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
SUNBEAM - Analysis and Bioinformatics Center (ABC) (UM1 Clinical Trial Not Allowed)
Activity Code

UM1 Research Project with Complex Structure Cooperative Agreement

Announcement Type
New
Related Notices

None

Funding Opportunity Announcement (FOA) Number
RFA-AI-21-060
Companion Funding Opportunity
None
Number of Applications

Only one application per institution is allowed as defined in Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)
93.855
Funding Opportunity Purpose

The purpose of the SUNBEAM - Analysis and Bioinformatics Center (SUNBEAM-ABC) is to establish a mechanistic omics center to support the birth cohort study Systems Biology of Early Atopy (SUNBEAM). The center will assay biologic samples collected within the SUNBEAM cohort using omics and systems biology approaches to identify determinants of atopic disease, focusing on food allergy and atopic dermatitis (AD) in newborns, infants, and very young children. SUNBEAM-ABC will support the SUNBEAM birth cohort study by providing analytic infrastructure for a comprehensive understanding of molecular and cellular pathways that contribute to atopic disease development and to identify early predictive biomarkers.

Key Dates

Posted Date
September 21, 2021
Open Date (Earliest Submission Date)
January 15, 2022
Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
February 15, 2022 Not Applicable Not Applicable July 2022 October 2022 January 2023

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

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.

Expiration Date
February 16, 2022
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

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

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

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

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

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to establish a mechanistic omics center (SUNBEAM-ABC) to support the birth cohort study Systems Biology of Early Atopy (SUNBEAM). The center will assay biologic samples collected in SUNBEAM using omics and systems biology approaches to identify determinants of atopic disease, focusing on food allergy and atopic dermatitis (AD) in newborns, infants, and very young children. SUNBEAM-ABC will support the SUNBEAM birth cohort study by providing analytic infrastructure to comprehensively understand molecular and cellular pathways that contribute to atopic disease development and to identify early predictive biomarkers.

Background

SUNBEAM is a general population birth cohort study supported by several NIAID-funded consortia in which pregnant women (at any stage of pregnancy), the offspring’s biologic father, and the offspring are enrolled at 12 study sites in the US. SUNBEAM participant enrollment was initiated in March 2021 with the goal to enroll at least 2500 pregnant women. The total study period is approximately 6 years, including approximately a 30-month enrollment period, approximately 6 months of pregnancy observation for every enrolled pregnant woman, and 36 months of observation for every enrolled infant. SUNBEAM's objective is to study the role and interrelationships of novel and established clinical, environmental, biological, and genetic early-life factors in the development of allergic diseases through age 3 years, with an emphasis on food allergy and AD. SUNBEAM will collect biologic and environmental samples from parents and offspring from the time of enrollment (during gestation; data taken from the parents) through 3 years of age (data taken from parents and offspring directly) for rigorous analyses. In addition, SUNBEAM will rigorously phenotype the offspring for food allergy and AD. The SUNBEAM biologic samples are collected and stored to allow for extensive omics approaches. These include genomics, epigenomics, transcriptomics, proteomics, metabolomics, and microbiomes. Integration of omics data through systems biology approaches will result in deeper understanding of the early factors that contribute to the development of allergic diseases and will unveil endotypes and molecular targets for disease prevention.

SUNBEAM Case Cohort Design

For biologic sample analysis, SUNBEAM will utilize a case-cohort design that will provide a common control group across multiple case-control analyses, thereby reducing the number of samples that need be assayed. During enrollment, 20% of the pregnant women will be randomly identified to be included in a common Control Subcohort. For the analysis of a given disease, such as AD, all cases will be identified and selected from the entire birth cohort, including the Control Subcohort; however, non-cases will only be selected from inside the Control Subcohort. Thus, the sample size for the case-cohort analysis will be the number of participants in the Control Subcohort (which will consist of cases and non-cases) plus all cases that arise outside of the Control Subcohort. In the context of the case-cohort design, only samples collected from the Control Subcohort and the cases that arise outside of the Control Subcohort will be assayed. This Control Subcohort can be used for the investigation of any number of disease outcomes. Although it is anticipated that the case-cohort design will be used for most investigations involving stored samples, a nested case-control design may be used if the situation warrants. A cumulative incidence of 6% for food allergy (approximately 150 cases) and 10% for AD (approximately 250 cases) is expected in this general population SUNBEAM cohort.

