AoI-0003 N95 RESPIRATOR INDUSTRIAL BASE CAPACITY PRESERVATION.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 N95

Respirators by providing a warm supply chain that can rapidly expand to meet domestic medical emergencies. 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 domestic production capacity of 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 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 141M 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 (120 days) 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.

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 NIOSH Approved N95 respirator.

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

1. What is your company’s maximum production rate of NIOSH approved N95 respirators per month? Please provide the location where production occurs. If your company produces masks at multiple manufacturing facilities, please specify the location and maximum monthly production capacity for each location.

LOCATION

QUANTITY OF NIOSH Approved N95 Respirators/MONTH

2. Under what circumstances is this level of production achieved (i.e. 24/7 operation, additional resources, etc.)?

3. 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.

4. 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.

5. 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?

6. 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.

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

8. 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?

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

10. 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?

11. 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.

12. 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?

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

14. 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.?

15. 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?

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

17. 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?

18. 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.

5. AoI Open Period

1) Solution Briefs may be submitted immediately upon reviewing this AOI. Solutions Briefs will be accepted until 23 November 2021 04:00PM CT.

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

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