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 Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the 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 (this NOFO).
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 (see RFA-RM-23-016).

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

Recent metagenomic sequencing and bioinformatic innovations provide an unprecedented opportunity to characterize the human virome and its host dynamics across diverse human cohorts and tissue types. These efforts are expected to translate into novel diagnostic biomarkers and therapeutic interventions.

The objective of this initiative is to characterize the human virome and its dynamics, utilizing longitudinal, diverse human cohorts. This initiative aims to characterize the viruses that comprise the human virome and provide an accurate estimate of its richness and complexity across multiple tissue types and distinct anatomical body sites.

To organize and standardize efforts to characterize the human virome, this NOFO aims to establish the Virome Characterization Centers (VCCs).

The VCCs will:

• Utilize an adequate number of samples for each sub-initiative to have sufficient statistical power to test the study hypotheses and the significance of experimental findings.
• Identify eukaryotic and prokaryotic viral composition within diverse human populations, including multiple cohorts across age, ethnicity, sex/gender, and geographic location in people without evidence of overt disease, by accessing well characterized and phenotyped cohorts.
• Collect, process, and analyze the virome and human fractions of each sample and determine the relationships between the virome and other components of the host.
• Efficiently study the human virome across tissues by planning for the collection and use of biospecimens from at least two anatomical priority sites. Six anatomic sites have been identified as priorities: blood; respiratory tract; gastrointestinal and urogenital tracts (including urine and stool); oral cavity; central nervous system (sampling cerebrospinal fluid); and skin (including hair follicles). Other biospecimens of interest include tears and breast milk. Applicants should propose a minimum of two priority sites but may propose additional sites for later investigation. In these cases, it is recommended that applicants consider staggering the introduction of these additional projects based on prior experience, preliminary results, resources and personnel, and synergy with other projects. A scale-up period may be proposed to take place after the initial setup phase of the VCC is complete (described below).
• Categorize virus taxonomy (eukaryotic and/or prokaryotic/bacteriophage) and characterize newly identified viruses.
• Determine factors that influence virome composition and its host dynamics.

It is expected that by the end of the five years of funding, the HVP Consortium as a whole will provide an assembled HVP database representing viruses from diverse cohorts in terms of demographics and health status, multiple anatomical body sites, multiple geographical locations, and other variables. All VCCs will be funded as Cooperative Agreements, and the NIH will exercise discretion and selective funding post merit review in order to ensure a comprehensive coverage of the priority sites.

In coordination with the consortium Organization and Data Coordination Center (CODCC), a setup phase will be implemented during the first 4-6 months of the Center grants to facilitate harmonization between the VCCs and to establish overall consortium policies. These efforts will include developing standards for sample collection, processing, and storage; defining appropriate cohort characteristics; and data acquisition procedures and system interoperability. As such, all Investigators involved in the VCC must actively participate as members of the HVP Consortium across the five years of provided funding. Communication across the VCC, between recipients, and with the CODCC is essential to ensure consistency in protocol execution, sample collection, and data quality. Each VCC should establish a CODCC liaison to facilitate these cross-consortium activities.

Virome Characterization Centers (VCC) Organization

This NOFO uses the multi-component U54 mechanism. Each VCC will include five cores:

• Administrative
• Biospecimen Collection
• Biospecimen Analysis
• Data Analysis and Submission
• Ethical, Legal, and Social Implications (ELSI)

Each Core should have a well-defined and distinct function as described below and be synergistic without being highly inter-dependent. The different Cores should also be integrated to achieve the overall goal of the VCC.

Administrative Core

Each VCC will be required to establish an Administrative Core, which will collaborate closely with its own and other VCCs Data Analysis & Submission Cores and the HVP CODCC to develop harmonious Standard Operating Practices, to evaluate novel approaches to assessing the human virome (especially as developed by projects in the Developing Novel and Innovative Tools to Interrogate and Annotate the Human Virome initiative), and to coordinate activities with other HVP Consortium groups. More specifically, the Administrative Core, in addition to completing the research goals outlined in their own applications, will work collaboratively with all members of the HVP Consortium to contribute to developing metrics for data generation and metadata standards, participate in cross-site studies, engage in cross-training, and guide development of data analysis and visualization tools that can be used by the broader scientific community.

The Administrative Core led by the contact PD/PI of the VCC must demonstrate experience in managing complex multi-disciplinary teams involved in eukaryotic and prokaryotic virus isolation from multiple sites, viral sequencing, and virus characterization or related expertise. Each VCC Administrative Core will be responsible for Center activities, including but not limited to: supervising, managing, coordinating, and monitoring Center progress, activities, milestones and timelines; overseeing the Project Management and Staffing Plan, including scientific and fiscal flexibility considerations; overseeing the Data Management and Sharing Plan; administering and overseeing Collaborative Pilot Projects in accordance with consortium policies; the implementation of the Plan for Enhancing Diverse Perspectives; and communicating with NIH staff.

Other responsibilities of the Administrative Core include coordinating various components of the VCC, coordination with other VCCs, and facilitating communication and coordination with the HVP CODCC to ensure timely submission of data collected in accordance with the agreed Standard Operating Procedures (SOPs) and Common Data Elements (CDEs) as approved by the HVP Steering Committee.

Data generation, quality assessment, and submission of data and metadata by each VCC will be assessed by the Steering Committee of the HVP Consortium for meeting goals and milestones.

Biospecimen Collection Core

The primary objective of the Biospecimen Core is in the collection and processing of samples from existing cohorts to be used in isolating and characterizing the human virome according to the standards established by the HVP Consortium, and the Steering Committee of the CODCC. Applicants must have access to, or the ability to obtain, human samples of sufficient quality along with extensive metadata from individuals with diversity in gender, race, socio-economic status, geography, and other relevant diversity parameters. Biospecimen samples should represent the human lifespan and cohorts with the following age ranges are envisioned (birth-5, 6-12, 13-25, 26-60, 61 and above).

The Biospecimen Core in collaboration with the Administrative Core should establish the study cohort including potential recruitment and obtaining participant consent. This Core will also be responsible for coordinating with other VCCs and the CODCC in the harmonization of cohort characteristics.

