CSO_AOI_Questions and Answers.pdf

16 November 2021

Questions/Answers

CSO:

1. In the CSO paragraph 1.5.1.b stated that diagrams(s) or figures are strongly encouraged. These may take considerable space in a document. Are these required to be within the five page limit of the brief?

Answer: Yes, the 5-page limit applies to the entire content of solution brief.

2. The over-arching CSO states that the Solution brief content must include what is in 1.5.2 Spiral 1 below. The AoI has an additional 22 questions. Are our responses to the 22 questions required to fit into the 5 page limit (or 15 slide limit) required by the CSO?

Answer: As stated in the CSO, solution briefs should not exceed five (5) pages or 15 slides. The answers to AoI questions are part of the solution brief and subject to the 5-page limit.

Responses may be narrated, bulletized, listed as Q then A or just listed as the answers, as long as they are part of the solution. Additionally, each solution gets its own 5 pages, but it has to be identified as a separate solution and submitted separately.

3. Following the executive summary, it is recommended that (1) the outline in the CSO be strictly adhered to, or (2) is it preferred to present the format as direct answers to the specific questions given in the AOI as the main body?

Answer: The CSO does not specify format. As long as all of the answers to all questions/requirements for both the CSO and AoI are included within your 12pt font/5pg limit, we will accept any format.

4. Just the questions themselves take up nearly 3 pages in addition to having to address the eight

(8) Spiral 1 required areas that must be included in the submission. Even if the font size were reduced from the required 12-pt it would be very challenging to provide meaningful responses limited to 5 pages / 15 slides. Is there a way to amend the page limit and increase it to 8 - 10 pages?

Answer: At this time, we are not amenable to changing the page limitations. However, we have no particular formatting requirements, nor do we require you to restate our questions within the body of your solution.

5. When are we likely to get a response to our CSO proposal?

It is the Government’s intent to wait to respond once all submissions are reviewed and rated.

An exact date cannot be provided, as the review timeline may depend on how many solutions are submitted. Ideally, the Government would like to make Spiral 2 selections by the end of the calendar year.

AoI-0001:

1. Please confirm the period of performance for any Solution Brief submitted for AoI 0001 can be up to 24 months.

a. The CSO states: “The period of performance for any Solution Brief or proposal submitted under this CSO should be 1- 12 months (unless otherwise specified in the AoI).”

b. The AoI 0001 states briefs should be provided to “expand domestic production capacity of glove manufacturing NBR within the next 6-24 months.”

Answer: The period of performance of up to 24 months for any Solution Brief submitted for

AoI 0001 is confirmed.

2. Please clarify the Government expects offerors to include in their Solution Briefs:

a. Answers to items 1-9 in the CSO (Page 9) AND

b. Answers to Questions 1-22 in the AoI (Pages 3-5).

Answer: Both answers to items 1-9 in the CSO (Page 9) and answers to Questions 1-22 in the

AoI (Pages 3-5) have to be included in the solution brief.

3. Is the Solution Brief response to the questions in AoI-0001 the same as the Spiral 1 submission?

Answer: Yes, the solution brief is the same as the spiral one submission outlined in the CSO.

4. If the Solution Brief response is the Spiral 1 submission, is there a 5-page limit in responding to the 22 questions contained therein, or should the Solution Brief be limited to 5 pages and contain the responses to the questions in AoI-0001 as an attachment?

Answer: The expectation is that all required content, questions, answers and information from both the CSO and AoI are contained within the 5pg or 15 slide limit.

6. Will awards be granted only after the end of the open period, November 23rd, or will awards be made before that date?

Answer: Please be advised that no awards will be made prior to Spiral III.

7. The AOI, Section 1, states that the “USG has a minimum requirement to produce an additional

180k wet metric tons per year to sustain the domestic glove industry.”

a. Does the Government anticipate that one offeror will be able to produce 180k wet metric tons per year after 24 months?

b. Will the Government accept offers proposing to produce the full 180k wet metric tons per year requirement?

c. Will the Government accept offers proposing to produce less than 180k wet metric tons per year?

d. Does the Government have a goal for the number of awards to be granted for NBR production facilities?

