Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Allergy and Infectious Diseases (NIAID)

Funding Opportunity Title

Emerging Infectious Diseases Research Centers - Coordination Center (U01 Clinical Trial Not Allowed)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-AI-19-029

Companion Funding Opportunity

RFA-AI-19-028, U01 Research Project – Cooperative Agreements  

Catalog of Federal Domestic Assistance (CFDA) Number(s)

  93.855

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to solicit applications for an Emerging Infectious Diseases Research Centers Coordination Center (EIDRC CC) for the Emerging Infectious Diseases Research Centers (EIDRC). The EIDRC CC will oversee and coordinate select aspects of each EIDRC’s research project(s) involving data management, sample collection and storage, sharing of reagents, diagnostics, and resources, and will facilitate collaboration between the newly awarded EIDRCs, and other USG and international agencies, as appropriate. 

Key Dates
Posted Date

March 5, 2019

Open Date (Earliest Submission Date)

May 28, 2019

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

June 28, 2019, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

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.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

November 2019

Advisory Council Review

January 2020

Earliest Start Date

March 2020

Expiration Date

June 29, 2019

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Research (R) 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.


There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.
  4. Table of Contents

    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

    Part 2. Full Text of Announcement
    Section I. Funding Opportunity Description

    The purpose of this Funding Opportunity Announcement (FOA) is to solicit applications for an Emerging Infectious Diseases Research Centers Coordination Center (EIDRC CC) for the Emerging Infectious Diseases Research Centers (EIDRC, companion RFA-AI-19-028).  The EIDRC CC will oversee and coordinate select aspects of each EIDRC’s research project(s) involving data management, sample collection and storage, sharing of reagents, diagnostics, and resources and will ensure collaboration between the newly awarded EIDRCs, and other United States Government (USG) and international agencies, as appropriate. 

    The EIDRC CC will be responsible for overall coordination and communications among the EIDRCs network and for implementing alternate plans including redirecting research and/or sharing of resources and expertise in the event of an outbreak when a rapid and coordinated response is vital to stemming the spread of a pandemic. The EIDRC CC will also be key to interfacing with wider USG entities and other agencies to make available reagents in support of diagnostics, therapeutics and vaccines.

    Background

    A core component of the NIAID mission in the 2017 Strategic Plan is to “develop flexible domestic and international capacity to efficiently undertake research required in response to newly emerging threats wherever they occur.”  Clearly, recent infectious pathogens with significant potential to threaten the United States are emerging /re-emerging with increasing frequency (e.g., Hantavirus Pulmonary Syndrome in 1993, Nipah virus in 1998-99, West Nile virus in 1999, Rift Valley Fever virus in 2006-07, Chikungunya virus in 2013-14, Ebola virus in 2014-15, 2018, Zika virus in 2015-16, and yellow fever virus in 2016-17). Most of these naturally occurring outbreaks have been caused by RNA viral pathogens characterized by zoonotic reservoirs and/or arthropod vectors propagating transmission to humans. These outbreaks have revealed gaps in the NIAID research infrastructure that impact the ability to respond rapidly and effectively to these emerging pathogens; obtaining contemporary knowledge of the pathophysiology and natural history, accurate detection/diagnosis of the infections, and development of critical research and product development reagents were challenges during previous outbreaks. 

    This FOA and its companion will serve as important components of the broader NIAID strategy for pandemic preparedness by establishing infrastructure and scientific expertise in geographic regions of the world that are prone to emerging and re-emerging infectious diseases. The EIDRCs  will draw on skills from teams of multidisciplinary scientists, including infectious disease clinicians, epidemiologists, virologists, clinical microbiologists, veterinarians, and entomologists, to conduct field studies of endemic diseases that have the greatest potential of becoming pandemic threats, such as zoonotic and vector-borne viruses, develop reagents for the broader research community and have the flexibility and ability to re-direct work among the EIDRCs in the event of an outbreak to mount a rapid and effective research response.

