Part 1. Overview Information

Key Dates

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide,except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts ).

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

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Accessible, well-maintained, and efficiently operated data resources are critical enablers of modern biomedical research. Data resources, through good data management practices, are the key to data and knowledge discovery, integration, and data reuse, as outlined by the FAIR Data Principles (Findable, Accessible, Interoperable, and Reusable digital objects). In order to sustain a healthy and productive data resource ecosystem it is critical to ensure that each component: (a) delivers scientific impact to the communities that they serve; (b) employs and promotes good data management practices and efficient operation for quality and services; (c) engages with the user community and continuously address their needs; and (d) supports a process for data life-cycle analysis, long-term preservation, and trustworthy governance.

In order to better support such a modern data resource ecosystem, NIH makes a distinction between data repositories and knowledgebases. While each activity is important for advancing biomedical research, data repositories and knowledgebases can have unique functions, metrics for success and sustainability needs.

Biomedical knowledgebases have the primary function to extract, accumulate, organize, annotate, and link growing bodies of information related to core datasets, in compliance with the FAIR Data Principles. Biomedical data repositories on the other hand accept submission of relevant data from the community to store, organize, validate, archive, preserve and distribute the data, in compliance with the FAIR Data Principles. The funding announcement for biomedical data repositories is at PAR-20-089 .

This funding opportunity announcement supports the biomedical knowledgebases that are important to the mission of the NIH Institutes and Centers participating in this announcement. The evaluation of the repositories will empasize their utility and impact, quality of data and services and efficiency of operations, community needs and engagement, trustworthiness of stewardship and governance.

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 FOA.

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

• 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)

• 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 Institutions)

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant organizations

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

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• 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.
• eRA Commons - Applicants must have an active DUNS number to register in eRA Commons.Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but 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 DUNS number and 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 his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

The application can be submitted as a single PD/PI or as a multiple PD/PI application. Visit the multiple PD/PI Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide, and the Grant Policy Statement on Multiple Principal Investigators.

The PD/PI is strongly encouraged to devote at least 2.25-person months to the project.

2. Cost Sharing

This FOA 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.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. 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 NOT-OD-11-101)

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 FOA. 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 SF424 (R&R) Application Guideexcept where instructed in this funding opportunity announcement 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 may be delayed or not accepted for review. All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA. All instructions in the SF424 (R&R) Application Guide must be followed. All instructions in the SF424 (R&R) Application Guide must be followed. All instructions in the SF424 (R&R) Application Guide must be followed.

Facilities and Other Resources: Describe the infrastructure and institutional environment that support the knowledgebase. Describe partnerships with any infrastructure providers.

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

If a project manager is included, it is strongly recommended that the individual be appointed as a Senior/Key person with adequate authority to administer operational aspects of the biomedical knowledgebase.

R&R Budget

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

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

Research Strategy: The Research Strategy must consist of the following three subsections, uploaded as a single pdf attachment:

A. Critical metrics for a successful biomedical knowledgebase

B. Resource Development Plan

C. Management and Sustainability Plan

A. Critical Metrics for a successful biomedical knowledgebase:

The proposed application should present a compelling justification for support of the biomedical knowledgebase as a highly valued data resource. The application should address four critical metrics:

1). Scientific Significance: The data resource should have a national and international significance, with relevance and an explicit mission statement that describes the importance to the NIH domains of science. The application should include and document use cases that describe the significance of the resource on biomedical research. The resource should present metrics and other evidence to demonstrate past and/or future use, utility, and scientific impact.

The resource should advance knowledge and understanding within in its primary scientific field and across related fields of science. The knowledgebase should aggregate data and information and demonstrate a critical need to a significant segment of the biomedical research community.

2). Community Engagement and Impact: The data resource should demonstrate that there is sufficiently large or potential research usage and a userbase to warrant NIH support. The application should document impact and methods used to engage targeted research community(ies).

The application should document impact of information through citations, data or information coordination across a field or fields of study, and overall usage and users. Tracking metrics include unique and sustained users, use of information, coordination within and across fields of science, user participation in curation and quality control/assurance, etc.

