Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of General Medical Sciences (NIGMS)

Funding Opportunity Title
Resource Center for the Support for Research Excellence (SuRE) Program (U24 - Clinical Trial Not Allowed)
Activity Code

U24 Resource-Related Research Projects Cooperative Agreements

Announcement Type
New
Related Notices
  • March 9, 2022 - Notice of Participation of the National Center for Complementary and Integrative Health (NCCIH) in PAR-21-169, "Support for Research Excellence (SuRE) Award (R16 Clinical Trial Not Allowed). See Notice NOT-AT-22-015
  • March 8, 2022 - Notice of Participation of the National Center for Complementary and Integrative Health (NCCIH) in PAR-21-173, "Support for Research Excellence First Independent Research (SuRE-First) Award (R16 - Clinical Trial Not Allowed). See Notice NOT-AT-22-014
Funding Opportunity Announcement (FOA) Number
PAR-21-227
Companion Funding Opportunity
PAR-21-169 , R16 Research Excellence Award
PAR-21-173 , R16 Research Excellence Award
Number of Applications

Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)
93.859
Funding Opportunity Purpose

This funding opportunity announcement encourages applications for a Resource Center as part of the Support for Research Excellence (SuRE) program to develop and sustain research excellence at U.S. higher education institutions that receive limited NIH research support and serve students from groups underrepresented in biomedical research (see NOT-OD-20-031). The Resource Center will: (1) assist SuRE-eligible institutions to build research capacity, (2) conduct outreach and training to their professional staff and faculty, and (3) collect and report data relevant to the goals of the R16 SuRE programs.

Key Dates

Posted Date
April 27, 2021
Open Date (Earliest Submission Date)
August 24, 2021
Letter of Intent Due Date(s)

Not Applicable

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
September 24, 2021 Not Applicable Not Applicable March 2022 May 2022 July 2022

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Expiration Date
September 25, 2021
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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.

Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

The National Institutes of Health (NIH) recognizes that scientists and students from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. Benefits of a diverse scientific workforce include fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved populations participate in, and benefit from research, and enhancing public trust. Yet many institutions that enroll significant numbers of students from groups underrepresented in science are under-resourced and their faculty receive fewer NIH research grants (Hoppe 2019). There is a pressing need to enhance biomedical research capacity and opportunities for student research at these institutions. The Support of Research Excellence (SuRE) program aims to develop and sustain research excellence at such institutions through supporting investigator-initiated research with strong student participation and providing resources to establish and/or strengthen Offices of Sponsored Programs (OSPs).

Program Objectives

The SuRE program supports research capacity building at institutions that enroll significant numbers of students from backgrounds nationally underrepresented in biomedical research (see NOT-OD-20-031), award baccalaureate and/or graduate degrees in biomedical sciences, and receive limited NIH Research Project Grant funding. It seeks to develop and sustain research excellence of faculty investigators and provide students with research opportunities while catalyzing enhancement of institutional research culture and enriching the research environment. The SuRE program will support investigator-initiated research in the biomedical, clinical, behavioral and social sciences (collectively termed "biomedical" sciences) that falls in the mission areas of NIH Institutes, Centers, and Offices. Research activities funded by the SuRE program require participation by students. Two SuRE R16 Funding Opportunity Announcements (FOAs, PAR-21-169 and PAR-21-173) have been published to support investigator-initiated research projects. This FOA supports a SuRE Resource Center to enable broader participation in the SuRE program nationally, thus maximizing the program’s impact in developing and sustaining research excellence at eligible institutions. Specific activities of the SuRE Resource Center must include, but are not limited to, the following areas:

Assist SuRE-eligible institutions to build research capacity:

  • Administer a competitive seed grant program to support the establishment of and/or strengthen OSPs.

Conduct outreach and training to administrators, faculty and OSP professional staff at SuRE-eligible institutions:

  • Conduct outreach to SuRE-eligible institutions to provide information on institutional eligibility, submission of applications, and grants management.
  • Disseminate information about the SuRE R16 FOAs to a geographically and demographically balanced pool of eligible faculty investigators.
  • Provide training to faculty investigators in preparing SuRE and other research grant applications.
  • Provide professional training to OSP staff at SuRE-eligible institutions.
  • Organize biennial SuRE Program Conferences for faculty, students, and research administration staff to facilitate scientific exchange, collaboration, and career development.

