June 6, 2023 - This PAR has been reissued as PAR-23-199
July 27, 2022 - Notice of Intent to Publish a Funding Opportunity Announcement for ClinGen Genomic Curation Expert Panels (U24 Clinical Trial Not Allowed). See Notice NOT-HD-22-036
May 11, 2022 - Notice of Change to PAR-20-101 "Genomic Expert Curation Panels (U24 Clinical Trial Not Allowed)". See Notice NOT-HD-22-007
October 28, 2021 - Reminder: FORMS-G Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2022 - New Grant Application Instructions Now Available. See Notice NOT-OD-22-018.
September 13, 2021 - Updates to the Non-Discrimination Legal Requirements for NIH Recipients. See Notice NOT-OD-21-181.
August 5, 2021 - New NIH "FORMS-G" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2022. See Notice NOT-OD-21-169.
August 5, 2021 - Update: Notification of Upcoming Change in Federal-wide Unique Entity Identifier Requirements. See Notice NOT-OD-21-170
April 20, 2021 - Expanding Requirement for eRA Commons IDs to All Senior/Key Personnel. See Notice NOT-OD-21-109April 23, 2021 - Notice of Additional Information for PAR-20-101. See Notice NOT-HD-21-028.
August 23, 2019- Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-137
93.865, 93.399, 93.867, 93.242, 93.853
The purpose of this FOA is to establish expert panels that will select genes and genomic variants associated with diseases or conditions of high priority to participating NIH Institutes and Centers (ICs) and systematically determine their clinical significance for diagnosis and treatment of these diseases or conditions. The Genomic Expert Curation Panels funded through this FOA are required to utilize the NHGRI Clinical Genomics Resource (ClinGen) and the NCBI ClinVar procedures, interfaces, tools and informatics infrastructure to determine the strength of evidence supporting the clinical significance of the selected genes and variants that will support development of clinical practice guidelines.
January 23, 2020
30 days prior to application receipt date
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.
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.
Clinical genetic testing is becoming increasingly routine in clinical practice and genome-scale sequencing is leading to the identification of many genomic variants with vastly differing clinical relevance. Many of these tests reveal a large number of variants of unknown significance (VUS) due to a variant’s rarity or to differences in the interpretation of its role by clinical laboratories or clinicians, potentially leading to inappropriate medical interventions.Though variants have been identified for certain Mendelian disorders, for the majority of the over 80 million variants in the human genome currently there is no clear understanding of their impact on human health.
NIH established a clinical genomics infrastructure to develop an openly accessible knowledge base that promotes data sharing and provides standardized infrastructure and tools for determining the clinical relevance of genetic variants through two initiatives: the Clinical Genomics Resources (ClinGen) and the Clinical Variant Database (ClinVar) of clinical variation. ClinVar is a publicly and freely available database maintained by the National Center for Biotechnology Information (NCBI) that aggregates information about genomic variation and its relationships to human health (http://www.ncbi.nlm.nih.gov/clinvar/). ClinGen is an NHGRI-funded central resource additionally supported by NCI and NICHD. ClinGen defines the clinical relevance of genes and variants for use in precision medicine and research by standardizing clinical annotation and interpretation of variants and implementing evidence-based expert consensus (https://www.clinicalgenome.org/). This integrated infrastructure supports disease/disorder specific expert panels to determine the clinical applicability of genes and/or variants utilizing genomic, clinical, computational, and functional data. ClinGen has developed a clinical validity framework for identifying and assigning the level of evidence to support determination of gene-disease relationships. Furthermore, they have implemented standard approaches for curation and interpretation of both sequence and copy number variants. Variants evaluated by ClinGen-endorsed expert panels are deposited in ClinVar. Based on its rigorous and transparent procedures, ClinGen has been recently recognized by the FDA as the first public genetic variant database that can be used to validate genetic variant information in regulatory submissions. The ClinGen framework and tools can be found at https://www.clinicalgenome.org/tools/#heading_0.
