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

The National Institute of Allergy and Infectious Diseases (NIAID) supports complementary research programs to understand, control and prevent viral diseases and related pandemics. This Funding Opportunity Announcement solicits applications to establish the Antiviral Drug Discovery (AViDD) program of multidisciplinary Centers focused on discovery and development of antivirals against coronaviruses (CoVs) and one or more select RNA viruses with pandemic potential. NIAID is issuing this FOA in response to the declared public health emergency issued by the Secretary, HHS, for the 2019 Novel Coronavirus (COVID-19), and within the provisions described in the "American Rescue Plan Act of 2021."

Typical drug discovery programs require several years to progress from target validation through initial lead series identification and optimization to selection of a candidate drug for clinical trials. Therefore, if efforts are initiated only after an outbreak or pandemic occurs, it is unlikely that a virus-specific small-molecule therapeutic will be available within a useful timeframe to have clinical impact. A potentially more effective approach is to invest drug discovery efforts aimed at building a more robust pipeline of antiviral lead series and drug candidates, so when a new outbreak or pandemic occurs, there will be more options available for clinical deployment. NIAID’s intention of the AViDD Centers is to support focused antiviral drug discovery efforts directed toward key viral pathogens or viral families and/or common drug targets or mechanisms-of-action with the aim of generating a more substantial pool of antiviral lead series and candidate drugs with the potential to address the immediate threat of Severe Acute Respiratory Syndrome CoV-2 (SARS-CoV-2), as well as provide antiviral drug candidates that might quickly pivot to address future viral outbreaks or pandemics. Of particular interest for this effort is identification and development of oral drug candidates with suitable safety profiles for broad use in the outpatient setting.

The objective of this FOA is to establish a program of multidisciplinary research Centers focused on the discovery and development of new antiviral drug candidates and lead series with the aim of generating a more robust pipeline of novel antivirals targeting key viral pathogens. NIAID encourages highly integrated, multidisciplinary teams working collaboratively to address immediate and potential future antiviral needs. Antivirals of interest include small molecules and biotherapeutics that directly block viral targets to be used as monotherapy or in combination with other drugs. Efforts in these Centers are expected to focus on SARS-CoV-2 and other coronaviruses involved in historical and possible future outbreaks, as well as one or more additional priority RNA viruses.

Each Center will encompass a multi-project multidisciplinary research platform that employs innovative virology, biochemistry, structural biology, medicinal chemistry, genomics and/or systems biology approaches to identify and select essential virus-specific targets for discovery and development of antivirals against CoVs, emphasizing SARS-CoV-2, and additional RNA viruses of pandemic potential. The platform will also provide for identification of conserved structures and functions that are shared between the selected CoVs and RNA viruses that will be targeted for antiviral development. Based on targets defined for drug development, lead series and candidates will be identified through iterative cycles of evaluation and refinement using state-of-the-art screening technologies, structure-based design and medicinal chemistry. Subsequent advancement of inhibitors of viral functions to lead candidates will require specialized evaluations, including testing against live viruses in cell culture and animal models, as well as exploring the pharmacology and toxicology of the therapeutic candidates.

Activities in the various projects within the Centers are anticipated to range from early basic and discovery-based efforts, such as identification and validation of novel viral targets, to discovery and optimization of lead series with activity against a specific pathogen or viral family, to late-stage preclinical development and IND-enabling profiling of specific drug candidates. NIAID encourages development of modern technologies or platforms that target a wide array of pathogens. While early target identification and validation efforts in the Centers may be led by academic labs, NIAID requires Centers to include industry expertise actively participating in projects pursuing later-stage antiviral development to ensure access to high-quality chemical libraries and input of medicinal chemistry and pharmacology expertise. For the purpose of this FOA, "industry" is defined as a large or small, domestic or foreign, pharmaceutical, biotechnology, bioengineering, or chemical company, or a related non-profit entity. Additionally, each Center will consider anticipated regulatory barriers for the targeted antiviral or technology, particularly for new classes of drugs for which there are no precedents for FDA approval.

