It is critical that applicants follow 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 the 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 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

The NIH recognizes the need to diversify the scientific workforce by enhancing the participation of individuals from diverse backgrounds, including those from groups identified as underrepresented in the biomedical, clinical, behavioral and social sciences workforce because scientists and trainees from different backgrounds bring a variety of perspectives, creativity, and individual enterprise to address complex scientific problems. A diverse NIH-supported scientific workforce will also improve global competitiveness, contribute to robust learning environments, and enhance public trust.

The United States has seen an increase in the number of Ph.D. degrees in the biomedical sciences earned by scientists from groups and backgrounds traditionally underrepresented in the biomedical sciences (Gibbs, et al., 2016, eLife 2016;5:e21393); however, the attrition of scientists from underrepresented groups biomedical research pathways continues to be an issue (Valantine, Lund & Gammie, CBE-Life Sciences Education, 2016, 15:fe4, 1-5).

With the recognized need to enhance diversity in the biomedical research workforce, the NIH Director requested input from the NIH Advisory Committee to the Director (ACD) regarding actions that the NIH should take to make transformative progress in this area. In 2012, the ACD Working Group on Diversity in the Biomedical Research Workforce explored ways to improve the recruitment of individuals from diverse backgrounds, including those from underrepresented groups in biomedical research and methods to sustain their interest in and prepare them for successful biomedical research careers. The Working Group provided recommendations, endorsed by the ACD, about ways to develop and support individuals from diverse backgrounds, including those from underrepresented groups in the biomedical sciences, throughout their research career (from undergraduate study to acquisition of tenure in an academic position or the equivalent in a non-academic setting). In response to these recommendations, the NIH established the Common Fund Program "Enhancing the Diversity of the NIH-Funded Workforce," also known as the Diversity Program Consortium (DPC).

The first phase of the Enhancing the Diversity of the NIH-Funded Workforce Common Fund program allowed for the formation of a national consortium through which awardee institutions, in partnership with the NIH, began implementing and evaluating training and mentoring programs to engage individuals from diverse backgrounds, including those from groups underrepresented in the biomedical sciences and help them prepare for and succeed in biomedical research careers. The DPC was developed in the context of existing programs through which NIH and other entities have made significant investments to engage scientists and institutions using a variety of training, mentoring, and research capacity-building approaches. Although these programs have shown positive outcomes for trainees and participants, data on the specific factors that contribute to successful outcomes is limited. The primary goal of the DPC is to provide robust evidence on effective ways to engage and sustain the interest of individuals from diverse backgrounds, including from underrepresented groups in the biomedical research workforce and to encourage the dissemination of successful interventions to a wide variety of institutions across the United States.

The first phase of the program provided an opportunity to establish the types of interventions and evaluative frameworks needed to begin understanding and addressing multi-dimensional factors that strongly influence success. The DPC implemented interventions and evaluative practices designed to understand effective approaches to mentoring, student engagement, research capacity building, faculty development, and infrastructure development. The interventions were designed around the following questions:

• What are the hallmarks of a successful biomedical research career at each phase of the training process?
• What motivates students to enter biomedical research career paths, and what factors contribute to their sustained participation?
• What factors influence emerging scientists from diverse backgrounds, particularly those from underrepresented groups, to enter, exit, or sustain a biomedical research career, and how can these factors be addressed?
• What must happen during different training stages to ensure that trainees from diverse backgrounds, including those from underrepresented groups, develop the skills, knowledge, and competencies essential to successful biomedical careers, and careers in the NIH-funded biomedical research workforce?
• How do institutional structures and resources facilitate successful research training and professional development activities?

The second, and final, phase of this program, will allow the DPC to continue gathering data required to address the questions listed above and to assess the longer-term outcomes. During this phase, grantees are expected to refine their approaches and evaluations and to focus on sustainability and dissemination of successful interventions to enhance diversity in the biomedical research workforce. Additional relevant questions for the final phase include, but are not limited to:

• How can training, mentoring, and research capacity interventions to enhance diversity be institutionalized so that their impact continues beyond the period of funding from the NIH Common Fund?
• How can successful approaches to enhance diversity be widely disseminated to other institutions to provide maximum impact at a national level?

The program consists of three highly integrated initiatives, in which awardees work together as the Diversity Program Consortium. The three components are described below.