3). Quality of Data and Services and Efficiency of Operations: The application should document adherence and support of the FAIR data principles as well as use of community standards for data and metadata, data identifiers, provenance of data, adequate infrastructure and storage. In addition, the Knowledgebase should employ a digital identifier (DOI or other). The application should document curation methods and quality of and coverage of curated information, standards, versioning and utility. Quality control/quality assurance procedures and metrics should be described. Knowledgebases are expected to show capabilities beyond manual curation methods. The application should also address unique capabilities such as search, user portals and other activities that are pertinent to knowledge enhancements derived from data integration or aggregation. The application should also address capabilities for user guidelines, tutorials, or other outreach activities. The application should address innovations and improvements in the efficiency of operations and assurance of information quality.

4). Governance: The application should document processes for developing terms of use, appropriate processes for data licenses and policies for privacy and ethics. The biomedical knowledgebase funded through this mechanism requires an external advisory committee. The application should describe the role of the external advisory committee; however, names of existing or proposed committee members should not be included in the application and members should not be contacted or appointed prior to review of this application. The repository is expected to document its trustworthiness to its users community through public evidence of data management practices, or certification based on community standards such as CoreTrustSeal, ISO 16363:2012, or other community recognized repository management best practices.

B. Resource Development Plan:

The application should include a description of critical milestones such as certification of trustworthiness, proof of FAIR implementation , performance metrics, a timeline for completion and whether critical milestones depend on the completion of antecedent milestones. Metrics for identifying successful completion of resource aims and goals, and criteria for acceptable outcomes should be defined.

C. Project Management Plan and Sustainability Plan:

Project Management Plan: Applications should describe the management and decision-making processes that promote the use and utility of the biomedical knowledgebase. The management plan should include all personnel, consultants, and other significant contributors regardless of effort level.

Sustainability Plan: Applications should also describe the long-term sustainability of the resource that extends beyond the lifetime of the award. This section should also include plans and criteria for data archival in cold storage, data security and data sunsetting within the knowledgebase.

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

The following modifications also apply:

• All applications, regardless of the amount of direct costs requested for any one year, must address a Data Sharing Plan.

• Allowable software development must be limited to that which provides essential functions or significantly increases the efficiency of operation of the repository. For any software developed in service to efficiency of operations, applications should include terms associated with software awards, including a software sharing plan, and fostering use of open source software.

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide. When involving human subjects research, clinical research, and/or NIH-definedclinical 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.

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

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

Foreign applications should present special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or applications should augment existing U.S. resources in important ways.

Foreign applications should include institutional commitment. Institutional commitment will be taken into consideration when making funding decisions.

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 Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

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.

For Biomedical Knowledgebases, non-research F&A rates apply.

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 Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

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 announcement, note the following:

The Biomedical Knowledgebase award supports well defined resources that shall extract, accumulate, organize, annotate and link growing bodies of information related to core datasets. The resource should provide publicly available documentation on the services offered; be responsible for providing high technical quality services; demonstrate a focus on the uses of the data and offered services; demonstrate capability to support long-term sustainability, data preservation and use/reuse; and demonstrate a robust infrastructure to support repository operations. Repository management could consider adopting best practice management principles, such as, but not limited to, OAIS (ISO 14721), ISO 16363, or CoreTrustSeal.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed). Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the proposed Resource address an important scientific need that is well justified? Is the scope of activities proposed for the Resource appropriate to meet those needs? Could the needs have been easily satisfied in other ways? Will successful completion of the aims bring unique advantages or capabilities to the field?

Does the mission statement clearly articulate the scientific areas covered? Will the resource have a national and international footprint in the appropriate scientific communities? Is the potential user community sufficiently broad and does the resource’s userbase represent a significant coverage of potential users and appropriate scientific domains to warrant support?

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles for the Resource with qualifications well suited to organize and maintain the resource, maintain quality control and equitable access, and manage record keeping? If the Resource is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the project?

Innovation

Does the application propose a novel resource not otherwise available to the broader research community? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned, appropriate, and adequately developed? Are the plans for the maintenance of the Resource adequately developed? Are appropriate plans in place for assurance of quality control and do investigators promote strategies to ensure a robust and unbiased scientific approach? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects? Are potential problems, alternative strategies, and benchmarks for success presented?

