Department of Health
and Human Services (HHS)
and Human Services (HHS)
National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
UM1 Research Project with Complex Structure Cooperative Agreement
Only one application per institution is allowed as defined in Section III. 3. Additional Information on Eligibility.
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.
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.
Not Applicable
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.
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:
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. Skin tape strip RNA for transcriptomics will not be available for use in applications in response to this RFA. 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.
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.
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.
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.
Not Allowed: Only accepting applications that do not propose clinical trials.
Need help determining whether you are doing a clinical trial?
NIAID intends to commit an estimated total of $3.0 million in FY 2023 to fund 1 (one) award.
Application budgets are limited to $1.8 million direct costs and need to reflect the actual needs of the proposed project
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.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Local Governments
Federal Governments
Other
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
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:
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.
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:
The letter of intent should be sent to:
Louis Rosenthal, PhD
Telephone: 240-669-5070
Email: rosenthalla@niaid.nih.gov
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
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.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
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:
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Specific Aims: List 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.
Subsection B: SUNBEAM-ABC Administrative Group
Subsection C: SUNBEAM-ABC Research Projects Group
Subsection D: SUNBEAM-ABC Bioinformatics and Data Integration Group
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:
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.
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile 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.
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the 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.
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Does the 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
Subsection C: SUNBEAM-ABC Research Projects Group
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
Subsection D: SUNBEAM-ABC Bioinformatics and Data Integration Group
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the 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
Subsection C: SUNBEAM-ABC Research Projects Group
Subsection D: SUNBEAM-ABC Bioinformatics and Data Integration Group
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:
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
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.
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:
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.
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.
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.
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:
Data Sharing Responsibilities
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:
Access to Data
Areas of Joint Responsibility include:
Research Plans
Protocol Development
Research Activities
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.
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.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov
Gang Dong, MD PhD
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3508
Email: gdong@niaid.nih.gov
Louis Rosenthal, PhD
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-5070
Email: rosenthalla@niaid.nih.gov
Nicole Guidetti
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-6934
Email: nicole.guidetti@nih.gov
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 2 CFR Part 200, 42 CFR Part 52 and 45 CFR Part 75.
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