National Institutes of Health (NIH)
National Human Genome Research Institute (NHGRI)
Note: Not all NIH Institutes, Centers, and Offices (ICOs) participate in Announcements. Applicants should carefully note which ICOs participate in this announcement and view their respective areas of research interest at the ICO-Specific Scientific Interests website. ICOs that do not participate in this announcement will not consider applications for funding.
U01 Research Project – Cooperative Agreements
See Part 2, Section III. 3. Additional Information on Eligibility.
The Genomics Research to Elucidate the Genetics of Rare Diseases:innovation (GREGoRi) initiative seeks to accelerate a paradigm shift in rare disease diagnosis by reimagining the tools, molecular technologies and analytical approaches used to identify the causal gene(s) and/or variant(s) underlying rare genetic disorders. The purpose of this Notice of Funding Opportunity is to establish the GREGoRi Data Coordination and Outreach Center. The Data Coordination and Outreach Center will act as the central point of coordination for the GREGoRi Research Program, and will be responsible for ensuring that the protocols, data, metadata, computational tools and other resources developed as part of GREGoRi are made available to the broader research community.
As a leading authority in the field of genomics, the mission of the National Human Genome Research Institute (NHGRI) is to accelerate scientific and medical breakthroughs that improve human health by driving cutting-edge research, developing new technologies, and studying the impact of genomics on society. Congress initially established NHGRI to characterize the structure and function of the human genome, including the mapping and sequencing of individual genes. This also includes reviewing and funding research proposals, developing training programs, coordinating international genome research, communicating advances in genome science to the public, and reviewing and funding proposals to address the ethical and legal issues associated with this research. NHGRI supports the development of methods, resources and technologies to improve the health of all humans through advances in genomics research. NHGRI supports research that accelerates foundational resources, technology development, and experimental and computational approaches for basic genomics and functional genomics research; for the application of genomics to medical science and clinical care; and to support ethical, legal and social implications (ELSI) research concerning societal issues that need to be addressed, especially as genomic science advances. For years, NHGRI has participated in the NIH effort to turn discovery into health by helping small businesses develop innovative genomics technologies that improve health and save lives. NHGRI also develops and supports initiatives that expand opportunities for genomics education and careers, cultivating genomics training programs and workforce development initiatives.
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS - New/Renewal/Resubmission/Revision, as allowed | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| October 30, 2026 | Not Applicable | Not Applicable | March 2027 | May 2027 | July 2027 |
All applications are due by 5:00 PM local time of applicant organization.
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.
No late applications will be accepted for this Notice of Funding Opportunity (NOFO).
Not Applicable
It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).
Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.
Applications that do not comply with these instructions may be delayed or not accepted for review.
There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.
Background and Program Overview
Over the last decade, rapid advancements in the development of high throughput and cost-effective genome sequencing technologies have made it possible to obtain a precise molecular diagnosis for many individuals with an undiagnosed but likely genetic disease. However, a substantial proportion of individuals with a suspected genetic disease – more than 50% – remain undiagnosed after undergoing clinical genetic testing. In 2021, NHGRI launched the GREGoR (Genomics Research to Elucidate the Genetics of Rare Disease) Consortium, with the goal of developing new approaches to identify causal variants in individuals with rare genetic disease, particularly where whole exome sequencing was not successful. The research centers funded in phase I of GREGoR use approaches such as whole genome sequencing, RNA sequencing, and other methods to solve these more challenging cases. The data generated in GREGoR are shared with the broader research community via NHGRI's Analysis, Visualization, and Informatics Lab-space (AnVIL) through the AnVIL Portal.
Today, whole exome sequencing (WES) is considered to be a first-line approach for identifying the underlying cause of rare genetic disorders. While powerful, whole exome sequencing has a number of critical limitations that may contribute to the high rate of unsolved cases. First, WES cannot readily identify more complex variants such as copy number variants (CNV), repeat expansions, or structural variants (SV) that may contribute to disease. An additional challenge is that WES focuses primarily on protein coding regions of the genome, and is unable to detect potential causal variants in regulatory regions, introns, or other non-coding functional elements in the genome. Due to advances in the development of genomic and other molecular technologies, it is now possible to investigate many aspects of genome organization and function comprehensively and at scale, including RNA, protein and metabolites, genomic interactions, and the epigenome. In order for these technologies to be used to their fullest potential in the clinical genetics setting, more concrete guidance and the development of best practices supporting their use for rare disease diagnosis are needed.
