Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background and Objectives

The NHGRI Genomic Data Science Analysis, Visualization, and Informatics Lab-space (AnVIL) is a scalable and interoperable resource for the basic and clinical genomic research communities that leverages a cloud-based infrastructure to democratize data access, sharing, and computing across large genomic and genomic-related datasets. The AnVIL platform facilitates integration and computing on and across large datasets generated by NHGRI programs, initiatives funded by the National Institutes of Health (NIH), and other agencies supporting human genomic research. The key components of the AnVIL Program include:

1. Infrastructure and cost controls
2. Cloud platform interoperability
3. Data onboarding
4. Tool identification, onboarding, and deployment
5. Community building and user support
6. System and data security
7. Leveraging technological opportunities
8. Governance and project management

As an NIH-Designated Data Repository, the NHGRI AnVIL platform is authorized to share controlled-access datasets with the research community. This authorization complies with the NIH Genomic Data Sharing (GDS) Policy for controlled-access genomic datasets, including associated metadata and phenotypic data. In addition, the AnVIL Program has successfully ingested over 4.5 petabytes of data, integrated genomic data analysis tools and resources such as Bioconductor, Galaxy, PharmCAT, seqr, and Dockstore to serve both the basic and clinical genomic research communities, developed outreach and educational tools, and successfully piloted the Data Use Ontology System to understand the use of a semi-automated data access management service to manage compliant sharing of controlled-access data.

In February 2021, the NHGRI hosted a workshop titled Genomic Medicine XIII: Developing a Clinical Genomic Informatics Research Agenda to develop a research strategy on the use of genomic-based clinical informatics resources to improve the detection, treatment, and reporting of genetic disorders in a clinical setting. In addition, in October 2021, NHGRI hosted another workshop titled Future Directions of the NHGRI Analysis, Visualization, and Informatics Lab-space (AnVIL) to identify gaps, challenges, and future opportunities related to NHGRI's investments in the AnVIL Program. Outcomes from these workshops highlighted support for the AnVIL’s existing infrastructure and services and identified opportunities to expand the AnVIL team’s activities to better support both the basic and the clinical genomic research communities. Specifically, these activities include increasing the availability of analysis tools and workflows, increasing outreach and educational offerings, addressing challenges related to using cloud-based services, improving interoperability with other cloud-based data resources, and increasing support for the clinical research community.

Over the next five years, AnVIL should transition from being primarily a data submission and sharing platform to serving as a multi-functional discovery platform to perform basic and clinical genomic research. AnVIL should also further develop as a resource for genomic data science education. In addition, the AnVIL Program should build on current successes (e.g., advancing data sharing, platform development, and outreach) while also evaluating and leveraging new scientific and technical advances to improve its services.

Two Funding Opportunity Announcements (FOAs) have been released to achieve NHGRI's vision for the renewal of the AnVIL Program: RFA-HG-22-020, The NHGRI Genomic Data Science Analysis, Visualization, and Informatics Lab-space (AnVIL) (U24 Clinical Trial Not Allowed) , and RFA-HG-22-021, The NHGRI Genomic Data Science Analysis, Visualization, and Informatics Lab-space Clinical Resource (ACR) (U24 Clinical Trial Not Allowed). RFA-HG-22-020 is a limited competition FOA that focuses on the continued development, maintenance, and user support of the AnVIL Program. RFA-HG-22-021 is an open competition FOA that focuses on integrating clinical genomic research components into the AnVIL Program. The AnVIL Program encompasses all efforts under both RFAs, while the AnVIL team is defined as the combined group of all awardees under both FOAs. All members of the AnVIL team are expected to work together closely to achieve the goals of the AnVIL Program.

The specific objectives and requirements of this FOA, RFA-HG-22-020, are the following:

1. Infrastructure and cost controls

Over the next five years, the program should further develop the existing AnVIL cloud-based infrastructure and interfaces to provide users with a cloud-based platform that provides scalable compute and storage. The infrastructure should provide a storage system that allows both frequent data usage and high-performance computing applications, as well as less frequent usage and long-term archiving. Additionally, the AnVIL platform should be able to accommodate growth in storage, computing, and network traffic needs over the project period. The interfaces should be user-friendly, customizable, and designed to encourage the use of robust best practice workflows, including the selection of both tools and parameters.

