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. 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 backgrounds traditionally underrepresented in the biomedical sciences (Gibbs, et al., 2016, eLife 2016;5:e21393); however, the attrition rate of scientists from underrepresented groups 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 backgrounds underrepresented in biomedical research, 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 groups underrepresented 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 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 approaches to engage individuals from diverse backgrounds, for example, 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 diversity enhancing 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 enhance diversity by engaging and sustaining the interest of individuals in the biomedical research workforce and to encourage the dissemination of successful diversity enhancing interventions to a wide variety of institutions across the United States.

The first phase of the Enhancing the Diversity of the NIH-Funded Workforce Common Fund program also 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 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 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. 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 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, e.g., those from groups underrepresented 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, e.g., those from groups 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 various backgrounds, e.g., those from underrepresented groups. The NRMN consortium 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 consortium 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 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 methods of taking a scientific approach to understanding training, mentoring and research capacity building interventions is an innovative design that is likely to serve as a model for biomedical training programs across the Nation. The purpose of this FOA is to provide funds to institutions to take the DPC scientific approach to understanding the effectiveness of biomedical research training, mentoring or research capacity building interventions aimed at enhancing diversity in the biomedical research workforce.

Through this FOA, NIH intends to fund primarily undergraduate institutions with a commitment to providing educational opportunities to research-oriented students from diverse backgrounds, e.g., individuals from groups underrepresented in the biomedical research workforce (see NIH s Interest in Diversity). The DPC Dissemination and Translation Awards (DaTA) program is not intended for professional schools or awardees of the DPC (see Section III.1. Eligible Applicants below).

Funded institutions are expected to take a rigorous scientific approach to understanding the effectiveness of a biomedical research training, mentoring or research capacity building intervention by employing DPC experimental methods. The research results are expected to include and move beyond participation satisfaction, self-reporting of perceived skills gained, or self-reporting of effectiveness. Accordingly, the interventions are to be centered not only on psychosocial factors (e.g., engagement, belonging, science identity, self-efficacy, career satisfaction), but also on outcomes (e.g., pursuit of a science degree, degree attainment, success in career transition, grant submissions, publications) as described in the DPC data elements/survey instruments and hallmarks of success. As appropriate, the proposed studies should inform the field about the effectiveness of the duration, frequency, and intensity of the intervention and whether those effects can be enhanced by reinforcement sessions. The proposed projects should provide the scientific community with sound evidence of short-, medium-, and long-term effects of the efficacy of the interventions. The interventions should be cost-effective, practical, realistic, scalable and sustainable at a broad range of institutions. Funded institutions will be expected to disseminate the results to inform the biomedical community on what factors influence and foster a sustained career in the biomedical research workforce and why those factors have an influence. The following are possible areas for exploration.

Training program related. NIH is interested in determining what are the specific design elements of training programs that enhance persistence in the biomedical research pathway of trainees from diverse backgrounds, (e.g., those from underrepresented groups). Research on the basic elements of training programs should help to inform what aspects are instrumental for building a diverse pool of future scientists. Typical elements include, but are not limited to:

• Early engagement in the research culture
• Authentic research experiences
• Inclusive, supportive, and safe research environments
• Access to affordable support services (e.g., housing, food, counseling, tutoring)
• Supportive cohorts and learning communities
• Activities that build science identity (e.g., presenting at scientific meetings)
• Effective mentor training
• Trainee access to skilled mentors, sponsors and coaches
• Oversight and support throughout the trainees career

Scientific Skills Development. NIH encourages active-learning research training interventions that will develop a diverse pool of well-trained scientists who have the skills required to conduct research in an ethically responsible and rigorous manner and to enter the range of careers in the biomedical research workforce. The types of training interventions are varied and may include, but are not limited to, teaching active-learning courses and/or just-in-time modules that focus on skill development. Skill areas include the following:

• Technical (e.g., appropriate methods, technologies, and quantitative/computational approaches),
• Operational (e.g., independent knowledge acquisition, rigorous experimental design, and interpretation of data)
• Professional (e.g., management, leadership, communication, and teamwork)

Psychosocial factors. NIH recognizes the need for continued research into the psychosocial factors that influence persistence in the biomedical research workforce. The training and mentoring interventions to address certain psychosocial factors include, but are not limited to, those that focus on following:

• Reducing stereotype threat
• Diminishing imposter syndrome
• Overcoming micro aggressions
• Increasing micro affirmations
• Mitigating unconscious bias
• Increasing cultural awareness and sensitivity
• Emphasizing cultural assets
• Engaging family and support systems
• Supporting the need for a higher purpose (e.g., giving back to the community)

Faculty Development. NIH recognizes that the mentorship from research-based faculty is critical for providing excellence in research training, enhanced resources and scholarly productivity. Examples in this area include, but are not limited to, the following faculty development interventions:

• Pilot Projects
• Grant writing coaching
• Mentor training and mentorship activities
• Support for research sabbaticals
• Support for release time to perform biomedical research
• Recognition for research training and mentoring