Cohorts should strive to have participants with an absence of overt disease or to be of a certain health status as established by the HVP Consortium, incorporating physiological, and mental well-being. The cohort of cohorts will be assessed programmatically so that there is not an over-representation of certain diseases or conditions, and that participants are aligned with the average health of the U.S. population.

Preference will be given to applicants having demonstrated access to longitudinal cohort samples and phenotypic data. While the NIH recognizes that a statistically significant analysis of variability among multiple samples with the stated criteria might not be achieved within the time frame of the grant, it strongly encourages the inclusion of as much diversity as possible so that the human virome database captures this heterogeneity, as well as commonalities among groups.

The types of biospecimens collected, including clinical pathology when relevant, and the frequency and the methodology used will depend on the specific types of analyses to be performed, but at least will conform with SOPs established for the HVP Consortium as a whole during the first year of the project. In order to maximize the utility of data generated by the HVP Consortium, VCCs are strongly encouraged to establish consents during the setup phase that (a) explicitly allow open (non-restricted) data sharing and (b) allow sharing samples with other HVP-funded groups, as well as other NIH-funded projects of related scope.

The leadership of the Biospecimen Core is responsible for ensuring relevant expertise, and the Core should develop specific, quantitative annual milestones for collecting, processing, annotating, preserving, and classifying biospecimens. Biospecimen collection, preservation and quality management will be assessed by the Administrative Core for meeting the goals and milestones established by the HVP Steering Committee. Depending on the quality and quantity of biospecimens collected, the collection core is expected to share these samples within the consortium for cross-validation efforts.

Applicants must be able to perform comprehensive characterizations of the quality of human biospecimens and describe plans for biospecimen management and minimization of sample degradation. The VCCs should take the lead for establishing best practices for collection and preservation of samples from each proposed anatomical site to be assessed. The Biospecimen Core of each VCC will work closely with similar Cores from other VCCs, the CODCC, as well as other groups working on similar challenges, such as the Global Virome Project and other NIH or federally funded grant recipients. The Biospecimen Cores of the HVP will establish best operating practices for biospecimen management throughout the HVP Consortium. VCCs are strongly encouraged to plan a prospective collection strategy, including collection of appropriate epidemiological and anatomical data alongside data on specimen collection. VCCs are strongly encouraged to identify robust biological and statistical rationales for sampling decisions from human donors such as temporal sampling across the lifespan. The VCCs will implement accepted best practices for collection and preservation of samples, adapting them as needed for consortium-wide use. VCCs are strongly encouraged to develop enrollment criteria that will minimize the risk of abnormal or degraded tissue and pursue broad donor consent for unrestricted sharing of data for research purposes to maximize the utility of biospecimens and data.

Some of the challenges that the core will need to address include:

• Developing a clear and common protocol on how to collect tissues and biospecimens, or if it is a repository, collect all metadata and information on how samples were collected;
• Identifying availability of existing samples from donors, especially specimens not readily collected in routine schedules. Fresh tissue from enrolled participants, and the possible use of rapid autopsy, donors and biobanks should be explored;
• Capturing and preserving whole viruses and viral nucleic acids and proteins in biological samples. This will include preserving the whole biospecimen in such a manner that the biospecimens have not been processed to remove the phage signal;
• Optimizing among all VCCs the best operating practices for pre-analytical handling and processing of biospecimen samples- it is acknowledged that there could be more than one processing protocol;
• Characterizing and minimizing degradation of samples during specimen collection, pre-analytical processing, storage and shipping. Particular attention should be placed on reducing RNA degradation during sampling and extraction;
• Collecting biospecimens and experimental metadata in a consistent and interoperable format using existing, established ontologies and standards where appropriate;
• Providing a strong rationale/statistically-powered calculations for sample size and presenting evidence that the project has access to the necessary sample size and/or the means to collect additional samples.

Biospecimen Analysis Core

The primary objective of the Biospecimen Analysis Core is to provide high resolution state-of-the-art molecular and cellular interrogation of biospecimens for the purpose of identifying existing eukaryotic and prokaryotic viruses (replicating and integrated), viral particles, proviruses, and viral proteins, and to characterize viruses that will contribute to building the human virome database. The Biospecimen Analysis Core will generate high resolution, high content, high-throughput biomolecular data to discover viruses contained within human tissues and biospecimens.

The responsibilities of the Biospecimen Analysis Core include establishing and optimizing SOPs for the collection of relevant metadata, including validation and benchmarking of assays, and generating high quality data using multiple assays with metrics for data quality control, reproducibility, and virome variation. Assays should be capable of assessing biospecimens for the purpose of characterizing the virome using a multi-scale and multi-dimensional approach. Other Cores of the VCC are expected to work with the Biospecimen Core to set up a framework for collecting high quality biospecimens in a consistent manner from human subjects, possibly including biobanks, as well as surgery and early autopsy materials, with a strong rationale for the sampling approach and collection of appropriate metadata that will enhance the utility of data.

The Biospecimen Analysis Core will also work closely with the Data Analysis & Submission Core and CODCC on topics such as providing data in consistent formats with sufficient metadata describing the origin and nature of the biospecimen from which viruses are located, details of collection and pre-analytical processing, details of the assays performed, and any filtering of the data performed prior to submission to the central CODCC. The Biospecimen Analysis Core needs to be flexible and agile in their data collection strategies such that new technologies introduced through technology development projects or related virome characterization projects (functional studies) might be quickly tested, validated, and adopted over the course of the grant.

The Biospecimen Core will identify and characterize the components of the human virome including, but not limited to:

• Sequencing (including shotgun whole genome, 16S rRNA, and RNA sequencing);
• Determining initial viral tropism (cell types and anatomical sites where virus is found). Interactions of virus with host factors will be assessed in collaboration with the HVP Characterization of Functional Interactions Between Viruses and Human and Microbial Hosts projects (RFA-RM-23-017);
• Imaging with the goal to use technologies and analytical tools that permit spatio-temporal visualization and identification of viruses within cells and their environment in vivo and ex vivo.