To address the challenges related to the use of cloud-based infrastructure, AnVIL should provide interfaces to support users in provisioning and de-provisioning cloud resources, managing user accounts, managing payments to underlying cloud providers, tracking billing, reporting on usage, and configuring parameters so users can control spending rates. The AnVIL team will collaborate with representatives from NIH initiatives that provide cloud services, discounts, and credits such as the NIH Science and Technology Research Infrastructure for Discovery, Experimentation, and Sustainability (STRIDES) Initiative.

Concerns about cost are a major barrier to the adoption of cloud services. Addressing these concerns will be a major focus for the AnVIL Program and will require both technical resources and user training. Technical resources include tools that help users ensure that they will not incur unexpected costs while using the cloud resources and services provided by AnVIL. For example, notifications could be used to promptly alert users if the absolute spending or the rate of spending pass certain thresholds. Quotas could also be used to allow users to limit their spending. Tools should be developed for both estimating and analyzing costs. Innovative solutions enabling users to leverage discounted cloud resources such as spot or reserved instance pricing should be explored. Functionality should be proposed to eliminate or minimize payment and cost barriers for students and researchers performing inexpensive work on, or evaluating whether to use, the AnVIL platform for larger projects. The combined used of an on-premises system with cloud-based infrastructure to reduce cloud egress and other costs for AnVIL users could also be explored. User outreach requirements regarding cost controls is addressed in the Community building and user support key component.

AnVIL is also expected to continue to develop technical approaches and systems to streamline and facilitate the controlled data access request processes for AnVIL users and the NHGRI Data Access Committee.

Awardees should work closely with awardees under RFA-HG-22-021 to scope, prioritize, and implement improvements to the AnVIL infrastructure and cost controls to meet the needs of the clinical genomic research community.

2. Cloud platform interoperability

The AnVIL team should participate in and contribute to the establishment of a NIH federated data ecosystem through efforts such as the NIH Cloud Platform Interoperability (NCPI) and the adoption of standards and APIs such as those developed through the Global Alliance for Genomics and Health (GA4GH) and Health Level Seven’s Fast Healthcare Interoperability Resources (FHIR). This should include active contribution to the development and implementation of standards and APIs that improve the user experience across these platforms. Additionally, adherence to Findable, Accessible, Interoperable, Reusable (FAIR) principles' requirements established by the NIH and the scientific community is expected. Examples of how the AnVIL team is expected to implement FAIR principles in the federated ecosystem include: adopting agreed-upon search and indexing approaches, deploying reusable and portable analysis workflows that work seamlessly on datasets distributed across cloud service providers and software platforms, standardizing metadata and adopting common data models and ontologies, and deploying common application programming interfaces (API) to allow data access and for sharing data and tools. The web portal and other user interfaces should also be designed to facilitate interoperability with other public resources following FAIR principles.

3. Data onboarding

In general, the AnVIL platform is expected to host datasets associated with NHGRI programs and other datasets that are expected to have, or already have, broad utility to the genomic research community. The datasets hosted by the AnVIL Program, and their online or archival storage status, will change as NHGRI’s research priorities and dataset usage change. It is anticipated that the AnVIL team will work in collaboration with data generators, owners, and managers to facilitate dataset ingestion and hosting on the AnVIL platform. AnVIL should continue to accept, store, and make available to the broad research community both unrestricted and controlled access data and associated metadata, including individual-level phenotypic information, genomic (whole genome, exome, and genotyping) data and other data types, including for example single-cell, other omics and imaging datasets. Interfaces should be provided to facilitate submission and updates of datasets, and the identification of common submission errors such as deviations from a data model or missing files.

The adoption of controlled vocabularies, ontologies and other types of data standards for metadata representation is critical to allow cross data analysis. To harmonize metadata and phenotype classification and facilitate comparisons across studies hosted by the AnVIL platform, data models should be interoperable through the use of commonly used controlled vocabularies, standards, and ontologies such as the PhenX Toolkit, the NIH Common Data Elements, the Human Phenotype Ontology, and Online Mendelian Inheritance in Man (OMIM) terms. In addition, the AnVIL team is expected to work closely with data submitters to ensure appropriate harmonization efforts have been performed.

