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

Genomic Centers for Infectious Diseases (U19 Clinical Trial Not Allowed)

Activity Code

U19 Research Program – Cooperative Agreements

Announcement Type

Reissue of RFA-AI-13-009

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-AI-18-004

Companion Funding Opportunity

None

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

 93.855 

Funding Opportunity Purpose

The purpose of this initiative is to support Genomic Centers for Infectious Diseases (GCID) to promote broad use and expand the application of genomics technologies and computational analysis to understand infectious diseases, with an emphasis on pathogens, their interaction with the host and microbiome, and to aid in the development of novel genomics-based tools to diagnose, prevent and treat infectious diseases. The GCID will support innovative technology development in all aspects of genomics, including the use of synthetic and genome editing technologies as well as functional genomics to address basic, translational, and clinically relevant questions in host-pathogen interactions. The knowledge generated, including research data, analytical software tools, computational models, experimental protocols, and reagents, is expected to be widely disseminated to the scientific community through publicly accessible databases and reagent repositories.

Key Dates

 

Posted Date

March 15, 2018

Open Date (Earliest Submission Date)

May 22, 2018

Letter of Intent Due Date(s)

May 22, 2018

Application Due Date(s)

 June 22, 2018, 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

October 2018

Advisory Council Review

January 2019

Earliest Start Date

April 2019

Expiration Date

June 23, 2018

Due Dates for E.O. 12372

Not Applicable

** ELECTRONIC APPLICATION SUBMISSION REQUIRED**

NIH's new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically using ASSIST or an institutional system-to-system solution; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

Required Application Instructions

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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.


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
Purpose

The purpose of this initiative is to support Genomic Centers for Infectious Diseases (GCID) to promote broad use and expand the application of genomics to understand pathogens, their interaction with the host and microbiome, and to aid in the development of novel genomics-based tools to diagnose, prevent and treat infectious diseases. The GCID will support innovative technology development in all aspects of genomics, including the use of synthetic and genome editing technologies as well as functional genomics to address basic, translational, and clinically relevant questions in host-pathogen interactions. The knowledge generated, including research data, analytical software tools, computational models, experimental protocols, and reagents, is expected to be widely disseminated to the scientific community through publicly accessible databases and reagent repositories.  

Background

Over the past fifteen years, NIAID/Division of Microbiology and Infectious Diseases (DMID) has continuously expanded its genomics activities by establishing comprehensive centers and programs to provide the scientific community with critical genomic and other "omic" data sets, reagents, and research resources to conduct basic and applied infectious diseases research. The NIAID Genomic Sequencing Centers established in 2003, and the 2014 NIAID Genomic Centers for Infectious Diseases and Functional Genomics Centers revolutionized how scientists study infectious diseases by applying whole genome sequencing and functional genomics technologies to study a wide variety of biological questions related to pathogen evolution, fitness, virulence, and interactions with its host and microbiome and for high-throughput assignment of function to microbial and viral genes.

In addition to large-scale genome sequence resources, the GCID and Functional Genomic Centers have made significant contributions in technological advances leading to the efficient and rapid generation of pathogen sequencing data from emerging and ongoing outbreaks directly from clinical samples. This includes development of laboratory and computational protocols, tools, and platforms for effective processing of challenging samples. Similarly, their use of novel expression vector platforms, synthetic gene design, reverse genetics, animal models of human disease, and defined sets of biochemical and immunologic assays has been very successful in identifying, characterizing and determining the role of previously uncharacterized genes. Together, these activities have supported NIAID's efforts to understand and respond to high priority and emerging infectious disease threats.

The intersection of clinical or translational research with genomics technologies for infectious diseases is an area of rapid growth. Currently, the GCID are exploring how to develop and apply large scale genomics to improve diagnosis of infectious diseases by understanding genomic and transcriptomic content of pathogens and their human host. In addition, genomic studies aimed at understanding pathogen and host responses are being developed to aid in vaccine and therapeutic development. Additional development in these areas holds great promise for the infectious disease research community.

Research Objectives and Scope

This Program will support cutting-edge development in genome-scale technologies and generation of genomic resources, datasets, and computational tools that will continue to improve infectious disease research for sustained and broadly applicable scientific innovation. Through this FOA, a number of Genomic Centers for Infectious Diseases (GCID; hereafter also collectively referred to as the "GCID Program") will be established to generate large-scale genomic resources including sequencing and experimental data that will be publicly accessible for use by the infectious disease research community. In addition, the GCID Program will support advanced technological development of genome sequencing, related genomic technologies, functional genomic tools, and supporting bioinformatics tools and their application to infectious diseases.

It is expected that the GCID Program will use, develop, and/or improve innovative applications of sequencing to provide rapid and cost-efficient production of high-quality genome sequences of microorganisms and invertebrate vectors of infectious diseases, host and microbiome. The genomic sequencing projects will support basic and translational research. In addition, the GCID Program will use, develop, and/or improve genome-scale technologies to understand the functional aspect of genomic elements. The GCID Program will incorporate emerging technologies in synthetic and gene editing biology of pathogens and/or host somatic cells to address questions in infectious disease genomics. The GCID Program will not only provide insights into the biology of microbes, their role in pathogenesis, and their interactions with the host, including the microbiome, but also support research with clinical or translational applicability. Moreover, the Program will examine genetic variations in human pathogens and across the human genome to identify genetic associations with observable phenotypes in the pathogen and in the human host.

