Part 1. Overview Information

Key Dates

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).

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

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

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

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



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. Notice of Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

 Background

Genomic medicine is being increasingly used in patient care. The utility of genomic sequencing in the practice of genomic medicine has been greatly enhanced by the categorization and annotation of pathogenic genetic variants by the American College of Medical Genetics and Genomics (ACMG). However, translational research to advance our understanding of genomic and non-genomic factors that contribute to penetrance, expressivity, and pleiotropy of variants categorized to be pathogenic or likely-pathogenic is needed for more precise and effective practice of genomic medicine. The need for increased research to develop tools to translate genomic research findings into clinical applications has been highlighted by NHGRI-convened workshops (Genomic Medicine XIII, NHGRI Machine Learning in Genomics Workshop: Tools, Resources, Clinical Applications, and Ethics).

Machine Learning (ML) and Artificial Intelligence (AI) have been used for pattern discovery and classification for several decades. Recent advances in computational resources have increased the ability of ML/AI tools to learn and discover previously unrecognized patterns from large, complex multimodal datasets. ML/AI techniques have successfully identified novel patterns in non-genomic clinical datasets, receiving FDA approval for ML/AI-enabled medical devices in fields such as radiology, cardiology, and various other disciplines of medicine.

The potential for using novel ML/AI approaches in translational genomics is facilitated by the vast amounts of multimodal data that have become increasingly available through advances in standards and policies that encourage the sharing of data in a findable, accessible, interoperable, and reusable (FAIR) manner. Utilizing FAIR multimodal data along with rich biological annotations in knowledgebases and literature to train ML/AI models could potentially improve our understanding of the impact of genomic and non-genomic contributors to disease. Furthermore, the capability of such tools to learn from new data and knowledge, complemented by rapidly evolving ML/AI methods, has the potential to increase their future applicability in genomic medicine.

Maximizing the potential of ML/AI requires thoughtful attention to the ethical, legal, and social implications (ELSI) of its use in genomic medicine and healthcare more broadly. Several areas of concern have been raised related to the use and implementation of ML/AI in healthcare. These include biases in data and algorithms leading to misdiagnosis, ambiguities in accountability for misuse of the data and tools, unintended loss of patient privacy and confidentiality, lack of adequate regulatory oversight and monitoring, legal ambiguities around intellectual property rights, overreliance on ML/AI tools in decision making, challenges in patient-provider communication, lack of patient and provider confidence in ML/AI, and furthering of racial or ethnic health disparities. Conducting ELSI research to anticipate and address these and other ELSI issues during the development of ML/AI tools can help improve scientific rigor, reduce harm, and realize the potential for benefit across diverse populations.

For the purposes of this NOFO, the following definitions/descriptions are used:

• Artificial Intelligence (AI) refers to the capability of a computer system to mimic human cognitive functions such as learning and problem solving.
• Consortium refers to the Consortium which consists of the collective group of researchers  funded under this and the companion NOFO.
• Cross Validation refers to mutual validation of the ML/AI tools developed by MAGen Sites in the Consortium to validate their robustness and generalizability. Cross validation should be performed by MAGen Sites other than the Site that developed the tool using datasets distinct from those used for tool development and by users different from those at the Site that developed the tool. 
• Ethical, Legal, and Social Implications (ELSI) refers to an area of inquiry that may use multidisciplinary approaches to identify and define major areas of concern associated with the advancement of genetic and genomic science and the availability of new knowledge, data, and technologies. For more information, see “ELSI Research Programme of the NHGRI”
• Genomic Translational Research refers to integration of basic research, patient-oriented research, and population-based research performed in an academic setting that mimics clinical settings with the long-term potential for integrating into genomic medicine.
• Machine Learning (ML) refers to application of AI where mathematical models of data are used to help computers learn with or without direct instruction.
• MAGen is the abbreviation for ML/AI Tools to Advance Genomic Translational Research.
• MAGen Coordinating Center (CC) refers to the recipient funded through this NOFO RFA-HG-24-005.
• MAGen Sites refers to the recipients funded through the companion NOFO, RFA-HG-24-004.
• ML/AI Technologies refers to algorithms, software, or platforms for ML/AI tool development.
• ML/AI Tool refers to a validated stand-alone software package that includes ML/AI pipelines and model parameters that can be implemented and cross validated.
• Multimodal Data refers to datasets that span different datatypes and contexts (e.g., imaging, text, genomic, environment etc.).
• Pathogenic Variant refers to variant with strong clinical evidence for likelihood of causing disease.
• Primary Data Generation for ML/AI Tool Development refers to generation of new primary data (in contrast to derived data which refers to existing data that has been transformed).
• Social Determinants of Health (SDOH) refers to conditions in the environments where people are born, live, learn, work, play, worship, and age that affect a wide range of health, functioning, and quality-of-life outcomes and risks.