If the resource is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the resource? Are an appropriate plan for work-flow and a well-established timeline proposed?

Are appropriate approaches described for the generation, maintenance and distribution of the resource? Is a prioritization plan included for making the resource available to the broader community? Are there plans for the sustainability of this resource beyond the proposed period of support?

Will the biomedical knowledgebase appropriately support and enable the FAIR data principles? Does the application make use of appropriate community standards?

Is the proposed appropriate governance model appropriate? Does the management plan adequately describe processes that will be used for decision making?

Does the biomedical knowledgebase have an appropriate resource development plan? Are the milestones and performance metrics appropriate for the goals defined and is the work feasible in the timeline proposed?

Is the sustainability plan adequate and does it address processes and policies for cold data storage, data security and data sunsetting?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Does the application make use of state-of-the-art infrastructure and technologies needed to achieve the goals of the resource? If unique capabilities are proposed are these appropriate to increase the use and utility of the resource? Will the resource significantly improve its efficiency of operations?

Protections for Human Subjects

For research that involves human subjects but does not involve one of thecategories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; (3) Genomic Data Sharing Plan (GDS);and Software Sharing Plan.

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIH Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• 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.

• Will receive a written critique.

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 FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• 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 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 grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Institutional Review Board or Independent Ethics Committee Approval: Grantee 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 awardee 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, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

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

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.htmlhttps://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.htmlor call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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

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

Definitions:

NIH Program Official

A NIH Program Official (PO) will provide the standard programmatic oversight and stewardship of the projects, including review of pre-award and award documents/requirements, review of progress reports and budgets, approval of changes in scope, budget allocation or aims, and any other programmatic issues that may arise. The PO will serve as an ex officio member of the External Advisory Committee.

NIH Project Coordinator

One or more NIH Program Staff will serve as Project Coordinator (PC), to monitor progress in scientific aims, identify possible collaborations with other NIH funded initiatives, review of milestones and other scientific issues, and oversee collaborative projects amongst awardees. The PC will serve as a scientific representative of the NIH to the investigators in accordance with policies and procedures of the cooperative agreement mechanism. The PC will provide NIH scientific programmatic involvement with the awardee that is anticipated during the performance of the activities supported by this Cooperative Agreement, including review of milestones. The PC will work closely with the PD/PI to maximize progress towards the goals of the project and the program and will serve as a voting member of the External Advisory Committee.

Roles and Responsibilities:

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

• define the details for the project. PD(s)/PI(s) will agree to accept close coordination, cooperation, and participation of NIH staff in those aspects of scientific and technical management of the project as described under "Program Staff Responsibilities".
• Organize and host necessary annual scientific or programmatic meetings

• Advertise the resources available to the community through outreach activities
• Assemble the External Advisory Committee and participate in EAC activities
• Manage and coordinate project activities scientifically and administratively at the awardee institution and with any collaborating institutions;
• Ensure that all data and information are disseminated according to the FAIR principles; that is data and information should be identifiable and annotated with metadata including data quality and assurances
• Ensure that all data and information involving human subjects has the appropriate security and clearances
• Wherever possible, adhere to the Open Science Initiative, to guarantee the right of others to read, redistribute, modify, and freely use any software.
• Update goals and milestonesat the time of award and provide summaries of progress toward those goals, including the ProjectManagement Plan,at least yearly, as requested by NIH. The milestones will be reviewed annually (and at other times, if necessary), and new milestones will be negotiated, as needed by working with the Project Coordinator as appropriate.
• Participate in regular discussions with the NIH staff

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government 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:

Program Official :

• Responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice
• Review the progress of the project and monitor for compliance with NIH Grants Policy;
• Make recommendations to the NIH for continued funding based on performance and compliance with the Terms and Conditions of the award;
• Conduct more frequent progress reviews, with the possibility that the awardee submit quarterly progress reports should problems arise in the conduct of the study;
• Serve as an ex officio member of any External Advisory Committee

Project Coordinator:

