It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

This Funding Opportunity Announcement (FOA) is associated with the COVID-19 Supplement funded through the Paycheck Protection Program and Health Care Enhancement Act (P.L. 116-139) which directs the National Cancer Institute of the NIH to develop, validate, improve, and implement serological testing and associated technologies . The purpose of the FOA is to establish Serological Sciences Centers of Excellence with the goal of identifying and advancing research opportunities to characterize the immune responses elicited by SARS-CoV-2 viral infection; understanding the mechanisms driving the serological, humoral and cellular immune responses; determining host, genetic, and environmental modifiers of the immune response; determining the serological correlates of disease pathogenesis and protection against future infection; defining access, communication, and implementation barriers related to SARS-CoV-2 serological testing. These Centers will be part of a Serological Sciences Network (SeroNet). Other components of the Network will include Serological Sciences Research Projects (U01), the FNLCR Serology Laboratory, Serological Capacity Building Centers (CBC) and a Serological Sciences Network Coordinating Center (SSNCC) which will be managed through Frederick National Lab for Cancer Research (FNLCR), a Federally Funded Research and Development Center. It may also include SBIR grants and other grants and contracts related to serology associated with SARS-CoV-2. SeroNet activities will be coordinated by the SeroNet Steering Committee in which all Network members must participate.

All components are expected to collaborate across the entire Network, sharing data, results and reagents. These components are:

• Serological Sciences Centers of Excellence (U54; this RFA) The SeroNet Centers of Excellence will carry out 2-3 projects in basic and applied serological research to characterize the immune responses elicited by SARS-CoV-2 viral infection, understand mechanisms driving the broad immune responses, determine modifiers of the immune response, identify serological correlates of disease pathogenesis and protection against future infection, or define access, communications and implementation barriers to serological testing.
• Serological Sciences Research Projects (U01) RFA-CA-20-039 - The SeroNet Research Projects will carry out a research project in basic and applied serological research to characterize the immune responses elicited by SARS-CoV-2 viral infection, understand mechanisms driving the broad immune responses, determine modifiers of the immune response; identify serological correlates with disease pathogenesis and protection against future infection, or define access, communications and implementation barriers to serological testing.
• FNLCR Serology Laboratory The Serology Lab will implement and qualify SARS-CoV-2 assays, develop qualified assay standards, and generate novel reagents. The Serology Lab will also procure and characterize serum samples from SARS-CoV-2 patients and controls and establish serum panels. The Serology Lab will share these assays, reagents, and standards within SeroNet.
• FNLCR Capacity Building Centers (CBC) CBCs will develop and expand serological testing capacity and practice in the community. CBCs will conduct serological standardization and assay development and scale up to screening capacity to reach at least 10,000 patients per week with FDA-Emergency Use Authorization (EUA) authorized assays.
• Serological Sciences Network Coordinating Center (SSNCC) (managed by the FNLCR) The Coordinating Center will work closely with NIH staff and SeroNet component staff and investigators to manage all aspects of SeroNet coordination including organizing Steering Committee and Investigator Meetings, managing Network communication and outreach, coordinating reagent sharing and distribution, and facilitating and coordinating Network data management.

Each proposed Serological Sciences Research Project must be focused on research related to the serological response to SARS-CoV-2, characterization of the innate or adaptive immune response to SARS-CoV-2, other correlates of immunity, patient outcome and/or disease pathogenesis and the development of novel serological assays for SARS-CoV-2, or definition of access, communication and implementation barriers. Proposals with cancer relevance are encouraged.

Applications spanning the full range of research and research designs, from basic research to population science research, will be considered responsive.