Research Objectives, Scope, and Approach

The purpose of this Notice of Funding Opportunity (NOFO) is to solicit applications for the ML/AI Tools to Advance Genomic Translational Research (MAGen) Consortium Coordinating Center. The MAGen CC will provide technical, scientific, and administrative coordination to support the Consortium research activities including development of Consortium wide plans, coordinated ELSI-informed ML/AI tool development and cross validation, and dissemination of the developed resources. The MAGen CC will work closely with the MAGen Sites funded by the companion NOFO to explore the feasibility of developing Machine Learning (ML) and Artificial Intelligence (AI) tools that can enhance the accuracy and precision of predicting how individuals with pathogenic genetic variants manifest disease.

The MAGen Consortium will collaboratively identify both genomic and non-genomic factors influencing disease development in individuals carrying pathogenic genetic variants. The ML/AI tools will leverage existing multimodal genomic and non-genomic data and will be cross validated in genomic translational research settings to ensure the robustness and generalizability of the tools for translational purposes. In addition, the Consortium will explore the ethical, legal, and social implications (ELSI) of integrating ML/AI tools into genomic medicine through the establishment of a framework for ELSI studies and through implementation of ELSI research projects. 

Applicants interested in applying to this NOFO should read the companion NOFO carefully and understand the roles and expectations from the MAGen Site awardees and understand the goals of the Consortium.

Given the risks involved in achieving MAGen goals e.g., selection of suitable gene sets, drafting of a suitable framework for ELSI studies, the capability to undertake cross-validation, the challenges around converging data models among others, this  NOFO utilizes a UG3/UH3 cooperative agreement mechanism which entails a Two-Phase, one-application approach to accomplish the goals. The focus of the UG3 Phase is the development of necessary Consortium-wide consensus around the risks identified above and other aspects that could impact achieving the goals of the MAGen consortium. The focus of the UH3 Phase (if successful) will be the actual development and execution of the consensus approach developed in the UG3 Phase. The objectives of the MAGen CC in the two Phases are:

UG3 - Design Phase (Years 1-2)

1. Technical and Scientific Coordination:
   • Support development of the Consortium’s resources that are foundational for the UH3 Phase. These include a framework for ELSI, research projects, gene sets for tool development and cross validation, data model, ML/AI tool requirements, datasets transformed for tool development and cross validation, cross validation plan etc.
   • Lead the development of a Consortium-wide data model. The MAGen CC will seek input from the MAGen Sites and develop a Consortium-wide data model to be adopted by the MAGen Sites for ML/AI tool development and cross validation for their multimodal datasets. Leveraging existing standards such as the Observational Medical Outcomes Partnership (OMOP) Common Data Model, or the Fast Healthcare Interoperability Resources (FHIR), is strongly encouraged.  The MAGen CC will facilitate the adoption of the Consortium’s data model by the MAGen Sites through training, sharing of pre-processing scripts developed by the MAGen Sites to import the data into the model etc. Instantiation of the data model into a physical database for ML/AI tool development and cross validation is not required to be developed.
   • Serve as a liaison between the MAGen Sites and the team supporting the cross validation platform selected by the Consortium, such as the Analysis Visualization and Informatics Lab-space (AnVIL) or other NHGRI-approved platform. The MAGen CC will facilitate the use of the platform by the Consortium’s members, for example by establishing workspaces, implementing control access, and providing user training etc.
   • Lead the development of a Consortium-wide plan for the dissemination of MAGen developed tools and resources. While the resources will be shared through AnVIL (or other NHGRI-approved platform), resources may also be shared in other community repositories, as appropriate. The plan must include specifications and protocols for the preparation of items prior to dissemination and a corresponding timeline. It is important that at a minimum, tools, resources, and products for dissemination must include, but are not limited to the following: 
     • The framework for ELSI used to guide ML/AI tool development and validation,
     • Validated ML/AI tools, corresponding metadata for the intended use of these resources by the research community (1) version control; (2) methods to document and share training and validation experiments; (3) choice of model registries and model sharing platforms etc.
     • Common data model
     • Data pre-processing scripts as appropriate
     • Cross validation plan
     • Research Findings
     • Best practices
     • Gaps in data, technologies, and policies which remain to be addressed.
2. Serve as an Administrative and Coordinating Center:
   • Convene an on-line kick-off meeting of all MAGen Sites and the MAGen CC within 30 days from the establishment of the Consortium.
   • Organize and facilitate in-person and virtual Consortium meetings, such as the Consortium-wide, Steering Committee (see below), working groups, and External Scientific Panel (see below) meetings, and generate meeting agendas, notes, and reports.
   • Develop and implement Consortium-wide processes and best practices for facilitating communication, documenting decisions made by the Consortium, resolution of issues, and maintaining resources established or used collaboratively by the Consortium. Processes should be transparent, constructive, and accessible across the Consortium.
   • Establish suitable methods for hosting web conferences, support internal communications and document sharing.
   • Lead the development of Consortium milestones in coordination with the MAGen Sites and NHGRI staff and track progress of Consortium activities and identify deviations from milestones.
   • Utilize innovative ideas to ensure the development of consensus within the Consortium to meet all the MAGen short and long-term goals.