Some of the key challenges that the Biospecimen Analysis Core is expected to address include, but are not limited to:

• Integration, automation, benchmarking, and validation of sequencing, imaging, and omics assays;
• Characterizing and reducing technical variation of common assays between VCCs;
• Assessing technical versus biological noise/variations;
• Adapting appropriate quality control practices, such as identifying and analyzing missing, incorrect, or sparse data;
• Annotating and defining multiple viruses within data identified in various cell types and with their extracellular environments;
• Establishment of collaborative arrangements with the CODCC and HVP Consortium to ensure the data produced are compatible, harmonized, and interoperable with other NIH-funded efforts focused on human virome characterization.

Data Analysis & Submission Core

The primary objective of the Data Analysis & Submission Core is to construct the human virome database produced by the VCC and making it available to the scientific community through submission to publicly-available data repositories. The Data Analysis & Submission Core will be responsible for data annotation, curation, analysis, and submission to public repositories (with help and guidance from the HVP CODCC as needed). It will also be responsible for building datasets from the data generated by the Biospecimen Analysis Core, including the registration of the data with respect to characteristics of the identified viruses, sample preparation, analyses, identification and annotation of cell types and extracellular compartment, and preparing different datasets for sharing through public data repositories. Demographics related to each biological specimen should also be captured in the record of data.

The Data Analysis & Submission Core should include a robust computational capability and is strongly encouraged to use existing software packages and analysis methods that would enhance scientific rigor, reproducibility, and usability. The Data Analysis & Submission Core will also work closely with the other VCCs and the CODCC to develop and implement Consortium-wide open data and metadata standards, data quality metrics, common data elements, integration of imaging and omics data, and analytical tools for annotation.

Roles of the Data Analysis & Submission Core include ensuring that data are collected and submitted to public repositories conforming with the agreed practices and principles of the Consortium including SOPs, CDEs and the Consortium's data sharing policy. In addition, each individual Data Analysis & Submission Core will be responsible for cross-validation of assays within and across VCCs and interpretation of data generated by that VCC.

The Data Analysis & Submission Core will design and conduct at least one preliminary study in collaboration with the HVP Characterization of Functional Interactions Between Viruses and Human and Microbial Hosts projects (RFA-RM-23-017) to further validate functional characteristics of identified viruses.

Deep analytical capabilities in computation and Artificial Intelligence are expected to facilitate data analysis. A strong computational capability is expected to be part the Data Analysis & Submission Core.

Ethical, Legal, and Social Implications (ELSI) Core

The primary objective of the ELSI core is to protect participants, investigators, and NIH staff in matters of privacy, safety, and legality by providing guidance on ELSI and policy issues. Functions of the ELSI core will span across the VCCs and Consortium in coordination with the CODCC.

ELSI experts should be involved in administrative and planning matters and closely work with the Administrative Core. This core should also plan and implement procedures put in place to prevent and mitigate incidents such as adverse events, discrimination, and mistreatment of participants.

Responsibilities of the ELSI Core related to participant safety include working closely with the IRB and the Biospecimen Core, such as reviewing and providing assistance with informed consent documents. This includes ensuring clarity and brevity of informed consent documents and that participants understand provisions in the informed consent documents. In the interest of maintaining participant privacy, the ELSI core will work closely with the Biospecimen Analysis Core and the Data Analysis & Submission Core on key issues such as:

• Filtering human contamination (i.e., uniquely identifiable genomic sequences belonging to sample donors from processed samples).
• Keeping up to date on technological advances that would make it possible for publicly available data to be traced back to enrolled participants.
• Perform research on potential risks to people, including the potential uses of data and the application of the Genetic Information Nondiscrimination Act (GINA) to HVP data.

The ELSI core will also assist the Data & Submission Analysis core in the return of results to participants. The nature and amount of information to be reported back to those recruited should be discussed and coordinated across the HVP Consortium in accordance with NIH and Federal clinical studies and human subjects research protection policies (https://grants.nih.gov/policy/humansubjects/policies-and-regulations/research-guide-notice.htm).

Lastly, the ELSI Core is responsible for setting up modes of communication to allow all involved parties to report ELSI issues and feedback on ELSI measures (such as providing an email address for all such correspondences).

Other VCC Application Considerations

There are a number of additional issues that applicants should consider when crafting their applications.

• Collaborative Pilot Projects: Each VCC will be required to set aside $250,000 in funding each year in project period years 3, 4, and 5 to support multiple collaborative pilot projects that support research that capitalizes on new findings, validates new tools, methods, or approaches, and/or to determine additional functional characteristics of novel viruses. These pilot projects must be in collaboration with members of other HVP Consortium projects and must be evaluated and approved by the NIH prior to initiation. Each PD/PI can contribute a maximum of $50,000 to a single collaborative pilot project, and projects can last no more than two years.
• Governance of the HVP Consortium: The grants funded under this NOFO will be cooperative agreements (see Section VI. 2. Cooperative Agreement Terms and Conditions of Award). Close interactions among the award recipients and NIH will be required to maintain this complex program. All components will be governed by the HVP Steering Committee (see Section VI: Terms and Conditions of Cooperative Agreement).
• Performance Requirements: The grants funded under this NOFO shall meet yearly milestones (as defined by investigators and NIH Program Officials at the time of award) and cooperatively interact with and actively seek input from NIH.
• Evaluation of the Program: As the efficiency of the funded research is an important priority for NIH, representatives from all grant projects will be expected to participate in an external evaluation process of the HVP coordinated by NIH Program Staff (see Section VI: Terms and Conditions of Cooperative Agreement).
• Consortium Funding Opportunities: VCC applicants are encouraged to read the Consortium Organization and Data Coordination Center (RFA-RM-23-016), Characterization of Functional Interactions Between Viruses and Human and Microbial Hosts (RFA-RM-23-017), and Human Virome Project: Developing Novel and Innovative Tools to Interrogate and Annotate the Human Virome (RFA-RM-23-018) funding opportunities for more information regarding other aspects of the HVP Consortium.

Incomplete Applications

The following types of applications are incomplete and will not be reviewed:

• Applications that do not address all sub-sections described in the Research Strategy instructions (see Section IV.2: Content and Form of Application Submission - PHS 398 Research Plan).