These harmonized data should support querying, retrieval, and access management. These functions should be accessible through an interactive dataset catalog for users. This catalog should support queries to identify datasets and to build sample cohorts on factors such as sample size, consent groups, inclusion/exclusion criteria, data use limitations, cohort demographics, data type, sample collection protocols.

4. Tool identification, onboarding, and deployment

In order to enable analyses, the AnVIL platform should provide access to common genomics tools while also allowing researchers to bring their own tools and pipelines. Where there are best practice workflows for data processing and analysis, such as variant calling pipelines or RNA-Seq pipelines, the AnVIL platform should facilitate the generation of processed datasets of broad interest to the community. The AnVIL platform should also make these pipelines readily accessible for users to use on their own data.

To increase the availability of analysis tools and workflows and support innovation, the AnVIL platform should also allow users to develop, optimize, deploy, share, and reuse statistical, visualization and other types of genomic or other omics applications and analysis workflows. This should be done in a way that balances the AnVIL platform’s security posture with the needs of the biomedical research community. The AnVIL team should explore, develop, and implement innovative approaches to allow users maximum flexibility to deploy their own tools without compromising the security of the platform or data.

The AnVIL platform should provide a collaborative environment for NHGRI-funded consortia and individual researchers where datasets and analysis workflows can be shared and prepared for release to the broad scientific community through AnVIL platform interfaces. For research networks and consortia, this may require tooling and interfaces to support and manage permissions to access datasets by consortium members. The AnVIL team is expected to work with representatives from NHGRI-funded data coordination centers and appropriate NIH program officials to assist in the establishment of consortium member accounts and management of their access privileges to the consortium data and computing resources.

The AnVIL platform should include a web-based portal and programmatic user interfaces. These interfaces should provide administrative, training, technical, pricing, and general information about the resource. Through these interfaces, users should be able to understand not only the overall purpose and capabilities of the AnVIL platform, but also how to access datasets, study-related documentation, and training materials. The portal should accept and process requests for accounts, data access, and user support.

Awardees under this RFA are expected to work closely with awardees under RFA-HG-22-021 to ensure that tools and workflows relevant to the clinical genomic research community are fully integrated into the AnVIL platform.

5. Community building and user support

One of the key goals of this RFA is to increase outreach to genomic researchers and expand educational offerings and user support in genomic data science. In particular, the AnVIL Program is focused on enabling users from the basic and clinical genomic research communities to leverage cloud-based resources to conduct genomic based research.

According to the Notice of NIH’s Interest in Diversity (NOT-OD-20-031), diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform teams having a homogeneous background. This theme was further developed in the 2020 NHGRI strategic vision, which emphasizes that the promise of genomics cannot be fully achieved without attracting, developing, and retaining a diverse workforce, which includes individuals from groups that are currently underrepresented in the genomics enterprise. The AnVIL team has been actively involved in the Genomic Data Science Community Network, the Research Centers in Minority Institutions Virtual Applied Data Science Training Institute (VADSTI) to better enable genomic data science researchers to use cloud based resources. The AnVIL team will continue to be committed to supporting students, researchers, institutions, and consortia with a broad set of perspectives, backgrounds, and academic disciplines in using cloud-based resources for genomic based analyses. Moreover, the AnVIL Team is expected to closely collaborate and support the educational activities of the awardees of the RFA-HG-22-002 Educational Hub for Enhancing Diversity in Computational Genomics and Data Science and its partner institutions to provide full opportunity and participation to individuals from diverse backgrounds, including those from groups underrepresented in the computational genomics and data science workforce.

The AnVIL team will develop and implement AnVIL-focused outreach and engagement efforts for both experienced and inexperienced users, including for example online videos, webinars, hackathons, and workshops. These activities should cover a range of topics, including:

• General introductions to the AnVIL platform and genomic data analysis
• Purchasing, estimating, and monitoring cloud costs
• Managing access privileges
• Running best practice workflows

Focus should be given to sustainable approaches that train the trainers and that develop online user communities.

