The Common Fund Venture Program is a new area of Common Fund support that provides a framework for development of short-term Common Fund initiatives that embrace bold approaches and are responsive to the shared priorities of NIH Institutes, Centers, and the Office of the Director.

Venture initiatives are Common Fund investments and so must meet Common Fund criteria, as expressed below. However, additional criteria also apply, emphasizing brief, modest investments that can be implemented quickly in response to emerging opportunities. Venture investments should be lightweight and nimble while having a strong potential to accelerate science quickly.

What makes Venture initiatives special?

• They are Bold: they are daring investments with potential for significant, outsized impact
• They are Nimble: they can be implemented rapidly in response to scientific opportunity
• They are Focused: they are limited to three years, up to $5 million annually to invest in a clearly defined research topic

What makes Venture initiatives consistent with the Common Fund?

• Common Fund criteria will apply to Venture investments, with accelerated timelines and nimble project management. Venture initiatives will be:
  • Transformative: projects have strong potential for exceptionally high and broadly applicable impact in biomedical/behavioral research
  • Catalytic: projects are time-limited investments of 10 years or less, designed to capitalize on new scientific knowledge or breakthroughs to accelerate and enable subsequent research
  • Goal-driven: projects include defined goals to develop specific deliverables (such as new knowledge, data sets, resources, methods, or technologies)
  • Synergistic: projects advance the missions of multiple ICOs, and are relevant to multiple diseases or conditions
  • Novel: projects pursue innovative solutions to specific scientific challenges important to the NIH mission but that no other entity is likely or able to address
• Venture initiatives are not:
  • Pilot programs to prepare for larger Common Fund investments
  • A means to address high-priority projects for individual ICOs
  • Support for exploratory, open-ended research without specific goals and milestones
• Governance:
  • Ideas for new Venture initiatives are submitted through the ICO Directors to the Office of Strategic Coordination, which oversees the NIH Common Fund, leveraging public input as appropriate. Initiative idea submissions can derive from any areas of biomedical and behavioral research. All proposals are evaluated for responsiveness to the Common Fund and Venture criteria, and are considered by the Venture Board, made up of ICO Directors. Promising ideas are recommended by the Board for full development. The NIH Director provides final approval. Updates on the progress of each Venture initiative will be described on their individual website. 

What is the Venture NBSxWGS initiative?

The overall purpose of the Newborn Screening by Whole Genome Sequencing (NBSxWGS) Collaboratory is to assess the feasibility of a collaborative, multi-state model for newborn screening (NBS) that would use genomic sequencing as a first-tier screening assay for a select group of genetic conditions that are actionable in the first year of life. With approximately 70 to 80% of the more than 10,000 known rare diseases stemming from genetic causes, and roughly 70% manifesting in childhood, the early identification of individuals affected by these conditions holds immense potential for altering disease trajectories by initiating interventions before symptoms emerge or early in the disease course when those interventions are most likely to improve health outcomes.  

What is the title of this Research Opportunity Announcement (ROA)?

Newborn Screening by Whole Genome Sequencing (NBSxWGS) Collaboratory (OT2)  

What is the announcement number of this ROA?

OTA-25-004

What is the purpose of this announcement?

The purpose of this announcement is to invite applications from eligible organizations to support the Newborn Screening by Whole Genome Sequencing (NBSxWGS) Collaboratory, a milestone-driven feasibility study. With significant community involvement and input, this initiative will assess the feasibility of developing a collaborative model to allow incorporation of genomic sequencing, as a screening tool for select monogenic diseases that are actionable in early childhood, into the existing state-based U.S. public health newborn screening program that currently screens newborns for a small number of diseases having devastating consequences if not treated promptly.

Whom can I reach out to with questions about this announcement?

All questions are welcome. Please reach out to Dominique Pichard and Matthew Arnegard with questions about the NBSxWGS initiative ([email protected]). Please reach out to Erna Petrich ([email protected]; subject line must include “NBSxWGS”) with financial or Other Transaction agreements questions.

What are the key dates for planning our application?

Research Opportunity Announcement Released	March 5, 2025
Informational Webinar (A recording of the webinar will be posted following the webinar.)	To be posted
Letters of Intent (LOI) Due LOIs are required. (Email confirmation will be provided acknowledging receipt of the LOI. The email from NIH confirming receipt of the LOI must be included in the “Project Information Summary” section of the full application.)	Friday, April 4, 2025, by 5 PM local time of applicant organization
Application Due	Wednesday, May 14, 2025, by 5 PM local time of applicant organization
Award Negotiations	To begin on or about Monday, May 16, 2025
Earliest Start Date	Friday, August 29, 2025

What organizations are eligible?

Please see ROA Section 2, Eligible Organizations, for the full listing of eligible organizations. 

