Frequently Asked Questions

Proposers' day will take place on February 15 in the Phoenix area, with in-person and virtual participation options. Please see the PARADIGM Proposers' Day website for additional information, registration, and to submit questions about the program. 

All participants will be included in presentations throughout the day. A poster session will be available for in-person participants only. Virtual participants will join through a webinar link. There will be no individual meetings for in-person or virtual participants. 

In-person participants may present a poster and are encouraged to network with other event participants. Potential performers are not able to help with Proposers’ Day arrangements. 

Yes. Participation in Proposers' Day is elective. Participation is not required for abstract or proposal submission, nor does it inform abstract or proposal evaluation. All information discussed and presented during Proposers' Day will be made publicly available. 

An organization may submit up to two abstracts per technical area (TA) but may only submit one proposal for each technical area per section 1.3.1 of the Solicitation. All abstracts will be evaluated independently regardless of their affiliation. An Organization is defined as a registered entity with a unique entity identifier (UEI) per SAM.gov. 

Please see section 1.3.1 of the Program Solicitation. Each proposal may address only one of the five technical areas (TAs). An organization may submit multiple independent proposals to different TAs, which will be evaluated separately. An organization may act as a primary performer on a proposal to one TA and a primary performer or subcontractor on additional proposals to different TAs. An organization may not act as a primary performer on one TA and a primary performer or subcontractor on a separate proposal addressing the same TA. 

This Program Solicitation may result in multiple awards of Other Transaction (OT) agreements. However, the number of awards selected will depend on the quality of the proposals received and the availability of funds. Proposers are encouraged to propose a realistic, justifiable, comprehensive, and reasonable budget that aligns with their proposed solution. 

Award selections and funding decisions are based solely on proposal submissions. All decisions will be made in accordance with the processes outlined in the solicitation. 

Proposals must be led by one PI under a single organization, and the composition and roles of additional team members or co-PIs is the responsibility of the proposing team. Co-PIs from other institutions are allowed. Proposal section 1.5.1 describes team composition: Proposals are expected to include all the required expertise to achieve the goals the TA to which they are proposing. Specific content, communications, networking, and team formation are the sole responsibility of the proposing teams. Proposers must submit a single, integrated proposal led by a PI under a single prime contractor that addresses all program Phases relevant to proposed TA. Proposals must designate a project manager for the entirety of the effort. The project manager will serve alongside the PI as a primary point of contact for scientific and administrative matters, and he or she will ideally hold an advanced degree in a relevant field of study. Proposals should provide a detailed plan for coordination, including explicit guidelines for interaction among collaborators/subcontractors of the proposed effort. 
 

Abstracts are due February 27, 2024, 4:00PM ET. The proposal due date is listed in the draft solicitation. Any changes to this date will be listed in the final solicitation. 

Please review the program solicitation section 6.3.3: Intellectual Property for details. 

Abstracts and other submitted documents will not be in the public domain. 

For abstract submission instructions, please see the PARADIGM special notice (ARPA-H-SN-24-06) requesting abstracts on sam.gov. 

Abstract review and response will be provided within 2-3 weeks of the abstract submission deadline. ARPA-H will provide feedback on all submitted abstracts. ARPA-H will not be selecting organizations to move forward but will be encouraging or discouraging proposal submission. An organization can choose to submit a proposal regardless of the feedback provided.  

The PARADIGM team is not providing a budget cap for proposals. Proposed budgets are evaluated based on the program solicitation Section 5: Evaluation of Proposals. 

Yes. Each abstract must respond to one TA and address all requirements outlined in the solicitation related to that TA.  

PARADIGM envisions CDP-based care that represents a financially sustainable service model for existing providers and health systems in a way that positively impacts the trajectory of rural hospitals at risk of closing. Commercial transition deliverables described in the program solicitation are described in each TA with a goal of supporting CDP adoption and sustainability. 

ARPA-H complies with the Department of Health and Human Services (DHHS) salary cap for Executive Level II. For 2024, this limit is $221,900. 