Answer:

a. The Government does not have a definite anticipation at this time.

b. Yes

c. Yes

d. No.

8. Section 1 indicates a total domestic demand for acute and non-acute care nitrile gloves of 3.65 billion gloves per month, or 43.9 billion gloves per year. To provide enough information to address questions items 9 and 10, please provide the estimated annual demand for gloves specifically from US Government procurement contracts. In other words, what portion of the

43.9 billion gloves per year is for US Government demand?

Answer: Due to the uncertainties surrounding the current and/or future pandemics, the

Government cannot separate US Government from US commercial demands.

9. The total domestic requirement of NBR is stated as 270,000 wet metric tons of NBR. The use of

“wet metric tons” implies this is the quantity of NBR latex (water-based dispersion) required.

NBR latex is nominally 50% solids, meaning each wet metric tons contains 0.5 dry metric tons dispersed in water. Therefore, 270,000 wet metric tons is equivalent to 135,000 dry metric tons. Based on this quantity of dry NBR to make 43.9 billion gloves, an assumed glove weight of approximately 3 grams per glove can be calculated.* Please confirm that the HHS assumptions are based on an average glove weight of 3 grams per glove.

*Glove weight = (270,000 wet tons NBR) x (0.5 dry tons NBR / wet ton NBR) x (1,000,000 grams/ton) / (43,900,000,000 gloves) = 3.1 grams/glove.

Answer: The calculation assumptions cannot be confirmed. As a reminder, the solution brief proposal has to utilize wet metric tons.

10. Page 2 of the AoI contains Priority Access language that all contracts will be subject to. Could you please explain how the obligations under this provision (to provide priority access over non-rated orders) differ from existing DPA requirements.

Answer: Per the Priority Access Language, "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.”

11. In question 3, is the intended scope of the question related to regulatory requirement specific to the use of NBR in acute and non-acute care gloves, or should the response include regulations related to operating a chemical manufacturing facility, such as state and federal EPA environmental permits?

Answer: Question 3 addresses regulatory approvals for the manufacture of the NBR.

Therefore, regulations related to operating a chemical manufacturing facility, such as state and federal EPA environmental permits and all other applicable approvals should be included.

12. Does question 3 refer to having EPA and other regulatory approvals needed to begin production of NBR in the United States or does this question refer to whether our NBR product currently meets EPA and other regulatory standards?

Answer: It refers to both.

13. Please clarify the definition of “market cost” in question 7. Does it refer specifically to the average market price of nitrile gloves, the cost of manufacturing NBR, or the market price of

NBR?

Answer: Market cost refers to the cost of manufacturing NBR.

14. Please provide a definition for “sustainment plans/expectations” as used in question 9, or a sample response.

Answer: Sustainment plans/expectations refer to the company's business plan/strategy for sustainment of required level of production and reach-back capability for the period of 10 years.

15. In question 13, is this referring to cost-sharing between our company and other commercial partners, or is it referring to cost-sharing between the federal government and our company?

Answer: It is referring to cost-sharing between your company and other commercial partners.

16. #7: change in market cost (“Market Cost” indicates raw material Market or glove industry

Market?)

Answer: It refers to raw material market.

17. #9, 10: I assume that these two questions include generally identical points; how should we continue to become profitable and sustainable after the USG’s initial investments?

Answer: Your assumption is correct.

18. #10 has a description on “supply chain disruption”, would you kindly elaborate on this?

Answer: Supply chain disruption refers to any negative impact on your supply chain efficiency, such as supply shortages, reduced productivity, demand drops and surges, etc.

19. #13: in terms of “cost sharing” referred in the question, from our perspective, can we understood this as any type of partnerships that includes financial investments on our facility? If not plz guide us to the right path.

Answer: Your assumption is correct. Cost sharing implies cost sharing between your company and other commercial entities.

20. # 14 C: low, medium and high levels of investment means our scale of investment, or total amount of investment that might vary according to our construction schedule?