The Building Infrastructure Leading to Diversity (BUILD) Initiative:

The BUILD initiative was designed to allow sites to implement and study innovative approaches to engaging and sustaining the interest of trainees from diverse backgrounds, including those from underrepresented groups in biomedical research, potentially helping them on the pathway to become future contributors to the NIH-funded research enterprise. BUILD sites were also funded to implement interventions at the faculty and institutional levels to maximize opportunities for faculty development and research capacity building. An integral component of the BUILD initiative is the long-term evaluation of the interventions. In the first phase, awardees were selected because they identified needs at their institutions and proposed robust approaches to understanding how certain interventions could enhance the diversity of the biomedical research workforce. In the second phase, awardees demonstrating rigorous preliminary results will continue to evaluate the interventions to understand the longer-term impact of the programs and will continue to focus on building research capacity to successfully compete for research and training grants. Awardee institutions are also expected to develop sustainability plans and dissemination methods, which will broaden the Diversity Program Consortium's impact to non-BUILD institutions, and provide more institutions with opportunities to increase the persistence of biomedical trainees from diverse backgrounds, including those from underrepresented groups and enhance the research capacity in biomedical research-related fields.

The National Research Mentoring Network (NRMN) Consortium:

Mentorship is crucial in the development of any scientist's career; however, the ACD Working Group on Diversity noted that the community lacks evidence on how to promote successful mentoring relationships for trainees from diverse backgrounds, including those from underrepresented groups. The NRMN was developed to understand the elements that contribute to productive mentoring relationships, and to develop mentoring tools and resources across the national community of researchers in the biomedical research workforce.

During the first phase of the program, the NRMN was tasked with developing a highly networked set of motivated and skilled mentors from various disciplines linked to mentees across the country. In addition, the NRMN cores were selected to provide training opportunities for mentors, to facilitate networking and professional opportunities, and to collect data on effective practices for mentoring. As part of the Diversity Program Consortium, the NRMN contributed to the development of hallmarks of success and participated in data collection in collaboration with the Coordination and Evaluation Center (CEC).

In the second phase of the program, the NRMN initiative will continue to develop mentoring and networking opportunities for biomedical researchers from diverse backgrounds, including those from underrepresented groups, from undergraduates through early career faculty. To broaden the number of innovative strategies explored and increase the likelihood of impact, sustainability, and dissemination, the NRMN will be organized as a consortium of independent research projects, a Resource Center, and a Coordinating Center. The NRMN Coordinating and Resource Centers will work with the independent research projects to enhance dissemination and to promote synergies to provide evidence and resources for effective mentoring to enhance the diversity of the biomedical research workforce. The NRMN Coordination Center will coordinate data collection and storage with the CEC, and build upon and improve instruments and processes developed in the first funding period.

The Coordination and Evaluation Center (CEC):

The scale of the DPC's scientific approach necessitated a center to coordinate the consortium-wide evaluation and data collection efforts, and to store the vast amount of data collected. During the first phase, the CEC was responsible for coordinating consortium-wide activities and working with the BUILD and NRMN programs to develop site-specific and consortium-wide hallmarks of success, robust evaluation plans, and the data sharing agreement. These consortium-wide development activities were established through consensus in Executive Steering Committee meetings (See Section VI for details about the Executive Steering Committee). The CEC coordinated the clearance through the Office of Management and Budget to allow for the secure collection and reporting of data from BUILD and NRMN awardees. The CEC also facilitated consortium-wide working groups, meetings, discussions of approaches, progress, and lessons learned.

The CEC's evaluation activities and coordination responsibilities will continue in the second phase of the program. The consortium-wide hallmarks and consortium-wide evaluation plans will be maintained during the second phase, and the CEC will work closely with BUILD and NRMN awardees to gather data and conduct program evaluations. In addition, the CEC will increase outreach and dissemination of successful interventions.

The long-term impact of this catalytic, trans-NIH program will be in the broad dissemination of effective, evidence-based training and mentoring strategies. The DPC's method of taking a scientific approach to understand training interventions is an innovative design that is likely to serve as a model for biomedical training programs across the Nation.