 Transition from UG3 to UH3 Phase

• The transition from the UG3 to the UH3 phase is contingent upon the successful completion of milestones proposed for the UG3 phase. Milestones proposed in the application by the MAGen CC for activities pertinent to the CC may be revised and approved by the NHGRI during the UG3 and UH3 Phases to align with the Consortium-wide milestones.  Consortium-wide milestones are developed by the MAGen Sites and the MAGen CC and the NHGRI staff to enable coordinated development of the Consortium-wide resources which is a key feature of the MAGen program.

Four months prior to the expiration of the UG3 award, the recipient will need to submit the transition package which will include the UG3 report delineating progress toward achieving UG3 milestones and activities, as well as the milestones proposed for the UH3 phase. This application will be administratively reviewed internally by the NHGRI for consideration for the UH3 phase award. Thus, recipients of the UG3 awards should note that there is no guarantee of a subsequent UH3 award. Consideration for the UH3 award is contingent upon submission of this transition package and satisfactory progress towards the UG3 milestones. 

The criteria to determine the continuation to the UH3 Phase will be based on the satisfactory progress of the MAGen CC in meeting the Consortium’s milestones and deliverables. Such criteria include but are not limited to:

• Drafting a framework for ELSI agreed upon by the Consortium that reflects ELSI issues relevant to a broad range of groups who may be impacted, directly or indirectly, by use of ML/AI tools.
• Identification of at least one ELSI Research Project for implementation by each Site during UH3 Phase.
• Identification of the Consortium-wide gene set for which ML/AI tools can be developed and cross validated.
• Development of the ML/AI tool requirements that can adequately address the clinical questions and engender trustworthiness in the results.
• Preparation of datasets that are adequate and appropriate to support ML/AI tool development and cross validation for the assigned genes.
• Development of a mature, comprehensive, and suitable data model to allow ML/AI tool development by the different MAGen Sites.
• Development of a cross validation plan that can feasibly address the robustness and generalizability of the ML/AI tools to use distinct datasets and in distinct translational research settings.

In the event of an UH3 award, all recipient PD/PIs and the NHGRI staff will negotiate the final list of milestones for the entire Consortium for each year of support.