Priority Viral Pathogens

Each AViDD Center supports a multi-project research platform directed towards discovery and development of antivirals targeting coronaviruses, with an emphasis on SARS-CoV-2, and one or more viral pathogens from the following RNA virus families of pandemic potential:

• Paramyxoviruses
• Bunyaviruses (Bunyavirales)
• Togaviruses
• Filoviruses
• Picornaviruses
• Flaviviruses

Although assays utilizing model systems (e.g. pseudoviruses or replicons) for early discovery are acceptable, lead development activities in the Centers must focus on targeting virulent members of the pathogens listed above under appropriate biosecurity and biosafety conditions.

AViDD Center Structure

Each Center in the AViDD program will be organized around a research platform focused on discovery, development and/or use of one or more antivirals and/or antiviral technologies that target specified RNA viruses with the objective of translating research results to product development. Each Center will include the following components:

Administrative Core

An Administrative Core will manage, coordinate, and supervise all Center activities under the direction of the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)). The Administrative Core will also ensure seamless communication across the projects through regular (at least annual) meetings of Center participants and other data sharing approaches. In addition, the Administrative Core will coordinate detailed communication of Center efforts and progress with NIAID program staff, including organizing annual reverse site-visits at NIH.

Each Center will include a Scientific Advisory Board (SAB) that will act as an independent, external advisory body for the PD(s)/PI(s) but will not be involved in the day-to-day activities of the Center. The SAB will facilitate Go/No-Go decision making and recommend new research directions as appropriate. The SAB will participate in Center annual meeting(s) to review Center activities and evaluate progress, adherence to milestones and timelines, and the continued relevance of each Research Project to the overall Center objective(s). The SAB will also attend the separate annual Center reverse site-visit at NIAID. If requested by the PD(s)/PI(s) and NIAID Project Scientist, the SAB will provide a comprehensive written evaluation of the group's activities and recommendations following the annual reverse site-visit. Additionally, the SAB will be responsible for guiding and reviewing Center program-sponsored Developmental Research Projects and Mentored Projects. The SAB will include the PD(s)/PI(s) and at least 5 non-conflicted external advisors. For a Center engaged in preclinical product development activities, at least 2 of the external advisors must have demonstrated and relevant industry-level expertise. SAB membership will be established in consultation with NIAID program staff. Potential external SAB members MUST NOT be named in the application or contacted prior to completion of review activities.

The Administrative Core will also manage the Developmental Research Projects and Mentored Projects that take advantage of emergent technologies and new research opportunities.

• The key purposes of the Developmental Research Projects are expanding the scope and range of research, investigators, and institutions involved in antiviral discovery, allowing for testing of novel ideas (with little preliminary data), and developing new technologies. The use of Developmental Research Projects permits maximal flexibility to advance in directions that seem most scientifically fruitful; successful projects may also mature and replace full Research Projects that are no longer contributing significantly to the objectives of the Center. As a result, the scientific members of the Center may change during the award. The Developmental Research Projects may involve scientists associated with the Center or may extend to appropriate scientists outside the Center interested in contributing to the research platform of the Center.
• The goal of the Mentored Projects is to increase the availability of qualified researchers and other personnel for antiviral discovery research by providing opportunities to further their professional advancement. Mentored projects must relate to the Center objectives and may be used to support post-doctoral fellows, early career investigators, or senior investigators new to the field of antiviral discovery and development. NIAID recognizes a need to promote diversity in the biomedical research workforce and encourages its efforts to lead to opportunities for talented researchers from all groups including underrepresented racial and ethnic groups, persons with disabilities and women.

Scientific Cores

A Center may include one or more scientific cores to provide resources and/or facilities that are essential for the activities of two or more Research Projects. Scientific Cores are intended to only serve the needs of Center project researchers and they may not conduct research independent of the served Research Projects. In lieu of a Scientific Core, use of existing institutional core facilities may be included in specific Research Projects.

