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

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 have a modest investment of up to $5M per year

What makes Venture initiatives consistent with the Common Fund?

• Common Fund criteria will apply to Venture investments, with accelerated timelines and nimble project management. Venture initiatives will be:
  • Transformative: Projects 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
• 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

What is the Venture SysBio Initiative?

The Common Fund Systems Biology Data Platform (SysBio) Leveraging the Accelerating Medicines Partnership (AMP) Venture Initiative aims to integrate various data types that will allow researchers to explore the role of a specific gene, molecule, cell, or pathway across tissues involved in different diseases. Through the Accelerating Medicines Partnership (AMP), many NIH Institutes and Centers funded research that generated multifaceted data sets in a variety of chronic diseases distributed across multiple data platforms. The SysBio initiative will create a centralized portal and tools so that researchers can search for data across these platforms, empowering reuse and reanalysis of currently disconnected datasets. SysBio will integrate rich data types including phenotypic, clinical, molecular, and patient reported outcomes data. Using data sets from the AMP programs, researchers can explore hypotheses across different tissues in different diseases and identify shared mechanisms within subsets of patients. This Venture Initiative will lay the groundwork for a future goal of expanding access and tools to include data from other cohorts outside of the AMP programs.

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

Systems Biology Data Platform Leveraging the Accelerating Medicines Partnership (OT2)

What is the Announcement Number of this ROA?

OTA-24-008

What is the purpose of this announcement?

1. This initiative is part of the Venture Program, a new effort within the Common Fund to support novel, short-term, bold initiatives that have the potential for significant impact in biomedical and behavioral research. Venture initiatives are innovative and nimble, introducing additional flexibility for the Common Fund to tackle a wider variety of research topics. Venture initiatives embrace scientific risk and have strong potential to accelerate science rapidly. These short-term initiatives will be supported for a maximum of 3 years and will include clearly defined goals and milestones to facilitate rigorous measurement of research progress. Each Venture initiative is expected to produce specific deliverables, which can be new knowledge, methods, technologies, or devices.
2. The purpose of this announcement is to invite applications from eligible organizations to establish the Systems Biology Data Platform (SysBio) Leveraging the Accelerating Medicines Partnership (AMP). Award(s) made through this announcement will support SysBio by providing technical and administrative coordination and support to enable broad use of the data sets and knowledge generated by the different initiatives funded by AMP and, potentially, other complementary data sets. The recipient(s) will work collaboratively with the AMP data platforms and the NIH Institutes, Centers and Offices that support them, to coordinate the activities needed to integrate data from across the AMP ecosystem. The end product of SysBio will constitute a platform to enable the research community to query data across the different tissues and conditions studied in the different AMP projects from a single access point.
3. Given the evolving landscape in interoperability projects, and the emerging tools and best practices, this ROA sets out the intended goals for SysBio, and specifies the identified requirements for achieving them. However, the expectation is that applications will provide a roadmap for SysBio that balances these goals with what is feasible, or will become feasible, within the time and budget constraints. The actual scope and tasks, including milestones, will be negotiated before awards are made and periodically reviewed afterward. Funds may be increased, extended, reallocated, recuperated or terminated in cases where unexpected findings, bottlenecks or roadblocks may modify plans or prevent completion of a project attempting to develop the Systems Biology Data Platform Leveraging AMP. Certain milestones may be designated as “go/no-go” milestones and must be successfully achieved by the specified timepoint for project continuation; failure to meet “go/no-go” milestones will be the basis for project termination.

What is the Accelerating Medicines Partnership (AMP)?

The Accelerating Medicines Partnership (AMP) is a public-private partnership, including NIH, the FDA, the Foundation for NIH, industry and advocacy organizations. The goal of AMP is to improve the development of new diagnostics and treatments for chronic diseases.

What current projects are included in AMP?