    Research Objectives and Scope

    The Emerging Infectious Diseases Program comprised of the EIDRC CC and the EIDRCs, is designed to improve our knowledge of emerging and re-emerging infectious diseases, complement and leverage existing NIAID international research efforts when possible, and allow NIAID to develop the flexibility and capacity to respond rapidly and effectively to outbreaks where they occur.  The program as a whole is designed to improve our knowledge of the natural history, incidence, and prevalence of emerging/re-emerging infectious diseases. In many instances, re-emerging pathogens circulate at low levels for several years before breaking out and causing major public health problems, in other cases new pathogens emerge rapidly.

    The EIDRC CC should be well positioned to interface and coordinate efforts of the EIDRC network with other USG and international agencies and programs conducting complimentary studies so as not to duplicate efforts, but also to identify synergies and opportunities to leverage existing resources, when possible.  The EIDRC CC will have relevant scientific and administrative expertise to provide oversight and coordination for the EIDRCs working in one or more geographic areas located within the tropical or subtropical regions of the world (Tropics: latitude between 23.5o -Tropic of Cancer and Capricorn- Subtropics: between tropic and temperate zones (35-66.5o N and S of the equator). Importantly, the EIDRC CC will oversee and administer a pilot research program conducted by the EIDRCs with the aim to develop expertise among the next generation of investigators and in-country scientists in emerging infectious disease research while expanding regional research capacity.

    EIDRC CC Structure

    Administration and Leadership Team

    The EIDRC CC Administration and Leadership Team (CC Admin Team) will be responsible for organizing, coordinating, and facilitating communications with the individual EIDRCs and NIAID and for providing oversight for the implementation of activities that facilitate progress and completion of the overall goals of the EIDRC and NIAID.  The CC Admin Team also will implement alternate plans for the EIDRCs in the event of an outbreak. Beginning in the second year of the award and in consultation with NIAID, the CC Admin Team will develop, solicit, review and award pilot research projects to the EIDRCs. The CC Admin Team also will assist in providing reagents, tools and assays to other EIDRCs and researchers to support the development of translational products such as therapeutics and vaccines.  They will also assist the External Advisory Committee (EAC) and NIAID to coordinate and organize the annual review of the Emerging Infectious Diseases Program (both the EIDRCs and the EIDRC CC).

    Data Management and Analysis Team

    The Data Management and Analysis Team for the EIDRC CC is responsible for providing guidance to standard sample collection and storage, oversight and inventory of data and biological samples, including: harmonization, quality control, and uniformity of data collection processes, troubleshooting data system problems and developing solutions. This Team also is responsible for receiving data and samples from the EIDRCs and directly depositing all relevant data, samples, reagents, tools, etc. as outlined to the appropriate databases and repositories, as well as adhere to appropriate NIH and EIDRC CC guidelines on quality and regulatory oversight pertaining to human subjects’ research.  Team members will also work with the EID CC and EIDRC Administration and Leadership Teams as instructed to develop efficient study designs and statistical calculations and provide support for the preliminary and final data analyses for the study.  This team will serve as the hub for expertise with sharing data portal(s) as approved by NIAID.

    External Advisory Committee (EAC)

    One External Advisory Committee, comprised of experts in the field outside of the EIDRCs and EIDRC CC, will be established after award to review progress for the Emerging Infectious Diseases Program (EIDRCs and EIDRC CC) and to share recommendations for the program with NIAID as part of the annual programmatic review meeting. For each EIDRC, the EAC will make recommendations to the CC regarding the continuation or re-direction of the research program(s), in addition to assessing each EIDRC’s progress in the areas of collaboration and coordination with the other EIDRC.  For the EIDRC CC, progress will be assessed based on the EIDRC CC’s ability to manage data and sample collection across all the EIDRC, meet timelines, coordinate calls and meetings, and administer the pilot research program, as well as execute other duties and tasks. Note that applicants should not name or contact potential EAC members in their application.

    Annual Programmatic Meetings

    The EIDRC CC will develop, plan and coordinate an annual program meeting to include the PD/PI(s) and key personnel of the EIDRCs, to articulate and establish the major roles and functions of the program and to facilitate collaborations, provide progress reporting, seek new research directions and ideas, and update NIAID on issues of need.  These meetings will be attended by the PD(s)/PI(s), Key personnel, NIAID staff, and the EAC membership, and will be held in the Washington DC area.  