Submitting an abstract is not a requirement for submitting a full proposal. The final solicitation will be posted as soon as it is available along with instructions for submission. Please keep an eye on SAM.gov for the official release. 

No. The program solicitation (PS, Section 1.3.1) states that each proposal responsive to this PS may address only one of the five TAs detailed below. An organization may submit multiple independent proposals to different TAs, which will be evaluated separately, but may only submit one proposal for each TA.   

Many resources exist, including formal sources like the SAM.gov Help pages, SAM.gov training, and the GSA blog. 

The final program solicitation will be posted as soon as it is available. Please keep an eye on SAM.gov for the official release. We will also extend the FAQ deadline past 3/25/24, as listed in the draft solicitation. The deadline for submitting FAQs will occur after the final solicitation is posted, and the date will be posted in the final solicitation. 

Unfortunately the PARADIGM team is unable to accommodate meetings with potential proposers, or to discuss abstract feedback or potential approaches to PARADIGM technical areas.

Yes, the page limit has been changed to 30 pages. Please see Amendment 02, posted April 8, 2024.

A budget narrative is required. The human subjects research documentation can be included as an attachment to the proposal and will not count against the page limit. 

For budget purposes, proposers should plan that these will be two separate meetings. Organization and Governance needs will evolve during the program and meeting cadences may vary based on those needs. 

The Assurance of Compliance documentation should be included as a separate attachment to the Technical & Management Document and will not be included in the 30 page limit. The Technical & Management document can be found in the OT Bundle Templates Zipped folder on Sam.gov. Please ensure you use the most recent versions of all template documents.  
 

The Model OT has been posted with Amendment 01. The representations and certifications requirement has been removed as it is expected that all offerors will have current reps and certs in SAM.gov.

The Innovative Claims Table should be used to link the technical goals, challenges, metrics and milestones described in the Program Solicitation to the proposed technical plan. TA1 requires innovation at many points, in order to provide simulated and actual care in the context of a PARADIGM care delivery platform (CDP), collect user experience data, and guide the development of the CDP platform itself. 

Resumes may be submitted in any format.

The PI does not have to work full time at the submitting organization.

All metrics and milestones from the draft PS will be reflected in the final PS. Proposers should thoroughly review the final PS and amendments for content changes.  

No. An organization may submit no more than one prime proposal per TA. There is no limit on the number of proposals an organization may be a sub-awardee.  

Yes. Questions will be accepted until 5 business days prior to the final proposal due date.

Volume 1 consists of two documents, The Technical & Management Document, and the Task Description Document. The technical & management section is limited to 30 pages. The technical & management section should include the entirety of the proposed solution for evaluation by the PARADIGM team. The Task Description Document will ultimately become an attachment to the award (similar to a contract SOW) and should detail all of the tasks, subtasks, milestones, etc.  

Non-U.S. citizens are eligible to apply. Section 3 of the Solicitation describes proposer eligibility: Non-U.S. entities may participate to the extent that such participants comply with any necessary nondisclosure agreements, security regulations, export control laws, and other governing statutes applicable under the circumstances. However, Non-US entities are encouraged to collaborate with domestic U.S. entities. In no case will awards be made to entities organized under the laws of a covered foreign country (as defined in section 119C of the National Security Act of 1947 (50 U.S.C. § 3059)) or entities suspended or debarred from business with the Government. 

For more information on international participation, please see the General Program FAQs.     

Yes, a non-US company can register for a UEI, which is required to submit a proposal but not to participate in Proposers’ Day. A non-US company can participate in Proposers’ Day. A non-US company does not need to be represented by a US-based organization. For more information on international participation, please see the General Program FAQs.     

Each proposal responsive to this solicitation may address only one of the five TAs. An organization may submit multiple independent proposals to different TAs, which will be evaluated separately, but may only submit one proposal for each TA. An organization may act as a primary performer on a proposal to one TA and a primary performer or sub-awardee on additional proposals to different TAs. An organization may act as a primary performer on one TA and a primary performer or sub-awardee on a separate proposal addressing the same TA. An organization may act as a sub-awardee on multiple proposals to the same TA or different TAs.   

