The Common Fund Venture Program is a new area of Common Fund support that provides a framework for development of short-term initiatives that embrace scientific risk 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 Program 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 employ a lightweight and nimble approach while having a strong potential to accelerate science quickly.

The Venture Program launched in Fiscal Year 2024 with two new initiatives: Oculomics and SysBio.

What makes Venture initiatives special?

• They are brief, focused investments in a clearly-defined, cross-cutting topic (3 years, non-renewable)
• They are designed to be simple initiatives with a single funding opportunity
• They focus on bold projects that embrace scientific risk with the potential for significant scientific impact that outsizes the investment
• They are milestone-driven, with clear, concrete goals focused on a specific outcome, in the form of new knowledge, methods, or technologies
• They require only a modest investment of up to $5M per year

What makes Venture initiatives consistent with the Common Fund?

• Common Fund Program criteria will apply to Venture investments, but with accelerated timelines and nimble project management. Venture initiatives will be:
  • Transformative: Projects are expected to have exceptionally high and broadly applicable impact
  • Catalytic, Short-term, and Milestone-driven: Projects will be brief in span (3 years, non-renewable) with clear goals and milestones
  • Synergistic/Enabling: Programs will add value to the NIH Institutes, Centers, and Offices (ICOs)
  • Cross-cutting: Programs must be relevant to multiple ICOs
  • Novel/Innovative: A high level of innovation is required for each project in areas that do not currently have large NIH investments
• 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 Oculomics Initiative?

The Common Fund Development and Application of Imaging Technologies for Oculomics (Oculomics) Venture Initiative aims to support development and application of novel, noninvasive ocular (eye) imaging technologies, machine learning algorithms, and other tools to identify highly sensitive and specific biomarkers for diseases that affect the entire body. Oculomics can have a significant impact on early detection of diseases before the onset of symptoms, and can help clinicians with early disease intervention, risk assessment, tracking disease progression, and supportive therapeutics. Ocular imaging technologies provide a unique opportunity for measurement of indicators for of diabetes, hypertension, stroke, and coronary, inflammatory, metabolic, and renal diseases. Because of its noninvasive nature, Oculomics has the potential to provide advanced health care to all communities, including rural and underserved communities throughout the world.

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

Development and Application of Ophthalmic Imaging Technologies to Advance Our Understanding of Systemic Diseases (OT2)

What is the Announcement Number of this ROA?

OTA-24-006

What is the purpose of this announcement?

The purpose of this announcement is to invite applications from eligible organizations to support the development and application of novel, noninvasive ocular imaging technologies and associated machine learning algorithms, as appropriate, to identify systemic disease biomarkers with high sensitivity and specificity for early disease detection, classification, and monitoring.

The anticipated outcome of proposed efforts will be the development, application and initial translation of new imaging technologies and machine learning algorithms for the detection and identification of novel systemic disease biomarkers. By the end of the three-year period of performance, developed technologies should be demonstrated in appropriate animal models of disease or human patients. This Research Opportunity Announcement (ROA) is intended to support innovative ophthalmic imaging technology development for advancing our understanding of systemic diseases that can lead to new methods for disease prevention, detection, diagnosis, and treatment. Technologies may include, but are not limited to, novel ophthalmic imaging approaches as well as Artificial Intelligence/Machine Learning (AI/ML) algorithms and computational models.

What is an ICO?

ICO stand for NIH Institutes, Centers and Offices.  The National Institutes of Health is made up of 27 different components called Institutes and Centers. Each has its own specific research agenda, often focusing on particular diseases or body systems. All but three of these components receive their funding directly from Congress, and administrate their own budgets.  The Office of the Director (OD) is the central office at NIH. The OD is responsible for setting policy for NIH and for planning, managing, and coordinating the programs and activities of all the NIH components, and is organized into Offices; to which the “O” in “ICO” refers.

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

All questions are welcome. Please reach out to Tony D. Gover, Ph.D. (gover@nih.gov) and Mary Ann Wu, Ph.D. (maryann.wu@nih.gov) Please also reach out to Erna Petrich (DOTM@nih.gov) (Subject line must include the words “OCULOMICS” with additional financial/agreements questions

 

What are the key dates in the timeline for planning our application?

