AoI 0003 N95 Questions Answers_24Jan2022.pdf

CSO: FA810122SC001

AoI-0003

N95 RESPIRATOR DOMESTIC PRODCUCTION CAPACITY PRESERVATION

Questions & Answers

21 Jan 2022

1. We have multiple facilities producing N95’s. Will production asset transfers be permitted? (Reference AoI-0003 Revision 6, Page 1, Section 1, 2nd paragraph “existing domestic production capacity”)

The NIOSH-approved non-surgical N95 respirators should currently be manufactured domestically, which includes U.S. and Canada.

2. Are you strictly looking for NIOSH N-95 respirators which is N category and 95% filtration only? (Reference AoI-0003 Revision 6, Page 2, Section 3, 1st paragraph, “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)”

The request is for NIOSH-approved non-surgical N95 respirators only.

3. AoI-0003 Revision 6 specifies that all NIOSH approved N95 respirators and styles are acceptable (Valve vs non-valved). Respirators with valves have practically no source control since respiratory droplets potentially containing the virus are allowed to escape. Should valve styles be excluded? Reference AoI-0003 Revision 6, Page 2, Section 3, 1st paragraph, “This AOI is specific to the CDC NIOSH under 42 CFR part 84 approved non-surgical N95 respirators”

The request is for NIOSH-approved non-surgical N95 respirators only, which includes valve and non-valved.

4. Can you please provide additional clarification why the target demand changed from 141M to 100M masks monthly at full manufacturing capacity? (Reference AoI-0003 Revision 6, Page 1, Section 2, 1st paragraph, “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”. Please note we have been following multiple news articles that have emphasized a target of 141M per month and saw the comments from Dawn O’Connell, the assistant secretary for preparedness and response at the Department of Health and Human Services, during a Senate hearing on January 11, 2022 that HHS is looking to award contracts soon to mask makers to produce 141 N95s per month.

Further analysis has resulted in this requirement’s adjustment downward.

5. There is no mention if a respondent can offer non-surgical N95’s with an exhalation valve. Will the USG accept in addition to non-valve, non-surgical N95’s without a valve, accept an N95 with an exhale valve?

See question 3.

6. What is the reason behind limiting awards to only 2-3 companies?

This was based on market research.

7. Is there a minimum viable threshold established that you're seeking from each contractor? No You seek a total of 20-30 million in minimum capacity per month, but would you consider one company at 3 million per month if the others can cover the balance to meet the total need or does the volume need to split evenly? Yes

8. Does the 90-120 day timeline need to begin at the date of award, or is there an allowance for a timeline before that 90 day expectation would start? For clarity, do we need to be ready to surge within 90 days from today, or could we offer a solution for 90 day surge AFTER a short lead-time to prepare/staff for it?

The USG expects this monthly level of production to be executable no more than 90 or 120 days after notification by the PCO; this notification could come at any time.

9. Would the DAFACT COVID-19 Taskforce consider submissions from U.S.

manufacturers who currently manufacture PPE other than N95 masks, if the manufacturer could ensure that they have the capability to quickly meet capacity for N95 production?

The request is for current existing manufacturers of NIOSH-approved non-surgical N95 respirators.

If so, what kind of timeline would the manufacturer be given to bring their facility up to speed to meet production of N95 masks?

In accordance with AoI 0003, “Only current domestic manufactures of non-surgical NIOSH approved N95 Respirators will be considered for this AOI.”

10. Will it be possible to contract for the production of N95 masks for a period of 12 months?

This effort is not intended for the procurement of any end items; this would be executed in a separate contractual effort.

11. Given that we cannot fully predict the nature of future pandemics, would it not be more advantageous for the Government to retain the flexibility in ensuring companies can preserve their production capacities for both surgical and non-surgical N95 respirators? The reason for our request is to ascertain the Government’s interest in a holistic, turn-key solution that reflects our company’s unique, rapid response capabilities to adapt our manufacturing lines. At the beginning of the current COVID-19 pandemic, demand for surgical N95 respirators surged dramatically, as health care customers sought to buy the same N95 respirator models with which they are most familiar, on which their personnel are already fit tested, and which meet existing FDA regulations. During non-pandemic times, many of these health care workers are typically fit tested on only surgical N95 respirators. To have these health care workers also fit tested on non-surgical N95 respirators (in order to facilitate a swift shift to non-surgical N95 respirators during a pandemic) would present a significant logistical hurdle.

Additionally, encouraging companies to have this flexibility would greatly enhance their commercial viability, which we understand is also an important evaluation consideration for the Government, as they can more effectively respond to market demand in the future.

The request is for NIOSH-approved non-surgical N95 respirators only.