CSO QA_FA7013-20-S-0002_Final_rev1.pdf

CSO FA7013-20-S-0002

Q and A

FINAL

Date

Area of Interest (AoI) Question Government Response

7/17/20 4‐Pharma

Are all Solution Briefs for the Pharmaceutical Industrial Base Expansion AOI due by 12pm EDT 8/3/2020? Or are they accepted until 8/15/20? Solution Briefs will be accepted until 12:00PM EDT; 3 Aug 20202

7/17/20 4‐Pharma

The Pharmaceutical Industrial Base Expansion AOI document states this request is in support of the HHS/ASPR priorities.

What role will HHS/ASPR play in reviewing Solution Briefs?

The Department of the Air Force Acquisition Task Force (DAF ACT) combined with the Joint Acquisition Task Force (JATF) will lead rapid solicitation and execution of contracts in support of the JATF mission. The Government will evaluate Solution Briefs against criteria stated in this CSO.

7/17/20 4‐Pharma

Is the Pharmaceutical Industrial Base Expansion AOI open to partnered solutions? If so, how should the partner organization be identified in the proposal?

CSO Paragraph 1.6.1.1. Small Business and Domestic Sourcing, section (a) states: During Spiral 1 Solution Briefs and Spiral 2, Oral Presentation, offerors shall identify their small business size and socio‐economic status, as well as small business size and socio‐economic status of any proposed team members or subcontractors under the NAICS identified in this paragraph or the NAICS the offeror believes would be appropriate pursuant to FAR 52.219‐1, Small Business Program Representations (February 2020). CSO Paragraph 1.6.2 Spiral 1 identifies the Solution Brief Content.

7/17/20 4‐Pharma

Are organizations with previous government contracting experience preferred for the Pharmaceutical Industrial Base Expansion AOI?

CSO Paragraph 1.6.3. Spiral 1 Solution Brief and Paragraph 1.6.9. Spiral 3 CSP both provide the Basis of Evaluation for each Spiral.

7/20/20 1‐ Masks Will the USG be willing to fund real estate improvement under the solicitation?

As long as it ties directly to Industrial Base Expansion, it meets the general requirements of the AOI.

7/20/20 1‐Masks

I do not want to provide too much information in Spiral One.

Is it ok to provide high level details on the investments we wish to make? Is this something where you might fully fund an investment or is this more like a Loan?

The government is looking for offerors to respond to any or all production sections based on their resident expertise and ability to expand domestic production capacity of N95 FFRs, Surgical Masks, reusable respirators, and filtration media within the next 6‐24 months. These expansion proposals may be based at existing manufacturing facilities, new facilities, or through new partnerships that leverage novel facilities and capabilities to support this domestic expansion effort. CSO Paragraph 1.6.2 Spiral 1 ‐ Solution Brief Content provides the information required for the Solution Briefs to be submitted. The above referenced CSO and AoI contain additional details as to what the Government is soliciting in solutions briefs.

FINAL

Date

Area of Interest (AoI) Question Government Response

7/21/20 1‐Masks

I am writing regarding the “Mask Aol” statement issued recently by your group. Specifically the need for the following items: a. N95 respiratorsb. Surgical masksc. Reusable respirators d. Filtration media. 1‐Are you currently seeking to acquire the items mentioned in the statement? 2‐If so, is there a timeline for the acquisition of the items and at what capacity/volume?

The intent of this AoI is to understand industry’s ability to produce all aspects of the mask chain domestically. This AoI solicits solution briefs to meet Health and Human Services Assistant Secretary for Preparedness and Response (HHS/ASPR) priorities for meeting Strategic National Sourcing 2.0 strategy to expand domestic production capacity of N95 FFR’s, Surgical Masks, reusable respirators, and filtration media within the next 6‐24 months. These expansion proposals may be based at existing manufacturing facilities, new facilities, or through new partnerships that leverage novel facilities and capabilities to support this domestic expansion effort. The above referenced CSO and AoI contain additional detail as to what the Government is soliciting in solutions briefs.

Thank you for your question. Upon review, we have determined there is not a current requirement that aligns to your offering. We encourage you to remain engaged with the DoD as the interagency response to COVID‐19 evolves.

Follow‐up response: Thank you for your interest and sharing your company’s information and capabilities regarding equipment that can perform testing.

While the Screening and Diagnostics Area of Interest is not looking for laboratories that can perform tests on COVID‐19 samples, the equipment may be considered. It is recommended you view and continue to monitor https://beta.sam.gov for opportunities in matching your capabilities to active government requirements. Once you find there is an active solicitation, please follow the posted instructions.