• Developing novel assays, and preclinical and computational model systems to test adaptive and innate immune responses to SARS-CoV-2 infection that inform immune parameters and serological markers associated with asymptomatic vs symptomatic infection, disease severity, risk of re-infection or vaccine efficacy.
• Understanding the mechanisms underlying innate, cell-mediated, and humoral immune responses to SARS-CoV-2 including macrophage activating syndrome and cytokine storm - as well as how disease severity differs as a function of immune health status.
• Determine if therapeutics (e.g. remdesivir, antivirals) and passive antibody therapies used to treat COVID-19 modulate serologic and immune responses to SARS-CoV-2 (e.g. antibody-dependent enhancement).
• Characterizing the serologic differences resulting from natural infection vs. vaccination against SARS-CoV-2, and how they correlate with the persistence or longevity of the response.
• Identifying genetic and epigenetic determinants (e.g. HLA types) that modulate the development and durability of immune responses against SARS-CoV-2 infection and associated serological correlates.
• Understanding what factors affect the SARS-CoV-2 immune response or pathogenesis including SARS-CoV-2 viral load, health conditions (e.g., diabetes, obesity, cardiovascular disease, precancerous conditions), co-infection with other viruses (e.g., HIV, HPV, CMV), or the presence of endemic coronavirus antibodies.
• Understanding how precancerous conditions, cancer, and/or cancer therapies (i.e., chemotherapy, radiation, immunotherapy, hormonal therapy, combinations) affect serologic and immune responses to SARS-CoV-2 infection and the clinical course of infection, and conversely how the immune response to SARS-CoV-2 affects precancerous conditions, cancers, and responses to cancer therapies.
• Understanding how patient demographic factors (e.g., age, sex, ethnicity), behavioral (e.g., smoking, physical activity), and environmental factors affect immune or serological responses to SARS-CoV-2 infection.
• Researching the clinical and public health implementation of validated serologic assays, their interpretation, and follow-up for health outcomes.
• Approaches to promoting and ensuring equitable access to serologic testing, identification of contextual factors associated with the uptake of SARS-CoV-2 serologic testing, and whether differential access further exacerbates health disparities and health outcomes.
• Determining the ethical, legal and social implications of serologic testing for SARS-CoV-2 in diverse populations and the best methods for appropriate communication of results and interpretation at the individual, provider, and population level; for example, the impact of serologic testing on employment, housing, health insurance, access to federal benefits.

This is an emergency FOA due to the SARS-CoV-2 global pandemic; therefore, applicants do not need to provide extensive background information or preliminary data in this application.

Intervention trials addressing behavioral, health care delivery, or implementation research related to serologic testing and serologic outcomes are appropriate for this RFA. These research efforts should include a broad and diverse population, including consideration of age, sex, gender, race, socioeconomic status, rural populations, ethnicity, as well as specific vulnerable populations (e.g., individuals with comorbidities such as autoimmune disease, immunosuppression, and obesity, medically underserved, and cancer populations across all age groups childhood, adolescent and young adult, and older populations). Leveraging ongoing cohort studies and registry data is encouraged.

Applications for Serological Sciences Centers of Excellence should have the following structure:

• Administrative Core to manage and coordinate all Center research and activities and serve as the liaisons between the Centers and the other components of SeroNet. Responsibilities of the Administrative Core include ensuring the data collected conform with the agreed practice and principles of the SeroNet Standard Operating Procedures (SOPs), Common Data Elements (CDEs) and data sharing plan as approved by the SeroNet Steering Committee.

• Research Projects should be well developed research programs. Each Center should include 2-3 Research Projects that closely integrate into the organizing framework and together constitute a multifaceted approach to the serological response to SARS-CoV-2. Leaders and senior investigators of the team will be expected to participate in trans-SeroNet initiatives such as those focused on antibody detection, sample preservation, clinical/epidemiological data collection, and clinical utilization of serological testing.

• Shared Resource Cores should provide technical, experimental, or computational expertise that is essential to more than one Research Project within the Center. Each Center may propose up to 2 Shared Resource Cores.

Applications proposing the following topic areas would be considered non-responsive to this FOA, and will be returned without review:

• Interventional clinical trials of vaccines and other therapeutics
• Fundamental virology studies
• The long-term impact of SARS-CoV-2 infection on co-morbidities, unrelated to cancer or precancers.

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

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

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:

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o 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)

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

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

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

Applicant Organizations

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

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• 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.
• o In the case of Emergency awards, if the applicant is unable to comply with the requirement to complete and maintain SAM registration at the time of application submission, contact the agency immediately.
• o 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.
• eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but 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 DUNS number and 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 underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

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.