The AnVIL team should also systematically solicit and address user feedback about the interfaces, the instructional resources available, and the general operations of the resource. User feedback should be instrumental in improving the quality of AnVIL’s services and informing development priorities. Regular meetings with AnVIL’s user community should also be used to enable interactive user feedback and to showcase the work being performed on AnVIL.
Meaningful metrics should be developed that capture the usage and impact of the AnVIL platform to assist NHGRI in evaluating how AnVIL is serving the broad genomic research community. Metrics should address the usage by users from a wide range of expertise and institutional affiliations. These metrics should seek to provide insight into how the AnVIL Program can improve the quality of its services for a variety of users. AnVIL should also develop and track metrics to evaluate the quality and effectiveness of user-facing activities such as responding to help desk tickets.

User education is also a key element of cost control. AnVIL users will need support to understand, leverage, and adopt cost controls. Education in how to use technical quotas, run cost estimators, and generate reports, especially during new user onboarding, will be critical. Managing billing is a major challenge for many users of cloud computing resources. Instructional materials and tools to help users track and manage billing for cloud services should be developed, implemented, and updated as the needs of users change.

6. System and data security

Providing a secure environment is of critical importance for the AnVIL Program. The AnVIL platform should continue to implement security configurations and controls that follow NIST-800-53 rev 4 Moderate security guidelines, or equivalent. In addition, working in collaboration with the awardees of RFA-HG-22-021, the AnVIL’s data access and security controls should meet the needs of the clinical genomic research community, including Health Insurance Portability and Accountability (HIPAA) compliance.
Security encompasses confidentiality, integrity, and availability. While all three elements are important for the AnVIL Program, maintaining confidentiality of controlled access data is a particularly high priority. Confidentiality includes ensuring that data are accessible only to authorized users and only for authorized purposes. Data security protection and proper stewardship of human genomic, phenotypic, and other sensitive information stored and distributed by the AnVIL Program are of the utmost importance. The Notice for Use of Cloud Computing Services for Storage and Analysis of Controlled-Access Data Subject to the NIH Genomic Data Sharing (GDS) Policy (NOT-OD-15-086) allows investigators to perform genomic analyses on a cloud platform. The NIH security best practices and provisions should be implemented to protect the privacy and confidentiality of research participants and to prevent unauthorized access to data. The resource is also expected to develop policies and procedures for notifying NHGRI and managing any loss of data or compromise of data confidentiality.

The AnVIL team should conduct regular audits of the AnVIL platform’s data security and protection processes, which should be validated by third party independent assessments.

The AnVIL team is expected to establish and maintain a user authentication system to allow secure access to the AnVIL platform’s data and computing services by individual researchers and groups of users with different access privileges. The user authentication and authorization processes developed for the AnVIL platform should also be compatible with those utilized by other NIH resources, such as Researcher Auth Service (RAS).

Some data, in particular datasets to be used for clinical research purposes or data derived from international population cohorts, may have to be hosted in specific geographic areas according to law or policy. The AnVIL platform will need to be able to accommodate these requirements as enabled by cloud platforms.

Awardees under this RFA are expected to work closely with awardees under RFA-HG-22-021 to ensure that the security of the AnVIL platform meets the needs of the clinical genomic research community, for example to make the AnVIL platform a Health Insurance Portability and Accountability (HIPAA) compliant resource.

7. Leveraging technological opportunities

Over the project period of this award, new scientific and technological advances for supporting genomic data sharing, access, and computing in a federated data ecosystem may emerge. The AnVIL team should aim to rapidly identify, evaluate, and incorporate these to improve the quality of the platform's services. Examples include, but are not limited to, the optimization of analysis tools and workflows for genomic research, the adoption of new data compression methods to reduce storage costs for imaging data, and tools to improve data security and protection of research participant data.

8. Governance and project management

Awardees under this FOA should work in close collaboration with the awardees under the companion RFA-HG-22-021 for the governance and project management of the AnVIL Program. The project management structure should ensure the efficient planning, initiation, implementation, and timely completion of all activities and day-to-day oversight of the activities. Metrics to assess the utilization of the resource and its impact on the genomic research community should also be developed. In addition, specific timelines and milestones should be developed and updated as needed, in collaboration with the other AnVIL Program awardees, NHGRI staff and the AnVIL Steering Committee, and the External Consultant Committee (see below). In addition, the project management should involve frequent interactions and communications with NHGRI staff, including hosting site visits and preparing additional reports as requested by NHGRI staff. Finally, the project management structure should ensure efficient engagement with NIH-funded consortia that are using the AnVIL platform for their data and analysis needs.

