FAQ

Is this Funding Opportunity open to academics or do only companies qualify?

It is open to both academia and industries as long as the respondents meet all the requirements described in the EZ-BAA and the special instructions .


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


Yes. Applicants from outside of the United States are eligible to apply for funding.


Yes. Abstract submissions should include a cost-share that is within our target range of minimum 30-50% minimum ,unless you satisfy the regulatory exception (included below for reference). Currently, none of the DRIVe partners 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. To qualify for no cost-share under an 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.


Projects funded under this program have data sharing requirements with the U.S. government consistent with government regulation (FAR 52.227-14 Rights in Data). The program requires that you share all data (including raw data) generated under the project for government use consistent with the regulation.


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.


I know Solving Sepsis is interested in diagnostics but are they also interested in therapeutics?

Yes. The Solving Sepsis program is interested in host-based therapeutics that include demonstration of efficacy in sepsis-relevant models, with a clear regulatory plan for FDA approval.


Proposed approaches should include demonstration of effectiveness in sepsis relevant models (e.g. utilizing sepsis patient samples, sepsis patient data).


Solving Sepsis is interested in the host response to sepsis and therefore is only interested in host-based approaches when considering development of diagnostics, devices and therapeutics. BARDA has other existing programs for pathogen-targeted approaches.


References must be included in the technical description section of the application but can be provided as a text link to a compiled list of references. Additionally, a PMID can be provided instead of the full reference.


My technology seeks to diagnose/treat bacterial-derived sepsis- is this a sufficient strategy for my abstract?

Solving Sepsis is interested in medical countermeasures that address sepsis of any etiology (i.e. bacterial, viral, other) versus approaches that are limited to sepsis induced by a subset of pathogens.


This may include establishment of partnerships with appropriate device fabricators/manufacturers, addressing the potential to scale, intellectual property and the means to address adoption in hospitals or other clinical settings.


The technology must demonstrate improved outcomes for sepsis patients. Please provide preliminary data to support the technology evaluated in sepsis patients or in a sepsis model.


Yes! Please reach out to SolvingSepsis@hhs.gov so that we can coordinate with the appropriate division and discuss a cross-collaboration idea as well as the best mechanism to submit the idea.


Is the ImmuneChip+ program open to academics or do only companies qualify?

It is open to both academia and industries as long as the respondents meet all the requirements described in EZ-BAA.


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


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. To qualify for no cost-share under an 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.


ImmuneChip-funded projects have data sharing requirements with the U.S. government consistent with government regulation (FAR 52.227-14 Rights in Data). ImmuneChip+ program requires that you share all data (including raw data) generated under the project for government’s use consistent with the regulation.


The ImmuneChip+ program requires that all applicants already have a mature, validated tissue chip.


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


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. All applicants are required to request a market research call prior to submitting an application.


What is out of scope of the ReDIRECT program?

The ReDIRECT program is NOT interested in the development of new drugs as medical countermeasures. We are however interested in reformulation of existing drugs that are approved in any country as long as there are no safety issues, the offerer has freedom to operate given the intellectual property status of the proposed therapeutic, and there is currently a clear commercial indication.


The ReDIRECT program is only interested in therapeutics that are either (1) passed Phase 2 or are in undergoing Phase 3 clinical trials for their primary indications, or (2) FDA-approved for their primary indication. The purpose of the program is to repurpose existing therapeutics that are easily accessible in the community as medical counter measures.


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


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


Projects completed under ReDIRECT funding are NOT guaranteed additional funding from any government source (including ReDIRECT). However, if a therapeutic demonstrates significant potential, additional funding opportunities may be available for advanced development through the BARDA Broad Agency Announcement.


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.


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


It is preferred that therapeutics are either FDA-approved or in late stage Stage 2/3 clinical trials for their primary indication. Additional data to support the secondary indication as a medical counter measure against a chemical threat is preferred.


Applicants have two options:

  1. Share their therapeutic with BARDA through a Material Transfer Agreement for testing in the BARDA Non-Clinical Network. These studies are conducted at no cost to you.
  2. Apply for funding through the DRIVe EZ-BAA to conduct their own proof-of-concept studies.

I know Solving Sepsis is interested in diagnostics but are they also interested in therapeutics?

Yes. The Solving Sepsis program is interested in host-based therapeutics that include demonstration of efficacy in sepsis-relevant models, with a clear regulatory plan for FDA approval.


Proposed approaches should include demonstration of effectiveness in sepsis relevant models (e.g. utilizing sepsis patient samples, sepsis patient data).


Solving Sepsis is interested in the host response to sepsis and therefore is only interested in host-based approaches when considering development of diagnostics, devices and therapeutics. BARDA has other existing programs for pathogen-targeted approaches.


References must be included in the technical description section of the application but can be provided as a text link to a compiled list of references. Additionally, a PMID can be provided instead of the full reference.


My technology seeks to diagnose/treat bacterial-derived sepsis- is this a sufficient strategy for my abstract?

Solving Sepsis is interested in medical countermeasures that address sepsis of any etiology (i.e. bacterial, viral, other) versus approaches that are limited to sepsis induced by a subset of pathogens.


