Q-A_2.pdf

DEPARTMENT OF HEALTH & HUMAN SERVICES Office of the Secretary

Office of the Assistant Secretary for Preparedness & Response

Washington, D.C. 20201

27 July 2018

BAA-18-100-SOL-00018 – Questions & Answers

Please see the responses below to the list of industry questions received to-date (most recent questions and answers are highlighted in bold text):

1. Question: May an investigator or offeror submit more than one proposal? Is there a limit to the number of proposals submitted by an individual?

Answer: There is currently no limit to the number of abstracts that can be submitted by an offeror. Each abstract will be reviewed through the process. If the proposal is deemed Unacceptable, the offeror will have an opportunity to re-submit at a later date. It is recommended that an offeror submit only their best products for consideration with the potential to radically transform Health Security.

2. Question: May an institution submit more than one proposal on behalf of investigators/teams? Is there a limit to the number of proposals that may be submitted by an institution?

Answer: An institution is currently allowed to submit more than one abstract on behalf of investigators, or teams. There is currently no limit to the number of abstracts received by an offeror. It is recommended that an offeror submit only their best products for consideration with the potential to radically transform Health Security.

3. Question: Is there a limit to the number of institutions that may collaborate or partner together on a single proposal?

Answer: There is currently no limit to the number of institutions that may collaborate or partner together on a single abstract.

4. Question: Are there limits on the allowed project period (period of performance)? And, are proposals expected to be a pilot or demonstration in nature, in order to be conducted more rapidly over a period of a few months?

Answer: There is currently no limit to the allowed project period (period of performance); however, part of the evaluation includes the “Ability to transition technology and expand use of application”, therefore communicating DRIVe team interest in seeing innovative ideas transition for follow-on investment outside the EZ- BAA. This requires a realistic schedule, as well as realistic costs, and a transition strategy. Based on the $749,000 limit, we are expecting programs to be more pilot in concept than full development, however organizations may elect to leverage only limited Federal funds with a significant cost share contribution.

5. Question: Does the combined synopsis/solicitation posted for BAA-18-100-SOL-00018 on FBO contain requirements similar to an existing contract or will this be a new requirement?

Answer: BAA-18-100-SOL-00018 is a new requirement.

6. Question: In the solicitation BAA-18-100-SOL-00018, there is a description of the cost elements that must be included in the abstract. However, there is no mention of allowable overhead/facilities, administrative costs, or fee/profit. Are these included in the $749,000 total budget limit, or are they in addition to $749,000 budget limit?

Answer: Any proposed fee/profit and indirect costs including, but not limited to, Fringe, Overhead, and G&A shall be included within the $749,000 budget limit.

7. Question: Can you confirm if BARDA still anticipates releasing a separate BAA entitled “DRIVe BAA” that is not capped at $750,000?

Answer: This cannot be confirmed at this time.

8. Question: I am interested in joining the pre-proposal conference being held on 22 June 2018 at 2:00pm EDT, however I could not locate this information on the DRIVe website. Please clarify where this information is posted, or how to participate?

Answer: The pre-proposal conference was held 22 June 2018 at 2:00 pm. Please access the pre-proposal conference at https://www.drive.hhs.gov/resources.html Should future conference calls be scheduled a modification to BAA-18-100-SOL-00018 will be published on FedBizOpps. Also, please continue to check FedBizOpps and Drive.hhs.gov for information regarding the pre-proposal conference.

9. Question: Will reviewers be comprised of U.S. Government employees, or will they be outsourced “consultants”?

Answer: Reviews will likely include both USG personnel, internal and external consultants, and other reviewers as necessary to support the team. All reviewers will be required to sign non-disclosure agreements and also address any potential conflict of interest prior to review.

10. Question: Are offerors permitted to submit a list of reviewers that they expressly do not wish to be involved in the review of their Abstract (due to known or perceived conflicts of interest)?