1. Alzheimer’s disease 2.0, a successor to AD 1.0 Target Discovery and Preclinical Validation Project
   1. Note: the name listed above is the correct name of the AD 1.0 project
2. Autoimmune and Immune-Mediated Diseases (AIM), a successor to AMP Rheumatoid Arthritis and Lupus
3. Bespoke Gene Therapy Consortium (BGTC)
4. Common Metabolic Diseases (CMD), a successor to Type 2 Diabetes
5. Heart Failure
6. Parkinson’s disease (PD)
7. Schizophrenia (SCZ)

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

All questions are welcome. Please reach out to Anthony Kirilusha, Ph.D. (Anthony.kirilusha@nih.gov) and sysbio@od.nih.gov with questions about this initiative. Please also reach out to Erna Petrich (DOTM@nih.gov) (Subject line must include the words “SYSBIO” with additional financial/agreements questions.

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

Research Opportunity Announcement Released	March 13, 2024
Informational Webinar	March 18, 2024, at 3:00 PM ET
Letters of Intent (LOI) Due	April 3, 2024, by 5:00 PM local time of applicant organization
Application Due	May 15, 2024, by 5:00 PM local time of applicant organization
Award Negotiations	To begin on or about June 12, 2024

What organizations are eligible?

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

Are there any other eligibility restrictions?

• A successful SysBio application will include teams of individuals with expertise in the following:
  • Hands-on working experience in biomedical data and knowledge resources and their use.
  • Understanding of the needs of biomedical research and the wider user community in finding, accessing, and using biomedical data and knowledge.
  • Development and management of scalable data resources and tools suitable for working with biomedical data.
  • Portal development and management using best research software development practices, and experience in developing platforms with good user experience/user interface features (UX/UI).
  • Management and security of personally identifiable research data (e.g., genomics, other -omics, phenotypic and clinical data, imaging).
  • Multi-cloud computing.
  • Interoperability solutions (e.g. APIs or other microservices, data standards and ontologies, portable workflow languages).
  • Computer and personally identifiable data security (e.g., single sign-on, multi-factor authentication and authorization, audit logging, data de-identification, privacy preserving computation in accordance with Federal security policies (e.g. FISMA)).
  • Administration and project management of complex research projects involving federated teams.

NOTE: Specific data and/or knowledge integration projects may involve the use of human data, and must comply with all applicable laws and policies, including IRB review.

Can we apply for this opportunity without submitting a letter of intent?

LOIs are not required to be eligible to submit a full application. However, submitting an LOI is strongly recommended.

Is a resource sharing plan required?

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Is a data management and sharing plan required?

All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

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

• Yes. NIH IRP investigators can participate in the Venture Program SysBio 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 SysBio 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-24-008. 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, Resource Sharing Plan, and Data Management and Sharing Plan. 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 ($4,800,000 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 SysBio initiative through Research Opportunity Announcement OTA-24-008?

• Yes, other federal agencies of the US Government may apply to the SysBio 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 SysBio 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.
 

What is the budget for this opportunity?

1. The Common Fund may allocate up to $4,800,000 for the first-year total costs (direct + F&A) for the four functions defined above. The level of funding for awards made under this solicitation and how funds may be split between the functions has not been predetermined. The funding split will depend on (1) the objectives for the functions proposed by the applicants and how well they fit with the goals of SysBio, (2) the quality of the applications received, (3) availability of funds and (4) programmatic priorities.
2. The NIH may elect to negotiate any or all elements of the proposed budget.

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

1. Institutions with an established Facilities and Administrative (F&A) rate should use their federally approved rate to calculate indirect costs.
2. Indirect costs on cloud computation, cloud storage, and cloud hosting are capped at 10%. This supersedes the institutionally established indirect costs rate.

How should the budget request be organized?

1. The detailed budget request should be provided for each year of the three year work period. For each year, it should provide the overall expected cost for each of the following categories: personnel, equipment, travel, funds for third parties (i.e., sub-applicants), if applicable, other direct costs, and total cost (with indirect costs included). The key team members must attend SysBio or AMP virtual meetings and actively participate in consortium-wide working group and committee activities. Costs associated with these activities must be appropriately reflected in the proposed budget.
2. Budget justification must be provided for all budget items.
3. Budgets must adhere to latest NIH salary limitation notice. NOT-OD-24-057: Guidance on Salary Limitation for Grants and Cooperative Agreements FY 2024 (nih.gov)

Are sub-applicants required to provide a budget?