SUNBEAM Sample Collection

SUNBEAM will collect, process, and store environmental and biological samples to support its scientific objectives. Samples being collected include:

  • From the newborn/infant/child: cord blood, peripheral blood (whole blood, plasma and serum), skin tape strips, skin and nasal swabs, nasal secretions, urine, saliva, stool, hair.
  • From the mother: peripheral blood (whole blood, plasma and serum), skin tape strips, breast milk, skin and vaginal swabs, urine, hair, stool
  • From the father: peripheral blood (whole blood, plasma and serum), skin tape strips, skin and nasal swabs, stool
  • From the home: house dust

In addition to the samples, SUNBEAM will collect extensive clinical information via questionnaires and visit procedures. Descriptions of clinical procedures and the frequency of sample collections for all children and their parents are included in Section 6.6 Visit Windows and Schedules of Events of the SUNBEAM protocol. A central biorepository tracks and stores most of the samples collected during the entire study period.

SUNBEAM Clinical Endpoints

To complement the collected biologic samples and environmental samples, clinical assessments of the children are conducted at ages 2, 5, 12, 24, and 36 months.

SUNBEAM has two primary clinical endpoints:

IgE-mediated, immediate-type food allergy: Assessment for food allergy to milk, egg, and peanut begins at age 5 months. Assessment for allergy to wheat, soy, tree nuts (cashew, hazel, and walnuts), fish (cod), shellfish (shrimp) and sesame begins at age 12 months. The diagnosis of food allergy will be based on the Food Allergy Algorithm (see Appendix A in the protocol [www.niaid.nih.gov/grants-contracts/questions-answers-sunbeam-abc-rfa]) that uses absence of or historical response to food exposure, serum allergen-specific IgE and skin prick testing, and, when recommended by the algorithm, an oral food challenge. Detailed information regarding the clinical assessments for food allergy is included in Section 6.4.6 Clinical Endpoint Assessments of the SUNBEAM protocol).

Atopic dermatitis (AD): AD and its severity will be assessed at each visit. The diagnosis of AD is based on the presence of a dry or itchy rash in specific areas of the body that lasts at least 4 weeks or requires medication. Clinical assessments, diagnostic criteria, and severity scoring for AD are described in Section 6.4.6 in the protocol.

Secondary clinical endpoints in SUNBEAM include sensitization to food allergens and aeroallergens, recurrent wheeze, and seasonal and perennial allergic rhinitis and conjunctivitis.

SUNBEAM Database and Statistical Support

The SUNBEAM database is a Remote Data Capture (REDCap) database that is maintained by NIAID via the Long-Term Cohort Platform (LTCP). LTCP is a clinical data management system provided by NIAID for data management and data collection for the duration of SUNBEAM. The NIAID Office of Cyberinfrastructure and Computational Biology (OCICB) designed, built, and maintains this system as well as the supporting infrastructure in the NIAID Discovery and Collaboration Platform.

Statistical support for SUNBEAM is provided by a Statistical and Clinical Coordinating Center funded by NIAID. The support includes, but is not limited to, collecting, curating, storing, and maintaining the clinical and laboratory study data in the SUNBEAM database, providing expertise, advice, and assistance in the development of statistical design plans, conducting interim and final statistical analyses of the study data, preparation of summary data reports and supporting manuscript development.

SUNBEAM-ABC Research Objectives and Scope

SUNBEAM-ABC will create a discovery infrastructure that will explore SUNBEAM biologic samples and conduct systems level analyses in order to contribute to the goals of the SUNBEAM cohort. In pursuing its objectives, the SUNBEAM-ABC will work collaboratively with the SUNBEAM Steering Group and with the NIAID Statistical and Clinical Coordinating Center. The SUNBEAM-ABC PD/PI(s) will become members of the SUNBEAM Steering Group.

SUNBEAM-ABC will have the option of generating its own database(s) for the storage of laboratory data generated from the SUNBEAM sample assays or, in close collaboration with the NIAID Statistical and Clinical Coordinating Center, utilize the SUNBEAM database for this purpose. Any database(s) utilized for laboratory data storage must be selected and configured to provide smooth and easy functions for combining the SUNBEAM clinical and other laboratory data with the data generated by the SUNBEAM-ABC activities.

