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.

No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

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

Conformance to all requirements (both in the Application Guide and the NOFO) 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. Notice of Funding Opportunity Description

Background

The human virome is defined as a collection of all viruses that are found in or on humans, including both eukaryotic and prokaryotic (bacteriophages) viruses. Excluding the relatively small number of viruses that cause obvious clinical disease, the virome is largely understudied and their molecular interactions within human hosts remain mostly uncharacterized. Whether and how virome composition and interactions impact human health and disease remains largely unknown.

The overall goal of the Human Virome Program (HVP) is to characterize the human virome, including eukaryotic and prokaryotic viruses. The HVP will also create tools, models, and methods that will enable in-depth study of the virome’s breadth and variation, its association with host factors and its influence on health and disease. It is anticipated that exploration of the human virome will provide insights into the health effects of inter-kingdom interactions (host-virome and microbiome-virome) occurring within the human body and inform future studies examining novel disease connections. The HVP consists of four initiatives that will work synergistically to achieve the goals of the program. These initiatives will be:

1. Characterizing the human virome and its dynamics by utilizing longitudinal, demographically diverse (i.e., age, sex, race, ethnicity, etc.) human cohorts (see RFA-RM-23-019).
2. Facilitating the discovery and annotation of viruses by developing tools, models, and methods that will improve detection, sensitivity, contaminant removal, and scalability (RFA-RM-23-018).
3. Studying interactions between the virome and the human host, as well as with other components of the human microbiome (see RFA-RM-23-017).
4. Creating a Consortium Organization and Data Collaboration Center (CODCC) that will serve as an organizational and cooperation hub for the HVP Consortium and external groups and through the creation of a human virome catalog and data portal (this NOFO).

Outcomes from this research program will be foundational for building a human virome atlas and translating new knowledge into the discovery of novel health- and disease-related biomarkers and potential therapeutic targets for a myriad of virally-associated human diseases.

This program is funded through the NIH Common Fund as a short-term, goal-driven strategic investment, with deliverables intended to catalyze research across multiple biomedical research disciplines. The NIH Common Fund supports cross-cutting programs that are expected to have exceptionally high impact. All Common Fund initiatives are expected to support the development of bold, innovative, and often risky approaches to address problems that may seem intractable or to seize new opportunities that offer the potential for rapid progress.

All applicants are strongly encouraged to contact NIH Staff to discuss the alignment of their proposed work with the goals of this NOFO and the HVP. 

Research Objectives and Scope

This NOFO is intended to support the Consortium Organization and Data Collaboration Center (CODCC) that will oversee HVP Consortium administration and collaboration, protocol and data standardization, data analysis, integration, and visualization for the broader scientific community to further the HVP goal of extensively characterizing the human virome. The HVP Consortium will consist of PDs/PIs and key personnel of the CODCC, scientific projects funded through other HVP funding opportunities (see companion NOFOs RFA-RM-23-017, RFA-RM-23-018 and RFA-RM-23-019), and NIH staff. Each HVP-funded scientific project will nominate a CODCC liaison who will be responsible for day-to-day interactions between their project and the CODCC. The CODCC will be responsible for working with initiative projects to standardize protocols and data across the HVP Consortium. The CODCC will be responsible for creating and maintaining an HVP Data Portal, a publicly accessible interactive dashboard with compelling visualizations and search capabilities that catalogs the tools, technologies, and methods developed by the Consortium. An important component of the HVP Data Portal will be the creation of the Human Virome Reference Dataset, a catalog and virtual repository of human virome sequences generated by the HVP and other external efforts.

Responsibilities of the CODCC

The CODCC has two main responsibilities: overseeing the organizing administration and management of the HVP Consortium as well as data acquisition, analysis and integration of HVP outputs from various consortium components. Importantly, the CODCC is responsible for the creation and up-to-date maintenance of an HVP Data Portal that contains the Human Virome Reference Dataset, a catalog of human viruses. The CODCC is expected to have demonstrated capability to work with a variety of data types and tools generated by projects from current (see companion NOFOs) and future HVP funding opportunities. The CODCC is expected to provide training, documentation, and technical support for end users within the consortium. Plans should recognize the different types and experience of users within the HVP Consortium and without. The CODCC will promote collaboration and communication among HVP investigators and will coordinate the standardization of protocols to be used in the HVP. The CODCC is responsible for coordinating outreach activities, including engaging foundations, societies, and other national and international entities with a shared interest in the human virome.

While HVP investigators will be responsible for submitting the data generated to publicly-accessible repositories (e.g., NCBI), the major purpose of the CODCC will be to facilitate, curate, and disseminate all data, metadata, analyses and visualization tools, computational models, and completed viral sequences generated by the HVP Consortium and to do so in a manner that ensures interoperability with data from other virome efforts. Compiled virome sequences are expected to be assembled into a searchable Human Virome Reference Dataset that will be made publicly accessible through an HVP Data Portal. Additionally, the CODCC will ensure that HVP reuses applicable common data elements, data and metadata standards, clinical and epidemiological data requirements, and data processing pipelines to integrate HVP into the Common Fund Data Ecosystem (CFDE). The CODCC will also coordinate HVP activities, including in-person and virtual HVP Consortium Steering Committee meetings and cross-consortium working groups and integration into the larger Common Fund Data Ecosystem (CFDE). Finally, the CODCC will promote collaboration and communication among HVP investigators and the broader research community in coordination with the Common Fund Data Ecosystem (CFDE).

Open and Controlled HVP Data Access - To the extent that information considered for inclusion in HVP, either as separate datasets or in combination with other data, triggers human subjects, privacy, or other laws or regulations, the CODCC must establish appropriate data sharing policies and data access procedures consistent with the provision of data to the public with a minimal embargo period, taking all steps needed to protect the information, and take other steps to protect the information of research participants. In addition, if the CODCC stores and permits controlled access to genomic data, the included datasets must be consistent with the NIH Genomic Data Sharing Policy (NOT-OD-14-124) and the NIH Notice for Use of Cloud Computing Services for Storage and Analysis of Controlled-Access Data Subject to the NIH Genomic Data Sharing Policy (NOT-OD-15-086), as applicable. Finally, the CODCC will be primarily responsible for developing, getting approval, and implementing any Consortium-level data sharing policies.