Research Projects

Each Center must include interdependent Research Projects focused on discovery, development and/or advancement of new or improved antivirals targeting select RNA viruses of pandemic potential, with a specific focus on SARS-CoV-2 or those with pan-coronavirus activity. Each Research Project must clearly and directly contribute to the Center platform approach and objective(s). The PD/PI will monitor all Research Projects and actively promote efforts that foster integration, collaboration and synergy across the projects. Research Project Leaders may be affiliated with either an academic organization or industry.

Research Projects are expected to incorporate state-of-the-art technology and approaches and may include consortium arrangements for required activities. Applicants are encouraged to carefully consider the scope and range of research proposed and develop a Center that is coherent overall and consistent with available resources and personnel.

Example AViDD Centers:

Center platforms and objectives may range from discovery and development of single or multiple antivirals targeting specific pathogens to development of modern technologies or platforms that target a wide array of pathogens, and activities may range from early basic and discovery-based efforts to late-stage preclinical development with industrial participation. Examples of hypothetical AViDD Centers follow:

Drug Discovery Targeting Viral Replication

• Administrative Core
• Scientific Core: Animal model development and candidate antiviral evaluation
• Research Project 1: Identification and validation of novel replication targets
• Research Project 2: Essential viral enzymes as targets for novel drugs with pan-CoV activity
• Research Project 3: Discovery of novel lead series targeting Nipah or Hendra virus replication
• Research Project 4: Discovery of novel lead series targeting replication in filoviruses
• Research Project 5: Preclinical evaluation of SARS-CoV-2 replication inhibitors as oral drug candidates

Novel Targets for Antiviral Drug Discovery

• Administrative Core
• Scientific Core: Target-based and antiviral screening assays for priority RNA viruses
• Scientific Core: Structural biology with representative targets from priority RNA viruses
• Research Project 1: Viral assembly processes as targets for novel drug discovery
• Research Project 2: Discovery of novel nucleoside/tide drugs with potential broad-spectrum antiviral activity
• Research Project 3: Identification and validation of novel (non-polymerase) targets important in viral lifecycles
• Research Project 4: Artificial-Intelligence to identify novel targets and drugs that inhibit viral lifecycles
• Research Project 5: Discovery of novel lead series targeting viral enzymes essential for replication

Novel Antiviral Drugs Targeting Proteases

• Administrative Core
• Scientific Core: Target-based and antiviral screening assays for priority RNA viruses
• Scientific Core: Medicinal chemistry for rapid expansion of SAR for lead series
• Research Project 1: Viral proteases as targets for novel drug discovery
• Research Project 2: Repositioning known antiviral protease inhibitors for pan-CoV activity
• Research Project 3: Harnessing host protein degradation pathways to discover novel inhibitors of viral proteases
• Research Project 4: Comparative Structural Biology of viral proteases to inform drug discovery
• Research Project 5: Preclinical Evaluation of SARS-CoV-2 drug leads targeting viral proteases

Applications including the following types of studies will be considered non-responsive and will not be reviewed:

• Projects that do not target coronaviruses (including SARS-CoV-2) and one or more pathogens from the viral families listed above.
• Antiviral approaches that block host targets or modulate host immune-response.
• Projects proposing the discovery and/or development of therapeutic monoclonal antibodies (mAbs), therapeutic polyclonal antibodies or plasma-based therapeutics.
• Projects proposing the discovery and/or development of a vaccine.
• Projects proposing repurposing of an FDA-approved drug.
• Clinical trials: Clinical research may be supported but not clinical trials. See NOT-OD-15-015 for the NIH Definition of a Clinical Trial.

For additional information about the Antviral Drug Discovery (AViDD) Centers for Pathogens of Pandemic Concern FOA, see "Frequently Asked Questions at https://www.niaid.nih.gov/research/avidd.

NIAID plans to hold a pre-application informational webinar for this FOA. Details about webinar registration will be available at this same link shortly after FOA publication. Participation in the webinar is not required to submit an application in response to this RFA.

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)

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

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

Applicant Organizations

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

• 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. 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.

Multi-PDs/PIs can only be named on the application level and are not allowed on the Research Project or Core level.

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).

Section IV. Application and Submission Information

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.