The purpose of the Coordinating Center is analogous to the previous NRMN Administrative Core. The Coordination Center will provide infrastructure and expertise surrounding data collection, storage, and reporting for the NRMN. Additionally, the PD(s)/PI(s) and personnel involved with the award are expected to work with the DPC's CEC to develop data collection and analysis protocols, as well as to ensure data integrity, privacy, and security. The leadership and key personnel of the NRMN Coordination Center are expected to have broad experience working collaboratively to assess and evaluate biomedical research training and mentoring activities, involving trainees from diverse backgrounds, including those from underrepresented groups. The ability to work with multiple communities while providing strong leadership in evaluative activities is essential to the success of NRMN. The NRMN Coordination Center should include individuals with expertise in multi-site evaluation as well as in coordination, communication, and consensus-building among diverse groups of stakeholders. The NRMN Coordination Center should also include individuals with knowledge and expertise regarding factors that contribute to decisions to pursue, or not to pursue, biomedical research careers and the current evidence base related to training and mentoring practices as well as the approaches to evaluate them. The PD(s)/PI(s) should have expertise with data management and analysis.

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

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

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:

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o 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) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH 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) (formerly CCR) 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 and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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.

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

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).

Buttons to access the online ASSIST system or to download application forms 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.

It is critical that applicants follow 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

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

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

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

The letter of intent should be sent to:

Mercedes Rubio, Ph.D.
Telephone: 301-594-3900
Email: [email protected]

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.

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

All instructions in the SF424 (R&R) Application Guide must be followed. In addition, funds for the PD(s)/PI(s) to attend the annual grantees meetings should be budgeted.

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 application should describe how the NRMN Coordination Center will provide support to the NRMN grantees. Activities should include, but not be limited to, the following:

• Collaborate with the DPC's CEC to develop data collection and analysis protocols, as well as to ensure data integrity, privacy, security and long-term storage.
• Ensure that evaluation metrics for the NRMN are compatible with those established during the first phase of the DPC.
• Coordinate ongoing data collection, data management, and reporting activities across the NRMN and the CEC.
• Maintain, refine, and revise standardized evaluation approaches and data collection protocols, including individual and institutional demographic characteristics, nature of participation in the NRMN related activities/programs, and achievements.
• Use effective quantitative or qualitative approaches to detect the unique impact of the NRMN activities.
• Conduct an outcomes evaluation of the NRMN according to consortium-specified metrics, including an evaluation of interim milestones when applicable.
• Conduct a process evaluation, including external input, of the NRMN activities to assess implementation and ongoing operations and their impact on program outcomes.
• Maintain a centralized, secure database through which the various NRMN components can track outcomes. These data should be collected and maintained in formats that are easily analyzable and shareable to better evaluate the progress and successes of the NRMN.
• Plan and enable effective communications across the NRMN to facilitate CEC objectives of data solicitations and coordination.
• Coordinate annual meetings with the PD(s)/PI(s) of the NRMN U01 and U24 awards to facilitate communication about progress, preliminary findings, and the sharing of successes and challenges.
• Arrange for and host monthly PD(s)/PI(s) conference calls and arrange for similar calls for the various NRMN components, as needed.
• Facilitate efficient communications between the NIH Program Officials and the NRMN Key Personnel to allow for consultations, project oversight, and setting strategic directions.
• Disseminate evaluation results to relevant stakeholders, including professional societies, research organizations, medical and basic science associations, academic institutions, federal agencies, and other organizations.

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, with the following modification:

To achieve the goals of this funding initiative, the collection of certain data is critical. Accordingly, consistent with achieving the goals of this program, all applicants, regardless of the amount of direct costs requested for any one year, are expected to use the Data Sharing requirements set forth in "Diversity Program Consortium Data Sharing Policy." A copy of this policy can be found at: https://www.nigms.nih.gov/training/dpc/Pages/datasharing.aspx.

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

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

Appendix:

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Use only for applications with due dates on or after January 25, 2018. When involving NIH-defined human subjects research, clinical research, and/or 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.

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

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

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

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

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.

This initiative is not subject to intergovernmental review.

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

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. 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 responsiveness by the National Institute of General Medical Sciences (NIGMS), NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

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.

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.

Does the proposed NRMN Coordination Center address the needs of the various components that it will coordinate? Is the scope of activities proposed for the NRMN Coordination Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the broader NRMN network?

