Department of Health
and Human Services (HHS)
and Human Services (HHS)
EXPIRED
National Institutes of Health (NIH)
Office of Strategic Coordination (Common Fund)
This Funding Opportunity Announcement (FOA) is developed as a Common Fund initiative (http://commonfund.nih.gov/) through the Office of the NIH Director, Office of Strategic Coordination (https://dpcpsi.nih.gov/). All NIH Institutes and Centers participate in Common Fund initiatives. The awards issued in response to this FOA will be administered by the National Institute of Dental and Craniofacial Research (NIDCR) on behalf of the NIH.
R03 Small Grant Program
Reissue of RFA-RM-19-012 - Pilot Projects Enhancing Utility and Usage of Common Fund Data Sets (R03 Clinical Trial Not Allowed)
None
93.310
Several valuable and widely available data sets have been generated by multiple Common Fund programs. The purpose of this funding opportunity announcement (FOA) is to announce the availability of funding to demonstrate and enhance the utility of selected Common Fund (https://commonfund.nih.gov/) data sets, including generating hypotheses and catalyzing discoveries. Award recipients are asked to provide feedback on the utility of the Common Fund data resources.
30 days prior to the application due date
February 19, 2021
No late applications will be accepted for this Funding Opportunity Announcement.
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.
March 19, 2021
All applications are due by 5:00 PM local time of applicant organization.
June/July 2021
August 2021
September 2021
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.
Introduction
This funding opportunity announcement (FOA) aims to promote innovative research to enhance the utility and usability of selected Common Fund data sets. The submission of small research (R03) applications is encouraged from institutions and organizations proposing projects that lead to enhanced use of selected Common Fund (https://commonfund.nih.gov/) data sets by the wider scientific community.
Small research (R03) grants provide flexibility for initiating discrete, well-defined projects that can be completed in one year and require only limited levels of funding. This program supports different types of projects including, but not limited to, the following:
Conducting pilot or feasibility studies based on analyses across two or more Common Fund data sets;
Building synthetic cohorts, combining and comparing data sets;
Developing research methods, or analytic tools to support data visualization, harmonization and integration;
Curating and/or annotating information in the data sets;
Developing workflows and tools to automate data integration and interoperability;
Applying new artificial intelligence/machine learning/deep learning approaches for metadata harmonization to aid in data integration;
Developing new approaches and tools for simultaneous analysis of data residing on multiple platforms (e.g., data sets residing in two separate cloud platforms).
This initiative is funded through the NIH Common Fund, which supports cross-cutting programs that are expected to have exceptionally high impact. All Common Fund initiatives invite investigators to develop bold, innovative, and often risky approaches to address problems that may seem intractable or to seize new opportunities that offer the potential for rapid progress.
This Funding Opportunity Announcement does not accept applications proposing clinical trial(s).
Background
Since its initial inception as the NIH Roadmap for Biomedical Research, the NIH Common Fund (https://commonfund.nih.gov/) has supported many transformative research programs that generate new technologies, methods, and data. Many of these programs generate rich public data sets containing a variety of multi-dimensional molecular and phenotypic data from several organisms including mouse and human. To maximize the impact of these data, engage a broader community of end-users for wider adoption of these data sets, and to obtain feedback from award recipients to enhance the data resources, the Common Fund plans to support small research projects (R03) encouraging the use of Common Fund data sets. Awards are intended to enable novel and compelling biological questions to be formulated and addressed, and/or to generate cross-cutting hypotheses for future research.
Objectives and Scope
The goals of this FOA are to 1) promote the use of Common Fund data sets by supporting pilot studies based on analyses across two or more Common Fund data sets; 2) enhance the utility of existing Common Fund data sets by developing workflows, analytic and simulation tools which will enable simultaneous analysis of multiple Common Fund data sets; and 3) demonstrate the added-value of integrating multiple Common Fund data resources in addressing biomedical research questions.
Investigators are encouraged to utilize various approaches including, but not limited to, systems approaches, advanced data science methods for data set integration and harmonization, and incorporating computational modeling to bring together high throughput genotype and phenotype data sets. Because information regarding the user experience could help NIH improve its data resources, the awardees will be asked to provide feedback on usability and utility of data sets and public data portals, which the awardees can provide in their close-out reports.
The established Common Fund data sets listed below are well-poised for increased community use. Applicants must propose to use two or more data sets from the following list, although they can propose to use other data sets (both NIH Common Fund data sets and other NIH data sets) as well. Integration across multiple data sets is required.