The NIH promotes broad and responsible sharing of genomic research data and respects the privacy and intentions of research participants. Some data generated by the HVP will be open access, which means that no authentication or authorization is necessary to access it. Other data generated will be controlled access, which means that the database of Genotypes and Phenotypes (dbGaP) authorization and eRA Commons authentication are necessary for access to this data when the data is made publicly available. Whether a dataset is open or controlled is determined according to NIH Data Access Policies in a process that is driven by informed consent of research participants. HVP is expected to use a process that provides consent for general research purposes. Decisions on which data generated by the HVP are open or controlled access will be made in conjunction with the HVP investigators, the Program Officer, and the NIH Office of Science Policy.

The HVP CODCC will be responsible for establishing a cloud-based platform aggregating, cataloging, and displaying all data generated by the HVP. The CODCC will share all HVP data within the HVP Consortium (both controlled and open access data) but will distribute open access data to the public subject to the rules and guidelines set forth by the HVP Consortium. While data submission to publicly-accessible repositories will be the primary responsibility of the data generators (e.g., HVP project investigators), the CODCC will be responsible for coordinating and facilitating the process and ensuring any controlled access data are submitted to the appropriate repository (e.g., the Genomic Data Commons, dbGaP) for distribution to the public in a timely fashion. Consequently, the CODCC will be responsible for the creation of a robust system that can distinguish between and segregate controlled-access and open-access data. Because the HVP CODCC will only distribute open access data to the public and will rely on other NIH repositories for distribution of controlled access data, the HVP CODCC will not become an NIH Trusted Partner.

Administration and Management (Including Consortium Coordination and Outreach)

• Providing the administrative infrastructure and support necessary to facilitate and coordinate all common activities of the HVP;
• Identifying an administrator(s) who will dedicate substantial effort to the administrative core activities and who will collaborate closely with the CODCC PD(s)/PI(s), NIH staff, and HVP PD(s)/PI(s);
• Establishing a Consortium working group(s) to develop common protocols and standards on specimen collection (including consent language), processing, storage, and analysis;
• Developing and maintaining an HVP Data Portal accessible through the web that will constitute the main entry point for sharing resources and information related to HVP activities;
• Implementing user-friendly approaches to navigate and access resources generated by the HVP, including protocols, data standards, biospecimen and reagent information, tutorials, analysis and visualization tools, and completed virome sequences. The HVP Data Portal should be structured in a way that allows for multiple levels of access, based on the level of confidentiality of the data, resource, or information being requested, such as "NIH Staff", "HVP Investigator" and "Public" access levels;
• Collaborating with HVP Investigators and NIH staff to ensure that all data, protocols, biospecimen and reagent information, analysis and visualization tools, and completed virome sequences generated or developed by HVP Investigators are deposited in a timely manner and made accessible to the HVP Data Portal consistent with NIH genomic data sharing policy and in a manner that allows interoperability with other human virome characterization efforts;
• Demonstrating the capacity to develop a virtual repository of biospecimens, tools, and reagents;
• Collaborating with NIH staff to organize HVP scientific meetings, including a HVP Kickoff Meeting that will occur 3 months after awarding and subsequent annual 2-3 day in-person HVP meetings. The consortium meeting will generally have 50-100 attendees and take place in the Bethesda, MD area or other areas within the country as determined by the consortium Steering Committee. All attendees will support their own travel and lodging through their funded grants except for approximately six External Program Consultants, whose travel will be supported by the CODCC;
• Arranging for and supporting travel costs of approximately six NIH-appointed External Program Consultants to the annual consortium-wide grantees meeting;
• Collaborating with NIH staff to organize and coordinate HVP governing and advisory bodies, including the HVP Steering Committee and subcommittees, HVP working groups, and external scientific panels. Managing these regular and recurring activities by organizing web-based conferences, preparing meeting agendas, taking meeting minutes, and drafting reports for the various committees, working groups, and panels to be shared in a timely fashion. Developing and making accessible to the consortium members and NIH staff all significant HVP consortium-related documents, including policies, reports, and standard operating procedures generated by the various HVP committees;
• Facilitating other HVP activities, including - but not limited to - small topical workshops, collaborations with outside groups, implementation of HVP developed policies, and consortium opinion and perspective pieces;
• Facilitating interactions with other human virome research efforts, whether supported by NIH or non-NIH partners, in coordination with the Common Fund Data Ecosystem. These may include consortia, biorepositories, databases, or non-profit organizations involved in activities relevant to the mission of the HVP. The focus should be on developing interactions that can benefit both investigators and partners of the HVP program through the sharing of data and information, expertise, and reagents, or through leveraging the coordination of research and technology development in areas of common interest;
• Managing or facilitating other outreach activities, including but not limited to, organizing sessions and tutorials at scientific meetings and managing the HVP social media presence;
• Evolving, adapting, and improving during the project period in response to the needs of the HVP community. The CODCC team should solicit user feedback and otherwise evaluate all aspects of the usability of the HVP Data Portal to best serve the needs of the HVP and broader research community. As the data generation, storage, analysis, and dissemination needs of the HVP evolve over time, the CODCC may be asked to implement modifications to its workflows as agreed upon by the HVP Investigators and NIH staff. The CODCC should be flexible and nimble in their implementation of data coordination, analysis, and outreach workflows;
• Providing NIH staff with quantitative updates on data deposition, data quality, and data usage statistics regularly and upon request.