Sharing of genomic data is critical for the determination of clinical significance of a gene and its variants.To that end, ClinVar is a community submission-driven knowledgebase that can receive submissions of varying complexity ranging from primary submitters for a single variant to authoritative assertions of clinical significance prepared by expert panels. ClinVar utilizes a four-star rating system to provide information about the level of review of the submissions. ClinVar assigns three stars for ClinGen approved expert panel submissions. As a result of their FDA recognition, ClinGen expert panels submissions are additionally marked in ClinVar with an FDA Recognized Database label (https://www.ncbi.nlm.nih.gov/clinvar/variation/239906/). ClinGen has developed the procedures to support the formation of expert panels along with a suite of curation interfaces and tools to support their expert panel activities. These procedures, interfaces, and tools facilitate a systematic process for analyzing evidence in a uniform and streamlined manner by expert panels.
Currently ClinGen-established expert panels span a number of disease areas including: cardiovascular diseases, hearing loss, hemostasis/thrombosis, hereditary cancers, inborn errors of metabolism, neurodevelopmental disorders, neuromuscular disorders, and RASopathies. ClinGen continues to consider additional disease areas as new opportunities arise, as well as new genes or variants within existing domains (https://www.clinicalgenome.org/affiliation/).
This FOA invites applications to establish Genomic Expert Curation Panels. These panels may identify clinical domains of high priority to participating NIH Institutes and Centers (ICs), select candidate genes that will have a high impact on clinical practice in these high priority areas, analyze all relevant variant data utilizing the ClinGen procedures, interfaces, and tools to make determinations of clinical significance. Specific IC interests include:
The Expert Curation Panels are required to collaborate with ClinGen and ClinVar utilizing the ClinGen suite of curation interfaces and tools and to submit their underlying data to these resources in order to share data with the field. Training on these tools is required and is provided through ClinGen online resources and/or staff for new curation groups. NIH Expert Curation Panel PD/PIs, coordinators and other key staff are expected to participate in ClinGen working groups and share curation procedures and outcomes with ClinGen and ClinVar.
Because of the large number of diseases and limited funds for this program, investigators are encouraged to form collaborations with other researchers in the same disease area and submit one application, rather than competing or complementary applications. Disease areas that have already established an Expert Curation Panel should provide compelling justification for the need for support through this initiative.
The scope of this FOA is to establish Expert Curation Panels in areas of high priority to the participating ICs. The Expert Curation Panel will select and review genes and their variants within the specified domain that have the potential for clinical applicability utilizing the procedures and tools developed by ClinGen. The role of the expert panel is to evaluate the strength of existing publicly available evidence supporting the clinical significance or actionability of the selected genes to support clinical practice and submission to ClinVar.
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.
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Project period is limited to 3 years.
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
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 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.
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.
Currently funded PD(s)/PI(s)are eligible to apply but must provide a strong justification to be considered for support.,
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:
Melissa A. Parisi, MD, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
All instructions in the SF424 (R&R) Application Guide must be followed. Funds can be used to support partial salary of the Expert Curation Panel chair and, if applicable, the co-chair(s). Other panel experts can receive nominal consulting fees. The primary emphasis of the budget should be on supporting a project coordinator, biocurators, and bioinformatics specialists. Both domestic and international Expert Panel members can receive nominal consulting fees. Funds can also be used for meeting support and travel to face-to face meetings and the annual Curating the Clinical Genome Conference (https://clinicalgenome.org/about/events/) by the PI and other appropriate members. There may be additional costs associated with training on ClinGen tools. Regarding budgeting for consultants, if they will not be conducting a substantive portion of the research, their fees will not be considered to be a sub-award, and therefore, no indirect costs would be involved. If they are conducting a substantive portion of the research, a sub-contract will be required. All costs, including indirect costs, come from the parent award.
1. Describe the clinical domain(s) identified within the scope of priorities described by the participating ICs and identify the disease/disorder genes and/or variants selected for curation. Provide a justification for why this area is ready for analysis and why particular genes/variants were selected. Document their potential for clinical actionability.
2. Describe the leadership (including a chair and co-chair, if needed) and membership of the Expert Curation Panel as well as other key group members, including a project coordinator and clinical and informatics curators who will provide support for the Expert Curation Panel. Describe the membership of the Expert Curation Panel that will select and evaluate the clinical relevance of genes/variant to be curated. Include details about how each member will contribute to establishing the clinical actionability of the genes/variants being curated.
3. Provide a description of how you will ensure that the panel reflects multiple institutions and takes into account work within the international context.