Mentoring Interventions. Research in this area will inform the community about which kinds of mentoring relationships, strategies and approaches have significant impacts on the academic and professional successes of individuals from diverse backgrounds, (e.g., those from groups underrepresented in the biomedical research workforce). Examples in this area include, but are not limited to testing mentoring interventions that enhance:

• Science identity
• A sense of belonging in the research community
• Self-efficacy
• Persistence
• Research productivity
• Career transitioning
• Career success

Applications with the following will be deemed non-responsive and will be withdrawn without review:

• A description simply to provide a training, mentoring, or research capacity service without a testable hypothesis, intervention framework, and a clearly articulated population with the appropriate controls.
• An application that does not address interventions that will focus on enhancing the diversity of the biomedical research workforce.
• A research plan proposed by the PD(s)/PI(s) that duplicates their efforts on other federally funded research or training grants (see NIH RePORTER).
• A description of a narrow project that will provide results that are not generally applicable to the broader biomedical research community.

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

Applicant institutions are limited to domestic associate s degree-granting and baccalaureate degree-granting colleges/universities that received an average of NIH research project grant (RPG) funding of less than $7.5 million total costs per year over the past 3 fiscal years and have at least 25% of undergraduate students supported by Pell grants. These eligibility requirements are intended to target funds to relatively under-resourced institutions with a demonstrated commitment to students from financially disadvantaged backgrounds. These requirements are based on the recognition that (1) many students from low-income backgrounds are also nationally underrepresented in biomedical research, and (2) institutional commitment to these students often takes priority over investments in research infrastructure.

For the purposes of determining eligibility, the annual level of NIH RPG funding will be calculated over the preceding three fiscal years (e.g., FY 2016, FY 2017 and FY 2018), as reported on the NIH RePORT website under NIH Awards by Location & Organization. The percentage of undergraduates with Pell grants will be based on student financial aid data for the applicant institution, as reflected in the National Center for Education Statistics IPEDS Data Center website (e.g., use 2016-2017 data if submitting in FY2019), http://nces.ed.gov/ipeds/datacenter/Default.aspx.

BUILD (RFA-RM-18-006), NRMN (RFA-RM-18-002, RFA-RM-18-003, RFA-RM-18-004) and CEC (RFA-RM-18-005) awardee institutions, as well as Health Professional Schools, are not eligible to apply to this FOA. Health Professional Schools and Colleges provide education and training leading to a health professional degree (including but not limited to: MD, DDS, DO, PharmD, BSN, DVM, OD, DPT, DC, ND, DPM). Health Professional Schools and Colleges may include schools of medicine, dentistry, osteopathy, pharmacy, nursing, veterinary medicine, public health, optometry, allied health, chiropractic, naturopathy and podiatry.

A signed letter is required from the Provost or similar official with institution-wide responsibility verifying the eligibility of the applicant institution at the time of application submission according to the eligibility criteria indicated above. See the application instructions for the Letters of Support attachment on the PHS 398 Research Plan form in Section IV.2 Instructions for Application Submission.

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) 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.
• o NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

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

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

Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) 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).

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.

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.

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.

PD(s)/PI(s) are expected to attend the annual DPC meeting along with other national meetings, where their research findings can be shared, discussed and disseminated. Travel costs associated with attendance at such meetings may be requested in the budget.

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

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

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

Research Strategy: Applicants are expected to propose an intervention that aligns with the goals of the DPC and to use the methods and policies of the DPC, including the data sharing agreement, the hallmarks of success, and the associated data elements/survey instruments. Applications should include the following:

• Alignment with the DPC goal of enhancing diversity of the biomedical research workforce.
• Relevant background on the topic, including references to the primary literature.
• The hypothesis being tested, and an overview of the intervention.
• The theoretical basis for the intervention (i.e., the set of concepts, definitions, and hypotheses that explain or predict why the intervention will increase the success of individuals from groups underrepresented in the biomedical research pathway).
• Demographics, background variables, and training stage of the study population applicants should provide a description of the qualities and issues of the population(s) selected for study. The population may include students and/or faculty. Applicants are expected to use the data elements/survey instruments of the DPC.
• The matched controls and/or comparison groups. Applicants are encouraged to use rigorous methods, e.g., a randomized control trial approach, case controls, matched pair design or other designs appropriate to the research question.
• Recruitment strategies and methods to sustain the interest of participants and control/comparison groups.
• Details of the intervention. Describe any assumptions underlying the intervention design. Describe the duration, frequency, and intensity of the intervention and whether there will be reinforcement sessions.
• The short-, medium- and long-term outcome measures following the interventions(s) and how they align with the hallmarks of success.
• Data collection, handling, and storage methods as well as plans to participate in the data sharing agreement.
• Data analysis methodology, including sample size, statistical power, and analytical framework/statistical methods.
• Description of why the intervention is cost-effective, practical, realistic, scalable, and sustainable at a broad range of institutions.
• Detailed timeline with quantitative measures for achieving annual milestones integral to the success of the project. Applicants should provide plans for identifying impediments and critical decision points that could require a revision in the work plan. NIH program staff will use the milestones to assess progress. Continued funding is dependent upon showing progress.
• The research team. NIH recognizes that most of the interventions and underlying assumptions are complex in nature and expects that their study will require multidisciplinary approaches. NIH strongly encourages a collaborative effort among biomedical researchers, program administrators, educators, psychologists, sociologists, biostatisticians, and/or economists. Explain how these research team will bring complementary and integrated expertise to ensure rigor, validity, generalizability, and integration of the research elements.
• Dissemination plans. It is expected that the awardee will follow DPC guidelines and practices when publishing research findings from this project. Applicants should describe the plan and timeline to disseminate the research findings to the community (e.g., through presentation at professional meetings and publications in peer-reviewed journals) and to make the intervention and evaluation methods available to the broader training community.