Scientific projects are encouraged to include microorganisms from NIAID's List of Emerging Infectious Diseases, which includes NIAID Category A-C Priority Pathogens, clinical isolates, closely related species and strains, and invertebrate vectors of diseases. Emphasis will be placed on projects that propose sequencing multiple strains and isolates of specific microbial species, populations and communities rather than on sequencing individual microorganisms.

For purposes of this initiative, genome-scale technologies include high-throughput sequencing, comparative genomic sequencing, single nucleotide polymorphism identification, genotyping, gene expression, whole-genome mutagenesis, and metagenomics. High-throughput sequencing is defined as the capability to: a) produce high quality sequencing data in a highly efficient manner with continuous increase in efficiency and decrease in costs; b) generate a diverse variety of genome sequence products; c) develop and implement new technologies, bioinformatics resources, data analysis, and laboratory management systems; and d) maintain an automated sequencing production pipeline with quality control measures to ensure high quality sequence reads. 

Applications proposing the following will be considered non-responsive and will not be reviewed:

  • Applications that focus exclusively on genomic technology development in the absence of use of the technology to sequence and characterize human pathogens and their interaction with the host.
  • Applications that propose clinical trials.
  • Applications that propose genome editing of human embryonic stem cells.
  • Applications that do not have technology development and propose only hypothesis driven research projects.
  • Applications proposing studies on HIV or AIDS.
GCID Program Structure

Administrative Core

The Administrative Core, headed by the Center PD/PI, will be responsible for managing, coordinating, and supervising all Center activities; including monitoring progress with respect to Milestones, implementation of the overall Project Management Plan, and the proposed Timelines. The scientific and technical expertise and research teams may be distributed among various Institutions.  In such cases, the Administrative Core will be responsible for ensuring cohesiveness and synergy among the GCID members. The Administrative Core will also be responsible for the Outreach Activities of the Center, as well as the Collaborative Pilot Projects Plan and its administration.

Collaborative Pilot Projects - It is anticipated that awardees will identify areas of shared scientific or technological interest across the different awarded GCIDs, therefore this FOA will support Collaborative Pilot Projects for small-scale studies that will benefit from the expertise and/or capabilities across GCID and that will be relevant to the broader research community. Collaborative Pilot Projects will be identified, selected, and supported through the Administrative Core with input from the Administrative Core Leader, the Steering Committee, and NIAID. Collaborative Pilot Project funding is intended to provide modest support that will promote collaboration across Centers and provide the opportunity to develop sufficient preliminary data as a basis for an application for independent research support.

Technology Core

The technology core will offer high-throughput genomic technologies to provide shared resources to the Research Projects. At a minimum, large-scale high-throughput sequencing, transcriptomics, and metagenomics (and related microbiome technologies) would be expected as three of the technologies in the core. Additional technologies may include functional genomic technologies such as high throughput mutagenesis, cloning, or genome editing capabilities (for pathogen and host somatic cells). A capability to use or incorporate synthetic genomics or single cell technologies is also strongly encouraged. The technology core should work in synergy with the research projects to develop innovative genome technologies.

Data Management, Analysis, and Resources Dissemination Core

The Data Management, Analysis and Resource Dissemination core will be responsible for supporting sample tracking, laboratory data management, data storage, and for providing data access, data transfer, and integrated data analysis as a shared resource to the Research Projects. It is expected that a vast amount of data and other types of resources will be generated through the Centers and these data activities are essential for the efficient and successful performance of the Center. Sample tracking may include managing and reviewing IRB documentation and clinical and meta data associated with (clinical) samples. In addition, the core should implement new, improved and enhanced bioinformatics analysis pipelines. The core should be capable of innovation in bioinformatics, genomic data analysis and visualization, as well as enhance existing data integration workflows and pipelines, and develop new ones that serve as community accepted standards. Such applications and pipelines will be made available for use by the broader infectious disease community via the NIAID-Bioinformatics Resource Centers (BRC). 

Scientific Core

One optional Scientific Core may be included to provide scientific services or resources that are not duplicative of other services or facilities available in the required cores.

Research Projects

Each application must propose four Research Projects, each centered around the themes of viruses, bacteria, fungi, and parasites and vectors, respectively. Each Research Project will use a combination of genomic sequencing, functional genomics, and bioinformatics analyses to understand infectious diseases with a focus on human pathogens and their interaction with the host and the microbiome. The four proposed Research Projects should be synergistic and fit under the Center's overarching central theme. Projects should emphasize application and development of innovative genome-scale technologies that could be broadly applicable to the infectious disease research community at large. It is encouraged that the research projects include components to aid biomedical translation by supporting understanding of improved diagnostics, therapeutics, or vaccines targets, though the projects themselves should not propose to develop translational products. Research projects should include methods to validate significant biological findings from high-throughput activities.

Annual Programmatic Meetings

Each year a one or two-day meeting will be held, and each awarded Center will assume responsibility for the meetings' organization at least once over the award period. These meetings are anticipated to be held at a location at/near Bethesda, MD or at another NIAID-approved site.