UH3 - Development Phase (Years 3-5)

1. Technical and Scientific Coordination:
   • Support the refinement of Consortium-wide resources developed in the UG3 Phase.
   • Continue to serve as a liaison between the MAGen Sites and the Consortium cross validation platform team to support onboarding of the MAGen Sites, for example creating workspaces, user accounts, user training etc.
   • Implement processes to share the ML/AI tools and results for cross validation
   • Implement processes for timely sharing of lessons learned and ELSI research findings to facilitate their use in ongoing Consortium activities to the extent possible.
   • Maintain the data model in accordance with the agreed upon processes and best practices established in the UG3 phase.       
   • Continue to facilitate its adoption by the MAGen Sites through training, ensuring data preprocessing scripts developed by MAGen Sites are shared with adequate annotation for reuse by the entire Consortium to import their data into the model for cross validation etc.
   • Support the implementation of the developed dissemination plan.
2. Serve as an Administrative and Coordinating Center:
   • Continue to provide coordination of transdisciplinary research efforts of the MAGen Consortium.
   • As necessary, refine Consortium-wide processes for communication, discussion, and documentation of consensus, progress, constraints, limitations, issues, resolutions, and updates related to resources that are to be collaboratively established by the Consortium and used across the Consortium.
   • Organize and facilitate in-person and virtual Consortium meetings, such as the Consortium-wide, Steering Committee (see below), working groups, and External Scientific Panel (see below) meetings, and generate meeting agenda, notes and reports.
   • Maintain platforms for hosting web conferences and support internal communications and document sharing.
   • Lead the development of Consortium milestones and track progress of Consortium activities and identify deviations from milestones.

 Data sharing

Recipients are expected to comply with the NIH Data Management and Sharing Policy (NOT-OD-21-013) and NIH Genomic Data Sharing Policy (NOT-OD-14-124). NHGRI supports the broadest appropriate data sharing with timely data release through widely accessible data repositories. Please follow the NIH guidance on writing a Data Management and Sharing (DMS) Plan here, and ensure the Plan is in alignment with NHGRI’s data sharing expectations, which are summarized at genome.gov/data-sharing.

Consortium Formation and Governance

This NOFO uses the Cooperative Agreement mechanism. Successful applicants will become members of the Consortium comprising investigators funded in response to either one of the two NOFOs: RFA-HG-24-004 and RFA-HG-24-005. 

A Steering Committee (SC) will be the main governing body of the Consortium. The SC will be composed of the PD(s)/PI(s) from each Consortium’s award and NIH program staff. In addition to the PD(s)/PI(s), key personnel from each Site and working group representatives will be eligible to attend SC meetings. The SC will establish subcommittees or working groups to facilitate collaborative work and to achieve the Consortium’s goals. Major scientific decisions such as the framework for ELSI, identification of genes, variants, and datasets to be used for tool development, data model, tool requirements, cross validation plans, ESLI Research projects, Consortium milestones etc., will be determined by consensus, and as needed, by majority vote of the SC, where each funded Site, the MAGen CC, and the NHGRI will each have a single vote. The SC will meet regularly and be assisted by the activities of working groups. 

An External Scientific Panel (ESP) of independent experts will provide input on performance, priorities, and overall progress of the Consortium, including the administrative review of the Consortium’s accomplishments for the transition from the UG3 to UH3 phase. The ESP will consist of individuals with a broad range of expertise, including multi-modal data, ML/AI tool development, software engineering, clinical research physicians, and ethicists/social scientists, and other areas as needed. The ESP will meet semi-annually (one conference call and one in-person meeting per year), in conjunction with Steering Committee meetings, as appropriate. Following each meeting, the ESP will generate recommendations for the SC to consider and respond to.

Informational Webinar and Frequently Asked Questions

An informational webinar will be held for potential applicants. During the webinar, NHGRI staff will present overviews of both this and its companion NOFO and answer questions from prospective applicants. The informational webinar is open to all prospective applicants, but participation is not a prerequisite for submission of an application. Time, date, and dial in information will be posted at: https://www.genome.gov/event-calendar/MAGen-NOFO-Webinar. The webinar connections will open 15 minutes in advance of the start time.  A recording of the webinar will be posted on the above website, together with a list of Frequently Asked Questions from the applicants.

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Governments

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

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 not allowed. 

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 NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information

• System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

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. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1.2 Definition of Terms.

3. Additional Information on Eligibility

Number of Applications

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:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

Letter of Intent

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

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

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

The letter of intent should be sent to:

Ajay Pillai, Ph.D.
Email: ajay.pillai3@nih.gov

Page Limitations

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.

SF424(R&R) Cover

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the How to Apply - Application Guide must be followed.

R&R Budget

All instructions in the How to Apply - Application Guide must be followed.

