Yes. In our interconnected world, where diseases and health issues transcend borders, and where the most challenging health problems cannot be solved by any one country, it is essential for nations to work together to improve healthcare and promote global well-being. ARPA-H recognizes the importance of international cooperation and coordination, and will continue to explore opportunities to do so.
While ARPA-H will prioritize awards to entities (organization or individuals) that will conduct funded work in the United States, it is not a requirement. For clinical trials, ARPA-H strongly prefers that they be performed in the United States. However, trials in other countries will be considered on a case-by-case basis at ARPA-H's discretion.
ARPA-H follows HHS financial assistance regulations and policies. For financial assistance awards, the methodology would need to be otherwise in accordance with HHS requirements, which places an 8% cap for indirect costs reimbursed to foreign entities awarded HHS cooperative agreements. For other transactions (OTs), there is greater latitude for negotiating costing methodologies. Proposers would need to provide their methodology to the ARPA-H Program Manager for approval, to ensure it meets the nature and needs of the project.
They will vary depending on the award type as well as the project and will not be unique to international participants. Financial assistance awards will follow regulatory requirements for reporting. However, additional reporting will be negotiated for all award types. ARPA-H Program Managers are significantly involved with performer progress; therefore, ARPA-H Programs typically follow a monthly reporting structure.
This will depend on the nature and needs of the project and is not a unique consideration for international participants. Project manager costs are not forbidden nor discouraged on ARPA-H awards, but the type, amount, and mix of labor is subject to negotiation.
No, at this time only U.S. citizens are eligible to become Program Managers.
IP rights will be part of award negotiations between the ARPA-H and the proposer, regardless of country of origin.
Note that, for both domestic and international performers, there are more flexibilities regarding IP under Other Transactions than under Financial Assistance Regulations. For example, the Bayh-Dole Act, as implemented in 47 CFR part 401, applies to Cooperative Agreements, but does not apply to Other Transactions.
Non-U.S. citizens are eligible to apply. Proposals must be led by one PI under a single organization, and the composition and roles of additional team members or co-PIs are the responsibility of the proposing team. Co-PIs from other institutions are allowed. Non-U.S. companies can register for a unique entity identifier (UEI), which is required to submit a proposal. A non-U.S. company does not need to be represented by a U.S.-based organization, but they do need to make sure they are addressing how their solution will be of benefit to the U.S. taxpayers.
There is no preference for an international entity performing as a prime contractor or subcontractor. It is dependent on the merits of the proposal and the qualifications of the proposer.
Please contact the Division of International Affairs at firstname.lastname@example.org.