Are foreign institutions eligible to apply for this initiative as the primary applicant?

No. Non-domestic (non-U.S.) entities (i.e., foreign applicants) are not eligible to apply. Non-domestic components of domestic organizations are also not eligible to apply.

Can an NIH Intramural Research Program (IRP) investigator submit an application for the NBSxWGS initiative? 

No. IRP investigators cannot apply as the prime recipient for the NBSxWGS initiative. However, IRP investigators can potentially participate in this initiative with certain limitations (see ROA Section 2, Eligible Organizations, and Section 8, Developing Applications, for details).

Can other federal agencies of the U.S. Government apply to the NBSxWGS initiative through Research Opportunity Announcement OTA-25-004? 

Yes, federal agencies of the U.S. Government other than NIH may apply to or be involved in the NBSxWGS initiative, provided that they have statutory authority to receive funding beyond their congressional appropriation. The applicant must include the citation of the agency’s statutory authority in the application. 

Are there any other eligibility restrictions?

Yes. Other eligibility requirements are detailed in the ROA in Section 2, Eligible Organizations, and Section 3, Eligibility Requirements.

May I apply for this opportunity without submitting a Letter of Intent (LOI)?

No. Interested applicants must submit a LOI. The LOI is needed so that NIH staff can plan the review panel and mitigate potential conflicts of interest. 

What content is required in the LOI?

The LOI may not exceed 4 pages and must contain the following (all combined into a single PDF):

• Heading: Project Title, Contact Principal Investigator (PI), Business Official, and Applicant Institution.
• Project Summary/Abstract (1-page): The Project Summary/Abstract must briefly summarize the proposed project, including its scientific rationale, specific aims, major milestones, scientific approach, endpoints/outcome measures, and expected impact. Literature citations are allowed but not required.
• List of Key Personnel (3-pages): List all key personnel for the proposed project and for any subprojects with proposed budgets. Provide each person’s name, current title and affiliation, and a concise statement of their role(s) and responsibilities for the proposed project. As applicable, also provide each key person’s eRA Commons ID; briefly state their prior experience in obtaining IRB and other regulatory approvals for studies involving the return of genetic sequencing results to research participants; and briefly summarize their history of receiving awards from NIH and any other federal agencies.

How should Letters of Intent be submitted?

The LOI must be submitted by email as a PDF attachment to [email protected] by Friday, April 4, 2025, local time of applicant organization. The LOI may only be submitted by one of the PIs (either the Contact PI or other PI) or by the institutional Signing Official (SO) or Recipient Business Official (RBO) for the prime recipient’s application. LOIs submitted by other means or from other parties will not be considered. 

Email confirmation will be provided (as a “reply all” response) acknowledging receipt of the LOI. The submitted LOI must be included in the full application.

What are Other Transactions (OTs)?

Other Transactions (OTs) are funding mechanisms, which are not grants, cooperative agreements, or contracts, authorized under the Other Transaction Authority (OTA) by the 21st Century Cures Act.

OTs are used by components within the NIH, including the Common Fund, which have been authorized by Congress to use them. They allow the NIH to:

• Seek participation of non-traditional research partners.
• Foster innovation and nimbleness to develop and engage in programmatic activities.
• Alter the course of the project in real-time to meet the overarching goal.
• Conduct objective review of applications.
• Expand, modify, partner, not support, or discontinue awarded activities based on performance and programmatic need.
• The Other Transactions Authority is governed by 42 U.S. Code § 282 (n)(1)(b). Other Transactions (OTs) are not grants, cooperative agreements, or contracts. They are used by the NIH to provide considerable flexibility in establishing policies for the awards. Policies and terms for individual OT awards may vary between awards, each negotiated with a specific agreement, which may be expanded, modified, partnered, not supported, or later discontinued based on program needs, changing research landscape, and/or availability of funds.

Are OT applications reviewed by the standard NIH peer review process?

• Applications to Other Transactions Research Opportunity Announcements (ROAs), such as this one, are not reviewed by the standard NIH peer review process, but instead, they use custom review processes.
• Responsive, full applications submitted in response to the solicitation will be reviewed by subject matter experts (SMEs) via an Objective Review process. Objective Review will involve the submission of written critiques by SMEs against the Review Criteria listed in the ROA and may involve interactive discussions between those experts and NIH Program staff. The SME's may include NIH federal employees, NIH contractors, federal employees of other agencies, and outside experts, as needed.
• Components of the full applications may be accepted into the final plan in whole, in part, or may be omitted. The outcome of each review could result in a modified work plan for each application based on reviewers’ comments and recommendations.

Does the NIH Policy on Data Management and Sharing (NOT-OD-21-013) apply to this ROA? 