4D Nucleome (4DN) (https://www.4dnucleome.org/): Reference nucleomics and imaging data sets, including an expanding tool set for open data processing and visualization
Extracellular RNA Communication (exRNA) (https://exrna.org/): Catalog of exRNA molecules found in human biofluids like plasma, saliva, and urine; and potential exRNA biomarkers for diseases
Gabriella First Kids First (KF) (https://kidsfirstdrc.org/): Data from whole-genome sequencing of cohorts with structural birth defects and/or susceptibility to childhood cancer, with associated phenotypic and clinical data
Genotype-Tissue Expression (GTEx) (https://www.gtexportal.org/home/): Whole genome- and RNA sequence data from multiple human tissues to study tissue-specific gene expression and regulation, including tissue samples
Glycoscience (GL) (https://glygen.org/): A data integration and dissemination project for carbohydrate and glycoconjugate related data
Human BioMolecular Atlas Program (HuBMAP) (https://hubmapconsortium.org/): An open and global platform to map healthy cells in the human body to determine how the relationships between cells can affect the health of an individual
Illuminating the Druggable Genome (IDG) (https://druggablegenome.net/): Data on understudied druggable proteins, including mRNA and protein expression data, phenotype associations, bioactivity data, drug target interactions, disease links, and functional information
Integrated Human Microbiome Project (iHMP) (https://hmpdacc.org/ihmp/): Microbiome, epigenomic, metabolomic, and phenotypic data for 3 cohorts
Knockout Mouse Phenotyping Program (KOMP2) (http://www.mousephenotype.org/): Data from broad, standardized phenotyping of a genome-wide collection of mouse knockouts
Library of Integrated Network-based Cellular Signatures (LINCS) (http://lincsproject.org/): Molecular signatures that describe how different types of cells respond to a variety of agents that disrupt normal cellular function
Metabolomics Workbench (https://www.metabolomicsworkbench.org/): Metabolomics data and metadata from studies on cells, tissues, and organisms
Molecular Transducers of Physical Activity in Humans (MoTrPAC) (https://motrpac-data.org/data-access): Data contain assay-specific results, associated metadata, quality control reports, and animal phenotype data related to molecular transducers that underlie the effects of physical activity
Stimulating Peripheral Activity to Relieve Conditions (SPARC) (https://sparc.science/): Maps and tools to identify and influence therapeutic targets that exist within the neural circuitry of a wide range of organs and tissues
This FOA accepts different types of projects with the intent of generating preliminary and/or validation data for subsequent funding including, but not limited to, the following:
Investigation of gene expression, genome topology, protein expression, and/or epigenetic patterns across several disease conditions, phases of the lifespan, or in analysis of sexual dimorphism
Identification of biomarkers (metabolites, genetic variants, DNA methylation and/or histone marks) associated with various diseases and risk factors
Machine learning and computational approaches to identify likely areas of the genome and genetic variations/mutations related to human diseases
Network analysis across genetic variation, expression profiling, and/or GWAS data to reveal pathways associated with various diseases
Enhancement of information in the data resources through the development of analytic tools, curation and annotation of existing data, or addition of phenotypic or clinical information.
Applications are expected to utilize the existing data in the above listed Common Fund data sets. Generation of new data should be limited to testing/validation of predictions. As noted in the R&R or Modular Budget section, if experimental studies are proposed, there is a budget limit for such activities.
Frequently Asked Questions regarding this FOA will be posted on the Common Fund Data Usage (https://commonfund.nih.gov/datause) website. Applicants are encouraged to review the FAQs prior to submitting their applications.
See Section VIII. Other Information for award authorities and regulations.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
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.
Need help determining whether you are doing a clinical trial?
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
The NIH Common Fund intends to commit approximately $2,000,000 in FY 2021, contingent upon receiving scientifically meritorious applications and having funds available. 6-8 awards are anticipated from this solicitation.
The maximum project period for an application submitted under this FOA is one year.
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.
Program Directors/Principal Investigators (PDs/PIs) and key personnel of the Data Coordinating Centers (DCCs) of the Common Fund programs, and researchers who are involved in the DCC activities as senior/key investigators are not eligible to respond to this announcement. Applicants who are not sure about their eligibility are strongly recommended to contact the Program Officers listed below to discuss their situation.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
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.
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:
Haluk Resat, Ph.D.
Office of Strategic Coordination (OSC)
Office of the Director (OD)
Telephone: 301-827-6671
Email: [email protected]
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this 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.
All instructions in the SF424 (R&R) Application Guide must be followed.
If experimental approaches are proposed, they should be limited to 20% of the requested budget.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Applicants must propose to use at least two Common Fund data sets from the list under Part 2, Section I, Funding Opportunity Description, although they can propose to use additional data sets. Integration across multiple data sets is required. Applicants should provide justification for why particular data sets were chosen for study. The applicant should provide sufficient evidence that the proposed work is feasible, will advance the overall stated goals by increasing knowledge and/or broader utility of the data sets under study, and will enable novel and compelling biological questions to be formulated and addressed to form the basis for a subsequent research application.