Sub-applicants are required to provide details of cost breakdown. Prime applicant should follow their internal policies and procedures to calculate sub-applicant’s budget.

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 is a PEDP?

Broadly, diverse perspectives can refer to the people who do the research and the places where the research is done, as well as who participates in the research as part of the study population. The PEDP should provide a holistic and integrated view of how enhancing diverse perspectives is viewed and supported throughout the application and can incorporate elements with relevance to any review criteria as appropriate. The PEDP will be considered a part of the scientific and technical merit of the proposed project and assessed as part of the scientific evaluation in making funding decisions consistent with applicable law.

Are PEDPs required?

All applicants must include a summary of strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity.

What should be included in a PEDP?

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

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

Are additional letters of support allowed?

Additional letters of support are not allowed and will not be considered during review process. Please do not include letters of support in the application beyond the required institutional letter of support.

What is the expected duration of the project?

1. The expected initial project duration is 3 years. Given the dynamic nature of SysBio, applicants must provide detailed description of the goals, milestones and deliverables for the first year. Provided details should include the goal of the milestone, its deliverables, completion criteria, due dates, how success is defined for a given milestone (e.g., Go/No-Go criteria), and payment/funding schedule. Each year 1 milestone must also have an explicit total cost associated with its completion. An example template is provided below for reference. Applicants must also provide the goals, milestones and deliverables for years 2-3. Details for the latter may not be as extensive, however, enough details should be provided such that the overall goals and aims of the project over the three-year period can be properly assessed in the review. For years 2-3, budget by milestone is optional and not required, but a detailed budget request is still required.
2. Applicants should plan such that key team members attend the mandatory virtual SysBio P I meetings. Similarly, the key team members are expected to participate in and often lead the technical working groups and committees, which needs to be considered in planning the project and personnel involvement.

Can you provide an example table of milestones and deliverables?

Milestone	Tasks/Subtasks	Due Date (Months after award)	Milestone Definition	Estimated total (direct and 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	$375,000
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	$500,000
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	$500,000

1. Note 1: Applicants must ensure that the total budget request (cf. Sections 8.4) is consistent with the sum of item budget estimates in Milestones and Deliverables table for the project.
2. Note 2: Provided costs for the task should include all the costs for personnel, equipment, facilities, other resources, travel, and other associated costs.
3. Note 3: Total cost (direct and indirect) for the tasks should be provided.

What are the important dates for the full application?

Applications must be submitted via Application Submission System & Interface for Submission Tracking (ASSIST) by May 15, 2024 at 5:00 pm (based on the local time of the applicant organization).

What must be done before I submit an application to the eRA Commons ASSIST system?

1. To submit an application via ASSIST, the applicant organization must be registered in eRA Commons (See Submission Instructions). You must be registered in eRA Commons, which may take up to six (6) weeks or more to complete, applicants should therefore begin the registration process as soon as possible.
2. On the eRA Commons home page, select the “Register Organization” link for more details.

Will late applications be accepted?

No, as stated in the Research Opportunity Announcement, late applications will not be accepted.

How do I submit the application in the eRA Common ASSIST system?

1. Applicants must submit the full application via the NIH eRA Commons ASSIST system by 5:00 PM local time on the due date (May 15, 2024). Use OTA-24-008 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.
2. To submit a full application via ASSIST, the applicant organization must be registered in eRA Commons (See Submission Instructions of ROA). You must be registered in eRA Commons, which may take six (6) weeks or more to complete, so applicants should therefore begin the registration process as soon as possible.
3. On the eRA Commons home page, select the “Register Organization” link for more details.

How do I complete registration, if I have not done so already?

1. To complete registration, if you have not done so already, you may need to register for the following:
2. 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.
3. 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.
4. 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 Signing Official (SO) and at least one Program Director/Principal Investigator (PD/P I ) account in order to submit an application.
5. 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.

What are Other Transactions (OT)?