Applications in response to this FOA are required to include whole blood transcriptomics and high parameter cytometry analysis of fixed blood cells at a minimum. Other potential analyses of interest include, but are not limited to, serum/plasma proteomics, plasma metabolomics, and cellular studies using frozen viable peripheral blood mononuclear cells. Proposed analyses need to use established and validated laboratory assay methods and procedures.

Applications proposing any of the following topics will be deemed non-responsive and will not be reviewed.

  • Animal research
  • Assay development
  • HIV/AIDS research

SUNBEAM-ABC Organizational Structure

SUNBEAM-ABC will consist of the following distinct functional groups that will operate as a single entity: Administrative Group, Research Projects Group, and Bioinformatics and Data Integration Group.

Administrative Group

The Administrative Group will support the coordination of the efforts and activities across SUNBEAM-ABC. This group will be responsible for communication, cohesion of the functional groups, and coordination with the NIAID Statistical and Clinical Coordinating Center, the SUNBEAM Steering Group, and NIAID.

Research Projects Group

The Research Projects Group will be responsible for planning, implementing and oversight of biological sample assays for the research projects proposed within SUNBEAM-ABC. All proposed research projects must include unbiased, quantitative systems biology experimental approaches with the human samples collected from SUNBEAM participants (e.g., transcriptomics, epigenomics, proteomics, metabolomics, lipidomics), and analyses of outcome will follow the case-cohort design as described above. Applicants must propose at least two research projects. One project must be peripheral whole blood transcriptomics, and the second project must be high parameter cytometry analysis of fixed blood cells. Additional projects with other omics analyses can be proposed. In addition to the above-described samples from the case cohort design, samples from all SUNBEAM participants can be available for assaying if appropriately justified in the application.

Bioinformatics and Data Integration Group

The Bioinformatics and Data Integration Group will provide bioinformatic expertise and data integration (multi-omics approaches) and analysis support, including computational modeling and machine learning, if necessary, for the identification of factors that contribute to the development of atopic disease in young children and early biomarkers of food allergy and AD. This group will support data integration and analysis for the omics outcomes produced by the research projects of SUNBEAM-ABC and other omics data derived from SUNBEAM. The Bioinformatics and Data Integration Group will coordinate with the NIAID Statistical and Clinical Coordinating Center to utilize and integrate the SUNBEAM-ABC findings with clinical research data.

The SUNBEAM protocol and additional information can be found in Questions and Answers for SUNBEAM-ABC RFA: https://www.niaid.nih.gov/grants-contracts/Questions-Answers-SUNBEAM-ABC-RFA.

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

Section II. Award Information

Funding Instrument

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

Application Types Allowed
New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

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 an estimated total of $3.0 million in FY 2023 to fund 1 (one) award.

Award Budget

Application budgets are limited to $1.8 million direct costs and 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 project period is 5 years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Governments

  • 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
Foreign Institutions

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

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

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

Required Registrations

Applicant organizations

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

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

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

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

Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.

The NIH will not accept duplicate or highly overlapping applications under review at the same time.  This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101)

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

Letter of Intent

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

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

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

The letter of intent should be sent to:

Louis Rosenthal, PhD
Telephone: 240-669-5070
Email: rosenthalla@niaid.nih.gov

Page Limitations

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

, with the following additional instructions:

The Research Strategy must consist of the following subsections with the indicated page limits:

Subsection A: SUNBEAM-ABC Overview - one required-12 pages

Subsection B: SUNBEAM-ABC Administrative Group - one required-12 pages

Subsection C: SUNBEAM-ABC Research Projects Group - minimum of two projects required-12 pages for each project

Subsection D: SUNBEAM-ABC Bioinformatics and Data Integration Group- one required, 30 pages

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

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

, with the following additional instructions:

Include funds with justification for the following:

  • For single PD/PI applications, the PD/PI must commit an overall minimum of 1.8 person-months for SUNBEAM-ABC activities. For multi-PD/PI applications, one of the PDs/PIs must commit a minimum of 1.8 person-months for SUNBEAM-ABC activities.
  • Travel and other expenses for SUNBEAM-ABC PDs/PIs to attend two (2), one and a half (1.5) day SUNBEAM Steering Group meetings per year in the Rockville, Maryland area.
R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Specific Aims: List the overarching objectives of the SUNBEAM-ABC, as well as the objectives of the individual groups within the subsections A-D.