Research Opportunity Announcement Released	March 11, 2024
Letters of Intent (LOI) Due (LOIs are required. Only invited applicants meeting LOI screening criteria will be eligible to submit a full application)	April 16, 2024, by 5:00 PM local time of applicant organization
Notification of LOI Screening results	Provided to applicants by April 25, 2024
Application Due	May 27, 2024, by 5:00 PM local time of applicant organization
Award Negotiations	To begin on or about June 12, 2024

May 27th is a federal holiday, does this mean the submission date will be the following day?

No. The submission date is May 27th by 5:00 PM local time of the applicant organization, regardless of the federal holiday.

What organizations are eligible?

• Higher Education Institutions
  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education
• The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • Asian American Native American Pacific Islander Serving Institutions (ANNAPISIs)
• Nonprofits Other Than Institutions of Higher Education
  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Faith-based or Community-based Organizations
  • Regional Organizations
• For-Profit Organizations
  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)
• Governments
  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • American Indian/Native American Tribal Governments (Federally Recognized)
  • American Indian/Native American Tribal Governments (Other than Federally Recognized)
  • Eligible Agencies of the Federal Government
  • S. Territory or Possession
• Other
  • Independent School Districts
  • Native American Tribal Organizations (other than Federally recognized tribal governments)

Are foreign institutions eligible?

• Non-domestic (non-U.S.) Entities (Foreign applicants) are not eligible to apply.
• Non-domestic components of domestic organizations are not

Are there any other eligibility restrictions?

The outcome of proposed efforts will be the development and application of new imaging technologies for the detection and identification of novel systemic disease biomarker(s). This initiative encourages but does not require the development of machine learning algorithms to support the application of novel imaging technologies. By the end of the three-year period of performance, developed technologies should be demonstrated in appropriate animal models of disease or human patients. Products from this initiative are expected to be matured for future clinical validation. Applicants must address at least one systemic disease in neurology, cardiovascular, or metabolic diseases/disorders. Applications that focus on more than one systemic disease/disorder, more than one area of disease/disorder or utilize multiple imaging modalities are encouraged. This ROA is not intended to support expansion of previous or ongoing efforts that currently utilize OCT, OCTA or fundus photography for detection of systemic diseases. However, applications proposing new efforts that utilize OCT, OCTA, or fundus photography and can demonstrate a novel approach and/or clear technological advancement over existing technology may apply.

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

No.  IRP investigators cannot apply as the prime recipient for the Oculomics initiative.  

Can NIH IRP investigators participate as collaborators with the lead recipient for the Oculomics initiative? #IRPinvestigatorscollaborators

• Yes. NIH IRP investigators can participate in the Venture Program Oculomics Initiative, with certain limitations. Intramural investigators may collaborate with extramural investigators when both have expertise that could contribute to the goals of the program.  
• For projects that involve IRP investigators, separate letters originating from and signed by each participating IRP investigator’s Scientific Director must be included in the application, in accordance with the NIH Intramural Sourcebook. The letter(s) must describe the intramural aim(s) and include the requested budget and justification for the intramural activity. 
• The number of person months and justification for all federal employees who will be committed to the project must be included in the letter, in accordance with the NIH Intramural Sourcebook. This will allow the reviewers to evaluate the suitability of proposed staff to conduct the work.

Can NIH IRP investigators request salary funds for their effort in the project?

• No. No support may be requested from any federal agencies, including the NIH intramural program, for salary or related fringe benefits for career, career conditional or other federal employees (civilian or uniformed series) with permanent appointments under existing position ceilings or any costs related to administration of facilities support.

Can NIH IRP investigators request funds for the project besides their salary? 

• Funds may be requested for IRP investigator participation and are limited to the costs required for carrying out the proposed work, provided those costs can be specifically identified with the Venture Program Oculomics Initiative project. 
• Costs may include:
  • Salary for staff to be specifically hired under a temporary appointment for the project
  • Consultant costs
  • Equipment
  • Supplies 
  • Travel
  • Other items typically listed under Other Expenses.

Where in the application should IRP investigators include a budget request and justification?

IRP investigator costs must not be included in the application budget request or budget justification to OTA-24-006.  Instead, a specific IRP budget request must be included in the letter(s) from the Scientific Director(s).  

In which sections of the application should include IRP investigator participation be described? 

Include IRP investigator participation in the Research Strategy, Leadership Plan, Milestone and Deliverables, Biosketches, Plan for Enhancing Diverse Perspectives, and PHS Human Subjects and Clinical Trials Information.  Information (if relevant) for all other sections (Equipment and Facilities, Institutional Letter of Support, Budget and Budget Justification, Resource Sharing Plan, Data Management and Sharing Plan) should be provided in the Letter from the IRP investigator’s Scientific Director.