This may include establishment of partnerships with appropriate device fabricators/manufacturers, addressing the potential to scale, intellectual property and the means to address adoption in hospitals or other clinical settings.


The technology must demonstrate improved outcomes for sepsis patients. Please provide preliminary data to support the technology evaluated in sepsis patients or in a sepsis model.


Yes! Please reach out to SolvingSepsis@hhs.gov so that we can coordinate with the appropriate division and discuss a cross-collaboration idea as well as the best mechanism to submit the idea.


Is the ImmuneChip+ program open to academics or do only companies qualify?

It is open to both academia and industries as long as the respondents meet all the requirements described in EZ-BAA.


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


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. To qualify for no cost-share under an 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.


ImmuneChip-funded projects have data sharing requirements with the U.S. government consistent with government regulation (FAR 52.227-14 Rights in Data). ImmuneChip+ program requires that you share all data (including raw data) generated under the project for government’s use consistent with the regulation.


The ImmuneChip+ program requires that all applicants already have a mature, validated tissue chip.


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


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. All applicants are required to request a market research call prior to submitting an application.


Is this Funding Opportunity open to academics or do only companies qualify?

It is open to both academia and industries as long as the respondents meet all the requirements described in the EZ-BAA and the special instructions .


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


Yes. Applicants from outside of the United States are eligible to apply for funding.


Yes. Abstract submissions should include a cost-share that is within our target range of minimum 30-50% minimum ,unless you satisfy the regulatory exception (included below for reference). Currently, none of the DRIVe partners 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. To qualify for no cost-share under an 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.


Projects funded under this program have data sharing requirements with the U.S. government consistent with government regulation (FAR 52.227-14 Rights in Data). The program requires that you share all data (including raw data) generated under the project for government use consistent with the regulation.


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.


Is this Funding Opportunity open to academics or do only companies qualify?

It is open to both academia and industries as long as the respondents meet all the requirements described in the EZ-BAA and the special instructions .


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


Yes. Applicants from outside of the United States are eligible to apply for funding.


Yes. Abstract submissions should include a cost-share that is within our target range of minimum 30-50% minimum ,unless you satisfy the regulatory exception (included below for reference). Currently, none of the DRIVe partners 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. To qualify for no cost-share under an 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.


Projects funded under this program have data sharing requirements with the U.S. government consistent with government regulation (FAR 52.227-14 Rights in Data). The program requires that you share all data (including raw data) generated under the project for government use consistent with the regulation.


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.


What is out of scope of the ReDIRECT program?

The ReDIRECT program is NOT interested in the development of new drugs as medical countermeasures. We are however interested in reformulation of existing drugs that are approved in any country as long as there are no safety issues, the offerer has freedom to operate given the intellectual property status of the proposed therapeutic, and there is currently a clear commercial indication.


The ReDIRECT program is only interested in therapeutics that are either (1) passed Phase 2 or are in undergoing Phase 3 clinical trials for their primary indications, or (2) FDA-approved for their primary indication. The purpose of the program is to repurpose existing therapeutics that are easily accessible in the community as medical counter measures.


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


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


Projects completed under ReDIRECT funding are NOT guaranteed additional funding from any government source (including ReDIRECT). However, if a therapeutic demonstrates significant potential, additional funding opportunities may be available for advanced development through the BARDA Broad Agency Announcement.


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.


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


It is preferred that therapeutics are either FDA-approved or in late stage Stage 2/3 clinical trials for their primary indication. Additional data to support the secondary indication as a medical counter measure against a chemical threat is preferred.


Applicants have two options:

  1. Share their therapeutic with BARDA through a Material Transfer Agreement for testing in the BARDA Non-Clinical Network. These studies are conducted at no cost to you.
  2. Apply for funding through the DRIVe EZ-BAA to conduct their own proof-of-concept studies.
Is this Funding Opportunity open to academics or do only companies qualify?

It is open to both academia and industries as long as the respondents meet all the requirements described in the EZ-BAA and the special instructions .


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


Yes. Applicants from outside of the United States are eligible to apply for funding.


Yes. Abstract submissions should include a cost-share that is within our target range of minimum 30-50% minimum ,unless you satisfy the regulatory exception (included below for reference). Currently, none of the DRIVe partners 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. To qualify for no cost-share under an 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.


Projects funded under this program have data sharing requirements with the U.S. government consistent with government regulation (FAR 52.227-14 Rights in Data). The program requires that you share all data (including raw data) generated under the project for government use consistent with the regulation.


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.


Is this Funding Opportunity open to academics or do only companies qualify?

It is open to both academia and industries as long as the respondents meet all the requirements described in the EZ-BAA and the special instructions .


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


Yes. Applicants from outside of the United States are eligible to apply for funding.


Yes. Abstract submissions should include a cost-share that is within our target range of minimum 30-50% minimum ,unless you satisfy the regulatory exception (included below for reference). Currently, none of the DRIVe partners 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. To qualify for no cost-share under an 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.


Projects funded under this program have data sharing requirements with the U.S. government consistent with government regulation (FAR 52.227-14 Rights in Data). The program requires that you share all data (including raw data) generated under the project for government use consistent with the regulation.


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.