Answer: DRIVe will not be managing such a list. However, all reviewers will be screened in advance for Conflict of Interests. If a prospective offeror believes a conflict of interest may exist, the situation shall be addressed with the Contracting Office via DRIVeContracting@hhs.gov prior to abstract submission.

https://www.drive.hhs.gov/resources.html mailto:DRIVeContracting@hhs.gov

11. Question: Section D of the BAA-18-100-SOL-00018 stipulates “…offers must have at a minimum…equipment as required for performance.” Is this to be interpreted as all of the equipment? If the offeror does not have all of the equipment which would offer more data-rich, high-resolution informative measures, can the proposed budget include allowance to acquire such equipment?

Answer: The offer should communicate in their abstract their existing capabilities or ability to secure the necessary equipment (e.g., Contract Research Organization) to support their product and their abstract.

12. Question: Will the Abstract, especially if of non-U.S. origin, be shared with other Government agencies?

Answer: We reserve the right to share abstract information with any U.S. Government agency. For example, we have PHEMCE partners (Government Agencies such as FDA, NIH, DOD, CDC) that may gain access to abstracts for future requirements discussion.

Any abstract information that is appropriately marked as proprietary will not be shared outside the Government.

13. Question: What is the duration of an award?

Answer: Generally speaking, DRIVe anticipates that EZ-BAA awards will be short in duration. However, specific Period of Performance (POP) for awards vary by project proposed.

14. Question: Has there been a delay in the issuance of the solicitation? Previously, it was anticipated to be released on or about June 4th, 2018 but I have not seen anything released.

Answer: The EZ BAA (BAA-18-100-SOL-00018) was posted on June 4th, 2018.

Please see the FedBizOpps website as well as the www.drive.hhs.gov.

15. Question: Our company is considered a Federally Funded Research and Development Center (FFRDC). We are required to get confirmation that we are eligible to apply since FFRDC is not specifically called out as being eligible to apply on the DRIVe website.

Are we eligible?

Answer: Federally Funded Research and Development Centers (FFRDCs) and Government entities (Government/National laboratories, military educational institutions, etc.) are subject to applicable direct competition limitations and cannot propose to this BAA in any capacity unless they address the following conditions:

FFRDCs shall (1) clearly demonstrate that the proposed work is not otherwise available from the private sector, and (2) provide a letter on letterhead from their sponsoring organization citing the specific authority establishing their eligibility to propose to government solicitations and compete with industry, and (3) remain compliant with the http://www.drive.hhs.gov/ associated FFRDC sponsor agreement and terms and conditions. This information is required for FFRDCs proposing to be prime contractors or subcontractors.

Government entities shall clearly demonstrate that the work is not otherwise available from the private sector and provide written documentation citing the specific statutory authority (as well as contractual authority, where relevant) establishing its ability to propose to Government solicitations. Specific supporting regulatory guidance, together with evidence of agency approval will be required to establish eligibility. BARDA will consider eligibility submissions on a case-by-case basis; however, the burden to prove eligibility for all team members rests solely with the offeror.

16. Question: Our company is headquartered in France and has been contacted by U.S.

offerors to join in their proposal, but we were not sure whether our participation as a non-U.S. based private sector organization is allowed? If allowed, are we also eligible for funding?

Answer: Foreign companies are allowed to submit a proposal or be a partner in a proposal. Additionally, foreign companies are eligible to receive funding.

17. Question: In the EZ-BAA, there is a description of the “cost” elements that must be included in the abstract. However, there is no mention of allowable overhead, facilities, administration costs, nor fee/profit. Are these included in the $749,000 total budget limit, or are they in addition to $749,000 budget limit?

Answer: These cost elements are all included in the $749,000 budget limit. Please see the resource section of the DRIVe website for a sample cost estimate:

https://drive.hhs.gov/files/DRIVe_EZ-BAA_Sample_Cost_Proposal_Final.pdf

18. Question: I participated in the pre-proposal teleconference on June 22nd, 2018 and was very intrigued to learn about the initiative that is forthcoming from DRIVe in regards to eradicating animal testing. Would you be able to provide a bit more insight into this program and what sorts of proposals the agency will be looking for?