Non-responsive Applications

Applications addressing the following topics will be deemed non-responsive and will not be considered for review:

• Projects that focus solely on mechanistic studies aimed at understanding biological processes and functional studies that will not result in characterizing virome attributes.
• Projects proposing to use non-human samples or human biospecimens with a large percentage of diseased or dysfunctional characteristics.
• Projects that propose to assess less than two priority sites.
• Projects that do not propose all the required components of the VCC organization as described.
• Projects that fail to focus on characterizing the virome within the context of the human host. For example, studies that aim to characterize phage present in individual microbiota that may be components of the human microbiome (as identified in previous studies) but are not being considered as part of the human host samples under assessment.
• Projects with restrictive patient/donor consent forms that will hinder broad sharing of data and specimens.

HVP Consortium Responsibilities

Investigators funded through grants 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) (RFA-RM-23-016). 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 investigators 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 will establish and coordinate working groups to facilitate collaboration and shared interests among the HVP award 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, this NOFO 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. The collaborative pilot projects for investigators in the Virome Characterization Centers will be proposed during the second, third, and fourth years of the project period and initiated in the third, fourth, and fifth years of the project period. 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 Governments

• Eligible Agencies of the Federal Government- including the NIH Intramural Program
• U.S. Territory or Possession

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 his/her organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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

2. Cost Sharing

This 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.

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 or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this NOFO. See the administrative office for instructions if planning to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed in this notice of funding opportunity to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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:

Roberto Flores-Munguia, PhD, MPH
National Institute on Aging (NIA)
Email: [email protected]

Page Limitations

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

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing a multi-component application.

Revision applications must include an Overall component and the components that are affected by the revision. Therefore, the component requirements listed below may not apply to the revision application.

The application should consist of the following components:

• Overall: required, minimum 1, maximum 1
• Administrative Core: required, minimum 1, maximum 1
• Biospecimen Collection Core: required, minimum 1, maximum 1
• Biospecimen Analysis Core: required, minimum 1, maximum 1
• Data Analysis & Submission Core: required, minimum 1, maximum 1
• Ethical, Legal, and Social Implications Core: required, minimum 1, maximum 1

Overall Component

When preparing the application, use Component Type Overall .

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

SF424(R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall)

Follow standard instructions.

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.

Project/Performance Site Locations (Overall)

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research and Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this NOFO) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

Leadership Effort Commitment: The VCC contact PD/PI must commit and maintain through the life of the award a minimum of 2.4 person-months of effort. For applications with multiple PDs/PIs, a minimum effort of 1.8 person-months is required for the Contact PD/PI and 1.2 person-months of effort for each additional PD/PI is required.

VCC Program Manager: Based on the complex roles the VCC will play within the HVP, the VCC PD(s)/PI(s) are strongly encouraged to propose and budget for a VCC Program Manager to manage day-to-day operations and work with the other HVP PD(s)/PI(s), NIH staff, and HVP Investigators to manage and coordinate HVP activities.

Travel Funds: The budget should include sufficient funds to support travel for PD(s)/PI(s) and pertinent members of the Center to attend annual HVP Consortium meetings and workshops.

Collaborations: It is anticipated that recipients will identify areas of shared scientific or technological interest across the different awarded initiatives within the HVP Consortium. Therefore, this NOFO 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 during project years 2, 3, and 4 and performed in years 3, 4, and 5. Each proposed pilot project must be able to be completed within 1-2 years and may not receive additional funding beyond this 2-year time frame. Center budgets must include a minimum of $250,000 in direct costs to support several collaborative pilot projects of up to $50,000 in direct costs each year. Collaborative Pilot Projects will be identified, selected, and supported through the Administrative Core of the VCC. Scientific review and approval of all pilot projects by NIH Program staff is required prior to funding and study implementation.

Equipment: If pieces of specialized equipment or computers exceeding $5,000 are requested, the application must provide a clear justification for the purchase in Budget Justification.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.

Specific Aims: Specific Aims should address the three subsections described below:

• Overall VCC Research and Management Strategy
• Goals and Milestones
• Resource Sharing Plan

Research Strategy:

• Provide an overview of the structure of the VCC.
• Describe the vision and goals of the VCC and how these contribute to accomplishing the overall goals of HVP.
• Describe the VCC goals and how they relate to characterization of the virome within diverse participants across multiple priority anatomical body sites.
• Provide goals and milestones for the entire VCC. The applicant must provide a detailed description of the VCC's vision and organization. In lieu of the standard sub-sections listed in the SF424 (R&R) Application Guide, the Research Strategy must consist of the following modified sub-sections:

Virome Characterization Center Research Strategy: Provide a description and rationale for the major theme and structure of the VCC, its goals and objectives, and background information to provide feasibility of accomplishing these goals. Describe the access to samples and data of previously established longitudinal cohorts, the ability to recontact cohort participants, and the assays to be deployed. Describe the timeline for the VCC and include a required setup phase within the first six months of the project start date. Highlight when each Core will start, the rationale for this timing, and the ramping up of protocols. Provide plans for activities to be performed during the setup and scale-up phases of HVP and how the VCC will lay the groundwork for longer-term plans, including how the work may be expanded to include additional and wider range of sites and donors. In addition, propose a plan for coordination and collaboration within the Consortium, including with other VCCs, Consortium initiatives, and the CODCC. Describe synergies and possible collaborations with the wider research community that could enhance the productivity of the VCC.

Virome Characterization Center Management Strategy: Without duplicating information present in the biosketches, applicants should provide evidence of successful management of large, multi-component programs and prior experience with generating significant, high-quality data as part of a Consortium. In addition, the overall strategy should describe how the skills of individual team members will translate into the collective capability of the VCC, how the team brings complementary multidisciplinary scientific expertise required for the integration of data, and how the diverse expertise of the team members increases the capability of accomplishing the goals of the HVP.

Goals and Milestones: Applicants should define a clear set of annual milestones for the proposed project that are consistent with the goal of developing a HVP resource database of well characterized resident viruses found in or on humans. Explain the overall strategy for achieving the goals and objectives of the VCC and how the different components of the VCC will interact to achieve these goals. Specifically, applicants must provide a timeline with milestones and details of how the VCC will ramp up data generation and analysis during the funding period. The applicant should also describe metrics associated with evaluating achievement of milestones and what action will be taken, and when, if a milestone is not met or is significantly delayed. Applicants should describe how they will prioritize their activities to ensure that the goals of HVP will be achieved. Milestones may be revised at the time of the award and yearly, as described in the terms and conditions of a Cooperative Agreement below.