Budgets should include costs for hosting regular teleconferences and meetings of the SC and its working groups. Include the costs for organizing and hosting a virtual kick-off meeting of the Consortium to be held within 30 days of award. The budget should include the costs to organize and host one annual in-person (2 days, 1-2 nights) Consortium-wide meeting for the UG3 and UH3 Phases.  The MAGen CC should budget for twice monthly SC virtual meetings in the UG3 Phase, and monthly SC virtual meetings in the UH3 Phase and other virtual meetings as appropriate. The budget should include travel costs for 8 ESP members.

Discuss how the unique composition of the research team will ensure successful completion of the project. Effective management of the MAGen CC requires a significant commitment by the Program Director(s)/Principal Investigator(s). For an application proposing a single PD/PI, the PD/PI is expected to devote at least 1.2 person months annually to the project.  The budget should include support for a dedicated Project Manager who will devote a minimum of 6 person months. The appropriateness of the effort of key personnel must be justified in the budget justification.

Costs for any cloud, or storage and computing infrastructure proposed for data model and cross validation environment development and maintenance should be included and justified in the budget.

The budget should include any funds required to support sharing of scientific data under this NOFO, as per guidance on allowable costs for data management and sharing on its Budgeting for Data Management & Sharing webpage.

R&R Subaward Budget

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Research Plan

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Research Strategy

Specific Aims: Provide the overall goals for the entire application. The Specific Aims section should include distinct Aims for the UG3 and UH3 phases. Applicants must submit a single application that includes both the UG3 and UH3 phases.

Research Strategy: Organize the Research Strategy in two separate UG3 and UH3 subsections. For each subsection (UG3 and UH3), the significance, innovation, and approach should be clearly highlighted. Do not repeat information or experimental details in the UH3 section that are already described in the UG3 section. The MAGen CC is expected to support the Consortium’s collaborative activities. These are outlined for each of the UG3 and UH3 phases in the section titled Research Objectives, Scope, and Approach in Section I of this NOFO. These include the criteria specified under Technical and Scientific Coordination and Serve as an Administrative and Coordinating Center. Note that these involve some activities with primary responsibility to the CC and others where the CC’s role is guidance and facilitation. Driving the Consortia towards consensus is an important goal of the applicants to this NOFO and applicants are encouraged to propose innovative approaches; this will entail adaptability and willingness towards flexibility around the proposed approaches. Applicants should propose plans, approaches, benchmarks for success and risk mitigation strategies to achieve the goals of this NOFO.

Provide an overall operational plan and organizational structure to accomplish the goals of this NOFO. Given the highly collaborative nature of the Consortium activities, and the inter-relatedness between the tasks in each of the phases, describe innovative approaches for supporting technical and administrative coordination. For MAGen Consortium to succeed in its aims it will need to arrive at a consensus on many challenges (as outlined in Section I of this NOFO)  and the applicant is encouraged to propose innovative methods that would drive the Consortia towards required consensus. Describe the approach to bring diverse teams together to enable synergistic and collaborative team science across the Consortium, and evidence of strong leadership complemented by scientific insight. Risky aspects, potential problems and alternative strategies for risk mitigation should be provided.

Provide a staffing plan and describe the expertise of the proposed team to support Consortium-wide activities. Demonstrate scientific expertise in data model development for multimodal datasets, and to support the coordination of ML/AI tool development and cross validation activities in a cloud environment in translational research settings.

Provide approaches for timely, effective, and efficient sharing of resources within the Consortium, and for disseminating them to the research community.

Milestones (required): Applicants must include a section entitled Milestones and provide milestones for BOTH the UG3 and UH3 phases of the award within the research strategy. Provide semi-annual quantitative and qualitative milestones. Within this section, describe the suitability of the chosen milestones to achieve the goals for transition to the UH3 phase and to complete the goals for the UH3 phase. The milestones should be specific, scientifically rigorous, and not simply a restatement of the Specific Aims. They should address critical points of the proposed program and describe research outcomes by providing quantifiable measures for success within the UG3 and UH3 phases of the award.

Applicants are alerted that given the highly collaborative nature of the consortium’s activities, these milestones may be renegotiated prior to and during the award period.

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.