Answer: DRIVe is starting with two initial programs, but has plans to continue to grow.

One of the potential upcoming areas of interest includes eradicating animal testing due to the importance to look for solutions to identify and select countermeasures that do not result in animal use to the previous and current levels of extent.

DRIVe views this as an opportunity to invest in developing technologies based on work others have accomplished, however getting it through a regulatory approval process so that it can be leveraged for countermeasures and have an impact on pharmaceutical development in the field. This is part of DRIVe’s capture zone when RFIs, summits, etc… will occur in the future. As DRIVe continues to build out this area of interest, there will be future solicitations for abstracts or proposals outlining new requirements.

Currently, any suggested ideas for this area of interest can be submitted under AOI #3.

19. Question: What is the level of maturity that DRIVe expects from proposals to any of the three areas of interests? What is the extent in which preliminary data to support an idea is required?

Answer: DRIVe is looking for technology that is at least at TRL-3; this is the hit-to-lead stage with a validated concept for any of the three areas of interest. There is also no limit, so technology can be a later stage as well. Submissions are not restricted to early technologies; it may also be a proof-of-concept to take technologies to the next step.

The initial EZ-BAA is seeking disruptive innovation and providing support for it.

20. Question: What specific quantitative and qualitative metrics are expected in the abstract?

Answer: DRIVe is expecting offerors to illustrate these metrics in the abstracts. If awarded, these metrics can be negotiated prior to award. These metrics are mainly used to monitor progress and success of the project and to assess and value DRIVe’s investment in the project being funded. The DRIVe program understands that the proposed technologies will be innovative and disruptive, and are expecting the offeror to propose a method for determining successful metrics.

21. Question: When will the portal be open? Can we do anything in the meantime?

Answer: The portal is expected to be available in August. In the meantime, we encourage all prospective offerors to look at the information and resources on the DRIVe website and email DRIVeContracting@hhs.gov with any pre-proposal questions.

22. Question: How detailed do you want the cost section? If we are using a CRO partner, do we need to have detailed information in the initial abstract, or is that something that will be discussed and negotiated at a later point?

Answer: The EZ-BAA outlines the cost information you need to include as part of your abstract. Additionally, a sample cost estimate is provided on the DRIVe website resource section located here:

https://drive.hhs.gov/files/DRIVe_EZ-BAA_Sample_Cost_Proposal_Final.pdf

If an abstract proceeds to negotiations, then the DRIVe program has the potential to ask for more detailed cost information.

23. Question: DRIVe is looking for a disruptive idea. Every entrepreneur in the world thinks that his or her idea is disruptive. How are you going to gauge that? Do you have any metrics in a particular area to gauge whether an idea is disruptive or not?

Answer: DRIVe has recruited experts in the field to join our team in the Sepsis and ENACT areas of interest. These experts are familiar with current state-of-the-art mailto:DRIVeContracting@hhs.gov technologies and can determine incremental innovation from disruptive innovation.

Unfortunately, we are unable to provide specific metrics to gauge disruptive technologies. As a result, we simplified the application process to decrease the burden of proposal development.

24. Question: The Truth In Negotiation Act (TINA) currently requires offerors to certify to $750K but will be increasing their threshold to $2 million. How will this impact the amount of money that can be requested to the EZ-BAA?

Answer: The limit for a contract is $749,000 as expressed and illustrated in the EZ-

BAA.

25. Question: Is the EZ-BAA open to international participants?

Answer: Yes. DRIVe is seeking innovation domestically, as well as internationally;

including companies that BARDA has not previously partnered with.

26. Question: If we have a solution or potential solution to only a portion of an area of interest, can we propose or do we have to try and cover the entire topic? For example, Sepsis has a lot of pieces.

Answer: Our topics are complex, and we do not expect a proposal limited to $749,000 to address all elements of an area of interest. If one element of an area of interest is included in a proposal, this will also be considered.