7/22/20 2‐Screening

Is the JATF and DAF ACT open to companies submitting alternative screening solutions that could work in conjunction with analyzers & assays for blood/serological testing?

Thank you for your question. Upon review, we have determined there is not a current requirement that aligns to your offering. We encourage you to remain engaged with the DoD as the interagency response toCOVID‐19 evolves.

7/23/20 1‐Masks

JATF_CSO_COVID_19 Response document talks extensively about prototypes. Given our advanced stage of development, do we ignore references to prototyping and focus solely on production volumes? Provide information appropriate to the stage applicable to your submittal.

Does this RFQ include labs that can perform tests on Covid‐19 samples to see if they are positive or negative? Or equipment only that can perform the tests?

2‐Screening7/21/20

FINAL

Date

Area of Interest (AoI) Question Government Response

7/23/20 1‐Masks

JATF_CSO_COVID_19 Response, page 8, 1.6.2 Spiral 1 (point

5) Estimated Price and Delivery Schedule: Is it acceptable to propose lower volumes of N95 FFRs in Q4‐2020 (Oct‐Dec) and show ramp up in volumes through Q1‐2021 and achieving large‐scale production by Q2‐2021?

Provide information appropriate to the stage applicable to your submittal to include planned production ramp up and associated schedule to reach Full Rate Production.

7/23/20 1‐Masks

JATF_CSO_COVID_19 Response, page 8, 1.6.2 Spiral 1 (point

6) Estimated Costs for any testing, validation or scaling requirements:

a. [REDACTED] will cover the cost of testing & validation, so this will not be included in our Solution Brief – please confirm this is acceptable Approach is acceptable.

7/23/20 1‐Masks

[REDACTED] can significantly accelerate its manufacturing capacity if it has access to additional capital (~$5‐7MM), which would enable [REDACTED] to purchase additional electrospinning machines and automation equipment.

i. Can we describe our ramp up capability and itemize the associated capital costs if we are not prototyping?

ii. Do we need to repay these ramp‐up costs, and if so, over what time period?

Capital costs will be evaluated if included in the proposal. Repayment of ramp‐ up cost associated with increasing the domestic production of items called for in the AoI is not anticipated.

7/23/20 1‐Masks

[REDACTED] was incorporated in 2020 and does not have full‐ year financial statements. Does this exclude [REDACTED] from this program? Provide financial statements/data as available.

7/23/20 1‐Masks

Do we limit our Solution Brief solely to a supply of N95 FFRs, or can we propose adding other essential products (e.g.

surgical masks, HVAC filters, etc.) as described above, in the same Solution Brief, recognizing these additional products may be subject to a degree of prototyping?

Refer to the instructions provided in the Mask AoI. The above referenced CSO and AoI contain additional detail as to what the Government is soliciting in solutions briefs.

7/23/20 2‐screening

Please confirm that the submission suspense is 12:00 PM EST 3 August 2020 (AOI paragraph 3.2); or, is it 15 August (close out of the CSO)? Submissions are due 12:00 PM EST 3 August 2020.

FINAL

Date

Area of Interest (AoI) Question Government Response

7/23/20 2‐screening

We are in the RDTE phase of a non‐wet chemistry manportable CoVid‐19 screening/diagnostic device. The underlying technologies are individually verified in the laboratory to have high (>90%) detection specificity and sensitivity of the SAR‐COV‐2 virus. We anticipate applying for FDA EUA in the early fall. Given the AOI expectation that proposed solutions have an EUA or have submitted for an EUA, will you accept and evaluate our solutions brief without that EUA submission in place?

As stated in the AoI, "...test analyzers or assays which either have an existing U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) or can submit evidence of having submitted an FDA EUA packet as well as have a high throughput test processing..." Additionally, if you do not meet the criteria for the Screening and Diagnostics Area of Interest (AoI), perhaps the following BARDA BAA would be a more appropriate solicitation for you at this time:

Biomedical Advanced Research and Development Authority (BARDA) Broad Agency Announcement (BAA):

https://beta.sam.gov/opp/0bba3967c3404799aba43a1a9b3456ed/view Thank you for your interest and sharing your company’s information and capabilities. It is recommended you view and continue to monitor https://beta.sam.gov for opportunities in matching your capabilities to active government requirements. Once you find there is an active solicitation, please follow the posted instructions.