Data Analysis and Integration (Including Data Standards, Storage, Visualization, and Dissemination)

• Developing an HVP Data Portal for user-friendly visualization of and access to HVP data (linked raw data and derived datasets), metadata, analysis and visualization tools, and computational models generated by the HVP. The web-interface should provide controlled-access to both HVP investigators and the broader scientific community;
• Ensuring the knowledge base is flexible and extensible to visualize, manage, and integrate multiple types of data, including but not limited to, genomics, transcriptomics, molecular and cellular imaging, structural data, and epidemiological and clinical data;
• Collaborating with the Virome Characterization Centers' Ethical, Legal, and Social Implications (ELSI) cores for potential return of research results and for coordinating communication strategies to allow all involved parties to report ELSI issues and feedback on ELSI measures;
• Collaborating with HVP Investigators and NIH staff through HVP working groups to reuse/establish common data elements, data standards, metadata requirements, data freezes and public release of data, clinical and epidemiological data requirements, and controlled vocabularies for all HVP data to ensure that the data are findable, accessible, interoperable, and reusable (FAIR) to ensure the data and results are maximally useful to the public;
• Collaborating with HVP Investigators to develop and implement common data submission, processing, visualization, and quality control pipelines for the diverse range of HVP datasets, as well as implementing data analysis and visualization tools at the HVP Data Portal;
• Creating a catalog of human virus sequences generated from the HVP and other external efforts called the Human Virome Reference Dataset that is accessible from the HVP Data Portal;
• Developing and sharing tutorials, detailed walkthroughs, and other materials that facilitate use of HVP-generated data by the broader scientific community;
• Facilitating data use by the broader scientific community by depositing datasets generated by HVP Investigators in appropriate unrestricted or controlled-access databases and support user-friendly access to these databases. The HVP Consortium should agree with the adoption of a minimum core group of FAIR-compliant metadata that must accompany virome data deposited in the HVP Data Portal and publicly-accessible databases;
• Collaborating with NIH staff and relevant public data/resource repositories to ensure the long-term archiving and distribution of the most important datasets and resources developed by the HVP beyond its funding period.

HVP Consortium Responsibilities

Investigators funded through awards under this NOFO and the companion NOFOs, as well as appropriate NIH staff, will constitute the HVP Consortium. In addition to completing the research goals outlined in their applications, successful applicants will be expected to work collaboratively with all members of the HVP Consortium, including the Consortium Organization and Data Collaboration Center (CODCC). The HVP Consortium will encourage the initiation of new collaborative research projects across the entire consortium.

A key aspect of this program is the formation of a consortium-type partnership amongst all HVP award recipients. Shared responsibilities derived from the use of the cooperative agreement mechanism are described in the Cooperative Agreement Terms and Conditions of Award and will be further articulated during the kickoff meeting of the HVP Consortium that will take place three months after awards are made. All HVP award recipients will be required to attend this initial HVP kickoff meeting, as well as the annual HVP investigator meetings, and other essential meetings as required by the consortium.

The Steering Committee will be the main governing body for the HVP and will be composed of PDs/PIs and key personnel from each HVP award, NIH program staff (Program Officials and Project Scientists), and the NIH HVP working group. Each of the four HVP initiatives (represented in subgroups) and NIH have a vote on Steering Committee decisions and recommendations and will be based on a majority vote. If needed, other government staff members may also participate in HVP Steering Committee meetings as non-voting members. An Executive Committee will be formed to manage the Steering Committee, and it will consist of two PD/PI chairs, other key project personnel, and key NIH officials. The PDs/PIs serving as chairs must be from two different HVP projects and will be selected by NIH staff during at the first meeting of the Steering Committee following award issuance. A third co-chair might be selected, depending on the composition and needs of the Executive Committee. The chair positions will rotate amongst the PDs/PIs every two years or as needed. NIH staff will select or approve all Executive Committee appointments.

The CODCC in consultation with NIH staff will establish and coordinate working groups to facilitate collaboration and shared interests among the HVP recipients. Each recipient is expected to participate in working groups that are relevant to their research interests. It is anticipated that recipients will identify areas of shared scientific or technological interest across the different awarded initiatives within HVP. Therefore, the companion NOFOs to this funding opportunity will support collaborative pilot projects for small-scale studies that will benefit from the expertise and/or capabilities across the HVP and that will be relevant to the broader research community. Collaborative pilot projects will be proposed by HVP investigators and approved by NIH.

Plan for Enhancing Diverse Perspectives (PEDP)

This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP) as part of the application (see Section IV.2 SF424(R&R) Other Project Information. Other Attachments). Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance material. Applications must include a Plan for Enhancing Diverse Perspectives (PEDP) submitted as Other Project Information as an attachment (see Section IV). The PEDP will be assessed as part of the scientific and technical peer review evaluation, as well as considered among programmatic matters with respect to funding decisions.

Technical Webinar for Applicants

Prospective applicants are invited to a pre-application webinar on October 16, 2023, from 12:00-1:30 PM ET. NIH staff will discuss the initiative and answer questions about the application and review process. Questions for the webinar should be submitted ahead of time to [email protected] by 11:59 PM local time on October 13, 2023. Additional questions may be taken during the webinar if time allows. Register for the webinar and join on Webex. The webinar will be recorded and posted on the Human Virome website.

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 NOFO.

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 Government

• 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) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted 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 Grants.gov registration; 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 their 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 NOFO does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 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 NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

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 NOFO. 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 How to Apply - Application Guide except where instructed in this notice of funding opportunity 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:

Emmanuel Mongodin, PhD
National Heart Lung and Blood Institute (NHLBI)
Email: [email protected]

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

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

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

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

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

Plan for Enhancing Diverse Perspectives (PEDP) (Required- 1 page maximum)

In an "Other Attachment" entitled "PEDP.pdf", all applicants must include a summary of strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity. 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 (significance, investigator(s), innovation, approach, and environment) as appropriate. Where possible, applicant(s) should align their description with these required elements within the research strategy section. 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. The PEDP may be no more than one-page in length and should include a timeline and milestones for relevant components that will be considered as part of the review. Examples of items that advance inclusivity in research and may be part of the PEDP can include, but are not limited to:

• Discussion of engagement with different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
• Description of any planned partnerships that may enhance geographic and regional diversity.
• Plan to utilize the project infrastructure (i.e., research and structure) to support career-enhancing research opportunities for diverse junior, early- and mid-career researchers.
• Plan to enhance recruitment individuals from diverse backgrounds, including groups historically underrepresented in the biomedical, behavioral, and clinical research workforce (see NOT-OD-20-031), such as underrepresented racial and ethnic groups, those with disabilities, those from disadvantaged backgrounds, and women.
• Proposed monitoring activities to identify and measure PEDP progress benchmarks.

Description of any training and/or mentoring opportunities available to encourage participation of students, postdoctoral researchers and co-investigators from diverse backgrounds. For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see the Human Virome website.

