Part 1. Overview Information

Key Dates

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

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

No late applications will be accepted for this Funding Opportunity Announcement.

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

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

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

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose

The National Institute of Allergy and Infectious Diseases (NIAID) supports complementary research programs to understand, control and prevent viral diseases and related pandemics. As part of pandemic preparedness planning, the purpose of this Notice of Funding Opportunity (NOFO) is to solicit applications for a Coordination and Data Sharing Center (CDSC) for the Research and Development of Vaccines and Monoclonal Antibodies for Pandemic Preparedness (ReVAMPP) Network. The ReVAMMP Centers, supported by separate companion NOFOs (RFA-AI-23-019 and RFA-AI-23-020), will consist of multi-project cooperative agreements that establish comprehensive, cooperative basic, and translational research Centers to carry out in-depth research on prototype members of select virus families that have the potential to emerge as pandemic pathogens. Together the CDSC and ReVAMPP Centers will form the ReVAMPP Network. This new Network will align with the goals of the American Pandemic Preparedness Plan: Transforming Our Capabilities (AP3), which was announced in September 2021, and recognizes the need for a trans-government investment and response to combat future pandemics and NIAID's Pandemic Preparedness Plan. 

Background

The emergence and re-emergence of infectious diseases continues to threaten the health of Americans and people worldwide. Over the past two decades, the public health community has responded to emerging infectious diseases including those caused by Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-1), the 2009 H1N1 influenza virus, Middle East Respiratory Syndrome Coronavirus (MERS-CoV), Ebola virus, Zika virus, and most recently, SARS-CoV-2. The global pandemic caused by SARS-CoV-2 further underscored the continual threat of newly emerging and re-emerging pathogens and the critical value of basic and translational research for pandemic preparedness. Continuing to build a robust basic research portfolio and advancing translational science for other viral families with pandemic potential is essential for biomedical countermeasure preparedness. To mitigate risks associated with emerging or re-emerging pathogens, NIAID’s intent for the ReVAMPP network, consisting of the CDSC and ReVAMPP Centers, is to promote focused and coordinated research needed to develop vaccines and monoclonal antibodies (mAbs) for prototype-pathogens from viral families known to infect humans (Cassetti MC, et al. JID. 2022;jic296, Graham BS and Corbett KS J Clin Invest. 2020;130(7):3348–3349).

The unprecedented rapid development of vaccines and mAbs for SARS-CoV-2 was enabled by decades of foundational research on related coronaviruses which allowed scientists to quickly and effectively respond once SARS-CoV-2 emerged. Likewise, in responding to pandemics over the last two decades, we have learned that the optimal strategy to prepare for the next one is to adopt a model of advanced, preparatory global coordination of scientific research and response efforts. Strategic, advanced programmatic coordination of existing and new pandemic preparedness networks will allow us to leverage and synergize valuable research findings/outputs and funding, including the discovery and development of potential shared reagents, assays, models, vaccine platforms, etc.  A separate, but integrated team of administrators, communicators, and data science experts embedded within the research network will play a key role, in translating the successes of the network and will allow our investigators and our Institute to prepare in advance to rapidly share information with key stakeholders across the globe when a new pandemic/outbreak occurs. 

Research Objectives and Scope

The objective of this NOFO is to establish a comprehensive CDSC to support the ReVAMPP Centers. The CDSC is expected to establish and maintain a collaborative ReVAMPP Network platform for data sharing to harmonize reagents, tools, assays, models and exchange knowledge on structure/function-based vaccine solutions and antigen/immunogen design as well as assess the utility of vaccine technology platforms for virus families studied across the ReVAMPP Network. The CDSC is also expected to facilitate effective communications across the ReVAMPP Centers by scheduling and managing all network-wide meetings, tracking overall network progress and outputs, developing opportunities for collaboration among the Centers, such as establishing working groups, and under the direction of NIAID program, collating information and facilitating exchange and dissemination with other NIAID/NIH Programs, U.S. Government (USG) partners and other key stakeholders, including the World Health Organization (WHO), Bill & Melinda Gates Foundation (BMGF), and Coalition for Epidemic Preparedness Innovations (CEPI) among others as appropriate.

The CDSC will develop new or reuse and adapt existing data sharing platforms and data templates for all types of data generated by the ReVAMPP Centers which may include building on publicly available platforms and templates within other NIAID-supported programs such as ImmPort.  These platforms and templates may include those related to reagents, tools, assays, models, vaccine technology platforms, immune epitope design and/or correlates of protection. The CDSC will also develop, in conjunction with NIAID and the ReVAMPP Centers’ PD(s)/PI(s), a network wide ReVAMPP governance structure and provide guidance as to engagement with stakeholders within and outside the research centers.