Track SuRE grantee institutions progress in developing research capacity and gather community feedback on the SuRE program:

  • Track annual SuRE-grantee institutions research support received from federal, state, industry and private sources using publicly available data to assess institutional progress in developing research capacity.
  • Gather feedback from R16 institutions, research administration staff, PDs/PIs, and students on ways to improve the operations of the Resource Center in fulfilling the goals of the SuRE Program, through the Resource Center’s outreach activities and during the biennial SuRE Program Conferences.
  • Collect and report utilization data on institutions and PIs that engage with the Resource Center and outcomes associated with institutional engagement with the Center.

Program Requirements

The purpose of the SuRE Resource Center is to provide support to SuRE-eligible institutions and faculty applicants and awardees. Thus, it is imperative that all applicants to this award gain a thorough understanding of the SuRE and SuRE-First R16 FOAs (PAR-21-169 and PAR-21-173) prior to responding to this FOA. Applicants should also be familiar with the research environment, needs, and challenges of SuRE-eligible institutions and investigators.

Applicant institutions should have the infrastructure and commitment to manage a Resource Center that offers a competitive seed grant program as well as training and outreach activities to institutions and faculty investigators nationwide. The Program Director(s)/Principal Investigator(s), PD(s)/PI(s), are expected to be experienced in leading large research resource programs and in working with higher education institutions and faculty investigators. To meet the needs of a national program, the Resource Center should consist of strong central leadership, experienced management personnel to implement the key activities of the Program Objectives, and geographically balanced regional coordinators of outreach to institutions and faculty investigators.

The Resource Center will be governed by a Steering Committee, which will include the PD(s)/PI(s), representatives of senior institutional officials from SuRE-eligible institutions, representatives of SuRE-supported faculty investigators, a representative from a national scientific professional society, and a NIGMS Project Coordinator. For details on the composition and responsibilities of the Steering Committee, see Section VI.2 under Cooperative Agreement Terms.

Applicants are encouraged to contact the NIH representatives listed in Section VII. Agency Contacts early in the planning stages of an application to ascertain whether the proposed resources address programmatic priorities.

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

Section II. Award Information

Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

Application Types Allowed
New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trials.

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. NIGMS intends to fund one Resource Center award.

Award Budget

Application budgets are limited to $750,000 per year in annual direct costs, excluding facilities and administrative (F&A) costs on consortium arrangements, and must reflect the actual needs of the proposed project.

Award Project Period

The maximum project period is 5 years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

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
Foreign Institutions

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.

Required Registrations

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.
  • 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.

Eligible Individuals (Program Director/Principal Investigator)

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.

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

Only one application per institution, normally identified by having a unique entity identifier such as DUNS or IPF, is allowed.

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 Guide except 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.

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

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.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

Facilities & Other Resources. Describe the institutional environment(s) in which the Resource Center will operate and be located, including the institutional support and other physical resources available to the Resource Center leadership and management personnel that can contribute to the success of the SuRE program. Include the following information:

  • Institutional environment, infrastructure, or human potential at the involved organizations/sites that may be leveraged to the advantage of the Resource Center and the SuRE program.
  • Available resources within the scientific or administrative environment that will support electronic information handling and analysis activities.
SF424(R&R) Senior/Key Person Profile

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

R&R Budget

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

A minimum of 2 person-months annual effort is required for each key personnel, who must include the PD(s)/PI(s), management personnel, and regional coordinator(s). Budgets must also include funds for:

  • A competitive seed grant program of at least $250,000 direct costs per year to fund 4-6 one-year awards in each project year, to establish or strengthen OSPs.
  • The development and delivery of trainings for OSP staff and faculty investigators.
  • Necessary travel by key personnel for training and outreach activities.
  • A biennial SuRE Program Conference and allowable costs associated with hosting this conference, including hotel/facility and audio-visual costs.
  • Travel expenses for key personnel and non-NIH Steering Committee members to attend the biennial SuRE Program Conference.
  • A travel award program to defray the costs of one OSP staff from each seed grant awardee institution to attend a biennial SuRE Program Conference.
  • Administrative costs associated with online content, including website development, online platform licensing, and technology support.
R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Specific Aims: Outline Specific Aims for the proposed Resource Center along with the main benchmarks for their realization.