NHGRI is committed to the timely release of well-documented open-source software and analyses including models and tools developed from proposed studies. Applicants should describe a plan for open dissemination of methods, protocols, software, and tools to the community such that they are readily usable and extensible, where applicable. Methods, protocols, tools, and software should be well-documented and where applicable made available via version-controlled public repositories including AnVIL as appropriate.

• Solutions that enhance reproducibility when used by the community and ability of the community to integrate into automated pipelines should be emphasized.
• In the Resource Sharing Plan, a plan for sharing software should describe how improvements or tool customizations will be managed and disseminated to the scientific community. Applicants should take responsibility for creating the original and subsequent official versions of a piece of software.

For a list of frequently asked questions about Best Practices for Sharing Research Software, see https://datascience.nih.gov/tools-and-analytics/best-practices-for-sharing-research-software-faq.

Other Plan(s): Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.
• NHGRI supports the broadest appropriate genomic, phenotypic, and metadata data sharing with timely data release through widely accessible data repositories. Per NOT-HG-21-022, NHGRI expects applications awarded under this NOFO to share comprehensive metadata and, where applicable, phenotypic data, use standardized data collection protocols and survey instruments for capturing data, as appropriate, and use standardized notation for metadata (e.g., controlled vocabularies or ontologies) to enable future data harmonization and secondary data analyses.

To ensure that maximal scientific benefit is derived from this significant public investment, this funding opportunity aims to advance and accelerate research by supporting rapid sharing of the resulting data with the broad scientific community for research use in the AnVIL platform as possible and appropriate, through submission of variant interpretations to ClinVar, and through publication in the scientific literature. 

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the 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.

PHS Assignment Request Form

All instructions in the How to Apply - Application Guide must be followed.

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

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

4. Submission Dates and Times

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.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information

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 NHGRI, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NHGRI Referral Office by email at troyerj@mail.nih.gov when the application has been submitted. Please include the FON and title, PD/PI name, and title of the application.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy

Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

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

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.

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.

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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NHGRI, 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.

Appeals of initial peer review will not be accepted for applications submitted in response to this NOFO.

 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 appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities. These include:
  • Program balance, meaning the need for this program to include multiple approaches and scientific perspectives to enhance the likelihood that program goals will be met.
  • Potential to work effectively in large collaborative efforts or research consortia, which may be based on previous experience with NIH-funded research consortia, if applicable.
  • Quality of plan for dissemination 
  • Institutions that have not received substantial funding from NH in the past.
  • Inclusion of new investigators and experienced investigators that are new to NHGRI consortia.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding. 

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. 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 NOFO will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

• Federalwide Standard Terms and Conditions for Research Grants
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, 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.

If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website.

HHS recognizes that NIH 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 NOFO.

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 System for Award Management (SAM.gov) requirements. SAM.gov requires Federal agencies to review and consider information about an applicant in the designated integrity and performance system (currently SAM.gov) prior to making an award. 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 addition to the information available in the responsibility/qualification records in SAM.gov, 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 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.

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.

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

• Determining research approaches, designing protocols, setting project milestones, and timelines and conducting research to meet the objectives of this NOFO.
• Leading, participating in, and contributing to the Consortium activities. 
• Adhering to the Consortium-established plans, processes, best practices, and SOPs.
• Implementing recommendations of the ESP
• Ensuring that the software, resources, materials, etc. are released appropriately according to the Resource Sharing Plan and the Consortium’s resources dissemination plan.
• Ensuring that the data generated under this project are released according to the NHGRI’s approved Data Management and Sharing Plan.
• Adhering to the guidelines and policies regarding data sharing, data access, and intellectual property established by the NIH, NHGRI, and the Steering Committee (SC) for the Consortium.
• Preparing abstracts, presentations, and publications in a timely manner.
• Not disclosing confidential information.
• Attending and participating in SC and other working group meetings, and implementing the decisions, guidelines, and procedures delineated by the SC, External Scientific Panel, and NHGRI, as appropriate.
• Interacting with other relevant NHGRI and NIH activities, as needed.
• In the event of no transition to the UH3 phase of the award, submitting a close-out plan within two (2) months of the award termination.  
• Recipient(s) will retain custody of and have primary rights to the data and software developed under these awards, subject to Government policies regarding rights of access consistent with current DHHS, PHS, and NIH policies.