Answer: The question refers to different scenarios of production schedule depending on how much investment your company receives and the benefits of each scenario.

21. What we’d like to clarify is that our plan is to build a new subsidiary company that will be 100%

US company. And in fact the CEO is also a US citizen. With this provided case, it would be still considered as foreign-owned? If so, in our CSO, which part should be highlighted in order to prove our ability to obtain necessary clearances and approvals to proscribed information and comply with US laws?

Answer: In the scenario you provide, although the company will be located in the United

States and managed/led by a US citizen, it will still be foreign-owned. The CSO does not specify formatting. You may include the information regarding your ability to obtain necessary clearances and approvals anywhere within your solution briefing. However, all information provided is subject to the 12pt font, 5-page or 15 slide limit.

AoI-0002:

1. In section 1 of AoI-002 the requirement for additional NBR capacity is stated as 270,000 wet metric tons of NBR including. The use of “wet metric tons” implies this is the quantity of NBR latex (water-based dispersion) required. From the quantities of Butadiene, Acrylonitrile and

MAA listed, it is apparent the assumed NBR composition is 66.6% butadiene / 30.0% acrylonitrile

/ 3.7% MAA. NBR latex is nominally 50% solids, meaning each wet metric tons contains 0.5 dry metric tons. From these assumptions, the quantities of monomers (key chemicals) required can be calculated as 90K tons butadiene, 40.5K tons Acrylonitrile, and 5K tons MAA (see calculations below). Therefore the quantities of required key chemicals stated in section 1 of AoI-002 are double the amount needed for 270 wet metric tons of NBR latex. This error is likely due to omission of the solids content in the calculation of the key chemicals. Please review our calculations and confirm if the quantity of monomer listed is incorrect, or if the quantity of NBR latex shown should be stated as dry tons instead of wet tons.

Metric Tons Butadiene = (270,000 wet tons NBR) x (0.5 dry tons NBR / wet ton NBR) x (0.666 tons butadiene / dry ton NBR) = 89,910 tons butadiene

Metric Tons Acrylonitrile = (270,000 wet tons NBR) x (0.5 dry tons NBR / wet ton NBR) x (0.30 tons butadiene / dry ton NBR) = 40,500 tons acrylonitrile

Metric Tons MAA = (270,000 wet tons NBR) x (0.5 dry tons NBR / wet ton NBR) x (0.037 tons butadiène / dry ton NBR) = 4,995 tons MAA

Answer: The calculation assumptions cannot be confirmed. As a reminder, the solution brief proposal has to utilize wet metric tons.

2. Is it possible that, per the AOI- that those submitting could be invited for Spiral 2 and/or 3 before the 23rd of November? If it is possible that those submitting could be invited for Spiral 2 and/or 3 before the 23rd, is it then also possible an Award decision could be made before the

23rd?

Answer: No. The solution brief submission deadline of 23 November exists strictly within

Spiral I, therefore, no invitations for Spiral II or III will be made prior to this date.

AoI-0003:

1. Are we excluded from this offer because we are not the manufacturer? Is there any way that our company could be considered for this solicitation?

Answer: 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 gowns. 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.

2. Concerning the FA810122SC001, AOI-0004, would you kindly help us understand the correct responsive format you are requiring? The CSO calls for a Spiral Solution Brief, 5 written pages or

15 slides outlined by topic consistent with sections 1-10 (Exec Summary, Tech Concept, Offer

Responsibility, etc). However, the AOI is in a Question & Answer format and provides that the offeror, "answer the questions", which seemingly contradicts the CSO Spiral format provision.

Any clarification you can provide on the preferred responsive format would be greatly appreciated.

Answer: The solution brief should include the answers to the questions asked. We don't specify formatting (e.g. narrative vs. bullets), but it does need to stay within the 5 page or 15 slide limit. Please answer the AOI questions while following the CSO formatting.

3. May we include attachments to the Solution Brief (diagrams, building specs, machinery, vertical integrations, etc.) and if so, are those exhibit attachments excluded from the 5 page limit?

Answer: You are welcome to submit attachments; however, they will be included in page/slide counts.