Steering Committee

A Steering Committee will be established by the NIAID in collaboration with the awardees to review the progress in meeting the goals of all Centers funded under the Program and will make recommendations for the continuation or re-direction of all projects and activities of the funded Centers on an ongoing basis and in consultation with the NIAID staff. In addition, the Steering Committee will make recommendations about Collaborative Pilot Projects. The Steering Committee is expected to consist of investigators who are not current collaborators of the funded programs.

Scientific Working Group(s)

At least one Scientific Working Group (SWG) may be established by the NIAID in collaboration with the awardees to promote cross-Center collaboration.  A SWG is defined as a group of GCID investigators who share a common interest in a specific area of scientific or technological focus that is critical to addressing the implementation of genomics in infectious diseases.  The goal of a SWG is to promote multi-disciplinary collaborations that result in successful applications for new collaborative pilot projects or other research projects and awards.

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
Renewal

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 $12 million in FY 2019 to fund 2-3 awards.

Award Budget

Applicants may propose budgets of up to $3.75 million direct costs per year, which includes up to $75,000 in direct costs for either one or a maximum of two Collaborative Pilot Projects per year. Application budgets need to reflect the actual needs of the proposed project.

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:

o   Hispanic-serving Institutions

o   Historically Black Colleges and Universities (HBCUs)

o   Tribally Controlled Colleges and Universities (TCCUs)

o   Alaska Native and Native Hawaiian Serving Institutions

o   Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)
  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
  • Non-domestic (non-U.S.) Entities (Foreign Institutions)
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) (formerly CCR) – 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 and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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.

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

A button to access the online ASSIST system is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

Most applicants will use NIH's ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

2. Content and Form of Application Submission

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

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:

B. Eleazar Cohen, PhD
Telephone: 240-669-5081
Fax: 240-627-3153
Email: ecohen@niaid.nih.gov

Page Limitations

Component Types Available in ASSIST

Research Strategy/Program Plan Page Limits

Overall

6 pages

Admin Core (Use for Administrative Core)

6 pages

Core (Use for Technology Core, and Data Management, Analysis and Resources Dissemination Core)

12 pages each

Project (use for Research Projects)

12 pages each

Optional Core (Use for Scientific Core)

6 pages

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

Instructions for the Submission of Multi-Component Applications

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

The application should consist of the following components:

  • Overall: required
  • Administrative Core: required (maximum 1)
  • Data Management, Analysis and Resources Dissemination Core: required (maximum 1)
  • Technology Core: required (maximum 1)
  • Scientific Core: optional (maximum 1)
  • Research Projects: required (minimum 4; maximum 4)
Overall Component

When preparing your application in ASSIST, use Component Type 'Overall'.

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

SF424 (R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement  (Overall)

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

Research & Related Other Project Information (Overall)

Follow standard instructions.

Facilities & Other Resources: Summarize the specific features in the environment and/or resources that make this application strong or unique.

Project/Performance Site Location(s) (Overall)

Enter primary site only.

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

Research & Related Senior/Key Person Profile (Overall)

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

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

Budget (Overall)

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

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

PHS 398 Research Plan (Overall)

Specific Aims: List in priority order, the broad, long-range objectives and goals of the proposed Center. Concisely describe the hypothesis or hypotheses to be tested.   

Research Strategy: Summarize the overall research objectives and strategic plan for the multi-project application. Applications responding to this FOA should describe the central theme of the proposed Program and explain how the proposed Research Projects are synergistic and fit under the overarching Program theme.

Describe the conceptual wholeness to the overall program – by giving a statement of the general problem area and by laying out a broad strategy for addressing the problems. As the strategy develops, cite each Research Project and Core to describe its place in the overall scheme. Highlight the innovation and significance across the Center, including in the research projects and technology development. In addition, explain ongoing, planned, and potential collaborations nationally and internationally to conduct basic and clinical research. There should be an overall description of the Center's plan to disseminate the research data and resources generated, as well as the protocols and reagents that may be applied to other fields of research. Lastly, include an overview of the Program's outreach activities and describe the Program's commitment to developing new talent and disseminating expertise in emerging genomic technologies.

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.

Appendix:

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

PHS Human Subjects and Clinical Trials Information (Overall)

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

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form (Overall)

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

When preparing your application in ASSIST, use Component Type 'Admin Core.'

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

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

  • Applicant Information
  • Type of Applicant (optional)
  • Descriptive Title of Applicant's Project
  • Proposed Project Start/Ending Dates
PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

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

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

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

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

List all performance sites that apply to the specific component.

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

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

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

  • Include the budget for travel to the annual GCID Program meeting. Each Center should ensure the support for meeting attendance by the PD/PI, the Project Leaders, Cores Leaders, and other key personnel.
  • Do not include the costs for organizing the annual meeting.
  • Include funds for the Collaborative Pilot Projects. A maximum not to exceed $75,000 in direct costs should be reserved for the Collaborative Pilot Projects beginning in the second year to fund one or a maximum of 2 projects per year, from years 2-5 of the parent award.
  • Include funds to support the management of the Pilot Project Program.

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

PHS 398 Research Plan (Administrative Core)

Specific Aims: Describe the proposed activities and services of the Administrative Core. Describe how the work to be completed will support the goals of the GCID Program.       

