20-S-5028_Amendment 0001.pdf

FA8650-20-S-5028

Amendment 0001

BioIndustrial Manufacturing Innovation Institute (MII)

Funding Opportunity Announcement Number: FA8650-20-S-5028

Amendment Number: 0001

The purpose of this amendment is to respond to questions submitted through 10 March 2020.

Questions and answers are provided as follows:

Q1. What is the relationship between Under Secretary of Defense for Research and Engineering (USD(R&E)) and the Air Force Research Laboratories (AFRL)? More specifically, who is the final source selection authority for the MII? Is it AFRL or USD(R&E)?

A1. As this is not a FAR-based effort, there is no Source Selection Authority. The BioIndustrial MII is being done under a Cooperative Agreement awarded by AFRL. AFRL will make the award based on an impartial peer review in accordance with 32 CFR 22.315(c). Only government employees will participate in the actual decision or selection of proposals for award..

Q2. Tracy lamented that much of the U.S. manufacturing capability, despite being developed in the U.S., has been off-shored. But this is driven primarily by economics. How do you envision the BioInd MII will address this?

A2. A central overarching goal of each MII is to foster a globally-competitive U.S.

manufacturing base in emerging technology focus areas for which no economic leaders have yet emerged so there is opportunity to establish a U.S. manufacturing base. Each concept paper and proposal should describe how the MII will address the economic competitiveness within their business strategy, technical strategy, and revenue strategy. Furthermore, the FOA describes common elements of the example projects on pages 26 and 27, and several relate to how they will meet the objectives of the MII. Note that economics is only one of several drivers for off-shoring of manufacturing capability, but has been referenced as a primary driver. Others include location (close to others in the ecosystem), talent (access to a sufficient and well trained workforce), access to facilities (research and development (R&D) and test beds), and even trade opportunities.

Q3. Is there any opportunity for FAR-based contracts?

A3. Not under this award.

Q4. Will cost share exceeding more than 1:1 be given higher priority for award consideration?

A4. Cost share will be evaluated as subfactor 1.4 under Factor 1: Business Plan (see pages 51 and 52 of the FOA). Sub-Factor 1.4: Cost Share. The makeup, extent, and quality of commitments, within the cost share plan proposed over the life of the award. This includes the amount, source, timing of availability, quality, applicability, and any constraints on the cost share over the period of performance. Also, page 5 of the FOA states, “Cost share significantly more than 1:1 offered by industry or other non-federal government funding in order to increase the capability of a BioIndustrial MII will be considered favorably.” This means that cost share exceeding the 1:1 ratio is will be considered favorably within this subfactor, under the terms “amount” and “extent.”

Q5. Why the name change?

A5. DoD changed the name to better align with the institute’s goal of manufacturing products using domestic biomanufacturing. The term ‘synbio’ incorrectly implied that the focus of the effort would be making artificial forms of biology – this is incorrect. Bioindustrial may include synthetic biology platforms along with non-synthetic manufacturing platforms but synthetic biology is not the primary focus.

Q6. What is your definition of long-term economic impact? What specific metrics are you looking for?

A6. See Thrust Areas beginning on page 15 of the FOA, including Thrust Area 5 and the Education and Workforce Development (EWD) section.

Q7. Why has there been a shift in emphasis for this MII from synthetic biology to biotechnology?

A7. DoD changed the name to better reflect the scope of the institute. The scope of the institute has not significantly changed from it’s original purpose.

Q8. What’s the biggest reason for the innovation gap with regard to tech transfer?

A8. This question is outside the scope of the Q&A of the proposers’ day for this FOA.

Q9. Standardization of strains for manufacturing only should be emphasized. There is substantial work in the space of standardization of strains that is not related to scale-up. Should the MII not be careful to avoid dilution?

A9. Standardization of strains is an important concept for the BioInd MII. The goal here is to easily prototype and rapidly reconfigure strains for manufacturing. Early adoption of a strain engineering standard will increase the agility and productivity of the MII.