Not entirely. Typical government grant procurement regulations and policies do not apply to OT awards (see the NIH web page on Other Transactions to learn more). However, like other NIH-funded projects, the NBSxWGS Collaboratory initiative intends to maximize the amount of data from this initiative that may be made available to the public. Given the sensitivity around data collected on newborns and privacy concerns that have been raised as part of NBS programs in the U.S., a key feature of NBSxWGS is incorporating the perspectives of a Community Advisory Board (CAB) in multiple aspects of the initiative, including data sharing. Therefore, as indicated in the ROA, applicants are required to submit a draft Data Management and Sharing Plan (NOT-OD-21-013), with the understanding that the final Data Management and Sharing Plan will be developed in consultation with the CAB and the NIH NBSxWGS Working Group. 

What is the budget for this opportunity?

The Common Fund Venture Initiative may allocate up to $4,800,000 (direct + F&A) costs per year for up to three years per award. Support of one project is anticipated. The funding will depend on (1) the objectives for the project proposed by the applicants and how well they fit with the goals of NBSxWGS Collaboratory initiative, (2) the quality of the applications received, (3) availability of funds, and (4) programmatic priorities. The NIH may elect to negotiate any or all elements of the proposed budget. Institutions with an established F&A rate should use their federally approved rate to calculate indirect costs with the following exceptions:

• F&A costs for genomic sequencing including reagents, consumables, sequencing platform and instrument maintenance, sample preparation, bioinformatics analysis etc., will have a cap of fifteen (15) percent. This supersedes the institutionally established F&A rate. The institutionally established F&A rate will apply to personnel costs, including those related to genomic sequencing.
• F&A costs on foreign components will be reimbursed at a rate of eight (8) percent of modified total direct costs, exclusive of tuition and related fees.

How should the budget request be developed and organized?

The detailed budget request must provide the overall expected cost for each of the following categories and for each of the three years: personnel, travel, funds for third parties (i.e., subrecipients such as PHLs) if applicable, other direct costs, and total costs (with F&A costs included). Detailed quotations are required for equipment items exceeding $10,000.

Budgets must adhere to latest NIH salary limitation notice (See Salary Cap Summary (FY 1990 - Present) | Grants & Funding.)
For the purpose of preparing an application, the following considerations and assumptions are provided to allow applicants to develop a proposed budget:

• A key goal of this project is to include a varied set of state PHLs (between 5-10) with varying degrees of experience, or no experience, with NIH funded research and WGS. Applicants are not expected to include the names of collaborating state PHLs in their application but may list preferred options or those PHLs with which they have relevant experience. The NIH anticipates that the list of PHLs will be finalized during negotiation with program staff prior to award.
• Because PHLs will not be identified in the initial application and some budgetary considerations may not be fully apparent at the time of application submission, applicants are expected to submit estimated budgets for the PHLs. Applicants should provide the rationale and justification for the estimated PHL budgets for use in the negotiation process.
• Include an estimate of per newborn sequencing costs, including analysis and personnel costs. Note: F&A rates for DNA sequencing costs (not including staff salaries) will be limited to 15%.
• Include an estimate of the total number of anticipated babies to be sequenced.
• Include a budget estimate for confirmatory sequencing of screen-positive babies. Assume ~2% of all babies sequenced will screen positive based on published experience of sequencing asymptomatic newborns in the U.S.
• Include standard budget estimates to support the remaining activities.

Where can I find the budget form?

For budget details, applicants must download the form from https://commonfund.nih.gov/OTforms and then complete SF424 budget forms on their own computers instead of in internet browsers. The prime applicant is responsible for including all third parties’ budgets and budget justifications. In order to successfully upload budget forms as an attachment into ASSIST, the applicant should flatten the fillable PDF. There are a number of methods to flatten a PDF, the easiest of which is to print it as a PDF.

What is the expected duration of the project?

The expected project duration is 3 years.

Are milestones and deliverables required for each project year?

Yes. Applicants are required to provide a table of milestones and deliverables for each year of the three-year application. Milestones must be specific, quantifiable, and scientifically justified. Milestones, due dates, and estimated costs should be provided in a table, an example of which is provided in ROA Section 8.4, Milestones and Deliverables.

Can you provide an example table of milestones and deliverables?

Example table of milestones and deliverables:

• Note 1: Applicants must ensure that the total budget request is consistent with the sum of item budget estimates in Milestones and Deliverables table for the project.
• Note 2: Provided costs for the task should include all the costs for personnel, equipment, facilities, other resources, travel, and other associated costs.
• Note 3: Total cost (the sum of direct and indirect) for the tasks should be provided.
   