Research Strategy:  

Describe how the Administrative Core will achieve the following responsibilities of the Center:

  • Establishment and monitoring of overall Center progress including timelines and milestones;
  • Establishment of outreach activities beginning in year 1 of the award;
  • Establishment of an Intellectual Property Plan;
  • Organization of Annual Programmatic Meetings, site visits, and teleconference calls;
  • Organization of the Steering Committee and other activities to be defined over the course of the award period in response to emerging needs.  Names of Steering Committee members should not be proposed as part of the application since Steering Committee members will be independent, non-affiliated experts and will be selected in collaboration with NIAID;
  • Development, design, establishment and monitoring of Collaborative Pilot Projects;
  • Communication with other Centers regarding collaboration and coordination of activities and projects;
  • Communication and interaction with NIAID staff.

Management Plan

Include a Management Plan that describes the organization of the proposed program and its management structure.  The Management Plan should include:

  • A description of the organization of the proposed program and its management structure, including integration of the separate components to form an efficient pipeline, key personnel, section leaders, and reporting relationships
  • If applicable, describe how multiple institutions will share resources and work collaboratively as a GCID, as appropriate and consistent with achieving the goals of the program.
  • A description of how GCID resources will be prioritized, allocated and managed.
  • A plan for how samples and associated meta/clinical data will be tracked, reviewed and managed to ensure responsible broad data sharing, as appropriate and consistent with achieving the goals of the program.
  • A conflict resolution plan.
  • A plan to engage the Steering Committee and NIAID, including details of how to interact with the Steering Committee aside from the Steering Committee's required annual review meetings. Do not name Steering Committee members as part of the application since Steering Committee members will be independent, non-affiliated experts and will be selected in collaboration with NIAID.

Outreach Activities Plan

Describe the Outreach Activities that will begin in the first year of the award and are expected to instruct and increase the number of infectious disease researchers that can use the approaches, methodologies and resources (datasets, analysis tools, etc.) generated under the Center.

Examples of appropriate outreach activities include workshops to promote the use of technologies and analysis tools developed by the Center, and short-term training appointments of undergraduate, graduate, post-doctoral candidates and junior faculty with expertise in microbiology and infectious diseases.

Collaborative Pilot Projects Plan

Describe how the collaborative pilot projects will be used to promote development of shared scientific or technological interest across the different awarded GCIDs. Describe how the Core will ensure that collaborative pilot projects will focus on one of the scientific areas or cores and will take advantage of genomic or bioinformatics technologies and synergistic opportunities that result from collaboration between two or more Centers; and that the activities will not duplicate projects already undertaken by any Center in the GCID Program.

Applicants should not submit descriptions of Collaborative Pilot Projects in their application.

The Pilot Project Plan should include:

  • A description of the process to identify and develop collaborative projects across Centers;
  • A description of the review process and evaluation criteria that will be used to select the most promising projects for funding;
  • Proposed timeframe for project identification, review and delivery of recommendations;
  • Plans for managing progress and monitoring the success/productivity of funded projects; and a discussion of how funds associated with each Collaborative Pilot Project will be managed.

Scientific Working Groups

Describe how the Administrative Core will establish and monitor Scientific Working groups in collaboration with other GCID. Working groups will be expected to meet on a regular basis and to have tangible outcomes of their collaborative work, including meeting agendas, meeting notes, possible research products such as abstracts, posters, or scientific papers.

Milestones and Timelines

Applicants must provide milestones and timelines and a plan meeting these milestones in a section of the Administrative Core entitled "Milestones and Timelines" that should address all Research Project and Core activities.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, 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.

Appendix:

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

PHS Human Subjects and Clinical Trials Information (Administrative Core)

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

Data Management, Analysis and Resources Dissemination Core

When preparing your application in ASSIST, use Component Type 'Core.'

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

SF424 (R&R) Cover (Data Management, Analysis and Resources Dissemination Core)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Data Management, Analysis and Resources Dissemination Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Data Management, Analysis and Resources Dissemination Core)

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

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

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

Project /Performance Site Location(s) (Data Management, Analysis and Resources Dissemination Core)

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Data Management, Analysis and Resources Dissemination Core)

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

Budget (Data Management, Analysis and Resources Dissemination Core)

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

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

PHS 398 Research Plan (Data Management, Analysis and Resources Dissemination Core)

Specific Aims: List in priority order the broad, long-range objectives and goals of the proposed Core. In addition, state the Core's relationship to the Program's goals and how it relates to two or more individual Research Projects or other proposed Cores.        

Research Strategy: 

Describe how the proposed Core activities will contribute to meeting the Program's goals and objectives and explain the rationale for selection of the general methods and approaches proposed to accomplish the specific aims. In addition, indicate the relevance of the core to the primary theme of the application.

Provide details for data integration, management and tracking activities of the Program. Discuss how reagents, resources, and data obtained and generated under this Program shall be rapidly deposited into public repositories, such as the NIAID Biodefense and Emerging Infections Research Resources Repository (http://www.beiresources.org/), or the Bioinformatics Resource Centers.

Describe how the Data Management, Analysis and Resource Dissemination Core will perform innovative development in the areas of bioinformatics and data analysis that will support the scientific questions addressed in each research project.

Describe the planned computational innovations and the supporting technologies that will be developed through the Center.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

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

Appendix:

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.   

PHS Human Subjects and Clinical Trials Information (Data Management, Analysis and Resources Dissemination Core)

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

When preparing your application in ASSIST, use Component Type 'Core.'