    Applications proposing any of the following topic areas will be considered nonresponsive and will not be reviewed:

    • Applications that focus on pathogens that are not on the NIAID list of Emerging diseases (https://www.niaid.nih.gov/research/emerging-infectious-diseases-pathogens) Program focus should be emerging/remerging viruses, but if studying coinfected population with a pathogen not on the Emerging Diseases list, application should include a strong justification and rationale for inclusion.
    • Pathogens already studied by other NIAID funded networks, such as influenza, tuberculosis, malaria, antibiotic resistant pathogens Please contact the Scientific/Research Contact if further clarification is needed.  
    • HIV, SIV or AIDS studies.
    • Genome-wide association studies (GWAS).
    • Behavioral research.

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

    Section II. Award Information
    Funding Instrument

    Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

    Application Types Allowed

    New

    The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

    Clinical Trial?

    Not Allowed: Only accepting applications that do not propose clinical trials

    Need help determining whether you are doing a clinical trial?

    Funds Available and Anticipated Number of Awards

     NIAID intends to commit $1M in FY 2020 to fund 1 award.

    Award Budget

    Recommended budgets for direct costs of up to $ 500,000 per year may be requested.    

    Award Project Period

     The scope of the proposed project should determine the project period. The maximum period is 5 years.  

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

    Section III. Eligibility Information
    1. Eligible Applicants
    Eligible Organizations

    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)

    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)
    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.

    Required Registrations

    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.
    • 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.

    Eligible Individuals (Program Director/Principal Investigator)

    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.

     Applicants for an EIDRC (RFA-AI-19-028) may also apply to this FOA.

    2. Cost Sharing

    This FOA 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.  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
    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 FOA. 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 Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement 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:

    Eleazar Cohen, Ph.D.
    Telephone: 240-669-5081
    Email: ecohen@niaid.nih.gov


    Page Limitations

    All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following additional instructions:

     For this specific FOA, the Research Strategy is limited to 30 pages.

    Instructions for Application Submission

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

    SF424(R&R) Cover

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

    SF424(R&R) Project/Performance Site Locations

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

    SF424(R&R) Other Project Information

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

    SF424(R&R) Senior/Key Person Profile

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

    Within the biosketch describe experience with use of and/or coordination of databases and repositories for large international research programs highlighting experience with NIH, NIAID, USG and international agencies.

    R&R or Modular Budget

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

    In Year 01, include funds in the budget for the PD(s)/PI(s), collaborators, key personnel, and up to eight members of the EAC to travel and attend a kickoff meeting to be held shortly after the award over 1 full day in the Bethesda, MD area. Beginning in Year 02 include funds in the budget for an annual program meeting to be held over two full days in the Bethesda, MD area.  Do not include costs associated with organizing and holding the kickoff or annual program meetings.

    Include costs associated with submission of data into publicly accessible portal(s) approved by NIAID.  Also include costs associated with biological sample collection, processing, shipping, and storage. Also include costs for depositing all relevant data, samples, reagents, tools, etc. to the appropriate databases and repositories.

    For year 02 and annually after, include funds for implementing a $500,000 pilot research program (5-10 pilot projects).

    R&R Subaward Budget

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

    PHS 398 Cover Page Supplement

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

    PHS 398 Research Plan

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

    Specific Aims: Describe the specific aims of the EID CC with respect to oversight and coordination of a large multi-site international research program.

    Research Strategy:

    In a clearly labeled section entitled “Administrative Plan”:

    • Describe the administrative and organizational structure of the EIDRC CC Administrative and Leadership Team (CC Admin 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, teams, or sites. Specifically address how the CC Admin Team will communicate with EIDRCs and NIAID to ensure coordination and collaboration across the Emerging Infectious Disease Program.
    • Describe strategies for oversight and implementation of standardized approaches to ensure efficient cooperation, communication and coordination across the multiple sites and Team structures. 
    • In addition to day-to-day plans and process for oversight and coordination between the EIDRC CC and the EIDRCs, provide clear plans for coordination and facilitation and overall collaboration between and among the EIDRCs, local Ministries of Health (MOH), and NIAID if/when an outbreak occurs.
    • Highlight how the proposed staffing plan incorporates scientific and administrative expertise that incorporate and leverage experience to fulfill the goal to develop the flexibility and capacity to respond rapidly and effectively to outbreaks in emerging infectious diseases in an international setting.
    • Describe the overall management approach, including how resources will be managed, organized, and prioritized, and how subcontracts and consultants, if applicable, will be selected/funded and monitored.