Research Strategy: The Research Strategy must consist of the Subsections A and B, as defined below.

Subsection A: Resource Center Overview

  • Describe the overall vision and general strategy of the proposed Resource Center.
  • Describe the organizational structure of the Resource Center and its governance. Outline methods to effectively manage, communicate, and coordinate the various responsibilities of the Resource Center team. Highlight any innovative organizational or management strategies.
  • Describe plans for the establishment of the Steering Committee (do not name potential members); for the operation of the Steering Committee; for ensuring diversity of its members in terms of institutions, regions, roles, expertise and backgrounds; and for maintaining effective communication with NIGMS.
  • Without repeating information in biosketches, summarize the collective Resource Center team expertise.
    • Delineate the roles and responsibilities of the PD(s)/PI(s).
    • Describe the duties assigned to all management personnel to accomplish the Center’s key activities: implementing the seed grant program, organizing the outreach and training activities, tracking data relevant to SuRE-grantee institutions' progress in developing research capacity, gathering SuRE community feedback on the Resource Center, and collecting utilization data for the Resource Center.
    • Describe the responsibilities of the regional coordinators in outreach and training activities.

Subsection B. Resource Center Functions

Describe concrete plans (including work-flow, timelines, benchmarks for success, etc.) for the following specific functions of the Resource Center:

Assist SuRE-eligible institutions to build research capacity:

  • Provide a brief analysis of common challenges faced by OSPs at SuRE-eligible institutions.
  • Describe plans to better understand and assess what is needed to support OSPs.
  • Describe plans to solicit, receive, evaluate, award, and manage seed grants to establish or strengthen OSPs, especially at institutions that have not previously participated in the SuRE programs or its predecessor SCORE programs.

Conduct outreach and training to SuRE-eligible institutions, faculty, and OSP professional staff:

  • Describe strategies to conduct outreach to eligible institutions to raise awareness of the SuRE program, including specific plans to contact institutions that have not previously participated in the SuRE or SCORE programs.
  • Describe the types of training that will be developed and/or offered to SuRE-eligible faculty in preparing for submission of SuRE and other research grant applications. Describe the materials to be developed and strategies for delivery.
  • Describe the types of training that will be developed and/or offered to enhance the skills of OSP staff. Describe the materials to be developed and strategies for delivery.
  • Describe the types of outreach and training that will be developed and conducted to help SuRE-eligible institutions increase their capacity to conduct high-quality, student-centric biomedical research.
  • Provide an overall plan for the biennial SuRE Conferences.

Track SuRE-grantee institutions progress in developing research capacity and gather community feedback on the SuRE program:

  • Propose strategies to track annual SuRE-grantee institutions research support received from Federal, State, industry and private sources using publicly available data to assess institutional progress in developing research capacity.
  • Propose strategies to gather feedback from R16 institutions, OSP staff, PDs/PIs, and students on ways to improve the operations of the Resource Center in fulfilling the goals of the SuRE Program, through the Resource Center’s outreach activities and during the biennial SuRE Program Conferences.
  • Propose metrics and collection strategies to track Resource Center utilization by R16-eligible institutions and investigators.
  • Provide a summary of the tracked outcomes to be reported to NIGMS.

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.

Appendix:

Only limited Appendix materials are allowed. Follow all 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.

PHS Assignment Request Form

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 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.

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 and NIGMS. Applications that are incomplete or non-compliant will not be reviewed.

Post Submission Materials

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 SuRE Resource Center must have all the requisite skills and technical/operational capabilities to efficiently facilitate and coordinate efforts to: conduct outreach to a geographically diverse pool of applicant institutions; provide training and support to SuRE institutions, PD/PIs and OSP staff; and collect and report data relevant to the goals of the R16 SuRE award programs.

Overall Impact

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).

Scored Review Criteria

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 Center address the needs of the SuRE Program that it will serve? Is the scope of activities proposed for the Resource Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the SuRE program?

Specific to this FOA: How strong are the overall strategies of the proposed Resource Center in terms of expanding institutional participation in the SuRE program? What is the likelihood that the proposed Resource Center will significantly advance the goals of the SuRE program and increase research capacity at SuRE-eligible institutions?

