provide the manufacturing location where current production occurs and the NIOSH approval number for the non-surgical N95 respirators. If your company produces respirators at multiple manufacturing facilities, please specify the location and maximum monthly production capacity for each manufacturing location.

LOCATION

QUANTITY OF NIOSH Approved N95

Respirators/MONTH

Manufacturing Location (City, State) Quantity N95 NIOSH

Respirators/Month NIOSH Approval Number

3. Under what circumstances is this level of production achieved (i.e.

24/7 operation, additional resources, etc.)?

4. Are your company’s devices (N95 Respirators) listed on the FDA certified equipment list? If not, please define your plan and timeline to reach certification.

5. Can your company produce other products utilizing the same production lines/equipment that are used to produce N95 respirators? If so, describe your plans to remain commercially viable without continual government demand or investment.

6. What are potential risks to your company’s ability to achieving your maximum production capacity (i.e. Lack of skilled labor, supply chain risks, lack of raw materials, etc.)? Please detail your company’s plans/strategies to mitigate these risks?

7. As a general practice, during the current pandemic (COVID‐19), does your company keep a specific level of safety stock of N95 respirators?

Does it keep a safety stock of raw materials to mitigate potential supply chain disruptions? Please specify locations and counts of these stocks.

8. How many days would it take your company to achieve N95 respirator full rate production following notification from the

USG?

a. For ramp‐up timeframes of 90 and 120 days, is there a potential price difference and if so, what re those price breaks?

b. Note: Amendments to previously submitted solutions will be accepted.

9. Would you be willing to consider a contractual provision that would seek to maintain a minimum capability of your capacities or give the USG priority during national emergencies, in exchange for a negotiated compensation plan?

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

11. 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?

12. 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.

13. 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 must 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?

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. 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.?

16. Do you currently comply with 21 CFR 820 standards, (no exceptions)?

If not, what would be needed to do so? Has the firm been audited according to these standards?

17. What other regulatory and quality standards (e.g., spec sheets) would be needed to implement production, e.g. ISO 13485, ISO 9001?

18. 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?

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

4. 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

2. Solutions briefs for this Area of Interest shall be submitted at the email below: N95.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.

mailto:N95.CSO.dafact@afwerx.af.mil

4. AoI Open Period

1. Questions pertinent to this AoI should be sent to N95.cso.dafact@afwerx.af.mil by 4:00 PM CST, 21 January 2022.

2. Solution Briefs may be submitted immediately upon reviewing this AOI.

Solutions Briefs will be accepted until 27 January 2022 12:00PM CST.

a) Both new solutions and 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 line of the email.

b) Amended proposals shall replace the original submission entirely and will be evaluated independently. Thus, all AoI submission requirements will remain in full force and effect.

c) Failure to submit a complete solution amendment that complies with all submission requirements of the AoI may result in an incomplete solution and potential disqualification.

d) For ease and speed of evaluation, the Government requests that amended solutions include one version of their submission striking through removed text and highlighting new text. This document is not subject to the page number limitations, but solely for the purpose of quickly identifying the changes from the previous submission. The second/final version will be a “clean” copy that highlights additional information, but does not included information that was struck through and removed. The clean version must conform to the page and formatting limitations outlined in the CSO.

3. Evaluations will begin within two business days of receipt of solutions.

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

N95.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 mailto:N95.cso.dafact@afwerx.af.mil 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.

DEFINITIONS

This AoI is specific to the CDC NIOSH under 42 CFR part 84 approved non-surgical

N95 respirators. Definitions added for clarity.

Non-surgical N95 respirator: N95 filtering facepiece respirator, commonly abbreviated N95 respirator, is a particulate-filtering facepiece respirator that meets the U.S. National Institute for Occupational Safety and Health (NIOSH) N95 classification of air filtration, meaning that it filters at least 95% of airborne particles. An authentic N95 respirator is marked with the text "NIOSH" or the NIOSH logo, the filter class ("N95"), a "TC" approval number of the form XXX-XXXX, the approval number must be listed on the NIOSH Certified Equipment List (CEL) or the NIOSH Trusted-Source page,[5] and it must have headbands instead of ear loops.

Surgical N95 respirators: Surgical N95 Respirators used in Healthcare are approved by Centers for Disease Control and Prevention (CDC) National Institute for Occupational Safety and Health (NIOSH) and must meet both NIOSH and FDA requirements. It is used to protect the wearer from particles or from liquid contaminating the face. The key difference between Surgical and non is the fluid resistance and the resulting FDA clearance of surgical N95s. Surgical N95 respirators are class II devices regulated by the FDA, under 21 CFR 878.4040, and CDC NIOSH under 42 CFR Part 84.

N95s respirators regulated under product code MSH are class II medical devices exempt from 510(k) premarket notification, unless:

o The respirator is intended to prevent specific diseases or infections, or o The respirator is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or o The respirator contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms).