This NOFO will utilize a bi-phasic, milestone-driven cooperative agreement award mechanism with the UG3 Phase consisting of the first 3 years, and UH3 Phase consisting of years 4 and 5.  Although applicants will apply for five years of funding, near the end of year 3, grantees will submit a transition package for the UH3 Phase which will be evaluated by NIAID program staff for progress towards the development of Network data sharing platforms and facilitation of Network communication and collaboration. The administrative review will be based on successful achievement of milestones included in the application and negotiated with the recipient prior to award, overall network advancement, and the availability of funding. 

CDSC Structure

Administration and Leadership Team

In consultation with the ReVAMPP Centers, the CDSC Administration and Leadership Team will be responsible for establishing a comprehensive coordination and communications plan to support the ReVAMPP Network. They will coordinate and facilitate communications across the ReVAMPP Centers and between each ReVAMPP Center and NIAID by scheduling and managing all network-wide meetings, and tracking overall network progress and outputs, and establishing opportunities for the Centers to collaborate such as the establishment of working groups. Specifically, the CDSC Administration and Leadership Team will track and coordinate sharing of reagents, tools, and assays to ReVAMPP Centers and collaborating researchers to support the development of translational products including vaccines and mAbs. 

In cooperation with NIAID, the CDSC Administration and Leadership Team will provide summary information and coordinate information exchange with other NIAID Programs, USG partners and key stakeholders, including the WHO, BMGF and CEPI, among others as appropriate. 

The CDSC Administration and Leadership Team will also provide oversight of the implementation of all activities that facilitate progress and completion of the overall goals of the ReVAMPP Network. The CDSC will coordinate and organize a ReVAMPP Network-wide review meeting annually in the Rockville, MD area or other NIAID approved site with the format to be determined by NIAID.

The CDSC will be required to attend an annual CDSC progress meeting to evaluate progress and effectiveness as a coordination and data center. Adherence to timelines related to ReVAMPP Network tracking, working group outputs, data platforms and template establishment will be assessed. As part of an annual review, the CDSC will be required to set up 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 CDSC. On an annual basis, the SAB will provide feedback related to effectiveness and appropriateness of programmatic duties of the CDSC as stated in the NOFO by providing a short, written summary of their findings. The SAB will include at least 3 non-conflicted external advisors with appropriate 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 CDSC Administrative Leadership Team will assist the ReVAMPP Centers with managing quality and regulatory oversight pertaining to human subjects’ research as needed. 

The CDSC will also develop a ReVAMPP Network governance structure in conjunction with NIAID and the ReVAMPP Centers’ PDs/PIs and provide guidance as to engagement with stakeholders within and outside the research centers.

Data Management and Analysis Team

The ReVAMPP CDSC Data Management and Analysis Team will be responsible for establishing a comprehensive data sharing center to support the ReVAMPP Centers and the overall Network. 

The CDSC will foster and build upon the open-science policy by establishing and maintaining a public facing website and privately accessible (to Network members only) web portal, as well as develop an appropriate data sharing platform and templates for all types of data generated by the ReVAMPP Centers. The CDSC is expected to collaborate with other NIAID-supported data management programs, post award, to leverage existing data and metadata standards and templates. The CDSC will create a network-wide terms of confidentiality agreement to be signed by all ReVAMPP Centers for data and information shared within the ReVAMPP Network. Data will be shared confidentially within the Network to harmonize information/data related to reagents, tools, assays, animal models, vaccine technology platforms, immune epitope design and/or correlates of protection. This will allow the Network to accelerate translational research and the development of prototype vaccines and mAbs for viruses of pandemic concern. This team will serve as the hub for expertise with sharing data portal(s) as approved by NIAID. The CDSC will also work with the ReVAMPP Centers as instructed to develop efficient study designs and statistical calculations and provide support for the preliminary and final data analyses. 

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

• Clinical trials: Clinical research may be supported but not clinical trials, as defined by the NIH (https://grants.nih.gov/policy/clinical-trials/definition.htm).
• Applications that do not include a clear section on Milestones with Go/No-Go criteria

This NOFO solicits applications for the ReVAMPP Coordinating and Data Sharing Center (CDSC) that will oversee data coordination and sharing for the ReVAMPP Centers in the ReVAMPP Network. For ReVAMPP Center programs proposing research on virus families from Flaviviridae and Togaviridae see the companion NOFO, RFA-AI-23-019 and on virus families from Bunyavirales, Paramyxoviridae and Picornaviridae see the companion NOFO, RFA-AI-23-020. 

For additional information about the Research and Development of Vaccines and Monoclonal Antibodies for Pandemic Preparedness (ReVAMPP) Network - Coordination and Data Sharing Center (CDSC), see "Frequently Asked Questions (FAQ)" link here: https://www.niaid.nih.gov/grants-contracts/questions-and-answers-revampp-funding-opportunities. 

Webinar Announcement

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

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

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

Local Governments

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

Federal Government

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

Other

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

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

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

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

Applicant Organizations

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

• System for Award Management (SAM)– Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

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

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

Applicants to this NOFO will not be eligible to submit to or participate in the companion ReVAMPP Centers NOFOs (RFA-AI-23-019 and RFA-AI-23-020) because of the unique, centralized role of the CDSC in ReVAMPP Network coordination and communication. 

