New Research Opportunity in Computational Modeling of Hormone Homeostasis

New Research Opportunity in Computational Modeling of Hormone Homeostasis is sponsored by NIH Office of Research on Women's Health (ORWH). Initiative leveraging advancements in computational modeling to deepen understanding of sex-specific hormonal biology.

Computational Modeling of Hormone Homeostasis Research Opportunity Announcement | DPCPSI Computational Modeling of Hormone Homeostasis Research Opportunity Announcement Computational Modeling of Hormone Homeostasis Research Opportunity Announcement Program Formation and Governance Outline of This Opportunity Requirements – Computational Modeling of Hormone Homeostasis Initiative Multiple Principal Investigators and Partnerships among Applicants’ Institutions Project Manager/Director (PM/PD) Requirements Financial and Risk Assessment 8.

1 Application Submission Instructions 8. 4 Milestones and Deliverables 9. 1 Review of Full Applications 9.

2 Post-review Funding Plan Special Award Terms and Information 10. 3 OT Agreement Governance 10. 4 Reporting and Project Meetings 10.

5 Management Systems and Procedures 10. 6 Financial Management System Standards 10. 7 Organizational Conflicts of Interest (OCIs) 10.

10 Public Policy Requirements and Objectives Overview Information #overview Participating Organization(s) National Institutes of Health (NIH) Components of Participating Organizations This Other Transactions Research Opportunity Announcement (OT ROA) is to support the Computational Modeling of Hormone Homeostasis initiative.

This research opportunity will be administered by the NIH Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), Office of Research on Women’s Health (ORWH) and Office of Strategic Coordination (OSC). Research Opportunity Title Computational Modeling of Hormone Homeostasis (OT2) Activity Code This funding opportunity will use the Other Transactions Authority (OTA) governed by 42 U.S. Code § 282 (n)(1)(c) .

OT awards are not grants, cooperative agreements, or contracts and use an OTA, provided by law. Policies and terms for individual OTs may vary between awards. Each award is therefore issued with a specific agreement, which is negotiated with the recipient and may be expanded, modified, partnered, not supported, or later discontinued based on program needs, changing research landscape, performance, and/or availability of funds.

Research Opportunity Announcement (ROA) Number OTA-26-004 Research Opportunity Purpose The purpose of this announcement is to invite applications from eligible organizations to support the Computational Modeling of Hormone Homeostasis, a milestone-driven research initiative.

With significant community involvement and input, this initiative will advance the development of in silico computational approaches that model and simulate human hormone homeostasis, with an emphasis on applicability to sex-specific efficacy and toxicity evaluation of therapeutics.

Key Dates Release Date of this Research Opportunity Announcement: April 6, 2026 Letters of Intent (LOI) Due Date: April 24, 2026, by 5pm local time of applicant organization. LOIs are required to submit a full application. Application Due Date: June 8, 2026 by 5:00 PM local time of applicant organization.

Applications will only be accepted following successful competition of the corresponding Letter of Intent and must include a copy of the Invitation to Submit. Late applications to this ROA will not be accepted. Award Negotiations: to begin on or about July 13, 2026.

Applicants are expected to respond to written inquiries and attend videoconferences or teleconferences as requested. Earliest Start Date: September 1, 2026 Informational Webinar: Webinar information will be posted on NIH DPCPSI webpage .

Frequently Asked Questions (FAQs) : Information regarding the Computational Modeling of Hormone Homeostasis initiative, the ROA, application requirements, the Objective Review, review criteria, and all other information will be added to the FAQs on a rolling basis. Potential applicants are advised to check the FAQs page often.

Agency Contacts #agencycontacts NIH encourages inquiries concerning this announcement and welcomes the opportunity to answer questions from potential applicants Scientific Contacts Jielu Lin, Ph. D.

Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI) Office of the Director (OD), NIH Email: [email protected] (Subject line must include “Computational Modeling of Hormone Homeostasis”) Financial/Agreements Officer Contact Erna Petrich Other Transactions Agreements Officer Office of Strategic Coordination (OSC) Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI) Office of the Director (OD), NIH Email: [email protected] (Subject line must include “Computational Modeling of Hormone Homeostasis”) Back to Navigation The overall goal of the Computational Modeling of Hormone Homeostasis initiative is to advance the development of in silico computational approaches that model and simulate hormone signaling pathways and homeostasis, with an emphasis on applicability to sex-specific efficacy and toxicity evaluation of therapeutics.