1. Other Transactions (OT) are a special type of legal instruments other than contracts, grants or cooperative agreements. Generally, these awarding instruments are not subject to the Federal Acquisition Regulation (FAR), nor to grant regulations unless otherwise noted for certain provisions in the terms and conditions of award. They are, however, subject to the OT authorities that govern the initiative and/or programs as well as applicable legislative mandates. The NIH and its components, including OSC, have been authorized by Congress to use them. They provide considerable flexibility to the government to establish policies for the awards, so the policies and terms for individual OT awards may vary between awards. Each award is therefore issued with a specific Agreement, which is negotiated with the recipient and details terms and conditions for that specific award. Program and administrative policies and the terms and conditions of individual awards are intended to supplement, rather than substitute for, governing statutory and regulatory requirements. Awards or a specified subset of awards also may be subject to additional requirements, such as those included in executive orders and appropriations acts (including the other transaction legislation cited in the Agreement), as well as all terms and conditions cited in the Agreement and its attachments, conditions on activities and expenditure of funds in other statutory or regulatory requirements, including any revisions in effect as of the beginning date of the next funding segment. The terms and conditions of the resulting OT awards are intended to be compliant with governing statutes.
2. For the awards funded under this ROA, the NIH will engage in negotiations, and all agreed upon terms and conditions will be incorporated into the Agreement. Either a bilateral agreement or a Notice of Award (NoA) will be used as the official Agreement. The signature of the Signing Official in the application certifies that the organization complies, or intends to comply, with all applicable terms and conditions, policies, and certifications and assurances referenced (and, in some cases, included) in the application instructions.

What happens after the 3^rd year of the SysBio initiative?

The program will establish a workspace that will provide federate access to AMP data. Common Fund Venture support will end after year 3. Funded teams should consider applying to other funding opportunities (grants, contracts, OTs, challenges, etc.) if they wish to continue their work when funding ends.

Is the inclusion of commercial off-the-shelf components allowed, encouraged, or discouraged?

We do not have a position on the inclusion of the commercial off-the-shelf components. We want the resulting product to be accessible to as many users as possible. Any components must factor into the plan for transferring support of SysBio should it go to a new awardee or should funding for the resource be discontinued. Specifically, NIH expects that a free/fully paid, worldwide, transferrable license be provided for all software components, including those off-the-shelf.

How is this different from the current portals at the NIH?

SysBio should be built on an infrastructure that allows for integration with other NIH data infrastructure efforts.

Will the data be retrieved from the AMP sites on an as-needed basis depending on the research need?

We are open to seeing how the applicants want to address this as we review the technical proposals.

Will non-funded applicants have access to the harmonized data platform toward the development of new grants in the field?

Yes. We hope as many researchers as possible will use SysBio to drive forward their scientific use cases and enable their research, both basic and clinical.

The program structure and OT funding vehicle specifically state that they aim to support a high tolerance for risk, what do the program administrators see as the risky parts/key technical challenges of this program?

• The data in different AMP programs is heterogeneous; they can be combined but one of the technical risks will be to identify the data sets and build the most constructive approach to creating an integrated solution that allows a researcher to search across multiple data sets without having to look through each one individually. Creating tools to harmonize data across the AMP and other platforms will be a challenge.
• Use cases will be defined by discussions with AMP teams but are not yet determined. The goal of SysBio is ultimately to support use cases to enable scientists to use the platform in creative ways, which may result in new requirements.
• We anticipate that potential additional milestones or additional challenges will need to be resolved.

Is there a portal or mechanism to collaborate or communicate with the various AMP teams?

A communication plan between the awardee and AMP teams will be established by the NIH.

Is a pure cloud system expected or can it include hybrid institutional systems with cloud workspaces?

Any solution that meets the basic security and implementation requirements in the ROA will be considered.

Are there any requirements to deploy workspaces that adhere to memory safe programming language mandates?

There are no requirements regarding memory safe programming languages in the ROA.  We will evaluate the proposed solutions in the context of technical and data security requirements outlined in the ROA.

Can we use Artificial Intelligence (AI) in proposed methods to house data within the platform itself, while avoiding data egress from the platform?

If the platform has its own dedicated machine learning functionality that it uses to either assist harmonizing data or assist querying, this is acceptable. The SysBio platform cannot be used as a conduit to provide data to ChatGPT or other external AI systems.