4. Describe how the Expert Curation Panel will carry out its functions. Based on the number of genes or variants proposed, determine whether individual working groups focused on specific subsets of genes or variants will be established, and how these will be related to the Expert Curation Panel. Describe the work of these subgroups, key members that will provide oversight and those undertaking the process of curation. Ensure that there is adequate biocuration and operations staffing to accomplish the outlined goals of the expert panel. Include information about staff who will support the group and planned interactions with ClinGen.
5. Describe the procedures for gene-disease/gene variant assessments utilizing the ClinGen/ClinVar procedures and interfaces. Include the gene-disease/variant curation guideline development, curation review process and policies for resolving differences.
6. Describe the ClinGen training to be undertaken by the PI, experts, coordinator, curators, the curation summaries prepared by curators, the process by which they will be reviewed by the Expert Curation Panel rules, and the process used by the Expert Curation Panel for decision making. Provide a plan for work-flow and timeline.
7. Describe plans for regular Expert Curation Panel meetings both remote and face-to-face. At least one annual in-person meeting is recommended. Scheduling this meeting either at a regularly attended professional meeting or in conjunction with the annual Curating the Clinical Genome (https://www.clinicalgenome.org/about/events/curating-the-clinical-genome-2019/)meeting is encouraged.
8. Describe plans for integration with ClinGen working groups and curation activities.
9. Describe plans for interaction with ClinGen and participation in the relevant working groups, including the Coordinators, Curators, and Bioinformatics ClinGen working groups, monthly ClinGen webinars and attend the annual face to face meetings, e.g., Curating the Clinical Genome Conference.
10. If this is an application from an existing Expert Panel, provide a justification for the need for this panel, e.g. different group of genes.
Letters of Support:
Letters of support from Expert Curation Panel members who are not listed as key personnel should be included in the Letters of Support Section.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:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.
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.
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, NIH. Applications that are incomplete or non-compliant will not be reviewed.
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 U24 mechanism invites applications to support research projects contributing to improvement of the capability of resources to serve biomedical research. The Genomic Expert Curation Panels provide an infrastructure within which panel members are able to utilize the tools developed by ClinGen and ClinVar to determine the clinical significance of individual genes and genomic variants to diseases or disorders of high priority to the participating ICs. Accordingly, the review will emphasize whether the Expert Curation Panels have the breadth of expertise and institutional representation to assess the clinical actionability of the genes and/or variants they have selected. Reviewers should also assess how well the Expert Curation Panels will utilize the ClinGen/ClinVar curation resources in their determination of clinical 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 curation of the genes/variants selected make a significant contribution toclinical practice?
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?
Does the Expert Panel membershipinclude broad institutional and technical representation? Is there international representation? Is there adequate staffing to support the curation process?
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?
Howwell have the applicants described their utilization of the ClinGen/ClinVar procedures and suite of tools for curating genes/variants? For existing Expert Curation Panels, is the justification adequate for continued support, e.g. new group of genes/variants associated with the conditions being currently curated?
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?
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?
For research that involves human subjects but does not involve one of thecategories 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.
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.
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.
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.
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
For Renewals, the committee will consider the progress made in the last funding period.
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).
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).
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.
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:
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.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.
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.
For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.htmlhttps://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.htmlor call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.
The PD(s)/PI(s) will have the primary responsibility for:
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
Project Scientist(s) -- NIH staff will have the role of Project Scientist(s) through technical assistance, advice, and coordination. The Project Scientists' responsibilities are defined as follows:
Program Official Additionally, an Institute Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The Program Official will:
Areas of Joint Responsibility include:
None; all responsibilities are divided between awardees and NIH staff as described above.
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 arbitration. An Arbitration Panel composed of three members will be convened. It will have three members: a designee of the Genomic Expert Curation Panel chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.
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 agreementsare 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.
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email:GrantsInfo@nih.gov(preferred method of contact)
Grants.gov Customer Support(Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Melissa A. Parisi, MD, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Cancer Institute (NCI)
Jonathan Pevsner, PhD
National Institute of Mental Health
National Institute of Neurological Disorders and Stroke
Grace Shen, Ph.D.
National Eye Institute (NEI)
Telephone: (301) 451-2020
Baishali Maskeri, PhD
Center for Scientific Review (CSR)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Mental Health (NIMH)
Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
National Eye Institute (NEI)
Telephone: (301) 451-2020
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