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

SF424 (R&R) Cover (Technology Core)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Technology Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Technology Core)

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

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

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

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

List all performance sites that apply to the specific component.

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

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

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

Budget (Technology Core)

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

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

PHS 398 Research Plan (Technology Core)

Specific Aims: List in priority order the broad, long-range objectives and goals of the proposed Core. In addition, state the Core's relationship to the Program goals and how it relates to two or more individual Research Projects or other proposed cores.

Research Strategy:  

Describe the high-throughput genomic technologies organized into a Technology Core that will provide shared resources to the Research Projects. At a minimum, high-throughput sequencing, transcriptomics, and metagenomics (and related microbiome technologies) must be included as three of the technologies in the Core. In addition, functional genomic technologies such as, but not limited to, high-throughput mutagenesis, cloning, or genome editing (pathogen and/or host somatic cells) capabilities can be included in the Technology Core. Applicants are strongly encouraged to demonstrate the capability to use or incorporate synthetic genomics or single cell technologies into the Core.  

For each technology, explain the rationale for selection of the general methods and approaches proposed to accomplish the specific aims. In addition, this section should indicate the relevance of the core to the primary theme of the application.

The Technology Core should include a description of the following:

  • State-of-the-art, large-scale, high-throughput genomic and metagenomic sequencing and genotyping capabilities, as well as methodologies, technologies, laboratory information management system (LIMS), automated production and quality control pipelines to produce genomic data in a highly efficient manner to maintain continuous increases in efficiency and decreases in costs.
  • Capacity to generate diverse genome sequence products from microbes and invertebrate vectors of infectious diseases and human hosts, transcriptome, and microbiome to study infectious pathogens and their interaction with the host in a large-scale production sequencing environment.
  • Platforms for examining genetic variation in populations and communities of human pathogens and related organisms and across the human genome with the goal of identifying genetic associations with observable phenotypes in the pathogen and in the human host, including the microbiome. These include, for example, microbial genetic correlates of disease emergence, virulence, and transmissibility, and host genetic variation that are associated with susceptibility to infection, disease severity, progression and outcome, responses to vaccination, and therapeutics.
  • Assembly and annotation platforms for assembly of genomes and RNA transcripts and preliminary identification of open reading frames and annotation of gene function.
  • Capability to employ innovative strategies to address new scientific opportunities in a flexible and timely manner.
  • Functional genomics capabilities including but not limited to high-throughput mutagenesis, cloning, gene silencing, etc.
  • Capability to evaluate, develop and incorporate enhancements, modifications and improvements in existing genomic, metagenomics, RNA sequencing, genotyping and other related technologies, platforms and resources to maintain a high throughput state-of-the-art genomics program to increase efficiency and decrease cost.
  • Capability to develop standard operating procedures (SOPs), protocols and methods for new and improved technologies, project design, and analysis methods and tools for dissemination into the broader scientific community.

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.

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

PHS Human Subjects and Clinical Trials Information (Technology Core)

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

Scientific Core

When preparing your application in ASSIST, use Component Type 'Optional Core.'

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

SF424 (R&R) Cover (Scientific Core)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Scientific Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Scientific Core)

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

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

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

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

List all performance sites that apply to the specific component.

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

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

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

Budget (Scientific Core)

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

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

PHS 398 Research Plan (Scientific Core)

Specific Aims:  List in priority order the broad, long-range objectives and goals of the proposed core. In addition, state the core's relationship to the Program's goals and how it relates to two or more individual Research Projects or other proposed cores.    

Research Strategy:   Provide details of the services or resources provided by the scientific core to at least two Research Projects and clarify how the scientific core is not duplicative of other services or facilities provided by the other cores.

Describe and justify the role of the Core in the overall Center research activities, describe how the proposed core activities will contribute to meeting the Center's goals and objectives. For each technology, explain the rationale for selection of the general methods and approaches proposed to accomplish the specific aims. In addition, this section should indicate the relevance of the core to the primary theme of the application.

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.

Appendix: Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.   

PHS Human Subjects and Clinical Trials Information (Scientific Core)

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

When preparing your application in ASSIST, use Component Type 'Project.'

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

In total, each application should include four Research Projects, one on viruses, one on bacteria, one on fungi and one on parasites and vectors.

SF424 (R&R) Cover (Research Projects)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Research Projects)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Projects)

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

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

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

Project /Performance Site Location(s) (Research Projects)

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Research Projects)

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

Budget (Research Projects)

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

Do not budget for costs associated with prospective human sample collection. They will not be covered by the grant.

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

PHS 398 Research Plan (Research Projects)

Specific Aims: List, in priority order, the broad, long-range objectives and goals of the proposed Research Project. Concisely describe the hypothesis or hypotheses to be tested. In addition, state the individual research project's relationship to the Program's goals and how it relates to other projects or cores.  

Research Strategy:  

Describe the theme of the Research Project in terms of its individual focus on viruses, bacteria, fungi, or parasites and vectors.

Relevant to the theme, describe the use and combination of next generation, state-of-the-art genomics sequencing technologies, functional genomics and bioinformatics analyses to understand the pathogens and their interaction with the human host. Describe how the Research Project takes best advantage of the current state-of-the- art in high-throughput sequencing; how they drive the development of important new project capabilities; and how they are distinct from other projects going on at lower scale or by other means. Describe how the genomic studies will be validated experimentally. Applicants should explain how the proposed Research Project is synergistic and fit under the Center's overarching central theme.