AnVIL Steering Committee (ASC)

The ASC will constitute the main governing entity of the AnVIL Program. The ASC includes key personnel from all AnVIL awardee institutions (both RFA-HG-22-020 and RFA-HG-22-021) including PDs/PIs and project managers and the NHGRI AnVIL Program staff. The ASC will provide guidance regarding uniform data use procedures and policies across the program and ensure robust participant protection practices for data access and management that adhere to NIH policies and best practices. In addition, the ASC will develop criteria and assist in prioritizing datasets, software, tools, and workflows to be hosted and made accessible to the broad clinical and scientific genomic research communities via the AnVIL platform. It is anticipated that the ASC will meet once a week. Major decisions involving the AnVIL Program will be determined by consensus or, as needed, by majority vote of the ASC. Each primary awardee site will have one vote, regardless of the number of participants from those sites that are part of the ASC. NIH staff that are part of the ASC will collectively have only one vote. If a vote ends in a tie, then one of the members of the External Consultant Committee will be temporally added as an impartial member of the ASC who will review the arguments and make a recommendation to resolve the dispute.

External Consultant Committee (ECC)

The ECC assesses the AnVIL Program’s operations, scientific progress, guidelines to streamline data access, oversight of ethics concerns and participant protection practices, adoption of new technology solutions, cost-effective use of cloud resources, and interoperability with other data resources in consultation with NHGRI staff. The ECC members should have expertise in a broad range of topics relevant to genomic medicine and genomic research including genomic technologies, computational genomics, data science, cloud computing, data management, data sharing concerns (such as participant protection issues), and Ethical Legal Social Implication issues. Applications should not include proposed ECC members or recruit members to serve on the ECC prior to the peer review of the application.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Section III. Eligibility Information

1. Eligible Applicants

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)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations
• Non-domestic (non-U.S.) Entities (Foreign Institutions)

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• 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.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier 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. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Only one application per institution (normally identified by having a unique UEI or NIH IPF number) is allowed.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

This is a limited competition RFA. Only recipient organizations funded under RFA-HG-17-011 are eligible to apply.

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Chris Wellington
Email: anvil@mail.nih.gov

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

For this specific FOA, the Research Strategy section is limited to 30 pages.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed.

Without duplicating information contained the biosketches, describe the investigator's experience successfully coordinating and collaborating with efforts of comparable size and complexity. Describe the investigator’s scientific expertise in data science and data management. Also describe the investigator’s expertise in making data accessible to the research community, performing outreach to the scientific community, and managing consortium logistics.

R&R Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

Since effective management of this resource requires a significant commitment by Program Director(s)/Principal Investigator(s), they should devote sufficient time to serve their proposed roles.

Budgets should include costs required for active participation and hosting of virtual and in-person meetings of the AnVIL Program, including:

1. ECC meetings.
   Frequency: twice a year, one in-person meeting and one virtual meeting.
   Hosting: budget to host 2 in-person meetings over the 5-year project period. Travel costs for 10 ECC members should be included in the hosting costs.
2. AnVIL Team meetings.
   Frequency: once a year, in-person.
   Hosting: budget to host 2 in-person meetings over the 5-year project period.
3. Community workshops.
   Frequency: every other year, in-person.
   Hosting: budget to host 1 in-person meeting over the 5-year project period.

Awardees under this RFA and the companion RFA-HG-22-021 will rotate the hosting responsibilities for these meetings over the 5-year project period.

R&R Subaward Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Research Strategy:

Applicants are reminded that over the AnVIL Program renewal period, AnVIL should transition from being primarily a data submission and sharing platform to serving as a multi-functional discovery platform to perform basic and clinical genomic research, and a resource for genomic data science education.

The Background and Objectives in Section I above includes eight key components which should be read carefully. No single application to this RFA is expected to address all eight key components of the RFA, but if a key component is addressed in the application, the following information should be provided:

• A detailed plan for how the applicant proposes to meet the component’s objectives, both independently and in collaboration with the other awardees of the AnVIL Program, including those under this RFA and the companion RFA-HG-22-021.
• Benchmarks for success
• Proposed timelines and milestones for the whole project period
• A description of anticipated key issues and challenges

Applicants are encouraged to include in the application additional topics or features that may improve the quality and effectiveness of the services provided by the AnVIL platform.