For additional differences between surgical masks and N95 respirators, please see CDC's infographic: https://www.cdc.gov/niosh/npptl/pdfs/UnderstandDifferenceInfographic- 508.pdf.

https://www.cdc.gov/niosh/npptl/pdfs/UnderstandDifferenceInfographic-508.pdf https://www.cdc.gov/niosh/npptl/pdfs/UnderstandDifferenceInfographic-508.pdf

Updated Questions & Answers Previously Posted to Sam.gov:

1. Can you please clarify whether the “Solution Brief” submission for AoI-0003 consists solely of the responses to Section 3 “Specific Information for N95 Respirator Domestic Production Capacity

Preservation,” or whether it also incorporates the CSO Spiral 1 Solution Brief as further described in CSO section 1.5.2 “Spiral 1 – Solution Brief Content,” inclusive of executive summary, price, scaling costs, etc.?

Answer: Solution briefs need to include 1.5.2 information as well as responses to section 3.

2. Section 1.5.2 calls for a brief that “…should not exceed five (5) single-sided written pages using 12-point font or, alternatively, Solution Briefs may take the form of briefing slides which should not exceed fifteen (15) slides unless otherwise stated on the subject AoI.” Is this limit separate from the answers to section 3, or does it need to incorporate section 3 responses within the limit?

Answer: You need to incorporate section 3 with the limit.

3. For AoI-0003, does the clause referenced in the CSO “…small disadvantaged business, 8(a), women-owned, veteran-owned, service-disabled veteran-owned, and HUBZone small business concerns, and any related identifications.” provide that any of these designations would have a level of preference in any initial contract or subsequent procurement?

Answer: The requirement is to identify yourself as a small business. At this time, no preference is given to small business. We are unable to speculate if preference will be given for future/subsequent procurements.

4. Is the five (5) single-sided written page limit specific to the Solution Brief only? Do we also have to include our answers to the 18 questions asked in AoI-0003 within the five pages or is that a separate submission?

AoI-0003:

Answer: The CSO calls out that solutions are to be 5 pages, single spaced, 12pt font (or) if you choose to do it in a briefing format, no more than 15 slides. The

AoIs have questions that we require answers to. The answers to those questions are part of the solution brief and subject to the 5-page limit. You can narrate those responses, bulletize them, list Q then A or just list the answers, as long as they are part of your solution.

5. Is there a preferred format for the Solution Brief?

Answer: Other than the required formatting called out in the CSO, there is no preferred formatting.

6. Our specific question is may we submit as a Niosh approved Non-medical N95 mask that is accepted now because of the EUA but will not be seeking further FDA approval? Would we be grandfathered in when EUA expires?

Answer: The National Institute for Occupational Safety and Health (NIOSH) approves respirators in accordance with 42 CFR Part 84. Part 84 certification regulation provides for nine classes of filters (three levels of filter efficiency, with three categories of resistance to filter efficiency degradation). The three levels of filter efficiency are 95%, 99%, and 99.97%. The three categories of resistance to filter efficiency degradation are labeled N (Not resistant to oil), R (Resistant to oil), and P

(oil Proof). These certification categories apply only to nonpowered, air‐purifying, particulate‐filter respirators. This AOI is specific to the CDC NIOSH under 42 CFR part

84 approved non-surgical N95 respirators. All required certifications must already exist and not be in progress.

7. Regarding the FY22 DAF ACT COVID-19 Commercial Solutions Offering (CSO), N95 Area of Interest

0003, volumes are stated as 141M per month. Can you please confirm that this is 141Million per month?

Answer: The overarching goal is 141 million a month. However, your proposal should reflect what your maximum capacity is. The updated overarching goal is for

100 million N95 non-surgical respirators a month.

8. Will you be acquiring flat-fold (or so-called duck-bill style) N95 masks as well?

Answer: No This AOI is specific to the CDC NIOSH under 42 CFR part 84 approved non-surgical N95 respirators, regardless of style.

9. Do you require surgical FDA approval for the N95, or are you only seeking NIOSH certification?

Answer: We are looking for the Both This AOI is specific to the CDC NIOSH under 42

CFR part 84 approved non-surgical N95 respirators.

10. What does minimum viable capability mean operationally?

Answer: That means what level of capacity do you need to sustain to remain minimally viable…stay alive, not go bankrupt.

11. Will the mask output from minimal viable capability be exclusively sold to the U.S. Government?

Answer: No, the effort is not intended for the procurement of any end items; this would be executed in a separate contractual effort.

12. Can additional documents be submitted as a reference in an Appendix not be counted against the maximum of 5 written pages or 15 slides? These are not intended to be elaborate but to support the Solution Brief.

Answer: No, all additional documents/attachments will count towards page count.

13. On AoI 0003 there are 18 questions that require a response. Is it okay to submit our responses to these questions using this same outline? If we edit the document to include our responses this may expand this document from 6 pages to possibly 8-10 pages. Please confirm this is okay and that these responses to these 18 questions will not be part of our maximum 5 written pages or

15 slides.