Through this Initiative, the NIH seeks to enable the research community to identify nascent opportunities and priorities for technology-led, innovative, high-impact research that will generate the critical empirical support needed for evaluating an intervention’s clinical benefit in a sex-specific manner, thereby transforming women’s health outcomes.

There are clinically significant sex differences in pharmacokinetics, dosing, treatment response, and toxicity of drugs and biologics. Yet the molecular mechanisms underlying these differences are poorly understood. Sex differences can emerge from a variety of mechanisms.

In addition to reproductive tissues, sex hormones interact with multiple tissues and body systems such as the lungs, bones, and immune system, and are integral to shaping and maintaining the balance of both the gut and vaginal microbiomes.

Further, dynamic changes in hormonal homeostasis over the lifespan, such as those associated with puberty, fertility, menstrual cycle, pregnancy, and menopause, can trigger systemic responses such as immune pathway reactions or signal transduction effects. Incorporating such hormonal complexity into biomedical research has been challenging. Animal models often fail to reliably predict nuanced human physiological responses by sex.

Most non-human mammals do not menstruate or undergo menopause, thereby further limiting the utility of animal models in research on the health of women. How sex influences the biological and physiological processes relevant to therapeutic efficacy and toxicity remains a significant knowledge gap. In silico computational techniques have strong potential in closing the knowledge gap.

In particular, modeling frameworks designed to integrate multiple mechanistic- and data-driven components have strong potential to capture complex, systems-level interactions between hormone homeostasis, cellular responses, and tissue/organ-level physiology.

While the number of computational studies examining drug toxicity and efficacy have grown significantly over the past years, very few explicitly address sex differences in treatment response. There is an urgent need to develop better systems-level models that are tailored to complex female/male physiology, accounting for sex as a biological variable .

As such, expanding our mechanistic understanding of the relationship between hormones and therapeutics holds promise for streamlining drug/biologics testing and propelling bench-to-bedside translation. A deeper understanding of these mechanisms will not only improve predictive accuracy, but enhance study design by enabling more precise modeling of the breadth of sex-specific physiological and treatment responses.

Ultimately, the NIH envisions a technological breakthrough that has so far remained beyond reach—a simulated whole person or multi-organ, multi-scale system able to generate scientifically realistic and clinically meaningful predictions. If successful, this initiative will take the first step towards accelerating regulatory approval pathways and transforming the development of safer, more effective drugs and biologics.

Award Information #awardinformation The Computational Modeling of Hormone Initiative will utilize Other Transaction (OT) awards. Program Formation and Governance #proforgov Close interactions between the recipient and NIH will be required to maintain this initiative. Program governance will rest with the prime recipient in collaboration with NIH Program staff from DPCPSI and from multiple NIH Institutes, Centers, and Offices.

DPCPSI program staff will be primarily responsible for the stewardship of the initiative and report to the Directors of Office of Research on Women’s Health and the Division of Program Coordination, Planning, and Strategic Initiatives for final funding decisions. NIH will provide funds on a cost-reimbursement basis, and as agreed upon and included in the Terms and Conditions of Award.

Funds may be increased, extended, reallocated, recovered, or terminated in cases where unexpected findings, bottlenecks, or roadblocks may modify plans or prevent completion of the project. See Section 10 for special award terms and additional information about program governance. Objective Review: NIH will convene an appropriate review group to evaluate applications.

See the Objective Review section of this opportunity for further details. Eligibility: See the Eligibility section of this opportunity. Application budget: The NIH may allocate up to $5,000,000 (direct + F&A) costs per year for up to three years per award for the Computational Modeling of Hormone Homeostasis initiative awards.

The NIH anticipates issuing multiple awards contingent upon NIH appropriations, availability of funds, programmatic priorities, and the submission of a sufficient number of meritorious applications. The application budget should reflect the proposed activities and personnel needs of the project. The OT mechanism allows for significant flexibility to make budget adjustments as needed to meet NIH’s programmatic priorities.

Award levels may increase or decrease over time based on funding availability, establishment or termination of sub-awards, recipient performance, and other programmatic priorities. It is anticipated that funds will be allocated on a yearly basis. Cost sharing is not required but may be proposed.

However, including a cost share will not impact an applicant’s chances of selection. Anticipated number of Awards: NIH anticipates making approximately four (4) awards. Award Project Duration: Project duration is anticipated to be up to three (3) years, subject to program needs, scientific progress, and availability of funds.