Letters of Support: Provide all letters of support that are appropriate, including any letters of support from institutional officials. Letters should address the commitment of the parent organization or any of its partners to the VCC and its goals. The parent institution is expected to provide documented evidence of space dedicated to the needs of the VCC, protected time to devote to VCC activities, staff recruitment, dedicated equipment, or other financial support for the proposed VCC. Both the parent institution and pertinent departments should provide assurance of their commitment to the VCC.

If collaborative linkages are being developed between the VCC and other centers in related areas, a letter of agreement from the collaborating Center PD(s)/PI(s) should be included. Do not provide letters of support from individuals who will not be directly involved in the Center's research activities.

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.

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. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component.

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.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form (Overall)

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

Administrative Core

When preparing your application, use Component Type Administrative Core.

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

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Project /Performance Site Location(s) (Administrative Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Administrative Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Administrative Core)

Budget forms appropriate for the specific component will be included in the application package.

Leadership Effort Commitment: The VCC contact PD/PI must commit and maintain through the life of the award a minimum of 2.4 person-months of effort. For applications with multiple PDs/PIs, a minimum effort of 1.8 person-months is required for the Contact PD/PI and 1.2 person-months of effort for each additional PD/PI is required.

Travel Funds: The budget should include sufficient funds to support travel for PD(s)/PI(s) and pertinent members of the Center to attend annual HVP Consortium meetings and workshops.

Equipment: If pieces of specialized equipment or computers exceeding $5,000 are requested, the application must provide a clear justification for the purchase in Budget Justification.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Administrative Core)

Specific Aims: State the specific aims for the Administrative Core and provide a rationale and description of how each aim enhances the operation of the Center and its value to the HVP.

Research Strategy: In lieu of the standard Research Strategy sub-sections (Significance, Innovation, Approach), use the sub-sections defined below to explain how the Administrative Core will effectively administrate and coordinate the Center's activities:

Leadership Plan: Describe the leadership team and how components of the VCC, including key personnel, will interact within the VCC itself and with the broader HVP Consortium 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 VCC and participation in consortium activities such as teleconferences, development of SOPs etc. Describe plans for soliciting, selecting, and administering pilot projects. Describe how synergy and integration within the VCC and with the other VCCs will be fostered. The parent institution should provide assurance of its commitment to continuing support of the VCC in the event of a change in directorship and a well-defined succession plan should be in place.

VCC Coordination Plan: Provide an overview of the VCC organization, including coordination and interactions between the different VCC Cores. Describe the lines of responsibilities, including, as applicable, the effort distribution across the participating institutions. Describe how the Administrative Core will manage and coordinate communication, day-to-day activities, and collaborations within the VCC. Describe plans for assessing progress of the VCC to meet its goals and milestones. Describe and, preferably, demonstrate through presentation of preliminary data strategies for how the components of the VCC will work together to minimize confounding variables in data generation.

Consortium Coordination Plan: Describe plans for collaborating with other HVP sites and NIH program officials to design or improve Consortium operations and implement protocols. Describe plans to work with the CODCC to optimize strategies for data collection and analysis and to facilitate public access of HVP data. Describe plans for collaborating with other VCCs on topics including, but not limited to, SOPs, assay protocols, consent materials and data analysis. State willingness to adhere to Consortium wide policies and procedures established by the NIH and the HVP Steering Committee, including data access, publication, and intellectual property policies. Applicants should also describe plans for, and willingness to abide by, Memoranda of Understanding and other sharing agreements potentially needed for data and biospecimen sharing within the Consortium and other related programs.

Letters of Support: Provide all letters of support that are appropriate for this core, including any letters of support from institutional officials. Letters should address the commitment of the parent organization, or any of its partners, to the VCC and its goals. If collaborative linkages are being developed between the VCC and other centers in related areas, a letter of agreement from the collaborating Center PD(s)/PI(s) should be included. Do not provide letters of support from individuals who will not be directly involved in the Center.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

Biospecimen Collection Core

When preparing your application, use Component Type Administrative Core.

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

SF424 (R&R) Cover (Biospecimen Collection Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Biospecimen Collection Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Biospecimen Collection Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Biospecimen Collection Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Biospecimen Collection Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Biospecimen Collection Core)

Budget forms appropriate for the specific component will be included in the application package.

Leadership Effort Commitment: The Core Leader of this core must devote a minimum of 1.8 person-months of effort to the Biospecimen Collection Core of the HVP. For applications with multiple Core Leaders, a minimum effort of 0.8 person-months is required for the Contact PD/PI and 0.6 person-months of effort for each additional Core Leader is required.

Travel Funds: The budget should include sufficient funds to support travel for PD(s)/PI(s) and pertinent members of the Center to attend annual HVP Consortium meetings and workshops.

Equipment: If pieces of specialized equipment or computers exceeding $5,000 are requested, the application must provide a clear justification for the purchase in Budget Justification.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Biospecimen Collection Core)

Specific Aims: State the specific aims for the Biospecimen Collection Core and the general approach to sample collection, handling, storage, and distribution. A minimum of two priority anatomical sites should be chosen, with feasibility and access to samples indicated as well as a plan for ramping up efforts.

Research Strategy: Applications should highlight aspects of the proposed activities that speak to the significance and innovation of the approach. In lieu of the standard Research Strategy subsections (Significance, Innovation, and Approach), describe the activities of the Biospecimen Collection Core using the sub-sections listed below.

Cohort Characteristics: Describe the level of access to a source of relevant human samples (i.e., from ongoing or previous well-characterized clinical or observational studies, post-mortem samples, or other approved sources) immediately upon award. Provide a description of the cohort, available samples, and ability to recontact and reconsent participants. With a goal of identifying common and rare viruses within a collection of heterogeneous samples, describe how the selection of subjects will favor diversity, through the inclusion of individuals of both sexes, and multiple ethnicities, and geographic status. Virome Characterization Centers are strongly encouraged to develop enrollment criteria that will minimize the risk of abnormal or degraded tissue. Applicants are also encouraged to consider Ethical, Legal and Social Issues (ELSI) of tissue collection and, if appropriate, to consider return of results to donors or their families in coordination with the ELSI Core.

