CSO QA_FA7013-20-S-0002_28Jul20.pdf

CSO FA7013-20-S-0002

Q and A

7/28/2020

Date Area of

Interest (AoI) Question Government Response

7/17/2020 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

7/17/2020 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.

7/17/2020 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.

7/17/2020 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.

7/20/2020 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.

7/20/2020 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 that supports the manufacturing of 100 million final dosage forms for each of the proposed products.

7/28/2020

Date Area of

Interest (AoI) Question Government Response

7/20/2020 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.

7/21/2020 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.

7/21/2020 2‐Screening

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?

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.

7/28/2020

Date Area of

Interest (AoI) Question Government Response

7/22/2020 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.

7/23/2020 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.

7/23/2020 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.

7/23/2020 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.

7/23/2020 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.

7/23/2020 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.

7/28/2020

Date Area of

Interest (AoI) Question Government Response

7/23/2020 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.

7/23/2020 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.

7/23/2020 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..."

7/28/2020

Date Area of

Interest (AoI) Question Government Response

7/28/2020 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.

7/28/2020 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.”

7/28/2020

Date Area of

Interest (AoI) Question Government Response

7/28/2020 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.

7/28/2020 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.

7/28/2020 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.

7/28/2020

Date Area of

Interest (AoI) Question Government Response

7/28/2020 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 per month. 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.

7/28/2020 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