Q10 & 11. Is there a reason BIOTECH is written in all caps and abbreviated in that way? Is this a new standard to use/share when talking about biotechnology in DoD context?

A10 & 11. There is no specific reason to capitalize and/or abbreviate BioTech when coordinating with the government evaluation team. The formatting was used for internal purposes and will not be used as a requirement on future communications.

Q12. Will the Q&A produced [at proposer’s day] be included on your program site as FAQ folder?

A12. Questions and answers will be published as an amendment to the FOA on beta.sam.gov and grants.gov at the Government’s earliest convenience.

Q13. During Dr. Gollihar’s presentation, he stated “we expect this to be a hub and spoke model” in relation to the structure of the Institute. Can you please clarify as the whether the DoD has pre-determined as MII structure or is this institute being considered under all models determined by the proposing team? In short, does DoD has a preferred model or will all models be given equal consideration?

A13. The DoD does not have a preferred model or structure for the BioInd MII, and all proposed MII structures will be considered. Concept papers and Full Proposals will be evaluated based upon the factors stated in Section V of the FOA, starting on page 51. Each proposal should describe how the proposed MII structure best addresses the objectives of the MII, including the technical objectives contained in paragraph D of Section I (page 14).

Q14. Will applications be reviewed and evaluated for the procedures they include to address containment, inactivation, and removal of antibiotic resistance markers in proposals they receive?

A14. Please review Factor 2 of Section V (page 52). All concept papers and full proposals will be evaluated in accordance with Section V of the FOA.

Q15. DoD’s stated purpose is to help technologies through the valley of death. During San Jose open day, three separate breakout teams of industry practitioners highlighted the need for intermediate scale fermentation capacity and accompanying DSP. Despite this, the FOA appears to sidestep the need for infrastructure (Thrust Area 2) and minimizes the emphasis on DSP (Thrust Area 3) in favor of more academic initiatives such as development of scale-down models (Subthrust 2c). Could the department please comment on this observation and explain the rationale?

A15. This was not the conclusion that was intended. To the drafters original point, the DoD recognizes that infrastructure and DSP need to be emphasized (see page 12: While the MII will have capabilities across the design-build-test-learn cycle (DBTL), special emphasis on efficient scale up and separation technology development across multiple classes of products should be maintained given current industrial challenges (Technical Thrust Areas 2 and 3). Additionally, the DoD recognizes that “the technical thrust areas will require different considerations and proposers are encouraged to consider how they would prioritize and orient the MII in order to maximize impact to the field” (page 5). The DoD appreciates the input from the RFI process and agree that need for intermediate scale capacity and DSP is greatest.

Q16. Will proposals be reviewed for procedures to evaluate projects for: use of CRISPR, genetic stability, gene transfer potential, inclusion of health and safety data development needs to support regulatory approval processes?

A16. Please review Section V (page 52). All concept papers and full proposals will be evaluated in accordance with Section V of the FOA.

Q17. Is there a focus on increasing the quality and integrity of data to maximize the potential of Artificial Intelligence and Machine Learning?

A17. The BioIndustrial MII will focus on all thrust areas outlined in the FOA, beginning on page 15.

Q18. How does the DoD regard industry participants who have received foreign investment, particularly from China?

A18. Please see the Foreign Interest Participation Guidelines beginning on page 37 of the FOA.

Foreign interest participation must be in the best interest of the MII, DoD, U.S. industry and U.S.

economic development. Individual projects will be evaluated on a case by case basis and may be subject to export control laws and regulations:

“Wholly- or majority owned U.S. subsidiaries of foreign interests organized and operated in the United States may be an MII member, sub-recipient, contractor, and/or third party contributor if they can demonstrate to the MII and DoD that:

a) Foreign interest participation complies with export-control laws, ITAR, and EAR

b) Foreign interest participation is in the best interests of the MII, DoD, U.S. industry, and U.S. economic development

c) Actual FOCI is determined and measures necessary to negate or mitigate FOCI to protect IP and other measures are implemented commensurate with the establishment of the subsidiary’s role with the MII

d) Manufacturing work is conducted in the United States and contributes to the creation and preservation of U.S. jobs e) The MII and its members are in compliance with 8 U.S.C. §1324a (Unlawful Employment of Aliens) and 8 CFR §274a.2. (Verification of Identity and Employment Authorization)

f) Foreign interest participation meets other conditions deemed necessary by the MII and DoD to protect U.S. Government interests”

Q19. Do you need to be an existing nonprofit to send a proposal?