Can we submit an LOI for a particular function to give you options to mix and match components?

• You may, however, each application should address all four functional areas that are outlined in the ROA because they will be scored as such.
• Applicants interested in only one specific function are encouraged to seek a collaborative team that will collectively address all functional areas.

Is this just a visualization portal or do you expect integrative analytic capability?

Visualization will be helpful, but we also want more analytic capability.  The deliverable should emphasize flexibility and maximize the reuse value of AMP data to advance the NIH mission – promote health and reduce illness. The awardee will need to maintain flexibility to address unforeseen needs driven by the demands of the scientific community.  

Are there any predilections on the data type to anchor data models around?

Transcriptomics will be the most common data type across the AMPs and will most likely be a starting point to harmonize the metadata. We do not have a formal requirement of a model. We are looking for interoperability whether that is metadata, standards, or technical standards that have the ability to integrate into a much larger data ecosystem of additional data types, data sources, and data volume.

Will the portal be transferred to the Common Fund Data Ecosystem (CFDE) at the end of year three?

The portal will not be transferred to CFDE at the end of year three because the SysBio program and the resulting portal will no longer be funded by the Common Fund at that point.  Having the portal be interoperable with CFDE is a strongly desirable trait and could enable continued engagement with CFDE provided the portal is sustained beyond that point through non-Common Fund sources.

I am currently a member of a team funded by a federal OT award. Am I still eligible to participate as part of SysBio through another institution's team?

Being a part of a team working on another federal OT does not affect eligibility to participate in SysBio, provided effort requirements listed in Section 4 of the ROA can be met.

Should I include all details requested in the full proposal for the project information summary as outlined in section 8.3 of the ROA? Specifically, should the LOI contain proposed budgets per year for the 3 years, project dates, and effort estimates for key personnel?

The project information summary should include proposed budgets for the 3 years of work, but the budgets do not have to be itemized and justification does not need to be included. Please provide total direct and indirect (if applicable) costs you plan to request for each of the three years. Estimated effort for key personnel is required but is not binding.  Key personnel and their effort can be adjusted during preparation of the full application even after the LOI has been submitted.

Section 8.4 of the ROA states the Common Fund may allocated $4.8 million for the first year total costs. Are there any budget allocation requirements for years 2 or 3?

The “Application budget” subsection (page 5) states that the Common Fund may allocate up to $4,800,000 per year total costs (direct + F&A) for up to three years to the SysBio initiative. In addition, funding in years 2 and 3 is contingent upon scientific progress and congressional appropriation of funds. The proposed budget should always be commensurate with the scope of the proposed work.

Would ownership of any Intellectual Property (IP) created as a result of this effort rest within NIH only?

The IP terms and conditions are part of the negotiation process with potential recipients prior to award and during the award lifecycle. Generally speaking, any IP will be retained by the recipient, but NIH is granted licensing rights. Recipients of SysBio 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.

Would the development team be required to develop and work completely out of an NIH-owned cloud bucket and environment?

It is not required for team members to work out of an NIH-owned cloud bucket and/or environment, as long as you can meet the security requirements and provide an adequate Termination and Transition Plan (see ROA).

If NIH requests to transfer one team’s operations to another team, are there any details on the expected transition timeline?

There is no pre-determined expectation of a timeline; however, the transfer timeline and process are subject to negotiation. The transfer should be completed within the period of time specified during negotiation and should not impact the experience of the platform/cloud workspace users.

Will NIH ownership of the portal have any impact on the performing team’s ability to develop interoperability capabilities? If so, to what degree?

We do not anticipate that NIH ownership of the system will impede the development of interoperability capabilities. However, OT is an agile funding mechanism, and the specifics of this implementation will be negotiated and subsequently evaluated by NIH throughout the course of the project.

Will the software used in the SysBio system be required to have a particular copyright license?

There is no formal licensing requirement for software used in or developed for SysBio. NIH strongly encourages open sharing of biomedical research data and software. The choices made about licensing may affect the specifics of the Termination and Transition Plan (see ROA).