Describe how the Research Project includes as many of the characteristics delineated below as scientifically appropriate:

  • Studies of human infectious diseases caused by pathogens in NIAID's List of Emerging and Re-emerging Infectious Diseases, which includes NIAID Category A-C Priority Pathogens.
  • Large scale effort examining populations of human pathogens and related species and their host and focused on a research hypothesis.
  • Scalable technological and bioinformatics pipelines to sequence and analyze the target pathogen.
  • Functional genomics studies to understand pathogens and their interaction with the host.
  • Studies of infected samples from human subjects are of highest priority.
  • Concurrent use of 2 or more high-throughput, next generation sequencing applications such as sequencing the genome and examining gene expression with transcriptomics technologies on "matched" samples (i.e. same sample source), when feasible, to generate a diversity of genomic data to be integrated and analyzed.
  • Studies that have the potential to provide genomic data sets of broad use and value to the infectious diseases scientific community.
  • Inclusion of novel technologies including synthetic biology, genome editing, and single cell genomics.

Provide a description of the anticipated samples for the Research Project and proposed timelines for availability from collaborators, as necessary. Although the Program will not support prospectively collecting samples, applicants are encouraged to seek collaborations with investigators that will collect prospective human clinical samples.

Indicate the targeted microbial organism/s and the related human host, microbiome and infectious disease to be studied. Describe any new methodology and its advantage over existing methodologies. Describe any novel concepts, approaches, tools, technologies, and data analysis methods for the proposed studies.  Describe components to aid biomedical translation by supporting improved understanding of diagnostics, therapeutics, or vaccines, though the projects themselves should not propose to develop translational products. Describe the methods to validate significant biological findings from high-throughput activities, along with a discussion of potential difficulties, limitations, and alternative approaches. Provide milestones and timelines for each Research Project.

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.

Appendix: Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.   

PHS Human Subjects and Clinical Trials Information (Research Projects)

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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 described throughout the SF424 (R&R) Application Guide.

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

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

4. Submission Dates and Times

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

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

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization's profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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

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. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact - Overall

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Center 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 Center proposed).

  • Are the overall Center's goals significant and focused on studies that meet the purpose and objectives of the FOA?
  • Does the Center advance the use of high-throughput sequencing, for example in providing a motivation to modify technical approaches, requiring the development of new analytical methods, strategies, or project designs, particularly if these are likely to inform general approaches, or become early, good examples for similar project types undertaken by others in the field?
  • Does the Center address new opportunities or critical gaps by applying large-scale sequencing technologies to address important questions in studying infectious diseases with a focus on the pathogen and host? Is the Center likely to have an influence on translational and/or clinical research?  
  • Is the Center scientifically compelling?
  • Are the individual projects or at least their overall structure synergistic and will the project encourage a shift towards high-throughput genomic sequencing approaches to infectious diseases research that focuses on the pathogen and its interaction with the host?
  • Are there coordination and synergy of the individual research projects and cores towards the achievement of the central objectives of the Center?
  • Is there an adequate commitment to developing new talent and disseminating expertise in emerging genomic technologies?
  • Do the proposed plans ensure that the Center has a high probability of success?
  • Is there a high likelihood that the Center will accomplish significant contribution to the genomics field for each of the four groups of organisms selected and beyond the current state-of-the-art levels of sequencing throughput, data quality and cost?
  • Do(es) the PD(s)/PI(s) have documented training, leadership skills, scientific and technical skills, and managerial competence to successfully plan, manage, conduct and direct a Program and Research Projects having goals, size and complexity similar to those of the proposed Program, including experience in successfully managing a large scale genome sequencing program, have time commitment as well as demonstrated ability to manage this program and establish collaborations and to obtain microbial and human clinical samples for genomic projects? 
  • For applications designated multiple PD(s)/PI(s), is the Leadership Plan both adequate and appropriate to ensure that there will be sufficient coordination and communication among the PD(s)/PI(s)?
Overall Impact - Research Projects

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 - Research Projects

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 there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?   

Specific to this FOA:

Will the proposed sequencing and related genomic technology platforms and bioinformatics analysis pipelines and related developmental technologies have broad applicability to the field of infectious diseases? Are the genomic findings likely to have a long-lasting effect on the specific field of research?

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 FOA:

  • Do(es) the Project leader(s) have documented training, leadership skills, scientific and technical skills, and managerial competence to successfully plan, manage, conduct and direct a Research Project having goals, size and complexity like those of the proposed Program? Is the project leader(s) likely to succeed in managing a large-scale genome sequencing project?
  • Does the project leader(s) have time commitment as well as demonstrated ability to manage this project and establish collaborations and to obtain microbial and human clinical samples for genomic projects?
  • Is there an adequate staffing plan appropriate to the scope of the proposed work?
  • Does the project leader(s) have a successful record of collaborations with infectious diseases and organism communities and appropriate track record for collaborative activities and public dissemination of generated resources?
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?   

Specific to this FOA:

Will the proposed sequencing and related genomic technology platforms and bioinformatics analysis pipelines and related developmental technologies provide innovative new tools or paradigms for using genomics strategies to study infectious diseases?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the 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 children, justified in terms of the scientific goals and research strategy proposed?    

