REACT MAI Frequently Asked Questions

Program information can be found in the MAI module announcement. https://sam.gov/opp/ac0008be64dd4fdbad8c4e8197730907/view

Submissions are open to individuals and groups in academia, industry, or other research areas. Please see the MAI for further information.

Abstracts (6 pages max) describe the technical approach and pitch the proposed idea to the REACT team. The intent of the abstract is to provide guidance on strategies that are within scope for the program and that are likely to achieve program goals. Negative responses will inform performers on whether they want to expend the effort to write a full proposal; however, anyone may submit a full proposal, regardless of the status of the abstract. Proposals fully describe the technical approach, teaming, budget, etc. Details and formatting guidelines can be found in the Module Announcement. Please submit all abstract and Stage 1 proposal documents as PDFs.

Abstracts are due on December 7th, 2023, at 4PM EST. The due date will be listed in the final Module Announcement and on SAM.gov.

Abstract submission is strongly encouraged. Based on the content of the abstract, the ARPA-H team will either encourage or discourage a full proposal. Applicants are still able to submit a proposal even if discouraged after abstract submission. The intent is to save the proposers the significant time necessary to assemble a full proposal. The goal is to provide clear feedback on whether the ideas align with the goals of the Module Announcement; however, proposals are reviewed without regard to feedback given as a result of abstract review.

In the interest of fairness to all proposers, the REACT team is unable to schedule any related calls or meetings after sidebars associated with Proposers' Day. We recommend submitting an abstract. Specific questions may be submitted to REACT@ARPA-H.gov. Since any questions submitted and their respective answers may be published on the FAQ page, it is recommended that you remove any proprietary information.

ARPA-H is interested in biomedical research with high impact potential and that are not evolutionary or incremental advances in the current state of the art. More details can be found on the ARPA-H website at https://arpa-h.gov/. 

Yes, ARPA-H is frequently announcing new programs and we recommend you look to these first for the newest opportunities. ARPA-H also has an agency-wide Open Broad Agency Announcement (75N99223S0001) accepting abstracts.

ARPA-H does not conduct its own research. Instead, ARPA-H funds research organizations (universities, medical centers, etc.) to conduct such work. If you are interested in volunteering for studies, please look for volunteer opportunities at hospitals, universities, or research institutions near you. The National Institutes of Health (NIH) has information on volunteering at https://www.clinicaltrials.gov/. The current state of the project and any updates can be found on the REACT program page at https://arpa-h.gov/research-and-funding/programs/react/. 

The government generally does not take ownership of intellectual property produced under awards. Under Cooperative Agreements, IP ownership is retained by the performer for any IP created under an award. The government receives a license to use the IP for federal purposes. For Other Transactional Agreements, IP will be subject to negotiations between the proposer and ARPA-H. ARPA-H wants to ensure IP restrictions do not impede the application of breakthrough technologies to the people who can benefit from these technologies.

Master Announcement Instructions (MAI) and the REACT Module announcement can be found on SAM.gov at https://sam.gov/opp/599fae2feb024960b3e62c011d128bdc/view 

There is not required minimum calendar effort for the lead PI, but time proposed must be sufficient to lead the proposed work.

The bibliography is not included in the 6-page limit for the abstract.  

Indirect costs can be included within each element in the table.  

Proposers’ Day is a forum where guidance is given on the nature of the program and the process for applying. More critically, performers who have capabilities in one of the tasks associated with the effort can describe their capabilities through a “lightning talk”, a short 3-minute presentation, or through a poster. While ARPA-H does not participate in teaming, there will be ample opportunities for proposers to interact with others to form teams.

Additional Proposers’ Day information can be found in the Special Notice (ARPA-H-SN-23-05) at https://sam.gov/opp/00a458a1a252448aac9a5145bbc47c5a/view.

Participation in the REACT Proposers’ Day is not a requirement for submission of an abstract, proposal, or selection for funding.

There are no intrinsic limits; however, if Proposers’ Day is oversubscribed, ARPA-H may limit in-person attendance to (2) individuals per department or company. Virtual attendance will be available to those who cannot attend in person.

Yes. Both in person and virtual attendance require registration. Proposers’ Day Registration closes on Monday November 6th at 5:00 PM EST. Additionally, no travel plans should be made before confirmation of registration and attendance by the REACT team. ARPA-H is not responsible for any travel costs incurred to attend the Proposers’ Day. 