Both primary and secondary analyses of Common Fund data sets may be proposed in order to develop hypotheses to address research questions. Data analyses proposed should utilize two or more Common Fund data sets from the list above, and may include other NIH data sets, as long as the external data are currently accessible through a public controlled access database, or can be shared through such a database. For example, studies proposed may combine data within cohorts or across phenotypically different cohorts to more powerfully address research questions if the intent is to catalyze the discovery of new variants, to reveal unrealized common genetic pathways shared by related conditions, or to provide a means to generate preliminary data supporting larger projects focused on functional studies.
Applicants may enhance the value of Common Fund data sets for the research community by proposing to develop analytic methods, tools, pipelines, or workflows that can be incorporated into the data sets and used to address research questions. Applicants may also propose approaches that reflect unique and under-utilized aspects of the listed Common Fund data sets (e.g., using tissue samples from GTEx). If experimental approaches are proposed, expense of the associated research activities should be limited to 20% of the project budget.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 include a Data and Resource Sharing Plan. The Data and Resource Sharing Plan will be considered during peer review and by program staff as award decisions are being made as appropriate and consistent with achieving the goals of the program. It is expected that data (including resultant raw, derived, aggregated, and summary data), tools, workflows, and/or pipelines created or used with support from this FOA will be provided to the relevant data coordinating center or to another public data repository to be shared with the wider scientific community, in a timely manner that would enable other researchers to replicate and build on the analyses for future research efforts.
In the Data and Resource Sharing Plan, applicants should describe the anticipated timeline, formats, and methods of providing the data and other products used or created under this FOA to the relevant Data Coordinating Center or public repository. Some example resultant data types could include variant call files from multi-sample comparisons, plots or graphs of variant associations, lists or tables of gene summaries, network/pathway analysis results, and other summary statistics. Where applicable, applicants should describe how they plan to share any tools, pipelines, or workflows used or created through open access channels (e.g. public GitHub links).
For applications that aim to co-analyze Common Fund data with other genomic data sets that are currently accessible through an NIH approved repository (e.g., dbGaP) or some other public controlled access database (e.g., European Genome-phenome Archive), applicants must describe the database through which the proposed data are accessible to the research community and the details of the data sets including any data use limitations based on the associated consent form.
For applications that aim to co-analyze Common Fund data with genomic data sets that are not currently accessible through an NIH approved repository (e.g., dbGaP) or some other public controlled access database (e.g., European Genome-phenome Archive), applicants must describe their ability and willingness to submit the individual-level sequence data to an NIH-approved repository (e.g., dbGaP) and provide an associated Institutional Certification using the current NIH template (https://osp.od.nih.gov/scientificsharing/institutional-certifications/ (https://osp.od.nih.gov/scientific-sharing/institutional-certifications/)). If the Institutional Certification is not available, provide a Provisional Certification and describe the anticipated data use limitations and associated modifiers separately. If submitting a Provisional Certification with the application, please note that a completed Institutional Certification may be required prior to award.
Only limited Appendix materials are allowed. No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
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.
For this particular announcement, note the following:
The R03 small grant supports discrete, well-defined projects that realistically can be completed in two years and that require limited levels of funding. Because the research project usually is limited, an R03 grant application may not contain extensive detail or discussion. Accordingly, reviewers should evaluate the conceptual framework and general approach to the problem. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or from investigator-generated data. Preliminary data are not required, particularly in applications proposing pilot or feasibility studies.
Awards to be made through this announcement will be limited to one year of support, so reviewers should evaluate the items below with this temporal framework in mind.
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).
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?
Will the work proposed enhance the utility of Common Fund datasets for the wider scientific community and/or add information value to the data sets?
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?
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?
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?
Specific to this FOA:
Will the project integrate data across multiple data sets?
Will the proposed methods enable unique knowledge generation from the utilized Common Fund data sets?
Is it likely that the proposed work will generate preliminary data to form the basis for a subsequent research application?
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?
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?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Protections for Human Subjects
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
Inclusion of Women, Minorities, and Individuals Across the Lifespan
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
Not Applicable
Renewals
Not Applicable
Revisions
Not Applicable
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 Center for Scientific Review, 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 appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights 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.
Not Applicable
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.
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: [email protected] (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: [email protected]
Haluk Resat, Ph.D.
Office of Strategic Coordination (OSC)
Office of the Director (OD)
Telephone: 301-301-827-6671
Email: [email protected]
Chris Kinsinger, Ph.D.
Office of Strategic Coordination (OSC)
Office of the Director (OD)
Telephone: 301-594-8174
Email: [email protected]
Yuanna Cheng, M.D., Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-435-1195
Email: [email protected]
Dede Rutberg
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-443-4295
Email: [email protected]
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 42 CFR Part 52 and 45 CFR Part 75.