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:

Ann-Marie Brighenti, PhD
Telephone: 301-761-3100
Email: ann-marie.brighenti@nih.gov

Available Component Types	Research Strategy/Program Plan Page Limits
Overall	12 pages
Admin Core	12 pages
Core (use for Scientific Cores)	6 pages each
Project (use for Research Projects)	12 pages each

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
• Scientific Cores: optional, each Scientific Core must support at least two Research Projects
• Research Projects: required, minimum 5, maximum 10

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. with the following additional instructions:

Facilities & Other Resources

Describe any unique features in the environment and/or resources that make this a strong research program.

Include a section entitled BSL3/4 facilities detailing availability of adequate access to BSL3/4 biocontainment facilities to support the proposed Center platform. Applicants must identify all Research Projects within the application that will require BSL3/4 containment facilities and provide a description of facilities including those that are available currently or planned at either the applicant institution or though consortium institutions. A table format may be used to list each activity that requires BSL3/4 access and the likely facilities to be used. All information on BSL3/4 facilities should be contained in the Overall and not within individual Research Projects.

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: List in priority order, the broad, long-range objectives and goals of the proposed Center. Concisely describe the Center objectives.

Research Strategy: This narrative section summarizes the overall research plan for the multi-project application. The multi-project application should be viewed as a confederation of interrelated research projects, each capable of standing on its own scientific merit, but complementary to one another. This is an important section for it provides the group of investigators an opportunity to give conceptual wholeness to the overall program by giving a statement of the general problem area and by laying out a broad strategy for attacking the problems.

Applicants should clearly define the Center platform and its significance regarding the scientific approach in terms of discovery and development of antivirals against coronaviruses (CoVs) and select RNA viruses with pandemic potential. Discuss the rationale behind the overall approach and antivirals selected for development, the public health need and benefit of a successful effort, and the range of activities being pursued. Additionally, each application must detail how each Research Project contributes to the Center platform, objectives, and project interdependence. Applications should outline expected synergies provided by the proposed center structure and any other special features that make this application strong or unique.

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.

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 Administrative 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.

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.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core 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.

• The Core Lead must commit at least 0.6 (CY) person months effort per year to these responsibilities.
• Include funds for the overall administrative effort, collaborative activities, communications, and publications. Fees for services rendered by external SAB members are allowed.
• Include costs related to Regulatory expertise as defined effort or periodic consultation.
• Each Center application budget must include funds for the PD(s)/PI(s), Project Leaders, external SAB members, additional Center Key Personnel and postdocs/researchers/students (at the discretion of the PD/PI), to attend regular (at least annual) Center meetings for data presentation, progress evaluation and related activities.
• Each Center application budget must include funds for the PD(s)/PI(s), Project Leaders, external SAB members, additional Center Key Personnel (at the discretion of the PD/PI) to travel and attend annual mandatory reverse site-visits at NIAID in Years 1-4 of the project period.
• The Administrative Core budget should include all expenses necessary to support the Developmental Research Projects. Developmental Research Projects will initiate in Years 2 and 4 of the project period. Budgets should include estimates for the number and costs of Developmental Research Projects that are fully justified in the Budget Justification. The specific number of Developmental Research Projects to be supported is at the discretion of the Center leadership; however, total funding for these projects may not exceed $1,000,000 direct costs in any one year. Developmental Research Projects are limited for one or two years, with a range of $200,000 to $250,000 per project per year, direct costs. The Developmental Project Leader must commit at least 1.2 (CY) person months effort per year. Budgets for Developmental Research Projects can be requested in years 2-5 of the project period and must be completed by the award end date.
• The Administrative Core budget should include all expenses necessary to support Mentored Projects. Budgets may include salary and research costs of candidates, as well as other reasonable costs. Justification for all requested costs should be included in the Budget Justification. The specific number of Mentored Projects to be supported is at the discretion of the Center Leadership; however, no more than $600,000 direct costs may be requested in any one year. Mentored Projects are limited for up to three years. The activities must require that each candidate have a mentor and devote at least 9.6 (CY) person months effort per year to the project. Budgets for Mentored Projects can be requested in years 2-5 of the project period and must be completed by the award end date.