Sample Acquisition Pipeline: Describe the type, volume, source, frequency, and sampling approach for human biospecimen collection, including biological, technical, and statistical power justification. Provide details of the number of samples, including tissue types, that can be acquired and processed each year. Virome Characterization Centers are strongly encouraged to identify robust biological and statistical rationales for sampling decisions, for example, whether to focus on intra-individual sampling, inter-individual sampling across the lifespan, or temporal sampling. Describe how the Biospecimen Characterization Core will interact with other arms of the Consortium to establish Consortium-wide best-practices for collection and preservation of tissues, quality control practices, and assembly of specimen metadata for downstream interrogation and analysis. Describe quality assurance and quality control metrics that will be developed and/or employed to protect biospecimens from factors that could influence specimen integrity (i.e., temperature, humidity, light, structural quality) and to ensure high sample quality upon shipping.

Informed Consent: Provide details about the breadth of informed consent to be obtained from donors; biospecimens will potentially be analyzed or re-analyzed later in the consortium using new and cutting-edge assays and data tools that will be introduced after award, so careful attention must be paid to the design of donor consent forms at the time of specimen collection to allow for unrestricted sharing of data for research purposes. Consent forms that allow for the broadest possible data sharing are strongly encouraged to maximize the utility of biospecimens and data. The strongest applications will have a broad data sharing consent and, conversely, restrictive data sharing plans will be considered as a negative feature of the application.

Letters of Support: Provide all letters of support that are appropriate for this core, including any letters of support from institutional officials. Letters should address the commitment of the parent organization, or any of its partners, to the VCC and its goals. If collaborative linkages are being developed between the VCC and other centers in related areas, a letter of agreement from the collaborating Center PD(s)/PI(s) should be included. Do not provide letters of support from individuals who will not be directly involved in the Center's research activities.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Biospecimen Collection Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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.

Biospecimen Analysis Core

When preparing your application, use Component Type Administrative Core.

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

SF424 (R&R) Cover (Biospecimen Analysis Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Biospecimen Analysis Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Biospecimen Analysis Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Biospecimen Analysis Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Biospecimen Analysis Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Biospecimen Analysis Core)

Budget forms appropriate for the specific component will be included in the application package.

Leadership Effort Commitment: The Core Leader of this core must devote a minimum of 1.8 person-months of effort to the Biospecimen Analysis Core of the HVP. For applications with multiple Core Leaders, a minimum effort of 1.5 person-months is required for the Contact PD/PI and 1 person-months of effort for each additional Core Leader is required.

Travel Funds: The budget should include sufficient funds to support travel for PD(s)/PI(s) and pertinent members of the Center to attend annual HVP Consortium meetings and workshops.

Equipment: If pieces of specialized equipment or computers exceeding $5,000 are requested, the application must provide a clear justification for the purchase in Budget Justification.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Biospecimen Analysis Core)

Specific Aims: The Biospecimen Analysis Core is at the core of the activities of the VCC, and it should effectively and efficiently contribute to the overall objectives of the VCC and HVP. State the specific aims for the Biospecimen Analysis Core and provide a rationale and description of how each aim addresses a specific aspect of characterizing of viruses from the chosen anatomical sites. A minimum of two should be chosen with a plan for ramping up efforts for each additional site being assessed.

Research Strategy: Applicants should highlight aspects of their proposed activities that speak to the significance and innovation of the approach. In lieu of the standard Research Strategy subsections (Significance, Innovation, and Approach), describe the activities of the Biospecimen Analysis Core using the sub-sections listed below.

Biospecimen Management: Provide an overview of how the Biospecimen Analysis Core will interact with the Biospecimen Collection Core to collect and analyze biospecimens in a manner that reflects the expected diversity of samples, consistent with the goal of the VCC.

Characterization Pipeline: Provide a general overview of the assays that will be deployed and the various data types that will be collected to characterize the virome in the selected tissues. Describe the reproducible, quantitative, and sensitive nature of the assays to be deployed and any strategies used to calibrate and optimize them. State if technologies proposed within the application can be considered analytically validated. If not, provide plans and timelines for analytical validation. Provide a workflow for data collection that describes how high-content, high-throughput data at high resolution will be collected for comprehensive characterization of each biospecimen. If assays are in different geographical areas, provide a plan for how biospecimens will be divided or transported for analysis. Describe a strategy to monitor and ensure the quality of instrument performance and data generated across the VCC. Applications should describe typical error rates for the proposed assays and steps for data quality management.

Scaling and Standardizing the Pipeline: Describe plans for how the data generation pipeline will be scaled up during the project, including expectations for different datasets to be generated such as preliminary data, calibration data, validation data, and production data. Provide a plan to work collaboratively with other VCCs when/if harmonization is needed. Describe plans for scaling the pipeline including how emerging technologies may be incorporated into the pipeline, optimization of existing assays to enhance throughput or building additional analytical capacity.

Imaging: Discuss technologies and analytical tools to permit spatio-temporal visualization, tracking and tracing of viruses in cells and their environment in vivo and possibly ex vivo, including whole body imaging if appropriate. Discuss plans for building additional analytical capacity to accommodate new or updated imaging, single cell, or other technologies developed through the HVP initiative on Developing Novel and Innovative Tools to Interrogate and Annotate the Human Virome (RFA-RM-23-018).

Letters of Support: Provide all letters of support that are appropriate for this core, including any letters of support from institutional officials. Letters should address the commitment of the parent organization, or any of its partners, to the VCC and its goals. If collaborative linkages are being developed between the VCC and other centers in related areas, a letter of agreement from the collaborating Center PD(s)/PI(s) should be included. Do not provide letters of support from individuals who will not be directly involved in the Center's research activities.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Biospecimen Analysis Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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.

Data Analysis & Submission Core

When preparing your application, use Component Type Administrative Core.

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

SF424 (R&R) Cover (Data Analysis & Submission Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Data Analysis & Submission Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Data Analysis & Submission Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Data Analysis & Submission Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Data Analysis & Submission Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Data Analysis & Submission Core)

Budget forms appropriate for the specific component will be included in the application package.

Leadership Effort Commitment: The Core Leader of this core must devote a minimum of 1.8 person-months of effort to the Data Analysis & Submission Core of the HVP. For applications with multiple Core Leaders, a minimum effort of 0.8 person-months is required for the Contact PD/PI and 0.6 person-months of effort for each additional Core Leader is required.