7/28/20 4‐Pharm

Please confirm the 100M Unit figure listed in the AoI #04 General Information/Expansion Request. For API specifically, are you asking for enough API to manufacture 100M doses of finished medicinesfor each proposed API? For example, if Midazolam and Succinylcholine are two proposed APIs of interest, we should propose enough API volume to manufacture 100M doses (e.g. vials, etc.) of Midazolam and 100M doses (e.g. vials, etc.) of Succinylcholine?

Yes. The offeror should provide solutions that support 100M units of each Pharma Product included in its Solution Briefing. Specifically, include enough KSM and/or API capacity that supports the manufacturing of 100 million final dosage forms for each of the proposed products.

FINAL

Date

Area of Interest (AoI) Question Government Response

7/28/20 1 ‐ Masks What is the quota for N95 mask and Surgical Mask?

The intent of this AoI is to understand industry’s ability to produce all aspects of the mask chain domestically. This AoI solicits solution briefs to meet Health and Human Services Assistant Secretary for Preparedness and Response (HHS/ASPR) priorities for meeting Strategic National Sourcing 2.0 strategy to expand domestic production capacity of N95 FFR’s, Surgical Masks, reusable respirators, and filtration media within the next 6‐24 months. These expansion proposals may be based at existing manufacturing facilities, new facilities, or through new partnerships that leverage novel facilities and capabilities to support this domestic expansion effort.

Though there is no specific quota and we will consider any proposal that addresses the requirements of the CSO, the intent of the CSO AOI is to expand domestic production within the next 6‐24 months. Furthermore, the AOI requires the solution to provide a timeline establishing domestic production.

7/28/20 2 ‐ Screening

On the beta.sam.gov announcement, the due date for the submission is listed as Aug 15, 2020 05:00 pm EDT, however, the instructions for the Screening and Diagnostic AOI state the submission date for the solutions brief is Aug 3, 2020 2:00PM EDT. Can you confirm which submission date is correct? Can you confirm that the completed Spiral 1 solutions brief should be submitted to this email address (JATFCSO_AOI_SCREENING@afwerx.af.mil)?

As stated in the AoI: “Solutions briefs for this Area of Interest shall be submitted at the email below: JATFCSO_AOI_SCREENING@afwerx.af.mil ” and “Solutions Briefs will be accepted until 12:00PM EDT; 3 Aug 2020.”

7/28/20 4 ‐ Pharma

Under this CSO program, is it an acceptable of funds, in part or in full, to build out, equip and initially staff a new, moderately scaled biologics process development and GMP manufacturing facility if we were to use that facility for our internal API programs that are currently performed in India and for other 3rd party API programs that are aimed at other infectious diseases?

Per the AOI #4, "The JATF would like to understand industries' ability to expand their domestic capacity to produce enough KSM, API, and fill‐finish/final dosage forms by at least 100M units (tablets, capsule, sterile vials etc.) per year."

Specific to [REDACTED] solution strategy, reference COVID‐19 JATF Commercial Solution Opening paragraph 1.6.2 for scope of content. Also, paragraph 1.6.3 includes criteria specific to the price assessment.

FINAL

Date

Area of Interest (AoI) Question Government Response

7/28/20 4 ‐ Pharma

I have a question on Pharmaceutical Industrial Base Expansion Area of Interest (AoI). After reading the overarching announcement, it states that this closes on 15Aug, but the AOI states 03Aug. This may be a question for clarification, and we would like to know if the due date/suspense on this AOI is also 15Aug. If not, I would like to know if the date could be pushed back to 15Aug so that we could put together an acceptable submission. With a short suspense, we will not be able to submit a response, but if the date is moved, the Government will benefit from a qualified and technically acceptable submission.

The DoD encourages max participation from all interested offerors. All offerors that submit Solution Briefs prior to 3 Aug 2020 (12:00PM EDT) will be considered for an invitation to compete in subsequent Spiral(s) based on evaluation criteria captured in COVID‐19 CSO paragraph 1.6.3.

7/28/20 4 ‐ Pharma

1. Does hand sanitizer supply have any relevance to this? 2.

Would the ethanol from the brewing or distillation process have any relevance to this? I know a number of breweries / distilleries that are making it and have the ability to do greater volumes. Reading through the announcement it doesn't sound like it, but before discarding this I figured I would ask for clarification.

Proposals should support the critical pandemic response pharma categories listed in AOI#4.