How are funds requested for the IRP investigator and/or related to IRP participation provided if the project is selected for funding? 

The project budget, including for the IRP investigator and/or IRP participation, will be determined during award negotiation and will not exceed the total cost of the allowable budget ($1,600,000 TC/year).  For projects selected for funding, IRP investigator funds will be issued through an Interagency Agreement (IAA) and terms and conditions of funding included in an associated Memo of Understanding (MOU).

Can other federal agencies of the US Government apply to the Oculomics initiative through Research Opportunity Announcement OTA-24-006? 

• Yes, other federal agencies of the US Government may apply to the Oculomics initiative EXCEPT for NIH investigators, who cannot apply as the prime recipient.  See FAQ for participation of Intramural Research Program investigators as collaborators. 
• Applications that are submitted by or involve federal agencies, EXCEPT for NIH investigators who must refer to FAQ, must include the citation of the agency's statutory authority to receive funding beyond their congressional appropriation in the budget justification.

Can Federally Funded Research and Development Centers (FFRDC) or University Affiliated Research Centers (UARC) apply?

Submissions by FFRDC/UARC as a prime recipient or subrecipient must include an approval letter from the sponsoring agency Contracting Officer stating that FFRDC/UARC’s competition and participation at the proposed budget levels and per the Oculomics Initiative Research Opportunity Announcement and terms and conditions governing funding are allowed. The concurrence from the sponsoring agency of the proposed work by the FFRDC/UARC must be resubmitted prior to award issuance if the project is selected for funding.
 

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

Interested applicants must submit a Letter of Intent (LOI) and supporting documentation.

How will Letters of Intent be screened?

Project Narratives will be screened by NIH staff to determine the technical merits of the project and the relevance to the purpose of the Oculomics Venture Initiative based on the following criteria:

• Research Idea: The degree to which the project addresses the goal of the Oculomics Venture Initiative. The degree to which the proposed imaging technology demonstrates a clear technological advancement from previous efforts. How well the scientific rationale is supported.
• Research Strategy: How well the specific aims, objectives, and milestones are likely to accomplish the goals stated in the LOI.
• Personnel: How the background and experience of the PI and other key personnel are appropriate to successfully complete the proposed development effort.
• Impact: The degree to which the proposed development effort, if successful, will have an impact on accelerating the movement of promising diagnostic technologies into clinical application and the impact these new technologies will have on disease screening, diagnosis, and monitoring.

When will I be notified about the Letter of Intent screening results?

Following the Letter of Intent screening, Principal Investigators (PIs) will be notified by the “Notification of LOI Screening results” date shown at the top of OT-24-006 as to whether they are invited to submit full applications or not; however, they will not receive feedback (e.g., a critique of strengths and weaknesses) on their Project Narrative.

How should Letters of Intent be submitted?

Letters of intent must be submitted by the applicant organization's business/signing official via email as two PDF attachments, as described in OT-24-006, to oculomics@od.nih.gov . LOI's submitted by other means will not be considered.

What are Other Transactions (OT)?

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 (OT) 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 such as this one, are not reviewed by the standard NIH peer review process, but use custom processes referred to as Objective Review.
• 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 described below, and interactive individual discussions between those experts and NIH program staff. The SME's may include NIH staff, other federal staff, and individuals external to federal government.
• 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.

Who is eligible to apply for an Other Transaction (OT) Award?

Prospective applicants may or may not have received NIH funding in the past. All entities public and private, small or large, for-profit or not-for-profit, eligible Agencies of the Federal Government (including NIH Intramural Research Program) are eligible to apply. Unaffiliated individuals who are U.S. citizens are also eligible to apply. For a list of anticipated eligible organizations please see the Other Transaction Opportunity Announcement (OTA-24-006).

What is a PEDP?

A PEDP or “Plan for Enhancing Diverse Perspectives” is a summary of strategies to advance the scientific and technical merit of the proposed project through inclusivity. This plan should be applied throughout all of the proposed Oculomics research plans.

What does "diverse perspectives" mean for a research project?

Broadly, diverse perspectives refer to the people WHO* do the research and the places WHERE** research is done, as well as WHO PARTICIPATES*** in the research as part of the study population.