Specific to this FOA:

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?   

Specific to this FOA:

  • Is there evidence of rapid implementation of new genomic and computational technologies?
  • Is there adequate evidence of sufficient institutional support for the PD(s)/PI(s) in terms of laboratory space, equipment and other resources?
Overall Impact - Individual Cores

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Core 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 Core proposed).

Review Criteria - Individual Cores

Reviewers will consider each of the review criteria below, as appropriate for the individual core, in the determination of scientific merit and provide an overall impact score, but will not give separate scores for these items.

Administrative Core
  • Is the administrative and organizational structure clearly defined and is it appropriate and adequate to accomplish the objectives of the Center?
  • Are the Management and Staffing Plans appropriate to facilitate attainment of the objectives of the proposed Center?
  • Are the experience, level of commitment, and availability of the Administrative Core Director adequate to manage the overall Center?
  • Is the plan to establish the Outreach Activities adequate and appropriate?
  • Are the plans for coordination, problem identification and resolution and the establishment of a strong collaborative environment for the program appropriate?
  • Are the plans for Collaborative Pilot Projects adequately described and appropriate? Will the Pilot Projects provide an appropriate opportunity for collaborative projects and take advantage of potential synergies across centers?
  • Are the management plan and communication within the Center appropriate?
  • Are the proposed timelines and objectives for the overall Center adequate?
Technology Core
  • Are the experience, level of commitment, and expertise of the Core Leader and key personnel adequate to manage the Core?
  • Are the proposed plans that describe how the Center will evaluate, develop and incorporate enhancements, modifications and improvements in existing genomic, metagenomics, RNA sequencing, functional genomics, and other related technologies, platforms, pipelines and resources to maintain a high throughput state-of-the-art omics Technology Core to increase efficiency and decrease cost adequate?
  • Is the relationship of the Core to the central focus of the overall Center strong?
  • Are the quality of the relevant facilities and usage appropriate?
  • Is there a high likelihood that the proposed program can produce high-quality genomic sequence data, based on the applicant's past experience and the proposed future plans for generating high quality genomic sequencing data and other kinds of large-scale sequencing projects focused on infectious diseases?
  • Are there adequate plans for increasing throughput while lowering costs? Does the Core Leader or key personnel have a successful record in this regard?
  • Does the Core propose creative approaches in sequencing technologies and bioinformatic data analysis pipelines that are likely to yield significant new knowledge in applying next generation genomic sequencing technologies to studying infectious diseases?
  • Are there adequate plans for technology development related to large-scale sequencing, identifying and solving critical integration problems, and adopting new sequencing platforms to increase efficiency and lower costs? Does the Core Leader or key personnel have a successful record in this regard and past experience to ensure success?
  • Is the proposed approach to sequencing adequate, especially as it may relate to the flexibility to address the variety of potential sequencing projects to be done? Does the Core Leader or key personnel have a successful record in this regard?
Data Management, Analysis and Resources Dissemination Core
  • Does the Core Leader or key personnel demonstrate the ability to perform required data management and analysis duties, for example, sample tracking, laboratory data management, data storage, quality control, data release and access, data transfer?
  • Are the described data management activities sufficient?
  • Are the proposed plans adequate to develop, enhance, establish and maintain technologically innovative bioinformatics and computational tools for genomics data sets generated by the Research Projects?
  • Is the Plan for sharing, access and release and public dissemination of generated data, tools, standards and research resources adequate and reasonable?
  • Are the experience, level of commitment, and expertise of the Core Leader and key personnel adequate to manage the Core?
  • Are the quality of the relevant facilities and usage appropriate?
  • Are there adequate plans for bioinformatics related to large-scale genomic sequencing, directed to projects studying infectious diseases for microbes, host and microbiome including infrastructure/laboratory information management, assembly, and primary annotation, comparative genomics analysis? Does the Core Leader or key personnel have a successful record in this regard to ensure success?
Scientific Core
  • If present, is the optional Scientific Core justified and relevant to the theme of the overall Center? Is adequate justification provided that the scientific core will support at least two Research Projects?
  • Is provision of resources and core services to the Research Projects critical and justified?
  • Are the experience, level of commitment, and expertise of the Core Leader and key personnel adequate to manage the Core?
  • Are the quality of the relevant facilities and usage appropriate?
Additional Review Criteria - Overall, Projects, Cores

As applicable for the component 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 six 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 six 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 Children 

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 children 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

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

Not Applicable

Additional Review Considerations - Overall, projects, Cores

As applicable for the component 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 .

