Part 1. Overview Information

Key Dates

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 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.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

The overarching goal of this R25 program is to support educational activities that encourage individuals from diverse backgrounds, including those from groups underrepresented in the biomedical and behavioral sciences, to pursue further studies or careers in research.

The NIH Research Education Program (UE5) supports research educational activities that complement other formal training programs in the mission areas of the NIH Institutes and Centers.

The overarching goal of this UE5 program is to support educational activities that encourage individuals from diverse backgrounds, including those from groups underrepresented in the biomedical and behavioral sciences, to pursue further studies or careers in computational genomics and data science research.

This NOFO will support educational activities with a primary focus on:

• Curriculum or Methods Development

Specifically, this UE5 will support the development of undergraduate and master’s degree-level classroom content, and hands-on as well as online exercises related to computational genomics, data science, cloud computing, or a combination of these topics, tailored towards students attending institutions with a mission to serve historically underrepresented populations in biomedical research.

NIDA supports innovative research addressing critical issues of neuroscience, genetics, behavior, prevention, treatment, epidemiology, etiology, health services, HIV/AIDS, and co-occurring opportunistic infections (e.g., viral hepatitis C, tuberculosis, sexually transmitted infections) associated consequences in substance using populations, medication development, or other research areas relevant to substance use disorder. NIDA encourages applications focused on educational activities that are related to computational genomics, data science, and/or cloud computing relevant to addiction training and research.

Background Information and Need for the Program

The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral and clinical sciences research workforce. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the researchers, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust.

Accordingly, the NIH continues to encourage institutions to diversify their student and faculty populations through means consistent with applicable law to enhance the participation of individuals from groups that are underrepresented in the biomedical, clinical, behavioral, and social sciences, for example, the groups noted in NOT-OD-20-031. The NIH currently provides multiple opportunities to develop research careers and encourages the participation of individuals from diverse backgrounds, including those from underrepresented groups in the biomedical and behavioral sciences. Reports from the National Science Foundation (NSF) (http://www.nsf.gov/statistics/wmpd/ ) , show that diversity remains important to advance at every level of the educational pipeline.

NHGRI has been engaging the scientific community to identify future research priorities and opportunities in human genomics, resulting in the 2020 Strategic Vision for Improving Health at the Forefront of Genomics. The Strategic Vision outlined the guiding principles and values for human genomics, including championing a diverse workforce which includes individuals from groups that are not well represented in biomedical research (see NHGRI’s Diversity Action Agenda) embracing interdisciplinary teams in genomic research, and increasing access to genomic medicine.

Concurrently, the Strategic Vision highlights the importance of computational genomics and data science (CGDS) in sustaining and improving a robust foundation for genomics. CGDS is the cross-cutting area where statistics and computer science are used to understand, analyze, and interpret information from genome sequences. Genomics is inherently a big data field, and appropriate skills in data science and data stewardship are now prerequisites for becoming a genomics researcher. Therefore, the future of genomic scientists needs to be sufficiently trained in data science. However, undergraduate and master’s level students at less-resourced educational institutions often lack access to the infrastructure and specialized training needed to obtain those skills.

In recent years, cloud computing technology has revolutionized CGDS, by democratizing access to genomics data sets, tools, and computing resources, and by enabling efficient genomic data sharing and collaboration. Through platforms such as the NHGRI AnVIL, NHLBI BioData Catalyst, the All of Us Research Hub and the NCI Cancer Research Data Commons, NIH has been a major promoter of the use of cloud computing for genomics in biomedical research. NIH’s Office of Data Science Strategy (ODSS), as part of its mission to implement the NIH Strategic Plan for Data Science, has been a key leader of NIH’s cloud computing implementation.

This initiative will leverage the NHGRI-funded AnVIL, and other NIH cloud-based platforms, to facilitate hands-on exposure to CGDS at the undergraduate and master’s degree levels among students enrolled at institutions with a historical and current mission to educate students from any of the populations that have been identified as underrepresented in biomedical research as defined by the National Science Foundation NSF, see http://www.nsf.gov/statistics/wmpd/).