A number of computational and analytical challenges also need to be addressed in order to fully realize the potential of these molecular approaches. For example, the integration of multiple molecular data types (including those generated by large-scale programs such as the Encyclopedia of DNA Elements (ENCODE), the Roadmap Epigenomics Program, or the Impact of Genomic Variation on Function (IGVF) Consortium) could inform variant prioritization, however doing so requires specialized domain knowledge or expertise that clinical genetics researchers may not have access to. Many current analytical approaches have other significant limitations, such as excluding many regions of the genome that may harbor disease-causing mutations, such as centromere, telomeres, repeat regions, and sex chromosomes, or not adequately accounting for more complex modes of inheritance. Finally, new genome representations such as the Human Pangenome Reference have the potential to better enable the identification of disease associated variation in whole genome sequence data, but most currently available tools rely on older, outdated reference genomes.
To close the diagnostic gap for rare diseases, there is a need for continued innovation in how such technologies are used in the clinical genetics setting, and in the computational tools and analytical methods that are used to identify and prioritize candidate genes or variants. In the second phase of GREGoR, GREGoR:innovation (GREGoRi), NHGRI seeks to catalyze a dramatic shift in rare disease diagnosis through the development of highly innovative solutions to some of the current challenges that face this field. In particular, GREGoRi will focus on accelerating the use of new or emerging molecular approaches in clinical genetics, on applying more established molecular technologies in innovative ways to obtain a molecular diagnosis, and on addressing significant computational challenges or analytical blind spots that have the potential to unlock new diagnoses.
To achieve the goals of GREGoRi, NHGRI is issuing an open call for applications through three notices of funding opportunity (NOFOs). These NOFOs are open to any investigator with ideas aligned with the goals of the program, regardless of whether they participated in the initial phase of the GREGoR Research Program.
The three NOFOs are:
Scope and Objectives
This NOFO solicits applications to establish the GREGoRi Data Coordination and Outreach Center (DCC), one of three components that make up the second phase of the GREGoR research program. The Data Coordination and Outreach Center will act as the central point of coordination for the program, and will be responsible for ensuring that the data, metadata, protocols, computational tools and other resources developed as part of GREGoRi are made available to researchers outside the program. The DCC is also tasked with supporting outreach efforts aimed at maximizing use of the GREGoRi data resource, and fostering a community of researchers engaged in the development of computational tools and analysis methods that leverage these data types to identify the causal gene(s) or variant(s) underlying rare genetic diseases.
Specific objectives of the Data Coordination and Outreach Center are as follows:
Coordinating the submission and release of GREGoRi data
The GREGoRi DCC will be responsible for receiving sequence and other molecular data, associated metadata, and phenotypic data from the Technology Integration Center (TechIC) and any other data generating projects that make up the consortium. The exact data types to be generated will be determined by the funded research groups, but are expected to include data from the following broad categories:
The DCC will work with the data generating components of GREGoRi to define the process, standards and timelines for these submissions, and ensure that data submitted meets agreed upon standards.
In order to ensure interoperability with data from phase I of GREGoR, it is anticipated that GREGoRi researchers will use the established GREGoR Data Model. The DCC will be responsible for managing any necessary updates to the data model, and work with the consortium members to ensure that all data submitted is in compliance with the established model.
Supporting innovation in the development of computational and analytical tools for rare disease diagnosis
A major goal of the GREGoRi program is the development of innovative tools that address key computational and analytical roadblocks in rare disease diagnosis. The GREGoRi DCC will support these efforts in several ways, that include, but are not limited to, the following:
Facilitating consortium activities, outreach, and collaboration
The GREGoRi DCC will serve as the consortium's central hub, coordinating logistics and communication among consortium members and external collaborators, and disseminating consortium information and other products to the broader research community. Key activities include, but are not limited to:
The DCC will also be responsible for organizing two annual in-person meetings of the consortium. The location of these meetings may rotate, and will be determined by the DCC with feedback from consortium members and NHGRI staff. One of these meetings will be limited to members of the Steering Committee, the other meeting will be a consortium-wide meeting (~75-100 attendees). The DCC will be responsible for securing a venue for the meeting (including A/V support), and coordinating logistics for these meetings.