Yes. Proposers’ Day will have virtual and in-person attendance options. 

Recordings of Proposers’ Day will be available following the event. Please check the REACT website after completion of the event for more details. 

While teaming is not required, it is strongly recommended that proposers seek out the strongest possible team member for each of the technical areas (TAs). This will ensure that all program goals are met. The REACT team will not suggest or direct teaming.

There is no set size or composition for teams. Team size and composition should be appropriate for project scope. It is strongly recommended teams are constructed with deep expertise in fields across all five Technical Areas.

Proposers may join any number of teams as subcontractors and can still submit a separate proposal as the Principal Investigator. Proposers must be very clear on how hours will be charged for each effort as well as what safeguards are present to ensure time is not double billed.

Each institution as the primary proposer may have a max of 3 active programs funded across all funding mechanisms of ARPA-H. The limit does not apply when the institution is not the primary proposer.  

Yes, potential performers may be a part of multiple abstracts/proposals, but can only be the lead PI on one submitted abstract/proposal. 

Yes, but they may be subject to additional scrutiny. Please see the MAI module for the rules and regulations. 

Principal Investigators (PI) cannot be changed, but Co-PIs and other team members may be changed, as long as initial capabilities remain or are expanded. 

A team of reviewers will evaluate proposals based on the evaluation criteria in the MAI Section 4 “Evaluation Criteria of Proposals”. 

Please refer to the Module Announcement Section 5 “Module Announcement Responses.” for a description of what the page limit encompasses.

While we encourage team members to be identified prior to abstract submission, it is not a requirement.

REACT anticipates that teaming will be necessary to achieve the goals of the program. Prospective performers are encouraged to form teams with varied technical expertise to submit a proposal to the REACT MAI. To facilitate this process, we have created a teaming page where prospective performers can share their profiles and learn more about other interested parties at https://arpa-h.gov/research-and-funding/programs/react/teaming/ 

While government entities can participate as sub-awardees, they are unable to participate in a program for which they will also be a regulatory body. 

Any method that can support the modified cells for one year is allowed; however, this should not require additional interventions from a clinician such as refilling a reservoir. 

Yes. Applicants can submit proposals for a Living Pharmacy and a Living Sentinel, but that does not guarantee that both approaches will be funded.

ARPA-H is interested in improving patient health and access. If you believe your research into disease X does not directly align with the REACT program, ARPA-H is frequently announcing new programs and we recommend you look to these first for the newest opportunities. ARPA-H also has an agency-wide Open Broad Agency Announcement (75N99223S0001) accepting abstracts. 

Any disease that can be treated with the defined release of hormones can be proposed as long as sufficient justification is provided as noted in the MAI module. Sufficient justification should include published studies and does not include basing the entire proposal solely on unpublished data. 

Closed loop is not a program requirement. For now, it is expected patients will interact with the devices independently.

One goal of the REACT program is to reduce the burden of therapy adherence, including taking a pill. To this end, the Living Pharmacy will be triggered through an external device, most likely a smartphone, and will allow for more precise control.

One key component of the REACT program is the creation of an accessible user interface. This may be achieved with a smartphone or other interface that is simple to use. Performers must design control software with the patient in mind that is intuitive and easy to use. 

A complete device that meets the requirements of the REACT program includes cell lines as well as the bioelectronic component. The bioelectronic component must modulate the delivery of therapy or convey the response of cells to a biomolecular target. Teaming is suggested to match your theranostic cell with performers who can provide any missing pieces. 

Sentinel reporting should be in line with the selected disease and testing requirements. It is also expected that on-demand results be available with a set lag time between requests.     

Information may be stored on the device or off it after transmission. The system should be capable of transmitting data to a clinician. Security regarding storage and transmission to patients and clinicians should be a consideration in the design.

In vitro and in vivo models should be chosen based on current literature and TA. The proposers must justify their selection and approaches.

The REACT effort enables the proposer to identify an appropriate therapy or therapies. Successful completion of the program will open further applications that are outside the scope of the current program. 

REACT is focused on delivery of hormones, cytokines, or other therapeutic molecules. The proposers should justify the proposed therapy and disease targeted. 

Performers must successfully demonstrate secure, two-way communication between the implanted devices and the patient. Proposals must contain a complete description of how communication will be secured. 