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: List in priority order, the broad, long-range objectives and goals of the proposed Core. In addition, state the core's relationship to the Center’s platform and how it relates to the individual Research Projects or other cores in the application.

Research Strategy: The Administrative Core must include a Management Plan that identifies and discusses: The Administrative Core structure, the roles of Administrative Core personnel, the facilitation of communications throughout the Center and with NIAID staff, and how a strong collaborative environment will be established within the program. The plan should specifically address continual evaluation of research and development progress, communications, group meetings and teleconferences, the identification and proposed resolution of problems and engagement of the NIAID staff as appropriate. A description of how consortia (subcontracts) will be managed should be provided and should include how communications such as periodic meetings and conference calls will be organized, managed and documented. The plan should also detail how Center and research-related travel will be managed.

Each Administrative Core must include the following:

Scientific Advisory Board:

Describe the composition and duties of the Scientific Advisory Board (SAB), including the categories of expertise to be represented on the SAB and how the SAB will be utilized to guide Center activities. The description should include a discussion of how the proposed expertise of the SAB will be integrated into the operations of the Center. Describe the procedures and approaches for obtaining SAB input via teleconferences, ad hoc and annual meetings, review of written materials/data, etc. If preclinical and/or product development activities are proposed in the application, the SAB must include at least two members with relevant industry-level experience and procedures for identification and selection of the SAB should be included. Candidates for the SAB MUST NOT be named in the application or contacted prior to completion of review activities.

Developmental Research Projects:

As the overall success of the Center will, in part, be determined by the choice of Developmental Research Projects and their growth into independent research grants to advance specific antivirals or related basic science studies, applicants must include a brief description for how topic areas for projects will be determined, how these topic areas fit into the Center platform, and procedures for soliciting applications for Developmental Research Projects; selecting the most promising projects for funding, consistent with the Center platform and overall Center goals; and monitoring success/productivity of the Developmental Research projects, including terminating them or promoting them to full project status. Developmental Research Project opportunities must be open and publicly announced. Discuss plans for creating opportunities for early career investigators and senior investigators new to the field. Developmental Research Projects will begin during the second and fourth years of the project period and the plan must address the management of the funds associated with the Developmental Research Projects. Applicants may not submit in their application detailed descriptions of projects or actual projects that would be supported by Developmental Research Project funds; these will be selected and approved after award.

Mentored Projects:

Provide a brief description of the policies, criteria, and processes for selecting candidates for Mentored Projects including special efforts to recruit qualified women and minorities. Include a description for how progress in Mentored Projects will be monitored. Solicitations must be open and publicly announced. Mentored Projects may support post-doctoral fellows, early career investigators, or senior investigators new to the field and who are interested in starting and pursuing research in the areas of antiviral discovery and development. Individual Mentored Projects are not intended for pre-doctoral candidates, nor are they appropriate for post-doctoral fellows who have been in a laboratory for more than six years. Do not submit projects for specific individuals; these will be selected and approved after award. Individual Mentored Projects may initiate in any of Years 2-5 of the project period, may not exceed three years, and must be completed by the end of the project period.

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.

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 Insert Name.

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.

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.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core 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.

The Core Leader should commit to the Core at least 1.2 (CY) person months of effort per year.

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: List in priority order, the broad, long-range objectives and goals of the proposed Core. In addition, state the core's relationship to the Center platform and how it relates to the individual Research Projects or other cores in the application.

Research Strategy: Describe and justify the role of the Core in the overall Center research activities, describe how the proposed Core activities will contribute to meeting the Center's goals and objectives, specify how a proposed scientific Core provides a unique service that cannot be obtained through institutional or commercial means, and explain the rationale for selection of the general methods and approaches proposed to accomplish the specific aims. In addition, this section should indicate the relevance of the Core to the primary objectives of the application. Provide details of the services or resources provided by the optional Cores to at least two Research Projects and clarify how the optional Cores are not duplicative of other services or facilities. Additionally, plans for staffing, managing, and prioritizing use of the Cores must be provided, as well as plans for determining fees to users if charging fees is necessary.

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.

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 Insert Name.

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.