Research Strategy: The Research Strategy should consist of the following subsections:

Subsection A: SUNBEAM-ABC Overview

Provide an overview of the proposed vision and scientific strategy of the SUNBEAM-ABC.

  • Describe and discuss the scientific goals of the SUNBEAM-ABC in the context of recent studies, current knowledge and knowledge gaps in the field of AD and food allergy, and the objectives of this FOA, to create a discovery infrastructure that will explore SUNBEAM biologic samples and conduct systems level analyses in order to contribute to the goals of the SUNBEAM cohort. Present a strategy that builds on previous research in the field and/or stems from novel, but well justified concepts.
  • Include data pertinent to the development of the overall research agenda and scientific goals.
  • Discuss the rationale of the proposed research for SUNBEAM-ABC, and how the expected outcomes will benefit SUNBEAM and influence future research in this area.
  • Provide a table or graphic representation of an overall SUNBEAM-ABC study timeline and discuss the study timeline of SUNBEAM-ABC sample and bioinformatic analyses in relation to the timeline of SUNBEAM.
  • Discuss the high-level policies, procedures and expectations for the implementation of the SUNBEAM-ABC.
  • Describe the experience of personnel in conducting similar large-scale, multi-omics, multi-center systems biology research, without duplicating information in the biosketches

Subsection B: SUNBEAM-ABC Administrative Group

  • Describe the overall organizational structure of the SUNBEAM-ABC, including the leadership structure, shared responsibilities, and succession planning for the PD/PI (or PDs/PIs).
  • Present a concise organizational chart of the Administrative Group. Describe the specific operations/functions and identify the nature and roles of the staffing plan associated with each operation.
  • Describe the day-to-day management and operations plan, including financial management of the award.
  • Describe how the Administrative Group will interact with the other functional groups, investigators, and staff. as well as the plan for SUNBEAM-ABC investigators to interact with the SUNBEAM Steering Group, the NIAID Statistical and Clinical Coordinating Center and NIAID staff in terms of meetings, teleconferences, and other communications.
  • Describe plans and procedures for establishing and maintaining committees that will facilitate SUNBEAM-ABC governance and management. Propose additional activities relevant to committee function, such as:
  • Developing and implementing policies to ensure the efficient operation and effective management of the functions of the SUNBEAM-ABC, including resolution of disputes and differences of opinion among SUNBEAM-ABC investigators.
  • Developing and implementing policies and procedures for planning, authorship, preparation, review and final approval of manuscripts resulting from SUNBEAM-ABC-supported studies, and for submission of manuscripts for publication in peer-reviewed journals.
  • Developing and implementing policies and procedures for publicizing the accomplishments and the data resulting from SUNBEAM-ABC studies to the scientific and lay communities and other relevant audiences. This includes policies for presentations at scientific meetings and for communications with the press.
  • In considering the above activities, indicate how they will be integrated with the respective activities of SUNBEAM and the SUNBEAM Steering Group.
  • If multiple sites are proposed, provide evidence of the ability of each site to generate and transmit data in an accurate and timely fashion and operate within the proposed organizational structure.
  • If international site(s) is/are proposed, describe plans for managing the complexity of handling biospecimens across countries.