Thus, the goal of this NOFO is to develop, implement, and evaluate classroom educational content and cloud-based hands-on analytical exercises in CGDS for students at such institutions, together with genomics research opportunities for students. The scope of this NOFO is specifically focused on (a) computational and analytical aspects of genomic sciences, and (b) use of cloud computing resources as educational tools.

Development of educational content for genomics research that does not have a significant analytical and computational component is not envisioned through the NOFO (also see Non-Responsive Applications section below).

Programmatic Approach

This NOFO is intended to support faculty members at eligible institutions to build new curricula in CGDS topics for the training of predoctoral (undergraduate and master’s degree level) genomic scientists and provide concentrated instruction in the tools, approaches and quantitative analysis concepts in CGDS. A specific requirement of this NOFO is for such curricula to deploy in an educational context, the data and analysis resources that are available through NIH-supported cloud platforms (such as AnVIL and the All of Us Researcher Workbench) in an educational context. Curricula funded through this NOFO will include a mix of classroom content in CGDS fundamentals, together with the use of the above cloud platforms for hands-on practical training in biomedical data analysis. Through RFA-HG-22-002, NIH has recently established the Educational Hub for Enhancing Diversity in Computational Genomics and Data Science (hereafter referred to as the Hub). Awardees of this NOFO (hereafter referred to as the Sites) are expected to make use of educational support resources developed by the Hub, and the Hub will assist with cloud computing, computational genomics and data science to enable the teaching of courses related to these topics at the undergraduate and master’s degree levels. The Hub will also assist with adapting curricula developed by the Sites for hosting on the cloud and disseminating these materials through a cloud-hosted portal they will develop for this purpose.

Regarding the interactions of the Hub and the Sites, the following lists provide guidance on individual activities envisioned from of these entities and also shared activities:

Sites awardees will:

1. Develop and deliver educational content in CGDS, in classroom, virtual, or hybrid settings
2. Create cloud-based analytical exercises in CGDS, interacting directly with user outreach teams from AnVIL, the All of Us Researcher Workbench, or other NIH cloud platforms
3. Apply for opportunity funds made available by the Hub for student research projects (see below) and if awarded, conduct these projects and analyze data hopefully leading to scientific publications
4. Make freely available the output of the above activities as well as provide them to the Hub for sharing with the broader educational community

The Hub will:

1. Assist in creating awareness of CGDS and cloud computing fundamentals among the Sites faculty and students
2. Assist in adapting educational content created by the Sites for utilizing data and tools from NIH-supported cloud platforms for hands-on student exercises
3. Administer a competitive opportunity funds program (see below) for Sites to apply for and receive funds for student research projects
4. Create a centralized resource and web portal integrating and disseminating educational content created by the Sites
5. Act as a community organizer for CGDS education with the Sites being the community members

The Sites and Hub together will:

1. Collaborate on sharing educational content developed by the Sites to the largest possible audience
2. Convene annually at a meeting organized by the Hub to share results and progress amongst themselves and with NIH

Beyond individual awards to applicant institutions, this NOFO also has a broader objective to create a community of institutions (formed of the Sites and the Hub) interested in working collectively to define, develop, and test content integrating CGDS into their existing biomedical science curriculum, with the intention that such content can be adapted by other institutions beyond the awardees of this NOFO. Although the curricular material will be developed for use by students at the applicant institution, it will also be shared through an open educational resource produced by the Hub that adheres to the FAIR (findable, accessible, interoperable, and reproducible) principles. Awardees will be expected to share any educational content they develop with the Hub and each other during the award period, so that the biomedical education community has a larger range of CGDS topics from which they can choose to offer courses to students. In its broader context, to facilitate the integration of CGDS topics into biomedical curricula nationally, this NOFO seeks to support a cohort of Sites that will work collaboratively and collectively to produce curricular materials that will aid in the development of a diverse future biomedical workforce.