Facilities and Other Resources: Note all information for BSL3/4 facilities must be addressed for the application in the Overall section.

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.

• 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.

Each project leader must commit at least 1.2 person months effort per year to their project.

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: List, in priority order, the broad long-range objectives and goals of the proposed project. Concisely describe the translational activities to be performed. In addition, state the individual research project's relationship to the Center platform and how it relates to other Projects or Cores.

Research Strategy: Use this section to describe how the proposed research will contribute to meeting the Center objectives and explain the rationale for selecting the methods to accomplish the specific aims. In addition to stating the biological significance of the research, indicate the project's relevance to the primary objectives of the program.

Describe the research design, conceptual procedures, and analyses to be used to accomplish the specific aims of the project. Describe any new methodology and its advantage over existing methodologies. Describe any novel concepts, approaches, tools, or technologies for the proposed studies. Discuss the potential difficulties and limitations of the proposed procedures and alternative approaches to achieve the aims. As part of this section, provide a tentative sequence or timetable for the project. NIAID requires Centers to include industry expertise actively participating in projects pursuing later-stage antiviral development to ensure access to high-quality chemical libraries and input of medicinal chemistry and pharmacology expertise. As applicable, describe how industry partners will be identified and incorporated into the proposed project to facilitate discovery, candidate evaluation and/or product development. For the purpose of this FOA, "industry" is defined as a large or small, domestic or foreign, pharmaceutical, biotechnology, bioengineering, or chemical company, or a related non-profit entity. Additionally, each Center will consider anticipated regulatory barriers for the targeted antiviral or technology, particularly for new classes of drugs for which there are no precedents for FDA approval. Describe anticipated regulatory barriers and propose research and/or strategies to overcome these barriers. For a project where multiple and/or complementary expertise is required, discuss plans for coordination among investigators and other collaborators and process to overcome obstacles to achieve the Center aims.

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.

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.

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

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.

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.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Program 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 Program 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 Program that by its nature is not innovative may be essential to advance a field.

Does the Program 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 Program 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 for the FOA:

Does the application have a single clearly defined and scientifically justified platform that supports the scientific goals of the FOA? Does the Center as a whole leverage scientific gains and synergy by combining the component projects into a multi-project program beyond the gains achievable if each project were pursued independently? Is the overall Center platform significant and focused on studies that increase knowledge needed to advance antiviral targets and/or drug discovery? How well does the overall program incorporate innovative concepts and approaches? Is the program as a whole cohesive and do the Research Projects and Cores relate to a common objective demonstrating cohesion, multidisciplinary interactions, coordination, and synergy?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the Program? 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?

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?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Program? 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 Program involves human subjects and/or NIH-defined clinical research, are the plans to address:

1) the protection of human subjects from research risks, and

2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific for the FOA:

Does the approach take into consideration the anticipated regulatory process and any anticipated regulatory barriers?

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?

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 Program 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 Program 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?

Are the Project Lead(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-Project Lead(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Specific for the FOA:

Is the proportion of academic and industry effort appropriate for the project? Is there appropriate and adequate representation of investigators with the necessary drug discovery and development experience and expertise? Are academic and industry partners sufficiently coordinated to facilitate discovery, candidate evaluation and/or product development?

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?

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

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?

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.

Is the administrative and organizational structure appropriate and adequate to achieve the goals of the proposed program? Is the Management Plan for fiscal accountability and communication within the program appropriate? Are the plans for coordination and the establishment of a strong collaborative environment for the program appropriate? Are plans for communication among the Centers adequate to facilitate collaborative activities? Do the PD/PI and Key Personnel commit sufficient time and effort to adequately manage the Program?

For the Mentored Projects, are there adequate merit, feasibility and level of creativity for the proposed approaches to increase the human resources available for antiviral research, including recruitment of sufficient qualified postdocs and early career or senior investigators new to the antiviral field and plans for the inclusion of women and minorities?

Is the Core sufficiently justified? Does it adequately support at least two Research Projects? Is the core appropriately connected to the central focus of the overall program? Are the facilities or services provided by the core (including procedures, techniques, and quality control) high quality? Will the services be used effectively? Are the core leader and key personnel well qualified and is there an adequate commitment of time?