Travel Funds: The budget should include sufficient funds to support travel for PD(s)/PI(s) and pertinent members of the Center to attend annual HVP Consortium meetings and workshops.

Equipment: If pieces of specialized equipment or computers exceeding $5,000 are requested, the application must provide a clear justification for the purchase in Budget Justification.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Data Analysis & Submission Core)

Specific Aims: State the specific aims of the Data Analysis & Submission Core, describing how it will assemble and validate virome characterization data and submit data to public repositories, in consultation with the CODCC.

Research Strategy: Applicants should highlight aspects of their proposed activities that speak to the significance and innovation of the approach. In lieu of the standard Research Strategy subsections (Significance, Innovation, and Approach), describe the activities of the Data Analysis & Submission Core using the sub-sections listed below. Describe the outputs from the VCC that will be submitted to public repositories in collaboration with the CODCC and the process for doing this.

Data Processing: Describe and demonstrate any existing or proposed data processing pipelines to be employed within the VCC. State how these pipelines might be scaled to meet the demands of increased throughput within the VCC. State the degree to which the resulting processed data is interoperable and meets the qualifications for FAIR data sharing standards. If pipelines that are standard in the field are not being employed within the VCC, provide justification for the use of in-house pipelines and provide examples of downstream analyses utilizing the output of the pipeline (to demonstrate interoperability). Describe a plan for assessing and managing data quality including identification of missing or out of range data, calibration drift, or user variability. Describe how the core will harmonize data processing with other VCCs and within the Consortium as a whole.

Data Analysis: Describe and demonstrate the computational approaches that will be employed within the Data Analysis & Submission Core that will result in the generation of high-content imaging and omics data from the Biospecimen Analysis Core. As appropriate, describe strategies that will be used to integrate data from different assays; integrate disparate omics and imaging data types and other approaches to connect disparate data. Describe how the core will harmonize data analysis with other VCCs and within the Consortium as a whole.

HVP Virome Database Construction: Describe and demonstrate plans to aggregate and integrate data and metadata from the broad range of experimental and computational approaches outlined throughout the application to characterize viruses identified within VCC. As appropriate, describe how samples from the same individual or multiple individuals can be analyzed to understand variability. Describe plans to develop or adapt computational tools for searching, cross-validation, and data visualization. Describe plans for how data analysis and database generation can optimize the data generation pipeline of the Biospecimen Analysis Core.

Consortium Coordination: Describe plans to work with the CODCC and other VCCs to develop common data formats and interoperable tools and procedures allowing seamless integration and presentation of the database generated by the Consortium. Describe how proposed analysis workflows or pipelines can be shared and harmonized across the Consortium. Demonstrate through evidence of collaboration and/or open-source algorithm and computational tool development the flexibility of the Data Analysis & Submission Core to incorporate disparate data types from emerging technologies incorporated after award. Analytical flexibility is an important aspect because the breadth of data types across the Consortium and technologies that may be employed in the future is currently unknown.

Letters of Support: Provide all letters of support that are appropriate for this core, including any letters of support from institutional officials. Letters should address the commitment of the parent organization, or any of its partners, to the VCC and its goals. If collaborative linkages are being developed between the VCC and other centers in related areas, a letter of agreement from the collaborating Center PD(s)/PI(s) should be included. Do not provide letters of support from individuals who will not be directly involved in the Center's research activities.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Data Analysis & Submission Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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.

Ethical, Legal, and Social Implications (ELSI) Core

When preparing your application, use Component Type Administrative Core.

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

SF424 (R&R) Cover (Ethical, Legal, and Social Implications (ELSI) Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Project /Performance Site Location(s) (Ethical, Legal, and Social Implications (ELSI) Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Ethical, Legal, and Social Implications (ELSI) Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Ethical, Legal, and Social Implications (ELSI) Core)

Budget forms appropriate for the specific component will be included in the application package.

Leadership Effort Commitment: The Core Leader of this core must devote a minimum of 1.8 person-months of effort to the Ethical, Legal, and Social Implications (ELSI) Core of the HVP. For applications with multiple Core Leaders, a minimum effort of 0.8 person-months is required for the Contact PD/PI and 0.6 person-months of effort for each additional Core Leader is required.

Travel Funds: The budget should include sufficient funds to support travel for PD(s)/PI(s) and pertinent members of the Center to attend annual HVP Consortium meetings and workshops.

Equipment: If pieces of specialized equipment or computers exceeding $5,000 are requested, the application must provide a clear justification for the purchase in Budget Justification.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Ethical, Legal, and Social Implications (ELSI) Core)

Specific Aims: State the specific aims of the Ethical, Legal, and Social Implications (ELSI), describing approaches to protect participants, grant recipients, and NIH staff in matters of privacy, safety, and legality for the HVP in coordination with other VCC ELSI Cores, the HVP Steering Committee, the CODCC, and NIH Program Staff.

Research Strategy: The research activities described should integrate qualitative and quantitative data studies from the biospecimen collection and data analysis & submission cores, legal and normative analyses, and other analytical or conceptual research methodologies with activities that facilitate the use of VCC research findings and expertise to inform the development of research, health and public policies and practices regarding the use of human virome information and technologies. A communications plan or strategy should be included that addresses the potential dissemination of ELSI information by the VCC.

Letters of Support: Provide all letters of support that are appropriate for this core, including any letters of support from institutional officials. Letters should address the commitment of the parent organization, or any of its partners, to the VCC and its goals. If collaborative linkages are being developed between the VCC and other centers in related areas, a letter of agreement from the collaborating Center PD(s)/PI(s) should be included. Do not provide letters of support from individuals who will not be directly involved in the Center's research activities.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

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

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

4. Submission Dates and Times

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. 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.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

For information on how applications will be automatically assembled for review and funding consideration after submission, refer to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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) and component Project Leads 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.

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.

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, non-compliant and/or nonresponsive will not be reviewed.