Additional information applicants should provide for specific components is described below.

1. Infrastructure and cost controls

Applicants should describe how their platform will allow users to access cloud services.

Applicants should also describe how they will enable researchers to access cloud services in a cost-effective manner. To reduce risks associated with dependence on a single cloud service provider, applicants should describe plans for building a foundation that enables the AnVIL platform to be deployed across multiple platforms, both cloud and non-cloud based.

Applicants should provide a plan for implementing streamlined technical solutions and administrative processes to review and authorize controlled-access data requests while upholding the study data use limitations.

2. Cloud platform interoperability

Applicants should describe their plans to participate and provide leadership for collaborative activities and interoperability approaches to use in the emerging federated NIH data ecosystem. These plans should specifically address NCPI, GA4GH, and FHIR and how the AnVIL platform will in general implement the FAIR principles.

3. Data onboarding

Applicants should describe how they will work with both individual researchers and consortia to ingest various datatypes into AnVIL. This should include primary data, analysis products, phenotypic data, and metadata. These plans should describe the division of responsibility with submitters, plans for communicating with submitters, and plans for streamlining the submitter experience. Plans for harmonizing across datasets should also be described, along with plans for enabling users to search across datasets.

4. Tool identification, onboarding, and deployment

Applicants should describe how tools will be identified, onboarded, and deployed on the cloud-based platform, including considerations towards reducing costs for running those tools in the cloud, improving the user experience and in observance of the AnVIL platform’s security framework.

5. Community building and user support

Applicants should describe plans for user outreach, engagement, and support. This should also address how the platform design will be guided by and closely coupled to user feedback.

6. System and data security

Applicants should describe the security certifications they plan to implement to ensure the protection and proper stewardship of sensitive information stored in the AnVIL infrastructure, and describe how they will achieve and maintain them over the award period. This should include the implementation of security standards such as the NIST-800-53 rev 4 Moderate , and HIPAA compliance.

Applicants should describe plans for implementing evolving technical solutions for user authentication and authorization to access controlled access datasets, such as the NIH Researcher Auth Service (RAS).

7. Leveraging technological opportunities

Applicants should describe how they will identify new technological opportunities, evaluate their value to the AnVIL platform and its users, and decide whether to implement them.

8. Governance and project management

Applicants should clearly describe the organizational structure of the AnVIL Program, with roles and responsibilities of key personnel. The project management plan should also describe how the PD(s)/PI(s) will manage the proposed resource, coordinate the day-to-day activities with the other AnVIL awardees and NIH staff, support achievement of the proposed goals and milestones, and resolve conflicts. In addition, describe how guidance and recommendations from the ASC and ECC will be incorporated in the implementation of the program.

Metrics to assess the utilization of the resource and its impact on the genomic research community should be described.

Applications should not include proposed ECC members or recruit members to serve on the ECC prior to the peer review of the application.

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

The following modifications also apply:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
• NHGRI expects all educational or outreach materials, software, workflows, and tools developed from this Program to be made available as soon as they are ready under an open-source license which will permit the public to use the materials without substantive restrictions. Awardees are expected to comply with the NIH Genomic Data Sharing Policy.

Appendix:

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form

All instructions in the SF424 (R&R) Application Guide must be followed.

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. 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. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by NHGRI , NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NHGRI Referral Office by email at bettie_graham@nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following: No single application to this RFA is expected to address all eight key components listed in the Background and Objectives, Section I, of the RFA. However, if a key component is addressed in the application, the applicant is expected to describe how they propose to meet the component’s objectives, both independently and in collaboration with the other awardees of the AnVIL Program, including those under this RFA and the companion RFA-HG-22-021.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NHGRI, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council for Human Genome Research. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Ability of the applicant to work effectively with the other members of the AnVIL Program.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: Generaland Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

• Federalwide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.htmlandhttps://www.lep.gov.

• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
  
• For guidance on administering programs in compliance with applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75 and 2 CFR 200, and other DHHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an assistance mechanism (rather than an acquisition mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipientsfor the project as a whole, although specific tasks and activities may be shared among the recipientsand the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• Determining technical and operational approaches to support the AnVIL Program and setting project milestones and timelines.
• Ensuring that the data, software, resources, materials, etc. produced as part of this project are released appropriately according to the Resource Sharing Plan.
• Ensuring staff supported under this award will adhere to the AnVIL Staff Code of Conduct included below.
• Interacting with other relevant NHGRI and NIH activities, as needed, to promote interoperability among similar or related NIH projects.
• Working collaboratively with the ACR PD(s)/PI(s) and the other AnVIL Program recipientsin support of the project’s governance structure.
• Being active ASC members and establishing AnVIL workgroups that support genomic research.
• Providing effective leadership and management.
• Accommodating necessary changes to improve the efficiency of operations or services.
• Providing interim reports or information requested by NHGRI staff.
• Providing logistical and administrative support for the External Consultant Committee (ECC) meetings, ASC meetings, and AnVIL workgroups.
• Addressing and implementing the guidance and recommendations of the ASC, the ECC, and NHGRI.
• Serving as active members of the ASC, NCPI, the NHGRI Educational Hub, and participating/leading working groups that focus on topics or activities that affect the value, quality, and efficiency of the operations and services provided by the AnVIL Program.
• Assisting in the development of policies that require coordinated action.
• Maintaining security certifications of the AnVIL platform and facilitating data security audits and certification by third parties.
• Maintaining necessary regulatory and policy compliance related to data access and data security for both unrestricted and controlled access data, including NIH-designated best practices for genomic data sharing.
• Working productively with program staff from other NIH institutes as needed.
• Agreeing to accept close coordination, cooperation, and participation of NHGRI staff in those aspects of scientific and technical management of the service as described under NIH Program Staff Responsibilities.
• Agreeing to be subject to Government rights of access to the AnVIL platform and services consistent with current DHHS, PHS, and NIH policies.
• Notifying NHGRI staff within 24 hours of being made aware of a data management incident under the genomic data sharing policy, a security breach, a data loss, or a system wide loss of data access.

NHGRI staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

The Project Scientist/Scientific Officer (PS/SO) at NHGRI also holds the dual role of Program Director (PD). The Program Director will have substantial scientific and programmatic involvement during the conduct of this activity through technical assistance, advice, and coordination, and also will be responsible for the normal scientific and programmatic stewardship of the award. The role of the Program Director will be to facilitate and not to direct the activities. The Program Director will be named in the Notice of Award, and will, along with other NIH staff, be represented as a single collective voting member of the AnVIL Steering Committee (ASC) and External Consultant Committee (ECC). The Program Director will have the following substantial involvement:

• Serving as a liaison and helping to coordinate activities among and for the recipients, including acting as a liaison to the NHGRI and as an information resource for the recipientsabout NHGRI and NIH priorities. The Program Director will also coordinate the efforts of the recipient(s) with other groups conducting similar studies.
• Assisting recipient(s) in the development, if needed, of policies for dealing with situations that require coordinated action.
• The Program Director will assist and facilitate the AnVIL team processes and not direct them.
• Providing advice on the management and technical performance of the award.
• Assisting in promoting the availability of the data and related resources developed in the course of the award to the scientific community.
• Being responsible for the normal scientific and programmatic stewardship of the award, including assessments of how well the recipienthas met any milestones required for each year of funding.
• Curtailing, withholding, or reducing support for any recipientthat fails to make satisfactory progress toward the work scope that NHGRI approved, has ethical or conflict of interest issues, or fails to comply with the Terms and Conditions of Award.
• Involving NIH or NHGRI staff who may assist the recipient(s) as designated by the Program Director.
• Where warranted and consistent with authorship and conflict of interest requirements of journals in which the AnVIL team members decide to publish, co-authoring manuscripts through their role in scientific program management.
• Other NHGRI staff may assist the recipient(s) as designated by the Program Director.

Areas of Joint Responsibility include:

Due to the complexity of the infrastructure and services provided by the AnVIL Program, a close collaboration among PIs/PDs of this RFA, the companion RFA-HG-22-021, and NHGRI staff is required to manage, assess, and implement the Program. This is accomplished by:

• Meeting weekly by conference call or in person to share information on data resources, methodologies, analytical tools, data analyses, preliminary results, etc.
• Establishing best practices for data integration and collaborative analyses as appropriate.
• Generating responses to ECC recommendations.
• Naming ASC members.
• Promoting the availability of the data and related resources developed in the course of this service to both the clinical and genomic research communities at large.
• Developing joint timelines and milestones.