• *WHO: The inclusion and empowerment of investigators and trainees from a variety of backgrounds, including those traditionally underrepresented in the biomedical research workforce (see NOT-OD-20-031), and investigators from different scientific disciplines, at varying career stages, and with varied skills, experience, and expertise.
• **WHERE: Participation of researchers from all relevant sectors, including diverse organizations and institutions (e.g.  research intensive and research-active, undergraduate, minority-serving, community-based etc.). Historically, largely well-resourced academic and research institutions have competed successfully for NIH funding. The goal is to broaden the Oculomics initiative’s reach by supporting projects, partnerships, and collaborations at institutions and organizations that, to date, have not often been part of NIH-funded work.
• ***WHO PARTICIPATES: To realize the broadest benefits to human health impacting all segments of the population, the Oculomics initiative is committed to promoting equity in research participation. To that end, maximum effort is encouraged to engage and recruit diverse participants for human studies. To make findings broadly relevant, it is expected that projects involving human participants or samples derived from humans should be collected in an ethically sound manner and consented appropriately.

How do PEDPs vary?

The PEDP will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the project aims are structured. Where possible, applicant(s) should align their description with the required elements within the research strategy section. The PEDP should include a timeline and milestones for relevant components. Examples of items that advance inclusivity in research and may be part of the PEDP can include, but are not limited to:

• Discussion of engagement with different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
• Description of any planned partnerships that may enhance geographic and regional diversity.
• Plan to develop transdisciplinary collaboration(s) that require unique expertise and/or solicit diverse perspectives to address research question(s).
• Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as participants including those from under-represented backgrounds.
• Plan to ensure equitable dissemination of data, tools, and products to all end users.

What must the PEDP include?

• Description of defined activities and actionable strategies for the inclusion of diverse perspectives in the project.
• Description of how the PEDP will bring unique advantages or capabilities to the project.
• Milestones or other metrics for the evaluation of PEDP activity progress and success.
• Proposed monitoring activities to identify and measure PEDP progress benchmarks.
• Anticipated timeline of proposed PEDP activities.

What guidance on the PEDP is available for applicants?

Questions not covered in the Oculomics FAQs and ROA can be directed to oculomics@od.nih.gov. Additional guidance and FAQs will be updated as needed

What is the budget for this opportunity?

The Common Fund Venture Initiative may allocate up to $1,600,000 total (direct + F&A) costs per year for up to three years per award. Support of three projects 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 Oculomics 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 Facilities and Administrative (F&A) rate should use their federally approved rate to calculate indirect costs for non-compute expenses.

Can you provide guidance on indirect costs? Are there any restrictions?

• Institutions with an established Facilities and Administrative (F&A) rate should use up to their Federally approved indirect rate to calculate indirect costs for non-compute expenses.
• Indirect costs for compute expenses in any application funded under this OT mechanism will be capped at a rate of ten (10) percent.
• 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, direct expenditures for equipment, and subawards in excess of $25,000.

How should the budget request be organized?

• The detailed budget request should provide the overall expected cost for each of the following categories and for each of the three years: personnel, equipment, travel, funds for third parties (i.e., subrecipients), if applicable, other direct costs, and total cost (with indirect costs included).
• Budget justification must be provided for all budget items and budget years. Detailed quotations are required for equipment items exceeding $5,000.
• Budgets must adhere to latest NIH salary limitation notice (See Salary Cap Summary/Guidance on Salary Limitation for Grants and Cooperative Agreements). https://grants.nih.gov/grants/guide/notice-files/NOT-OD-23-056.html

Are sub-applicants required to provide a budget?

Subrecipients are required to provide details of cost breakdown. Prime recipient should follow their internal policies and procedures to calculate subrecipient’s budget.

What is the expected duration of the project?

The expected project duration is 3 years. 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 the table. An example table template is provided below for reference.

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 (direct and indirect) for the tasks should be provided.

Milestone	Tasks/Subtasks	Due Date (Months after award)	Milestone Definition	Estimated total (direct plus indirect cost) for the task
1	1.1	3	Milestone Name/Description Bulleted list of tasks completed Bulleted list of deliverables (including data sharing) Completion criteria for the task Potential risk factors and decision points	$10,000
1	1.2	3	Milestone Name/Description Bulleted list of tasks completed Bulleted list of deliverables (including data sharing) Completion criteria for the task Potential risk factors and decision points	$10,000
2	2.1	6	Milestone Name/Description Bulleted list of tasks completed Bulleted list of deliverables (including data sharing) Completion criteria for the task Potential risk factors and decision points	$10,000

Where can I find the budget form?