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

The Project Scientist/Scientific Officer (PS/SO) at NHGRI is a dual role held by a NHGRI Program Director. The PS/SO will have substantial scientific and programmatic involvement during the conduct of this activity through technical assistance, advice, and coordination. The PS/SO will be responsible for the normal scientific and programmatic stewardship of the award. The role of NHGRI PS/SO will be to facilitate and not to direct the activities. It is anticipated that decisions in all activities will be reached by consensus of the Consortium’s members and NIH staff will offer input to this process.

This NOFO is a milestone-driven cooperative agreement program using the UG3/UH3 Cooperative Agreement mechanism involving NIH program staff in the negotiation of the final project plan before and during the award period, and monitoring of research progress. NHGRI’s funding for the MAGen Sites and the MAGen CC will be based on the satisfactory progress of the whole Consortium in meeting the Consortium’s milestones and deliverables.  The PS/SO will participate as a member of the SC and will have one vote. The PS/SO will be named in the Notice of Award and will have the following substantial involvement:

• Attending SC meetings as a voting member, and assisting in developing operating guidelines, quality control procedures, and consistent policies for dealing with situations that require coordinated action.
• Participating with SC members to set research priorities, decide optimal research approaches and protocol designs, and contribute to the adjustment of milestones and approaches as warranted. The PS/SO will assist and facilitate the committee’s process and not direct it.
• Serving as a liaison between the Consortium and NHGRI or NIH, recipient and as an information resource for the recipients about research activities. The PS/SO will also coordinate the efforts of the program with other groups conducting similar studies.
• Reporting periodically on the progress of the program to NHGRI’s leadership, and to the National Advisory Council for Human Genome Research.
• Serving as a liaison between the SC and the External Scientific Panel, attending External Scientific Panel meetings in a non-voting liaison member role, and arranging for timely preparation and distribution of the ESP’s meeting minutes.
• Serving on working groups of the SC and the External Scientific Panel, as appropriate.
• Providing advice in the management and technical performance of the award.
• Assisting in promoting the availability of the data, tools and other resources developed in the course of this program to the scientific community at large.
• Being responsible for the normal scientific and programmatic stewardship of the award, including monitoring and assessments of how well the recipient has met any milestones required for each year of funding.
• Curtailing, withholding, or reducing support for any recipient that fails to make satisfactory progress toward the work scope that NHGRI approved, has ethical or conflict of interest issues, or fails to comply with the Terms and Conditions of Award.

Where warranted and consistent with authorship and conflict of interest requirements of journals in which the Consortium decides to publish, participating in data analyses, interpretations, and co-authorship of the publication of Consortium results through their role in scientific program management.

Areas of Joint Responsibility include:

Close interaction among the participating Consortium member teams will be required, as well as significant involvement from the NIH, to develop appropriate strategies and tools to meet the goals of this NOFO. The recipients and the Project Scientist will meet regularly as the program SC.

The SC will be the main governing body of the Consortium. The SC will be composed of the PD(s)/PI(s) from each Consortium’s award and NIH program staff. In addition to the PD(s)/PI(s), key personnel from each Site and working group representatives will be eligible to attend SC meetings. The SC will establish subcommittees or working groups to facilitate collaborative work and to achieve the Consortium’s goals. Major scientific decisions such as the ELSI Framework, identification of genes, variants, and datasets to be used for tool development, data model, tool requirements, cross validation plan, ELSI research projects, Consortium milestones etc., will be determined by consensus, and as needed, by majority vote of the SC, where each funded Site, the MAGen CC, and the NHGRI will each have a single vote. The SC will meet regularly and be assisted by the activities of working groups.  

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: a designee of the SC chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

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

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

In accordance with the regulatory requirements provided at 2 CFR Part 200.113 and Appendix XII to 2 CFR Part 200, 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 (Responsibility/Qualification in SAM.gov, formerly 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 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

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: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-637-3015

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

Ajay Pillai, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 
Email: ajay.pillai3@nih.gov

Christine Cutillo
ODSS - Office of Data Science Strategy
Phone: none
E-mail: christine.cutillo@nih.gov

Rudy, Pozzatti, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-219-6235
Email: pozzattr@exchange.nih.gov

Lisa Oken
National Human Genome Research Institute (NHGRI)
Telephone: 301-594-5250
Email: Lisa.Oken@nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

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.