    In a clearly labeled section entitled "Data Management Plan":

    • Provide a plan for standard sample collection and storage, oversight and inventory of data and biological samples for the Emerging Infectious Diseases Program.
    • 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 EIDRCs. Within the plan, indicate the extent to which dedicated systems or procedures will be utilized to harmonize the acquisition, curation, management, inventory and storage of data and samples.  Describe process and procedures for receiving data and samples from the EIDRCs and directly depositing all relevant data, samples, reagents, and tools to databases and repositories.
    • Describe how training for the data and sample collection, in terms of the use of electronic data capture systems, will be provided to all staff including those at enrollment sites.
    • Describe the quality control procedures for the data and biological specimens, and how to identify and resolve issues with quality control that maintains integrity of data and specimens.

    Note: if the proposed research includes a clinical study, specific information for that study will be entered using the PHS Human Subjects and Clinical Trials Information and should not be duplicated in the Research Strategy.

    In a clearly labeled section entitled “Project Milestones and Timelines”:

    • Describe specific quantifiable, planned baseline research milestones by annum, and include annual timelines for the overall EIDRC CC and for tracking progress from EIDRCs, including collaborators, and Teams.  Milestones must specify the outcome(s) for each activity. Milestone criteria should not simply be a restatement of the specific aims. Using a Gantt chart or equivalent tool, describe the associated timelines and identified outcomes of the EIDRC CC.  Discuss how in the event of an outbreak, above timelines and milestones would be altered/adjusted to address urgent need. 

    In a clearly labeled section entitled, “Pilot Research Programs”:

    • Provide a clear plan for implementing a pilot research program (5-10 total awards) in year 2.
    • Describe process and procedures for soliciting proposed projects, reviewing proposals, awarding and developing pilot research projects across the EIDRCs. In particular, plans must include a description of how this program will specifically target the next generation of investigators including in-country scientists, as well as what mentoring resources will be devoted to ensure their success.

    NOTE: Do not include specific projects.

    NOTE: Investigators applying to both this FOA and RFA-AI-19-028, must include in this section a plan for avoiding potential Conflicts of Interest (COI) with respect to the pilot award program.

    Letters of Support: Include any letter necessary to demonstrate the support of consortium/site participants.

    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 that details the rapid sharing, release and access of datasets, analysis tools, computational models, reagents, and other resources, which are generated by the Center to the broader scientific community in adherence to the requirements and timelines described in the NIAID Data and Reagents Sharing and Release Guidelines and the NIH Genomic Data Sharing (GDS) Policy. NIAID encourages the use of NIH supported open access Data Sharing Repositories as a first choice and a list of them can be found at https://www.nlm.nih.gov/NIHbmic/nih_data_sharing_repositories.html.

    Appendix:

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

    PHS Human Subjects and Clinical Trials Information

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

    PHS Assignment Request Form

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

    Foreign Institutions

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

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

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

    4. Submission Dates and Times

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

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

    6. Funding Restrictions

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

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

    7. Other Submission Requirements and Information

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

    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 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. See Section III of this FOA for information on registration requirements.

    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. 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.

    Post Submission Materials

    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?  

    RFA/PAR only: Additional Questions may be added and should be explained to the applicant in Section IV.2.

    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 for this FOA: Do the investigators have expertise both in data and administrative management of scientific programs, including pilot research program?  Do the investigators have relevant experience working with USG and other international agencies related to coordination of efforts?

    Innovation

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

    Approach

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

    If the project involves human subjects and/or NIH-defined clinical research, are the plans to address

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

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

    Specific to this FOA: Do the investigators provide a clear and concise plan for how to coordinate and facilitate overall collaboration between the EIDRCs, NIAID, other international agencies and partners if/when an outbreak occurs? If applicable, are plans to mitigate COI-that may arise for selection, award, and management of Pilot Projects to be conducted at the EIDRCs- appropriate? Do the investigators provide a clear plan for achieving defined project milestones and timelines?