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

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time. 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 NOT-OD-11-101).

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 FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement 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.

Available Component Types	Research Strategy/Program Plan Page Limits
Overall	12
Admin Core (use for Administrative Core)	3
Shared Resource Core (optional; use for each Core)	3
Project (use for each Research Project)	6

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

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

The application should consist of the following components:

• Overall: required
• Administrative Core: required, maximum of one (1)
• Shared Resource Core: optional, maximum of two (2)
• Research Projects: required, minimum of two (2) and maximum of three (3)

When preparing your application, use Component Type Overall .

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

Complete entire form.

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

Follow standard instructions.

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.

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

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.

Specific Aims: State the overall vision and goals for the Center. The Specific Aims should be overarching, at a high level, and distinct from the aims of the individual components.

This is an emergency FOA due to the SARS-CoV-2 global pandemic; therefore, applicants do not need to provide extensive background information or preliminary data in this application.

Research Strategy: In this section, present a concise overall vision and plan for the proposed SeroNet Center. The vision should focus on the plans for the funding period of the Research Center and may briefly highlight how the Research Center will lay the groundwork for longer-term plans. This section should describe the fundamental question(s) that will be addressed by the Research Center and how they integrate to form an overall research theme. Items to be addressed include:

Research Theme. Define the overall research theme of the Research Center. Provide a brief background and rationale for this selection and outline the significance of research in the selected area.

• Center Organization. The Overall component should include a concise description of the structure of the Center including the organizing framework. This description should explain: (1) how the components of the Center, including key personnel, will interact; (2) why each component is essential for addressing the organizing framework of the Center; and (3) how the organization of the components into a Center will create an entity that is greater than the sum of its parts in terms of generating advances in fundamental science of SARS-CoV-2 serology.
• Center Integration. Applications should explicitly discuss the integration of work proposed in the application. While the Research Projects make up the foundation of the Serology Centers of Excellence, applicants are encouraged to describe cross-cutting elements in this Overall component. Applications should demonstrate that use of the research Center mechanism is essential to accomplishing studies that would not occur without the climate, facilities, and research resources that a research Center can uniquely provide.
• Center Expertise. The Overall component should demonstrate that the Center will include the necessary expertise and support the team science environment needed to complete the proposed research. The Applications should demonstrate plans for ongoing communication and sharing of data and resources within the Center.
• Research Projects. Briefly describe each project, including its scientific integration with the proposed organizing framework and a rationale for how each project will help, within the funded period, advance research to characterize the responses elicited by SARS-CoV-2 viral infection within the proposed organizing framework.
• Shared Resource Cores. Briefly describe any Shared Resource Cores, including the projects supported by the Core(s), and how the core(s) will support the projects.

Letters of Support: In addition to standard items, applicants may provide letters from the respective leadership official(s) in the institution(s) of the proposed center documenting specific institutional commitments to the proposed center.

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, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Resource Sharing Plan. The resource sharing plan for the Overall component should cover all the activities of the Center.
• The Resource Sharing Plan should describe the proposed process for making the primary data and resulting publications immediately and broadly available to the public.
• The Resource Sharing Plan should also describe approaches for making protocols, standard operating procedures (SOPs), and computational tools and other software broadly available.
• The Resource Sharing Plan should address sharing of data within a Center, across the Network, and with the broader research community,
• If a clinical trial is planned the Resource Sharing Plan should address participants' Study Consents and include (whenever possible) the option to use data and/or biospecimens for future research studies.
• Program staff may negotiate modifications to these plans prior to funding.

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

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

When preparing your application, use Component Type Admin Core .

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

Complete only the following fields:

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

Enter Human Embryonic Stem Cells in each relevant component.

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.

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

• In the Project Director/Principal (PD/PI) 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 forms appropriate for the specific component will be included in the application package.