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 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 http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.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, 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:

  • Coordinating the Projects and Cores within the overall Program.
  • Defining the research objectives, approaches and details of the projects within the guidelines of the RFA, and retaining primary responsibility for the planning, directing, and executing the proposed scientific activities.
  • Organizing, participating, and chairing one of the Annual Programmatic Meetings of all Centers funded under this FOA; these meetings and their organization will rotate among the Programs' sites on an annual basis. The programmatic kick-off meeting will be held shortly after award and will be organized by the NIAID Project Scientist in coordination with all funded Centers.
  • Organizing and chairing annual site visit activities.
  • Managing the Collaborative Pilot Projects.
  • Monitoring the activities and encouraging participation in the SWG.
  • Making sure that the NIAID Data Release Guidelines (see below) are properly implemented by the personnel of the Research Projects and Cores.
  • Advertising the availability of the Program generated resources through outreach activities.
  • Ensuring that results obtained from the Program are analyzed and published in a timely manner.
  • Providing suggestions for members of the Steering Committee within a few months from award.
  • Participating in the activities of the Steering Committee as needed and following the policies and procedures developed by the Steering Committee.
  • Provide semi-annual progress reports in a format to be defined by the NIAID after award.
  • Whenever possible, the awardee shall provide software certified by the Open Source Initiative (http://www.opensource.org/licenses/), to guarantee the right of others to read, redistribute, modify, and freely use the software.

Program Generated Data, Software and Other Resources

  • Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

Program-generated data and software include, for example:

  • all research data (both experimentally and computationally generated) and associated metadata;
  • database schema and specifications;
  • experimental protocols and Standard Operating Procedures (SOPs); and
  • data analysis tools, models and algorithms generated under this cooperative agreement, including source code, complete use documentation, and tutorials.
  • Program-generated novel reagents (e.g., expression vectors, mutant strains, libraries, protein clones), should be made available through NIAID-supported repositories, such as the NIAID BEI Resources (http://www.beiresources.org/) or in other repositories as identified by the Steering Committee in consultation with the NIAID.

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

  • The role of the NIAID/NIH Project Scientist in the cooperative agreement is to support and encourage the recipient's activities by substantial involvement as partners and facilitators in the process without assuming responsibilities that remain with the PDs/PIs. The NIAID Project Scientist will work closely with the PD(s)/PI(s) and other Program member scientists to facilitate collaborations and to leverage the resources available to the Program.
  • The NIAID Project Scientist will monitor the progress of the Program, help coordinate research approaches among all Centers funded through the FOA, and contribute to the shaping of Research Projects or approaches as warranted. The NIAID Project Scientist will support and facilitate this process but will not direct it. 
  • The NIAID Project Scientist will keep the Program informed about other ongoing studies supported by NIAID to avoid duplication of effort and encourage sharing/collaboration in infectious diseases research. The NIAID Project Scientist will coordinate access for the Program to other NIAID resources, as well as assist the research efforts of the Program by facilitating access to fiscal and intellectual resources provided by industry, private foundations, NIH intramural scientists and other federal government agencies as appropriate.
  • The NIAID Project Scientist will serve as a non-voting member of the Steering Committee and will assist in developing the operating guidelines and consistent policies for dealing with situations that require coordinated action.
  • The NIAID Project Scientist will retain the option to recommend, with the advice of the Steering Committee, the withholding or reduction of support from any cooperative agreement that substantially fails to achieve its goals according to the milestones agreed to at the time of the award or fails to comply with the Terms and Conditions of the award.

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

Areas of Joint Responsibility include:

The NIAID Project Scientist will provide overall coordination across all funded Centers, will coordinate with the PD(s)/PI(s) and hold regular program-wide discussions to facilitate the achievement of program goals. In the event that some members of the Program develop common research interests working groups may be formed to pursue collaborative activities.

In addition, PD(s)/PI(s), Research Project and Core Leaders and the NIAID Project Scientist will participate in the Steering Committee activities as needed. Discuss potential projects to be funded through the Pilot Project Program.

Annual Site Visits

These visits will be used by NIAID program staff to review and discuss progress; problems and obstacles and approaches to overcoming identified problems and obstacles; recommendations for modifications in project timelines, objectives, and research approaches/ methodologies based on outcomes to date; and future plans.

Bimonthly Teleconferences

These teleconferences will be held to discuss progress, problems, proposed solutions and any matter that is relevant to the scientific and financial administration of the Center and future activities. The schedule for those meetings will be established by the PD(s)/PI(s) and the NIAID Project Scientist.

Steering Committee

A Steering Committee will be established by the NIAID to review the progress in meeting the goals of all Programs funded under this FOA, including also the Outreach Activities and Collaborative Pilot Projects, as well as data/other resources' dissemination activities. The PD(s)/PI(s) of the awarded programs will provide NIAID with suggestions for members of the Steering Committee. The Steering Committee is expected to consist of approximately 10 individuals who are not key personnel or collaborators of the key personnel of any of the awardees. The Steering Committee will make recommendations for the continuation or re-direction of all projects and activities of the funded Programs on an ongoing basis and in consultation with the NIAID staff. The NIAID may re-budget individual U19 funds based on recommendations of the Steering Committee.

The Steering Committee will prepare concise (3-4 pages) summaries of the Steering Committee meetings which will be delivered in a timely manner to members of the group and NIAID. The Committee will meet on an annual basis in conjunction with the Annual Programmatic Meeting and on ad-hoc basis by conference calls, as needed. The Steering Committee's meetings will include NIAID staff, and may include PD(s)/PI(s) and other members of the funded Programs as necessary.

The Steering Committee will select one member to be the Chair of the Committee and the Chair will not be a NIAID staff member.

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

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

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 registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, 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)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

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

Scientific/Research Contact(s)

Liliana Brown, PhD
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-496-1884
Email: liliana.brown@nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Devon Bumbray-Quarles
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2950
Email: dbumbray@niaid.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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