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

R&R Budget

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

The following additional budget-related information must be included:

• Funds for hosting virtual and in-person meetings
• Travel stipends and honoraria for HVP program consultants appointed by NIH
• Scholarships for travel (a minimum of $40,000 required each year)
• Other costs required for the responsibilities of the CODCC and for the proposed activities under the Research Plan
• Budget requests must include costs for the PD(s)/PI(s) and up to three other members of the HVP to attend the annual HVP Consortium Investigator meeting
• Applicants must commit at least 1.2 person months (i.e., the equivalent of 10% effort for a full-year appointment) throughout the duration of the award (applications from PD/PIs committing less than 1.2 person months for the duration of the award will not be accepted)

R&R Subaward Budget

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

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

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

A CODCC applicant should propose a research plan to implement the overall purpose, main objectives, and responsibilities of the CODCC as described in the funding description above. In lieu of the standard sections listed in the SF424 (R&R) Application Guide, the Research Strategy must consist of the following modified sections:

Section 1: Overall CODCC Vision and Management

Overview and Goals – Applicants should describe the ultimate goals/deliverables of the CODCC. Deliverables should be quantitative whenever possible and should address critical items such as:

• Establish consortium-wide protocols and standards on specimen collection (including consent language), processing, storage, and analysis;
• Develop and release HVP Data Portal;
• Establish consortium-wide consensus for data formats and metadata requirements;
• Establish consortium-wide consensus for a data release policy;
• Develop and implement data submission, processing, quality control assessment, and download pipelines;
• Establish in-person HVP Steering Committee meetings
• Implement analysis and visualization tools for HVP Data Portal;
• Implement Human Virome Reference Dataset on the HVP Data Portal; and
• Develop user manuals and tutorials for the HVP Data Portal.

It will be difficult to predict the exact volume and types of data that will be submitted over the lifetime of HVP. Thus, as the data production, storage, analysis, and dissemination needs of HVP change with time, the CODCC may be asked to implement modifications to their workflow and deliverables and applicants must demonstrate their willingness and aptitude to be flexible in their implementation of HVP coordination.

Leadership Plan: Describe the leadership team and how components of the CODCC, including key personnel, will interact within the CODCC itself, with the broader HVP, the Common Fund Data Ecosystem, and NIH program staff. Describe prior experience in working as part of a research consortium or other large-scale collaborative activities to meet individual and group goals, including examples of such prior work. Describe how decisions will be made by the leadership team and carried out. Describe mechanisms to ensure effective internal management of ongoing research activities across the CODCC.

Milestones and Progress – Applicants should define a clear set of semi-annual milestones with metrics that will document progress towards the achievement of the ultimate goals. Milestones are goals that create decision points in the project and should include clear criteria for success. Quantitative milestones are required to provide clear indicators of a project's continued success or emergent difficulties and will be used to evaluate the application not only in peer review but also in consideration of the awarded project for funding of non-competing award years. Initial milestones for the CODCC must include organization of the kick-off HVP Consortium meeting to be held three months after award date. Milestones must also include establishment of the HVP Steering Committee, Working Groups for each initiative, and sub-committees as needed (e.g., Publication Committee) by 3-6 months following the launch of the HVP program. Additional examples of milestones include, but are not limited to, tracking time to develop data standards and formats, turn-around time to release submitted data in the HVP Data Portal and Human Virome Reference Dataset, or analysis and visualization software implementation activities. CODCC applicant must also detail how HVP data, tools, and specimens cataloged on both internal and external websites will be shared and how the CODCC will coordinate a compilation report of the results from the different consortium projects to be published at the completion of the HVP. Applicants should include plans for critically evaluating and revising these milestones on a regular basis. Applicants should also describe how they will prioritize their activities to ensure that the main goals of the CODCC will be achieved. Milestones may be revised at the time of the award. Applicants should describe plans to solicit user feedback, monitor metrics of data usage, and otherwise evaluate all aspects of the usability of the CODCC. This plan should describe the frequency of these evaluations and how this information will be used to improve the utility of the CODCC.

Management and Communication Plan – Applicants should describe the plans for management and integration of the CODCC activities. Applicants should describe how it will manage the proposed project, who will oversee the day-to-day activities (e.g., a CODCC Administrator if not the PD/PI) and how the management structure will support achievement of the proposed goals and milestones. Useful elements of this description include the organization of the proposed project; its management structure; key personnel and leadership structure; and oversight mechanisms for evaluating progress towards milestones. Applicants should describe plans for ongoing communication within the CODCC and between the CODCC and other components of HVP. Plans for addressing some of the anticipated challenges of the CODCC should also be included. The plan should also describe how the various elements of the proposed production effort will be integrated, and how collaborations or subcontracts, if proposed, will be managed.

Section 2: Administration and Management (Including Consortium Coordination and Outreach)

HVP Activity Coordination – Applicants should describe an approach to provide the administrative infrastructure necessary to facilitate and coordinate all common activities of the HVP. HVP activities that will be coordinated by the CODCC will include annual 2–3-day HVP in-person meetings and focused workshops, monthly HVP virtual Steering Committee and subcommittees meetings, virtual HVP working groups, and external scientific panels. The plan should describe approaches for managing these activities through in-person or web-based meetings, developing minutes, and drafting reports for the various committees and working groups. Additionally, the plan should describe an approach to develop, maintain, and make accessible all significant HVP-related documents, including policies, reports, standard operating procedures, and a secure site for storing manuscripts from HVP investigators submitted for publication. The plan should also include approaches to facilitate interactions and collaborations with outside groups, other Common Fund-supported research efforts, other NIH supported efforts, and/or non-NIH partners. The CODCC will also be responsible for making travel arrangements for external program consultants and for providing scholarships for junior investigators and trainees to travel to the annual HVP meetings. Applications should describe how travel scholarships will be managed including, but not limited to, application submission, evaluation, and selection. It is expected that the CODCC budget a minimum of $40,000 for travel scholarships each fiscal year.

HVP Consortium PDs/PIs are required to develop and execute collaborative pilot projects with other HVP PDs/PIs during their award period using set-aside funds as outlined in their respective HVP funding opportunities. The CODCC will facilitate interactions and cooperation amongst the HVP Consortium members and should provide a plan for promoting collaboration between members that will aid in the establishment of collaborative pilot projects. Collaborative pilot projects should encourage the use of biological specimens and datasets across the HVP Consortium. Proposals for collaborative pilot projects must be reviewed and approved by NIH prior to their start.

