GIVE Frequently Asked Questions (FAQs)

To help provide timely information about all aspects of the program, this page is updated periodically in response to questions from potential performers.

Full information about GIVE and the application process is in the solicitation on SAM.gov. Ask questions via the ARPA-H Solutions Portal linked below. Please note, you will first need to sign-in or register an account to submit a question. 

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General Questions

Section 2.3 of the GIVE ISO indicates that ARPA-H will consider applications from performers that propose alternative approaches that still meet the program vision (Section 1.3) within a 54-month period.  Alternative approach applications should explain why the alternative approach proposed is as good as or better than the approach described in the ISO.

Section 2.2 of the solicitation requires offerors to include a regulatory assessment and risk management plan as part of their proposal. ARPA-H has a unique statutory authority to work with the FDA in support of ARPA-H's priorities.
 

Offerors may propose to TA1, TA2, or both (see Section 2.1). Offerors should leverage Proposers’ Day and the ARPA-H teaming portal to form teams that, to the greatest extent possible, can meet the full scope of TA1, TA2 or both. See Section 3.3 of the ISO for guidance on teaming structures.

Offerors may propose approaches that align with the scope and objectives of the solicitation to manufacture, test and release RNA-containing modalities.

The GIVE Proposer’s Day event will take place on November 13, 2025, from 8:00 AM to 5:00 PM Eastern Standard Time (EST). For those unable to attend all or part of the event, materials presented during Proposer’s Day—including a recording—will be made available on the ARPA-H GIVE Program website after the event.

For the latest updates and access to posted materials, please refer to the GIVE Program webpage: https://arpa-h.gov/explore-funding/programs/give.

The GIVE solicitation (ARPA-H-SOL-25-129) will appear in the “Submit Solution Summary” drop-down menu beginning November 14, 2025. The option to submit a full proposal will become available only after solution summaries have been reviewed and encourage/discourage notices have been sent to submitters. If you have submitted a solution summary, you will receive instructions regarding full proposal submission following the review process.

For additional questions, please contact the program team via the GIVE questions portal: https://solutions.arpa-h.gov/Ask-A-Question.