• Center Administrator: Based on the complexity of the Serological Sciences Centers of Excellence, the Administrative Core Leader is strongly encouraged to propose and budget for a Center Administrator to manage day-to-day operations.
• Travel Funds: The budget should include funds to support travel for Center and Network activities, including but not limited to supporting the participation of PD(s)/PI(s) and other Center members in all SeroNet Investigator Meetings.
• Funds for Trans-Network Projects: Beginning in Budget Period 2, applicants must allocate 10 percent of their annual budget (within the Direct Costs cap) to a restricted fund to support collaborative activities with other components of SeroNet. The amount should be presented in the Other Expenses category under the heading "Collaborative Funds". Final decisions for the release of set-aside funds will be made by NIH staff based on recommendations of the SeroNet Steering Committee.

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.

Specific Aims: Outline Specific Aims for the Administrative Core.

Research Strategy: In lieu of the standard Research Strategy sub-sections (Significance, Innovation, Approach), use the sub-sections defined below to explain how the effective administrative and organizational capabilities.

• Management and Communication Plan. The application should describe the plans for management and integration of Center activities and communication and evaluation of progress across the Center. The plan should describe the leadership and communication strategies to manage and track progress of the multiple projects and sites that make up the Center. The plan should include a description of the Center leadership structure. Applicants should concisely describe oversight mechanisms that will be used by the Center PD(s)/PI(s).

• SeroNet Meetings and Other Network Activities. Provide a brief description of strategies for connecting and integrating the Center with the broader SeroNet. Funded Centers are expected to participate in SeroNet Investigators meetings to present results and to communicate with other Network investigators. The Center PD(s)/PI(s) are expected to attend the Investigator Meetings and participating faculty, postdoctoral associates, graduate students, and other Center members are all encouraged to attend. Center Investigators are also encouraged to organize and participate in other Network meetings and workshops, organize collaborative activities, promote Trans-Network collaborations, and share data through the SSNCC.

• Center and Program Evaluation. The Administrative Core should coordinate participation in Center program evaluation activities, including progress reports, site visits, and providing additional communication and materials to NIH as needed.

Letters of Support: In addition to standard items, applicants may provide letters from the respective leadership official(s) in the institution(s) of the proposed center documenting specific institutional commitments to the proposed center.

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, with the following modification:

Resource Sharing Plans should only be included in the Overall component. Individual components will adhere to the overarching Resource 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.

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

Shared Resource Core

When preparing your application, use Component Type Core .

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

Complete only the following fields:

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

Enter Human Embryonic Stem Cells in each relevant component.

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.

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

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

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.

Specific Aims: In addition to outlining the specific aims of the Shared Resource Core, list which projects will be supported by the Shared Resource Core.

• Value of the Core services to the Research Center and Research Projects;
• Interactions between the Core and Research Projects;
• Procedures for how the core prioritizes services to the proposed projects in the U54 Center, including allocating resources, cost effectiveness, and increased efficiency; and
• Quality control measures.

Any proposed new shared resources must not duplicate analogous resources already established in the applicant institutions. If existing cores and resources are to be used, then funding to augment such existing resources may be requested. Description of how work related to the Center will be prioritized within such a core must be provided.

Letters of Support: In addition to standard items, applicants may provide letters from the respective leadership official(s) in the institution(s) of the proposed center documenting specific institutional commitments to the proposed center.

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, with the following modification:

Resource Sharing Plans should only be included in the Overall component. Individual components will adhere to the overarching Resource 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.

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

When preparing your application, use Component Type Project .

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

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project starting with "Project 1:", "Project 2:", etc.
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

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.

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

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

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.

Specific Aims: State the specific aims of the Research Project and provide a rationale and description of how they fit into the overall research theme of the Research Center.

Research Strategy: Applicants should use the standard structure of the Research Strategy section (i.e., sub-sections Significance, Innovation, and Approach).

This is an emergency FOA due to the SARS-CoV-2 global pandemic; therefore, applicants do not need to provide extensive background information or preliminary data in this application.

Clearly describe the SARS-CoV-2 serological science research addressed by each Project. Explain how the proposed research will accelerate understanding the immune response to SARS-CoV-2 and inform the development of novel serological tests to further define the characteristics of COVID-19. If applicable, describe how the shared resource(s) will be used for the proposed research.