7/28/20 3‐ PPE

Is the gown quote 1.5 million per month for each Surgical Gown level, 2,3,4 (totaling 4,5 million per month?) Surgical Isolation Gowns level, 2,3,4 (totaling 4,5 million per month?)

Will these gowns be open or close styles? Will CAD patterns for cutting be provided for all types of gowns? What type of material are you needing these gowns constructed out of?

The numbers are a total of 1.5 million annually . You can have 1M level 2 and .5M level 3 to total 1.5M or however you need to break down the numbers. I am also sending you the FDA link that will answer all of the questions regarding the style and the types of materials that are needed to construct the gowns.

(https://www.fda.gov/medical‐devices/personal‐protective‐equipment‐ infection‐control/medical‐gowns) Most are now made from Spunbond Meltblown Spunbond (SMS) and Tyvek material but if you have a material that will pass the FDA testing that each level of gown must go through we will allow you to determine.

FINAL

Date

Area of Interest (AoI) Question Government Response

7/28/20 3‐PPE

I recently learned about the above opportunity and am debating about whether I should respond. I represent a Berry compliant manufacturer of fabrics used in isolation gowns.

We currently produce Level 1 and Level 2 compliant fabrics that are turned into resuable gowns by others. In reading the opportunity, I am not sure that I qualify because this is requesting end items. Is this correct or should I be submitting a response? Please advise and thank you for your time

We are looking for raw material manufacturers as well as those who make the products. If you have the ability and want to expand your manufacturing in the U.S. then yes you are qualified

7/28/20 1 ‐ Masks

I have a question about the Mask and respirators. I found a company who said they can cover as many as I need but they want to know how many mask and respirators would be needed for the monthly or weekly orders and destination items need to be sent so they can give me pricing

The intent of this AoI is to understand industry’s ability to produce all aspects of the mask chain domestically. This AoI solicits solution briefs to meet Health and Human Services Assistant Secretary for Preparedness and Response (HHS/ASPR) priorities for meeting Strategic National Sourcing 2.0 strategy to expand domestic production capacity of N95 FFR’s, Surgical Masks, reusable respirators, and filtration media within the next 6‐24 months. Additionally, the Mask AoI paragraph 2 states this CSO is intended expand domestic production of masks and respirators within the next 6‐24 months. These expansion proposals may be based at existing manufacturing facilities, new facilities, or through new partnerships that leverage novel facilities and capabilities to support this domestic expansion effort.

7/28/20 4 ‐ Pharma

As noted above, I am a pharmaceutical consultant with subject matter expertise in providing Pharmaceutical Research and Development and technical services. Can I participate in this solicitation by providing services outsourced through CMO’s? How will the contract awarded, will it be single POC?

DOD encourages max Industry participation. Solution Briefs will be evaluated per COVID‐19 CSO paragraph 1.6.3. The Government reserves the right to select all, some, or none of the Solution Briefs.

FINAL

Date

Area of Interest (AoI) Question Government Response

7/28/20 4 ‐ Pharma

In JATF_CSO_Pharma_AoI, Section 2, it states key Covid 19 drug categories. Does it mean that the manufacturer is required to be capable to manufacture all three categories i.e.

KSM, API and Finish product (FDF) or any one shall suffice?

Can the contract packagers, participate?

DOD is seeking domestic expansion in all three key steps (KSM, API, and Fill‐ Finish) specific to the pharmaceutical categories listed in AOI#4. Offerors may submit a Solution Brief addressing only one of the three key steps and its ability to expand domestic production (in that respective step) by at least 100M units (tablets, capsule, sterile vials, etc.) per year. Each Solution Brief will be evaluated per COVID‐19 CSO paragraph 1.6.3.

7/28/20 4 ‐ Pharma

In section 2 of the same file, does the participant company be existing manufacturers of listed Covid‐19 categories or we have to provided capabilities to develop and manufacture those drugs? If latter, then timelines can only be provided by knowing product names

All Offeror Solution Briefs will be evaluated using the same criteria listed in COVID‐19 CSO paragraph 1.6.3.

7/28/20 4 ‐ Pharma

In section 2c, Finished Dosage form Manufacturing: can different finish dose manufacturers sourced for multiple products and/or dosage forms?

Per AOI#4, fill‐finish dosage form options are listed as “tablets, capsule, sterile vials, etc.” specific to the critical COVID‐related pharmaceutical categories.

7/28/20 4 ‐ Pharma

Solution briefs – is there any template or any specific content for submission? It will be great if you can provide some details for maintaining uniformity with other submissions. Solution Brief Content is captured in COVID‐19 CSO paragraph 1.6.2.