Are the PD(s)/PI(s) and other personnel well suited to their roles in the NRMN Coordination Center? Have the PD(s)/PI(s) demonstrated leadership qualities and facilitation skills required to establish and implement the NRMN and DPC goals? Have the PD(s)/PI(s) demonstrated experience in coordinating data collection and evaluation activities across multiple sites? Do the investigators have the necessary experience and expertise to manage and analyze types of data that will be collected from the various programs? 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 NRMN Coordination Center? Are the PD(s)/PI(s) experienced with programs that focus on diverse participant populations? Do the investigators have experience disseminating evaluation findings to diverse stakeholders?

Does the application propose novel management strategies in coordinating the NRMN research U01 projects and NRMN Resource Center? Is a refinement, improvement, or new application of organizational concepts, management strategies or instrumentation proposed? Does the application include innovative quantitative or qualitative approaches, methodologies, or study designs to evaluate the effectiveness or impact of the NRMN programs and the collaboration with the CEC?

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the NRMN and the DPC? Does the application describe the proposed structure and roles of the NRMN Coordination Center leadership team and any other committees that will be instituted to help manage and ensure communication across all NRMN components? Are the plans to promote synergistic and collaborative interactions among all participants of sufficient strength, merit and feasibility? Will the leadership promote strategies to ensure a robust and unbiased scientific approach across the consortium, as appropriate for the work proposed? Are appropriate plans for work-flow and a timeline proposed? Are potential problems, alternative strategies, and benchmarks for success presented? Does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the consortium? Are the proposed evaluation methods robust and is the vision for comparing across the NRMN activities compelling? Are the approaches, criteria and plans to measure, monitor, track and evaluate the progress and performance of administrative and research activities thoroughly described and adequate to assess progress? Does the application include plans for periodic evaluations and advice by an independent group?

Will the institutional environment of the NRMN Coordination Center contribute to the probability of success in facilitating the NRMN consortium it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the NRMN Coordinating Center proposed? Will the NRMN Coordinating Center benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

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.

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

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 children 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.

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.

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.

Not Applicable

Not Applicable

Not Applicable

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.

Not Applicable

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).

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 (4) Software Dissemination Plan.

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.

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

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

• 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.

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

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory General Medical Sciences Council. 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.

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.

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.

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.

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 http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or 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.

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 continue as a cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated to continue during the performance of the activities during the second phase of the project. Under the cooperative agreement, the NIH purpose remains 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 has been and will remain 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.

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

• All aspects of the study, including any modification of project design, conduct of the project, quality control, data analysis and interpretation, preparation of publications, and collaboration with other investigators will be verified, confirmed and established when necessary by the Steering Committee.
• Awardee will agree to the governance of the Steering Committee and, for issues affecting the entire consortium, the Executive Steering Committee.
• Awardee will agree to accept close coordination, cooperation, and participation of the Enhancing the Diversity of the NIH-Funded Workforce Working Group in those aspects of scientific and technical management of the project as described under "NIH Program Staff Responsibilities."
• Awardee will provide goals and progress toward those goals at regular intervals as requested by the Steering Committee and the Executive Steering Committee.
• Awardee will ensure that resources (e.g. data sets; procedure manuals) developed during both phase I and phase II of this project are made publicly available and that results are published in a timely manner.
• Awardee will adhere to the Executive Steering Committee policies regarding intellectual property, data release and other policies that were established during phase I and are still applicable, and any additional policies that might be established during the course of this activity that are consistent with applicable NIH policies, laws, and regulations.
• Awardee 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. The members of the DPC will adhere to the DPC Data Sharing Policy. All evaluation-related data will be shared with the NIH at the conclusion of the award.