A19. Concept papers may be submitted by any organization that has the intention of creating a nonprofit organization for the BioIndustrial MII. However, if invited to submit a full proposal, the independent nonprofit organization has to exist, and must meet all legal requirements to be considered a functional non-profit and be able to enter into a cooperative agreement with the DoD.

Q20. There are several foreign subsidiaries of non-US headquartered companies with significant facilities, manpower, and expertise in the United States. May these subsidiaries be members of a proposal team (not prime) to leverage such US-based resources?

A20. The FOA contains very specific direction dealing with foreign participation, which would apply to Institute membership as well as the proposal team. From Page 37:

“Wholly- or majority owned U.S. subsidiaries of foreign interests organized and operated in the United States may be an MII member, sub-recipient, contractor, and/or third party contributor if they can demonstrate to the MII and DoD that:

a) Foreign interest participation complies with export-control laws, ITAR, and EAR

b) Foreign interest participation is in the best interests of the MII, DoD, U.S. industry, and U.S. economic development

c) Actual FOCI is determined and measures necessary to negate or mitigate FOCI to protect IP and other measures are implemented commensurate with the establishment of the subsidiary’s role with the MII

d) Manufacturing work is conducted in the United States and contributes to the creation and preservation of U.S. jobs e) The MII and its members are in compliance with 8 U.S.C. §1324a (Unlawful Employment of Aliens) and 8 CFR §274a.2. (Verification of Identity and Employment Authorization)

f) Foreign interest participation meets other conditions deemed necessary by the MII and DoD to protect U.S. Government interests”

Q21. Must synbio (genetic engineering) be employed, or are open communities (non-engineered, but use community selection approaches) viable?

A21. Biomanufacturing from traditional, non-genetically engineered biological organisms will be considered.

Q22. Can you describe any input you’ve received from industry participants which informed the

FOA?

A22. We can describe the extent and process, but not the input. The RFI process and the two workshops resulted in many inputs which were used by the Government team to build the FOA.

This feedback was used to help the government team develop the goals and objectives of the Institute, among other things.

Q23. Is there a preferred timeline for sustainability? 5 years? 10 years? Etc.

A23. “Sustainability” is defined as when the operating costs of the Institute are completely covered by revenue without DoD stand-up funding and has not been set as a requirement within a specific timeline within the FOA. However, the FOA states:

“the offeror should also include detailed information on sources (by organization), timing, extent (in dollars) of required cost sharing, and plans to ensure the financial sustainment of the MII. “

Also, the FOA requests a revenue strategy as part of the business plan, and that strategy should generally cover a timeline to include 5 years after the period of performance for the initial Cooperative Agreement.

Q24. Will there be industry or corporate reviewers, or only government?

A24. The reviewers will be from the Government team and will not include members from industry.

Q25. Can Federal/DoD employees contribute to MII proposals? If not, how can proposers describe how they meet DoD’s needs, or articulate a DoD-relevant target for quick start?

A25. No, Federal or DoD employees cannot contribute to proposals. See Paragraph D of Section III (page 35) of the FOA for information on participation of Federal Government Organizations.

Q26. Will there be an opportunity to perform multi-site visits for a single team? (e.g. central (host) and node)

A26. The specifics of site visits will be determined after review of proposed Institute structure and technical strategy, and may include one, none, or many.

Q27. Can a non-profit proposer be receiving Federal funds (e.g. a research consortium funded by NSF) or include Federal members who pay a fee to be part of the entity (e.g. a scientific society that requires paid membership)?

A27. Yes. Please see the definition of non-profit organization in 2 CFR 200.70.