Subsection C: SUNBEAM-ABC Research Projects Group

  • In two separately labeled sections within this subsection, clearly describe the design of the two required research projects: (1) whole blood transcriptomics and (2) high parameter cytometry analysis of fixed blood cells. Discuss the significance of the scientific questions that will be addressed, their role in the overall research strategy of SUNBEAM-ABC and SUNBEAM, and the potential impact of the proposed work. Note that the proposed research projects do not need to be hypothesis-driven, given that SUNBEAM-ABC supports discovery, and may not collect additional biological samples nor propose changes to the biological samples collected under the SUNBEAM clinical protocol.
  • Discuss the nature and scope of any proposed additional omics research projects (within the scope of SUNBEAM-ABC) that might support the overall research agenda. Discuss the significance of the scientific questions that will be addressed, their role in the overall research strategy of SUNBEAM-ABC and SUNBEAM, and the potential impact of the proposed work.
  • For each proposed research project, describe the types of personnel involved in conducting the research, data entry and management, and processing and handling of biologic samples.
  • Provide a summary of earlier studies documenting the performance metrics and robustness of proposed method(s) for the proposed research projects.
  • Provide pertinent information and/or data from preliminary studies that address the feasibility of the projects.
  • For each proposed research project, discuss difficulties and pitfalls that may be encountered and offer alternative approaches to be implemented, if needed. Detail plans to address batch effects and the challenges that varying levels of storage time and cell viability in frozen samples will introduce into the assays and analyses.
  • Include general concepts for sample size determinations and statistical methodologies in the context of the SUNBEAM design.

Subsection D: SUNBEAM-ABC Bioinformatics and Data Integration Group

  • Describe the rationale and approach for the application of bioinformatics tools to analyze and interpret the data from SUNBEAM-ABC activities.
  • Describe the innovation and feasibility of the proposed bioinformatic strategies to identify novel, key biologic pathways implicated in the early stages of AD and food allergy, and early predictive biomarkers. In addition, provide pertinent data from earlier or preliminary studies where these approaches were successfully used.
  • Discuss difficulties and pitfalls that may be encountered and offer alternative approaches to be implemented, if needed.
  • Emphasis should be given to systems biology and computational approaches that can contribute to understanding, visualization, integration, and analysis of multi-dimensional data. Applications should include:
  • Innovative high-level integrative analyses with careful consideration of statistical biases and confounders.
  • Approaches to advance statistical analyses of data sets generated. Examples of the types of analyses include pipelines for genome-wide analysis and interpretation of RNA-seq; pipelines and methods for interpretation of high parameter cytometry data, etc.
  • Approaches to perform systems-level analyses of multiple different datasets (e.g., immunological, proteomic, epigenetic, or clinical), including all omics data generated by this award and other SUNBEAM omics data, if available.
  • Statistical power considerations in the context of the expected size of the SUNBEAM cohort and its case-cohort design.
  • Describe detailed plans for coordination with the NIAID Statistical and Clinical Coordinating Center regarding integration of SUNBEAM clinical data into the SUNBEAM-ABC analyses.

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.

The following modifications also apply:

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
  • All SUNBEAM-ABC investigators are expected to share their SUNBEAM-ABC-supported data publicly through ImmPort (https://immport.niaid.nih.gov) or other public portals designated by NIAID and consistent with achieving the goals of the program.
Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form

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

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

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

See more tips for avoiding common errors.

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

 

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed). While each application will be evaluated in its entirety based on one overall impact score per application, each proposed research project within the SUNBEAM-ABC Research Projects Group and the SUNBEAM-ABC Bioinformatics and Data Integration Group within each application will also receive separate impact scores.

Scored Review Criteria

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific to this FOA:

Subsection A: SUNBEAM-ABC Overview

  • Are the scientific goals presented and justified in the context of recent studies, current knowledge in the field of AD and food allergy development, and the objectives of the SUNBEAM initiative?
  • Is an overall strategy presented that builds on previous research in the field and/or stems from novel, and well-justified concepts?
  • Are the presented data pertinent to the development of the overall research agenda and the scientific goals of the SUNBEAM-ABC of adequate quality?
  • Is the rationale of each proposed project sound, as it relates to the SUNBEAM-ABC overall research agenda?
  • Do the presented policies and procedures for the operation of the SUNBEAM-ABC provide assurances that the Groups can function efficiently and can successfully conduct the proposed studies?

Subsection C: SUNBEAM-ABC Research Projects Group

  • Does the application adequately discuss the clinical and scientific significance of the problems being studied, their role in the overall research strategy of the SUNBEAM-ABC?
  • Is each proposed research project expected to advance scientific understanding by helping identify novel biological pathways and predictors of early development of AD and food allergy?

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:

Subsection B: SUNBEAM-ABC Administrative Group

  • Is the plan for leadership succession appropriate if the PD/PI is unable to continue as the leader of the program?