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the Resource Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing multi-institutional endeavors? Do the investigators demonstrate significant experience with coordinating collaborative research resources and/or training centers? If the Center 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 Resource Center? Does the applicant have experience overseeing selection and management of sub-awards, if needed?

Specific to this FOA: Are regional coordinators appropriate and well integrated into the Resource Center's plans for expanding the range of academic institutions that participate in the SuRE program? Do management personnel and the overall team have the appropriate skills for implementing the key activities of the Resource Center?

Innovation

Does the application propose organizational concepts or management strategies in coordinating the SuRE program that the Resource Center will serve? 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 organizational concepts or management strategies proposed?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research program the Resource Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the program, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the program is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the program? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?

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?

Specific to this FOA: How likely are the outreach activities to result in a diverse participant pool at both the institutional and faculty levels? Does the team demonstrate a solid understanding of the challenges faced by OSPs at SuRE-eligible institutions, and are there appropriate plans to solicit additional information? Are the plans to develop and administer a seed grant program feasible and appropriate for strengthening OSPs? How likely is it that proposed training for their professional staff will lead to a more proficient research administration workforce? Are training and workshops for SuRE-eligible faculty and awardees well-designed to improve competitiveness for applying for SuRE and other research grants? Are the plans for outreach and training to promote research capacity development at SuRE-eligible institutions well conceived? Are the plans for the biennial SuRE Conference adequate for improved networking and collaborations among SuRE faculty and OSP staff, and for obtaining their feedback on the SuRE program? Is the proposed use of public resources to track growth in institutional research capacity appropriate? Does the proposed Resource Center demonstrate adequate capacity to manage communications and training among SuRE-eligible institutions, applicants, and awardees?

Environment

Will the institutional environment in which the Resource Center will operate contribute to the probability of success in facilitating the SuRE program it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Resource Center proposed? Will the Resource Center benefit from particular features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

Additional Review Criteria

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.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories 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

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

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

Not Applicable

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; and (3) Genomic Data Sharing Plan (GDS).

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 NIGMS, 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.

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.
  • Portfolio balance.

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 recipient's business official.

Awardees 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 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: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the 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, Recipients, 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 laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/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 FOA.

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 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

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, 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 recipientsis 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 recipientsfor the project, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

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

  • The operation of the Resource Center.
  • Determining the approaches, designing, and setting project milestones and implementing workflows.
  • Ensuring that interactions with SuRE-eligible institutions, their research administration staff, PD(s)/PI(s), and participating students are consistent with the goals of the SuRE program.
  • Creating web-based resources for the SuRE program including a website addressing NIH policies, procedures, application information and materials, web-based course content, and email and other web-based systems for group communication.
  • Serving as a voting member on the SuRE Program Steering Committee.
  • Scheduling, facilitating, and developing the agenda and content for the Steering Committee's conference calls and annual meetings, and preparing concise minutes or summaries of meetings for distribution.
  • Adhering to the decisions and recommendations of the Steering Committee to the extent compatible with applicable grant regulations.
  • Taking the lead role in developing strategies to promote the SuRE program to potential participants.
  • Soliciting, receiving and selecting applications for seed grant funding to establish and/or strengthen OSPs and managing related sub-awards.
  • Collecting and tracking Resource Center utilization information among R16-eligible institutions and investigators.
  • Planning and coordinating SuRE Program Conferences, taking the lead role to identify available hotel/facility space, and designating U24-supported staff to provide on-site logistical support.
  • Providing information to the NIH Program Officer(s) and NIH Project Coordinator(s) concerning progress, upon request.
  • Sharing knowledge, data, research education materials, and any other resources necessary and relevant to the SuRE program.

Recipients 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:

A designated NIGMS Program staff member will have substantial involvement as Project Coordinator for the SuRE Resource Center. The role of the Project Coordinator will be to facilitate, but not to direct, the Resource Center activities. The specific roles of the substantially involved NIGMS staff member(s) include the following activities:

  • Serving as a voting member of the Resource Center Steering Committee, as described below in "Areas of Joint Responsibility."
  • Identifying relevant NIH expertise and/or resources related to NIH and NIGMS funding mechanisms and initiatives, various NIH programs designed to help research investigators at underserved institutions, and other resources, expertise, or skills that may be relevant to optimizing the activities of the Resource Center, including designing the strategies to reach targeted audiences.
  • Assisting the Resource Center team with the promotion of the SuRE program and reaching the targeted institutions and investigators.
  • Working closely with the Resource Center on planning the biennial SuRE Conference.