HVP Standardization & Harmonization – Applicants should describe how the CODCC will work with HVP Investigators to develop and implement common protocols and standards for biospecimen collection, processing, and analysis and data submission, processing, and quality control for the diverse range of HVP datasets. The CODCC is expected to develop and disseminate guidelines and other material to assist HVP Investigators in standardizing their approaches and to provide support or training with emphasis on rigor, reproducibility, and consistency. The CODCC may be asked to assist HVP Investigators on analysis methods and/or conduct special analyses, such as analysis on viral diversity, characterization and discovery of novel viruses or novel elements of the human virome, or analysis of contamination.

Outreach, Documentation, and User Support – Applicants should describe a plan and allocate sufficient resources to provide outreach to the user communities to educate the community about the HVP and its data, resources, and tools. This plan should include resources for both specialists and non-specialists to make the best use of the HVP data, protocols, SOPs, computational models, and tools. Examples include presentations, short courses, or symposia offered independently or in conjunction with scientific meetings attended by the user community and social media. Provide plans to develop and update HVP CODCC user documentation on the Data Portal such as User's guides, FAQs, Troubleshooting Tips, web-based tutorials and other content to assist HVP CODCC data consumers, data providers, and general users. Describe typical user support activities to be performed by the HVP CODCC staff including, but not limited to, receiving and addressing user inquires, providing email support, maintaining publicly accessible website for helpdesk operations, providing news and announcements, hosting application use reports, frequently asked questions and troubleshooting tips, and providing summary reports of questions and responses, including frequency of inquiries and duration between inquiry and resolution as appropriate.

Section 3: Data Analysis and Integration (Including Data Standards, Storage, and Dissemination)

Data Portal Development – Applicants should describe plans for developing an interactive data portal that will constitute the primary access point and repository for sharing resources and data generated by the HVP Consortium, including protocols, data standards, biospecimen and reagent information, tutorials, analysis and visualization tools, and the Human Virome Reference Dataset. The portal will provide user-friendly submission of and access to HVP information, data (both raw data and derived datasets), metadata, analysis and visualization tools, and computational models generated by the HVP. The CODCC will link to and integrate the virome sequence data generated by the HVP through the HVP Data Portal, and as such, the HVP Data Portal will not be expected to store virome sequence data (e.g., raw sequence files). HVP-generated sequence data will be deposited and stored in an external publicly-available database (e.g., the Genomic Data Commons, Sequence Read Archive) using pipelines and quality metrics determined by the HVP Consortium. However, the CODCC is expected to store a processed version of HVP data as necessary for the purpose of visualization of the HVP data through the HVP Data Portal and creation of a searchable Human Virome Reference Dataset. The web-interface should provide access to both HVP members and the broader scientific community and should allow for multiple levels of access, based on the level of confidentiality of the data, resource, or information being requested, such as "NIH Staff", "HVP Investigator" and "Public" access levels. Applicants should describe a submission pipeline for both raw and derived datasets generated by HVP Investigators. Each submitted dataset must be assigned a unique identifier that enables subsequent tracking for submitted data of all types. This pipeline must include quality assurance steps to monitor the quality of the submitted data and metadata, along with steps to release these data and metadata to the public data portal in a timely fashion. As the identity of the actual funded projects will not be known at the time that the applications in response to this NOFO are due, applicants should provide a general submission plan. It is anticipated that most datasets handled by the CODCC will be next-generation sequencing data. There will also be associated clinical and epidemiological data. Structural and imaging data are also possible. The plan should describe how the CODCC will handle a range of data types and how the CODCC will provide the flexibility to accommodate increasing data volume and evolving data types. Applications should also describe plans to evaluate the usability of the Data Portal and to solicit user feedback to improve the Data Portal’s performance and utility. The plan should describe the capacity to scale activities as data volumes or complexity change over the course of the project. At the end of the project, the CODCC must be able and willing to transfer the HVP data and computational tools to any other informatics resource, as designated by the NIH.

The CODCC is responsible for developing and maintaining a virtual biorepository of biospecimens and reagents across the HVP. Applications must demonstrate the ability to develop and maintain a virtual biorepository of biospecimens and reagents and work with HVP Investigators to develop protocols and agreements. Applications should discuss the development of documentation and tracking for the virtual biorepository, as well as plans and timeline for testing and implementation. The virtual biorepository must be maintained and updated as new biospecimens or reagents become available or withdrawn. The CODCC will work with the HVP Consortium to develop procedures for access within and outside the HVP Consortium and will be responsible for access requests, review of requests, granting permission, and the preparation and dissemination of requested biospecimens or reagents. Annual reporting on the status and utility of the biorepository to the HVP Consortium and NIH is required.

Data Security -- Applicants should provide a plan for satisfying federal data security regulations. The HVP CODCC will be considered a federal electronic information system and as such, must meet the relevant federal regulations. This includes adopting and implementing the policies, procedures, controls, and standards of the HHS Information Security Program to ensure the integrity, confidentiality, and availability of Federal Information and the Federal Information system. The HHS Information Security Program is outlined in the HHS Information Security Program Policy, which is available on the HHS Office of the Chief Information Officer's (OCIO) Website, http://www.hhs.gov/ocio/index.html. This policy is in accordance with the Federal Information Security Management Act (FISMA).

The core data sets defined for the HVP are categorized as Federal Information Management Security (FISMA) Law. The security requirements for this CODCC implementation include, but are not limited to, preparation of an IT Security Plan, IT Risk Assessment, FIPS 199 Assessment, and performance of security control testing and evaluation. The recipients will be responsible for attaining the Authority To Operate (ATO) from the NIH Program Officer. Additionally, any proposed solutions using a commercial cloud must demonstrate an understanding of FedRAMP requirements (http://www.fedramp.gov) and describe an approach for achieving compliance if FedRAMP has not yet been achieved.

Data Storage and Access – Applicants should describe a plan for where and how all data, metadata, analysis and visualization tools, and computational models generated by the HVP will be stored. The data, tools, models, and atlases are expected to be stored on a commercial cloud. Local private servers, existing public data repositories, or a combination of these solutions can be proposed. The plan should include a description of why specific solutions are being implemented and how those advance the overall goals of the CODCC and the HVP.