Subsection D: SUNBEAM-ABC Bioinformatics and Data Integration Group

  • Does the investigative team have a successful track record of conducting large-scale, multi-omics, multi-center systems biology research with clinical samples?

Innovation

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

Approach

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

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific to this FOA:

Subsection B: SUNBEAM-ABC Administrative Group

  • Does the administrative structure of the SUNBEAM-ABC promote effective communications among its investigators, between its investigators and staff, the SUNBEAM-ABC, the SUNBEAM Steering Group and the NIAID Statistical and Clinical Coordinating Center?
  • Do the plans for the handling of the SUNBEAM-ABC finances support sound management?
  • Does the organizational chart of the structure of the SUNBEAM-ABC administration identify the types of staff associated with each operation and does it support sound operations?
  • Do the plans and procedures for establishing and maintaining the functions of committees responsible for the SUNBEAM-ABC governance and management support sound and efficient operations?
  • Is the plan for development of policies and procedures for resolution of disputes and differences of opinion among SUNBEAM-ABC investigators appropriate?
  • Is the plan for development of policies and procedures for planning, authorship, preparation, review, and final approval of manuscripts resulting from SUNBEAM-ABC-supported studies and for submission of manuscripts for publication in peer-reviewed journals appropriate?
  • Is the plan for development and implementation of policies and procedures for publicizing the accomplishments and the data resulting from SUNBEAM-ABC studies to the scientific and lay communities and other relevant audiences appropriate?

Subsection C: SUNBEAM-ABC Research Projects Group

  • For each proposed research project, do the management plans provided include adequate description of the types of personnel involved in conducting the research, data entry and management, and processing and handling of biologic samples? Are these plans appropriate for the project?
  • For each proposed research project, are the study assays established and feasible, considering the availability of biologic samples from the SUNBEAM cohort?
  • For each proposed research project, are the specific limitations that derive from the SUNBEAM cohort design and timeline (e.g., length of time biologic samples may remain frozen, viability after thawing, assay batch effects) adequately addressed?

Subsection D: SUNBEAM-ABC Bioinformatics and Data Integration Group

  • Is adequate emphasis given to systems biology and computational approaches that can contribute to understanding, visualization, integration, and analysis of multi-dimensional data?
  • Are plans for integration of SUNBEAM omics data produced outside this award adequate?
  • Are plans for coordination with the NIAID Statistical and Clinical Coordinating Center with regard to integration of SUNBEAM clinical data into the SUNBEAM-ABC analyses adequate to address this task?

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:

  • Are the administrative, data coordinating, and laboratory/bioinformatic centers, appropriate for the projects proposed?
  • Does the application adequately address the capability and ability to conduct the assays at the proposed site(s) or centers?
  • If international site(s) is/are proposed, does the application adequately address the complexity of handling biospecimens across countries?
  • If multiple sites are proposed, is there evidence of the ability of each site to: (1) generate and transmit data in an accurate and timely fashion; and (2) operate within the proposed organizational structure?

Additional Review Criteria

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

Study Timeline

Is the study timeline for the SUNBEAM-ABC data analysis and bioinformatics assessments concrete, feasible and coincident with the SUNBEAM timeline? Are there adequate opportunities within the timeline to re-assess progress and/or develop a plan to accelerate progress?

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

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

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

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

Resource Sharing Plans

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

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Institute of Allergy and Infectious Diseases (NIAID) , 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 will receive a written critique.

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.

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 recipient's business official.

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

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

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

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, Recipients, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

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

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

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

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

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, 2 CFR Part 200, 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 recipients 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 recipients for the project, as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