For contact information of other potential proposers who are looking for partners, visit the PARADIGM teaming page.  

Teaming is encouraged, multiple performer archetypes may have the capability to submit a strong proposal.   

Unfortunately downloading the sheet is not an option, however the entries may be filtered on the teaming page, and the entire table may be copied into a spreadsheet. 

PARADIGM proposals need not propose activities occurring in or limited to a specific geographic region. The solicitation does require that care delivery platform pilot testing and patient care activities occur in HRSA designated healthcare professional shortage areas (HPSAs). HPSAs are divided into several categories, all of which are acceptable locations for PARADIGM proposed activities. Proposals that meet all the technical requirements for CDP-based care delivery will be considered.  

Proposals submitted in response to the Program Solicitation are expected to address the program requirements as they are written. Proposals that are outside of the scope of the PARADIGM program will not be considered for selection. 

Abstracts are encouraged for any specific feedback.  

Yes.

Please see the PARADIGM Program Solicitation and visit Project Accelerator Transition Innovation Office page for further details about available transition and regulatory support.  

Entities who wish to develop new medical devices or incorporate emerging technologies are still required to meet all requirements outlined in the program solicitation for a proposal to a PARADIGM TA. 

PARADIGM’s vision is to develop a technology enabled platform that strengthens the capacity of local healthcare system infrastructure. Alignment with existing rural healthcare providers, systems and community organizations is described in detail throughout the program solicitation. 

PARADIGM defines hospital-level services as clinical diagnostic and therapeutic services that are typically available in centralized facilities. Providing these services in the mobile care delivery platform (CDP) will revolutionize patient access to high quality care. While the PARADIGM program solicitation outlines potential use cases that might be addressed in a strong TA1 proposal, ARPA-H encourages creative approaches to providing hospital-level services while meeting all requirements outlined in the solicitation.  

Each abstract and associated proposal should address only one TA. A proposer may submit multiple unique proposals to multiple TAs, with a maximum of one proposal to each TA.  

F&A costs are acceptable in proposed budgets for this program. It is expected that proposed budgets will include all costs necessary to successfully execute the proposed technical tasks. 

TA1 location will determine the location of service. TA1 will propose “home base” locations with reasonable existing EV infrastructure to make it cost-effective for TA2 to install and/or upfit the charging station for regular charging. TA1’s operations playbook will include a description of how the CDP is charged, staffed and re-stocked. TA2 fleet management plan is responsible for CDP design components that enable the operation. 

Please refer to metrics table in the program solicitation. Metrics relying on TA1 use cases are evaluated beginning in year 2.   

The program solicitation requires TA1 performers to define CDP-based care use cases, including working environments, device requirements, staffing requirements, and clinical workflows. Because TA5 performers must propose their intelligent task guidance system before learning the TA1-selected use cases and services, TA5 proposers may select an example service to describe their intelligent task guidance system, along with their capability to pivot and accommodate different use cases/services should others be selected by TA1 performers.  

The Program Solicitation does not specify exclusion of proposals on the basis of FDA approval. It is expected that devices that will be utilized for CDP-based patient care will be ready for use by TA1 performers by year 2 of the program. Proposers are expected to explain how any required approvals will be obtained in advance of requirements set in the program solicitation. 

PARADIGM’s TA1 technical description does not prescribe the professional training of CDP clinical personnel. Personnel must meet all professional credentialing needed in order to provide the proposed clinical services in the proposed geographic setting.  

Yes, proposals must include all services required to cover the CDP-based clinical use cases included in the proposal.   

No, TA1 is responsible for conducting user needs assessments and presenting the resulting product requirements to TA2 performers. Users include patients, clinical staff, ancillary staff, maintenance staff, operators and any others interacting with the CDP or its services. 

TA1 care delivery must meet requirements set forth in the solicitation, which does not specify proportion of care received in the CDP. 