Q28. What restrictions, if any, are there in an entity (e.g. company or university) in teaming on more than one proposal?

A28. The only restriction at this time is that each entity may be the Prime on only one submission. Entities can be a subrecipient on any number of submissions.

Q29. Why not use the DoD SAFE for submission of full proposals?

A29. The potential liabilities of retrieving proposals from an online dropbox, such as DoD SAFE, are not amenable to the DoD. All proposals must be submitted in accordance with the instructions provided in Paragraph C of Section IV, beginning on page 41.

Q30. What would a preferred (HUB) site look like?

A30. The DoD does not have a preferred model or structure for the BioInd MII, and all proposed MII structures will be considered. Concept papers and Full Proposals will be evaluated based upon the factors stated in Section V of the FOA, starting on page 51. Each proposal should seek to describe how the proposed MII structure best addresses the objectives of the MII, including the technical objectives contained in paragraph D of Section I (page 14).

Q31. Possible to comment on benefits for those offering access to scale-up facilities?

A31. Benefits of facilities access would be a point of discussion for the proposing team and should be addressed in concept papers and proposals in accordance with paragraph (e) beginning on page 22. Please review Section V (page 52). All concept papers and full proposals will be evaluated in accordance with Section V of the FOA.

Q32. How can for-profit organizations participate? Are they eligible for funding as a subrecipient to a non-profit?

A32. Yes. For profit companies may participate as team members.

Q33. What timeframe and max budgets are you contemplating? Multiyear? 3-5 years?

A33. Please refer to page 5 of the FOA.

Q34. How many quickstart/example projects do you hope/expect to fund?

A34. Offerors shall propose five example projects that demonstrate innovation beyond current practice, two of which will be quick start projects that will be informed by DoD priorities. These two quickstart projects are anticipated to be funded.

Q35. Can you provide an example of how other government organizations (e.g. National Labs or DoE Bioenergy Research centers) can and cannot partner with proposing team?

A35. Clear descriptions for how Federal Government organizations may participate with proposal teams are on page 35 of the FOA. It states that organizations and personnel may not participate in any proposal prior to award. FFRDC participation also described on that page.

Q36. Looking at the map of existing MIIs, there is a remarkable geographic concentration in the northeast quadrant of the USA. Can you explain what safeguards against implicit geographical bias will be used in the review and award process?

A36. Geographical location of MII headquarters are not considered as part of the evaluation process, and regions are not present in any of the factors. There has not been and will not be geographical bias as part of the evaluation and awards process. Please review Section V (page 52). All concept papers and full proposals will be evaluated in accordance with Section V of the

FOA.

Q37. How will the DoD ensure that commercial partners and/or vendors have a fair and equal opportunity to provide services or technology to the BioIndustrial MII? How will the DoD avoid vendor lock-in?

A37. Projects sponsored by the MII will be awarded in accordance with the MII’s award and evaluation process. Once established, the MII will create its processes for distributing projects among MII members.

Q38. The words “synthetic biology” are used in the notice, will the MII be interested in projects utilizing a systems-approach to select for non-engineered naturally-occurring microbes or is the MII only interested in utilizing engineered microbes?

A38. We are interested in all types of bioindustrial technology platforms that will enable the MII to develop/accelerate a sustainable manufacturing capability in the US. The institute will not limits it’s scope through defined terms; instead, it plans to leverage all tool sets and their application.

Q39. We are very interested in learning about entities that may be applying for the Bioindustrial MII with the intent of partnering with them to provide the best overall solution. Do you have any guidance for us on this? Any other suggestions?

A39. To help entities connect there is an independent page for teaming on Linked-In for this effort at https://www.linkedin.com/groups/12375496/ or search Bioindustrial Manufacturing Innovation Institute in the Link-In search field.

Q40. Question about whether plant technology is in scope or out of scope.

A40. At this point in time we are not limiting the MII to one or the other technology platform.

The MII team will evaluate all platforms and select for technologies that will provide an advantageous manufacturing production capability.

https://www.linkedin.com/groups/12375496/