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 .
Can large companies apply to this funding program?
Any entity can submit proposal via the EZ-BAA portal as long as they are registered with www.SAM.gov.
Can companies/universities outside of the United States apply for DRIVe funding?
Yes. Applicants from outside of the United States are eligible to apply for funding.
Do academic institutions also need to provide a 30% cost share?
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.
What are the data sharing requirements of this program?
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.
The EZ-BAA application is so short. Can I include links to figures or references?
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.
How do I indicate references in my abstract submission?
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.
What type of commercialization information should be included in my application?
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.
Is it possible to work with both DRIVe and another BARDA division on a project? How do I submit that idea?
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.
Can large companies apply to the ImmuneChip+ program?
Any entity can submit to ImmuneChip+ via the EZ-BAA portal as long as they are registered with www.SAM.gov
Can companies/universities outside of the United States apply for Immunechip+ funding?
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.
Do academic institutions also need to provide a 30% cost share?
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.
What are the data-sharing requirements of the Immunechip+ program?
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.
What state of technology development does the Immunechip+ program consider?
The ImmuneChip+ program requires that all applicants already have a mature, validated tissue chip.
Can you submit more than once and on multiple tissue areas?
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.
The EZ-BAA application is so short. Can I include links to figures or references?
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.
What is within scope of the ReDIRECT program?
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.
Can ReDIRECT projects be awarded to academic, 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 product/ technology development.
Can large companies apply to ReDIRECT?
Any entity can submit to ENACT via the EZ-BAA portal as long as they are registered with www.beta.SAM.gov.
May an institution submit more than one proposal on behalf of investigators/teams? Is there a limit to the number of proposal 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.
Can companies/universities outside of the United States apply for ReDIRECT funding?
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.
Do universities also need to provide a 30% cost share?
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.
Is follow-on funding available once ReDIRECT-funded EZ-BAA projects are completed?
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.
The EZ-BAA abstract is so short. Can I include links to figures or references?
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 resources are available to applicants in technical and business development?
Applicants are welcome to consult with DRIVe’s Accelerator network, which provides wraparound technical and business development support services.
Can you submit more than once and on multiple targets?
Yes, potential partners are free to submit more than one abstract so long as those projects are discrete, stand-alone projects.
What stage of development for therapeutics does ReDIRECT consider?
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.
What options are available for proof-of-concept studies to demonstrate a therapeutics’ efficacy against a chemical threat?
Applicants have two options:
- 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.
- Apply for funding through the DRIVe EZ-BAA to conduct their own proof-of-concept studies.
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.
Can large companies apply to the ImmuneChip+ program?
Any entity can submit to ImmuneChip+ via the EZ-BAA portal as long as they are registered with www.SAM.gov
Can companies/universities outside of the United States apply for Immunechip+ funding?
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.
What are the data-sharing requirements of the Immunechip+ program?
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.
What state of technology development does the Immunechip+ program consider?
The ImmuneChip+ program requires that all applicants already have a mature, validated tissue chip.
Can you submit more than once and on multiple tissue areas?
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.
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 .
Can large companies apply to this funding program?
Any entity can submit proposal via the EZ-BAA portal as long as they are registered with www.SAM.gov.
Can companies/universities outside of the United States apply for DRIVe funding?
Yes. Applicants from outside of the United States are eligible to apply for funding.
Do academic institutions also need to provide a 30% cost share?
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.
What are the data sharing requirements of this program?
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.
The EZ-BAA application is so short. Can I include links to figures or references?
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 .
Can large companies apply to this funding program?
Any entity can submit proposal via the EZ-BAA portal as long as they are registered with www.SAM.gov.
Can companies/universities outside of the United States apply for DRIVe funding?
Yes. Applicants from outside of the United States are eligible to apply for funding.
Do academic institutions also need to provide a 30% cost share?
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.
What are the data sharing requirements of this program?
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.
The EZ-BAA application is so short. Can I include links to figures or references?
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.
What is within scope of the ReDIRECT program?
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.
Can ReDIRECT projects be awarded to academic, 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 product/ technology development.
Can large companies apply to ReDIRECT?
Any entity can submit to ENACT via the EZ-BAA portal as long as they are registered with www.beta.SAM.gov.
May an institution submit more than one proposal on behalf of investigators/teams? Is there a limit to the number of proposal 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.
Can companies/universities outside of the United States apply for ReDIRECT funding?
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.
Do universities also need to provide a 30% cost share?
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.
Is follow-on funding available once ReDIRECT-funded EZ-BAA projects are completed?
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.
The EZ-BAA abstract is so short. Can I include links to figures or references?
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 resources are available to applicants in technical and business development?
Applicants are welcome to consult with DRIVe’s Accelerator network, which provides wraparound technical and business development support services.
Can you submit more than once and on multiple targets?
Yes, potential partners are free to submit more than one abstract so long as those projects are discrete, stand-alone projects.
What stage of development for therapeutics does ReDIRECT consider?
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.
What options are available for proof-of-concept studies to demonstrate a therapeutics’ efficacy against a chemical threat?
Applicants have two options:
- 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.
- 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 .
Can large companies apply to this funding program?
Any entity can submit proposal via the EZ-BAA portal as long as they are registered with www.SAM.gov.
Can companies/universities outside of the United States apply for DRIVe funding?
Yes. Applicants from outside of the United States are eligible to apply for funding.
Do academic institutions also need to provide a 30% cost share?
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.
What are the data sharing requirements of this program?
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.
The EZ-BAA application is so short. Can I include links to figures or references?
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 .
Can large companies apply to this funding program?
Any entity can submit proposal via the EZ-BAA portal as long as they are registered with www.SAM.gov.
Can companies/universities outside of the United States apply for DRIVe funding?
Yes. Applicants from outside of the United States are eligible to apply for funding.
Do academic institutions also need to provide a 30% cost share?
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.
What are the data sharing requirements of this program?
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.
The EZ-BAA application is so short. Can I include links to figures or references?
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.