Data/software ownership and transition to another grantee:

AnVIL recipientswill retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

Ownership of the data and software hosted, uploaded, or generated on AnVIL’s platform remains with the data and software providers. The recipientshave no possessor rights of the data, software, and workflows provided or generated by AnVIL platform users, who will retain ownership and control of their resources.

A fundamental objective of this cooperative agreement is to ensure that the valuable data, software, and workflow resources provided by AnVIL Program remain available without interruption to the research community if the recipientwithdraws, or otherwise can no longer manage the resource, or if the award is terminated by the NIH. At the end of the award, or if a new recipient has been selected prior to the end of the award, the recipientwill work with NHGRI staff and the new award recipient to transition the data and software to the new service, or to the Government.

Open-Source Technology:

Software, tools, workflows, and other technologies built under this RFA should be made available with an open-source license. The use of proprietary software, tools, and workflows is acceptable, but should be compatible, and not in conflict, with the broad resource dissemination requirements of this RFA.

Publications:

The PIs/PDs are encouraged to generate publications regarding the AnVIL Program’s infrastructure and services. However, use of the data hosted by the AnVIL for publication purposes should comply with the expectations of the AnVIL Staff Code of Conduct below.

AnVIL Staff Code of Conduct:

The AnVIL Staff Code of Conduct sets forth expectations for the responsible management and use of controlled-access data in National Institutes of Health (NIH)-supported repositories. Failure to abide by any term within this Code of Conduct is expected to be resolved between the NIH and the recipientinstitution which can lead to disciplinary action that may include, but are not limited to, termination of the staff from involvement in the data repository’s development and any other access to data in NIH-supported repositories. AnVIL staff is defined as a person or group of persons directed by NIH to develop and test platforms, pipelines, analysis tools, and user interfaces that store, manage, and interact with data from NIH-supported repositories via an NIH funding mechanism. Staff with access to controlled-access data in NIH-supported repositories for development purposes agree to:

1. Use datasets for the sole purposes of developing, testing and implementing the environment and building the infrastructure during both development and production phases of deployment (these functions include software development to enable researchers to access and analyze data);
2. Not perform hypothesis driven research in their AnVIL staff capacity;
3. Make no attempt to identify or contact individual participants or groups from whom data were collected, or generate information that could allow participants identities to be readily ascertained;
4. Maintain the confidentiality of the data and not distribute data to any entity or individual without appropriate approvals from the NIH;
5. Implement administrative and technical safeguards to prevent unauthorized access to the data and adhere to the NIH Security Best Practices for Controlled-Access Data Subject to the NIH Genomic Data Sharing Policy and any other relevant federal (e.g., FISMA) and institutional security requirements;
6. Ensure that only authenticated and authorized users can gain access to data files, as appropriate;
7. Report any inadvertent data release, breach of data security, or other data management incidents in accordance with any agreements and/or Institute or Center requirements.

No ownership rights of the datasets (including derived or derivative data) are granted to staff or their affiliates.

Staff who want to perform research using controlled access data hosted by the AnVIL are required to seek separate approval by the relevant NIH Data Access Committee via a Data Access Request. Finally, the NHGRI reserves the right to modify the AnVIL Staff Code of Conduct as needed.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NHGRI may be addressed by convening a Dispute Resolution Panel. It will be composed of three members: a designee of the ASC chosen without NIH staff voting, one NIH designee, and an ECC member with relevant expertise who is chosen by the ASC. This special dispute resolution procedure does not alter the recipient'sright to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Chris Wellington, B.S.
National Human Genome Research Institute (NHGRI)
Telephone: 301-480-3496
Email: anvil@mail.nih.gov

Ken Wiley, Jr., Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-435-5540
Email: anvil@mail.nih.gov

Rudy Pozzatti, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-402-8739
Email: pozzattr@exchange.nih.gov

Devon Bumbray-Quarles
National Human Genome Research Institute (NHGRI)
Telephone: 301-451-7928
Email: devon.bumbray-quarles@nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.