Program formation and governance
The award funded under this NOFO will be a cooperative agreement. The recipient will become a member of the GREGoRi Research Consortium, made up of investigators funded in response to the three related NOFOs. The recipient will be expected to work collaboratively with the other components of the GREGoRi Program and with NIH staff towards meeting consortium goals, in addition to the specific research goals outlined in their application.
Recipient responsibilities will include:
Outside Collaborations
Collaboration with stakeholder research communities outside of the GREGoRi Consortium helps maximize the impact of the Consortium's efforts. Recipients will also be expected to explore collaboration opportunities with other research projects and consortia with related interests or goals, such as the Impact of Genomic Variation on Function (IGVF) Consortium, the Human Pangenome Reference Consortium (HPRC), the Atlas of Variant Effects (AVE) Alliance, the Clinical Genome Resource (ClinGen), Molecular Phenotypes of Null Alleles in Cells (MorPhiC), Multi-Omics for Health and Disease (MOHD), or the Somatic Mosaicism across Human Tissues (SMaHT) Network. This may include participating in cross-consortium activities, such as working group meetings.
Data Sharing and Consents in GREGoRi
A major deliverable of the GREGoRi Research Consortium is the GREGoR Data Resource, which makes all molecular and phenotype data collected under this program available to researchers through controlled access via NHGRI's Genomic Data Science Analysis, Visualization, and Informatics Lab-space (AnVIL). In order to streamline access to this valuable resource, NHGRI expects GREGoRi researchers to use samples that have been consented for the broadest possible data sharing. It is expected that samples will be consented for General Research Use (GRU) or Health/Medical/Biomedical (HMB) without any additional data use limitations. The Technology Integration Center should aim to enroll all participants into a single consent group.
For More Information
Prospective applicants are strongly encouraged to contact the email address listed as the Scientific/Research Contact below to discuss the responsiveness of their planned project, and the alignment of the proposed work with the goals of the GREGoRi initiative.
In addition, NHGRI staff will hold an informational webinar for prospective applicants. At this webinar, staff will present an overview of the GREGoRi NOFOs and answer questions that applicants may have about the NOFOs. The time, date, and links to the webinar will be posted on the NIH website. The webinar is open to all interested applicants, but participation is not required to apply.
See Section VIII. Other Information for award authorities and regulations.
Cooperative Agreement: A financial assistance 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 NOFO.
The OER Glossary and the How to Apply Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.
Not Allowed: This NOFO only accepts applications that do not propose clinical trials. Note: Applications may propose activities involving human subjects that are not deemed clinical trials.
NHGRI intends to commit a total of $2 million in FY 2027 to fund 1 award.
Application budgets are limited to $1.25 million in direct costs per project year, and must reflect the actual needs of the proposed project.
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 NOFO.
Higher Education Institutions - Includes all types
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Local Governments
Federal Governments
Other
Non-domestic (non-U.S.) Entities (Foreign Organizations) 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.
NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts. All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. See NIH Grants Policy Statement 16.8 Collaborative International Research Awards.
Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding. This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components, funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.
Applicant Organizations
Applicant organizations must complete and maintain the following registrations as described in the How to Apply- 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.
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.
All PD(s)/PI(s) must be registered with ORCID. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.
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 their organization to develop an application for 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 How to Apply-Application Guide.
This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms.
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, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. 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 NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts). Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.
The following section supplements the instructions found in the How to Apply- Application Guide and should be used for preparing an application to this NOFO.
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply- Application Guide must be followed.
All instructions in the How to Apply- Application Guide must be followed.
All instructions in the How to Apply- Application Guide must be followed.
All instructions in the How to Apply- Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:
The Research Plan should describe plans to address the major objectives of the GREGoRi Data Coordination and Outreach Center, described in Section I above. This should include a description of the overall design, operational plan, and organizational structure appropriate to accomplish these goals. Specific points that should be addressed include, but are not limited to:
Coordinating the submission and release of GREGoRi data
Supporting innovation in the development of computational and analytical tools for rare disease diagnosis
Facilitating consortium activities and collaboration
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.