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

• The Project Scientists for the project will serve on the Steering Committee and the Executive Steering Committee. As they have during the first phase of the grant, the Project Scientists may work with the awardees on any issues that come before these Committees.
• The Project Scientists will continue to serve as a liaison between the awardee and the Enhancing the Diversity of the NIH-Funded Workforce Working Group. The coordinators of the Enhancing the Diversity of the NIH-Funded Workforce Working Group will periodically report progress to the Director of the Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), and the Chairs of the Working Group.
• The NIH reserves the right to withhold funding or curtail the study (of an individual award) in the event of (a) substantive changes in the agreed-upon work scope with which NIH cannot concur, (b) human subject ethical issues that may dictate a premature termination; (c) or project not progressing well.
• Support or other involvement of industry or any other third party in the study (e.g., participation by the third party; involvement of project resources or citing the name of the study or NIH support; or special access to project results, data, findings, or resources) may be advantageous and appropriate. However, except for licensing of patents or copyrights, support, or involvement of any third party will occur only following notification of and concurrence by NIH.
• Additionally, an NIH Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of joint responsibility include:

A Steering Committee will remain as the primary governing board for the cooperative agreement funded under this FOA. The Steering Committee membership will include the NIH Program Official(s), NIH Project Scientist(s), the PD(s)/PI(s) of the awarded cooperative agreement, who will serve as Steering Committee Chair(s), and two external members not involved in the project who are selected by the PD(s)/PI(s). Additional members of the Enhancing the Diversity of the NIH-Funded Workforce Working Group may be appointed to the Steering Committee by the co-chairs of the Working Group, but the total number of NIH votes may not exceed 1/3 of the Steering Committee voting membership. Other government staff may attend the Steering Committee meetings, if their expertise is required for specific discussions.

The Steering Committee will:

• Meet at least annually or as needed, with intermittent conference calls as needed.
• Develop recommendations for the DPC awardees, as needed, to refine the uniform procedures and policies developed during phase I to meet the goals of the FOA and the goals of the Enhancing the Diversity of the NIH-Funded Workforce Program.
• As needed, develop additional recommendations and policies for the DPC awardees to ensure the goals of the FOA and the goals of the Enhancing the Diversity of the NIH-funded Workforce Program continue to be met during phase II.
• Provide input to the PD/PI with respect to the activities of the CEC and its ability to coordinate and evaluate the activities of BUILD and NRMN sites, and progress in meeting the goals of the FOA.
• Schedule the time for, and prepare concise (3 to 4 pages) summaries of the Steering Committee meetings, which will be delivered to members of the group within 30 days after each meeting.
• Provide representation on the Executive Steering Committee (see below) to address issues relevant to the Diversity Program Consortium as a whole.

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. 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 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.

Executive Steering Committee:

An Executive Steering Committee (ESC) remains responsible for providing general oversight and guidance to the Diversity Program Consortium awardees. The ESC membership will continue to include one non-NIH member from the Steering Committee of each of the BUILD, NRMN, and CEC awards, the NIH Program Official and/or Project Scientists for each program, and a member of the Enhancing the Diversity of the NIH-Funded Workforce Working Group, who will serve as ESC Chair. The co-chairs of the Enhancing the Diversity of the NIH-Funded Workforce Working Group may appoint additional members from the Working Group to serve as members on the ESC, but the total number of NIH votes may not exceed 1/3 of the Executive Committee voting membership. Awardee members of the DPC will be required to accept and implement policies approved by the ESC. The CEC will be responsible for communicating ESC feedback and guidance to the BUILD, NRMN, and CEC Steering Committees.

The ESC will meet through monthly conference calls and at least once annually in person.

Responsibilities of the ESC include the following:

• Form sub-committees as necessary to work through detailed issues that affect the Diversity Program Consortium as a whole.
• Refine competencies to be targeted through BUILD and NRMN activities.
• Refine hallmarks of success in biomedical research careers at various career stages, as needed.
• Develop policies for adoption of mentoring standards, building upon those developed during phase I.
• Refine procedures and policies for sharing information between projects and with the wider community that were developed during the first funding phase, and implement dissemination in accordance with the agreed upon procedures and policies.
• Review and consider issues and progress of individual awardees so that lessons learned can be shared, and plans of the Diversity Program Consortium as a whole and of individual projects may be modified to have maximal impact.
• Contribute content and ideas for the CEC-managed program website for the purposes of sharing information both within the consortium and with the wider community.
• Plan for dissemination activities, including development of a public summary of lessons learned across the Program as a whole and applicability of the lessons to the wider community.

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.

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.

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 registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, 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)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Mercedes Rubio, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-3900
Email: [email protected]

Stephanie Constant, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-2881
Email: [email protected]

Kaneisha Akinpelumi, M.S.W.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-3915
Email: [email protected]

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, 402, and 405 of the Public Health Service Act as amended (42 USC 241, 282, and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.