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

  • Determine and coordinate the scientific activities of the SUNBEAM-ABC research; setting project goals and timelines; accepting and implementing common guidelines proposed by the SUNBEAM Steering Group.
  • Determine experimental approaches, set project milestones, conduct studies, and analyze and interpret research data.
  • Provide objectives for projects and costs to the NIAID Program Official (PO) and NIH Project Scientist (PS), at the outset of the award.
  • Serve as a voting member of the SUNBEAM Steering Group, and participate, along with critical staff, in SUNBEAM Steering Group meetings.
  • Adhere to the SUNBEAM-ABC guidelines and other policies that might be established, as agreed upon by the SUNBEAM Steering Group, and the NIAID PO.
  • Apprise the NIAID PO and NIH PS of any potential impediments to execution of the objectives of the project.
  • Ensure that primary and secondary data, protocols, procedures, and any other project-derived resources are made available to the SUNBEAM Steering Group (e.g., deposited in a centralized database, as specified by the PO and PS) according to a timeline agreed upon by the SUNBEAM Steering Group and PO.
  • Providing representation on all relevant subcommittees and working groups established by the SUNBEAM-ABC Administrative Group. Issues to address in working groups may include quality control, molecular interrogation, publications, intellectual property, data access, etc.
  • Agree not to disclose confidential information obtained from other members of the SUNBEAM-ABC and agree to the SUNBEAM-ABC intellectual property agreements, consistent with the terms and conditions of the cooperative agreement awards, applicable regulations, and the policies and practices of the award recipient institutions.

Data Sharing Responsibilities

  • Recipients are expected to make the biological samples, and other research tools, methods, data, and materials that they develop under the SUNBEAM-ABC award available to the research community, per policies established and decisions made by the SUNBEAM Steering Group and consistent with achieving the goals of the program.
  • To promote rapid public access to SUNBEAM-ABC-supported data, all SUNBEAM-ABC investigators are expected to share their SUNBEAM-ABC-supported data publicly through ImmPort (https://immport.niaid.nih.gov) or other public portals designated by NIAID and consistent with achieving the goals of the program. The privacy of participants will be safeguarded, and confidential and proprietary information will be protected. The PDs/PIs are responsible for developing data sharing plans and timelines for implementation to be presented to the SUNBEAM Steering Group and to the NIAID PO assigned to the grant for approval. Sharing plans and their timelines represent a commitment by the recipients to support and abide by the plan. The PD(s)/PI(s) will establish procedures to ensure that all members of SUNBEAM ABC and associated scientists conform to the data-sharing plan.

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

During the performance of the award, the NIAID Project Scientist(s) will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards as described below:

  • Provide guidance and support in the design of research activities.
  • Serve as a resource for assay design and development.
  • Provide scientific/programmatic support during the accomplishment of the research.
  • Advice in the selection of sources or resources, and in the management and technical performance.
  • Meet regularly with the SUNBEAM-ABC leadership through conference/video calls and may participate in other SUNBEAM-ABC activities as appropriate.
  • Participate in the decision-making process (developed through consensus).
  • In addition, an NIAID PO will be responsible for the programmatic stewardship of the award and will be named in the award notice.

Access to Data

  • The NIAID PS or designees will have access to all data generated under this cooperative agreement and may review the data as recorded on case report forms or in databases. Data must be available for external checking against the original source documentation. NIAID staff may use information obtained from the data for the preparation of internal reports on the activities of the study.
  • Additionally, an agency PO will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

Research Plans

  • Implementing, monitoring, and updating the research agenda for SUNBEAM-ABC to ensure consistency with the SUNBEAM agenda and relevance with the NIAID scientific priorities.

Protocol Development

  • The SUNBEAM-ABC PD(s)/PI(s) will fully develop the research protocols for the projects supported by this FOA with the participation of the SUNBEAM Steering Group, the NIAID Statistical and Clinical Coordinating Center and the NIAID Division of Allergy, Immunology, and Transplantation (DAIT) staff.

Research Activities

  • Reviewing the SUNBEAM-ABC research activities and goals on an agreed-upon schedule (but no less than once every year). Promoting, evaluating, and executing opportunities to collaborate with other federal or non-federal research sponsors.

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 recipient. This special dispute resolution procedure does not alter the recipient'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, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

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

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

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

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

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

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

Scientific/Research Contact(s)

Gang Dong, MD PhD
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3508
Email: gdong@niaid.nih.gov

Peer Review Contact(s)

Louis Rosenthal, PhD
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-5070
Email: rosenthalla@niaid.nih.gov

Financial/Grants Management Contact(s)

Nicole Guidetti
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-6934
Email: nicole.guidetti@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 2 CFR Part 200, 42 CFR Part 52 and 45 CFR Part 75.


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