Research activities and the associated milestones may be shortened or extended as needed within that project period. Workplans for research activities and the associated milestones will be negotiated with the NIH staff annually at a minimum. Authority: Other Transactions awards will be made pursuant to current authorizing legislation, including Section 402(n) of the Public Health Service Act, 42 U.S.C.

282(n)(1)(c), as amended. Outline of This Opportunity #outline Requirements – Computational Modeling of Hormone Homeostasis Multiple Principal Investigators and Partnerships among Applicants’ Institutions Project Manager/Director (PM/PD) Requirements Financial and Risk Assessment Special Award Terms and Information 1.

Requirements - Computational Modeling of Hormone Homeostasis Initiative #requirements This Research Opportunity Announcement (ROA) requires the development of computational models of the dynamic changes of biological processes and pathways mediated by hormone homeostasis, in order to advance mechanistic understanding of sex-specific therapeutic efficacy and toxicity.

For the purpose of this ROA, such therapeutics may include drugs and biologics intended to treat, cure, prevent or mitigate diseases, injuries, or conditions in humans. The application must describe the capability of the proposed approach in characterizing, by sex, the extent to which a drug or biologic engages the intended targets and leads to functional improvement, while limiting possible toxicity and side effects.

Consistent with the Advisory Committee to the Director working group recommendations , this ROA seeks applications intended to develop any computational techniques that integrate biological data with mathematical representations to construct computer-based models and simulations of human biology.

Examples of in silico computational approaches appropriate for this ROA include but are not limited to: Kinetic and dynamic modeling; Systems level biological modeling; Data-driven predictive models.

This ROA specifically calls for models strongly coupled with computational platforms and environments enhanced by artificial intelligence (AI), interactive machine learning, and/or natural language processing capabilities to automate, streamline and optimize data processing and model parametrization.

This ROA intends to support projects with a primary focus on innovative, early-stage, or unique computational methods development rather incremental extensions or applications of existing methods. If the proposed model builds upon an existing model, the applicant must address how the proposed approach represents a new breakthrough in the field.

The computational models developed under this initiative can draw on a variety of data sources (e.g., experimental, observational, clinical, human -omics, and tissue chip data) and have implications for many diseases, chronic conditions, and aspects of human biology relevant to women’s health. The application must delineate how the scientific topic focuses on women’s health.

Comparison of males and females is appropriate, so long as the application addresses how females may differ from males in a clinically meaningful manner.

Examples of scientific topics appropriate for this ROA include but are not limited to: Kinetic and dynamic models of the chemical cascades of systematically administered drugs to establish relevant links to hormone homeostasis; Three-dimensional cellular spatial organization and tissue microenvironment modeling; Characterization of hormonal effects on the female microbiome; Integration of hormone homeostasis into the modeling of mechanical features and mechanical environment of organs/tissues; and Systemic models of hormone influence on human drug-gene interactions; Examples of research NOT appropriate for this ROA include but are not limited to: Research that lacks a substantial focus on computational methods development; Primary experimental data generation and data collection from human participants may be proposed, but such activity must be model driven.

Applicants are encouraged to reuse existing data where appropriate. Correlative models (e.g., polygenic risk scores) that lack mechanistic representation of human biology or physiology; Research that does not include clear relevance for therapeutic evaluation in humans; Research that does not include clear relevance to women’s health.

Comparison of males and females to elucidate sex differences IS appropriate; Research that involves invertebrate or vertebrate animals; and By the end of the three-year period of performance, the model developed should demonstrate extensible, foundational capabilities that effectively, accurately and consistently predict sex-specific efficacy and toxicity of drugs and biologics. 2.

Eligible Organizations #eligibleorg Non-domestic (non-U.S.) Entities (Foreign applicants) are not eligible to apply. Non-domestic components of domestic organizations are not eligible. Foreign components, as defined in the NIH Grants Policy Statement , are allowed.

Any public or private non-domestic entity is ineligible to apply for this program as a primary applicant. Additionally, any non-domestic components of U.S. Organizations are ineligible to apply for this program as a primary applicant.

Public or private non-domestic entities and non-domestic components of U.S. Organizations are eligible to be listed as sub-contractors/recipients, so long as they are not excluded from applying for Federal programs throughout the U.S. Government (unless otherwise noted) and from receiving certain types of Federal financial and nonfinancial assistance and benefits.