There is no restriction on the organismal cell choice, but justification for the cell choice is required. Those using non-human cells should discuss the immunogenicity of their approach.

 he implantable device should be kept at a size that can be inserted with a minimally invasive outpatient procedure. Furthermore, successful proposals must focus on efficient designs that balance the required extent of cell engineering with the demand on the implanted device (e.g., power, space, timing).

As long as they do not interfere or conflict with metrics already specified in the MAI module, proposers are encouraged to define additional milestones and metrics to help illustrate progress towards the program goals. 

Proposers may choose the method of powering the device but must demonstrate the device provides >1 week of continuous operation with reserves for a second week in standby mode. 

Allogeneic cells must be encapsulated in the device allowing for direct control by the device. Implanted cells must also be sequestered from immune cells. 

Yes, as long as the production by the cells is fully under the control of the bioelectronic device.

 A complete device that meets the requirements of the REACT program includes cell lines as well as the bioelectronic component. The bioelectronic component must modulate the delivery of therapy or convey the response of cells to a biomolecular target. 

The goal of REACT is to reduce patient burden, so any component not fully implanted in the body must have strong justification for location.  

The goal of REACT is to directly treat or track the status of a disease. Future applications of the technology may be extended to non-disease clinical needs.   

The REACT call requires 5 different genes be inserted stably for 5 different proteins. This helps in supporting the future feasibility of expanding the device to other disease(s). 

The goal of this metric is to ensure the safe and routine integration of genes into cell lines in a manner that can be scaled and standardized. If an alternate, compatible system that can accomplish gene editing in a reliably safe manner can be established, it can be proposed. 

Yes, please provide a brief description of facilities and resources for all prime and subcontractors. This description should be included in the Tech & Management document. 

The bibliography requirements have been updated. Please refer to Amendment 02 of the Module Announcement. 

There is no template. Please include all necessary information that satisfies the requirements. This information will not count towards the page limit. 

The Technical and Management Volume is limited to 40 pages. Please refer to the module announcement, attachment volume instructions, and the MAI for which documents do and do not count towards the page limit as well as any other page restrictions.  

The VAS should be submitted with Stage 1 proposals and does not contribute to the 40-page proposal limit.  

TA1 addresses cellular engineering required for long-term maintenance and survival in the device. TA3 addresses the bioelectronic device, power management, communication with the patient, surgery requirement, and others.  

A Phase I clinical trial is required for the REACT program. Stages designated as options are stages which ARPA-H reserves the right to exercise based on funding availability and successful performance. All Steps must be included in a proposal in order for the proposal to be considered complete. Please see “Step III” on page 12 of the module announcement. 

Running and completing a Phase I clinical Trial is a requirement for the REACT program.  

Yes, the first assessment will be for Stage 1 Volume 1 proposals.  

Performers are responsible for identifying a CRO and requesting appropriate funds. Proposals must include plans and a budget for contracting third party groups to test carrier and intervention biocompatibility such as acute and subacute toxicity, biofouling, and safety during Steps I and II. Proposals must describe the type and number of tests necessary for regulatory evaluation and transition of the technology into humans. 

Non-US individuals are those who are not US citizens or permanent residents.  

Please submit proposals as four separate documents, covering the four required attachments.  

Proposing teams should provide individual names for both prime and sub-awardee personnel. If there are positions for which individuals have not yet been identified, please list the organization and indicate the person has not been identified yet.  

No, videos and links are not allowed.  

Stage 2 invitations will be announced at a later date.  

Proposers may use a start date of April 2024; although, that is not a guarantee of funding being initiated at that time.

No budget ceiling has been established, offerors are encouraged to propose a budget that aligns with the proposed solution/or project.

The REACT MAI module budget is $25-50M per proposal. 

Yes, the estimated budget is inclusive of all costs (direct + indirect). 

Direct Labor (fully burdened) should be the total dollar amount for your proposed labor. Labor hours should be the total number of estimated labor hours to be performed by all individuals working on the project. 

Yes, current HHS salary cap limits apply to all proposals submitted to the REACT solicitation.  

The subawardee totals should be added together and entered on the Subawardee line in the budget template. 
 

All team members regardless of their organization must comply with the OPM salary cap.  

The BOE requirements have been updated. Please refer to Amendment 02 of the Module Announcement.