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

Letter of Intent

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

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

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

The letter of intent should be sent to:

Noton Dutta, Ph.D.  
Telephone: 240-669-2857 
Email: [email protected]

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

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

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

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

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

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

Within the biosketch, describe experience coordinating large research networks, with use of and/or coordination of databases, and experience working with large international research programs including NIH, NIAID, USG and international agencies.

R&R Budget

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

Include funds for the overall administrative effort, collaborative activities, communications, and publications. 

Include funds for the PD(s)/PI(s), Project Leaders, external SAB members, additional CDSC Key Personnel (at the discretion of the PD(s)/PI(s)) to travel and attend annual mandatory CDSC progress meetings at NIAID in Years 1-4 of the project period. 

Include funds to plan, coordinate, and organize logistics for the annual ReVAMPP Network-wide review meetings to be held approximately over 1-3 full days in the Rockville, MD area or other NIAID approved site. Additional funds must be included for the PD(s)/PI(s), Project Leaders, and additional CDSC Key Personnel to travel to, attend, and run these meetings, which will be held annually. 

Include costs associated with submission of and depositing of all relevant data, tools, etc. into publicly accessible portal(s) approved by NIAID.

R&R Subaward Budget

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

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

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

Specific Aims:

List in priority order, the broad, long-range objectives, and goals of the proposed CDSC. Concisely describe the CDSC objectives with respect to oversight and coordination of the ReVAMPP Network and data management.  

Research Strategy: 

Administrative and Leadership Team Plan:  

Describe the administrative and organizational structure of the CDSC Administrative and Leadership Team. Include the unique features of the organizational structure that serve to facilitate accomplishment of the long-range goals and objectives. 

Describe how communications will be planned, implemented, and provided to collaborators, ReVAMPP Centers and stakeholders. Specifically address how the CDSC Administrative and Leadership Team will communicate with ReVAMPP Centers and NIAID to ensure coordination and collaboration across the ReVAMPP Network, for example, by establishing working groups. Describe plans to coordinate and facilitate collaborations with USG, international agencies and other partners including industry and private sector. Describe how unified network-wide policies around resource sharing within the Network and outside of the Network will be established in consultation with the ReVAMPP Centers.

Describe strategies for oversight and implementation of standardized approaches to ensure efficient cooperation, communication and coordination across the multiple Centers and collaborators. 

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 CDSC 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. Candidates for the SAB MUST NOT be named in the application or contacted prior to completion of review activities.

Data Management and Analysis Team Plan: 

Describe internal and external data acquisition strategies to achieve harmonization of systems and procedures for data management, data quality, data analyses, and dissemination for all data and data-related materials generated by the ReVAMPP Centers and the overall Network. 

Describe plans for development of infrastructure and capacity to manage, store, analyze, and share large, diverse datasets including the use of publicly available data-sharing platforms and templates when appropriate.

Describe the quality control procedures for the data, and how to identify and resolve issues with quality control that maintains data integrity.

Describe how the CDSC will provide support to the ReVAMPP Centers to develop efficient study designs and statistical calculation and for preliminary and final data analysis as needed.

Describe the plans for development of a public-facing website and network-only portal for sharing data.

Milestone Plan:

In a clearly labeled section titled "Project Milestones and Timelines", applicants must describe specific quantifiable, planned milestones by annum, and include annual timelines for coordinating the overall ReVAMPP Network and for tracking progress from ReVAMPP Centers, including collaborators, and stakeholders.  Describe how key milestones for the Network will be established in year 1 of the grant including data sharing infrastructure and communications plan. This plan must include criteria to be met by the end of Year 3 of the award for continuation to the UH3 phase. Milestones must specify the outcome(s) for each activity. Milestone criteria should not simply be a restatement of the specific aims.  Milestones should be quantifiable and include the completion of major CDSC activities, for example: development of a network-wide governance structure, a network communication plan, data sharing platforms and data templates; establishment of procedures for data management, data quality, data analyses, and dissemination for all data and data-related materials generated by the Centers; coordination and organization of network-wide meetings; establishment of an internal ReVAMPP network web portal and public facing website; and creation of a stakeholder engagement strategy for the Network.  A Gantt chart or equivalent tool should be used to describe the associated timelines and identified outcomes of the CDSC.

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. 

Other Plan(s):

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

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

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

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

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

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

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

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

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

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

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

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by NIAID, 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.

Section V. Application Review Information

1. Criteria

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

Overall Impact

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

Scored Review Criteria

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

Significance

Does the 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?

Investigator(s)

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

Specific to this NOFO: To what extent do the investigators have experience and expertise both in data and administrative management of large scientific/translational research programs?  To what extent do the investigators have relevant experience working with USG and other international agencies related to coordination of efforts? How adequate are the time and effort dedicated by the investigators and other key personnel to the CDSC based on the activities proposed?