ENACT

What is ENACT?

Rapid diagnosis and treatment of infectious diseases are critical to both the patient and the broader community. ENACT (Early Notification to Act, Control, and Treat) partners with innovators to develop disruptive technologies that detect, prognosticate outcomes, and enable early intervention following exposures to both natural and man-made infectious threats. To learn more about the ENACT program, please see more on the ENACT Program Factsheet.

Watch an introduction to the program, presented to the Digital Medicine Society on September 9, 2020





ENACT logo

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Vision

ENACT endeavors to upend the traditional doctor-patient paradigm by empowering patients, health-care providers, and public health organizations with early and actionable health status information. By supporting the development of novel sensors and data analytics approaches, ENACT aims to provide information that enables early indication of infection, reduces illness spread in an epidemic, enables faster diagnostics, improves adherence monitoring and intervention in clinical trials, and efficiently allocates medical resources.

Mission

ENACT helps develop accessible technological solutions that provide early and actionable health status information to empower the individual, health-care provider, and public health organizations to rapidly act, control, and treat infectious diseases. To this end, ENACT partners with academic and private sector teams to support research and development of novel physiological sensors, telehealth, and data analytics platforms.

Strategy

  • Develop noninvasive wearable and on-demand physiological and biomarker detectors that monitor physiological changes from the user’s baseline
  • Identify robust algorithms that analyze the resulting clinical data and detect health and illness signatures
  • Develop software platforms capable of detection changes in individual and population-wide health status
  • Identify the key markers of health status for enabling high-accuracy presymptomatic detection of infection

Program FAQ

Please carefully read the ENACT area of interest in the EZ-BAA solicitation on beta.sam.gov located here. If you have any questions not answered in the solicitation or in these Frequently Asked Questions below, please email Enact@hhs.gov




Can ENACT projects be awarded to academics, or do only companies qualify?

Yes, as long as the respondent meets all the requirements described in EZ=BAA, which includes a clear path to technology development.


Any entity can submit to ENACT via the EZ-BAA portal as long as they are registered with www.SAM.gov.


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.


Yes. Applicants from outside of the United States are eligible to apply for funding. Please note though that U.S.-based manufacturing of the proposed solution device/diagnostic will be prioritized.


Yes. Abstract submissions should include a cost-share that is within our target range of 30-50% minimum, unless you satisfy the regulatory exception described (included below for reference). Currently, none of the awardees under the DRIVe EZ-BAA have been awarded a contract that does not include a cost-share component below range, including all universities and non-profit organizations. Cost-share may be in-kind or cash contributions. It may also come from a third party investor/sponsor; however it is up to you to ensure you receive their contribution toward the proposed project. Many organizations offer to cover Overhead or Fringe Benefits. Some also offer pro-bono labor hours or sponsored equipment, materials, or subcontractor costs. A combination of all of the above could be acceptable. It would need to be indicated on a submission what is being cost-shared. In order to qualify for no cost-share under a EZ-BAA award, a respondent must show that there is "no probability that the respondent will receive present or future benefits from participation as described in Federal Acquisition Regulation (FAR) 16.303." Examples of present or future benefits include increased technical know-how, training for employees, acquisition of goods or services, development of a commercially viable product that can be sold in the commercial market and use of background knowledge in future contracts.


ENACT-funded projects have data sharing requirements with the U.S. government consistent with government regulation (FAR 52.227-14 Rights in Data). ENACT requires that you share all data (including raw data) generated from an under the project for government’s use consistent with regulation. Such data sharing typically does NOT include algorithms developed by ENACT partners.


Projects completed under ENACT funding are NOT guaranteed additional funding from any government source (including ENACT).


No. The government does not suggest or requiring any specific partnerships and will not provide match-making services.


At this time host based diagnostics are considered, but pathogen detection technologies are not considered to be within scope. Host based platforms should be targeted for use as wearables or at-home, and should not be designed specifically for use in doctor’s offices or clinics.


While there is no required starting TRL (technology readiness level), it is preferred that projects are close to ready for commercialization by the end of the funding period.


While FDA approval is typically not required by end of project, engagement with FDA typically is, but this depends on the proposed project.


ENACT cannot provide sample abstracts.


Yes, potential partners are free to submit more than one abstract so long as those projects are discrete, stand-alone projects.


While you can include links to figures or references, it is not mandated that reviewers view that outside information. At this time, the abstract format does not accept any figures, only text.


Applicants are welcome to consult with DRIVe’s Accelerator network, which provides wraparound technical and business development support services.


For more information, please contact us at ENACT@hhs.gov

Download the ENACT Program Factsheet