The HVP CODCC will be responsible for ensuring all data generated by the HVP is archived and retrievable. However, while the HVP CODCC will host and share all HVP data within the consortium (both controlled and open access data), the HVP CODCC will only distribute open access data to the public. The HVP CODCC will be responsible for submitting any controlled access data generated by HVP to the appropriate repository (e.g., the Genomic Data Commons, dbGaP) for distribution to the public. The data storage plan should describe a system that can distinguish between and segregate controlled-access and open-access data. Applicants should include a standardized set of access methods agnostic to cloud service provider. Applicants are strongly encouraged to consider the GA4GH DRS standard, which has been adopted by CFDE-affiliated data resources.

Information Technology and Technology Development – Applicants should discuss all pertinent informatics issues involved in providing the basic IT infrastructure/system administration for the proposed project and how existing data platforms may be reused for this project. The plan should describe a framework to facilitate complex data loading including detailed experimental descriptions and metadata, especially for experimental results generated using high throughput or data-intensive approaches. The database infrastructure should be flexible and extensible to manage and integrate multiple types of data that may be generated by HVP investigators, including genomics and clinical and epidemiological data. Incremental technology improvements may play an important role in increasing the efficiency and decreasing costs for the CODCC. Applicants are encouraged to include plans for such technology development activities and subsequent use by the Consortium in their applications including, but not limited to, new software tools to improve data management or making existing software more efficient (e.g., improving sequence read alignment software or data processing pipelines). The plans for technology improvement should be well described and the cost of the proposed technology development and its subsequent implementation should be justified in terms of reducing the overall operating costs for the CODCC. Additionally, applicants should describe a plan to develop an Application Programming Interface (API) to facilitate interactions with other Common Fund data coordinating centers and components of the Common Fund Data Ecosystem.

Interactions with HVP Data Producers – Development of the HVP CODCC will require the CODCC team to work closely with HVP Investigators and NIH staff. Applicants should describe plans and strategies for facilitating interactions between CODCC team and the HVP Investigators and NIH staff to:

• Establish standardized machine-readable data formats and common data elements using well-defined formats and associated controlled vocabularies;
• Define standard experimental metadata, epidemiological data, and clinical data required to be submitted with each dataset;
• Develop data submission, processing, and quality control pipelines for all data types that will be submitted to the CODCC;
• Ensure timely and efficient transfer of data and metadata to the CODCC;
• Establish regular data freezes to quantify productivity and facilitate analysis activities; and
• Establish a public data release policy. The plan will need to be flexible and responsive in following the evolving NIH policies on data management and sharing.

Data Wrangling – The CODCC must provide mechanisms and include adequate staff to interact with the data production groups to facilitate the timely and efficient transfer of data and metadata to the CODCC. The CODCC will develop workflows and processes for the deposition of data. Applicants should describe plans for working closely with HVP Investigators and NIH staff to ensure that all data and metadata, protocols, biospecimen and reagent information, analysis and visualization tools generated or developed by HVP Investigators are deposited in a timely manner and made accessible through the HVP Data Portal and consistent with NIH Data Management and Sharing policy and the approved Data Management and Sharing Plan. 

Implementation of Analysis and Visualization Tools – Applicants should describe plans to implement analysis and visualization tools developed by HVP Investigators or CODCC investigators at the HVP Data Portal. Priority should be given to tools and software that are modular, open-source, include appropriate documentation, use standard formats for data input and output, and are considered likely to be broadly useful to HVP Investigators and the research community at large. The HVP Data Portal should be user-friendly. The CODCC will provide NIH staff with quantitative updates on data deposition, data quality, and data usage statistics regularly and upon request.

Data Export and Dissemination – Applicants should describe plans for developing an export process and pipeline to permit timely transfer of HVP data from consortium data freezes or publications to appropriate public repositories and community databases to ensure the long-term availability of HVP generated data. These repositories may include, but are not limited to, the database of Genotypes and Phenotypes (dbGAP) at the National Center for Biotechnology Information (NCBI), Biostudies at the European Bioinformatics Institute (EBI), or Ensembl at the EBI and the Wellcome Trust Sanger Institute. Regardless of where datasets are deposited, the HVP CODCC will facilitate user-friendly access to the open access HVP-generated data and metadata for the duration of the Program. Data and metadata must be available in standard formats and adhere to the FAIR principles (Findable, Accessible, Interoperable, and Reusable) to ensure the data and results are maximally useful to members of HVP and the broader scientific community.

Sustainability - As described above, NIH's vision for the CODCC is that it will become a long-term resource of high value to the larger biomedical community. It is therefore likely that the CODCC will participate and contribute to the establishment of a federated ecosystem with similar programs, such as the Common Fund Data Ecosystem. The FAIR principles will be important to adopt, follow, and contribute towards their evolution. During the lifetime of the HVP, new scientific and technological advances are likely to happen in storing, access, and computing on data. The CODCC should aim to identify, evaluate, and incorporate new data science approaches and information technologies that improve the usage, quality, and quality, cost effectiveness and sustainability of the resources. Examples include, but are not limited to, the optimization of analysis tools and workflows for cloud platforms, the adoption of new data compression methods to reduce storage costs, advances in mapping and spatial statistics approaches, tools to improve data security and protection of research participant data, and the development of tools for the parallel deployment of analysis workflows in a federated ecosystem.

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:

The Resource Sharing Plan will be evaluated as part of the Approach criterion. In the Resource Sharing Plan, applicants should indicate a statement of willingness to abide by all policies related to resource sharing developed by the HVP Consortium and approved by NIH staff. All applications should address a Resource Sharing Plan. 

For reagents, investigators are encouraged to consult with NIH program officers to determine which reagents should be deposited at NIH approved-public repositories. Resources and reagents to be shared should be released rapidly and no later than the time of publication or at the end of the award, whichever comes first.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

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

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

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.

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.

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

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

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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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.

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.

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 NOFO 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 the Office of Strategic Coordination (OSC), NIH. Applications that are incomplete or non-compliant will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described 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.

Overall Impact

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).

As a part of the overall impact score, reviewers should consider and indicate how the plan to enhance diverse perspectives affects the scientific merit of the project.

