FAQs and Resources

General FAQs

What is DRIVe?

DRIVe is a new BARDA Division and stands for the "Division of Research, Innovation, and Ventures". It also represents the mindset of hyper focus, restless innovation, and entrepreneurial spirit at BARDA.

Why did ASPR/BARDA build DRIVe?

BARDA has been successful in developing and making available products that prevent, diagnose, and treat the illnesses and injuries caused by individual threat agents. In doing so, BARDA has found that systemic problems across most of the illnesses and injuries must also be resolved to save lives. DRIVe will solve problems that many health security threats have in common, systemic challenges, leveraging the flexibility provided to BARDA under the 21st Century Cures Act.

To infuse a new entrepreneurial spirit into biodefense, DRIVe draws the best in the field and the best in the business together to define the challenges. DRIVe accelerators across the country work like prospectors, identifying innovative potential solutions. We recognize that innovation can come from anyone anywhere in the U.S., or around the world, not just from Silicon Valley. DRIVe's nonprofit venture capital innovation partner will join other venture capitalists in funding development of the solution. Advanced development and manufacturing could be completed with support from BARDA through its portfolio partnerships, traditional contracts, or other transaction authority, through the innovation partner, or by private industry. Since many of the challenges DRIVe must solve for health security are also common problems in health care and biotechnology (examples: sepsis, detecting illness immediately), private investment is likely to further drive those solutions to the commercial market.

Many others have tried and failed to solve broad problems like sepsis. What makes you think you'll succeed?

BARDA was created to fill gaps in medical countermeasure development and solve problems no one else could, for example, bringing new influenza vaccine technology to the market for pandemic preparedness, surge capability for medical countermeasure production in an emergency, and clarifying a path to product approval using animal models for CBRN products. We focus on innovative problem-solving with a shrewd approach to risk and the flexibility to craft win-win public-private partnerships; this focus has led to 35 FDA-approved products in 12 years, demonstrating unprecedented success. We also are drawing on lessons learned and recommendations from federal agencies like DARPA and the agencies involved in In-Q-Tel on working with venture capitalists. With a strategic investment and venture capital approach, the government actually takes on less risk than it would with a traditional development grant.

What "new, inventive methods to help business, industry, and government collaborate to vault over the old obstacles" will DRIVe be using?

We'll use every tool at our disposal: from flexible consortiums, agreements, and contracts to venture capital investments and prize challenges.

BARDA has been described as a venture capital firm buried within HHS. How is DRIVe any different?

BARDA focuses on developing the means to prevent, diagnose, and treat the illness or injury caused by individual threat agents. DRIVe will solve problems that many health security threats have in common, systemic barriers to optimal effectiveness of countermeasures developed to address them. Projects in DRIVe will be supported by both private and public resources and by partners across the U.S. government.

BARDA is directed in legislation to focus on advanced research and development; NIH focuses on early research; DoD focuses on all phrases of research and development. Since DRIVe will be focusing on early research and development, shouldn't DRIVe be part of NIH or DoD?

BARDA is the right place for DRIVe, which will focus on technological and systemic gaps that create barriers to access and effectiveness of countermeasures—from early pathogen identification to the last mile of delivery and administration BARDA is the only division of any federal agency focusing on medical countermeasures targeted to save lives from national health security threats. NIH is focused on common health issues such as cancer and diabetes and does not have a specific health security mission. DoD primarily develops products to protect the lives of U.S. warfighters, not civilian populations. DRIVe is focused on the systemic problems that across BARDA's health security mission.

You're "investing" tax dollars. High risk investment means high probability of failure. How can you justify wasting tax dollars that way?

Finding solutions to systemic healthcare barriers across the spectrum of health security threats is a valuable use of tax dollars. Health security threats are high consequence events with high rates of injury, illness or death as well as social and economic instability. In an emergency, Americans will demand solutions. Identifying, incubating and accelerating these solutions will protect health and save lives. Like all pharmaceutical and medical product development, finding solutions to the systemic problems that cross all threats is a high risk-high reward endeavor. The solutions will have far-reaching impacts in medical care day-to-day as well as during health emergencies.

EZ BAA FAQs

These questions and answers are cross-posted on FedBizOps.

When will interested parties be able to submit an EZ BAA abstract?

We estimate that the EZ BAA electronic submission portal will be available in early September, 2018.

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

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.

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?

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.

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

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

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?

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.

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?

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

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?

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.

Can you confirm if BARDA still anticipates releasing a separate BAA entitled "DRIVe BAA" that is not capped at $750,000?

This cannot be confirmed at this time.

Will reviewers be comprised of U.S. Government employees, or will they be outsourced "consultants"?

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.

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)?

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.

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?

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.

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

No.

What is the duration of an award?

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.