GIVE Frequently Asked Questions (FAQs)

There is no expectation that IP arising from GIVE be open source (publicly available). 

It is up to each team to self-determine and document how intellectual property will be handled amongst team members. Please see Section 6.3, Intellectual Property, for more information.

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.

Yes, your organization can participate in the program. Teaming is highly encouraged to bring together a variety of expertise and specialties to accomplish the program’s goals. As an automation engineering firm, you could contribute by building, integrating, or automating analytical or bioprocess equipment, designing digital architecture, or supporting process optimization. Your expertise would complement other team members who focus on RNA sequence design or other areas, helping to create a robust and innovative combined proposal.

Teaming at Proposers’ Day is intended to bring together organizations of all sizes and specialties to share their technology, foster collaboration, and identify partners who will each contribute individual components to a combined proposal.

Teams may include large or small pharma companies, academic innovators, analytical or bioprocess equipment developer/manufacturers, automation engineering firms, CDMOs, reagent or consumable suppliers, digital software developers (eQMS (e.g., eMBR), LIMS, process monitoring), experts in process modeling and/or AI, or other organizations with expertise relevant to GIVE.

As part of a team, representative ways an individual organization could contribute include:

• Lead an effort or join a team to contribute your specific expertise.
• Develop, build, integrate, or automate analytical or bioprocess equipment.
• Design RNA sequences (active, legacy, or mimetic assets) to be manufactured.
• Develop, manufacture critical reagents or consumables to support and optimize processes.
• Offer know-how in commercialization and transition.
• Generate AI-enabled process models
• Design the digital architecture (i.e., process monitoring, eQMS, and data storage)

Offerors can organize their teams in two ways:

1. Prime/Sub-performer Teaming: One organization (the prime) leads the project, manages sub-performers, and is solely responsible for interactions with ARPA-H. Sub-performers support the prime but do not interact directly with the government. This structure offers centralized management and clear lines of responsibility.
2. Multi-Party Teaming: Multiple organizations collaborate as equal partners, each performing substantive technical work. All members sign a teaming agreement and are parties to the award, with one member acting as the administrative lead. Leadership and membership can change as needed, and all team members communicate directly with ARPA-H. This approach offers flexibility and shared responsibility.

Offerors should choose the structure that best fits their team’s expertise and project strategy. (Reference: GIVE ISO, Section 3.3)

The government cannot dictate or direct intellectual property (IP) strategy between team members. However, typical IP arrangements may evolve through stage-appropriate agreements that reflect the needs of each phase. For example, a solution summary may be developed using publicly available information or non-disclosure agreements (NDA), while an NDA may be necessary when preparing a full proposal. The appropriate agreements between team members during proposal development are at their sole discretion. The final IP terms and conditions between team members are often finalized during contract negotiation and are required prior to contract award.  

The GIVE Proposers’ Day will be held on November 13, 2025, at the Kellogg Conference Hotel at Capitol Hill, Gallaudet University, 800 Florida Ave NE, Washington, DC 20002. The event is hybrid, with both in-person and virtual attendance options.

The event will run from 8:00 AM to 5:00 PM ET. A formal agenda will be published prior to the meeting. For planning purposes, you can expect:

-    Morning: Registration and welcome, overview presentations by ARPA-H program staff
-    Midday: Lunch
-    Afternoon: Stakeholder discussions, Lightning talks, poster sessions, networking opportunities, Q&A session, and closing remarks
-    Post-event: A no-host social gathering will be held at the Kellogg Center immediately following proposer’s day conclusion providing additional opportunities for informal networking and team formation.

Thank you for your interest in the GIVE program! Unfortunately, we do not conduct 1:1 meetings with potential offerors outside of scheduled sidebars once the solicitation is posted to ensure we maintain a fair and open competition. Proposers’ Day and associated sidebars are currently the only scheduled opportunities for interaction with potential offerors and the program team. The program website, solicitation, and Proposers’ Day details can be found at the program page https://arpa-h.gov/explore-funding/programs/give.

Teaming is highly encouraged to bring together a variety of expertise and specialties to accomplish the program’s goals. Teaming at Proposers’ Day is intended to bring together organizations of all sizes and specialties to share their technology, foster collaboration, and identify partners who will each contribute individual components to a combined proposal.

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). ARPA-H welcomes submissions that differ in the timeline, provided that timeline does not exceed 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.

As part of our commitment to a fair and competitive process, we are unable to provide feedback or guidance on the competitiveness of specific approaches or combinations. We encourage you to carefully review the program goals, requirements, and evaluation criteria outlined in the GIVE ISO to determine the best strategy for your submission.