It is expected that funded institutions under this NOFO will work closely together through regular working group virtual conferences and in-person meetings every year coordinated by the Hub to enable participants to share experiences from their curriculum development activities and knowledge about relevant skills needed for CGDS education and research projects. The expected outcome of these interactions is that a community network of educational institutions will form composed of the Hub and Sites awardees who will together share educational content for use by other institutions interested in teaching CGDS at the undergraduate and master’s degree levels.

While the fundamentals of CGDS are amenable to being taught in classroom or lecture environments, for a well-rounded educational experience in this area, hands-on genomic research experience leading to the collection and analysis of data is a necessity. As a complement to classroom and cloud-based CGDS instructional content developed by the Sites, the Hub will also support opportunities for students at the Sites to conduct hands-on CGDS research projects. Specifically, during the second year of their three-year award periods, awardees of this NOFO will be expected to apply for a competitive opportunity to receive support for developing hands-on student research projects in CGDS, which will then be executed during the third award year. This opportunity funds program will be administered by the Hub.

Expected program activities for this NOFO include:

• Development and testing of undergraduate and master’s degree CGDS curricula that make use of NIH-supported cloud computing platforms
• Sharing of these curricula for use by the larger biomedical education community
• Community participation through adoption of curriculum, materials, and ideas
• Interaction with the Hub awardee
• Interaction with NIH cloud platforms such as AnVIL and the All of Us Researcher Workbench
• Contributions to papers and journals on the subject of curriculum development in CGDS and related core competencies being developed by the grants in the collaborative group.
• Participation in virtual conferences and biannual in-person meetings of the awarded sites.
• Development and execution of student research projects in CGDS

Key terms

For this NOFO, the following definitions apply:

CGDS is defined as an acronym for computational genomics and data science , referring to a set of topics which can include:

1. computational genomics as a stand-alone topic for educational content development
2. data science as a stand-alone topic for educational content development with or without a genomics component
3. educational content development that is at the intersection of these two topics.

Educational content is defined as material designed for classroom, virtual, or hybrid delivery for teaching CGDS topics to students at the undergraduate and master’s degree levels. This could include (but is not limited to) elements such as classroom lectures, instructional videos, interactive demonstrations, and practicum exercises that encourage and enable self-learning. Components of the educational content that involve data analysis will be expected to make substantial use of cloud computing platforms in the form of students completing data analysis exercises through cloud user accounts on NIH-supported cloud computing platforms. Use of non-cloud web servers, software installed on student computers or institutional high-performance computing servers is not covered by the scope of this NOFO.

Non-Responsive Applications

Applications with one or more of the characteristics listed below will be considered non-responsive and will not be reviewed:

• Proposed curriculum or method to be developed is not CGDS-focused.
• Proposed curriculum or method does not have a plan for utilization of the AnVIL or other NIH-supported cloud platforms as tools for CGDS education
• Proposed curriculum or method to be developed is intended for educational stages prior to the undergraduate level
• Proposed curriculum or method to be developed is intended for educational stages later than a master’s degree
• Application proposes only a research project, including an educational research project, rather than the development of a curriculum or educational method.
• Application proposes to teach curricula or methods currently available through the existing core curricula at colleges, graduate schools, medical schools, or resident training programs.
• Application proposes a summer-only duration for the educational content that is not counted towards academic semester credits (e.g., workshops or summer camps)
• Application proposes to disseminate a current or previous R25 funded curriculum or method.
• Application proposes use of non-cloud web servers, software installed on student computers or institutional high-performance computing servers for educational purposes.

Pre-Application Webinar

NHGRI will hold a pre-application webinar for potential applicants on September 1, 2023 at 2:00 pm ET. Participation in the webinar is optional and not required to submit an application. Information about the webinar can be found at: https://www.genome.gov/about-nhgri/Office-of-the-Director/Office-of-Genomic-Data-Science . The webinar connections will open 15 minutes in advance of the start time. During the webinar, NIH staff will give an overview of the NOFO and application submission process and field questions from potential applicants. Attendees can ask questions during the webinar and are encouraged to email questions in advance to Dr. Shurjo Sen at [email protected]. For those who cannot attend, a recording of the webinar will be posted on the above website.