For budget details, applicants shall 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’ budget and budget justification. 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 are the important dates for the full application?

Applications must be submitted via Application Submission System & Interface for Submission Tracking (ASSIST) by May 27, 2024 at 5:00 pm (based on the local time of the applicant organization). Note that even though this is Memorial Day, a Federal Holiday, it is the application due date. Applications received past this date will not be accepted. 

Which applications will be reviewed? Which will not be reviewed?

Only applicants that have submitted an LOI and have been invited to submit a full application are eligible to apply. Applications will only be accepted from entities listed in the Eligible Organizations section of this Announcement, who meet the criteria listed in the Eligibility Requirements. Applications submitted from organizations not included in the Eligibility section will not be reviewed. Applications that are deemed non-responsive or incomplete will not be reviewed.

If I am invited to submit an application, how do I register to the NIH eRA Commons ASSIST system?

• Applicants invited to submit a full application must submit via the NIH eRA Commons ASSIST system no later than May 27, 2024 by 5 PM local time of applicant organization. Use OTA-24-006 in the Funding Opportunity Announcement field. Here are instructions for submitting via the NIH eRA ASSIST system. Technical assistance is available from the eRA Service Desk.
• To submit a full application via ASSIST, the applicant organization must be registered in eRA Commons. If you are invited to submit a full application, you must be registered in eRA Commons, which may take six (6) weeks or more to complete, applicants should therefore begin the registration process as soon as possible.
• On the eRA Commons home page, select the “Register Organization” link for more details.
• To complete registration, if you have not done so already, you may need to register for the following:
  • System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. SAM registrations prior to fall 2021 were updated to include a UEI. The same UEI must be used for all registrations, as well as on the other transactions application.
  • eRA Commons - Once the unique organization identifier (UEI after April 2022) is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission of the full application. eRA Commons requires organizations to identify at least one RBO and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • 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.

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. Registration process can take a long time, so applicants should begin the registration process as soon as possible.
• Failure to complete registrations in advance of the due date is not a valid reason for a late submission. The RBO’s signature certifies that the applicant has the ability to provide appropriate administrative and scientific oversight of the project and agrees to be fully accountable for the appropriate use of any funds awarded and for the performance of the OT award-supported project or activities resulting from the application.

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.

How are Intellectual Property (IP) rights handled – is anything funded intended to be open access?

The IP terms and conditions are part of the negotiation process with potential recipients prior to award. Generally speaking, any IP will be retained by the recipient, but NIH is granted licensing rights. Recipients of OT awards are expected to comply with NIH Data Sharing and Management Plans, Resource Sharing plans, comply with NIH Public Access policy, and report inventions in iEdison.  

For background regarding legislative authority concerning intellectual property rights: The Bayh–Dole Act is US legislation dealing with intellectual property arising from federally funded research. This Act encourages researchers to patent and market their inventions by guaranteeing patent rights. This Act automatically grants first rights to a patent for an invention fully or partially funded by a federal agency to the awardee organization. To obtain these benefits, however, the inventor and the organization have several reporting requirements that protect the rights of the government. For more information on the Bayh-Dole Act and NIH’s Role, please read Guide Notice NOT-95-003.

When will the first funding period open? 

We anticipate Oculomics projects to be funded starting in FY24, with maximum 3-year project periods. The start date is anticipated to be no earlier than August 1, 2024, but no later than September 30, 2024. All key dates can be found on pp. 1 and 2 of the Research Opportunity Announcement OTA-24-006. 

Is this initiative limited to imaging technology, or can other ophthalmic diagnostic tools such as electroretinography form the basis of the work?

The project must be related to imaging technology. Non-imaging technologies such as electroretinography are not within scope of this initiative.

Are foreign partners allowed? Are industry partners encouraged?

Industry partners are encouraged. Foreign partners are allowed as sub-awardees, but they cannot be the primary awardee. You must justify why the foreign partner brings a unique component that you would not find in the U.S.

Is it mandatory to have partners from industry?

No, it is not mandatory, but we want to see an interdisciplinary team with expertise in all relevant areas of research and development included in the project, including commercial development. This does not have to necessarily come from industry partners if all components are met from academia or a non-profit organization.