Cost sharing must cover 25% of proposal budget in program year 4, and 50% in year 5. During these final years of the program, TA2 performers will have delivered CDPs to TA1 performers, and TA1 performers will be providing CDP-based care, and financial sustainability analyses should enable care provision in a way that leads to revenue and sustainability. It is possible that revenue from this new care model can be leveraged to support cost sharing in the final years of the program as CDP-based care moves toward its commercial transition, however ARPA-H does not prescribe the source of cost-share funds. 

TA1 performers are required to provide care in or adjacent to the CDP and evaluate the CDP technology in HRSA designated Health Professional Shortage Areas (HPSAs).  

TA1’s scope of work, as outlined in the program solicitation, includes demonstrating the financial sustainability, user acceptability and clinical effectiveness of the technology built by TA2-5 performers within the PARADIGM program. Developing a medical device and/or seeking FDA approval is out of scope for a TA1 performer.  

Yes, TA1 may describe multiple deployment sites for CDP field testing.  

Fleet management of vehicles should be accounted for in the TA2 budget. TA1 should propose a budget that includes personnel needed to conduct all TA1 deliverables, recurring direct costs such as personal protective equipment, cleaning supplies, use-case specific single use medical supplies, etc. TA2 budget should cover CDP maintenance, EV infrastructure upfitting, vehicle development and deployment, and all expenses related to on-board medical devices.  

Each proposal should identify one PI. Co-PIs and Co-investigators are acceptable.  

TA1’s key deliverables are focused on CDP field demonstration of clinical effectiveness, user acceptability and sustainability. While care may be provided adjacent to the CDP or by leveraging the CDP as a key resource, a proposal that does not include the CDP in the scope of work will not be considered for award. TA2’s key deliverables are focused on prototyping the CDP. They are required to conduct user needs assessments to include TA1 performers as well as external stakeholders outside the PARADIGM program. TA1’s research goals should focus on demonstrating CDP clinical effectiveness, user acceptability of the platform and financial sustainability of the business model related to care provided in or facilitated by the CDP.

Please refer to metrics table in the program solicitation. Metrics relying on TA1 use cases are evaluated beginning in year 2.   

The partner entity should be an organization or site that did not pilot the CDP during the PARADIGM program phase I or II.

TA1 services must support CDP-based clinical uses cases. CDP based use cases may include delivery of clinical services in or adjacent to the CDP. Ex: hospital-at-home, mobile or other distributed care models that take place outside the walls of a hospital or healthcare facility.

For TA1, cost sharing must cover 25% of the proposal budget in program year 4, and 50% in year 5. The cost share must be calculated based on the total cost during those years of the program.

Please thoroughly review the program solicitation including technical description of TA2 tasks, metrics and milestones and requirements. Further details are outlined around TA2 requirements including CDP integration, assembly, deployment, fleet management, research and infrastructure development. 

Please see TA2 requirements for vehicle design constraints. All proposed approaches that meet the requirements outlined in the program solicitation will be considered. We encourage proposers to submit an abstract for feedback on specific approaches.  

The program solicitation specifies connectivity with EHR systems but does not exclude other integrations that are not explicitly described. 

Please see the technical description of TA3 deliverables outlined in the program solicitation. Proposers are encouraged to leverage existing technology and experience in the approach to technical challenges.  

TA5 performers must propose a specific clinical service that is divided into clearly defined subtasks for the intelligent task guidance system. Proposals may include services such as performing an ultrasound in one or more anatomical regions or doing a standard medical procedure (e.g., venous blood draw).  

The goal of TA5 is solve the problem of limited specialized clinical staff in rural and healthcare provider shortage areas by upskilling medical personnel who will be staffing the vehicle CDP. For feedback on a proposed approach to a technical area, please submit an abstract. Abstract submissions will receive feedback within 2-3 weeks of the abstract submission deadline. 

The program solicitation does not specify a requirement for robotic solutions. For feedback on a proposed approach to a technical area, please submit an abstract. Abstract submissions will receive feedback within 2-3 weeks of the abstract submission deadline. 

TA5 is not limited to upskilling staff on the use of complex devices.