Frequently Asked Questions

Questions and answers from the webinar and other frequently asked questions will be posted here: https://www.genome.gov/about-nhgri/Office-of-the-Director/Office-of-Genomic-Data-Science

Research education programs may complement ongoing research training and education occurring at the applicant institution, but the proposed educational experiences must be distinct from those training and education programs currently receiving Federal support. UE5 programs may augment institutional research training programs (e.g., T32, T90) but cannot be used to replace or circumvent Ruth L. Kirschstein National Research Service Award (NRSA) programs.

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

Section II. Award Information

Other Award Budget 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)

Governments

• 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

• 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

• Community Colleges

To be eligible for this NOFO, the applicant institution must be a domestic institution located in the United States and its territories which:

• Has received an average of less than $25 million per year of R01 total cost of NIH support for the past three fiscal years, and;
• Awards undergraduate or master’s degrees in biomedical sciences, and;
• Has a documented historical and current mission to educate students from any of the populations that have been identified as underrepresented in biomedical research as defined by the National Science Foundation NSF, see http://www.nsf.gov/statistics/wmpd/ or has a documented historical record of recruiting, training and/or educating, and graduating underrepresented students as defined by NSF (see above), which has resulted in increasing the institution's contribution to the national pool of graduates from underrepresented backgrounds who pursue biomedical research career.

The sponsoring institution must assure support for the proposed program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program.

Institutions with existing Ruth L. Kirschstein National Research Service Award (NRSA) institutional training grants (e.g., T32) or other Federally funded training programs may apply for a research education grant provided that the proposed educational experiences are distinct from those training programs receiving federal support. In many cases, it is anticipated that the proposed research education program will complement ongoing research training occurring at the applicant institution.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• 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 registration; 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 SF424 (R&R) Application Guide.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

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)

Program Faculty

Researchers from diverse backgrounds, including individuals from underrepresented racial and ethnic groups, persons with disabilities, and women are encouraged to participate as preceptors/mentors. Mentors should have research expertise and experience relevant to the proposed program. Mentors must be committed to continue their involvement throughout the total period of the mentee’s participation in this award.

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 Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions will not be reviewed.

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:

Shurjo K. Sen, Ph.D.
Telephone: 301-827-7028
Email:[email protected]

Susan N. Wright, PhD
National Institute on Drug Abuse (NIDA)
Division of Neuroscience and Behavior (DNB)
Phone: (301) 402-6683
Email: [email protected]

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this NOFO.

Follow all instructions provided in the SF424 (R&R) Application Guide.

Follow all instructions provided in the SF424 (R&R) Application Guide.

Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:

Facilities & Other Resources. Describe the educational environment, including the facilities, laboratories, participating departments, computer services, and any other resources to be used in the development and implementation of the proposed program. List all thematically related sources of support for research training and education following the format for Current and Pending Support. Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program.

Other Attachments.

An Advisory Committee is not a required component of a Research Education program. However, if an Advisory Committee is intended, provide a plan for the appointment of an Advisory Committee to monitor progress of the research education program. The composition, roles, responsibilities, and desired expertise of committee members, frequency of committee meetings, and other relevant information should be included. Describe how the Advisory Committee will evaluate the overall effectiveness of the program. Proposed Advisory Committee members should be named in the application if they have been invited to participate at the time the application is submitted. Renewal applications with Advisory Committees should include the names of all committee members during the past project period. Please name your file Advisory_Committee.pdf .

The filename provided for each Other Attachment will be the name used for the bookmark in the electronic application in eRA Commons.

Follow all instructions provided in the SF424 (R&R) Application Guide.

Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:

• Include all personnel other than the PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff.
• Costs for the procurement of cloud services, if any, should be clearly identified and detailed justification should be provided.
• A 2.4 Calendar Month minimum level of effort from the PI is required.For Multiple PD/PI applications, the aggregate PI minimum level of effort must be 2.4 Calendar Months.
• Since this NOFO utilizes a cooperative agreement mechanism, costs for the level of effort from the PI are expected to include time for substantial communication with NIH and with the Hub
• Meeting and travel costs should be specified, including costs to attend an Annual Meeting hosted by the Hub
• Additional costs anticipated in the areas of resource dissemination

Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:

• Include all personnel other than the PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff.

Follow all instructions provided in the SF424 (R&R) Application Guide.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Research Strategy

Research Strategy section must be used to upload the Research Education Program Plan, which must include the following components described below:

• Proposed Research Education Program
• Program Director/Principal Investigator
• Program Faculty
• Program Participants
• Institutional Environment and Commitment
• Dissemination Plan

Research Education Program Plan

Proposed Research Education Program. While the proposed research education program may complement ongoing research training and education occurring at the applicant institution, the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support. When research training programs are on-going in the same department, the applicant organization should clearly distinguish between the activities in the proposed research education program and the research training supported by the training program. As a reminder, applicants may choose to address one or more of the activities listed in Section I. Funding Opportunity Description.

Proposed Research Education Program. While the proposed research education program may complement ongoing research training and education occurring at the applicant institution, the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support. When research training programs are on-going in the same department, the applicant organization should clearly distinguish between the activities in the proposed research education program and the research training supported by the training program.

The Research Program Education Plan is intended to describe how classroom-based and virtual learning will be combined with cloud computing-based hands-on exercises in CGDS topics and student research projects, to expand the future CGDS workforce. Content being developed may include elements such as classroom lectures, instructional videos, interactive demonstrations, and practicum exercises that encourage and enable self-learning. Use of innovative, active learning approaches is encouraged. Students are expected to learn specific analytical or computational genomics research methods or technologies and their application, as well as skills in interfacing with the cloud platform including cost-effective use of cloud computing resources for data acquisition, management, and analysis.

The Research Education Program should consist of the following sections.

1. Overview of CGDS courses and educational content that will be developed

In this section, applicants should:

• Provide an overview of the structure and content of the CGDS educational content that will be developed
• Describe how the content has direct relevance for educating students about human genomics (use of non-human data such as microbiome sequencing is allowable in a limited context but the overall focus should be on human systems)
• Provide the underlying rationale and evidence supporting the need for the program. Describe innovative aspects and explain the significance of the curriculum or methods development program beyond the applicant institution to a regional or national level.
• Describe how the content differs from existing courses available to students at the applicant institution, or is an adaptation or modification of those courses to make them responsive to this NOFO
• Describe ways in which the CGDS content developed will be tailored to account for students from diverse backgrounds, including those from groups underrepresented in the biomedical research workforce.
• Describe how the content will be taught, e.g., synchronous or asynchronous
• Describe plans for piloting and assessing the effectiveness and refining the content;
• Provide a timeline for course development, piloting and refinement, dissemination, evaluation, and maintenance. The timeline should indicate when the course materials will be publicly available;
• This section should include a description of previous experience in teaching CGDS topics to a diverse audience at the undergraduate and/or master’s degree level and in using cloud computing resources for research and educational purposes
• Provide support for the feasibility of the proposed activities and describe the benchmarks to be used to assess the success of the curriculum or methods development program.
• Consider potential problems that may be encountered and describe alternative strategies that could be employed.

