Development and Application of Ophthalmic Imaging Technologies to Advance Our Understanding of Systemic Diseases (OTA-24-006)

Development and Application of Ophthalmic Imaging Technologies to Advance Our Understanding of Systemic Diseases (OTA-24-006) is sponsored by NIH Common Fund. This Research Opportunity Announcement (ROA) aims to support the development and application of novel non-invasive ocular imaging technologies and tools to identify systemic disease biomarkers with high sensitivity and specificity.

Frequently Asked Questions | NIH Common Fund Informational webinar: Informational Webinar for OTA-24-006: Development and Application of Ophthalmic Imaging Technologies to Advance Our Understanding of Systemic Diseases View the presentation slides View the webinar recording Frequently Asked Questions Expand All to search section using Ctrl+F | Venture Program Frequently Asked Questions 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 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 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 Program criteria will apply to Venture investments, but 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 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. Oculomics Initiative Frequently Asked Questions 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.

OTA-24-006: Development and Application of Ophthalmic Imaging Technologies to Advance Our Understanding of Systemic Diseases Research Opportunity Announcement (OT2) Expand All to search section using Ctrl+F | 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?

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. 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.

( [email protected] ) and Mary Ann Wu, Ph. D. ( [email protected] ) Please also reach out to Erna Petrich ( [email protected] ) (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 28, 2024, by 12:00 PM local time of applicant organization (revised from the published date) 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?

The submission date has been changed. The original published date, May 27th by 5:00 PM local time of applicant organization, has been adjusted. The new receipt date is May 28th by 12:00 PM noon local time of applicant organization.

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 For-Profit Organizations (Other than Small Businesses) 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 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.

Salary for staff to be specifically hired under a temporary appointment for the project 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 [email protected] . 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) .

Plan for Enhancing Diverse Perspectives (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.

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 [email protected] . 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. Application and Submission 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