Additionally, please note that Section 2.3 of the GIVE ISO indicates that ARPA-H will consider applications from performers who propose alternative approaches, as long as they still meet the program vision described in Section 1.3 within a 54-month period. If you choose to submit an alternative approach, your application should clearly explain why your proposed method is as good as or better than the approach described in the ISO.

Yes, organizations may participate in more than one proposal for the GIVE program, including in different roles and team structures. This flexibility is intended to encourage broad collaboration and allow organizations to contribute their expertise across multiple teams and technical approaches. However, an organization may not serve as the prime (lead) on more than one proposal.

Please refer to the GIVE ISO, Section 3.3 (Proposer Team Structure) for more information on teaming structures.

Section 4.3 of the GIVE ISO directs applicants to Attachment A for the required Solution Summary format. Solution Summary submissions must follow the format, sections, and length specified in Attachment A of the solicitation. In addition to describing your idea, its novelty, and introducing key team members, you are required to include a brief budget overview (Basis of Estimate) with a timeline, requested federal funds, total project cost, and a breakdown of costs. Please refer to Attachment A for detailed requirements.

The intent of TA1 of the GIVE program is that the proposed solution should not require bespoke centralized oligonucleotide synthesis for each product. The solution should enable distributed, multi-product manufacturing using the same raw materials. 

As stated in Section 2.2.2, utilization of DNA templates manufactured in a centralized facility is out of scope. This means the solution should not depend on bespoke, centralized manufacturing of the entire DNA template for each product.

Applicants are encouraged to propose budgets that are appropriate and justified for their proposed work, in alignment with the scope and objectives of each technical area and stage. 

Please refer to the solicitation and attachments for guidance when preparing your submissions.

Thank you for your question. ARPA-H does allow entities to participate in multiple proposals under the GIVE program, as long as they are not serving as the prime on more than one of those proposals. However, the agency will not fund the same work more than once. If an entity is part of two proposals that are both selected for award, ARPA-H will work with the teams during the negotiation phase to ensure there is no duplication of effort. For example, at the discretion of the proposing team and assuming the same work is required for both proposals, work may be funded under one proposal and incorporated as an “input” to a second proposal if both proposals are ultimately selected.  

Each proposal will be independently reviewed and evaluated. In other words, proposals are not compared to one another, rather each is individually evaluated in relationship to the metrics outlined in the ISO. Therefore, contributing to more than one proposal will not hurt your chances of being selected.  

ARPA-H cannot comment on whether or not participating in multiple proposals may affect potential collaboration among partners as this is the responsibility of the team.

SAM.gov registration is not required at the Solution Summary submission stage.

SAM.gov registration is required at the full proposal submission stage. Please see Section 3.2, System For Award Management (SAM), of the GIVE ISO, for further details.

Yes, it is possible to change which TA you are addressing between the Solution Summary and the full proposal submission. For example, if you submit a solution summary that proposes to address both TA1 and TA2, you may choose to submit a full proposal that addresses only one TA. 

We recommend that you clearly indicate any changes in scope or focus in your full proposal and ensure that your submission fully addresses the requirements for the TA(s) you ultimately select.

The administrative lead named in the proposal submission will be named in the contract award. A  multi-party teaming structure allows the administrative lead (agent/lead member) to change at any time via a formal contract modification post award during the 54-month performance period.

The goal is to build a system that is robust, flexible, and future-proofed—capable of supporting a wide range of RNA modalities. The emphasis is on demonstrating the capability to produce a diverse range of RNA products (classes and categories).

No. The RNA products manufactured for demonstration do not need to be demonstrated as clinically viable during the program. The ISO outlines that RNA products must be demonstrated to meet phase-appropriate PQAs. The focus is on the ability to produce a variety of RNA molecules that are representative of the given category.

While we recognize the complexity involved in manufacturing for different editing approaches, the intent of the ISO phrasing is to group all “editing” approaches—including gene, base, and prime editing—into a single category, as outlined in ISO section 2.2.1. Specifically, “each RNA product from a different category (P/I cancer neoantigen therapy, gene/base/prime editing (e.g. CRISPR/Cas), RNA-based cell therapy (e.g. RNA-CAR), T-cell engager, etc.).” 

Offerors are encouraged to leverage the ARPA-H teaming portal to form teams that, to the greatest extent possible, can meet the scope of product diversity. 

Each offeror will be required to submit the quality target product profiles (QTPPs) for each RNA product to be manufactured in their proposal (3 RNA products from at least 3 different classes (mRNA, saRNA, transRNA, circRNA)) and each RNA product from a different category (P/I cancer neoantigen therapy, gene/base/prime editing, RNA-based cell therapy, T-cell engager, etc.). 

(Ref Section 2.2, Program Timeline, Phases, Milestones & Metrics, of the GIVE ISO).