• Participate in the process of coordinating collaborative project efforts and setting priorities;
• In consultation with the program officer, provide advice in the development of operating guidelines, quality control procedures, and consistent policies for dealing with recurrent situations that require coordinated action;
• Serve as a voting member of any External Advisory Committee or Steering Committee as a representative of the NIH extramural staff;
• Serve as a liaison to the NIH, and as an information resource for the awardees about related research activities;

Areas of Joint Responsibility include:

PD(s)/PI(s) will constitute the External Advisory Committee (EAC) and this committee is expected to consist of individuals who are not key personnel or collaborators of the key personnel of the award. The EAC meetings will include NIH staff and may include the PD(s)/PI(s) and other members of the funded project. The EAC will select one member to act as the Chair of the committee and the Chair may not be an NIH employee. The EAC will meet at least once a year.

Dispute Resolution:

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

3. Reporting

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

Project Management Plan: The Project Management Plan, included as part of the application, shall be updated yearly as part of the RPPR to include collaborative activities, new tasks, and completion of milestones.

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

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreementsare required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

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

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 threatensubmission by the due date, and post-submission issues)

Finding Help Online:http://grants.nih.gov/support/(preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: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

Raj Srinath, PhD
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone:301-827-6943
Email: raj.srinath@nih.gov

Jean Yuan, M.D., PhD
National Institute of General Medical Sciences
Email: Jean.Yuan@nih.gov

Lindsey L. Scott, M.S., Ph.D.
National Institute of Neurological Disease and Stroke
Telephone: 240-550-9694
Email: Lindsey.Scott@nih.gov

Nathan Stinson Jr., Ph.D., M.D., M.P.H.
National Institute on Minority Health and Health Disparities
Telephone: 301-594-8704
Email: stinsonn@mail.nih.gov

Christopher G. Duncan, PhD
National Institute of Environmental Health Sciences
Telephone: 984-287-3256
Email: christopher.duncan@nih.gov

Susan Wright, Ph.D.
National Institute on Drug Abuse
Telephone: 301-402-6683
Email: susan.wright@nih.gov

Office of Data Science and Emerging Technologies (ODSET)
National Institute of Allergy and Infectious Diseases(NIAID)
Email: datascience-foa@niaid.nih.gov

Daniel Falk, Ph.D.
National Institute on Alcohol Abuse and Alcoholism
Telephone: 301-443-0788
Email: falkde@mail.nih.gov

Juli Klemm, Ph.D.
National Cancer Institute
Telephone: 301-480-5778
Email: klemmj@mail.nih.gov

Rebecca A. Roper, MS, MPH
Center for Translation Research and Implementation Science
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-496-1051
Email: rebecca.roper@nih.gov

James Luo, PhD
Division of Cardiovascular Sciences
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0533
Email: luoja@nih.gov

James Gao, Ph.D.
National Eye Institute (NEI)
Telephone: 301-594-6074
Email: james.gao@nih.gov

Raymond Jacobson, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-451-3409
Email: jacobsonrh@mail.nih.gov

Sahar Rais-Danai
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-594-5032
Email: raisdanais@mail.nih.gov

Angela Urdaneta
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-451-2005
Email: urdanetaa@mail.nih.gov

Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email: ChiefGrantsManagementOfficer@ninds.nih.gov

Priscilla Grant, JD
National Institute on Minority Health and Health Disparities
Telephone: 301-594-8412
Email: grantp@mail.nih.gov

Jenny Greer
National Institute of Environmental Health Sciences
Telephone: 984-287-3332
Email: jenny.greer@nih.gov

Pam Fleming
National Institute on Drug Abuse
Telephone: 301-480-1159
Email: pfleming@mail.nih.gov

Kevin Heath
National Institute of Allergy and Infectious Disease
Telephone: 301-827-8033
Email: kevin.heath@nih.gov

Judy Fox
National Institute on Alcohol Abuse and Alcoholism
Telephone: 301-443-4704
Email: jfox@mail.nih.gov

Crystal Wolfrey
National Cancer Institute
Telephone: 240-276-6277
Email: wolfreyc@gab.nci.nih.gov

Anthony Agresti
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-827-8014
Email: agrestia@nhlbi.nih.gov

Karen Robinson Smith
National Eye Institute (NEI)
Telephone: 301-435-8178
Email: kyr@nei.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 45 CFR Part 75.