7/28/20 4 ‐ Pharma

Solution briefs ‐ If we are able to provide FDF manufacturing and/or packaging services, through CMO’s, shall we submit 2 separate solution briefs?

All Offeror Solution Briefs will be evaluated using the same criteria listed in COVID‐19 CSO paragraph 1.6.3.

7/28/20 4 ‐ Pharma

Contracting: The scope within strategic goal iv (Pharmaceuticals) specifies the ability to expand production up to 100 million units. However, the market conditions for some products do not warrant this level of expansion, while others may far exceed this threshold. Is the contracting team proposing a minimum purchase quantity, minimum contracting volume or other volume guarantees as part of the proposal? Shall the submission specify the quantities proposed for the specific products in question?

The Solution Brief should include the offeror’s ability to expand its domestic capacity to produce enough KSM, API, and fill‐finish/final dosage forms by at least 100M units (tablets, capsule, sterile vials etc.) per year. The AOI#4 requirement doesn’t include the purchase of the pharma product(s). The Offeror should specify the quantity capacity for each pharma product included in its Solution Brief.

FINAL

Date

Area of Interest (AoI) Question Government Response

7/28/20 4 ‐ Pharma

Quantities: Is it reasonable to assume that quantities produced above the JATF requirements may be commercially offered by the company submitting the bid? If so, what conditions or restrictions are expected by the US Government for the commercial sale of products made through this process? The AOI#4 requirement doesn’t include the purchase of the pharma product(s)

7/28/20 4 ‐ Pharma

Pricing: Given products already produced overseas may have pricing below what a US manufacturer may offer, what criteria will be used to evaluate the price of domestic production versus prevailing market pricing? Is there an allowable difference? Is pricing targeted to the lowest cost source globally or competitive to US manufacturers?

The AOI#4 requirement doesn’t include the purchase of the pharma product(s).

All Solution Briefs, specific to price assessments, will be evaluated per COVID19 CSO paragraph 1.6.3, “price will be considered appropriate as it relates to government funds availability.”

7/28/20 4 ‐ Pharma

Domestication: For domestic production of APIs, are there criteria established for what portion of production is required to meet the threshold to be deemed ‘domestic’? For instance, in a multi‐step production process, is it only the last step of production which converts a non‐US material to a US‐made material relevant for the purposes of deeming that product a ‘domestic’ product?

The specific key step(s) (i.e. KSM, API, FDF) included in the Offeror’s Solution Brief must be performed domestically to meet the AOI#4 requirement.

7/28/20 4 ‐ Pharma

Timing: What does JATF propose to do in support of the 24‐ month timeline? Can we assume accelerated FDA review, or support in obtaining technology licenses for products we do not currently manufacture?

The DOD intends to support Industry in achieving all COVID‐19 CSO AOIs. At this time, offerors should formulate Solution Briefs in accordance with information contained in the COVID19 CSO and relevant AOI.

FINAL

Date

Area of Interest (AoI) Question Government Response

7/28/20 2‐Screening

We are interested at responding to the CSO, Aol‐Screening and Diagnostics. I have the following questions:

1. For the Spiral 1 ‐ Solution Brief Content, 5. Estimated Price and Delivery Schedule:

2. Estimated price for each test kit and stocking up the testing kits, or the total cost of test kits, validation and scaling? If the price is for stocking up the testing kits, how many kits are targeted to be stocked?

3. Is there a production target the Joint Acquisition Force looking for? Currently, we have a production capacity of 50000/kit through our OEM in Canada. The assembly line of the test cassette is the limit for the production capacity. We can bring the assembly line in house domestically and to scale up to 100000/day, or 150000/day. What is the target capacity needed?

4. Is there a form template for completing estimated price, and estimated costs for any testing, validation or scaling?

5. Is the deadline August 3 or August 15?

As stated in the AoI: “Solutions Briefs will be accepted until 12:00PM EDT; 3 Aug 2020.” For your remaining questions, we do not have any additional templates or specific targets or requirements to provide, beyond those items and questions already included in the AoI.

It is recommended you view and continue to monitor https://beta.sam.gov for opportunities in matching your capabilities to active government requirements.

Once you find there is an active solicitation, please follow the posted instructions.

FINAL

Date

Area of Interest (AoI) Question Government Response

7/27/20 1‐Masks

Under 'current Mask Aol,’ we would like to propose expansion of nanofiber filtration media capacity expansion to meet the current need for PPE. Our questions are:

Are we allowed tp propose adding 2 machines to produce about 25 million masks/quarter/machine?