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, with the following modification:

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

Resource Sharing Plans should only be included in the Overall component. Individual components will adhere to the overarching Resource 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.

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

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

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) 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 Policy on Late Application Submission.

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

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

This initiative is not subject to intergovernmental review.

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

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

Pre-award costs may be incurred from January 20, 2020 through the public health emergency period and prior to the date of the federal award.

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 your application will be automatically assembled for review and funding consideration after submission go 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 Component of the SF424(R&R) Application Package. 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 DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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

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

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

For this FOA, note the following:

• This is an emergency FOA due to the SARS-CoV-2 global pandemic; therefore, applicants do not need to provide extensive background information or preliminary data in this application.
• Accordingly, reviewers will emphasize the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Applications with a cancer component will be given preference.

In addition, for applications involving clinical trials: A proposed Clinical Trial application may include study design, methods, and intervention that are not necessarily innovative but nevertheless address important questions or unmet needs. The results of the clinical trial may indicate that further development of the intervention is unwarranted or lead to new avenues of scientific investigation.

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

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

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?

Specific to this FOA: How well does the project propose to identify and advance research to characterize the adaptive and innate immune responses to SARS-CoV-2 leading to the development and implementation of serologic testing? If appropriate, to what extent does the proposed project consider the interaction between the SARS-CoV-2 immune response and cancer?

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is the trial needed to advance scientific understanding?

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?

Specific to this FOA: Are the backgrounds, expertise, and commitments of the PD(s)/PI(s) and other key persons in line with the overall goals of Serological Sciences Centers of Excellence? For applications involving multiple PDs/PIs, are their designated roles and responsibilities well defined, adequate, and complementary for achieving the goals of the proposed Research Center? How well do the proposed collaborations among the Serological Sciences Centers of Excellence PD(s)/PI(s) and other key persons integrate to achieve the overarching research goals? Have the investigators demonstrated ongoing records of collaboration?

In addition, for applications involving clinical trials

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

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?

Specific to this FOA: To what extent does this application propose approaches to increase the understanding of SARS-CoV-2 immune responses and the underlying mechanisms that will inform the development of novel serologic tests, or the clinical and public health implementation of validated serologic assays?

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have 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?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable:

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

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?

In addition, for applications involving clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

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.

How well do the proposed research projects address topics that are high priority to SARS-CoV-2 serological science research? Does the application identify a major research theme and are the proposed research projects linked to the theme? For each project, are the strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the research project? Are potential problems, alternative strategies, and benchmarks for success presented? How will the scientific knowledge gained from the proposed research projects accelerate understanding the immune response and inform the development of novel serological tests to further define the characteristics of COVID-19?

How well is the proposed Shared Resource Core matched to the needs of the research being proposed? What is the overall quality of the proposed core services? Are adequate quality control processes proposed for the facilities or services provided by the Shared Resource Cores (including procedures, techniques, and quality control)? What are the criteria for prioritization and usage of Core products and/or services? Are the qualifications, experience, and commitment of the Shared Resource Core Lead(s) and other key personnel adequate and appropriate for providing the proposed facilities or services? Will the proposed shared resource core(s) provide cost effective services? Is the environment for the shared resource core adequate to support the program as proposed?

Is the proposed Administrative Core well matched to the needs of the Center? Is the management proposed appropriate for scientific administration as well as fiscal administration, procurement, and personnel management? Is its role in the Center clearly defined? If appropriate, how well do the proposed activities for strengthening research administration address the needs of the Center?

Study Timeline

Specific to applications involving clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls?

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.

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.

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 Animal Section.

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.

Not Applicable

Not Applicable

Not Applicable

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

Not Applicable

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).

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan .

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.

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

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

• 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.
• Will receive a written critique.

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

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 FOA. 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.

Not Applicable

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 grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

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

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

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

Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

Awardee-selected projects that involve {clinical trials or studies involving greater than minimal risk to human subjects} require prior approval by NIH prior to initiation.