Letters of Support: Applicants are required to comply with the instructions for the Letters of Support as provided in the SF424 (R&R) Application Guide, with the following modification:

Institutional Eligibility Letter (1-page maximum). The Provost or similar official with institution-wide responsibility must certify eligibility by stating that all the components of the institution under the applicant DUNS or IPF number received an average of NIH research project grant (RPG) funding of less than $7.5 million total costs per year over the past 3 fiscal years and have at least 25% of undergraduate students supported by Pell grants, as described in Section III, "Eligible Organization". If this letter is not included, and does not certify these eligibility criteria, the application will be considered incomplete and will not be reviewed.

Institutional Support Letter. The application must include a letter from the applicant institution's leadership describing institutional commitment to the success of the proposed research and a willingness to allow participation in the DPC consortium. Institutional support may include resources or protected time that will contribute to the proposed intervention and execution of the research plan. If this letter is not included the application will be considered incomplete and will not be reviewed.

Letters of collaboration. Collaboration letters should be provided by authorized officials from partner institutions (if applicable) addressing their institutional commitment to the proposed project and DPC DaTA program goals. As applicable, letters should be included from key institutional leaders, faculty or senior investigators at partner organizations who will have substantial involvement in teaching, research training and mentoring, or other activities.

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 the program, 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 comply with the Data Sharing requirements set forth in Diversity Program Consortium Data Sharing Policy.

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.

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, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

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

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

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.

PD(s)/PI(s) are expected to attend the annual DPC meeting along with other national meetings, where their research findings can be shared, discussed and disseminated.

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 responsiveness by NIGMS. Applications that are incomplete, nonresponsive, and/or non-compliant will not be reviewed.

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

Only the review criteria described below will be considered in the review process.

Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific to this FOA: Will the proposed project provide the scientific community with evidence to understand the efficacy of the intervention designed to enhance diversity in the biomedical research workforce?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Specific to this FOA: Does the research team have complementary expertise to ensure rigor, validity, generalizability, and integration of the research elements?

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Specific to this FOA: Does the application seek to shift current practices for enhancing diversity by providing an understanding of the effectiveness of a biomedical research training, mentoring or research capacity building intervention?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility, and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in 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: Does the project align with the goal of enhancing diversity of the biomedical research workforce? Does the application provide a strong theoretical and scientific basis for the intervention? Is there a detailed description of the demographics, background variables, and training stage of the study population and the control/comparator group(s)? Does the project include the use of rigorous methods for the comparator group(s), e.g., a randomized control trial approach, case controls, matched pair design or other designs appropriate to the research question? Are the recruitment strategies and methods likely to sustain the interest of participants and control/comparison groups? Does the application describe the assumptions underlying the intervention design? Is the intervention well described (e.g., the duration, frequency, and intensity of the intervention and whether there will be reinforcement sessions)? Does the plan detail the short-, medium- and long-term outcome measures following the interventions(s) and how they align with the DPC hallmarks of success? Are the data collection, handling, storage, and analysis methods robust? Does the application provide plans for compliance with the DPC data collection, handling, and storage methods, as well as plans to participate in the data sharing agreement? Is the intervention cost-effective, practical, realistic, scalable, and sustainable at a broad range of institutions? Is the timeline feasible and does it provide achievable milestones integral to the success of the project? Is the dissemination plan likely to result in making the results available to the broader community?

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

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 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.

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.
• Balance of different approaches and interventions to be tested.

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 https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.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 DPC 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.
• Awardee will ensure that resources (e.g. data sets, protocols) developed during this project are made publicly available and that results are published in a timely manner.
• Awardee will adhere to the DPC Executive Steering Committee policies regarding intellectual property, data release, and other policies, as well as 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 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 DPC Steering Committee. The Project Scientists may work with the awardees on any issues that come before the Steering Committee.
• The Project Scientists will 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 DaTA awardees, as needed, to refine the uniform procedures and policies 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 DaTA awardees to ensure the goals of the FOA and the goals of the Enhancing the Diversity of the NIH-funded Workforce Program will be met.
• Provide input to the PD/PI with respect to the activities of the DPC.
• 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 DPC awardees, 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 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 hallmarks of success and data sharing agreements as needed.
• Refine procedures and policies for sharing information in accordance with the agreed upon procedures and policies.
• Resolve issues and review progress of the consortium-wide evaluation.
• 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 and implement dissemination activities.

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, 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: [email protected] (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: [email protected]

Anissa J. Brown, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email: [email protected]

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

Justin Rosenzweig
National Institute of General Medical Sciences (NIGMS)
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 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.