Q-A-1.pdf

DEPARTMENT OF HEALTH & HUMAN SERVICES Office of the Secretary

Office of the Assistant Secretary for Preparedness & Response

Washington, D.C. 20201

18 June 2018

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

Please see the responses below to the list of industry questions received to-date:

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: Please continue to check FedBizOpps and Drive.hhs.gov for information regarding the pre-proposal conference. Information should be posted very soon.

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. Due to procurement integrity we cannot discuss the specific makeup of reviewers.

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.

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 mailto:DRIVeContracting@hhs.gov 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: No.

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.

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.

Sincerely, Troy Francis Contracting Officer Office of Acquisitions Management, Contracts, & Grants (AMCG) Assistant Secretary for Preparedness & Response (ASPR) United States Department of Health & Human Services (HHS)