Scored Review Criteria

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.

Significance

Does the proposed CODCC  address the needs of the research consortium  that it will  coordinate ? Is the scope of activities proposed for the [Center] appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research consortium ?

Specific to this NOFO:

• To what extent d o the presented research experiences and activities demonstrate the investigator's ability to promote collaboration and successfully coordinate numerous high-impact, collaborative studies?
• To what extent does the proposed project consider unique challenges to conducting large multi-center studies, and how sufficient are  proposed plans  to address these challenges?

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the consortium ? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing collaborative research? Do the investigators demonstrate significant experience with coordinating collaborative  basic   research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their  leadership approach, governance, plans for conflict resolution, and organizational structure  appropriate for the consortium ? Does the applicant have experience overseeing selection and management of subawards, if needed?

Specific to this NOFO:

• To what extent d o the PDs/PIs have sufficient expertise in human virome research and large complex multi-omics datasets to manage and operate the CODCC as proposed?
• To what extent d o PDs/PIs have the necessary experience to develop and maintain a functional, user-friendly Human Virome Program Data Portal; create and maintain a Human Virome Reference Dataset; and manage data, metadata, and tools generated by multiple projects and institutions within the HVP Consortium?
• To what extent are the PDs/PIs and key personnel likely to be able to accomplish all objectives in a highly collaborative, fair, and flexible manner appropriate to the roles and responsibilities of the CODCC?

Innovation

Does the application propose novel [\organizational concepts, or management strategies,   in coordinating the research  consortium  the CODCC  will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of  organizational concepts, or management strategies   proposed?

Specific to this NOFO:

• To what degree are novel organizational concepts and analytical approaches (including innovative data management strategies and electronic and information technologies) proposed to support rapid and efficient integration of various data types and tools, and how likely are these to succeed and foster collaborative work across the entire HVP Consortium?
• To what extent are the proposed approaches innovative and useful for project coordination and logistical support? How likely are these innovative approaches to work in human virome research? How innovative and cost-effective are the proposed approaches?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research  consortium  the CODCC  will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the  consortium , as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the consortium  is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the consortium ? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific to this NOFO:

• To what extent will the proposed approaches enable successful administrative oversight and management of scientific activities across the HVP Consortium?
•  
• How likely w ill plans facilitate the dissemination of consortium results to the broad scientific community in a timely fashion? 
• How efficient are the proposed means of communication within the CODCC and among the different HVP projects?
• How sufficent a re plans  for establishing dedicated  biospecimen repositories for samples and resources  across many sites, and how likely are they to result in high-quality  biospecimen acquisition, storage, and dissemination?
• How feasible are the suggested timelines? 
• To what extent a re plans to monitor and evaluate biospecimen repositories and HVP Investigator submission compliance robust? 
• To what extent a re plans likely to ensure robust resource  collection and sharing across all HVP projects? 
• How adequate are the proposed informatic and statistical support and  management plans?
• To what extent a re plans for the development, security, and maintenance of the HVP Data Portal sufficient?

Environment

Will the institutional environment in which the CODCC  will operate contribute to the probability of success in facilitating the research  consortium  it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the CODCC proposed? Will the CODCC  benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

Specific to this NOFO:

• Are the currently available or novel resources proposed for   biospecimen storage scaled appropriately for HVP Consortium activities? 
• How sufficient i s the level of institutional support,  and how committed is  the institution  to participation in all expected CODCC activities?

Additional Review Criteria

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.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

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.

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (i.e., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

For [programs/projects/networks/consortia/resources] involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, 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 NOFO.

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 NOFO. Following initial peer review, recommended applications will receive a second level of review by the Council of Councils. 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.
• Compliance with data management and sharing policies.

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 2.4.4 Disposition of Applications.

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 NOFO 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: General and 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:

• Federal-wide Standard Terms and Conditions for Research Grants
• 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 will be required to complete an HHS Assurance of Compliance form (HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a condition of receiving the grant, to administer programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity, The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. 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 NOFO.

• 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.html and https://www.lep.gov.

• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/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 religious nondiscrimination laws and 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 (HHS) grant administration regulations at 45 CFR Part 75 and 2 CFR Part 200, and other HHS, 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 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 recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.

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

• Planning and conducting the operations defined by the terms and conditions of the cooperative agreement award.
• Overseeing the scientific development and management capacity of the CODCC.
• Reporting results and disseminating data and resources to the HVP Consortium and broader scientific community.
• Committing and maintaining the required effort toward the project each year.
• Agreeing to be an active participant in the HVP Consortium, including attending Steering Committee Meetings, participating in other consortium sponsored meetings and workshops, and participating in collaborative activities.
• Abiding by the governance of the HVP Consortium and all program policies and guidelines agreed upon by the HVP Steering Committee and approved by NIH Program Officials to the extent consistent with applicable rules and regulations.
• Maintaining the confidentiality of the information developed or handled by the CODCC, including, but not limited to, unpublished data, informatics tools, protocols, data analysis, confidential exchanges between members of the HVP Consortium, etc.  Refer to the Confidentiality Disclosure Agreement section below.
• Working closely with the HVP Consortium members to ensure that data, metadata, models, software, and tools developed by the HVP Consortium are deposited in the HVP Data Portal in a timely manner that is consistent with HVP Consortium policies.
• Coordinating with and leveraging, where feasible, the technology of the Common Fund Data Ecosystem (CFDE), a program that provides infrastructure to make diverse research data broadly available and to maximize their reuse and impact.
• Facilitating the public release and dissemination of results, data, resources, and other products generated by the HVP Consortium in a timely manner, consistent with achieving the goals of this program. The release and dissemination will be consistent with sharing policies and recommendations developed and approved by the HVP Steering Committee and NIH Data Management and Sharing Policy and Data Management and Sharing Plan .
• Prior to completion or termination of the CODCC, the recipient, in consultation with the NIH program staff, is responsible for ensuring all data, metadata, models, software, and completed references developed by the CODCC remain accessible to the research community.
• Organizing scientific working groups to facilitate collaborative projects and cross-testing of experimental and analytical concepts within the HVP Consortium.
• Reporting progress to the NIH Program Officials on all CODCC activities biannually. The PD(s)/PI(s) may be expected to provide additional information, outside the scope of the standard reporting requirement, as needed and requested by program staff members as requested.
• Being prepared for in-person or virtual annual site visits of NIH Program staff members and participation in the NIH-coordinated evaluation of the program.