The following instructions also apply:
The Resource Sharing Plan should summarize whether and how resources (e.g., educational materials; methods; models; physical products, materials, and reagents; protocols; research findings and products; and software) will be made available. Applicants should include a description of the format, an indication of who will be responsible for implementation and plans for long-term maintenance, whether there will be opportunities for community input and feedback, platform(s) or mechanism(s) that will be used to make resources publicly accessible, and proposed timeline for implementing the Resource Sharing Plan. Resource Sharing Plans should not duplicate other sections of the main Research Plan but should refer to them when appropriate. After initial review, NHGRI program staff may negotiate revisions of this plan with the prospective awardee. The final negotiated version of this plan will become a term and condition of the award.
Other Plan(s):
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:
Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide.
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 How to Apply- 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 How to Apply - 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 How to Apply- Application Guide must be followed.
All instructions in the How to Apply- Application Guide must be followed.
See Part 2. 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. 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.
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 How to Apply-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 Section 7.9.1 Selected Items of Cost.
Applications must be submitted electronically following the instructions described in the How to Apply – 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 form. 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 NOFO for information on registration requirements.
The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization's profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply – 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.
Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.
Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov.
Applicants are required to follow the instructions for post-submission materials, as described 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 scored review criteria and additional review criteria (as applicable for the project proposed). An application does not need to be strong in all categories to be judged likely to have a major scientific impact.
Reviewers will consider Factors 1, 2 and 3 in the determination of scientific merit, and in providing an overall impact score. In addition, Factors 1 and 2 will each receive a separate factor score.
Significance
Innovation
Approach
Rigor:
Feasibility:
Specific to this NOFO:
Investigator(s)
Evaluate whether the investigator(s) have demonstrated background, training, and expertise, as appropriate for their career stage, to conduct the proposed work. For Multiple Principal Investigator (MPI) applications, assess the quality of the leadership plan to facilitate coordination and collaboration.
Environment
Evaluate whether the institutional resources are appropriate to ensure the successful execution of the proposed work.
As applicable for the project proposed, reviewers will consider the following additional items while determining scientific and technical merit, but will not give criterion scores for these items, and should consider them in providing an overall impact score.
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, 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, 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.
This NOFO only accepts applications that do not propose clinical trials. Note: Applications may propose activities involving human subjects that are not deemed clinical trials.
When the proposed research includes Vertebrate Animals, evaluate the involvement of live vertebrate animals 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. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animals Section.
When the proposed research includes Biohazards, evaluate whether specific materials or procedures that will be used are significantly hazardous to research personnel and/or the environment, and whether adequate protection is proposed.
As applicable, evaluate the full application as now presented.
As applicable, evaluate the progress made in the last funding period.
As applicable, evaluate the appropriateness of the proposed expansion of the scope of the project.
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.
For projects involving key biological and/or chemical resources, evaluate the brief plans proposed for identifying and ensuring the validity of those resources.
Evaluate 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 (CSR), in accordance with NIH peer review policies and practices, 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.
Requests for reconsideration of initial peer review will not be accepted for applications submitted in response to this NOFO.
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 NOFO. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council for Human Genome Research (NACHGR). The following will be considered in making funding decisions:
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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.
Prior to making an award, NIH reviews an applicant's federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov. NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant's integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 "Federal awarding agency review of risk posed by applicants." This provision will apply to all NIH grants and cooperative agreements except fellowships.
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.
A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient's business official.
In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.
Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk. For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.
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.
The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:
All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.
By applying for or accepting federal funds from HHS, recipients certify compliance with all federal antidiscrimination laws and these requirements and that complying with those laws is a material condition of receiving federal funding streams. Recipients are responsible for ensuring subrecipients, contractors, and partners also comply.
Applicants and recipients are strongly encouraged to refer to the NIH Director's Statement of Priorities, entitled "Advancing NIH's Mission Through a Unified Strategy."
Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. Pursuant to 2 CFR 200.340, by accepting an NIH award, the recipient agrees that continued funding for the award is contingent upon the availability of appropriated funds, recipient satisfactory performance, compliance with the Terms and Conditions of the award, and may also otherwise be terminated, to the extent authorized by law, if the agency determines that the award no longer effectuates the program goals or agency priorities, in line with 2 CFR 200.340(a)(4).
Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.
Successful recipients under this NOFO agree that:
When recipients, subrecipients, or third-party entities have:
Cybersecurity plans and procedures must at minimum include the following:
All activities proposed in your application and budget narrative must align with applicable law, including but not limited to statutes, executive orders, federal regulations and applicable judicial holdings. Accordingly, discretionary awards shall not be used to fund, promote, encourage, subsidize, or facilitate; racial preferences or other forms of racial discrimination by the recipient, including activities where race or intentional proxies for race will be used as a selection criterion for employment or program participation; denial by the recipient of the sex binary in humans, or the belief that sex is a chosen or mutable characteristic; illegal immigration; or any other initiatives that compromise public safety. If an application does not align, the application will not receive funding to the extent permitted by law and applicable court orders.
For applications involving substance abuse, the application must not support harm reduction. Please see Updated Funding Guidance for Recipients on Supplies and Services.
For applications involving funding Medication-Assisted Treatment (MAT) or medications for opioid use disorder (MOUD), this funding should be used to provide comprehensive treatment and recovery support services rather than medication-only models for opioid use disorder. Services should include medications, where clinically indicated, in conjunction with psychosocial and other treatment and recovery support services. Funding can also be used to support individualized tapering and discontinuation of medications when clinically indicated. Please see Updated Funding Guidance for Recipients on MAT/MOUD.
As of October 1, 2025, HHS has adopted 2 CFR Part 200, with some modifications included in 2 CFR Part 300. These regulations replace those in 45 CFR Part 75. However, for NIH, under the Consolidated Appropriations Act for FY 2026, (P.L. 119-75, Division B, Title II, Sec. 224), the provisions relating to indirect costs in 45 CFR 75 continue to apply to NIH awards. Consistent with the statute, NIH will not apply updated thresholds outlined within 2 CFR Part 200, at this time.
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 (HHS) grant administration regulations at 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 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 NIH as defined below.
Cooperative agreement terms and conditions of award
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:
The agency program official or IC program director will be responsible for:
Areas of Joint Responsibility include
The GREGoRi Data Coordination and Outreach Center will be required to interact closely with the other members of the GREGoRi Research Consortium and with NIH staff in order to fully achieve the goals of the GREGoRi initiative.
NIH and the Data Coordination and Outreach Center will collaborate to create a transition plan to ensure valuable data, products, and resources remain available to the research community if the award recipient withdraws, the award is terminated, or the project is transferred due to a subsequent competition.
A Steering Committee will be the main governing body of the GREGoRi Research Consortium. The purpose of the Steering Committee will be to recommend directions for the consortium that are consistent with achieving the goals of the GREGoRi initiative, develop consortium policies that build synergy and improve communication and collaboration among the Consortium researchers, and provide a forum for discussing progress, challenges and opportunities for the consortium. The Steering Committee will be composed of the PD/PI(s) from each of the funded research groups and NIH program staff. Each grantee project in the Steering Committee will have one vote. NIH staff involved in the Steering Committee will collectively have only one vote. In addition to the PD(s)/PI(s), key personnel from each research group, including pre- and post-doctoral trainees, will be eligible to attend Steering Committee meetings. The Steering Committee will establish subcommittees or working groups, in order to facilitate collaborative work and standardize approaches, or to achieve other goals of the Consortium.
Dispute Resolution:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.
A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page. The DMS Plan must address the elements in the structured format. Where the DMS Plan Format Page requires a "Yes or No" response, no additional narrative is allowed.
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 Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.
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 Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.
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.
Grants.gov Support Center - Questions regarding Grants.gov registration and services (e.g., Workspace, subscriptions).
NHGRI GREGoR Team
National Human Genome Research Institute (NHGRI)
Email: nhgri-gregor@mail.nih.gov
Center for Scientific Review (CSR)
Email: NOFOReviewContact@csr.nih.gov
Grants Administration Branch
National Human Genome Research Institute (NHGRI)
Email: nhgrigab@mail.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 42 CFR Part 52 and 2 CFR Part 200.