2. Plans for utilization of NIH cloud computing resources

In this section, applicants should:

• Describe how educational content being developed will use data and/or tools available through the NHGRI AnVIL and other NIH-supported cloud computing resources such as the All of Us Researcher Workbench, NIMHD’s ScHARe platform, the NHLBI Biodata Catalyst, or NCI Cloud Resources.
• Describe plans for implementing hands-on CGDS data analysis components using cloud computing as part of any educational content that will be built
• Describe how the cloud computing component of any educational content being created connects to and extends the classroom-based or asynchronous components of those courses or lectures
• Describe plans for lowering barriers to use of the cloud among students who may have little or no prior experience with bioinformatics
• Describe strategies for working with their institutional administration for interfacing with cloud service providers, e.g. for setting up institutional billing accounts with cloud service providers

For awardees of this NOFO, the CGDS Educational Hub funded through RFA-HG-22-002 will create resources that are likely to be useful for activities described in this section. The training and user outreach teams of the different NIH cloud platforms listed above may also be able to offer assistance depending upon the responsiveness to their respective mission statements.

3. Plans for sharing of CGDS educational content

A primary focus of this NOFO is to have awardees share to the greatest possible extent any educational content they develop for use by other undergraduate and master’s degree granting institutions with an interest in CGDS education. Cloud computing as a technology lends itself uniquely as a way for sharing of data, resources, and tools; hence is expected to be the primary modality for educational content sharing by awardees, rather than awardee-hosted web portals, institutional storage facilities, or non-cloud repositories of NIH-funded data, tools, and resources. Applicants do not need to describe the technical specifics of converting research training materials into cloud-based learning modules but must be committed to making their educational content broadly accessible to students interested in CGDS research.

• Describe plans for the broader CGDS educational community (both individual users as well as institutions) to be able to access the content being developed
• Describe plans to update and maintain the educational content being developed as needed to stay abreast of developments in the fields of CGDS,
• Describe plans for communicating to the broader CGDS educational community the availability of content being developed
• Describe plans for interacting with the CGDS Hub to utilize the resources of the Hub for maximizing the sharing and dissemination of educational content being developed

4. Strategies for Utilizing Opportunity Funds for Student Research Projects

As a complement to classroom and cloud-based CGDS educational content development, the scope of this NOFO includes in year 2 an opportunity for the awardee to apply, and receive in year 3 up to $50,000 of funds for genomic research project executed by students, through a competitive opportunity which will be awarded and administered by the CGDS Hub. These projects will engage students in CGDS research using data sets that they themselves had a role in generating.

In this section applicants should:

• Propose and describe a plan for applying in the second year of the award for the Opportunity Funds program to develop independent genomic research projects that will be used as the substrate for subsequent hands-on experience in cloud-based CGDS analysis
• Include a description of the role that students will have in these projects
• Include a description of the role that the PD/PI and faculty will have in these projects
• Provide a strategy for maximizing student interest and participation in these projects
• Describe plans for using cloud computing as a tool for analyzing data generated by these projects
• Describe expected outcomes from these projects (e.g., term papers or peer-reviewed articles)
• As needed, propose and justify any other activities relevant to management of the Opportunity Funds that are not detailed in this section

5. Timeline

• Provide a detailed timeline (e.g., Gantt chart) of activities and milestones to track progress towards the objectives of the Research Education Program Plan. This should be organized by half years.

Program Director/Principal Investigator. Describe arrangements for administration of the program. Provide evidence that the Program Director/Principal Investigator is actively engaged in research and/or teaching in an area related to the mission of NIH, and can organize, administer, monitor, and evaluate the research education program. For programs proposing multiple PDs/PIs, describe the complementary and integrated expertise of the PDs/PIs, their leadership approach, and governance appropriate for the planned project.

The PD/PIs should have previous experience developing educational content at the undergraduate and master’s degree levels.

Institutional Environment and Commitment. Describe any additional aspects of the Institutional Environment and Commitment not addressed under Facilities & Other Resources or the required Institutional Commitment Letter of Support, described below. Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program. This section should not duplicate information provided elsewhere.

Dissemination Plan. A specific plan must be provided to disseminate nationally any educational materials developed under the auspices of the research education program, e.g., sharing course curricula and related materials via web postings, presentations at scientific meetings, workshops. The plan should include commitment to collaborate with AnVIL and/or other NIH cloud-based platforms, and the CGDS Hub on sharing of educational resources.