• The awardee institution will comply with the NIH Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval.
• The awardee 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, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

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

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. HHS provides guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
• Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment. Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf. 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.
• Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. Please 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 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

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) 2 CFR Part 200 Administrative Regulations, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, NIH Grants Policy Statement (which implements the aforementioned HHS Regulations (45 CFR Part 75), 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 awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

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

• Planning and conducting the activities and operations defined by the terms and conditions of the cooperative agreement award.
• Conducting the scientific research in the project, reporting progress and objectives to NIH staff, and reporting results to the scientific community.
• Awardees will be expected to participate in additional collaborative research activities identified post-award by the Serological Sciences Network (SeroNet) Steering Committee (SC).
• Assuming responsibility and accountability to the applicant organization officials and to the NIH for the performance and proper conduct of the research and administrative functions supported under this Funding Opportunity Announcement in accordance with the terms and conditions of award, and pertinent laws, regulations and policies.
• Actively participating in a cooperative, interactive, and collaborative manner with NIH staff, FNLCR Serology Lab staff, other SeroNet investigators, Capacity Building Centers (CBC), and the Coordinating Center at FNLCR, to maximize impact of the SeroNet and meet Program goals and objectives. This includes serving as a member of the SeroNet SC, as described below.
• Maintaining the confidentiality of the information developed or handled by the SeroNet, including, without limitation, unpublished data, protocols, data analysis, confidential exchanges between members of the SeroNet as well as any confidential information received by third party collaborators.
• To ensure compliance with NIH and individual IC open-access expectations, each SeroNet investigator is responsible for:

Ensuring all resulting publications and the underlying primary data are immediately and broadly available to the public, without embargo.

Ensuring protocols, standard operating procedures (SOPs), and computational tools and other software are made broadly available.

Ensuring the timely sharing of data both within a Center and across the Network and with the broader research community.

Ensuring the sharing of data through the Serological Sciences Network Coordination Center and other controlled access databases, consistent with achieving the goals of this program.

Ensuring if a human study (clinical trial or observational study) is planned the Data Sharing Plan should address participants' Study Consents and include (whenever possible) the option to use data and/or biospecimens for future research studies.

Ensuring that any industry collaborations are governed by an appropriate

confidentiality disclosure agreement (CDA) with terms that ensure the collaboration is conducted in accordance with the Cooperative Agreement, applicable NIH policies and procedures and any policies and procedures developed by the SC.

Operating in accordance with processes, goals, and policies established by the SeroNet SC.

Attending regular Investigator meetings of the SeroNet.

Participating in site visits of NIH Program staff members as requested/needed.

Awardees must adhere to a Network Communication Plan: A consensus Communication Plan will be drafted by the SC during the Kickoff Meeting of the SeroNet. This plan will clearly spell out interactive requirements that all SeroNet investigators are expected to follow, including:

Participating in regular conference calls and contributing to various sub-committees and working groups;

Participating and presenting findings at SeroNet investigator meetings;

Cooperating with the Serological Sciences Network Coordinating Center (SSNCC) in support of trans-Network interactions

Coordinating efforts with other members of the SeroNet

• In addition to standard annual Research Performance Progress Report (RPPR) submissions, Principal Investigators may be expected to supply additional progress-related information.

SeroNet PD(s)/PI(s) are also expected to organize and participate in collaborative activities and scientific or programmatic working groups.

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

A NIH Program Director acting as Program Official will named in the Notice of Grant award and will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The Program Official will make final decisions for the release of set-aside funds, based on the recommendation of the Steering Committee.

Additionally, designated NIH staff member(s) serving as Project Scientist(s) will have substantial programmatic involvement that is above and beyond the normal stewardship of an NIH Program Official.

NIH IC Project Scientists will be responsible for the following activities:

Assist and coordinate interactions and collaborations among the various investigators and any industrial partners and ensure access to other NIH relevant programs.

Serve as a resource for the research teams in making them aware of other ongoing NIH activities that may be relevant to the study.

Participate in site visits, as appropriate

• Evaluate the effectiveness and facilitate consortium-wide adoption of data- and tool-sharing and interoperability practices.