Letters of Intent (LOIs), due by the “Letters of Intent Due Date” as shown at the top of this notice, are required.

The following entities are eligible to apply under this ROA: 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 (AANAPISIs) 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 having statutory authority to receive funding beyond their congressional appropriation.

U.S. Territory or Possession Independent School Districts Native American Tribal Organizations (other than Federally recognized tribal governments) Applications that are submitted by or involve federal agencies other than NIH must include the citation of the agency's statutory authority to receive funding beyond their congressional appropriation.

NIH Intramural Research Program (IRP) investigators are not eligible to apply as the prime recipient agency Principal Investigator but may collaborate with extramural investigators on the project as co-Investigators, collaborators, or consultants if the IRP investigator(s) have expertise that could contribute to the goals of the initiative.

Applications that include IRP investigators must include a signed letter from their Scientific Director that describes the intramural aim(s), the staff time in person months for the IRP investigator(s), and any requested budget and justification for the intramural activity. See additional information in Section 8. Developing Applications.

3. Eligibility Requirements #eligrequire Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Principal Investigator(s) (PI(s)) is/are invited to work with their organization to develop an application for support. 4.

Multiple Principal Investigators and Partnerships among Applicants’ Institutions #multipis More than one individual may be named Principal Investigator (PI) in the application. One individual must be identified as the contact Principal Investigator. The contact PI must be employed by or affiliated with the applicant organization.

The PI and any multiple PIs (MPIs) must collectively commit a total of at least 20% level of effort to the project. If a multiple Principal Investigator (MPI) application is submitted, an MPI Leadership plan is required. Partnerships among institutions with investigators having complementary skills and expertise to meet the requirements of this ROA are not required but are allowed.

5. Project Manager/Director (PM/PD) Requirements #pmpdrequire NIH expects the proposed project to include an individual that will serve as the PM/PD for the project, with the appropriate scientific expertise and project management experience, who would support the PI(s) with project management and organizational oversight. Such an individual must commit at least 50% level of effort to the project.

6. Financial and Risk Assessment #finandrisk Applicants may be subject to financial analysis and risk assessment conducted by NIH staff. 7.

Cost Sharing #costshare Cost Sharing is not required but may be proposed. Those proposing to develop commercial applications or who are using other state or government resources may consider identifying a cost share percentage. Applicants may voluntarily choose to propose a financial plan that includes non-federal resources.

The budget submission must clearly identify and justify the use of these resources. Any voluntary cost share must be supported in the application by including a letter of support from the providing organization(s)/individual(s). Inclusion of cost sharing will have no influence on application selection.

8. Developing Applications #devapps 8. 1 Application Submission Instructions #appsubs Complete applications must be submitted under OTA-26-004 via NIH eRA Commons ASSIST no later than the “Application Due Date” shown at the top of this notice, by 5:00 PM local time of applicant organization.

Late applications submitted to this ROA will not be accepted. Applications that do not include an Invitation to Submit will not be accepted. Questions about the scientific scope of this announcement should be addressed to: Jielu Lin, Ph.

D. , Program Officer, DPCPSI (Email: [email protected] ) Letters of Intent (LOIs), due by the “Letters of Intent Due Date” as shown at the top of this notice, are required. 8.

2 Letter of Intent #loi Interested applicants must submit a Letter of Intent (LOI). LOIs will only be accepted from entities listed in the Eligible Organizations section of this Announcement that meet the criteria listed in the Eligibility Requirements. LOIs submitted from organizations not included in the Eligibility section will not be considered.

The information in the LOI also will be used to identify and mitigate potential conflicts of interest (COIs) for prospective reviewers. The LOI must be no more than six (6) pages with sections outlining the following: Heading: Title, Contact PI, Business Official, and Applicant Institution. Project Summary (no more than 2-pages): The Project Summary page limit applies to text and non-text elements (e.g., tables, figures, images).

Inclusion of URLs in the Project Summary is not allowed. The Project Summary must include the following: Scientific Rationale: describe the proposed computational model for the specific research topic. Briefly address how the proposed work advances the goal of the initiative if successfully completed.

Literature citations are allowed but not required. Research Strategy: state the overall objective, specific aims and one or two major milestones. This should include a brief description of the plan for assessing the credibility of the proposed model.