While Resource Center awardees will retain custody of the data and resources developed under these awards, NIGMS will have access to the measures, metrics, and reported data and may periodically review it.

Additionally, an NIGMS program official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The program official will not participate in the Steering Committee meetings for the Center.

NIGMS reserves the right to reduce the budget or withhold an award in the event of substantial awardee underperformance or other substantial failure to comply with the terms of award.

Areas of Joint Responsibility include:

A Steering Committee will be convened to serve as the SuRE Resource Center main governing board. At a minimum, the Steering Committee will be composed of the following voting members:

  • The PD(s)/PI(s) of the Resource Center, who will collectively have one vote and who will chair the committee.
  • Representatives from SuRE-eligible institutions who are senior institutional officials, who will each have one vote.
  • Representatives from the pool of SuRE awardees, who will each have one vote.
  • A representative from a national scientific professional society, who will have one vote.
  • The NIGMS Project Coordinator, who will have one vote.

Additional Resource Center staff members may participate in Steering Committee meetings as non-voting members.

The Steering Committee may decide to establish sub-committees for specific purposes. The NIGMS Project Coordinator may serve on such sub-committees as the Committee deems appropriate.

The Steering Committee will meet at least quarterly by teleconference and in person biennially in conjunction with the SuRE Program Conference.

Primary responsibilities of the Steering Committee include, but are not limited to, the following activities:

  • Serving as the main body overseeing the realization of the Resource Center objectives.
  • Ensuring that the content of all materials developed and delivered to SuRE participants are optimal for the goals of the SuRE program.
  • Monitoring the SuRE R16 program, identifying impediments to success, and developing appropriate strategies to overcome the problems.
  • Developing/approving policies and procedures for such aspects as:
    • Rules regarding SuRE applicant recruitment and seed grant evaluation.
    • Developing shared tools for disseminating information about the SuRE program.
    • Establishing/approving a master schedule of activities that reaches a diverse geographic and demographic audience.
  • Approving the final report of the Resource Center.

Dispute Resolution:

Disagreements between award recipients and the NIH that arise regarding matters related to the scientific direction of the funded program may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. The three members will be: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the Steering Committee without NIH staff or the awardee voting. 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.

Awardees will be required to report information regarding participation by eligible institutions in the training activities provided by the Resource Center, as well as institutional distributions of seed grant applications and awards, characteristics of participants, and growth in research capacity at SuRE awardee institutions.

4. Evaluation

In carrying out stewardship of grant programs, NIGMS will periodically evaluate the SuRE program, employing the measures identified below. In assessing the effectiveness of research capacity building investments, NIGMS may use information from progress reports and request information from databases, PD/PIs, and from participants themselves. Where necessary, PD/PIs and participants may be contacted after the completion of the grant period for updates on participants subsequent outcomes.

In evaluating the SuRE Program NIGMS expects to use the following measures:

  • Level of participation by eligible institutions in the training activities provided by the Resource Center.
  • Institutional distributions of seed grant applications and awards, characteristics of participants, and growth in research capacity at SuRE awardee institutions, including:
    • Outcomes of seed grants.
    • Overall numbers of research grants received.
    • Extramural research funding.
  • Indicators of career development for SuRE awardees, including:
    • Publications.
    • Tenure and promotion outcomes.
    • Speaker invitations.
    • Subsequent federal research grant application and awards.
  • Indicators of student research experience and growth, including:
    • Conference presentations.
    • Co-authorships on publications.
    • Degrees earned.
    • Professional employment outcomes of students.

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 agreements are 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.

Application Submission Contacts

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: 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: 301-945-7573

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

Scientific/Research Contact(s)

Irina Krasnova, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email: irina.krasnova@nih.gov

Peer Review Contact(s)

Stephanie Constant, PhD
National Institute of General Medical Sciences (NIGMS)
Email: stephanie.constant@nih.gov

Financial/Grants Management Contact(s)

Christy Leake
National Institute of General Medical Sciences (NIGMS)
Email: christy.leake@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.

Authority and Regulations

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.


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