Letters of Support

A letter of institutional commitment must be attached as part of Letters of Support (see section above: Institutional Environment and Commitment."

Resource Sharing Plan
Note: Effective for due dates on or after January 25, 2023, a Data Management and Sharing Plan is not applicable for this NOFO.

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

Resource Sharing Plans

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

When relevant, applications are expected to include a software dissemination plan if support for development, maintenance, or enhancement of software is requested in the application. There is no prescribed single license for software produced. However, the software dissemination plan should address, as appropriate, the following goals:

• Software source code should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories. Users should be permitted to modify the code and share their modifications with others.
• The terms of software availability should permit the commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.
• To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.

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.

After initial review, NHGRI program staff will conduct an additional administrative review of the plan for resource sharing and may negotiate modifications of this plan with the prospective awardee. The final negotiated version of this plan will become a term and condition of the award.

Appendix

Only limited Appendix materials are allowed. Follow the instructions for the Appendix as described in the SF424 (R&R) 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 SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

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

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH 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 SF424 (R&R) 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.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile 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.

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 SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by 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 [email protected] when the application has been submitted. Please include the NOFO number and title, PD(s)/PI(s) name(s), and title of the application.

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

For this particular announcement, note the following:

The goal of this UE5 program is to support educational activities that encourage individuals from diverse backgrounds, including those from groups underrepresented in the biomedical and behavioral sciences, to pursue further studies or careers in computational genomics and data science research.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to strongly advance research education by fulfilling the goal of this research education program, 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.

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 policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

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

Applications will be assigned on the basis of established PHS referral guidelines 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. 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.

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.

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.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

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

• Meeting the goals and objectives, as well as timelines and milestones.
• Providing effective leadership and management.
• Providing interim reports or information requested by NHGRI staff.
• Assisting in the development of policies for dealing with situations that require coordinated action.
• Data and software transition. At the end of the award, or if a new recipient has been selected prior to the end of the award, the recipient will work with NHGRI staff and the new award recipient to transition the data and software to the new service, or to the Government.
• Ensuring that educational resources and data created through this award will be stored within the geographical borders of the continental United States of America.
• Ensuring that the educational content created developed as part of this award are made publicly available according to NHGRI and the NIH policies.

Data/software ownership and transition to another grantee:

The recipient will host genomic data and educational content generated through this award, and is responsible for the proper stewardship and security of all data. A fundamental objective of this cooperative agreement is to ensure that the valuable data and software resources remain available without interruption to the research community if recipient withdraws or otherwise can no longer manage the resource or the award is terminated by the NIH.

Recipients(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 will have unrestricted cost-free access and use of the data and software generated by the recipient, including the right to transfer said data and/or software to other NIH-funded and/or managed resource projects, at the NIH's sole reasonable discretion upon termination or expiration of this cooperative agreement.

Open Source Technology: Educational content and software built as part of this award must be delivered under an open source model. Organizations may propose to use proprietary platforms, so long as the requirements for data transparency and interoperability are maintained.

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 (PD). In the Project Scientist role, the Program Director will have substantial scientific and programmatic involvement during the conduct of this activity through technical assistance, advice, and coordination. In the Scientific Officer role, the Program Director will be responsible for the normal scientific and programmatic stewardship of the award and manages concerns about bias as it affects the project. The role of NHGRI PS/SO will be to facilitate and not to direct the activities. The PS/SO will be named in the Notice of Award.