Applications Involving the NIH Intramural Research Program

Should intramural scientists submit an application through this NOFO, or should an extramural application include a collaboration with NIH intramural scientists, the requests by NIH intramural scientists will be limited to the incremental costs required for participation. As such, these requests will not include any salary and related fringe benefits for career, career conditional or other Federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative or F&A costs). These costs may include salary for staff to be specifically hired under a temporary appointment for the project, consultant costs, equipment, supplies, travel, and other items typically listed under Other Expenses. Applicants should indicate the number of person-months devoted to the project, even if no funds are requested for salary and fringe benefits.

If selected, appropriate funding will be provided by the Common Fund through the NIH Intramural Program. NIH intramural scientists will participate in this program as PD/PIs in accord with the Terms and Conditions provided in this NOFO. Intellectual property will be managed in accord with established policy of the NIH in compliance with Executive Order 10096, as amended, 45 CFR Part 7; patent rights for inventions developed in NIH facilities are NIH property unless NIH waives its rights.

Should an extramural application include the collaboration with an intramural scientist, no funds for the support of the intramural scientist may be requested in the application. The intramural scientist may submit a separate request for intramural funding as described above and as described in the NIH Intramural Source Book.

Post Submission Materials

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.

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.

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 project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

• How well do the selected cohorts and tissues sites contribute to the goal of characterizing the human virome?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

• How well d o the VCC PD(s)/PI(s) demonstrate the ability to develop, manage, and direct a scientific program of this size and complexity, including the time commitment and demonstrated ability to establish and manage collaborations?
• For the Administrative Core: How appropriate a re the experiences, level of commitment, and availability of the Administrative Core Director to manag ing the overall Center?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

• How innovative are proposed methods to meet and manage consortium coordination?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in 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?

• Overall: How well do the Cores demonstrate a willingness to collaborate with the HVP Consortium? How adequate are coordination, communication, cohesiveness, and synergy plans among the components of the VCC as they relate to characterizing the virome and building a consortium? To what extent are Cores willing to share resources with the VCC and HVP Consortium as specified in the Resource Sharing Plan?
• For the Administrative Core: How likely will the plans for communicating and collaborating with the CODCC and NIH staff facilitate the characterization of the human virome and building of a consortium ?
• How adequate and appropriate i’s the administrative and organizational structure to coordinate, supervise, and manage activities and accomplish the objectives of the Center? How adequate a re the proposed milestones, timelines, and objectives for the overall Center , including the plans for overseeing the VCC Cores and other resources? How appropriate i’s the Management and Staffing Plan to facilitating the attainment of the objectives of the proposed VCC? How appropriate a re the plans for coordination, problem identification, and resolution for the Program ? How appropriate a re plans for organizing programmatic meetings, site visits, and teleconference calls ?
• For the Biospecimen Collection Core: How likely will the population be available and obtainable? How robust are the plans for recruitment outreach and enrollment for data collection? How feasible are the planned recruitment timelines? How adequate is the plan for coordinating the dissemination of specimens within the VCC and with other VCCs? How sound is the plan for procuring and storing high quality biospecimens and clinical and epidemiological information? How strong is the scientific foundation and expertise for the multidimensional data collection proposed? How well d oes the accrual of biospecimens match plans for data analysis? How well w ill the proposed quality assurance and quality control plans facilitate successful assessment and characterization of viral content at the molecular, cellular, and tissue levels from the biospecimens?
• For the Biospecimen Analysis Core: How solid is the plan for interaction with the other components of the VCC, including the Biospecimen Collection and Data Analysis & Submission Cores? How likely will the Biospecimen Analysis Core be able to rapidly deploy the proposed assays ? If the investigators propose technologies for biospecimen analysis that have not been analytically validated, how sufficient are plans to validate the technologies within the proposed timeframe? How likely is it for the Biospecimen Analysis Core to achieve the throughput and quality necessary to create well characterized virome data ?
• For the Data Analysis & Submission Core: How adequate, appropriate, and consistent a re statistical analyses, procedures, and policies with accepted standards? How strong is the scientific foundation for the range of data processing, analysis, and computational modeling proposed? How well do the preliminary data demonstrate the validity of approaches that are not field standards (t his includes data processing, analysis, computational modeling, visualization and other algorithms)? How well do the plans of the Data Analysis & Submission Core ensure that data and algorithms are interoperable and meet the qualifications for FAIR data-sharing standards?
• For the ELSI Core: How well a re potential ethical issues addressed? How clearly described, reasonable, and appropriate a re the plans for evaluating the use and usability of the Center’s work products ? How open are lines of communication so all involved parties can quickly address ELSI issues?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

• How committed and supportive is the institution for the duration of the project?
• How sufficient are administrative structures for the day-to-day management of the VCC, including mechanisms for internal quality control of ongoing research?
• How adequate and relevant are the staffing, equipment, and other resources that are available to the VCC for characterizing the virome in selected tissues and cohorts?
• How appropriate a re the plans for establishing a strong collaborative environment for the VCC and with the HVP Consortium ?
• How much w ill the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Additional Review Criteria - Overall

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

Additional Review Considerations - Overall

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) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

For projects 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 on the basis of established PHS referral guidelines 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 appropriate national Advisory Council or Board. 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 resource 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: Grantee 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.

Prior Approval of Pilot Projects

Recipient-selected projects that involve studies involving greater than minimal risk to human subjects require prior approval by NIH prior to initiation.

• The recipient institution will comply with the NIH Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval.
• The recipient institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.

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.htmlandhttps://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.

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 investigators 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 CODCC in consultation with NIH staff will establish and coordinate working groups to facilitate collaboration and shared interests among the HVP award 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.

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 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’s haring Polic y and the approved 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 and Sharing Plan .
  • Reviewing the progress of the HVP award 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 grants 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 (or as needed) by videoconference. HVP Steering Committee members will attend the annual in-person HVP investigator meetings and other HVP Consortium meetings or workshops.

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 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. If additional Data Management and Sharing requirements need to be added, please insert what requirements are desired.

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.

Progress reports should briefly describe status of pilot projects, including data and safety monitoring, and should notify NIH of serious adverse events and unanticipated problems.

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 the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.

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

Section VII. Agency Contacts

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

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

Finding Help Online: 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]

Roberto Flores-Munguia, PhD, MPH
National Institute on Aging (NIA)
Email: [email protected]

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

E C Melvin
National Institute on Aging (NIA)
Telephone: 301-480-8991
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.