To house these machines we will either have to rent old industrial facility or build new facility. Is rent for the facility allowable cost in the budget ? As an alternative we will seek bank loans for a new construction, and if bank agrees to fund can that funds be used as matching funds towards total cost?

Though masks and respirator filters are near term priority due to acute shortages, however we believe HVAC air filters are going to be next in demand due to people asking for cleaner air. Can we proposed pleated HEPA filters for respirators as well as filters for healthcare facilities, nursing homes, govt.

buildings, among other made using nanofiber filtration media?

The intent of this AoI is to understand industry’s ability to produce all aspects of the mask chain domestically. This AoI solicits solution briefs to meet Health and Human Services Assistant Secretary for Preparedness and Response (HHS/ASPR) priorities for meeting Strategic National Sourcing 2.0 strategy to expand domestic production capacity of N95 FFR’s, Surgical Masks, reusable respirators, and filtration media within the next 6‐24 months. These expansion proposals may be based at existing manufacturing facilities, new facilities, or through new partnerships that leverage novel facilities and capabilities to support this domestic expansion effort.

7/28/20 1‐Masks

Would you prefer to receive information about face shields under the masks AOI or the gloves/gowns AOI, or at some other email address?

CSO 417013‐20‐S‐0002 COVID‐19 Joint Acquisition Task Force does not have a requirement for face shields. It is recommended you view and continue to monitor https://beta.SAM.gov for opportunities in matching your capabilities to active government requirements. Once you find there is an active solicitation, please follow the posted instructions. If you have questions, there is a POC, email, and/or phone number provided for assistance for each specific solicitation

FINAL

Date

Area of Interest (AoI) Question Government Response

7/24/20 2‐Screening

We are a provider of the rapid tests and do no do the actual throughput testing. The facilities who buy our tests do the testing. Are we safe in assuming we can reply to the solicitation with information on our tests and their availability without high throughput testing since the directions say "assays which either have an existing U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) or can submit evidence of having submitted an FDA EUA packet as well as have a high throughput test processing." In other words, must any responder also be able to also conduct the throughput testing? Or must we partner with one of the facilities who buy our tests in order to respond to the solicitation?

Thank you for your interest and sharing your company's information and capabilities related to the Screening and Diagnostics Area of Interest (AoI).

Please be advised that if you attempted to send an attachment, we did not receive it. To answer your question, as stated in the Screening and Diagnostics AoI, "... test analyzers or assays which either have an existing U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) or can submit evidence of having submitted an FDA EUA packet as well as have a high throughput test processing...."

It is recommended you view and continue to monitor https://beta.sam.gov for opportunities in matching your capabilities to active government requirements.

Once you find there is an active solicitation, please follow the posted instructions.

Multiple Please find our proposal attached below along with informational materials.

Thank you for your interest and sharing your company’s information and capabilities to possibly meet government needs. We are unable to accept your submission through these channels. It is recommended you view and continue to monitor https://beta.sam.gov for opportunities in matching your capabilities to active government requirements. Once you find there is an active solicitation, please follow the posted instructions. If you have questions, there is a POC, email, and/or phone number provided for assistance for each specific solicitation.

FINAL

Date

Area of Interest (AoI) Question Government Response

Multiple

We recently developed a [REDACTED] that is being mass produced, it has received Emergency Use Authorization (EUA) for COVID‐19 patients by Health Canada and is also waiting EUA from the FDA. Is this something you would accept in the

CSO?

Thank you for your interest in the Commercial Solutions Opening (CSO) that is currently active, JATF CSO COVID 19 Response. Please review the announcement at https://beta.sam.gov/opp/d6018f09d0bc420a955a053847d8491b/view and all the associated attachments in its entirety as it provides very specific instructions on what this CSO is soliciting as well as the procedures for submitting Solution Briefs in Spiral 1, and procedures for Spirals 2 and 3. If you have specific questions after reviewing everything, please send an email to the address identified on the last page for each Area of Interest (AOI); there are four different email addresses depending on the Mission Focus Area or AOI you are interested in.

For this CSO, the four Mission Focus Areas are:

1 ‐ Masks/Filters/Materials 2 ‐ Screening & Diagnostics 3 ‐ Glove/Gowns 4 ‐ Pharmaceutics Thank you and we look forward to receiving a Solution Brief from your company