The PS/SO will have the following substantial involvement:

• Participating in the process of setting scientific, administrative and technical priorities, deciding optimal approaches and protocol designs, and contributing to the adjustment to protocols or approaches as warranted.
• Serving as a liaison, helping to coordinate activities among and for the recipient(s), including acting as a liaison to the NIH, and as an information resource for the recipient(s) about scientific, administrative, and technical activities.
• Facilitate the dissemination of experiences and approaches among recipients of the program as well as other NIH-supported networks.
• Help reprogram efforts within the peer-reviewed scope of work, including options to modify program goals and milestones when programs are not making headway relative to timelines for achieving the objectives of the NOFO.
• Assist in coordinating the efforts of the resource with other groups conducting similar efforts at the NIH.
• Assisting in promoting the availability of the data and related resources developed in the course of the award to the scientific community.
• Periodically reporting on the progress of the program to NHGRI Division Directors, the NHGRI Director, and to the National Advisory Council for Human Genome Research.
• Providing advice in the management and technical performance of the award.
• Participating in data analyses, interpretations where warranted.
• Being responsible for the normal scientific and programmatic stewardship of the award, including assessments of how well the recipient has met any milestones required for each year of funding.
• Where warranted and consistent with authorship and conflict of interest requirements of journals in which the recipients decides to publish, co-authoring manuscripts through their role in scientific program management.
• 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.
• Other NHGRI staff may assist the recipient(s) as designated by the PS/SO.

Areas of Joint Responsibility include:

If there are multiple awards working toward a common goal, close interaction between the participating Recipient(s) and the PS/SO will be required, to manage, assess, and implement the award(s). This is accomplished by:

• Meeting every quarter calendar year to share information on data resources, methodologies, analytical tools, data analyses, preliminary results, etc.
• Establishing best practices for data integration and collaborative analyses as appropriate.
• Setting research priorities, deciding optimal research approaches and protocol designs, and contributing to the adjustment of research protocols or approaches as warranted.

The PS/SO will assist and facilitate the group process and not direct it.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NHGRI may be addressed by convening a Dispute Resolution Panel. It will be composed of three members: 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 disagreement for one award, the first member may be chosen by that recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

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:

• Federal-wide 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.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS Assurance of Compliance form (HHS 690)) in which the recipient agrees, as a condition of receiving the grant, to administer programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity, The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

• For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.
• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 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.

3. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the 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. Continuation support will not be provided until the required forms are submitted and accepted.

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 45 CFR Part 75.301 and 2 CFR 200.301.

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

Failure by the recipient institution to submit required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award.

In accordance with the regulatory requirements 45 CFR Part 75 and 2 CFR Part 200 and Appendix XII to 45 CFR Part 75.113 and 2 CFR Part 200.113, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

A final RPPR 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.

5. Evaluation

In carrying out its stewardship of human resource-related programs, the NIH or its Institutes and Centers will periodically evaluate their UE5 research education programs, employing the measures identified below. In assessing the effectiveness of its research education investments, NIH may request information from databases, PD/PIs, and from participants themselves. Where necessary, PD/PIs and participants may be contacted after the completion of a research education experience for periodic updates on participants subsequent educational or employment history and professional activities.

Upon the completion of a program evaluation, NIH and its ICs will determine whether to (a) continue a program as currently configured, (b) continue a program with modifications, or (c) discontinue a program.

In evaluating this research education program NHGRI expects to use the following evaluation measures:

For Programs Focusing on Curriculum or Methods Development:

• Aggregate number and demographic characteristics of participants exposed to the new curricula or methods
• General educational level of participants
• Effectiveness of the new curricula or methods assessed by skills/competencies gained compared to existing curricula or methods
• Dissemination and/or adoption of the new curricula or methods

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: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

SBA Company Registry (Questions regarding required registration at the SBA Company Registry and for technical questions or issues)
Website to Email: http://sbir.gov/feedback?type=reg

Shurjo K. Sen, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-827-7028
Email: [email protected]

Rudy Pozzatti, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-402-8739
Email: [email protected]

Donna Morris
National Human Genome Research Institute (NHGRI)
Telephone: 301-827-2745
Email: [email protected]

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: [email protected]

Pam Fleming
National Institute on Drug Abuse (NIDA)
Telephone: 301- 480-1159
Email: [email protected]

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 45 CFR Part 75 and 2 CFR Part 200.