The recipient will 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.

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

• One or more designated NIH program staff members will have substantial involvement as Project Scientist(s). Additionally, an NIH Program Director (serving as the NIH Program Official) will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.
• Specific roles and activities of NIH staff members include the following activities:
  • Serving as members of the HVP Steering Committee (NIH has one vote).
  • Assisting the Steering Committee, the HVP Consortium, and individual recipients in avoiding unwarranted duplications of effort across the HVP.
  • Assisting the recipients as a resource in facilitating their broader interactions with other NIH programs to disseminate results, tools, and models from the HVP and take advantage of existing NIH resources and infrastructures. This will specifically include acting as a liaison between the HVP and other relevant programs.
  • Ensuring that the HVP data- and tool-sharing infrastructure complies with NIH Data Management and Sharing Policy and the approved Data Management Sharing Plan .
  •  
  • Reviewing the progress of the HVP recipients (including HVP CODCC), conducting periodic site visits, and taking other actions as needed.
  • Participating in the organization of HVP meetings, specialized workshops, and webinars of the consortium.
  • Maintaining constant communication with the Common Fund Data Ecosystem.
• Progress Reviews: The annual evaluation by the Program Officer will be based on the non-competing application and progress report, center records, and assessments by the Project Scientist(s). NIH staff will review the management, performance, and utilization of the project. If concerns are identified by the Program Officer, the Project Scientist(s) will work with the PD(s)/PI(s) to develop plans to address them in the next year of support. In addition, NIH staff may conduct interim reviews of scientific progress beyond the normal yearly non-competing progress review to determine progress and may use information from progress reviews to inform future funding for the project.
• Special Reviews: Funds may be restricted pending completion of key award or consortium milestones independently of prior performance concerns. However, if concerns are identified about the performance or the management of the project, the Program Officer may conduct special reviews of the project as he/she deems necessary. NIH may engage outside experts to assist in these reviews. If concerns about the project arise and are not resolved, NIH may reduce or restrict the budget or reduce the term of support to phase out the project. In the event of long-term incapacitation of resource facilities, NIH may reduce the budget or term of support to phase out the project. Before any modifications are made, NIH staff will engage with the recipients in a positive manner and as allowed by the Cooperative Agreement mechanism to resolve performance issues in a timely manner where possible.

Areas of Joint Responsibility

The Steering Committee will be the main governing body for the HVP. The Steering Committee will be composed of HVP PDs/PIs and key personnel, NIH program staff, and the NIH HVP working group. Each of the four HVP initiatives and NIH have a vote (for a total of five votes) on Steering Committee decisions and recommendations and will be based on a majority vote. If needed, other government staff members may also participate in HVP Steering Committee meetings as non-voting members.

An Executive Committee will be formed to manage the Steering Committee and will be comprised of two PD/PI chairs, other key personnel, and key NIH officials. The PDs/PIs serving as chairs must be from two different HVP awards and will be selected by NIH staff starting at the first meeting of the Steering Committee following award issuance. A third co-chair might be selected, depending on the composition and needs of the Steering Committee. The chair positions will rotate amongst the PDs/PIs every two years or as needed. NIH staff will select or approve all Executive Committee appointments.

The HVP Steering Committee will meet monthly by videoconference or in-person annually at HVP Steering Committee Meetings or as needed.

The HVP Steering Committee will:

• Identify scientific and policy issues that need to be, or can benefit by being, addressed at the consortium level and develop recommendations to NIH Program Officials for addressing such issues.
• Ratify critical consortium issues through consensus.
• Review progress of the HVP toward meeting the overall consortium goals.
• Ensure that all HVP members utilize the resources developed by the HVP characterization centers, technology development projects, functional studies, and CODCC.
• Coordinate dissemination of consortium output to the broader research community.
• Ensure that the consortium takes advantage of existing NIH resources and programs.
• Establish, as necessary, subcommittees to ensure progress of the individual centers and the consortium.

Confidentiality

In order for recipients to fully comply with NIH and consortium data sharing policies as detailed above, all recipients will be expected to agree to a Confidentiality Disclosure Agreement (CDA) containing the following Statement of Confidentiality:

The parties fully understand the potential confidential nature of discussions and presentations and acknowledge that materials provided, and discussions held prior to and during meetings, may reveal confidential information. The parties agree to respect and maintain confidentiality of any non-public information that is received or become aware of through participation in workshops, meetings, and teleconferences associated with the NIH Common Fund sponsored grants in the Human Virome Program. Public information is classified as (a) is within the public domain prior to the time of the disclosure by the Disclosing Party/ies to the Receiving Party/ies or thereafter becomes within the public domain other than as a result of disclosure by the Receiving Party/ies or any of its representatives in violation of this Agreement; (b) was, on or before the date of disclosure, in the possession of the Receiving Party/ies; (c) is acquired by the Receiving Party/ies from a third party not under an obligation of confidentially; or (d) is hereafter independently developed by the Receiving Party/ies, without reference to the information received from the Disclosing Party/ies. The Parties will maintain this confidentiality for a period of seven years from the disclosure date or until the Confidential Information is classified as Public information based on a-d listed herein, whichever is earlier. The parties will not use such information for their personal benefit or for the benefit of their family, or associates of organizations to which they are connected or with which they have a financial involvement. Any breach of this agreement may be referred to the HHS Office of General Counsel. As to the parties’ participation in the development and conduct of these programs, the parties opinions and decisions will be based on their scientific judgment and medical or specialty expertise and will not knowingly be related to any other interest in organizations that may provide equipment, products or services to the studies.

Dispute Resolution

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right 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. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. 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 NOFOs 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 $25,000.  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 Appendix XII to 45 CFR Part 75, 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 – Award Term and Conditions 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: https://www.era.nih.gov/need-help (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: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Emmanuel Mongodin, Ph.D.
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-827-5968
Email: [email protected]

Center for Scientific Review (CSR)
Email: [email protected]

Louis Velasco
National Heart Lung and Blood Institute (NHLBI)
Telephone: 301-827-7977
Email: [email protected]

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.