    RFA/PAR only: Additional Questions may be added  and should be explained to the applicant in Section IV.2..

    Environment

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

    Additional Review Criteria

    As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

    Protections for Human Subjects

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

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

    Inclusion of Women, Minorities, and Individuals Across the   Lifespan 

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

    Vertebrate Animals

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

    Biohazards

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

    Resubmissions

    Not Applicable

    Renewals

    Not Applicable

    Revisions

    Not Applicable

    Additional Review Considerations

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

    Applications from Foreign Organizations

    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.

    Select Agent Research

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

    Resource Sharing Plans

    Reviewers will comment on whether the 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 (GDS).

    Authentication of Key Biological and/or Chemical Resources:

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

    Budget and Period of Support

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

    2. Review and Selection Process

    Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the 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.
    3. Anticipated Announcement and Award Dates

    After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

    Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

    Section VI. Award Administration Information
    1. Award Notices

    If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

    A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

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

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

    2. Administrative and National Policy Requirements

    All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

    Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  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. HHS provides general 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/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html.  Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/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. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. 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 http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

    In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements.  FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award.  An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS.  The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

    Cooperative Agreement Terms and Conditions of Award

    The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) 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:

    • Serving as the administration oversight for the proposed program(s), including retaining primary responsibility for the planning, directing and executing of proposed program(s).
    • Sharing data collected under this award through a NIAID approved portal(s), as well as sharing any collected biological samples with the scientific community, as appropriate and consistent with achieving the goals of the program.
    • 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 DHHS, PHS, and NIH policies.
    • Rapidly responding to outbreaks as directed by NIAID. Examples include but are not limited to; providing information, samples, data, reagents, etc. to another Center, the Coordination Center and/or other collaborators, in addition to planning and/or performing critical experiments to advance the development of new diagnostic tools and reagents.   but are not limited to; providing information, administrative support, samples, data, reagents, etc. to a Center and/or other collaborators.
    • Implementing pilot project program.
    • Demonstrating collaborative effort within the larger EIDRC network, including the other EIDRCs, NIAID, USG and other international partners, including local MOH.

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

    • Coordinate NIAID staff assistance, including participation in periodic on-site monitoring with respect to compliance with Federal regulations, quality control, accuracy of data recording, sample accrual, enrollment, etc.
    • Facilitate collaborations with and access to other NIAID-supported research resources and services.
    • Serve as liaison/facilitator between the awardee and the EIDRCs, related to database and biological sample storage (approved by NIAID).
    • The NIH Project Scientist will review and assist in developing the operating guidelines and consistent policies for dealing with situations that require coordinated action.
    • The NIH Project Scientist will periodically review the data generated under this award.
    • Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

    Areas of Joint Responsibility include:

    • The PD(s)/PI(s) and NIH Project Scientist will review the entirety of program milestones annually and update them based on recommendations from the EAC.
    • The NIH Project Scientist and the PD(s)/PI(s) will coordinate the overall network objectives and progress at the annual workshop to facilitate the achievement of program goals.
    • After award NIAID will establish an External Advisory Committee (EAC); the EIDRC CC will assist with establishing the EAC and assist the EAC and NIAID with the annual review process.

    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.

    3. Reporting

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

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

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

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

    Section VII. Agency Contacts

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

    Application Submission Contacts

    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

    Scientific/Research Contact(s)

    Jean Patterson, Ph.D.
    National Institute of Allergy and Infectious Diseases (NIAID)
    Telephone: 240-292-4830
    Email: jean.patterson@nih.gov

    Peer Review Contact(s)

    Eleazar Cohen, Ph.D.
    National Institute of Allergy and Infectious Diseases (NIAID)
    Telephone: 240-669-5081
    Email: ecohen@niaid.nih.gov

    Financial/Grants Management Contact(s)

    Bora Mpinja
    National Institute of Allergy and Infectious Diseases (NIAID)
    Telephone: 301-761-5434
    Email address: bora.mpinja@nih.gov

    Section VIII. Other Information

    Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

    Authority and Regulations

    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.

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