List of Key Personnel (no more than 4 pages): Provide a table that lists all planned key personnel for the proposed project and for any subprojects, providing the following information in separate columns: eRA Commons ID (if available) Institutional affiliation Role(s) and responsibilities for the proposed project A 1-2 sentence statement of their scientific expertise relevant to the proposed project The LOI must be submitted by email as a single PDF attachment to [email protected] by the “Letters of Intent Due Date” shown at the top of this notice.

The LOI may only be submitted by one of the applicant institution PIs (either the Contact PI or other PI) with the institutional Signing Official (SO) or Recipient Business Official (RBO) for the prime recipient’s organization copied on the email. Alternatively, the LOI may be submitted by the institutional SO or 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 LOI will be reviewed by NIH staff for responsiveness and likelihood of success based on the following criteria: How well the proposed project addresses the goal of the initiative How well the specific aims, major milestones, plan for assessing model credibility are aligned with the overall objectives stated in the LOI Appropriateness of key personnel’s scientific expertise and experience to successfully complete the proposed work Following review of the LOI, each applicant will be notified as to whether they are invited to submit a full application.

However, the applicant will not receive feedback on their project. 8. 3 Full Application #fullapp Only applicants who have submitted an LOI, and have received an Invitation to Submit a full application from NIH eligible to submit a full application.

Applications will be accepted only from entities listed in the Eligible Organizations section of this Announcement and only from applicants who meet the criteria listed in the Eligibility Requirements. Applications submitted from organizations not included in the Eligibility section will not be reviewed. Applications must be prepared and submitted using NIH eRA Commons ASSIST .

For instructions on how to submit through ASSSIST, refer to ASSIST-Instruction-Guide-for-NIH-Other-Transactions. docx. 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 PI and one person designated as the RBO. The registration process can take several weeks, so applicants should begin registration 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. Full applications must include the following components.

All attachments must be submitted as PDF using formatting standards provided at https://grants. nih. gov/grants/how-to-apply-application-guide/format-and-write/format-attachments.

htm#papersizeandmargins . Do not include additional project data, images, graphics, etc. in sections other than Research Strategy in order to circumvent page limits. The required application components (with page limits in parentheses) are the following: Abstract (1 page): Provide a summary of the planned activities and approaches and key achievable goals.

Specific Aims (1 page): Describe the specific aims and objectives the application proposes to achieve. Public Health Relevance (1 page): Include a 2-3 sentence statement of the project’s public health relevance. Invitation to Submit (1 page): Provide a copy of the NIH email, inviting submission of a full application.

Project Information Summary (no more than 2 pages): Provide the information about (note: do not upload this into the “Cover Letter Attachment” field in the ASSIST form but provide it as part of the Attachments section in the form): Number and title of this Research Opportunity Announcement. Principal Investigator(s) first and last name, title, institution, mailing address, email address, and phone number.

If multiple Principal Investigators are named, the Contact Principal Investigator must be clearly identified. Name and address of the submitting organization and department, if any, with the organizational Unique Entity Identifier (UEI) number and employment identification number (EIN) provided. Recipient Business Official/Signing Official first and last name, title, institution, mailing address, email address, and phone number.

Proposed budgets per year for 3 years (direct, indirect, and total costs). Proposed project period dates. Identify if the work involves human subjects.

Research Strategy (no more than 10 pages, including text and non-text elements): Provide the following: Scientific rationale and justification of the approach Short-term (first year) and long-term (second and third year) objectives of the proposed work A detailed description of the proposed model, including advantages and strengths.

Include a brief description of how the model addresses or account for sex as a biological variable as appropriate for the application Strategies for assessing the proposed model’s validity and credibility The proposed work’s potential scientific impact and clinical relevance Examples illustrating the experience and past success of the project team and team members in projects of similar scope Discussion of potential risk and alternative plans for mitigating risk Plans for reusing existing resources such as data repositories and biobanks, if applicable Plans for primary data collection (experimental or observational), if applicable, and an explanation why such activity is an integral part of model development or model performance evaluation.

Intellectual Property (IP) Strategy (1 page): Applicants must describe the IP landscape surrounding the applications.

This should include known constraints, if any, that could impede model development and data sharing (e.g., certain restrictions under transfer or sharing agreements, applicants' previous or present IP filings and publications, similar technologies that are under patent and/or on the market, etc.) and how these issues could be addressed as appropriate and consistent with achieving the goals of the program.