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

The LOI review will be done by the Oculomics working group with representation from NINDS, NIBIB, NEI, NIA, NHLBI, and OD program staff. The external review panel for the objective review will be recruited based on their expertise in relation to the scientific topics in the LOIs invited to submit full applications. The external review panel does not make funding decisions but will provide recommendations regarding scientific feasibility and innovation based on the criteria in the ROA. The Oculomics working group will make the final recommendations for funding to the Oculomics working group co-chairs and the Common Fund Director.

Can we target multiple neurological disorders including neurologic and neurodegenerative diseases, or should we focus on one disease only?

We encourage you to focus on multiple diseases if you can do that in the 3- year period of performance.

Is optical coherence elastography considered a suitable technology?

Yes, optical coherence elastography is considered a suitable technology.

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 can be $1.6 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 a team be made up of industry partners only?

Yes. There is no requirement to make academic or non-profit partners a part of the team. Regardless of the make-up of the project team, applicants must demonstrate that they possess the experience and skillsets required to ensure success.

Do one of the milestones have to focus on implementation and deployment of the technology?

Yes, at the level of demonstration, not validation. At the end of the 3-year performance period, we expect demonstration in an appropriate animal model of disease or human patients. We are not looking for validation of the technology for biomarkers because we understand this would require much larger human use studies.

Can you clarify restrictions around OCT/OCTA and fundus photography? Do you prefer other technologies beyond these?

The focus is on non-commercial advanced technologies that have come out in more recent years. We have left room for OCT/OCTA and fundus photography for inclusion of novel technologies of which we may be unaware and/or novel application of these technologies. If you can demonstrate novel utility of these techniques, they could be considered for the funding announcement. An NIH Committee will review the LOI to determine how well the project meets the intent of the announcement.

Would a modified visual field test, like static or kinetic perimetry, be considered imaging technology?

Most likely no, but we would be happy to discuss this to understand the details. Please email: tony.gover@NIH.gov.

What is an example of a project utilizing OCTA that would be appropriate?

We do not identify appropriate projects, instead project focus and design are left to the PI. We will consider proposals that identify the utility of these technologies.

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.

What factors influence the shortened timeline?

The timeline is shortened to allow NIH to commit the funds for this ROA by the end of the fiscal year (September 30, 2024).

If we are not academic PIs should we establish a venture proposal?

You do not have to be a part of academia to be eligible to apply. Academia, industry, and non-profit entities are eligible per the eligibility requirements stated in the ROA.

Will the funds include clinical assessment and FDA approval costs?

We are not expecting projects to get to the point of submitting to the FDA to seek approval for new diagnostics. We are looking for projects that are at a less mature technology readiness level and have higher risk. If you have a technology that is close to FDA approval stages and want more advice on whether this ROA would be appropriate, we are happy to discuss this with you. Please email tony.gover@NIH.gov.

Are diabetic eye diseases not preferred for this funding announcement?

Correct, the focus is on system diseases and not diseases of the eye.

Would an imaging technology for cornea be eligible?

You do not have to focus on the retina. As long as the technology is non-invasive and imaging-based with a focus on system diseases and not diseases of the eye, you can image any part of the eye.

Does the program focus on clinical studies or new technology?

The focus is on utilization of new technologies. At the end of the 3-year period of performance, human clinical studies would be appropriate for demonstration of the technology. However, we are not looking for validation type studies, as these are beyond the scope of this ROA.

By the end of year 3, do you expect demonstration of the technology in humans, or will animal models be sufficient?

Animal models are sufficient if the model is appropriate.

Are you looking for people who have experience bringing innovations to the market?

If people with experience bringing innovations to the market are part of the research team, this is encouraged, but not mandatory.

Is there a particular number of participants that you would like to see?

We want a robust list of applicants at the LOI stage.

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 Oculomics initiative is a one-time opportunity that will fund projects for up to $1.6 million per award this fiscal year (by September 30, 2024) 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 a different program at individual NIH ICs but not the Common Fund.

Would swept-source OCTA be an appropriate imaging modality?

Yes, swept-source OCTA is an appropriate imaging modality. We would be happy to talk with you to get details and provide clearer guidance. Please email: tony.gover@NIH.gov.

How many awards do you anticipate to fund?

We anticipate funding up to 3 awards by September 30, 2024.

Would pupillometry or eye tracking be considered acceptable imaging techniques?