4. Is there a page limitation to the response to AoI-0004 DOMESTIC INDUSTRIAL BASE EXPANSION

OF ISOLATION AND SURGICAL (L2/L3/L4) DISPOSABLE GOWNS MANUFACTURING AND MEDICAL

GRADE MAN-MADE FIBERS FOR PRODUCTION? The questions alone are nearly 8-pages. Also, there is a reference to Spiral 1 to 3 on page 12. Can you elaborate more on the different spirals?

Answer: CSO FA810122SC001 attachment "FY22 DAF ACT COVID-19 CSO.pdf" section 1.5.2 (a) calls out “Solution Briefs 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.”

5. Hilo intends to respond to both part A for gown automation and part B for MMF production as a vertically integrated facility. Are we limited to five pages for each part or is our limit five pages for any response?

Answer: Solution Briefs may be submitted separately for each part. We do not specify formatting (e.g. narrative vs. bullets), but each Solution Brief does need to stay within the 5 page or 15 slide limit. Please note that attachments will be included in the page/slide count.

6. Could you please clarify if the expectation is for a sterilized Level 2? This one usually doesn’t require FDA 510(k) either, so just trying to get clarity on the Level2 requirement from the government if it’s different than the AAMI standard.

Answer: The requirements are as follows: 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.

Class I gowns are non-sterile; Class II gowns are sterile.

7. We did not see a stated annual volume in AOI-0004 that the government seeks to establish for either surgical gowns or isolation gowns. Are there target annual volumes that you can share?

Answer: Original amounts were 400M disposable gowns a month (based on 2B/annual) – but that is overarching. Recent info shows ~900M to 1.44B/annual (180M to 288M).

8. Is there a margin limitation or requirement concerning the Spiral 1 Solutions Brief? Is there a margin limitation when inserting a graph or chart, or may we extend outside any minimum required margin (if applicable)?

Answer: The CSO does not specify margin limitations for text or graphics.

9. CSO provides for a 12 pt font, will that also apply to words/numbers inside a chart or graph, or may we use smaller font with those?

Answer: 12pt font is required for consistency.

10. Is the spiral brief required to be in black and white, or may we use color within charts or graphs?

Answer: The CSO does not specify color or black/white. You may choose either.

11. What details is the government seeking in response to this question (part A, question 6) as it is unclear what is meant by ‘process’ and ‘equipment regulatory approval’? Are there any additional details you can provide to point us in the right direction?

Answer: The Government wants a description of the proposed production process, and the intended steps and anticipated timeline that will be taken to achieve all necessary regulatory approvals (e.g., FDA) for equipment and its respective process.

AoI-0004:

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?

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: No, the request is for medical N95 respirators.

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.

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

Answer: No

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

Answer: We are looking for the N95 masks and these masks should be regulated by the FDA, under CFR 878.4040, and CDC NIOSH under 42 CFR part 84.

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.

Answer: At this time we are not amenable to changing the page limitations. However, we have no particular formatting requirements, nor do we require you to restate our questions within the body of your solution.

14. If using the 15 slide format, do submissions need to use the 12-point font specified?

Answer: 12pt font should be used to maintain consistency.

15. Is there a CSO section 1.6.3? Spiral 1 Solution Briefs: Shall be submitted as specified in Section(s)

1.6.2-1.6.3 of this CSO (Reference CSO, Page 3, Item 1.3 CSO Procedure, Spiral 1)

Answer: This is a typo. The paragraph should read 1.5.2-1.5.3. The CSO will be amended to make the correction.

16. Is there a CSO section 1.6.6 - 1.6.9? This question is for future preparation. Spiral 3 Request for

Commercial Proposal (CSP)Solution Briefs: “will be invited to submit a full written proposal following the instruction provided in Section(s) 1.6.6 - 1.6.9 of this CSO” (Reference CSO, Page 3, Item 1.3 CSO Procedure, Spiral 3)

Answer: This is a typo. The paragraph should read 1.5.6-1.5.9. The CSO will be amended to make the correction.