If patents pertinent to the proposed work have been filed, the applicants should indicate the details of filing dates, what types of patents were filed, application status, and associated United States Patent Office (USPTO) links, as applicable. Applicants must also discuss future IP filing plans.

Leadership Plan (1 page): This includes organizational and reporting structure and personnel responsibilities, relevant past performance for the team working in or leading projects that are similar in scope and objectives to the project being proposed in the application and any prior experience of the team working together such as in consortium or other multi-institution projects. If applicable, include a MPI leadership plan.

Milestones and Deliverables (no more than 6 pages): All applications must provide detailed information on milestones and deliverables for planned activities and partnerships, as further described below in Section 8. 4. Project Team (see page limits below); Provide the requested information in the specified format per the instructions below.

All Personnel (no more than 2 pages): Provide a table of key personnel and any additional paid and volunteer personnel (e.g., data coordinator, collaborator, partner, consultant, advisor, trainee, student, staff scientist, etc.) contributing in a substantial or meaningful way for the proposed project and for any subprojects, listing the following information in separate columns for each individual: eRA Commons ID (if available) Institutional affiliation Subrecipients (no more than 1 page): Provide a list of additional entities or organizations proposed to receive subawards and their roles.

Biosketches (no more than 2 pages per individual): Provide a biosketch of each named key individual.

The information in the biosketch should include the name and position title; education/training including institution, degree, date (or expected date), and field; list of positions and employment in reverse chronological order (including dates); list of up to three (3) past projects and activities (including the resulting accomplishments and deliverables) that are similar in scope and objectives and most relevant to the proposed work.

The format used for an NIH grant application is acceptable: https://grants. nih. gov/grants-process/write-application/forms-directory/biosketch Other Support (no page limitation): Provide Other Support for all key personnel using the NIH grant application Other Support Format Page work document as found here: https://grants.

nih. gov/grants-process/write-application/forms-directory/other-support . Other Supports must be included with the application, not submitted through SciENcv.

Equipment and Facilities (no more than 3 pages): Provide the information about the equipment and other physical resources available to the project team to adequately complete the project milestones. This should include a computing infrastructure that can adequately support the successful execution of the proposed work.

Institutional Letter of Support (no more than 2 pages): Provide a letter of support from the applicant organization indicating institutional commitment for the project (e.g., relaying support for contributions, including, but not limited to, support for training activities, licenses, and other resources) and preparations to enter into a negotiated Other Transaction Agreement.

Additional letters of support (no more than 2 pages per individual or organization): Letters of support will be reviewed. Only include letters from persons who have an assigned role in the project. Budget and Budget Justification (no page limitation): All applications must provide detailed budget information for planned activities and partnerships, as further described below in Section 8.

5. Bibliography (no page limitation). Resource Sharing Plan: (2 pages).

Individuals are required to develop a Resource Sharing Plan in accordance with the NIH Research Tools Policy . Specifically for this opportunity, it is expected that the proposed model is developed with an architecture that will facilitate model sharing. All applicants must include a plan for sharing model components, modeling parameters, as well as associated scientific data (also see Data Management and Sharing Plan).

The plan should describe how applicants will provide a sufficient amount of accurate information and model documentation to allow others to reproduce the model and perform external validation. The plan should also include an appropriate timeline for sharing. Applicants are required to make the mathematical model and associated data publicly available before a formal patent application is filed.

Delayed disclosure of research findings for the purpose of evaluating an invention for patent application or filing a patent application is not allowed. Data Management and Sharing Plan (2 pages): Responsible data management and sharing have many benefits to the scientific community, including enabling independent validation of research results.

All applications must develop a Data Management and Sharing (DMS) Plan in accordance with the NIH Data Management and Sharing Policy , with the following modification: Scientific data generated as a result of awards under this initiative must be made publicly available before a formal patent application is filed.

Such scientific data include, but are not limited to, primary experimental data, primary observational data, derived data from public repositories or non-public sources, and simulation data that are collected and generated as an integral part of model development and model performance evaluation. Some data employed for model development or performance evaluation may have restricted access (e.g., human research participant data).

The DMS policy outlies factors that might limit data sharing, including when sharing would compromise the privacy or safety of participants and when limitations are explicitly described in informed consent documents.

The application must address in the plan any potential limitations needed to protect privacy and confidentiality of participants and how access to the restricted data can be requested for independent model validation and assessment