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.

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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 National Institute of Allergy and Infectious Diseases 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 to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA . Following initial peer review, recommended applications will receive a second level of review by the National Advisory Allergy and Infectious Diseases Council . 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.

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.

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.

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.

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

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. 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 OMB administrative guidelines, HHS grant administration regulations at 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:

PD(s)/PI(s), will have the primary responsibility for coordinating the Projects and Cores within the overall Program. Specifically, the PD(s)/PI(s) have primary responsibility as described below.

• The PD(s)/PI(s) will be responsible for defining the research objectives, approaches and details of the projects within the guidelines of the FOA and retains primary responsibility for the planning, directing, and executing the proposed scientific activities.
• The PD(s)/PI(s) will monitor all Research Projects and actively promote efforts that foster integration, collaboration, and synergy across the projects.
• The PD/PI and Administrative Core staff are responsible for ensuring that appropriate systems are in place to provide for biosafety and security of materials, data, facilities and resources, including compliance with regard to Select Agent Regulations, Biosafety in Microbiology and Biomedical Laboratories (BMBL) Guidelines, Centers for Disease Control and Prevention and the National Institutes of Health, sixth Edition; U.S. Code of Federal Regulations 42 C.F.R. Part 73, 7 C.F.R. Part 331, and 9 C.F.R. Part 121.

In addition, the PD(s)/PI(s) will be responsible for:

• Organizing and chairing annual reverse site-visit activities. The annual reverse site-visits are anticipated to be held at a location at/near Rockville, MD or at another NIAID-approved site and will last up to 2 days. Symposia including representatives from all AViDD Centers may be organized during years 2-5 of the award period.
• Making sure that the NIAID Data Sharing Plan is properly implemented by the personnel of the Research Projects and Cores
• Advertising the availability of the Program generated resources through outreach activities.

Awardees 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 HHS, PHS, and NIH policies.

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

The role of the NIAID Project Scientist is to support and encourage the recipient's activities by substantial involvement as partners and facilitators in the process without assuming responsibilities that remain with the PDs/PIs. The NIAID Project Scientist will work closely with the PD(s)/PI(s) and other Program member scientists to facilitate collaborations and to leverage the resources available to the AViDD Program.

The NIAID Project Scientist will monitor the progress of the Program, help coordinate research approaches among all Programs funded through the FOA and contribute to the shaping of research projects or approaches as warranted. The NIAID Project Scientist will support and facilitate this process but will not direct it.

The NIAID Project Scientist will keep the Program informed about other ongoing studies supported by NIAID to avoid duplication of effort and encourage sharing/collaboration in infectious diseases research. The NIAID Project Scientist will coordinate access for the Program to other NIAID resources, as well as assist the research efforts of the Program by facilitating access to fiscal and intellectual resources provided by industry, private foundations, NIH intramural scientists and other federal government agencies as appropriate.

The NIAID Project Scientist will retain the option to recommend withholding or reduction of support from any cooperative agreement that substantially fails to achieve its goals according to the milestones agreed to at the time of the award or fails to comply with the Terms and Conditions of the award.

Additionally, a NIAID program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The assigned program official may also serve as the NIAID Project Scientist.

Areas of Joint Responsibility include:

• The NIAID Project Scientist and the PD/PI will hold regular program-wide discussions to facilitate the achievement of program goals.
• The PD(s)/PI(S) and the NIAID Project Scientist will collaborate in the establishment of the Scientific Advisory Board.

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 DHHS 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. Funds awarded using appropriations provided by the American Rescue Plan Act 2021 will be issued in unique subaccounts in the HHS Payment Management System, and will require separate financial reporting from any other funds awarded.

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.

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

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

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

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

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

Michael Schaefer, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240.627.3364
Email: mschaefer@niaid.nih.gov

Ann-Marie Brighenti, PhD
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-3100
Email: ann-marie.brighenti@nih.gov

Jordan Kindbom
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2983
Email: Jordan.kindbom@nih.gov

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.