• Ensure that the SeroNet data and resources are shared with the SSNCC in accordance with applicable policies.

• The NIH also retains the option of organizing periodic external review of progress of the work supported by the SeroNet award.
• In addition, FNLCR Staff managing the SSNCC will:
• Coordinate the activities SeroNet-SC, as described below
• Organize SeroNet investigator meetings and working groups
• Coordinate and support sharing of samples, reagents and data across SeroNet

The NIH reserves the right to terminate any SeroNet award in the event of (1) A substantial shortfall in accomplishing the management goals and responsibilities as stated in the reviewed application, (2) A failure to meet the SeroNet policies and procedures, (3) Substantive changes in the management of the SeroNet award that are not in keeping with the objectives of the FOA, (4) A failure to accomplish the scientific goals.

Areas of Joint Responsibility include:

The Serological Sciences Network (SeroNet) Steering Committee (SC) (SeroNet-SC) serves as the main governing board of the Network. All major scientific and policy decisions will be determined by the SeroNet SC. NIH Project Scientists involved with the management of the SeroNet will help the SC develop and draft sharing and operating policies that are in accordance with NIH guidelines.

Awardees will be responsible for accepting and implementing the goals, priorities, procedures, protocols, and policies agreed upon by the SeroNet-SC to the extent consistent with grants regulations. This includes compliance with program policies including, as applicable, policies on the use of common protocols, publication of study results, collaborative procedures, confidentiality, and sharing plans to be developed by the SC in collaboration with NIH.

Steering Committee: The SeroNet Steering Committee will be composed of the following members:

One PD(s)/PI(s) from each of the SeroNet U01/U54 awards, CBCs, FNLCR Serology Lab and FNLCR Coordinating Center

And

An NIH Project Scientist from each participating IC

Additional NIH staff may participate in Steering Committee meetings as needed (for example to provide additional expertise).

Additional non-voting members are encouraged to participate on the Steering Committee in an advisory capacity.

The Chair(s) of the Steering Committee (who cannot be NIH staff) will be selected by the Steering Committee. The Steering Committee will meet in association with the PI meetings and via teleconferences as needed.

The Steering Committee may establish subcommittees or working groups for specific purposes.

The SeroNet SC has the following primary responsibilities:

The SC will be tasked with establishing guidelines and agreements with regard to Network-specific scientific, strategic and administrative issues. Specific activities of the SeroNet SC will include, but are not limited to:

• Establishing procedures for the solicitation, evaluation and recommendation to awardees of collaborative/joint projects to be pursued with support of the set-aside funds from individual U01 and U54 awards;

• Identifying opportunities for sharing techniques, materials, information and tools developed within each individual SeroNet Center;

• Facilitating the development and utilization of SeroNet defined data and metadata standards and formats;

• Facilitating communication and fostering collaboration across the SeroNet;

• Reviewing progress of the SeroNet towards meeting the overall Network goals;

• Developing publication policies to facilitate collaborations and co-publications by Network members;

• Developing implementation processes and workflows for sharing data, tools, and resources generated by the SeroNet;

• Ensuring that the SeroNet leverages existing NIH resources and programs;

Evaluating collaborative activities and providing feedback to the NIH Program Staff;

• Discussing implementation of recommendations or suggestions from the NIH and any external consultants and planning a timely implementation strategy.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: 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 awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.

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

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

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

Funds awarded using appropriations provided by the H.R.266 (PL 116-139) Paycheck Protection Program and Health Care Enhancement Act will be issued in unique subaccounts in the HHS Payment Management System, and will require separate financial reporting from any other funds awarded.

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

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

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

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

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

Juli Klemm, PhD
National Cancer Institute (NCI)
Telephone: 301.480.5778
Email: [email protected]

Samantha Finstad, PhD

National Cancer Institute (NCI)
Telephone: 240.276.6460
Email: [email protected]

Erik J. Stemmy, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3380
Email: [email protected]

Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390
Email: [email protected]

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: [email protected]

Ann Devine
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2988
Email: [email protected]

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.