The focus of the ROA is on new imaging technologies, but the Oculomics committee will explore novel applications of developed technologies as well. We are happy to talk with you to get details and provide clearer guidance. Please email: tony.gover@NIH.gov.

Would deep learning artificial intelligence (AI) algorithms applied to existing OCT or OCTA imaging for purposes of investigating systemic diseases be within the scope of this funding application?

Potentially, provided you can demonstrate within your proposal that this isn’t an area already being pursued. We are happy to talk to you to get details and provide clearer guidance. Please email: tony.gover@NIH.gov.

Is there an emphasis on developing new hardware vs developing machine learning algorithms for existing hardware?

The emphasis is on the imaging technology itself for purposes of investigating systemic diseases. A machine learning component can be included in the proposal if it is appropriate for the development of the imaging technology. If you do not need machine learning algorithms for your technology development aims, then they are not required.

Is the ultimate goal to translate the imaging technology to humans beyond the 3 years of the Oculomics initiative?

Yes, translating the imaging technology to humans is the ultimate goal, and it would extend beyond the 3 years of the initiative.

Will you potentially look to combine aspects of different projects, akin to ARPA-H?

At this point we do not plan to combine aspects of the initial 3 awards.

Would you consider validation studies of one of the recently developed imaging technologies outlined in the ROA in a clinical population with particular systemic or neurological diseases?

This may be appropriate. We are happy to talk with you to get details and provide clearer guidance. Please email: tony.gover@NIH.gov.

How can I follow the Oculomics initiative?

Please consider signing up for the Oculomics listserv.

You can follow the Common Fund X account for details about this initiative as well as other Common Fund programs: @NIH_CommonFund.

Can the funds be used to add novel technology to already commercialized technology?

Yes, the funds may be used to add novel technology to already commercialized technology. However, the focus of the ROA is on new imaging technologies, but the Oculomics initiative allows novel applications of developed technologies as well.

Can you share a template of what is expected of the LOI?

The requirements of the LOI are outlined in the ROA.

Are this initiative’s full application requirements similar to the standard R01 with respect to significance, innovation, and approach sections?

The ROA outlines the requirements for the full application.

What is the rationale for promoting advanced technologies for systemic diseases?

The biomarkers that have been identified over years of study have shown promise, but they lack in clinical utility due to poor specificity and sensitivity. We expect that studies from these types of mechanisms will advance the field to increase specificity and sensitivity from newer ocular imaging technologies to the point where they would have clinical utility.

Can cell lines or iPSC-derived cells be used in the study?

Yes, cell lines or iPSC-derived cells may be used in the study.

Can you provide guidance on which parts of the standard 5-page biosketch should be included in the 2-page biosketch required for the LOI of this initiative?

The information to be included in the 2-page biosketch for the LOI is left to the applicant to determine. They should include the information they feel is the most relevant for the proposal. A 5-page biosketch is required for the full application of this proposal.

What would be considered high rates of sensitivity and specificity?

We do not have specific measures for this as it would depend on the technology proposed. You will need to demonstrate this to us within your proposal.

Would multimodal device development of various biomarker corroboration be of interest, putting structure and function together?

Yes, if this provides the biomarker with appropriate specificity and sensitivity.

Will AI with standard imaging be as compelling as AI with advanced imaging that is not yet in the clinic?

Potentially AI with standard imaging may be compelling. We are happy to talk with you to get details and provide clearer guidance. Please email: tony.gover@NIH.gov.

Is the ultimate goal of this initiative disease screening, diagnosis of disease, low-cost point of care, or advanced methods?

All of these aspects are important, however our current focus is on the development and application of novel ophthalmic imaging technology to reliably detect systemic disease biomarkers with high sensitivity and specificity.

How many specific aims would be appropriate?

This is completely dependent on the proposal. The proposed research activities will need to be within the budget limits and the 3-year period of performance.

What would you consider to be the optimal team structure for selection and success?

This is dependent on the proposal and inclusion of expertise in all of the key components. Presumably you would have vision scientists, clinicians, team member(s) familiar with the technology, and team member(s) with expertise in the systemic disease of study. However, this will be completely dependent on what you are proposing.

Will No Cost Extensions (NCEs) be considered for this initiative?

It is anticipated that a project will not extend beyond the awarded project period. NCEs may be considered on a case-by-case basis and only allowed provided there is strong justification.