Milestone	Tasks/ Subtasks	Start Date and Due Date (Months after award)	Milestone Definition	Estimated total cost (direct plus indirect cost) for the task
1	1.1	0, 3	Milestone Name/Description Bulleted list of tasks to complete Bulleted list of deliverables (including data sharing) Completion criteria for the task Potential risk factors and decision points	$100,000
1	1.2	1, 3	Milestone Name/Description Bulleted list of tasks to complete Bulleted list of deliverables (including data sharing) Completion criteria for the task Potential risk factors and decision points	$100,000
2	2.1	2, 6	Milestone Name/Description Bulleted list of tasks to complete Bulleted list of deliverables (including data sharing) Completion criteria for the task Potential risk factors and decision points	$100,000

What are the critical dates for submission of the full application?

Applications must be submitted via Application Submission System & Interface for Submission Tracking (ASSIST) by Wednesday, May 14, 2025, by 5 pm (based on the local time of the applicant organization). Applications received past this date will not be accepted.
To submit a full application, applicants must have submitted an LOI by Friday, April 4, 2025, local time of applicant organization. In addition, the email from NIH confirming receipt of the LOI must be included in the “Project Information Summary” section of the full application.

What registrations are necessary to submit a full application?

Full applications must be submitted via the NIH eRA ASSIST system. To submit an application via ASSIST, the applicant organization must have already registered for and been granted the following, which may take several weeks to complete: 

• System for Award Management (SAM): https://sam.gov/content/home – Applicants must complete and maintain an active registration, which requires renewal at least annually.
• Unique Entity Identifier (UEI): A UEI is issued as part of the SAM.gov registration process.
• eRA Commons: Once the unique organization identifier (UEI after April 2022) is established organizations can register with eRA Commons (https://www.era.nih.gov) in tandem with completing their full SAM and Grants.gov registrations.

How do I submit my application?

• Applications must be prepared and submitted using NIH’s eRA ASSIST. Complete applications must be submitted by the Recipient Business Official (RBO). The organization must be registered in eRA Commons with one person designated as the contact Principal Investigator (PI) and one person designated as the RBO.
• Applicants must submit the full application via the NIH eRA Commons ASSIST system no later than Wednesday, May 14, 2025, by 5 pm local time of applicant organization. Here are instructions for submitting via the NIH eRA ASSIST system including specific guidance for OTAs: https://www.era.nih.gov/help-tutorials/assist/era-training-assist.htm. Technical assistance is available from the eRA Service Desk: https://www.era.nih.gov/need-help.
• If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance.

Will NIH provide feedback on my application?

• NIH will NOT provide feedback on applications, except as a part of follow-up on an as-needed basis.
• NIH will not accept an appeal of the Objective Review or funding decision outcomes.
   

When will the first funding period open? 

We anticipate NBSxWGS projects to be funded starting in FY25, with a maximum of 3-year project periods. The start date is anticipated to be no earlier than August 29, 2025, but no later than September 25, 2025. All key dates can be found on pp. 1 and 2 of the Research Opportunity Announcement OTA-25-004. 

What will the review process be like and who will make up the review panel?

The panel for the Objective Review will be recruited based on their expertise in relation to the scientific topics in the LOIs. The review panel does not make funding decisions but will provide recommendations regarding scientific feasibility and innovation based on the review criteria in the ROA. Based on the Objective Review, the NBSxWGS Working Group will make the final recommendations for funding to the NBSxWGS Working Group Co-chairs and the Common Fund Director.

What is the typical budget size for a team with one PI or a team with a PI and clinician?

The application budget should reflect the proposed activities and personnel. The awarded budget size is dependent on the objectives proposed in the application and subsequently negotiated prior to award issuance. The maximum award amount is $4.8 million dollars total cost each year for 3 years, but the appropriate budget size depends on the negotiated proposal, scientific progress once funded, and funds available per congressional appropriation.

Can PIs submit multiple proposals?

PIs are welcome to submit multiple proposals so long as the scientific focus is unique for each proposal submitted. As such, the submission of multiple proposals is not encouraged or discouraged.

Can we expect the same Venture initiative funding a year from now, or will the funding be given once?

We do not anticipate reissuing this ROA next year. The NBSxWGS initiative is a one-time opportunity that will fund projects for up to $4.8 million per award in FY25 with the level of funding in Year 2 and Year 3 contingent upon scientific progress and congressional appropriation of funding. If funding for awarded projects were to go beyond the three-year period, it would be through different program(s) at individual NIH ICs rather than through the Common Fund.

How many awards do you anticipate to fund?

We anticipate funding one award by August 31, 2025.

How can I follow the NBSxWGS initiative?

The Please consider signing up for the NBSxWGS listserv. You can follow the Common Fund X account for details about this initiative as well as other Common Fund programs: @NIH_CommonFund.

Are Plans for Enhancing Diverse Perspectives (PEDPs) required?

No, they are not required at this time.