27. Question: Prior to abstract submission, is there any opportunity for DRIVe to have meetings with industry to have initial discussion before abstracts are submitted?

Answer: We are in the market research stage. You may reach out to members through the DRIVe website, at conferences, and the BARDA Tech Watch process. For specific AOI questions, please email SolvingSepsis@hhs.gov for Save Lives by Solving Sepsis area of interest, ENACT@hhs.gov for Early Notification to Act, Control and Treat (ENACT) area of interest, or DRIVe@hhs.gov for the Other Innovative Products with potential to radically transform Health Security area of interest. Once abstracts are submitted, the DRIVe technical team will not be able to discuss questions until after the abstract feedback is provided.

28. Question: For the Sepsis and ENACT areas of interest, will you be considering abstracts that describe experiments on animals?

Answer: We have to evaluate each abstract on an individual basis. Some of the technologies we are considering include a national sepsis database. This will likely not include animal testing; however, it depends on the technology proposed. The EZ-BAA is intended to find solutions to address any gaps.

mailto:SolvingSepsis@hhs.gov mailto:ENACT@hhs.gov mailto:DRIVe@hhs.gov

29. Question: In the EZ-BAA there is discussion about visualization technologies that may be suitable for the DRIVe areas of interest. What types of visual analytics is DRIVe interested in?

Answer: Visualization technologies are not specifically called out in the DRIVe EZ- BAA. This may have been viewed under visualization technologies in the BARDA-wide BAA posted on FedBizOpps (BAA-18-100-SOL-00003). If you have a visualization technology that meets the DRIVe mission, please review the DRIVe AOI descriptions in the EZ-BAA in FedBizOpps (BAA-18-100-SOL-00018).

Early Notification to Act, Control, and Treat (ENACT):

1. Question: I am a little confused about the terms "exposed" in the description "pre-exposed pre-symptomatic and exposed pre-symptomatic disease stages"? Does "exposed" mean infectious disease or some other agent?

Answer: The general objective of ENACT is the early detection of exposure to an infectious agent. However, early detection of exposure to chemical, radiological and/or nuclear agents may be of future interest. ENACT is targeting post-exposure, pre-symptomatic detection. For example, ENACT is interested in sensors and diagnostics that signal that an individual has been infected with influenza, prior to that individual experiencing symptoms. This early detection will enable the individual to seek appropriate therapy and infection control practices to prevent illness and further transmission to others.

2. Question: Is ENACT for patients who veer away from their predicted physiology, are off trajectory, and constitute an immediate indication for heightened surveillance and early intervention?

Answer: A number of approaches may enable the early identification of exposure to particular agents, including shifts in ‘predicted physiology’. Linking these ‘shifts’ to specific agents would be an important element of a proposal.

Solving Sepsis:

1. Question: Is DRIVe looking for applications to build the sepsis knowledge clearing house website? Or will that come from inside DRIVe to preferred providers, perhaps as a request for proposals?

Answer: The Solving Sepsis virtual community is not currently an area of interest under the EZ-BAA. Please continue to check the DRIVe website and FedBizOpps for other solicitations or mechanisms to support this activity.

2. Question: Is DRIVe looking for applications to build the sepsis clinical data base? Or is that going to work as a consortium to/from EPIC/Cerner/etc.

Answer: The Sepsis Database is envisioned to be more expansive than what can be covered under the current EZ-BAA and requirements are still being developed. The Solving Sepsis team will be actively seeking perspectives and insights on the best approach and will come forward with further guidance, and potentially a more focused solicitation. However, prototype development and/or algorithm development approaches are appropriate for this EZ-BAA.

Sincerely, Troy Francis Contracting Officer Division of Contract Management & Acquisition (DCMA) Biomedical Advanced Research Development & Authority (BARDA) Assistant Secretary for Preparedness & Response (ASPR) United States Department of Health & Human Services (HHS)